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1/1/2021 Murphy v. Implicito, 920 A. 2d 678 - NJ: Appellate Div.
2007 - Google Scholar
920 A.2d 678 (2007)

392 N.J. Super. 245
David MURPHY and Marilyn Murphy, Plaintiffs-Appellants,

v.
Dante IMPLICITO, M.D., George Jacobs, M.D., Defendants-Respondents.
Not in source.
Superior Court of New Jersey, Appellate Division.
Argued February 7, 2007.

Decided April 18, 2007.
682 *682 Barry D. Epstein, Rochelle Park, argued the cause for appellants (Epstein Beirne, attorneys; Michael J. Epstein, on the
brief).
Thomas B. Leyhane, New Brunswick, argued the cause for respondent, George B. Jacobs, M.D. (Hoagland, Longo, Moran,
Dunst & Doukas, attorneys; Mr. Leyhane, of counsel and on the brief).
William S. Mezzomo, Springfield, argued the cause for respondent, Dante Implicito, M.D. (McDonough, Korn, Eichhorn &
Schorr, attorneys; R. Scott Eichhorn, of counsel and on the brief).
Before Judges CUFF, WINKELSTEIN & FUENTES.
The opinion of the court was delivered by WINKELSTEIN, J.A.D.
Plaintiff, David Murphy, injured his back at work. He claims that contrary to his wishes, defendant doctors implanted cadaver
("allograft") bone in his spine during back surgery. In his complaint, he alleged medical negligence based on a lack of
informed consent; battery; and breach of contract; and his wife, Marilyn Murphy, claimed a loss of consortium.[1]
The case was tried in December 2003. After the completion of plaintiff's case, the court dismissed the complaint pursuant to
Rule 4:37-2(b). On appeal, in an unpublished decision, we affirmed the dismissal of the informed consent claim, but
reversed the dismissal of, and reinstated, plaintiff's battery and breach of contract claims, and his wife's per quod claim.
Murphy v. Implicito, No. A-3172-03, 2005 WL 2447776 (App.Div. Sept. 22, 2005).
Prior to the retrial, the parties requested that the trial court determine the scope of damages plaintiffs could potentially
recover. Accordingly, on November 17, 2006, the trial court entered an order limiting plaintiff's recovery to damages caused
directly by the use of cadaver bone material. The court also limited plaintiff's wife's per quod recovery to the battery claim
and barred her per quod claim for breach of contract. We granted plaintiff's emergent application for leave to appeal and
now reverse and modify the trial judge's order.
I. Background
In September 1996, plaintiff injured his back while lifting a pallet at work, causing him "horrific" pain, and leaving him unable
to sleep, sit in a chair, or lie down. His treating physician referred him to defendant Dr. Dante Implicito, an orthopedic
surgeon. After conservative treatment was unsuccessful, Dr. Implicito proposed surgery to remove pieces of bone from
plaintiff's spine and replace them with bone grafts. Plaintiff alleges he consented to the surgery only on the condition that
the doctor not place cadaver bone in his spine, and the doctor agreed to use plaintiff's own bone material ("autograft" bone).
The doctor testified that he did not recall this discussion.
At the request of plaintiff's workers compensation carrier, he received a second opinion from another orthopedic surgeon,
defendant Dr. George Jacobs, who agreed that plaintiff needed surgery. Plaintiff testified that he also informed Dr. Jacobs,
683 who was to act as a co-surgeon with Dr. Implicito, that he did not want cadaver bone used in the surgery, and that the *683
doctor agreed not to use it. Dr. Jacobs denied this conversation.
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1/1/2021 Murphy v. Implicito, 920 A. 2d 678 - NJ: Appellate Div. 2007 - Google Scholar
On the day of the surgery, July 22, 1997, plaintiff signed a consent-to-surgery form, which was also to be signed by a doctor.
The form described the surgery as a "lumbar diskectomy and fusion with iliac crest bone graft + `steffe plates.'" Murphy,
supra, No. A-3172-03 (slip op. at 4). Though someone had signed the form on the line where a doctor was to sign, both
doctors denied signing it.
During the surgery, the doctors removed bone fragments and grafted plaintiff's own bone to his spine. They also used
cadaver bone as dowels for the bone graft. Defendants do not dispute that they used cadaver bone in the surgery.
The grafted bone did not fuse, and consequently, because plaintiff remained in pain and continued to be totally disabled, his
workers compensation carrier referred him to another orthopedist, Dr. Steven Reich. After reviewing an x-ray of plaintiff's
spine, Dr. Reich informed him that cadaver bone had been used in the surgery. Plaintiff asserts that upon learning that
defendants used cadaver bone in the surgery, he became so upset that he bent a chair in the doctor's office. During his
deposition, Dr. Reich, who did not testify at trial, could not remember plaintiff having that reaction to the information.
Dr. Reich subsequently performed a second surgery, without using cadaver bone. He removed all the material from the first
surgery, including the cadaver bone. After the second surgery, plaintiff continued to experience pain and remained totally
disabled.
At the first trial, no expert opined that the first surgery failed because of the use of cadaver bone. Plaintiff's expert, Dr.
Hervie Sicherman, testified that non-fusion is a recognized potential outcome of the surgery. All of the parties' experts
agreed that the use of allograft bone created no increased risk of fusion failure.
Plaintiff's position on the motion to determine the scope of damages was that defendants failed to abide by the condition he
placed on the surgery — that defendants not use cadaver bone — and that the breach of that condition constituted both a
breach of contract and a battery. As such, plaintiff asserted he was entitled to recover damages not only directly arising from
the use of cadaver bone, but all damages arising out of the surgery, including his resultant disability. Defendants, on the
other hand, argued that plaintiff could only recover for the disability that he could prove directly resulted from the use of
cadaver bone.
The court essentially agreed with defendants' position. While ruling that plaintiff may be entitled to nominal damages and
damages for any psychological injury he suffered by virtue of defendants' use of cadaver bone, the judge limited plaintiff's
potential recovery for pain, suffering and disability to damages "created by the use of a component part, that is, the use of
the cadaver bone." The judge distinguished the New Jersey Supreme Court's decision in Perna v. Pirozzi, 92 N.J. 446, 460-
61, 457 A.2d 431 (1983), which permits the jury to consider and award all damages arising out of a surgery performed
without a patient's consent. The judge concluded that in Perna, because the physicians were not authorized to conduct the
surgery at all, all of the damages related to the surgery were available to the plaintiff. Here, however, the judge found that
the entire surgery was not at issue, but simply one component part of the surgery — the implantation of cadaver bone.
Specifically, the court said: "the [Perna] case discussed battery in the context of unauthorized touching of another, which,
684 again, *684 is not the aspect that the battery played in this case. There was no unauthorized touching of the plaintiff. There
was unauthorized use of a particular material...."
The judge also denied Marilyn Murphy's claim for per quod damages arising from the breach of contract claim. He stated: "I
would think, the per quod claim is limited to the damages, which flow from the defendant's alleged tort of battery. The [c]ourt
is not aware of authority for ... per quod damages [for] breach of contract."
To support his damages claims, plaintiff proposes to offer at retrial the testimony of both Dr. Reich and Dr. Sicherman that
the cadaver bone caused the failure of the first surgery. Because plaintiff did not proceed on that theory during the first trial,
defendants object to him presenting such evidence at the retrial.
II. Retrial Evidence
We begin our discussion with the question of whether plaintiff may offer new evidence and additional theories of liability at
the retrial. In Franklin Disc. Co. v. Ford, 27 N.J. 473, 492, 143 A.2d 161 (1958), the Supreme Court addressed this issue,
stating,
Where a new trial has been granted "the case stands as if there had never been a trial; the court has the
same power with reference to matters connected with the trial of the case as it had before the first trial was
had, and it is the duty of the court to proceed as in the first instance. The new trial is had as if there had
never been a previous one." New claims and defenses may be asserted in the subsequent trial.
[(citations omitted) (quoting Kimble v. Degenring, 116 N.J.L. 602, 603-04, 186 A. 451 (Sup.Ct.1936)).]
Our opinion in Sisler v. Gannett Co., 222 N.J.Super. 153, 536 A.2d 299 (App.Div. 1987), certif. denied, 110 N.J. 304, 540
A.2d 1283 (1988), also offers support for plaintiff's position. In Sisler, following the trial of a libel suit, the Supreme Court
reversed a jury verdict for the plaintiff. Id. at 156, 536 A.2d 299 (citing Sisler v. Gannett Co., 104 N.J. 256, 516 A.2d 1083
(1986)). In doing so, the Court articulated a new standard for private figure defamation claims where the defamatory speech
focused on the public interest, requiring that the defamatory statements be made with actual malice. Id. at 156, 158, 536
A.2d 299 (citing Sisler, supra, 104 N.J. at 279, 516 A.2d 1083). Following the Supreme Court's remand, the defendants
claimed the question of malice could not be relitigated because, during the first trial, the court had dismissed the plaintiff's
claim for punitive damages due to a lack of proof of actual malice. Id. at 158-59, 516 A.2d 1083. The trial judge agreed and
entered summary judgment for the defendants. Ibid. On appeal, we reversed, concluding that because the second trial
would be conducted "under a new standard ... [the] plaintiff should have the opportunity to make different tactical decisions
... [and] the new trial judge should have the right to make his own evidentiary rulings." Id. at 164, 516 A.2d 1083.
Guided by these principles, we conclude that in the retrial here, plaintiff is not limited to the same proofs and theories of
liability that he offered in the first trial. "[T]he case stands as if there had never been a trial." Kimble, supra, 116 N.J.L. at
603, 186 A. 451.
Nevertheless, given the history of this case, we also conclude that plaintiff may not proceed on the theory that cadaver bone
caused the first surgery to fail. None of the experts, including plaintiff's, have rendered an opinion consistent with this theory.
685 While Dr. Reich testified at *685 his deposition that the fusion failed, he did not say the failure of the fusion was caused by
the use of cadaver bone. In fact, he testified that the failure of the fusion was an "expected outcome" of the surgery. Neither
did Dr. Sicherman testify to a causal link between the use of cadaver bone and the failure of the fusion.
Thus, because during the pendency of this case, no expert has opined that the failure of the fusion was caused by the use
of cadaver bone, to permit plaintiff to proceed with that claim now would require reopening discovery. Plaintiff would either
require a new expert, or Dr. Reich or Dr. Sicherman would essentially have to render opinions contrary to those they
expressed in discovery or at the first trial. To counter the new opinion, defendants would be entitled to depose the expert
who rendered the new opinion, and perhaps obtain new opinions of their own. That in turn could lead to additional
discovery. At this stage of the proceedings, ten years post-surgery, to reopen discovery would simply be unfair to
defendants. Consequently, while plaintiff is not limited to the theories and proofs he presented at the first trial, he may not, at
the retrial, argue or present proofs that cadaver bone caused the first surgery to fail.
III. Damages
Next, we turn to the damages plaintiffs may be entitled to receive on retrial. As noted, we previously affirmed the dismissal
of plaintiff's informed consent claim. In doing so, we analyzed the distinction between that claim and plaintiff's battery claim
in the context of the New Jersey Supreme Court's decision in Howard v. Univ. of Med. & Dentistry of N.J., 172 N.J. 537, 800
A.2d 73 (2002). Murphy, supra, No. A-3172-03 (slip op. at 22-23). In this opinion, we will not repeat our analysis, but for
purposes of providing a more complete understanding of plaintiff's claims, we will capsulize our analysis on that issue.
In our prior opinion, we observed that the facts in Howard distinguished it from the case at hand. Murphy, supra, No. A-
3172-03 (slip op. at 22). In Howard, supra, the Supreme Court addressed whether the plaintiff's claim was properly
cognizable as one for battery or one for lack of informed consent where the doctor misrepresented his credentials, which
the plaintiff alleged induced him to proceed with a surgery he would not otherwise have undergone. 172 N.J. at 545-46, 556,
800 A.2d 73. The Court held that "only a claim based on lack of informed consent [would] lie" because no dispute existed
that the plaintiff consented to the procedure that the doctor performed, and the doctor who performed the procedure was the
one to whom the plaintiff had given consent. Id. at 552-53, 800 A.2d 73.
Here, however, the question is whether the doctors' breach of the condition plaintiff placed on his consent to the surgery
constituted a failure by the doctors to perform the operative procedure that plaintiff had authorized. A failure to conduct the
procedure authorized is the equivalent of operating with no consent, which constitutes a battery. Id. at 550, 800 A.2d 73;
Whitley-Woodford v. Jones, 253 N.J.Super. 7, 11, 600 A.2d 946 (App. Div.1992). The doctors' actions here, unlike the
misrepresentations of the defendant doctor in Howard, did not impact upon the risks to which plaintiff was exposed during
the medical procedure. Their actions went to the nature of the operative procedure that plaintiff had authorized. Plaintiff's
battery claim here is therefore distinguishable from his informed consent clam.
A. Battery
686 That takes us to plaintiff's claim for battery damages. A patient has three *686 avenues of tort relief against a doctor: "(1)
deviation from the standard of care (medical malpractice); (2) lack of informed consent; and (3) battery." Howard, supra, 172
N.J. at 545, 800 A.2d 73. A battery is an unauthorized touching or invasion of the patient's body. Matthies v. Mastromonaco,
160 N.J. 26, 36, 733 A.2d 456 (1999). It is an intentional tort that may occur, for example, "when a doctor does not obtain
the consent of his patient to perform a particular operative procedure." Whitley-Woodford, supra, 253 N.J.Super. at 11, 600
A.2d 946. "Any non-consensual touching is a battery. Even more private than the decision who may touch one's body is the
decision who may cut it open and invade it with hands and instruments." Perna, supra, 92 N.J. at 461, 457 A.2d 431
(internal citations omitted).
A claim against a doctor based on principles of battery is often restricted to cases in which a physician has not obtained any
consent or has exceeded the scope of consent. Matthies, supra, 160 N.J. at 35, 733 A.2d 456. Where the consent granted
by the patient is subsequently vitiated, the surgery is rendered a battery. Howard, supra, 172 N.J. at 550, 800 A.2d 73; see
also Hogan v. Tavzel, 660 So.2d 350, 352-53 (Fla.Dist.Ct.App.1995) (cause of action in battery will lie, and consent will be
ineffective, if consenting person was mistaken about the nature and quality of the invasion intended), review denied, 660
So.2d 901 (Fla.1996). As we have noted, an action for battery also lies where the patient consents to one type of surgery,
but the physician performs a substantially different surgery from that for which the consent was obtained. Howard, supra,
172 N.J. at 550, 800 A.2d 73. A battery action is also proper where a patient consents to the surgery being performed by
one doctor, but the surgery is performed by another. See id. at 551-52, 800 A.2d 73 (commonly referred to as "ghost
surgery"). "It is immaterial to the issue of battery that ... the operation was not negligently performed." Pugsley v. Privette,
220 Va. 892, 263 S.E.2d 69, 75 (1980); Perna, supra, 92 N.J. at 463, 457 A.2d 431 (nonconsensual operation is battery
even if skillfully performed).
When a patient gives limited or conditional consent, a doctor has committed a battery if the evidence shows that the doctor
acted with disregard of the consent given and thus exceeded its scope. Duncan v. Scottsdale Med. Imaging, Ltd., 205 Ariz.
306, 70 P.3d 435, 440 (2003); Murphy, supra, A-3172-03 (slip op. at 15). Consent is vitiated wherever the "nature and
quality," Hogan, supra, 660 So.2d at 353, of the surgery performed is "substantially different," Howard, supra, 172 N.J. at
550, 800 A.2d 73, from the one to which the patient consented. Simply put, if the condition a patient places on his consent
to a surgical procedure is material, and that condition is not fulfilled, the surgery is rendered a battery, just as if the doctors
had not obtained the patient's consent in the first instance.
Thus, here, if plaintiff can prove that the non-use of cadaver bone was a material condition of his consent to the surgery,
that defendants agreed not to use cadaver bone, and that they violated the condition, the surgery became a battery. That
said, the question becomes the extent to which plaintiff may be compensated for that battery — whether for the entire first
operation and its residuals, or, as the trial judge concluded, merely for the insertion of the cadaver bone and its
consequences.
Generally, in the case of a nonconsensual surgery, a patient-plaintiff may recover for all injuries proximately caused by the
687 mere performance of the surgery, whether the result of negligence or not. Perna, supra, 92 N.J. at 460-61, 457 *687 A.2d
431. Damages can include an award for mental anguish, and because battery connotes an intentional invasion of another's
rights, punitive damages may also be assessed in appropriate cases. Id. at 461, 457 A.2d 431. Even if harmless, a battery
entitles a plaintiff-patient to at least nominal damages. Id. at 460, 457 A.2d 431.
In a battery born of the breach of a conditional consent, damages are generally available for the excess harm caused by the
specific breach. According to the Restatement, "[i]f the actor exceeds the consent, [the consent] is not effective for the
excess." Restatement (Second) of Torts § 892A (1979); see also Piedra v. Dugan, 123 Cal.App.4th 1483, 21 Cal. Rptr.3d
36, 49 (2004) ("consent does not protect the actor from liability for the excessive act" (emphasis added)); Ashcraft v. King,
228 Cal.App.3d 604, 278 Cal.Rptr. 900, 902-04 (1991) (same). For example, damages for the act that exceeded the
consent may be separable from those damages arising out of the operation for which the doctor had obtained consent in a
situation where a plaintiff consented to one procedure, and while performing that procedure, the surgeon performed an
additional procedure. See Kinikin v. Heupel, 305 N.W.2d 589, 593 (Minn.1981) (giving example of surgeon performing
mastectomy during exploratory surgery).
Consistent with that line of reasoning, here, the trial judge concluded that the "excessive act" was the insertion of cadaver
bone, and he consequently held that battery damages could only be recovered to the extent that they resulted directly from
the use of that material. In part, we agree with that holding. To the extent that the jury can segregate the harm plaintiff
suffered from the use of cadaver bone specifically from the harm caused by the operation generally, damages based simply
on the excessive act may be appropriate.
But, that does not end the analysis. The Law Division ruling leaves open the question of what damages plaintiff will be
entitled to recover if the jury is unable to distinguish between the harm he suffered from the use of cadaver bone and the
harm he sustained from the operation itself. Though no case has directly addressed this issue, the answer to the question is
informed by the principles espoused in the Restatement — where "the harm caused by the excess is severable from that
resulting from the privileged act, the actor is ... liab[le] only for the excess," but where "it is impossible as a practical matter
to sever the harm resulting from the excess from that caused by [the] permitted act, the actor is subject to liability for the
entire harm." Restatement (Second) of Torts § 892A comment h (1979). These principles are applicable here. Accordingly, if
the jury is unable to distinguish between the harm plaintiff suffered from the use of cadaver bone and the harm he sustained
from the operation itself, the jury may award him all damages arising out of the surgery as if he had not given his consent to
defendants to perform the operation in the first instance.
Such a result is also consistent with the Court's decision in Perna, supra, which provides authority for a broad range of
damages for a plaintiff who is subject to a battery at the hands of a physician. The Court said:
Under a battery theory, proof of an unauthorized invasion of the plaintiff's person, even if harmless, entitles
him to nominal damages. The plaintiff may further recover for all injuries proximately caused by the mere
performance of the operation, whether the result of negligence or not. If an operation is properly performed,
688 albeit by a surgeon *688 operating without the consent of the patient, and the patient suffers no injuries
except those which foreseeably follow from the operation, then a jury could find that the substitution of
surgeons did not cause any compensable injury. Even there, however, a jury could award damages for
mental anguish resulting from the belated knowledge that the operation was performed by a doctor to whom
the patient had not given consent. Furthermore, because battery connotes an intentional invasion of
another's rights, punitive damages may be assessed in an appropriate case.
[Perna, supra, 92 N.J. at 460-61, 457 A.2d 431 (citations omitted) (emphasis added).]
Perna thus instructs that, depending upon the particular circumstances of the case, a jury has a range of choices available
to it in considering a damage award, from a token award of nominal damages, to damages "for all injuries proximately
caused by the mere performance of the operation, whether the result of negligence or not"; the jury may also choose to
award punitive damages. Ibid.
Applying those precepts here, if the jury determines that defendants committed a battery, and decides to award more than
nominal damages, and it is able to segregate the harm from the use of cadaver bone from the damages flowing from the
operation generally, it may award damages solely for the excess harm plaintiff suffered by use of cadaver bone. If, however,
the jury is unable to distinguish the harm caused by the use of cadaver bone from that caused by the surgery in general, the
jury may, but is not required to, award plaintiff damages for all of the injuries he suffered as a result of the operation. Bendar
v. Rosen, 247 N.J.Super. 219, 233, 588 A.2d 1264 (App.Div.1991) (issue of severability of injuries is for the jury).
We also conclude that defendants shall bear the burden to segregate the damages caused by the excessive act from those
resulting from the surgery in general. While not directly analogous, we liken defendant doctors' obligation here to that of a
defendant in a medical malpractice case where the plaintiff's preexisting injuries are aggravated by the doctor's tortious
conduct. In such a case, the burden to allocate the plaintiff's damages falls on the defendant. Verdicchio v. Ricca, 179 N.J.
1, 37, 843 A.2d 1042 (2004) (citing Fosgate v. Corona, 66 N.J. 268, 272-73, 330 A.2d 355 (1974)). As the Court in Fosgate,
supra, has observed,
where ... malpractice or [another] tortious act aggravates a preexisting ... condition, the innocent plaintiff
should not be required to establish what expenses, pain, suffering, disability or impairment are attributable
solely to the malpractice or tortious act, but that ... burden of proof should be shifted to the culpable
defendant who should be held responsible for all damages unless he can demonstrate that the damages for
which he is responsible are capable of some reasonable apportionment and what those damages are.
[66 N.J. at 272-73, 330 A.2d 355.]
While this case does not strictly implicate the aggravation of a preexisting injury, defendants, as the culpable parties, should
be responsible to demonstrate a reasonable basis to parse out the damages plaintiff suffered by reason of the implantation
of cadaver bone in his spine from the disability plaintiff incurred from the surgery in general. If defendants are unable to do
689 so, plaintiff may recover for all of the harm he suffered arising from the mere performance of surgery. See Restatement *689
(Second) of Torts § 892A comment h (1979).
If we assume that the testimony in the retrial will generally reflect that presented in the first trial, other factors the jury may
consider in deciding damages include whether, if defendants had refused to perform the first surgery without using cadaver
bone, plaintiff would have had another doctor, who would not use cadaver bone, perform the surgery; and, whether plaintiff
would have undergone a second surgery to have the cadaver bone removed even if the first surgery had not failed. The jury
may also consider that the failure of the fusion was a known risk of the surgery, and that the use of cadaver bone did not
cause the surgery to fail.
We recognize that the measure of damages under the unique circumstances of this case may be difficult to determine. Yet,
courts routinely invest juries with substantial discretion to decide what a reasonable person would consider adequate and
just damages under all of the circumstances. See Model Jury Charges (Civil), 6.11F, "Damages-Personal Injuries; Disability,
Impairment, Loss of the Enjoyment of Life, Pain and Suffering" (Dec. 1996). We are confident that the jury here can
exercise its charge, as juries do in any situation where a plaintiff is seeking noneconomic damages for personal injuries
suffered as a result of a defendant's conduct.
B. Breach of Contract
Next, we address plaintiff's claim for breach of contract damages. In our prior opinion, we concluded that plaintiff had a
viable breach of contract claim against defendants. We said:
Generally, when a claim arises out of a doctor's failure to provide appropriate medical care, the cause of
action is malpractice. In an appropriate case, however, where the doctor has made a special agreement to
provide medical services, the action may be for breach of contract.
Here, plaintiff claims this is such an appropriate case. He does not allege the doctors failed to provide
appropriate medical care. He asserts, instead, that they breached their agreement with him as to how they
would perform one of the material elements of the operation.
To establish a breach of contract claim, a plaintiff has the burden to show that the parties entered into a valid
contract, that the defendant failed to perform his obligations under the contract and that the plaintiff
sustained damages as a result. According to plaintiff's version of the facts, defendants agreed to perform a
fusion on plaintiff's spine using bone from plaintiff's hip, and agreed not to use cadaver bone; and they would
be paid for that operation. No dispute exists that defendants used cadaver bone, rather than bone from
plaintiff's hip. And, while the trial court ruled that as a matter of law the use of cadaver bone was not a
material breach of defendants' agreement to perform a spinal fusion, we find that giving plaintiff all
appropriate inferences on a motion to dismiss, that question more appropriately belonged to the jury.
[Murphy, supra, A-3172-03 (slip op. at 8-10) (internal citations omitted).]
Accordingly, if the jury concludes that defendants breached their agreement with plaintiff, it must then decide whether, under
all of the circumstances, compensation for the breach is warranted.
In the first trial, the judge, in determining that plaintiff could not prove damages based on a breach of contract theory, ruled
as a matter of law that the use of cadaver bone was not a material breach of defendants' agreement to perform a spinal
690 fusion. Murphy, supra, A-3172-03 *690 (slip op. at 11). We disagreed, concluding that was a question for the factfinder, not
the court. Ibid.; see Magnet Res., Inc. v. Summit MRI, Inc., 318 N.J.Super. 275, 286, 723 A.2d 976 (App. Div.1998) (whether
a breach is material is a jury question). We add here that even if the breach was not material, that only bears upon the
quantum of damages, as even a nonmaterial breach of a contract may be compensable. See Miller v. Mills Constr., Inc., 352
F.3d 1166, 1172 (8th Cir.2003); City of Miami Beach v. Carner, 579 So.2d 248, 254 (Fla.Dist.Ct.App.1991); 23 Williston on
Contracts § 63:3 (Lord ed.2002).
Next, then, we consider the breadth of damages available to plaintiff if he succeeds in his breach of contract claim. In
addressing this issue in our prior opinion, we saw "no reason to depart from the traditional model for breach of contract
damages, which permits a plaintiff to recover for such losses as may fairly be considered to have arisen naturally from the
defendant's breach of contract." Murphy, supra, A-3172-03 (slip op. at 10-11) (internal quotations omitted). That is,
compensatory damages are intended to compensate the injured party for loss caused by the breach by putting the injured
party in as good a position as it would have been in had the performance been rendered as promised. Donovan v.
Bachstadt, 91 N.J. 434, 444, 453 A.2d 160 (1982); see also Tarr v. Ciasulli, 181 N.J. 70, 92, 853 A.2d 921 (2004) (quoting
the trial judge, who noted that "[c]ompensatory damages are intended to make a litigant whole ... no more, no less"). We
continue to adhere to that proposition.
That broad proposition, however, has been found in other jurisdictions to be inapplicable in the context of a breach of
contract claim by a patient against his or her doctor. For example, in New York, breach of contract damages are restricted to
economic damages, i.e., expenditures for "nurses and medicines or other damages that flow from the breach." Robins v.
Finestone, 308 N.Y. 543, 127 N.E.2d 330, 332 (1955). On the other hand, some jurisdictions permit recovery of the full
panoply of damages, including recovery for mental anguish, pain and suffering. Sullivan v. O'Connor, 363 Mass. 579, 296
N.E.2d 183, 188-89 (1973); Stewart v. Rudner, 349 Mich. 459, 84 N.W.2d 816, 823-24 (1957). We find the analysis in
Sullivan to be instructive.
There, the patient obtained a jury verdict against the defendant surgeon for a breach of contract with regard to an operation
the surgeon performed on the patient's nose. 296 N.E.2d at 184. Rather than achieving the result the surgeon had
promised, the surgery left the plaintiff disfigured. Ibid.
The plaintiff sued her doctor, alleging medical malpractice and breach of contract. Ibid. The jury returned a verdict for the
defendant on the malpractice claim, but found for the plaintiff on the contract claim. Ibid. In discussing what damages were
appropriate in a breach of contract action by a patient against her doctor, the Massachusetts Supreme Court recognized
that some states limited recovery for breach of contract, precluding recovery for pain and suffering. Id. at 189. The court
rejected that position, however, holding that the plaintiff was not confined to recovery for out-of-pocket expenditures, but
"was entitled to recover also for the worsening of her condition, and for the pain and suffering and mental distress involved"
as a result of the surgery, including damages from a subsequent surgery that was necessary to attempt to correct the
691 deformity caused by the two prior operations performed by the defendant. Id. at 189. Relying on the Restatement of *691
Contracts § 341 and comment a to that provision, the court concluded that
no general rule barr[ed] such items of damage in actions for breach of contract. It is all a question of the
subject matter and background of the contract, and when the contract calls for an operation on the person of
the plaintiff, psychological as well as physical injury may be expected to figure somewhere in the recovery,
depending on the particular circumstances.
[Id. at 188-89.]
The court's reasoning is persuasive. In New Jersey, as we have observed, the traditional model for breach of contract
damages permits a plaintiff to recover "for such losses as may fairly be considered to have arisen naturally from the
defendant's breach of contract." Model Jury Charges (Civil), 6.18A, "Damages-Breach of Contract" (June 1983). And here,
because plaintiff's losses from the doctors' alleged breach of contract include personal injuries, we see no sound reason to
limit his recovery to economic loss.
In arriving at this conclusion, we do not write on a clean slate. We have previously indicated that no material difference
exists between different types of claims seeking relief for conduct proximately causing personal injuries, irrespective of
whether the act forming the basis for the cause of action is a breach of a duty defined by contract law or a breach of a duty
defined by tort law. Dunn v. Praiss, 271 N.J.Super. 311, 314, 638 A.2d 875 (App. Div.1994), rev'd on other grounds, 139 N.J.
564, 656 A.2d 413 (1995). We concluded in Dunn that, for purposes of contribution, a breach of a contractual duty
proximately causing personal injury may "be balanced against the negligence of another party so that their percentage
responsibilities can be assessed ... [in terms of] comparative fault." Id. at 324, 638 A.2d 875.
In Dunn, the patient's administratrix filed suit against a number of doctors who failed to diagnose the testicular cancer that
ultimately caused her husband's death. Id. at 314-15, 638 A.2d 875; Dunn v. Praiss, 256 N.J.Super. 180, 185, 606 A.2d 862
(App.Div.1992), cited in Dunn, supra, 271 N.J.Super. at 315 n. 1, 638 A.2d 875, certif. denied, 130 N.J. 20, 611 A.2d 657
(1992). In addition to bringing medical malpractice actions, the plaintiff also sought recovery for breach of contract. Dunn,
supra, 256 N.J.Super. at 186, 606 A.2d 862. In determining whether the right to proceed on the contractual claim could be a
basis for a right of contribution vis-à-vis the malpractice claims, we discussed the appropriateness of an apportionment by
examining whether the claim sounded in contract or tort. Dunn, supra, 271 N.J.Super. at 322-24, 638 A.2d 875. In finding
"no reason not to apportion responsibility based upon any civil wrong, including a breach of contract, that proximately
causes a personal injury," we observed that:
The line between a breach of contract and a tort is often hazy. A breach of a contractual duty which is a
proximate cause of a personal injury can easily be balanced against the negligence of another party so that
their percentage responsibilities can be assessed and contribution directed as comparative fault. This is
most clearly seen in contractual breach of warranty claims where the similarity to claims of negligence and
strict liability has been recognized by the courts[.] In fact the Legislature in N.J.S.A. 2A:58C-1 and 2 has
combined claims based upon contractual warranty, strict liability in tort and negligence in a single cause of
action. We see nothing in New Jersey law that is hostile to such apportionment.
692 *692 [Id. at 324, 638 A.2d 875 (internal citations omitted).]
The Supreme Court agreed with our analysis, holding that, for purposes of contribution, it is appropriate to apportion
responsibility between a negligence claim and a breach of contract claim alleged to have proximately caused personal
injuries. Dunn, supra, 139 N.J. at 577-78, 656 A.2d 413.
Consequently, we conclude that no matter how we label defendants' alleged fault here, whether breach of contract or
battery, if plaintiff sustained personal injuries as a result of that fault, the jury may award damages for all of plaintiff's injuries
proximately caused by that conduct. That award may be tempered, however, depending upon the resolution of the issue of
"excess" damages, as per our analysis of the damages recoverable for plaintiff's battery claim, supra, which is equally
applicable to the measure of damages available for the breach of contract claim.
In determining whether to award damages for breach of contract, and if so, how much, the jury may consider the same
factors we discussed with regard to its consideration of damages for battery: that plaintiff may have required a second
surgery to have the cadaver bone removed even if the first surgery had not failed; that he may have had another doctor
perform the back surgery if defendants had refused to refrain from using cadaver bone; and that the failure of the fusion was
not a result of the use of the cadaver bone, but was a known risk of the surgery. And, as we concluded in our prior opinion,
damages for breach of contract may not duplicate those for the battery cause of action. Murphy, supra, No. A-3172-03 (slip
op. at 21).
C. Per Quod Claim
Finally, we examine whether the trial court erred in holding that plaintiff Marilyn Murphy could not raise a per quod claim
derivative of plaintiff's breach of contract action. In general, a per quod claim includes the right of a husband or wife to
receive compensation for loss of affection, comfort, companionship, society, assistance and sexual relations lost as a result
of the other's personal injuries. Dan B. Dobbs, The Law of Torts § 310 at 841-43 (2001).
In New Jersey, no court has addressed whether a per quod claim is available to the spouse of a plaintiff who has suffered
personal injuries as a result of a breach of contract. Nevertheless, given that the concept of fault is a component of both of
plaintiff's causes of action, one sounding in tort and the other in contract, each resulting in personal injuries, we see no
reason why a per quod claim should be permitted for one and not the other. "Compensation should not be dependent on
what label we place on an action but rather on the nature of the injury inflicted on the plaintiff and the remedies requested."
Pickett v. Lloyd's, 131 N.J. 457, 470, 621 A.2d 445 (1993). So long as the breach of the contractual duty is a proximate
cause of a personal injury, "[t]he nature of the wrongdoer's conduct is not particularly relevant." Dunn, supra, 139 N.J. at
577-78, 656 A.2d 413. Thus, if plaintiff is successful in recovering damages for his claim that defendants breached their
contract with him, we see no reason why Marilyn Murphy's derivative claim should be precluded.
We consequently reverse and modify the November 17, 2006 order of the trial court and remand for additional proceedings
consistent with this opinion.
[1] All references in this opinion to plaintiff are to David Murphy.
Save trees - read court opinions online on Google Scholar.
1/1/2021 Shadrick v. Coker, 963 SW 2d 726 - Tenn: Supreme Court 1998 - Google Scholar
963 S.W.2d 726 (1998)
Donald R. SHADRICK and wife, Valerie Shadrick, Plaintiffs/Appellees,

v.
Wesley L. COKER, M.D., Defendant/Appellant.
Supreme Court of Tennessee, at Nashville.
February 17, 1998.
728 *728 G. Thomas Nebel, John B. Carlson, Williams/Nebel & Associates, P.C., Nashville, for Plaintiffs-Appellees.
Sam B. Blair, Jr., Baker, Donelson, Bearman & Caldwell, Memphis, for Amici Curiae, American Medical Association and
Tennessee Medical Association.
Robert T. Trentham, G. Brian Jackson, Trabue, Sturdivant & Dewitt, Nashville, for Defendant-Appellant.
OPINION
DROWOTA, Justice.
In this lack of informed consent medical malpractice action, the defendant, Wesley L. Coker, M.D., appeals from the Court
of Appeals' reversal of summary judgment entered by the trial court in his favor based on the expiration of the applicable
statute of limitations and statute of repose. The issue for our determination is whether the claims of the plaintiffs, Donald
Shadrick and Valerie Shadrick, are barred by the one-year statute of limitations or the three-year statute of repose for
medical malpractice actions. See Tenn. Code Ann. § 29-26-116.[1] After carefully examining the record before us and
considering the relevant authorities, we conclude that disputed issues of material fact exist regarding (1) when the statute of
limitations began to run and, (2) whether the fraudulent concealment exception to the statute of repose applies. Accordingly,
for the reasons explained hereafter, we affirm the decision of the Court of Appeals to reverse the trial court's grant of
summary judgment to the defendant.
BACKGROUND
The plaintiff, Donald Shadrick, injured his back at work in December 1988. He was treated for this injury by the defendant,
Wesley L. Coker, M.D., an orthopedic surgeon practicing in Nashville. On March 12, 1990, after three previous surgeries
performed by Dr. Coker failed to alleviate Shadrick's back pain, Dr. Coker performed a laminectomy and disc excision. This
surgery was done at West Side Hospital in Nashville, which is now Centennial Medical Center. During the March 12 surgery,
Dr. Coker inserted "pedicle screws"[2] and related hardware into Shadrick's spine to provide stability and help the vertebrae
fuse together. According to Shadrick's testimony, which must be assumed to be true for purposes of summary judgment
analysis, "no one told [him] before the operation that screws would be implanted" in his back and "nobody ever told [him]
about any risk of injury or any problems that could be caused by the screws." When Shadrick woke up after the surgery, he
was told by Dr. Coker that the screws had been put in his back and that the screws were "routine treatment" for the type of
surgery he had undergone.
729 *729 Following the March 12 surgery, Shadrick's pain worsened. He would fall on his buttocks when his "leg went out" due
to pain. Dr. Coker thought that Shadrick was merely "working through an inflammatory problem." However, an x-ray taken in
September 1990 revealed that one of the screws in Shadrick's back had broken on the same side he was having pain.
Shadrick underwent surgery that same month to repair the broken screw. Dr. Coker believed that the broken screw was
caused by Shadrick's repeated falls on his buttocks.
In November 1990, Shadrick again had surgery on his back. One of the purposes of this surgery was to remove the screws.
Shadrick continued to have pain after this surgery. Dr. Coker discussed with Shadrick the possibility that his pain was due to
scarring, about which little could be done.
Shadrick continued to complain of pain in his back following the removal of the screws. In March 1991, Dr. Coker and
Shadrick discussed Dr. Coker's belief that Shadrick "appears ... not [to] tolerate pain well and there probably is significant
evidence he has an emotional component to this [pain] problem." Dr. Coker subsequently referred Shadrick to a
psychologist. In September 1991, Dr. Coker wrote a letter to Shadrick's attorney which reflected Dr. Coker's view that
Shadrick's pain was psychosomatic because "he has unconsciously grasped the concept of having chronic pain and will not
consciously dismiss that from his mind."[3]
For over three years following the removal of the screws, Shadrick continued to have pain in his back. Shadrick continued to
see Dr. Coker for treatment. At no time did Dr. Coker attribute Shadrick's continued pain to the installation of the pedicle
screws. Due to the severity of his back pain, Shadrick has been unable to work.
On December 17, 1993, Shadrick saw a television program (ABC's "20/20") in which a story was done on pedicle screws. It
was from this program that Shadrick first learned that pedicle screws were experimental, that they had not been approved
by the Food and Drug Administration for use in the spine, and that such screws had been found to cause a number of
problems in patients. Until seeing the television program on December 17, 1993, Shadrick had been "led to believe that [he]
had undergone a routine procedure and that everything would be all right." Shadrick testified that had he been informed
about the true nature of pedicle implants he never would have elected to have surgery involving their use.
On December 16, 1994 — approximately four years and nine months after the pedicle screws were implanted in his back —
Shadrick filed this lawsuit against Dr. Coker and Centennial Medical Center.[4] The complaint alleged medical malpractice,
lack of informed consent and battery. The complaint also alleged that Dr. Coker fraudulently concealed the "true facts
concerning [his] actions and the true nature of the pedicle or back screws and related hardware." Shadrick claimed that prior
to his surgery on March 12, 1990, he was not informed that pedicle screws would be placed in his spine. He stated in an
affidavit that after the operation Dr. Coker informed him that screws had been used in the surgery, but that he was never led
to believe that the screws were anything other than "routine treatment." According to Shadrick, Dr. Coker never told him that
pedicle screws were experimental, that the screws had not been approved by the Food and Drug Administration for use in
730 spinal surgery, *730 or that there were risks associated with their use in the spine. Ms. Shadrick sued for loss of consortium.
In response to the plaintiffs' complaint, Dr. Coker filed a motion for summary judgment. He asserted in the motion that the
suit was barred by the three-year statute of repose and the one-year statute of limitations found in Tenn. Code Ann. § 29-
26-116.
The plaintiffs, in turn, filed the affidavit of Raymond O. Frederick, M.D., who is a surgeon and an expert in back problems.
According to Dr. Frederick, pedicle screws in 1990 were experimental in nature and had not been approved by the Food
and Drug Administration for use in spinal surgery. Moreover, according to Dr. Frederick, the standard of care in 1990
required Dr. Coker to ensure that patients who were to receive pedicle screw implants were fully advised that those implants
were not approved for use in the spine and to ensure that patients fully understood the risks. Dr. Frederick listed several
specific items that should have been part of the informed consent obtained by Dr. Coker from Shadrick, such as informing
him that pedicle screws were experimental as well as informing him of a list of possible complications and risks associated
with their use.[5] Because Dr. Coker did not provide Shadrick with the information identified by Dr. Frederick as being
required for informed consent, Dr. Frederick concluded that "to a reasonable degree of medical certainty, Dr. Coker ...
violated the applicable standard of care with respect to informed consent."
Dr. Coker did not file an affidavit nor did he file any affidavits of experts in response to Dr. Frederick's affidavit submitted by
Shadrick. Instead, Dr. Coker relied upon Shadrick's answers to discovery requests in arguing that Shadrick knew or
reasonably should have known of his cause of action in 1990 because Shadrick was told soon after the March 12, 1990
operation that the pedicle screws had been implanted in his back. Alternatively, Dr. Coker argued that Shadrick's cause of
action was barred by the three-year statute of repose.
The trial court granted Dr. Coker's motion for summary judgment. The court found that Shadrick's suit was not saved by the
discovery rule because he was told by Dr. Coker right after the surgery on March 12, 1990 that the screws had been
implanted in his back, which was something Shadrick knew he had not authorized before the surgery. Further, Shadrick
knew by November 1990 that one of the screws had broken and had to be replaced. Thus, he was placed on notice there
was a problem with the screws. The trial court also rejected Shadrick's contention that the fraudulent concealment exception
731 to the statute of repose applied because Dr. Coker made no affirmative concealment of the fact that the *731 screws had
been implanted in Shadrick's back. The trial judge opined that "[h]ere there was no affirmative concealment and the facts
were such that [Shadrick] knew or was on notice of inquiry that the implantation of the screws had been unsuccessful and
possibly harmful. Even if the doctor... . should have told [Shadrick] more about the screws, such information does not
change the fact that [Shadrick] knew or should have known in 1990 that there was a problem with the screws."
Shadrick appealed to the Court of Appeals. The Court of Appeals disagreed with the trial court's grant of summary judgment
and reversed. The court found that there were disputed issues of material fact as to when Shadrick should have discovered
his cause of action and whether there was fraudulent concealment on the part of Dr. Coker. The Court of Appeals reasoned
that because there was a confidential relationship between Dr. Coker and Shadrick (i.e., doctor/patient), there was an issue
of fact as to whether Dr. Coker's silence amounted to fraudulent concealment since Dr. Coker had a duty to inform Shadrick
of the experimental status of the pedicle screws.
Thereafter, we granted review to determine whether the one-year statute of limitations or the three-year statute of repose for
medical malpractice actions in Tenn. Code Ann. § 29-26-116 bar the Shadricks' suit against Dr. Coker. For the reasons that
follow, we agree with the Court of Appeals that there are disputed issues of material fact as to when the statute of limitations
began to run and whether the fraudulent concealment exception to the statute of repose applies.
ANALYSIS
I.
The standards governing an appellate court's review of a motion for summary judgment are well settled. Summary judgment
is appropriate only if there are no genuine issues of material fact and the moving party is entitled to judgment as a matter of
law. Tenn. R. Civ. P. 56.03. Dr. Coker, as the party moving for summary judgment, has the burden of demonstrating that no
genuine issue of material fact exists. Byrd v. Hall, 847 S.W.2d 208, 210 (Tenn. 1993). We are to review the record before us
without attaching any presumption of correctness to the trial court's judgment to determine whether the absence of genuine
issues of material fact entitle Dr. Coker to judgment as a matter of law. Robinson v. Omer, 952 S.W.2d 423, 426 (Tenn.
1997); Bain v. Wells, 936 S.W.2d 618, 622 (Tenn. 1997). Further, we are required to view the evidence in the light most
favorable to the nonmoving party, Shadrick, draw all reasonable inferences in his favor, and discard all countervailing
evidence. Byrd, 847 S.W.2d at 210-11. If both the facts and conclusions to be drawn from the facts permit a reasonable
person to reach only one conclusion, summary judgment should be granted. Robinson, 952 S.W.2d at 426; Bain, 936
S.W.2d at 622; McClung v. Delta Square Ltd. Partnership, 937 S.W.2d 891, 894 (Tenn. 1996)
II.
Shadrick's suit is based on the theory of lack of informed consent. He contends that Dr. Coker did not inform him prior to the
surgery in March 1990 that the screws were going to be implanted in his back, much less that the screws were experimental
in nature or that there were specific and material risks associated with their use. Therefore, Shadrick maintains he never
consented to their use.
A cause of action based on the lack of informed consent stems from the premise that a competent patient should be
allowed to formulate an intelligent, informed decision about surgical or other treatment procedures the patient undertakes.
Housh v. Morris, 818 S.W.2d 39, 41 (Tenn. App. 1991). The basic policy consideration which supports the recognition of the
cause of action for lack of informed consent has been explained as follows:
The root premise is the concept fundamental in American jurisprudence that èvery human being of adult
years and sound mind has a right to determine what shall be done with his own body... .' True consent to
732 what happens to one's self is the informed exercise of a choice, and that *732 entails an opportunity to
evaluate knowledgeably the options available and the risks dependant upon each. The average patient has
little or no understanding of the medical arts, and ordinarily has only his physician to whom he can look for
enlightenment with which to reach an intelligent decision. From these almost axiomatic considerations
springs the need, and in turn the requirement, of a reasonable divulgence by [the] physician to [the] patient
to make such a decision possible.
Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Cir.1972).
Accordingly, the law recognizes that a health care provider, such as a physician or surgeon, who proposes a treatment or
surgical procedure has a duty to provide the patient with enough information about the nature of the treatment or procedure
involved to enable the patient to make an intelligent decision and thereby give an informed consent to the treatment or
procedure. See Cardwell v. Bechtol, 724 S.W.2d 739, 750 (Tenn. 1987). Depending on the usual and customary advice
given to patients to procure consent in similar situations, the health care provider must typically inform the patient of the
diagnosis or nature of the patient's ailment, the nature of and the reasons for the proposed treatment or procedure, the risks
or dangers involved, and the prospects for success. See 70 C.J.S. Physicians and Surgeons § 93 (1987). The patient must
also be informed of alternative methods of treatment, the risks and benefits of such treatment and, if applicable, that the
proposed treatment or procedure is experimental. Id. Whether the information given to the patient is sufficient "depends on
the nature of the treatment, the extent of the risks involved, and the standard of care [applicable to the defendant health
care provider]." Cardwell, 724 S.W.2d at 749.[6]
When the health care provider performs the treatment or procedure without the requisite informed consent of the patient,
liability attaches for the resulting injuries regardless of whether those injuries resulted from negligence. Housh, 818 S.W.2d
at 42; German, 577 S.W.2d at 202; Ray v. Scheibert, 484 S.W.2d 63, 71 (Tenn. App. 1972). This is because the doctrine of
lack of informed consent is based upon the tort of battery, not negligence, since the treatment or procedure was performed
without having first obtained the patient's informed consent. Cardwell, 724 S.W.2d at 751; Cary v. Arrowsmith, 777 S.W.2d
8, 21 (Tenn. App. 1989). We have explained the relationship between lack of informed consent and battery as follows:
[T]he failure to give such information [needed to obtain an informed consent] is not the type of omission that
results in negligence, but rather it negates consent for the treatment. Without consent, the treatment
constitutes a battery.
[T]he correct analysis in our opinion is that if the evidence shows that the person had the capacity to
consent, then the question becomes whether the consent given was effective because it was based upon
adequate information on which to make the decision to submit to treatment; if not, then a battery results, but
if so, then the question becomes whether the defendant subsequently did anything negligent in the
administration of the treatment for which consent was obtained... .
These theories, battery and malpractice, are not ordinarily inconsistent, and no election of remedies is
733 generally required; if a battery exists, then malpractice may not necessarily be reached, but if no battery *733
can be shown, then the issue clearly emerges as one of malpractice. This distinction between battery and
malpractice (as a form of negligence) is consistently recognized in the case law.
Cardwell, 724 S.W.2d at 751.
This is not to suggest, however, that a health care provider is required to enumerate in detail every aspect of the proposed
treatment or procedure or discuss every possible thing that might go wrong in an effort to obtain the patient's informed
consent. "In the first place, to do so is humanly impossible. In the second place, if all the gory details of a proposed surgery
were graphically explained to every patient and all possible medical maladies that might result were enumerated we doubt
that a lay person would have the stomach to listen to it all; and if the patient did, would probably be in such a fearful state
that no rational decision could be made." Longmire v. Hoey, 512 S.W.2d 307, 310 (Tenn. App. 1974). Accordingly, health
care providers are generally not required to disclose risks that are not material, such as those that are extremely unlikely to
occur or one that a reasonable patient would not care to know due to its insignificance; risks that are obvious or already
known by the patient; risks that are unforeseeable or unknowable; or where the patient's medical condition renders
discussion of the risks and benefits of the treatment or procedure impossible or medically inadvisable, such as in an
emergency where the patient is unconscious or otherwise incapable of consenting, or where full disclosure would be
detrimental to the patient's total care, i.e., the patient is unduly alarmed or apprehensive to start with and additional
information would overload the patient and jeopardize his or her physical or emotional well-being. See Housh, 818 S.W.2d
at 42; Longmire, 512 S.W.2d at 310; Ray, 484 S.W.2d at 71; Ball v. Mallinkrodt Chem. Works, 53 Tenn. App. 218, 381
S.W.2d 563, 567 (1964); 70 C.J.S. Physicians and Surgeons § 94 (1987); Frantz, Annotation, Modern Status of Views as to
General Measure of Physician's Duty to Inform Patient of Risks of Proposed Treatment, 88 A.L.R.3d 1008 (1978).
Causes of action based on lack of informed consent, like traditional medical malpractice cases involving negligence, are
subject to the one-year statute of limitations and three-year statute of repose provided for in Tenn. Code Ann. § 29-26-116.
The so-called discovery rule, which was first adopted in Teeters v. Currey, 518 S.W.2d 512 (Tenn. 1974),[7] was codified in
1975 as part of Tenn. Code Ann. § 29-26-116(a)(2). That statute provides that "[i]n the event the alleged injury is not
discovered within the said one (1) year period, the period of limitation shall be one (1) year from the date of such discovery."
This Court has interpreted Tenn. Code Ann. § 29-26-116(a)(2) to mean that the statute of limitations commences to run
when the patient "discovered, or reasonably should have discovered, (1) the occasion, the manner, and the means by which
a breach of duty occurred that produced [the patient's] injuries; and (2) the identity of the defendant who breached the duty."
Stanbury v. Bacardi, 953 S.W.2d 671, 677 (Tenn. 1997) (quoting Foster v. Harris, 633 S.W.2d 304, 305 (Tenn. 1982)).
The plaintiff may not, however, delay filing suit until all the injurious effects and consequences of the alleged wrong are
actually known to the plaintiff. Wyatt v. A-Best Company 910 S.W.2d 851, 855 (Tenn. 1995). Similarly, the statute of
limitations is not tolled until the plaintiff actually knows the "specific type of legal claim he or she has," Stanbury, at 672, or
that "the injury constitute[d] a breach of the appropriate legal standard," Roe v. Jefferson, 875 S.W.2d 653, 657 (Tenn.
1994). Rather, as we have recently emphasized, the statute of limitations begins to run when the plaintiff knows or in the
exercise of reasonable care and diligence should know that an injury has been sustained as a result of wrongful or tortious
734 conduct by the defendant. Stanbury, *734 bury, at 677; see also Roe, 875 S.W.2d at 657 ("[T]he plaintiff is deemed to have
discovered the right of action if he is aware of facts sufficient to put a reasonable person on notice that he has suffered an
injury as a result of wrongful conduct."). "It is knowledge of facts sufficient to put a plaintiff on notice that an injury has been
sustained which is crucial." Stanbury, at 678. Such knowledge includes not only an awareness of the injury, but also the
tortious origin or wrongful nature of that injury. Hathaway v. Middle Tennessee Anesthesiology, P.C., 724 S.W.2d 355, 359
(Tenn. App. 1986).
Applying these principles to the record before us, we cannot agree with Dr. Coker's insistence that the statute of limitations
began to run as a matter of law in November 1990 (at the latest) when Shadrick had the surgery to remove the screws from
his back. It is true, as pointed out by Dr. Coker, that Shadrick was told upon waking up from the surgery on March 12, 1990
that the screws were implanted in his back. This was something Shadrick knew he had not authorized before the surgery.
Also, Shadrick knew he had received the surgical implants without being informed of any of the potential risks or
complications associated with their use. Finally, he knew that one of the screws had broken — one of the unmentioned risks
of the procedure — and had to have surgery in September 1990 to repair the broken screw.
However, we are not persuaded that these facts necessarily compel a reasonable person to conclude that Shadrick knew or
reasonably should have known that his problems were the result of wrongful or tortious conduct on the part of Dr. Coker.
Although Shadrick was told by Dr. Coker that the screws had been put in his back when he woke up from the March 12,
1990 surgery, he was also told at that time that the screws were "routine treatment" for the type of surgery he had
undergone. The fact that Shadrick was informed that the screws had been put in his back after the surgery "did not mean
anything to [him] because nobody ever told [him] about any risk of injury or any problems that could be caused by the
screws. At the time, [he] had no idea that the screws were experimental, that they had not been approved by the Food and
Drug Administration for use in the spine, or that they would cause [him] any problems." Indeed, it was not until December
17, 1993 while watching television that Shadrick learned that pedicle screws were experimental, that they had not been
approved by the Food and Drug Administration for use in the spine, and that such screws had been found to cause a
number of problems in patients. Until seeing the television program Shadrick had been "led to believe that [he] had
undergone a routine procedure... ." As a reasonable lay person, Shadrick could have believed Dr. Coker when he informed
him that the screws were routine for use in back-fusion surgeries, especially since Dr. Coker had never disclosed any risks
or potential complications related to the use of the screws or even their experimental nature.
Furthermore, it is significant that Dr. Coker offered a number of explanations for Shadrick's continuing back problems. Dr.
Coker attributed the failure of the screw that broke to Shadrick's repeated falls on his buttocks. He attributed Shadrick's
continuing pain to first an inflammatory problem, then to scarring about which little could be done, and then finally to
Shadrick's psychological state. At no time did Dr. Coker attribute Shadrick's continuing problems to the installation of the
pedicle screws. It was not until December 1993 that Shadrick realized that the pedicle screws were not "routine treatment"
and that there were specific, material risks associated with their use. As Shadrick put it, "I did not know or suspect until
December 17, 1993 that the implants placed in me by Dr. Coker ... were the cause of my problems."
Viewing this evidence in the light most favorable to Shadrick and allowing all reasonable inferences in his favor, we
conclude that there is evidence in the record from which a jury could reasonably find that Shadrick was reasonably unaware
of the wrongful or tortious origin of his injury until December 1993. Dr. Coker's argument that Shadrick was aware of his
claim in 1990 rings hollow given that Shadrick was never informed of the risks involved in the installation of pedicle screws
735 in his spine, was never *735 told that such medical devices were experimental, was told that the screws were "routine
treatment," and was led to believe that his continuing difficulties were due to a number of problems, none of which were
related to the implantation of the screws. Given these circumstances, a jury could find that Shadrick had no reason to
suspect that he had sustained an injury resulting from Dr. Coker's wrongful or tortious conduct until December 1993. Dr.
Coker has not met his burden of demonstrating that no genuine issue of material fact exists as to when the statute of
limitations began to run.
III.
Having decided that the one-year statute of limitations does not necessarily bar Shadrick's claim, we turn to whether there
are disputed issues of material fact regarding fraudulent concealment on the part of Dr. Coker so as to avoid application of
the three-year statute of repose.
Tenn. Code Ann. § 29-26-116(a)(3) provides that regardless of when a plaintiff discovers the cause of action, no cause of
action may be brought after three years from the date of the alleged malpractice. Hence, the three-year statute of repose
establishes a ceiling on the time in which a malpractice suit may be brought. The three-year limit is unrelated to the accrual
of the cause of action, commencing not on discovery like the statute of limitations, but on the date of the alleged wrongful
act. Braden v. Yoder, 592 S.W.2d 896, 897 (Tenn. App. 1979). Nonetheless, the statute of repose may be tolled where there
is "fraudulent concealment on the part of the defendant," in which case the cause of action must be brought within one year
after discovering that the cause of action exists. Tenn. Code Ann. § 29-26-116(a)(3).
To establish fraudulent concealment, a plaintiff must prove (1) that the defendant took affirmative action to conceal the
cause of action or remained silent and failed to disclose material facts despite a duty to do so and, (2) the plaintiff could not
have discovered the cause of action despite exercising reasonable care and diligence. Stanbury, S.W.2d at, n. 6; Benton v.
Snyder, 825 S.W.2d 409, 414 (Tenn. 1992). In this regard it has been observed that when there is a confidential or fiduciary
relationship between the parties, the "failure to speak where there is a duty to speak is the equivalent of some positive act
or artifice planned to prevent inquiry or escape investigation." Hall v. De Saussure, 41 Tenn. App. 572, 297 S.W.2d 81, 85
(1956). In our most recent case addressing the subject, we recognized that
the affirmative action on the part of the defendant must be something more than mere silence or a mere
failure to disclose the known facts. There must be some trick or contrivance intended to exclude suspicion
and prevent inquiry, or else there must be a duty resting on the party knowing such facts to disclose them... .
For example, such a duty arises where a confidential relationship exists, as between physician and patient.
In such cases, there is a duty to disclose, and that duty may render silence or failure to disclose known facts
fraudulent. This is the rule in Tennessee and in other jurisdictions.
Benton, 825 S.W.2d at 414 (emphasis in original) (citations omitted).
The third essential element of fraudulent concealment is knowledge on the part of the defendant of the facts giving rise to
the cause of action. Benton, 825 S.W.2d at 414. In other words, the defendant must be aware of the wrong. See Housh, 818
S.W.2d at 43 ("Basically, fraudulent concealment will be shown where the physician had knowledge of the wrong done and
concealed such information from the patient."); Ray, 484 S.W.2d at 72 ("Our Tennessee cases hold that knowledge on the
part of the physician of the fact of a wrong done is an essential element of fraudulent concealment.").
The fourth and final essential element of fraudulent concealment is a concealment of material information from the plaintiff.
Benton, 825 S.W.2d at 414. Concealment "may consist of withholding information or making use of some device to mislead"
736 the plaintiff in order to exclude suspicion or prevent inquiry. Id. When there is a relationship involving trust and *736
confidence between the parties which would impose a duty to make a full disclosure of the material facts, mere silence or
nondisclosure may constitute concealment. See 54 C.J.S. Limitations of Actions § 90 (1987). The rationale for this rule has
been explained as follows:
Fiduciary relationship, confidential relationship, constructive fraud and fraudulent concealment are all parts of
the same concept. [T]he nature of the relationship which creates a duty to disclose, and a breach of [that]
duty constitutes constructive fraud or fraudulent concealment, springs from the confidence and trust reposed
by one in another, who by reason of a specific skill, knowledge, training, judgment or expertise, is in a
superior position to advise or act on behalf of the party bestowing trust and confidence in him. Once the
relationship exists `there exists a duty to speak ... [and] mere silence constitutes fraudulent concealment.'
In the common knowledge of man, patients submit themselves to the skills and arts, proficiency and
expertise, of hospital personnel, once they become confined to the hospital. Indeed, most frequently, they
have no real choice in the matter; they are physically and intellectually unable to do much more than submit
and rely upon the medical superiority and ethical propriety of their attendants.
Garcia v. Presbyterian Hospital Ctr., 92 N.M. 652, 593 P.2d 487, 489 — 90 (1979) (citations omitted). See also Lynch v.
Waters, 256 Ga. 389, 349 S.E.2d 456 (1986)("The physician-patient relationship is a confidential one and silence or failure
to disclose what should be said or disclosed can amount to fraud... ."); Leach v. Shapiro, 13 Ohio App.3d 393, 469 N.E.2d
1047 (1984)("When the physician has knowledge of a fact concerning the patient's physical condition which is material to
the patient, this fiduciary relationship may render the physician's silence fraudulent."); Nixdorf v. Hicken, 612 P.2d 348 (Utah
1980)("Where a physician has knowledge of a fact concerning the patient's physical condition which is material to that
patient and he fails to disclose it, the confidence relationship between them creates a duty to disclose which may render his
silence fraudulent."); Hardin v. Farris, 87 N.M. 143, 530 P.2d 407 (1974)("Normally some positive act of concealment must
be shown... . However, in a confidential relationship where there exists a duty to speak, such as in a doctor-patient
relationship, mere silence constitutes fraudulent concealment.").
To summarize, a plaintiff in a lack of informed consent case (or any other medical malpractice case) attempting to toll the
statute of repose contained in T.C.A. 29-26-116(a)(3) by relying upon the fraudulent concealment exception to the statute
must establish that (1) the health care provider took affirmative action to conceal the wrongdoing or remained silent and
failed to disclose material facts despite a duty to do so, (2) the plaintiff could not have discovered the wrong despite
exercising reasonable care and diligence, (3) the health care provider knew of the facts giving rise to the cause of action
and, (4) a concealment, which may consist of the defendant withholding material information, making use of some device to
mislead the plaintiff, or simply remaining silent and failing to disclose material facts when there was a duty to speak.
Our review of the record before us demonstrates that there is evidence sufficient to create a jury issue on all the key
elements of fraudulent concealment. The evidence from which the jury could infer concealment consisted of Dr. Coker's
silence regarding the risks and complications associated with the use of pedicle screws in the spine and the failure to
disclose their experimental nature. This is particularly true since Dr. Coker and Shadrick had a confidential or fiduciary
relationship by virtue of having a doctor-patient relationship, which imposed a duty upon Dr. Coker to disclose material
information. Furthermore, the jury could infer that Dr. Coker attempted to conceal material facts (i.e., the risks and potential
complications and experimental nature of the procedure) associated with the wrong by offering various explanations for
Shadrick's continuing problems, none of which had to do with the implantation of the screws. There was also the assurance
by Dr. Coker to Shadrick that the screws were "routine treatment" for the type of surgery Shadrick had undergone. A jury
737 *737 could thus find that throughout Dr. Coker's treatment of Shadrick Dr. Coker allayed any possible suspicions that
Shadrick might have had concerning a claim against him by first representing that the screws were routine treatment and
then later attributing the complications to several different causes, none of which related to the screws. Evidence of
knowledge could also be inferred from this proof, particularly in light of Dr. Frederick's testimony that such information
should have been discussed with Shadrick (but wasn't) in order to have obtained his informed consent and comply with the
applicable standard of care.
Finally, we are also persuaded that, for the reasons discussed in the statute of limitations portion of this opinion, there is a
question of fact regarding whether Shadrick could have discovered the wrong (failing to obtain his informed consent)
through the exercise of reasonable care and diligence. We would only add that "[w]hether the plaintiff exercised reasonable
care and diligence in discovering the injury or wrong is usually a question of fact for the jury to determine." Wyatt, 910
S.W.2d at 854.
It follows that, after taking the strongest legitimate view of Shadrick's evidence and allowing all reasonable inferences in his
favor and discarding all countervailing evidence, more than one conclusion could be drawn from the evidence. Therefore,
this is not an appropriate case for summary judgment.
CONCLUSION
In view of the foregoing discussion, we conclude that disputed issues of material fact exist regarding when the statute of
limitations began to run and whether the fraudulent concealment exception to the statute of repose applies. Accordingly, we
affirm the reversal of summary judgment. Costs of this appeal are taxed to the defendant — appellant.
ANDERSON, C.J., REID, BIRCH and HOLDER, JJ., concur.
[1] Tenn. Code Ann. § 29-26-116 provides for a one-year statute of limitations in malpractice actions, but "[i]n the event the alleged injury is
not discovered within said one (1) year period, the period of limitation shall be one (1) year from the date of such discovery. In no event
shall any action be brought more than three (3) years after the date on which the negligent act or omission occurred except where there is
fraudulent concealment on the part of the defendant in which case the action shall be commenced within one (1) year after discovery that
the cause of action exists." Tenn. Code Ann. § 29-26-116(a)(1), (2) and (3).
[2] The "pedicle" is part of the vertebra.
[3] The letter from Dr. Coker to Shadrick's attorney states in pertinent part: "I think to simplify what has happened, it might be reasonable to
say that [Shadrick's] emotions have become imprinted with the pain that he initially experienced and his emotions have not let go of that
pain even though his disk and nerve appear to have let go of it. This type of fixation is not unheard of but it certainly is a difficult situation to
resolve. Obviously, [Shadrick] has had several surgical procedures, none of which have made him any better. The differential spinal test
plus the psychological tests indicated that he has a fixation on the pain which is not supported by his physical findings. This does not imply
in any way that [Shadrick] is mentally deranged, it only indicates that he has unconsciously grasped the concept of having chronic pain and
will not consciously dismiss that from his mind."
[4] The Shadricks voluntarily dismissed their appeal against Centennial Medical Center after this Court granted review. Thus, the only
defendant before us is Dr. Coker.
[5] According to Dr. Frederick, Shadrick should have been informed of the following: that the pedicle screws were not approved by the FDA;
that the screws were experimental; that the screws might cause a fracture of bony structures in the spine; that the screws might cause
bursitis to develop over the implants; that the screws might break or loosen; that the screws might cause delayed nerve root irritation or
injury due to displaced or broken implant components; that the patient might experience bone resorption around the implants resulting in
loosening or displacement of the device; that the implants might cause an allergic reaction to a foreign body due to metal sensitivity; that
the patient might suffer pain, discomfort or abnormal sensations caused by the presence of the implants; that additional surgery might be
required after normal healing has occurred to remove the implants; that the implants might cause irritation or discomfort; that the screws
might cause prolonged illness, a draining wound, the need for blood transfusions, the need for further major surgery and/or permanent pain,
deformity and inconvenience; that the screws might fail to achieve their objective and that the implants might in fact cause the patient's pain
level and disability to become worse; that the patient might suffer possible local or systemic adverse reactions from any potential
degradation products; that a mechanical grinding action could possibly occur that might generate wear debris; that the wear debris that
might occur could cause local bone loss in articulating joints; that excessive or repeated stresses on the implants might cause them to
break or loosen and cause the failure of the surgical procedure; that the patient was participating in a clinical investigation study; that the
screws might cause dural leaks; that the implants might cause paralysis; that the screws might cause sensory loss; that the screws might
cause loss of bowel or bladder control; that the implants might cause retrograde ejaculations or impotence; and that the screws might
cause scarring of nerve roots.
[6] The burden of proof on the standard of care element is controlled by Tenn. Code Ann. § 29-26-118, which requires that in a lack of
informed consent action the plaintiff prove, by expert testimony, "that the defendant did not supply appropriate information to the patient in
obtaining his informed consent to the procedure out of which plaintiff's claim allegedly arose in accordance with the recognized standard of
acceptable professional practice in the profession and in the speciality, if any, that the defendant practices in the community in which he
practices or in similar communities." See also German v. Nichopoulos, 577 S.W.2d 197, 204 (Tenn. App. 1978) ("[I]n matters of informed
consent the plaintiff has the burden of proving by expert medical evidence, (a) what a reasonable medical practitioner of the same or similar
communities under the same or similar circumstances would have disclosed to the patient about the attendant risks incident to a proposed
diagnosis or treatment and (b) that the defendant departed from the norm.").
[7] The creation of the discovery rule was necessary to "alleviate the intolerable result of barring a cause of action by holding that it
àccrued' before the discovery of the injury or the wrong." Foster, 633 S.W.2d at 305. Otherwise, a plaintiff would be required to sue to
vindicate a wrong at a time when the injury was "unknown or unknowable." Stanbury v. Bacardi, 953 S.W.2d 671 (Tenn. 1997).
1/1/2021 Friter v. Iolab Corp., 607 A. 2d 1111 - Pa: Superior Court 1992 - Google Scholar
414 Pa. Superior Ct. 622 (1992)

607 A.2d 1111
Frederick FRITER and Sally Friter, Appellant,

v.
IOLAB CORPORATION, Johnson & Johnson, Inc., Robert Reinecke, M.D., Jerome Peters, M.D.,
Estate of Kenneth Michaile, M.D., Deceased, and Kenneth Michaile, M.D., Ltd., and Wills Eye
Hospital.
Superior Court of Pennsylvania.
Argued September 18, 1991.

Filed May 1, 1992.
623 *623 Gerald A. McHugh, Jr., Philadelphia, for appellant.
Stephen A. Ryan, Bala Cynwyd, for appellees.
Before JOHNSON, FORD ELLIOTT, and HESTER, JJ.
FORD ELLIOTT, Judge:
This is an appeal from the October 18, 1990 order of the Court of Common Pleas of Philadelphia County granting defendant
Wills Eye Hospital's motion for judgment non obstante verdicto. We reverse.
On November 22, 1982, Dr. Kenneth Michaile implanted an Iolab Model 91Z anterior chamber intraocular lens into
Frederick Friter's left eye following cataract surgery at Wills Eye Hospital. This particular intraocular lens rests behind the
624 cornea and serves as a substitute lens after the *624 opacified natural lens has been removed from the eye. At the time of
Mr. Friter's surgery, this particular lens had not yet been approved for general use by the United States Food and Drug
Administration (FDA), but rather was the subject of a clinical investigation to determine its safety.
Prior to Mr. Friter's surgery, Wills Eye Hospital had applied for and received approval to participate in a clinical study
involving the Iolab Model 91Z lens. The hospital named Dr. Michaile, a member of its medical staff, to be one of its
registered investigators with permission to implant the experimental lens. Both Dr. Michaile, as a registered investigator for
Iolab, and Wills Eye Hospital, as an approved institution for conducting experimental studies, were bound by FDA
regulations to obtain an informed consent from any patient undergoing experimental treatment. The special five-page
consent form explained, among other things, the nature of the clinical investigation, the existence of known complications,
and the fact that there were, as yet, undetermined complications.
Frederick Friter was never informed, prior to surgery, that he was about to become a participant in a clinical investigation,
and that he was about to have an unapproved medical device implanted in the interior portion of his eye as a substitute for
his natural lens. As a result of the surgical implantation of the Iolab 91Z lens, Mr. Friter suffered numerous complications,
including filamentary keratitis, chronic and recurrent uveitis, damage to the corneal endothelium, hemorrhage, and the
threat of loss of vision in the eye.
As a result of the damage caused to his eye, Frederick Friter, and his wife Sally, filed suit against the Estate of Kenneth
Michaile, M.D., deceased, Kenneth Michaile, M.D., Ltd., and Wills Eye Hospital, seeking recovery for the injuries sustained
by the unauthorized placement into his eye of an intraocular lens which had not yet been approved and was still under
investigation by the FDA. At trial, the Friters asserted claims of battery against Dr. Michaile and Wills Eye Hospital for failing
625 to obtain an informed consent *625 prior to performing surgery on Mr. Friter's eye. A jury trial commenced in the court of the
Honorable Murray C. Goldman on September 19, 1989. On September 28, 1989, the jury returned a verdict in favor of the
Friters and awarded Mr. Friter 1.5 million dollars in damages, and Mrs. Friter $250,000 in damages.
Post-trial motions were subsequently filed on behalf of Dr. Michaile and Wills Eye Hospital. The Friters settled with the
Michaile defendants. However, the trial court granted Wills Eye Hospital's motion for a judgment n.o.v. This timely appeal
followed. Appellants now raise two issues for our consideration.
I. Did not the trial court erroneously enter judgment in favor of Wills Eye Hospital notwithstanding the jury's
finding that Wills Eye Hospital had assumed the responsibility of supervising the obtaining of plaintiff's
informed consent to surgery involving an unapproved medical device which was under investigation by the
defendant hospital?
II. When a hospital agrees to conduct a clinical study of a medical device under investigation by the Food
and Drug Administration and selects the surgeons who will carry out the study, and where the hospital
admits that it was the hospital's responsibility to assure that all physicians who participated in the
investigations were obtaining informed consent of their patients, is not the hospital liable for damages
resulting from the surgeon's failure to obtain informed consent?
Appellee, in its counter-statement of the questions presented, has framed the issues as follows:
I. Did the trial court correctly refuse to allow the hospital to be held liable for the intentional battery of failing
to obtain an informed consent?
II. Did the trial court correctly grant the hospital judgment n.o.v. where the law of this Commonwealth has
never imposed a duty to obtain a patient's informed consent on a hospital?
626 *626 III. Did the trial court correctly determine that, despite a hospital's involvement in a clinical investigation,
a hospital cannot be held liable for the tort of intentional battery?
In essence, all five questions presented to this court for review focus upon the same central consideration: whether
appellants, proceeding against the hospital under a theory of lack of informed consent, pled and proved facts sufficient to
justify the jury's verdict against Wills Eye Hospital, given that this Commonwealth, heretofore, has never recognized an
informed consent action against a hospital. It is that central question upon which this opinion will focus.
Instantly, we note that our standard of review when considering an appeal from an order granting a judgment n.o.v. is well
settled.
In the review of the record in an appeal from an order of a trial court which has granted judgment n.o.v., we
are required to consider the evidence and all reasonable inferences therefrom in the light most favorable to
the verdict winner.
Lowry v. State Farm Insurance Co., 392 Pa.Super. 77, 80, 572 A.2d 700, 701 (1990). The entry of judgment n.o.v. will be
reversed whenever the evidence favorable to the plaintiff, and the reasonable inferences therefrom, support plaintiff's theory
of liability. Handfinger v. Philadelphia Gas Works, 439 Pa. 130, 266 A.2d 769 (1970). It is with this standard in mind that we
address the merits of this case.
The gravamen of appellants' action against Wills Eye Hospital was that the hospital failed in its duty to ensure that a legally
effective informed consent was obtained from Mr. Friter prior to his surgery. Historically, the doctrine of informed consent
has been interpreted by appellate courts of this Commonwealth to apply only to surgeons who perform operations without
first securing the informed consent of the patient. The unconsented to operation is considered a non-consensual touching,
thus giving rise to an action by the patient for a "technical" battery. Doe v. Dyer-Goode, 389 Pa.Super. 151, 566 A.2d 889
627 (1989); *627 Malloy v. Shanahan, 280 Pa.Super. 440, 421 A.2d 803 (1980). To date, a hospital has never been held liable to
a patient under a theory of lack of informed consent. Appellee relies upon this well settled case law to support its position
that the trial court's decision to grant the motion for judgment n.o.v. was correct. However, such reliance ignores the factual
context in which these decisions rest. Indeed, were we to view this case as a traditional lack of informed consent action
against a hospital, we would be constrained to follow precedent and affirm the trial court's order. A review of trial court cases
which have addressed this issue demonstrates that two prevailing reasons are offered for relieving the hospital of liability.
The first reason offered is that Pennsylvania case law on informed consent is premised on a battery arising out of a medical
procedure performed by a physician and therefore the duty to inform as to the risks associated with that procedure only runs
as between doctor and patient. This "duty" analysis was summarized by the trial court in Margotta v. Lancaster General
Hospital, 47 Pa. D. & C.3d 300 (1987).
Our research uncovered only one Pennsylvania case, Hurley v. Won, 9 [Pa.] D. & C.3d 796 (1979), which
dealt specifically with a hospital's duty to obtain a patient's informed consent. Hurley at 798, held that there is
no duty, in Pennsylvania, on a hospital to obtain consent from a patient prior to an operation.
....
Our research failed to uncover any Pennsylvania authority for imposing an independent duty on a non-
physician to obtain a patient's informed consent. See, e.g. Smith v. Yohe, 412 Pa. 94, 194 A.2d 167 (1963);
Gray v. Grunnagle, 423 Pa. 144, 223 A.2d 663 (1966); Cooper v. Roberts, 220 Pa.Super. 260, 286 A.2d 647
(1971) (allocatur refused); Malloy v. Shanahan, 280 Pa.Super. 440, 421 A.2d 803 (1980) (plurality decision);
Boyer v. Smith, 345 Pa.Super. 66, 497 A.2d 646 (1985); and Festa v. Greenberg, 354 Pa.Super. 346, 511
A.2d 1371 (1986).
628 *628 Accordingly, we agree with both parties that Pennsylvania does not recognize an independent duty on a
non-physician to obtain a patient's informed consent. Absent the recognition of such a duty, we do not accept
plaintiff's invitation to create such a duty. Under the current state of the law, it appears with certainty that
plaintiff can not recover under Count II [informed consent].
Id. at 305-06.
As noted by the trial court in Margotta, Pennsylvania case law reflects the notion that heretofore it is only the physician who
has been held liable under a theory of lack of informed consent, for it is the physician who has the duty to obtain the
consent for a medical procedure which the physician performs. In the traditional surgical setting, this analysis is well
founded. However, the facts of this case are quite different for we are not here addressing the duty owed by a physician to a
patient but rather a duty owed by the hospital to the patient. In this instance, the hospital, as a participant in a clinical
investigation for the FDA, specifically assumed a duty to ensure that an informed consent was obtained by any patient
participating in the study.
In particular, under applicable federal regulations, Wills Eye Hospital had an affirmative duty to "[a]ssure that the rights of
human subjects are properly protected, that legally effective informed consent is obtained, and that the methods of
obtaining consent properly informs the human subject of the significant aspects of the study . . ." 21 C.F.R. § 813.66(a)(6)
(emphasis added). The legally effective informed consent referred to in the regulations was a specially designed five-page
consent which informed the patient of the significant aspects of the study, including any and all special risks associated with
an investigational study. As further evidence of the hospital's duties toward Mr. Friter, appellants offered the testimony of Dr.
Thomas D. Duane who was the ophthalmologist in chief at Wills Eye Hospital at the time of Mr. Friter's surgery. The
following excerpt from Dr. Duane's testimony clearly establishes that the hospital understood it had a duty to ensure that any
629 *629 doctors participating in investigational studies were obtaining the special informed consents required by the FDA.
Q. What I was asking you was, was it part of the function of the Institutional Review Committee to make sure
that the investigating doctors were obtaining the informed consent of their patients?
A. Yes.
Q. How, if you know and if you remember, did the Institutional Review Board go about making sure that the
investigating doctors were obtaining informed consent before implanting experimental lenses in their
patients' eyes?
A. We would have a discussion of it before it was instituted as a rule and then it would be professionally up
to the record room to tell us whether such a form is being used, and they check on each record because they
know it might be taken home by the ophthalmologist.
Q. All right. So what you're saying is that there was a rule at the hospital that a person in the record room
was to check to make sure that the special consent form was in the file?
A. For an investigational study.
Q. For an investigational study.
A. Yes.
Q. And if the consent form was not in the file, what was the record custodian supposed to do?
A. Report it to the ophthalmologist in chief, and I would get the guy and the hospital director and ask him why
the hell he hadn't filled out the form.
Q. Okay.
A. It's very important.
Q. Was that an ongoing function throughout the investigational study?
A. Yes.
Trial transcript, 9/19/89 at 323-24.
630 Further evidence of the hospital's duty presented itself through one of the hospital's own witnesses. Dr. Jay *630 Federman,
chairman of the hospital's Institutional Review Committee, also testified to the fact that it was the hospital's duty to "assure
that all physicians who partook in those investigations had an informed consent signed ..." Trial Transcript, 9/19/89 at 706.
In fact, the hospital had devised a method to ensure its duty to obtain an informed consent was fulfilled. Two witnesses
called by the hospital, Drs. Grohsman and Belmont, confirmed that it was standard procedure that the head operating room
nurse was not to allow an operation involving an investigational medical device to go forward without the necessary special
investigational consent form having been signed and placed in the patient's chart. However, in this instance, it is undisputed
that a signed consent form was not in Mr. Friter's chart.
Thus, under the facts presented in this case, the hospital had assumed a duty, pursuant to FDA regulations, to ensure that
any patient involved in a clinical study was made aware of the clinical nature of the procedure and the risks associated with
such experimentation, and had signed a consent form acknowledging that fact.
Therefore, one impediment as to why an informed consent action cannot lie against a hospital, that being the fact that only
the physician has the duty to obtain the consent, does not exist in this case. To the contrary, federal regulations specifically
mandated that the hospital assume the duty of obtaining informed consent.
The second major obstacle offered as to why a hospital cannot be held liable in an informed consent action, is that informed
consent is a battery action, and a hospital cannot commit a battery. However, a review of the definition of a battery reveals
that in this instance the hospital can be found to have committed a technical battery. The Restatement (Second) of Torts, §
18, states that "[a]n actor is subject to liability to another for battery if (a) he acts intending to cause a harmful or offensive
contact with the person of the other or a third person ..." In comment (c) to section 18 the meaning of "contact with another's
631 person" is more fully explained. As noted therein, "[i]t is not *631 necessary that the contact with the other's person be
directly caused by some act of the actor. All that is necessary is that the actor intend to cause the other, directly or indirectly,
to come in contact with a foreign substance in a manner which the other would reasonably regard as offensive."
In this instance, by applying to become and actually becoming an approved institution for conducting clinical studies, Wills
Eye Hospital intended to cause patients to come in contact with a foreign substance, namely, the experimental intraocular
lens. At the same time, the hospital agreed to abide by the federal regulations requiring it to ensure all patients were
informed of the experimental nature of the study and signed consent forms attesting to that fact. By failing in its duty to Mr.
Friter to obtain his informed consent, the hospital rendered Mr. Friter's contact with the foreign substance one which Mr.
Friter reasonably considered offensive. Thus, the hospital may now be held liable for committing a technical battery upon
Mr. Friter.
The idea that a corporation such as Wills Eye Hospital can be held liable for the intentional tort of battery is not new. In Field
v. Philadelphia Electric Company, 388 Pa.Super. 400, 565 A.2d 1170 (1989), this court held an electric company liable for
the intentional tort of battery. Analyzing comment (c) of section 18 of the Restatement (Second) of Torts, this court
concluded that the electric company had produced a contact, such that it could be held liable for battery.
The next issue before us is whether count one of appellants' complaint, entitled tort of intentional exposure to
radiation, states a cognizable cause of action. We conclude that it does. In the count, appellants allege that
PECO deliberately exposed Field to radiation by operating the reactor knowing that Field would be exposed
to dangerous levels of radiation and by deliberately venting radioactive steam on Field knowing his location.
We believe this states a cause of action in battery. See Restatement (Second) of Torts § 13 (battery requires
632 intent to cause offensive contact and resultant harmful *632 contact). The intentional act of venting steam
where the steam produced the contact is sufficient to state an actionable battery. See Restatement (Second)
of Torts § 18 comment c (intent to contact someone with offensive foreign substance constitutes contact for
purposes of battery).
Id., 388 Pa.Superior Ct. at 416-17, 565 A.2d at 1178.
Similarly, in the present case, the hospital, by participating in the clinical study, intended contact with patients who were to
receive the experimental lenses. Such contact by its nature is offensive. It is only when a consent to such a touching is
obtained that the hospital has a defense to the battery, as consent to the touching provides a defense in battery actions.
However, in this instance, the hospital failed in its duty to obtain that consent. Furthermore, as noted by this court in Field,
the fact that the corporation did not intend to harm anyone, is immaterial. Id. Thus, while we do not doubt that Wills Eye
Hospital never intended to harm Mr. Friter, that does not relieve them of liability for the battery in this instance.[1]
In conclusion, because under the facts of this case we find that Wills Eye Hospital had assumed an independent duty to
obtain Mr. Friter's informed consent, and because the hospital intended Mr. Friter to come in contact with a foreign
substance by way of the investigational study, there is no reason why the hospital should not be held liable under an
633 informed consent cause of action. The record reveals that the nature of the hospital's duty to obtain the *633 consent was
proved to the jury, and the jury recognized the existence of that duty. Accordingly, the jury returned a verdict in favor of
plaintiff. Thus, we conclude that under the facts presented in this case, Wills Eye Hospital may be held liable for failing to
obtain Mr. Friter's informed consent. Therefore, the trial court erred in granting the hospital's motion for judgment n.o.v.
Although our decision to reverse the trial court order granting Wills' motion for judgment n.o.v. effectively disposes of this
case, for the sake of completing the record on remand we note that Wills' had also raised several other trial errors by way of
post-trial motions. Specifically, Wills' alleged that appellants had failed to provide expert medical testimony to prove their
case; that the trial court had erred in admitting the FDA regulations into evidence; that the trial court erred in permitting
appellant's expert, Dr. Kirschner, to testify beyond his area of expertise and beyond the scope of his report; the trial court
erred in admitting the testimony of Dr. Duane; and that the trial court erred in denying Wills' motion for a post-trial
evidentiary hearing. With respect to these remaining issues, we find that Judge Goldman has thoroughly and correctly
disposed of them in his October 19, 1990 opinion and therefore affirm on the basis thereof.
We also note that through post-trial motions Wills raised issues concerning allocation of damages and remittitur, and
appellants presented a petition for delay damages. The trial court found these issues to be moot in light of its decision to
grant the hospital's motion for judgment n.o.v. Now that we have reversed the trial court's order, the trial court will
necessarily have to consider remittitur and delay damages in accordance with our remand order.
Accordingly, the order of the trial court granting Wills Eye Hospital's motion for judgment n.o.v. is reversed. The case is
remanded to the trial court for further proceedings consistent with this opinion.
Order reversed. Verdict reinstated and case remanded for judgment thereon. Jurisdiction relinquished.
[1] Before concluding, we note that this court is well aware that the supreme court formally adopted the doctrine of corporate liability in
Thompson v. Nason Hospital, 527 Pa. 330, 591 A.2d 703 (1991), while this matter was pending on appeal. In fact, a review of the pleadings
and transcript of this case reveal that appellant actually pled and proved all of the elements comprising a corporate liability action. However,
appellant did not ask us to apply that doctrine to the pleadings and transcript of this case, but rather requested we expand the doctrine of
corporate liability to encompass battery actions. This we will not do, as corporate liability has to date been premised on proof of negligence.
However, it is interesting to note that at the crux of the corporate liability doctrine is the notion that certain duties run directly from the
hospital to its patients.
1/1/2021 Anderson v. George H. Lanier Memorial Hosp., 982 F. 2d 1513 - Court of Appeals, 11th Circuit 1993 - Google Scholar
982 F.2d 1513 (1993)
Mildred ANDERSON, Plaintiff-Appellant,

v.
GEORGE H. LANIER MEMORIAL HOSPITAL, Defendant,
Surgidev Corporation, Defendant-Appellee,
CHATTAHOOCHEE VALLEY HOSPITAL SOCIETY, INC., d/b/a George H. Lanier Memorial Hospital
and Nursing Home, Third-Party Plaintiff-Appellee-Cross-Appellant,
v.
The BOARD OF TRUSTEES OF The UNIVERSITY OF ALABAMA, A Body Corporate for the
University of Alabama in Birmingham; Hugh Davis and Howard D. Clem, Sr., Third-Party
Defendants-Cross-Appellees.
Floareod HODO, Plaintiff-Appellant,
v.
Chattahoochee Valley Hospital Society, Inc., d/b/a George H. Lanier Memorial Hospital and Nursing
Home, Defendant-Third-Party Plaintiff-Appellee-Cross-Appellant,
The Board of Trustees of The University of Alabama, A Body Corporate for the University of
Alabama in Birmingham; HUGH DAVIS and HOWARD D. CLEM, SR., Third-Party-Defendants-
Cross-Appellees,
Alabama Hospital Association Trust, Defendant-Intervenor.
Jack LINDSEY, Plaintiff-Appellant,
v.
Chattahoochee Valley Hospital Society, Inc., d/b/a George H. Lanier Memorial Hospital and Nursing
Home, Defendant-Third-Party Appellee-Cross-Appellant,
The Board of Trustees of The University of Alabama, A Body Corporate for the University of
Alabama in Birmingham; HUGH DAVIS and HOWARD D. CLEM, SR., Third-Party-Defendants-
Cross-Appellees,
Alabama Hospital Association Trust, Defendant-Intervenor.
Charles WILLIAMS, an Individual, Plaintiff-Appellant,
Marlene Williams, an Individual, Plaintiff,
v.
Vicki L. TORSCH, as Executrix of the estate of Theodore Torsch, Deceased, Defendant,
CHATTAHOOCHEE VALLEY HOSPITAL SOCIETY, INC., d/b/a George H. Lanier Memorial Hospital
and Nursing Home, Defendant-Appellee, Third Party Plaintiff-Cross-Appellant,
v.
The BOARD OF TRUSTEES OF The UNIVERSITY OF ALABAMA, a Body Corporate for the
University of Alabama in Birmingham; HUGH DAVIS and HOWARD D. CLEM, SR., Third Party
Defendants-Cross-Appellees.
Nos. 91-7522, 91-7731.
United States Court of Appeals, Eleventh Circuit.
February 12, 1993.
1514 *1514 Roger Lucas, Lucas, Alvis & Kirby, Birmingham, AL, John A. Tinney, Roanoke, AL, Elizabeth Powell Jones,
Birmingham, AL, for appellants.
A. Joe Peddy, Smith, Spires & Peddy, Ina B. Leonard, Office of Counsel, Edward J. Kennedy, III, Robert D. Norman,
Norman, Fitzpatrick, Wood, Williams & Parker, Birmingham, AL, for third-party defendants.
Joe Espy, Les Hayes, III, Melton, Espy, Williams & Hayes, Montgomery, AL, for appellees in No. 91-7522.
John A. Tinney, Roanoke, AL, Roger Lucas, Birmingham, AL, for Williams.
Les Hayes, Melton, Espy, Williams, & Hayes, Montgomery, AL, for Chattahoochee Valley in No. 91-7731.
Before HATCHETT, EDMONDSON and BIRCH, Circuit Judges.
HATCHETT, Circuit Judge:
In this appeal, we reverse the district court's grant of summary judgment to a hospital because a jury must decide the
applicable statute of limitations period according to the law of the state of Alabama.
I. BACKGROUND
The four appellants in these consolidated cases, Charles Williams, Mildred Anderson, Jack Lindsey, and Floareod Hodo,
were patients of Dr. Theodore Torsch, an opthalmologist. Each of the appellants underwent cataract surgery at George H.
Lanier Memorial Hospital and Nursing Home (Lanier Hospital). During the surgeries, Dr. Torsch inserted experimental
intraocular lenses (IOLs) into their eyes. Ultimately, each of the appellants suffered pain and faulty vision as a result of the
lens implants.
In separate actions, the appellants sued Lanier Hospital alleging that the hospital failed to obtain their informed consent for
the experimental procedure. Williams sued the hospital for medical malpractice, fraud, and outrageous conduct. In separate
1515 lawsuits, *1515 Anderson, Lindsey, and Hodo sued the hospital for medical malpractice, negligence, outrageous conduct,
fraud, and fraudulent concealment. Anderson, Lindsey, and Hodo also sued Surgidev Corp., the IOL manufacturer, for
failing to assure that Dr. Torsch obtained their informed consent.
Prior to the surgeries, the defendant Surgidev had received an exemption from the laws prohibiting the use of experimental
instruments on human beings from the Food and Drug Administration (FDA).[1] Under the FDA's regulatory scheme,
Surgidev was the "sponsor" of the IOL program and Lanier Hospital was the institutional site of study.[2] As the institutional
site of study, FDA regulations required Lanier Hospital to establish and maintain an institutional review board (IRB) to
oversee the IOL clinical study. Surgidev recommended Dr. Torsch to serve as the "investigator," a qualified ophthalmologist
who could perform the eye operations and implant the lenses. Hodo, Anderson, and Lindsey allege that Surgidev had a
legal duty to ensure that Dr. Torsch secured informed consent from his patients.
II. THE APPELLANTS
Charles Williams is a fifty-three year old man who possesses a ninth grade education. He underwent eye surgery in January
of 1986. On the day of the surgery, Williams signed consent forms, but neither the hospital staff nor Dr. Torsch explained the
forms, and Williams testified that it would have taken him "half a day to read all that stuff." Williams alleges that Dr. Torsch
never explained to him that an experimental lens would be implanted in his eye.
In May or June of 1986, Williams visited two physicians because he suffered increasing pain in the eye on which Dr. Torsch
performed the surgery. The doctors told Williams "that they were surprised at the way Dr. Torsch performed the surgery."
Williams admitted that he thought Dr. Torsch may not have performed the surgery properly. Williams alleges, however, that
he did not find out about the experimental nature of the surgery until May, 1989. On July 20, 1989, he filed suit against
Lanier Hospital.
Mildred Anderson is a sixty-seven year old widow who possesses a fifth grade education. Anderson testified that she has no
education and is barely able to read and write. Anderson underwent initial eye surgery on her left eye in June, 1985, and Dr.
Torsch performed a second eye surgery in July, 1986. Just prior to her first eye surgery, Anderson received hospital consent
forms. Anderson testified that she signed the forms because she knew she was undergoing cataract surgery. No one read
or explained the contents of the forms to her. Anderson testified that Dr. Torsch did not advise her that he would be inserting
a lens in her eye.
After completion of the first surgery, Anderson experienced pain in her left eye and was unable to use it. Sometime in 1985
she saw a physician in Columbus, Georgia, who informed her that Dr. Torsch did not perform her eye surgery properly and
had inserted "the wrong thing in it." Anderson's second eye operation did not improve her vision or help alleviate the pain.
Anderson testified that she did not know that Dr. Torsch inserted an investigational lens in her eye until May, 1989. On May
31, 1989, Anderson filed suit against Lanier Hospital and Surgidev.
Jack Lindsey is a sixty-nine year old man who never attended school and can neither read nor write. In January of 1986, he
underwent eye surgery. Dr. Torsch never discussed with him possible problems or complications associated with cataract
surgery. On the morning of his surgery, Lanier Hospital staff asked Lindsey to sign "some papers." Lindsey marked an "X"
1516 on the lines provided. Lindsey stated that a nurse told him that "they going to put a *1516 glen [sic] in my eye, but they didn't
say what."
After his surgery, Lindsey complained of pain in his eye. Sometime in 1987, Lindsey went to see another physician in
Columbus, Georgia, because he could not use the eye. Lindsey testified that the physician advised him that Dr. Torsch
"ought to have been ashamed of himself, putting this kind of glen [sic] in my eye." Lindsey alleges he did not know of the
experimental nature of the lens in his eye until May, 1989. On May 31, 1989, he filed suit against Lanier Hospital and
Surgidev.
Floareod Hodo is an eighty-year old woman who possesses a fourth grade education. After undergoing surgery in January
of 1987, Hodo experienced problems with her eye. Approximately four to six weeks after her surgery, Hodo went to Atlanta
to have her eye examined. In March or April of 1987, a physician told Hodo that Dr. Torsch incorrectly performed the eye
surgery. Hodo claims that Dr. Torsch never discussed the nature of the surgery with her nor advised her that he was going
to insert a lens in her eye. Hodo did not learn of the experimental nature of her eye surgery until May, 1989. On May 24,
1989, she filed suit against Lanier Hospital and Surgidev.
III. PROCEDURAL HISTORY
On February 9, 1990, Lanier Hospital filed a third-party complaint against the Board of Trustees of the University of
Alabama (the Board), Hugh Davis, and Howard D. Clem, Sr., alleging that any acts or omissions that occurred at the
hospital were the responsibility of these parties. Pursuant to a Management Agreement, the University of Alabama at
Birmingham contracted to provide Lanier Hospital with a "competent and experienced Administrator." Davis served as
administrator at Lanier Hospital from August 1, 1984, until November of 1985. Clem became the interim administrator in
November, 1985, and retained the position until May, 1986, when the hospital appointed him full-time administrator. Clem
served as administrator at Lanier Hospital until July 17, 1987. Thus, the hospital sued the Board, Davis, and Clem for
indemnification in the event the appellants were successful in their lawsuits.
Lanier Hospital moved for summary judgment arguing that Alabama's two-year statute of limitations for medical malpractice
governed the actions. Because more than two years had elapsed between the operations and the filing of the lawsuits,
Lanier Hospital argued that the statute of limitations had run on all of the lawsuits. Surgidev also moved for summary
judgment asserting that it owed no duty under federal law to ensure that the hospital obtained informed consent from the
patients who received its IOLs. The third-party defendants, the Board, Davis, and Clem, also moved to dismiss Lanier
Hospital's third-party complaint.
The district court granted Lanier Hospital's motion for summary judgment as to all appellants, finding that their claims were
barred by Alabama's two-year statute of limitations. Further, the district court granted Surgidev's motion for summary
judgment as to all appellants finding that federal law did not impose a duty upon Surgidev to ensure that its "investigators"
obtained informed consent from each subject of the study. The district court also granted the Board's motion to dismiss
Lanier Hospital's third-party complaint on the basis of sovereign immunity. Lastly, the district court granted Davis's and
Clem's motions to dismiss the third-party complaint. The district court found that Lanier Hospital failed to show that Davis
and Clem violated any duty to the hospital and, in the event that Davis and Clem did owe a duty, that Lanier Hospital failed
to show that a violation of that duty caused any damage to the hospital.
IV. ISSUES
The issues presented in this appeal are: (1) whether the district court properly determined that the statute of limitations had
run on the plaintiffs' suit against Lanier Hospital; (2) whether the district court properly granted summary judgment in favor
1517 of Surgidev because Surgidev owed no *1517 duty to assure that Dr. Torsch obtained informed consent from the appellants;
and (3) whether the district court properly dismissed Lanier Hospital's third-party complaint against the Board, Davis, and
Clem.
Upon review of these issues, we hold that the district court entered judgment without an error of law on Surgidev's motion
for summary judgment. Further, we find that the district court correctly dismissed Lanier Hospital's third-party complaint.
Accordingly, this opinion will focus upon the summary judgment entered in favor of Lanier Hospital. We review a district
court's grant of summary judgment de novo. Beavers v. American Cast Iron Pipe Co., 975 F.2d 792, 795 (11th Cir.1992).
V. CONTENTIONS
Although the appellants concede that Alabama's Medical Liability Act governs their lawsuits, they contend that the statute of
limitations in the Act does not bar their lawsuits. The Medical Liability Act contains a two-year statute of limitations. The Act,
however, also contains a "savings provision" and is subject to the statutory period of limitation for fraud. Because the statute
of limitations for a cause of action for fraud does not begin to run until the date of discovery of the fraud, and runs no later
than four years from the date of the fraudulent act, the appellants argue that their lawsuits fall within the statute of
limitations.
On the other hand, Lanier Hospital argues that the substance of the action, not its form, should determine the applicable
statute of limitations period. Lanier Hospital asserts that because the plaintiffs' fraud claim is so intertwined with medical
malpractice, the medical malpractice statute of limitations should govern their lawsuits. Accordingly, Lanier Hospital
contends that the two-year statute of limitations on the appellants' lawsuits has run.
VI. DISCUSSION
The Alabama Medical Liability Act states that the statute of limitations period for actions against physicians, surgeons, or
medical institutions for liability error, mistake, or failure to cure is two years after the act, omission, or failure that gave rise to
the claim. The Act also contains a "savings provision" which provides that
if the cause of action is not discovered and could not reasonably have been discovered within such period,
then the action may be commenced within six months from the date of such discovery or the date of
discovery of facts which would reasonably lead to such discovery, whichever is earlier; provided further, that
in no event may the action be commenced more than four years after such act....
See Ala. Code § 6-5-482(a) (1975). In section 6-5-482(b), the Act states:
Subsection (a) of this section shall be subject to all existing provisions of law relating to the computation of
statutory periods of limitation for the commencement of actions, namely, section [] ... 6-2-3 ... provided, that
notwithstanding any provisions of sections, no action shall be commenced more than four years after the act,
omission or failure complained of....
Section 6-2-3 of the Alabama Statutes sets out the statute of limitations period for claims involving fraud. Specifically, that
section states:
In actions seeking relief on the ground of fraud where the statute has created a bar, the claim must not be
considered as having accrued until the discovery by the aggrieved party of the fact constituting the fraud,
after which he must have two years within which to prosecute his action.
Ala. Code § 6-2-3 (Supp.1992). Thus, claims brought under the Alabama Medical Liability Act involving fraud against a
health care provider are subject to the statute of limitations period for a cause of action for fraud. See Trammer v. Bernstein,
596 So.2d 572, 574-75 (Ala.1991). Nonetheless, the actions must be brought within four years of the fraudulent act. Bowlin
Horn v. Citizens Hospital, 425 So.2d 1065, 1070-72 (Ala.1982).
1518 *1518 All the parties acknowledge that the Alabama Medical Liability Act governs these lawsuits. Thus, the question
becomes which statute of limitations contained in the Act applies to the appellants' claims. Lanier Hospital argues that the
appellants' unsuccessful eye surgeries gave rise to their claims. Thus, the hospital asserts that the appellants' claims are
based upon Dr. Torsch's surgical procedure, not the failure to inform the appellants that an experimental lens would be
implanted in their eyes. Because the appellants claims are inextricably intertwined in the physician-patient relationship,
Lanier Hospital argues that the action giving rise to the appellants' claims was their individual eye surgeries. Accordingly,
Lanier Hospital argues that because each appellant filed his or her complaint after the two-year statutory period had run, the
district court properly granted summary judgment in favor of the hospital.
In the alternative, Lanier Hospital argues that in order to avail themselves of the time saving provision in the Alabama
Medical Liability Act, the appellants must show that: (1) their causes of action were not discovered within the two-year
statutory period; and (2) their causes of action could not reasonably have been discovered during the two-year statutory
period. Lanier Hospital argues that the appellants cannot show that their causes of action could not reasonably have been
discovered within two years. The hospital notes that each appellant experienced pain and vision problems with his or her
eye after the surgery. Further, several appellants sought medical attention from other physicians. Lanier Hospital asserts
that these actions occurred within the initial two-year limitations period. Thus, even applying the "savings provision," the
limitations period ran on the appellants' claims.
Lanier Hospital argues that this lawsuit is analogous to Sellers v. Edwards, 289 Ala. 2, 265 So.2d 438 (1972). In Sellers, a
physician left a surgical tool in the plaintiff's body after the surgery. The plaintiff repeatedly complained about pain in the
area of his surgery. Almost two years later, an X-ray revealed that a clamp had been left inside the plaintiff's body. The
plaintiff, however, did not file suit against the doctor until almost four years elapsed from the date of surgery alleging claims
for trespass, assault and battery, and breach of contract. Sellers, 265 So.2d at 439.
The Alabama Supreme Court held that the form of the action was not the determinative factor as to the statute of limitations
question. Instead, the decisive factor is the substance of the action. Because the Alabama Supreme Court found that the
plaintiff knew something was wrong after his initial surgery, it found that the two-year statute of limitations governing medical
malpractice barred the lawsuit. Sellers, 265 So.2d at 440.
In this case, Lanier Hospital asserts that the substance of the appellants' actions should dictate the statute of limitations,
rather than the form of the actions. The appellants knew something was wrong with their eyes within two years after their
surgeries, as did the plaintiff in Sellers. Moreover, the appellants sought medical attention from other physicians. Thus,
Lanier Hospital argues that each appellant possessed facts which could have reasonably led him or her to the discovery of
their causes of action.
The district court agreed with Lanier Hospital's arguments finding that in each case, the appellant knew within two years of
his or her initial surgery that it was unsuccessful. Further, the district court found that "each [appellant] had reasonable
cause to inquire and did actually inquire of others about facts known to them which reasonably would have disclosed that
Dr. Torsch had installed the wrong lens and that each could never be properly cured of the matter so treated by Dr. Torsch."
The district court noted that although the appellants may not have known that Dr. Torsch and Lanier Hospital failed to
assure that they had given their informed consent to the operation, each appellant knew that his or her eye had been
damaged as a result of the eye operation. Thus, the district court determined that the statute of limitations had run on each
1519 of *1519 the appellant's causes of action. The district court, however, was not able to consider the Alabama Supreme
Court's most recent decision concerning this very issue, Green v. Wedowee Hospital, 584 So.2d 1309 (Ala.1991).
The Green case, released a few months after the district court rendered its decision concerning these appellants, dealt with
the exact same fraud claims found in this case. In Green, a patient of Dr. Torsch instituted a fraud action against Wedowee
Hospital alleging that the hospital failed to inform him of the experimental nature of his eye surgery. The Green plaintiff also
alleged that the hospital failed to obtain FDA approval for performing the IOL surgery. Green brought his lawsuit against the
hospital over two years after Dr. Torsch performed his cataract surgery. Moreover, Green knew that Dr. Torsch was
replacing a lens in his eye. Wedowee Hospital moved for summary judgment, raising in part a statute of limitations defense.
Green, 584 So.2d at 1311.
Green contended that he did not become aware of the experimental and fraudulent nature of his lens replacement surgery
until April, 1989, over three years after the surgery. The Alabama Supreme Court reversed the lower court's grant of
summary judgment in the hospital's favor on statute of limitations grounds. The Alabama Supreme Court noted that
although an objective standard should be used to determine when a party should have discovered fraud for statute of
limitations purposes, "the mere fact that the standard is an objective one does not foreclose a jury determination on the
issue." Green, 584 So.2d at 1312 (citing Hicks v. Globe Life & Accident Ins. Co., 584 So.2d 458 (Ala.1991)). Further, the
Alabama Supreme Court reiterated:
The question of when a plaintiff should have discovered fraud should only be taken away from the jury and
decided as a matter of law in cases in which the plaintiff actually knew of facts which would put a reasonable
person on notice of fraud.
Green, 584 So.2d at 1312 (citations omitted) (emphasis in original). The Alabama Supreme Court held that the evidence in
the record revealed that Green did not have actual knowledge of the alleged fraudulent nature of his surgery before April,
1989, and a jury could have found that "Green acted reasonably in not discovering the alleged fraud until that time." 584
So.2d at 1312. Hence, the Alabama Supreme Court held that a jury should decide when Green learned of the fraud to begin
the running of the statute of limitations period. See also Howard v. Mutual Savings Life Ins. Co., 608 So.2d 379, 383
(Ala.1992) (citing Green and deciding that plaintiff's fraud claims should go to a jury even though plaintiff believed that an
insurance company did not pay her the benefits owed during the statute of limitations period. The court stated, "The
subjective standard of justifiable reliance is part of a review of the reasonableness of [plaintiff's] behavior under these
facts.").
To distinguish Green from this case, Lanier Hospital argues that Green involved only a fraud claim. Here, because the
appellants' fraud claims are intertwined with medical malpractice claims, the hospital asserts that the two-year statute of
limitations should be applied. We do not find Lanier Hospital's argument persuasive. In this case, the appellants' claims are
the same as the claim addressed in Green. The fraud the appellants allege is that Lanier Hospital did not obtain their
informed consent concerning an experimental procedure. The appellants are not arguing that their eye surgeries caused
injury; instead, their claim is that they were never put on notice that they were the subjects of research. Under the ruse of
removing cataracts, Dr. Torsch may have committed fraud on these appellants when he inserted experimental IOLs in their
eyes. Likewise, the hospital may have committed fraud if it failed to obtain their informed consent.
Lanier Hospital's form over substance argument is unavailing because the facts necessary to decide whether the appellants
were the victims of fraud are distinct from the facts needed to decide whether they were victims of medical malpractice. The
1520 appellants' fraud claims embrace *1520 the implantation of experimental lenses in their eyes that was not contemplated at
the outset of their surgeries. Like the plaintiff in Green, the appellants in this case may have been put on notice that Dr.
Torsch negligently performed their eye surgeries. The appellants, however, were not placed on notice that they were the
victims of an experimental procedure. Although evidence in the record suggests that some of the appellants were aware
that lenses had been placed in their eyes, this fact should not bar their claims. The plaintiff in Green was aware that a lens
was inserted in his eye. He was not aware that the lens was experimental. Green, 584 So.2d at 1311. Similarly, the
appellants in this case testified that they had no knowledge that the lenses in their eyes were experimental until sometime in
1989. Because a jury could determine that the appellants acted reasonably in not discovering the alleged fraud until 1989, a
jury should decide when the statute of limitations period began to run on their actions.
VII. CONCLUSION
Because a jury could conclude that the appellants acted reasonably in not discovering the fraudulent nature of their
surgeries until 1989, Lanier Hospital is not entitled to summary judgment based upon the statute of limitations. As to the
district court's grant of summary judgment in favor of Surgidev, and its dismissal of Lanier Hospital's third-party complaint
against the Board, Clem, and Davis, we find that the district court entered judgment without an error of law. Accordingly, we
reverse the district court's grant of summary judgment in favor of Lanier Hospital and affirm the district court's grant of
summary judgment in favor of Surgidev and its dismissal of Lanier Hospital's third-party complaint.
AFFIRMED IN PART, REVERSED IN PART.
[1] Section 520(g) of the Food, Drug and Cosmetic Act (1976), 21 U.S.C. § 360j(g), allows an exemption for IOLs so that qualified
ophthalmologists may use them for investigational purposes.
[2] See 21 C.F.R. § 813, et seq. (1988).
1/1/2021 Montgomery v. Bazaz-Sehgal, 798 A. 2d 742 - Pa: Supreme Court 2002 - Google Scholar
798 A.2d 742 (2002)
John MONTGOMERY and Marsha Montgomery, his Wife

v.
Vitasta BAZAZ-SEHGAL, M.D., Executrix of the Estate of Kuldeep Sehgal, M.D., Deceased, Greater
Pittsburgh Impotence Center and Aliquippa Hospital,
Appeal of Vitasta Bazaz-Sehgal, M.D., Executrix of the Estate of Kuldeep-Sehgal, M.D., Deceased,
and Greater Pittsburgh Impotence Center.
Supreme Court of Pennsylvania.
Argued March 5, 2001.

Decided June 18, 2002.
744 *744 Linton L. Moyer, Templeton Smith, Pittsburgh, for appellants, Vitasta Bazaz-Sehgal, M.D., Executrix of the Estate of
Kuldeep Sehgal et al.
Peter J. Pietrandrea, Cranberry Tp., for appellees, John and Marsha Montgomery.
Before FLAHERTY, C.J., ZAPPALA, CAPPY, CASTILLE and SAYLOR, JJ.
743
*743 OPINION OF THE COURT
Justice CASTILLE.
In this appeal, this Court reaffirms that the doctrine of informed consent, whether involving non-consensual surgery or a lack
of informed consent, sounds in battery, not in negligence, despite observations to the contrary in the published Superior
Court opinion below. The appeal also presents the question of whether, and when, expert medical testimony is necessary to
prove damages resulting from a medical battery. On this question, we are in agreement with the careful distinction drawn by
the Superior Court and, hence, we affirm its mandate.
745 In August of 1989, appellee, John Montgomery, began treating with Dr. Kuldeep *745 Sehgal,[1] a board certified urologist
specializing in male impotence, for complaints of premature ejaculation and inability to maintain an erection. Sehgal took a
history, performed a complete physical examination and ordered tests. Sehgal's ultimate diagnosis was that Montgomery's
impotence was caused by Peyronie's disease[2] and a slight venous leak, resulting in an insufficient blood supply to his
penis to form and maintain an erection. The following month, in an effort to treat Montgomery's impotence non-surgically,
Sehgal administered injections of Papaverine and Regitine, medications which are designed to increase the blood flow in
the penis.
In February of 1990, Montgomery returned to Sehgal and reported that the injections had not improved his condition.
Sehgal decided that corrective surgery was necessary. On March 30, 1990, Sehgal performed surgery on Montgomery at
Aliquippa Hospital during the course of which he implanted an inflatable pump prosthesis in Montgomery's penis. The facts
to this point are undisputed; it is the nature of the surgery performed, and whether Montgomery consented to the specific
procedure, that is disputed.
Since the legal questions involve the propriety of the trial court's refusal to permit any aspect of appellees' case to go to the
jury, the primary focus here must be upon appellees' evidence. Appellees claimed that, prior to the surgery, Sehgal merely
told them he intended to perform a revascularization, an outpatient procedure. A revascularization is designed to open and
repair the blood vessels leading to the penis to increase blood flow. Appellees alleged that the possible insertion of a penile
implant was not discussed with them prior to the surgery, nor did John Montgomery ever consent to the implantation of the
prosthesis—a procedure which resulted in Montgomery being admitted to the hospital for several days. Appellees claimed
that they first learned of the implantation when Montgomery awoke from the surgical anesthesia and a nurse presented him
with a warranty card for the prosthesis. Montgomery asked the nurse whether there was some mistake, whereupon the
nurse informed him that the prosthesis had been implanted in his penis. Dr. Sehgal denied appellee's claim that he never
informed appellees about the prospect of implanting a penile prosthesis.
Appellees then tried to reach Sehgal by telephone but were unable to speak to him until three days after surgery, when
Sehgal appeared in Montgomery's hospital room to discharge him. Appellees asked Sehgal why he had implanted the
prosthesis, and the doctor explained that he was saving Montgomery from a second surgical procedure at some later date.
John Montgomery replied that it was not up to the doctor, but up to him to determine whether he wanted such an object
placed in his body. Montgomery also told Seghal that he did not want the prosthesis and wanted it removed, but Sehgal
informed him that removal was not an option because there was "nothing there now."
According to Marsha Montgomery, when her husband was discharged, he remained in a "state of shock," and was also in
746 "plenty of pain" from the surgery. John Montgomery testified that he has *746 never gotten used to the device. He explained
that he had to be careful how he sits because it is "like sitting on a pin cushion," the device hurts at times, and there had
been times "that it felt like it wanted to come out through the head of it and it is plain discomfort." Montgomery also testified
to the mental effect of the implantation of the prosthesis, explaining that:
I sure as hell don't feel like a man, I'll tell you that. I don't feel one bit like a man. I mean, I felt like half a man
before because I had ejaculated early but I don't feel like no man, even half a man anymore because I go
[sic] to pump this thing up. Like I told my wife, I feel like I am a machine.
N.T. 1/12/98 at 179. Montgomery also testified that he could not achieve an erection without employing the device and that
there is no sensation or "fulfillment" upon ejaculation.
Appellees filed suit on May 28, 1993, alleging professional negligence, lack of informed consent and battery. Appellees
failed to identify any liability expert witnesses by the date established by the trial court, causing the trial court to issue an
order on June 15, 1995, which precluded appellees from calling any liability expert witnesses at trial. On September 15,
1995, Dr. Sehgal and Greater Pittsburgh Impotence Center,[3] relying on the trial court's preclusion order, filed a motion for
partial summary judgment arguing that appellees could not prove their professional negligence claim absent expert
testimony and requesting that the negligence claim be dismissed. The trial court granted the motion on November 8, 1995.
The matter then proceeded to a jury trial on the lack of informed consent and battery claims. At the close of appellees' case,
appellants motioned for compulsory non-suit on the grounds that appellees could not prove a connection between the
alleged battery and the requested damages without expert testimony. The trial court denied the motion, finding that
Montgomery's testimony regarding his objection and reaction to the presence of the prosthesis and the fact that it was
cumbersome did not require supporting expert testimony because the connection to the tortious conduct was obvious:
Mr. Montgomery's protestations to the presence of the prosthesis do[ ] not require an expert for him to say
that it is cumbersome and he never expected it to be there. I don't think that would require an expert....
[E]xpert medical testimony is necessary to establish the causal nexus of the injury to the tortious conduct in
those cases where the connection is not obvious. Clearly, as to the things of which [appellees' counsel]
complained, the connection is obvious.
At the close of all evidence, appellants moved for a directed verdict on the same ground alleged in support of a non-suit.
This time, the trial court, after reviewing Montgomery's testimony that he had a reduced or different physical sensation in his
penis, was unable to feel the physical pleasures of intercourse and could not sustain an erection without inflating the
prosthesis with a pump, determined that expert testimony was necessary to connect this sort of physical injury to the
implantation of the prosthesis and granted a directed verdict as to those damages. As to the mental anguish and loss of
747 consortium components of appellees' claims, the trial court initially denied the motion for directed *747 verdict on the same
basis that it had denied appellants' motion for non-suit. After further discussion with the parties, however, the trial court
reversed itself and found that appellees' claims for mental anguish and loss of consortium also could not be sustained
absent expert testimony. The trial court concluded that it could not determine the dividing line between which damages
would require medical testimony and which would not. Thus, the trial court granted a directed verdict as to all remaining
aspects of the case.
Upon appeal by the Montgomerys, a divided panel of the Superior Court issued a published opinion reversing and
remanding to the trial court to permit appellees the opportunity to pursue the battery claim and certain claims for damages
without the necessity of producing an expert witness. Montgomery v. Bazaz-Sehgal, 742 A.2d 1125, 1134 (Pa.Super.1999).
The majority opinion, authored by the late former President Judge Cirillo, began by opining that the differences between a
medical battery case and "a medical malpractice informed consent case grounded in negligence" were at the "heart" of the
appeal. Among those differences was the fact that an informed consent case requires expert medical testimony to establish
the physician's duty, while a medical battery claim requires only a showing of a non-consensual contact. The court then
noted that the matter sub judice involves a battery claim, and not a claim of negligence/informed consent.
On the battery claim, the court concluded that the evidence that Dr. Seghal had implanted an inflatable prosthesis into John
Montgomery's penis, without his permission, was sufficient to warrant the jury in a finding that a battery was committed.
Turning to the question of damages, and whether medical testimony was required to prove damages, the court took issue
with the trial court's inability to draw a "dividing line" between which alleged damages resulting from the battery would
require medical expert testimony and which would not. In the Superior Court's view, the law was clear that compensatory
damages were available in a medical battery action, even in the absence of expert testimony, for "direct, obvious and
foreseeable results" of the battery. It is only where the connection between the battery and the harm is not obvious that
expert testimony is required. Applying this distinction, the court determined that any injury involving Montgomery's "physical
sensation" would require expert testimony since, in light of his preexisting condition, the causal connection between the
battery and any diminished physical sensation was not so obvious as to be within the range of ordinary experience of non-
experts. On the other hand, the causal connection between the battery and the alleged mental and emotional injuries arising
from a non-permitted implantation of the prosthesis was sufficiently clear and direct that that question should have been left
to the jury.[4]
This Court granted discretionary review to consider two claims: (1) whether expert medical testimony is necessary to prove
that the performance of a surgical procedure—here, the implantation of a penile prosthesis—to which a patient did not
consent caused mental/emotional injury to the patient; and (2) whether the Superior Court was correct that non-consensual
748 *748 surgery cases are distinguishable from informed consent cases because non-consensual surgery constitutes a battery,
while lack of informed consent sounds in negligence. Although we disagree with the Superior Court on the latter point, that
disagreement does not affect our ultimate judgment, for we agree with the Superior Court that expert testimony was not
necessary for appellees' mental and emotional damages claim to go to the jury.[5]
We will address the second issue first, given its importance and relevance as background about the very nature of informed
consent and medical battery. "It has long been the law in Pennsylvania that a physician must obtain informed consent from
a patient before performing a surgical or operative procedure." Morgan v. MacPhail, 550 Pa. 202, 704 A.2d 617, 619 (1997),
citing Sinclair v. Block, 534 Pa. 563, 633 A.2d 1137 (1993); Gray v. Grunnagle, 423 Pa. 144, 223 A.2d 663 (1966).
The informed consent doctrine requires physicians to provide patients with "material information necessary
to determine whether to proceed with the surgical or operative procedure or to remain in the present
condition." Sinclair by Sinclair v. Block, 534 Pa. 563, 633 A.2d 1137, 1140 (1993). We have on several
occasions defined the nature of this "material information." We have stated that the information provided by a
physician must give the patient "a true understanding of the nature of the operation to be performed, the
seriousness of it, the organs of the body involved, the disease or incapacity sought to be cured, and the
possible results." Gray v. Grunnagle, 423 Pa. 144, 223 A.2d 663, 674 (1966). Thus, a physician must "advise
the patient of those material facts, risks, complications and alternatives to surgery that a reasonable person
in the patient's situation would consider significant in deciding whether to have the operation." Gouse v.
Cassel, 532 Pa. 197, 615 A.2d 331, 334 (1992). A claim that a physician failed to obtain the patient's
informed consent sounds in battery. Id.; see also Morgan v. MacPhail, 550 Pa. 202, 704 A.2d 617 (1997).
Duttry v. Patterson, 565 Pa. 130, 771 A.2d 1255, 1258 (2001) (emphasis supplied). As this Court has emphasized, the
informed consent doctrine derives from the very fact that surgical or operative procedures, if not consented to, amount to a
battery:
The rationale underlying requiring informed consent for a surgical or operative procedure and not requiring
informed consent for a non-surgical procedure is that the performance of a surgical procedure upon a patient
without his consent constitutes a technical assault or a battery because the patient is typically unconscious
and unable to object.
Morgan v. MacPhail, 704 A.2d at 620, citing Gray v. Grunnagle, 223 A.2d at 668-69. See also Gouse v. Cassel, 615 A.2d at
334 ("Lack of informed consent is the legal equivalent to no consent; thus, the physician or surgeon who operates without
his patient's informed consent is liable for damages which occur, notwithstanding the care exercised").
Thus, this Court has made clear on repeated occasions over a period of several decades that a claim based upon a lack of
749 informed consent involves a battery *749 committed upon a patient by a physician, an action which is distinct from a claim
of a consented-to, but negligently performed, medical treatment. Since surgery performed without a patient's informed
consent constitutes a technical battery, negligence principles generally do not apply. It follows, of course, that a claim
involving a surgical procedure performed without any consent at all by the patient, such as the implantation in the case sub
judice, also sounds in battery, and negligence requirements have no bearing on the matter. Indeed, a claim concerning the
lack of consent for surgery can be maintained even where there is no allegation of negligence in the actual performance of
the procedure. While negligence claims and informed consent claims often co-exist in the same tort action, they need not do
so. A lack of informed consent or a lack of consent claim is actionable even if the subject surgery was properly performed
and the overall result is beneficial.
In light of this discussion, it is apparent that the Superior Court erred in stating that, "[t]he differences between a medical
malpractice informed consent case grounded in negligence (commonly referred to as an "informed consent" case) and one
based on battery are at the heart of this case and must be kept clearly in mind." Montgomery v. Bazaz-Sehgal, 742 A.2d at
1130. The Superior Court also erred in further distinguishing informed consent from medical battery premised upon the
alleged applicability of negligence principles in informed consent cases. Id. ("Another difference is that while an informed
consent negligence claim requires the presentation of expert testimony in order to establish the physician's duty ..., a
medical battery claim does not") (citation omitted). No such distinction exists in our jurisprudence. Lack of consent for
surgery involves the same general concept without regard to whether consent was uninformed or completely lacking. The
result is the same—the patient is subjected to a surgical procedure to which he did not consent.
The fact that the Superior Court misconceived the battery contours of the informed consent doctrine, however, did not affect
its approach to the specific question of damages that led to its reversal in this case, since the claim at issue here in fact
does not involve the informed consent doctrine, but a claimed lack of consent at all for this particular procedure.[6] The
Superior Court correctly set forth the parameters of an action in battery: i.e., "there need be no physical injury, but only
some contact; the matter of permission goes to the quality of the contact, and consent to being so touched is a defense."
750 Montgomery v. Bazaz-Sehgal, 742 A.2d at 1133. Appellees unquestionably established a prima facie case of battery *750
by introducing evidence that Dr. Sehgal made physical contact with John Montgomery. Specifically, appellees testified that,
during consented-to revascularization surgery on Montgomery, Sehgal implanted a penile prosthesis without Montgomery's
knowledge or consent. This contact left a palpable reminder in the form of the prosthesis, which Montgomery discovered
only after he awoke. This evidence was sufficient to allow a jury to pass on the question of whether Sehgal committed a
battery.
We turn now to the issue of whether appellees were required to present expert testimony to prove that the implantation of
the penile prosthesis without Montgomery's consent caused appellees' alleged mental and emotional injuries. The Superior
Court correctly set forth the governing law with respect to the need for expert testimony in a case of alleged battery. It has
long been the law that damages for emotional injuries are compensable, even in cases not involving negligence, where
there is some evidence of physical contact or injury, even if the physical contact or injury is trivial in nature. In Hess v.
Philadelphia Transp. Co., 358 Pa. 144, 56 A.2d 89 (1948), for example, this Court allowed damages for mental suffering
where an electrical wire fell on the plaintiff's automobile while he was in the car, even though the plaintiff suffered no
physical injury beyond the electrical shock he suffered when the wire contacted his automobile. "`The nervous system is a
part of the physical organization, and this affidavit sufficiently alleges a physical injury. Mental suffering, as distinct from
bodily pain, can be considered in an action for damages for injury to the person, when such suffering is attendant upon and
results from a physical injury.'" Id. at 91, quoting North German Lloyd Steamship Co. v. Wood, 18 Pa.Super. 488, 1901 WL
3880 (1901), citing Wilcox v. Richmond & Danville R. Co., 52 F. 264 (4th Cir.1892).
Whether expert testimony is required to prove a causal connection between emotional injury and the physical injury
suffered, of course, is a separate issue. In Smith v. German, 434 Pa. 47, 253 A.2d 107 (1969), the issue was whether the
plaintiff's automobile accident caused his subsequent paranoia and schizophrenia. This Court set forth the following general
propositions governing when expert testimony is necessary to establish damages for mental injuries:
The law of this Commonwealth is well settled as to when medical testimony will be required to establish a
causal connection between the event demonstrated and the result sought to be proved. Though most of the
cases deal with plaintiffs who wish to show that a certain event caused a given injury, the rules are equally
applicable when a defendant seeks to disprove the causal connection (the automobile accident) presented
by the plaintiff by proving one (the marital difficulties) of his own. Thus in Florig v. Sears, Roebuck & Co., 388
Pa. 419, 130 A.2d 445 (1957), this Court held "Where there is no obvious causal relationship, unequivocal
medical testimony is necessary to establish the causal connection." See Auerbach v. Philadelphia Transp.
Co., 421 Pa. 594, 221 A.2d 163 (1966); Dornon v. Johnston, 421 Pa. 58, 218 A.2d 808 (1966). This test has
resulted in medical testimony being required to prove the causal connection between a heart attack and
heavy exertion thirty minutes earlier, Washko v. George L. Ruckno, Inc. 180 Pa.Super. 606, 121 A.2d 456
(1956), between a paralytic stroke and being struck by a swinging door, Fink v. Sheldon Axle Co., 270 Pa.
751 476, 113 A. 666 (1921), between a refracture and failure *751 on the part of the attending physician to be as
attentive as his patient requested, Dornon v. Johnston, supra.
But where "the disability complained of is the natural and probable result of the injuries, the fact-finding body
may be permitted to so find, even in the entire absence of expert opinion." Florig v. Sears, Roebuck & Co.,
supra, 388 Pa. at 424, 130 A.2d at 447. The two must be "so closely connected and so readily apparent that
a layman could diagnose (except by guessing) the causal connection." Id. See Tabuteau v. London G. & A.
Co., 351 Pa. 183, 40 A.2d 396 (1945); Mohr v. Desimone & Sayers, 110 Pa.Super. 44, 167 A. 504 (1933).
Id. at 108-09. The German Court held that, while the fact that the plaintiff was emotionally upset by the accident was within
the purview of the jury without the necessity of expert testimony, whether he suffered serious personality disorders arising
therefrom required expert testimony.
Applying these time-tested principles respecting whether and when expert testimony is required, the Superior Court drew a
careful distinction in this case between damages relating to a reduced or different physical sensation in John Montgomery's
penis and damages arising from the mental anguish and emotional impact of the very fact that the prosthesis was inserted
without his knowledge and consent. That distinction, we believe, was entirely proper.
There is no question that appellees' testimony concerned both physical and emotional damages and was often overlapping.
Thus, John Montgomery spoke of diminished sensation in his penis during intercourse, the fact that he could not achieve an
erection without pumping up the device and that he experienced pain and discomfort "like sitting on a pin cushion"
emanating from the device itself. Likewise, Marsha Montgomery testified that John was in a great deal of pain subsequent
to the procedure. But there was also ample evidence of anguish and harm arising from the very fact of the presence of the
unwanted device. John Montgomery testified that the prosthesis was cumbersome and embarrassing, and made him feel
like a machine because he had to pump the prosthesis in order to achieve an erection. Both appellees testified that the
device had a negative emotional impact on their marital relations.
The Superior Court correctly recognized the validity of the distinction initially drawn by the trial court between injuries arising
from physical sensations— i.e., John Montgomery's lack of sensation or sense of fulfillment from intercourse and the fact
that he could not achieve an erection without utilizing the prosthesis— and those involving the emotional impact of the
unwanted implantation of the prosthesis— i.e., John Montgomery's embarrassment, his feelings of being machine-like, and
the concomitant effect of the prosthesis on appellees' marital relations. Expert testimony obviously was required to prove
that Montgomery's physical injuries resulted from the implantation of the device. This is true particularly in light of
Montgomery's prior medical history, which included difficulties with premature ejaculation and soft erections. Absent expert
testimony, the ordinary layperson would be unqualified to determine whether these diminished physical sensations were a
result of the prosthesis or a result of the natural progression of Montgomery's pre-existing condition.
The alleged emotional injuries, however, are obvious and clearly connected to the prosthesis. It is within the range of
comprehension of jurors whether emotional injuries might reasonably be attributable to the implantation of a penile
752 prosthesis to which a patient did not consent *752 and which he first became aware of only after awaking from anesthesia
and being presented with a warranty card for the device. John Montgomery spoke directly to the emotional difference
between his pre-existing condition and his condition after implantation of the prosthesis. The jury did not require an expert to
explain to it the connection between an unwanted implantation of a penile prosthesis and the emotional injuries for which
appellees sought recovery. That John Montgomery might suffer these types of injuries is a direct and readily foreseeable
consequence of the unwanted procedure.
The law is well established that expert testimony is not necessary where the cause of an injury is clear and where the
subject matter is within the experience and comprehension of lay jurors. As the Superior Court so aptly noted, laypersons
are certainly capable of comprehending, without the assistance of an expert, appellees' mental and emotional damages and
determining whether those difficulties were occasioned by the unwanted and unexpected implantation of a penile
prosthesis. For this reason, the Superior Court decision vacating the trial court's grant of a directed verdict and remanding to
the trial court on this issue is affirmed.
Justice NIGRO and Justice NEWMAN did not participate in the consideration or decision of this case.
Former Chief Justice FLAHERTY did not participate in the decision of this case.
Justice SAYLOR files a concurring opinion.
Justice SAYLOR, concurring.
I join the majority in affirming the order of the Superior Court on the basis that expert testimony was not essential to support
the causation component of plaintiffs' medical battery claim seeking damages for mental and emotional injuries. I also agree
that the majority has aptly summarized the Court's existing approach to informed consent claims, which, like those entailing
lack of consent, are presently categorized as involving battery rather than negligence. Nevertheless, since the issue under
review here involves simple lack of consent to the procedure performed, I would not utilize the appeal as a vehicle to
reinforce the battery approach to lack of informed consent. Indeed, there would appear to be good reasons for the Court to
select an appropriate case to undertake a reevaluation of the battery paradigm for informed consent, particularly in light of:
the weight of authority in other jurisdictions;[1] the arguable incompatibility of the battery theory (and the corresponding
concept of touching) with evaluation of informed consent in the context of some medical treatments such radiation therapy
753 *753 and administration of oral medications; the arguable disharmony between intentional tort theory and its associated
scienter requirements with informed consent claims; and the discomfort of various appellate jurists with the approach such
as is apparent from their opinions.[2] Of particular significance, the Court has not yet taken the opportunity to consider a
series of recent legislative modifications to the informed consent statute,[3] which, on their face, appear to incorporate
central concepts of negligence theory.
[1] Dr. Sehgal died while the Superior Court appeal was pending. On October 12, 1999, that court granted the application of his widow,
Vitasta Bazaz-Sehgal, M.D., for substitution of personal representation.
[2] Peyronie's disease is an accumulation of plaque in the corpora cavernosa, which are two cylinder-like structures inside the penis
through which blood must flow to create an erection.
[3] Aliquippa Hospital was dismissed from the case during trial with no opposition from any other party. Therefore, Sehgal and Greater
Philadelphia Impotence Center were the sole remaining defendants.
[4] Judge Popovich dissented on grounds that he was "not convinced that the evidence of causation of [appellees'] psychological injuries is
sufficiently simple, obvious, clear and direct to allow recovery in the absence of expert testimony." Thus, it appears that Judge Popovich
agreed with the majority's legal standard, but disagreed with its application of that standard.
[5] The issues in this appeal are purely questions of law which, of course, are subject to plenary review by this Court. E.g. Navickas v.
Unemployment Compensation Review Board, 567 Pa. 298, 787 A.2d 284, 288 (2001), citing Temple University v. Unemployment
Compensation Board of Review, 565 Pa. 178, 772 A.2d 416, 418 n. 1 (2001); Caterpillar, Inc. v. Unemployment Compensation Board of
Review, 550 Pa. 115, 703 A.2d 452, 456 (1997).
[6] Beyond accurately pointing out the error in the Superior Court's description of informed consent as negligence-based, appellants do not
articulate in any persuasive fashion how that error prejudiced them. Appellants note that the Superior Court's error led it to disregard their
argument premised upon relevant authority in the form of the Superior Court's informed consent decision in Maliszewski v. Rendon, 374
Pa.Super. 109, 542 A.2d 170 (1988). Appellants' argument based upon Maliszewski is to the effect that, in informed consent cases, the
plaintiff must produce expert medical testimony to prove that the surgery caused the physical injuries for which the plaintiff seeks recovery.
Brief for Appellants, 12-16. As our discussion infra will make clear, the Superior Court in this case was careful in its opinion to distinguish
between claims for damages based upon physical injuries, for which it agreed that expert testimony was necessary, and claims for mental
or emotional damages, which it held did not require expert testimony. Accordingly, the error identified by appellants in Superior Court's
approach did not affect that court's decision on the controlling issue before us.
[1] Most jurisdictions treat lack of informed consent as sounding in negligence. See, e.g., Canterbury v. Spence, 464 F.2d 772 (D.C.Cir.
1972); Dunham v. Wright, 423 F.2d 940 (3d Cir.1970); Mink v. University of Chicago, 460 F.Supp. 713, 716-17 (N.D.Ill.1978); Cobbs v.
Grant, 8 Cal.3d 229, 104 Cal.Rptr. 505, 502 P.2d 1 (1972); Mallett v. Pirkey, 171 Colo. 271, 466 P.2d 466 (1970); Nishi v. Hartwell, 52 Haw.
188, 473 P.2d 116 (1970); Kennis v. Mercy Hosp. Med. Ctr., 491 N.W.2d 161 (Iowa 1992); Natanson v. Kline, 186 Kan. 393, 350 P.2d 1093
(1960); Hodge v. Lafayette General Hosp., 399 So.2d 744, 746 (La.App.1981); Downer v. Veilleux, 322 A.2d 82 (Me. 1974); Sard v. Hardy,
281 Md. 432, 379 A.2d 1014 (1977); Baird v. American Med. Optics, 155 N.J. 54, 713 A.2d 1019 (1998); Watson v. Clutts, 262 N.C. 153,
136 S.E.2d 617 (1964); Winkjer v. Herr, 277 N.W.2d 579 (N.D. 1979); Scott v. Bradford, 606 P.2d 554 (Okla.1980); Wilkinson v. Vesey, 110
R.I. 606, 295 A.2d 676 (1972); Wilson v. Scott, 412 S.W.2d 299 (Tex. 1967); Mason v. Ellsworth, 3 Wash.App. 298, 474 P.2d 909 (1970);
Trogun v. Fruchtman, 58 Wis.2d 569, 207 N.W.2d 297 (1973); Roybal v. Bell, 778 P.2d 108 (Wyo.1989).
[2] See, e.g., Morgan v. MacPhail, 550 Pa. 202, 211-12, 704 A.2d 617, 622 (1997) (Nigro, J., dissenting); Hoffman v. Brandywine Hospital,
443 Pa.Super. 245, 256, 661 A.2d 397, 402 (1995) (Beck, J., concurring); Stover v. Association of Thoracic and Cardiovascular Surgeons,
431 Pa.Super. 11, 26 n. 6, 635 A.2d 1047, 1054 n. 6 (1993); Wu v. Spence, 413 Pa.Super. 352, 355-57, 605 A.2d 395, 396-97 (1992);
Malloy v. Shanahan, 280 Pa.Super. 440, 444-50, 421 A.2d 803, 805-08 (1980) (Hoffman, J., dissenting).
[3] See Medical Care Availability and Reduction of Error (MCARE) Act, Act No. 2002-13, H.B. No. 1802, approved March 20, 2002 (codified
as amended at 40 P.S. §§ 1303.101-1303.748 (Supp.2002)); Act of Nov. 26, 1996, P.L. 776, No. 135, § 10 (as amended, 40 P.S. §
1301.811-A) (repealed and recodified as amended at 40 P.S. § 1303.504).
1/12/2021 Vietnam Veterans of America v. Central Intelligence Agency, Dist. Court, ND California 2013 - Google Scholar
VIETNAM VETERANS OF AMERICA; TIM MICHAEL JOSEPHS; and WILLIAM

BLAZINSKI, individually, on behalf of themselves and all others similarly situated;
SWORDS TO PLOWSHARES: VETERANS RIGHTS ORGANIZATION; BRUCE PRICE;
FRANKLIN D. ROCHELLE; LARRY MEIROW; ERIC P. MUTH; DAVID C. DUFRANE; and
KATHRYN McMILLAN-FORREST, Plaintiffs,
v.
CENTRAL INTELLIGENCE AGENCY; JOHN BRENNAN, Director of the Central
Intelligence Agency; UNITED STATES DEPARTMENT OF DEFENSE; CHARLES T.
HAGEL, Secretary of Defense; UNITED STATES DEPARTMENT OF THE ARMY; JOHN
M. McHUGH, United States Secretary of the Army; UNITED STATES OF AMERICA;
ERIC H. HOLDER, Jr., Attorney General of the United States; UNITED STATES
DEPARTMENT OF VETERANS AFFAIRS; and ERIC K. SHINSEKI, United States
Secretary of Veterans Affairs, Defendants.
No. C 09-0037 CW.
United States District Court, N.D. California.
November 19, 2013.
ORDER GRANTING IN PART AND DENYING IN PART PLAINTIFFS'

MOTION FOR SUMMARY JUDGMENT (Docket No. 490) AND
GRANTING IN PART AND DENYING IN PART DEFENDANTS'
MOTION FOR SUMMARY JUDGMENT (Docket No. 495)
CLAUDIA WILKEN, District Judge.
Plaintiffs Vietnam Veterans of America, Swords to Plowshares: Veterans Rights Organization, Bruce Price,
Franklin D. Rochelle, Larry Meirow, Eric P. Muth, David C. Dufrane, Tim Michael Josephs, William Blazinski
and Kathryn McMillan-Forrest move for partial summary judgment, holding that Defendants U.S.
Department of Defense and its Secretary Charles T. Hagel (collectively, DOD) and the U.S. Department of
the Army and its Secretary John M. McHugh (collectively, Army) have legal obligations under the
Administrative Procedures Act (APA) to provide notice and medical care to test subjects. Plaintiffs do not
seek summary judgment on any of their class or individual claims against the remaining Defendants or on
any of their other claims against the DOD and the Army. Defendants United States of America; U.S.
Attorney General Eric Holder; the Central Intelligence Agency and its Director John Brennan (collectively,
CIA); the DOD; the Army; and the U.S. Department of Veterans Affairs and its Secretary Eric K. Shinseki
(collectively, DVA) oppose Plaintiffs' motion and move for summary judgment on all of Plaintiffs' individual
and class claims against them.[1] Having considered the papers filed by the parties and their arguments at
the hearing, the Court GRANTS in part and DENIES in part Plaintiffs' motion and GRANTS in part and
DENIES in part Defendants' cross-motion.
https://scholar.google.com/scholar_case?case=16224867772468076932&q=Vietnam+Veterans+of+America+v.+Central+Intelligence+Agency&hl=en… 1/32
BACKGROUND
"Military experiments using service member[s] as subjects have been an integral part of U.S. chemical
weapons program, producing tens of thousands of `soldier volunteers' experimentally exposed to a wide
range of chemical agents from World War I to about 1975." Patterson Decl., Ex. 3, Docket No. 491-3,
VET001_015677. "On June 28, 1918, the President directed the establishment of the Chemical Warfare
Service (CWS)." Gardner Decl., Ex. 1, Docket No. 496-1, PLTF014154. CWS was originally part of the War
Department and became part of the U.S. Army on July 1, 1920. Gardner Decl., Ex. 16, Docket No. 496-22,
27-28. At the end of World War I, CWS was consolidated at the Edgewood Arsenal in Maryland. Id. In
about 1922, "the CWS created a Medical Research Division to conduct research directed at providing a
defense against chemical agents." Gardner Decl., Ex. 1, Docket No. 496-1, PLTF014154. Between 1920
and 1936, the Medical Research Division continued to carry out experiments regarding chemical warfare
agents, including experiments that used human subjects, mostly drawn from personnel working at
Edgewood Arsenal. Gardner Decl., Ex. 16, Docket No. 496-22, 28.
"Formal authority to recruit and use volunteer subjects in [chemical warfare] experiments was initiated in
1942." Gardner Decl., Ex. 1, Docket No. 496-1, PLTF014154. By the end of World War II, "over 60,000 U.S.
servicemen had been used as human subjects in this chemical defense research program." Gardner Decl.,
Ex. 16, Docket No. 496-22, 1. "At least 4,000 of these subjects had participated in tests conducted with
high concentrations of mustard agents or Lewisite in gas chambers or in field exercises over contaminated
ground area." Id. Human subjects were used in these tests to test the effectiveness of protective clothing,
among other things. Id. at 31. The most common tests were patch, or drop, tests, in which a drop of an
agent was put on the arm, to "to assess the efficacy of a multitude of protective or decontamination
ointments, treatments for mustard agent and Lewisite burns, effects of multiple exposures on sensitivity,
and the effects of physical exercise on the severity of chemical burns." Id.
After the conclusion of World War II, the CWS's research programs were scaled down and little research
was conducted between 1946 and 1950. "From 1955 to 1975, thousands of U.S. service members were
experimentally treated with a wide range of agents, primarily at U.S. Army Laboratories at Edgewood
Arsenal, Maryland." Patterson Decl., Ex. 3, Docket No. 491-3, VET001_015677; see also Answer to Fourth
Am. Compl. ¶ 5 (admitting "that the DOD used approximately 7,800 armed services personnel in the
experimentation program at Edgewood Arsenal"). During this time period, the focus of the human testing
was on newer chemical agents that were "perceived to pose greater threats than sulfur mustard or
Lewisite," including nerve gases and psychoactive drugs. Gardner Decl., Ex. 16, Docket No. 496-22, 46;
see also Answer to Fourth Am. Compl. ¶ 5 (admitting that the "DOD administered 250 to 400 chemical and
biological agents during the course of its research at Edgewood Arsenal involving human subjects").
Between 1954 and 1973, about 2,300 individuals, who entered military service as conscientious objectors
and ninety percent of whom were Seventh Day Adventists, were used as human subjects in experiments to
test biological agents at Fort Detrick in Frederick, Maryland. Gardner Decl., Ex. 12, Docket No. 496-18,
183.
The Department of Defense no longer tests live agents on human subjects. Gardner Decl., Ex. 4 (Depo. of
Anthony Lee), Docket No. 496-6, 45:1-46:8. Human testing of chemical compounds at Edgewood Arsenal
was suspended on July 28, 1976, although "protective suit tests" continued to take place between 1976
and 1979. Gardner Decl., Ex. 7 (Decl. of Lloyd Roberts), ¶ 4.
Various memoranda and regulations were intended to govern these experiments. In February 1953, the
Secretary of Defense issued the Wilson Directive to the Secretaries of the Army, Navy and Air Force.
Patterson Decl., Ex. 4, Docket No. 491-4, C-001. In it, he informed them that "the policy set forth will govern
the use of human volunteers by the Department of Defense in experimental research in the fields of atomic,
biological and/or chemical warfare." Id. The Wilson Directive stated, "The voluntary consent of the human
subject is absolutely essential," and provided,
This means that the person involved should have legal capacity to give consent; should be so
situated as to be able to exercise free power of choice, without the intervention of any element
of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion;
and should have sufficient knowledge and comprehension of the elements of the subject
matter involved as to enable him to make an understanding and enlightened decision. This
latter element requires that before the acceptance of an affirmative decision by the experiment
subject there should be made known to him the nature, duration, and purpose of the
experiment; the method and means by which it is to be conducted; all inconveniences and
hazards reasonably to be expected; and the effects upon his health or person which may
possibly come from his participation in the experiment.
Id. at C-001-02. It further stated, "Proper preparation should be made and adequate facilities provided to
protect the experimental subject against even remote possibilities of injury, disability, or death." Id. at C-003.
The memorandum provided, "The Secretaries of the Army, Navy and Air Force are authorized to conduct
experiments in connection with the development of defense of all types against atomic, biological and/or
chemical warfare agents involving the use of human subjects within the limits prescribed above." Id. The
Secretary of Defense warned that the addressees "will be responsible for insuring compliance with the
provisions of this memorandum within their respective Services." Id.
A June 1953 Department of the Army memorandum, CS: 385, repeated the requirements set forth in the
Wilson Directive and further stated, "Medical treatment and hospitalization will be provided for all casualties
of the experimentation as required." Patterson Decl., Ex. 5, Docket No. 491-5, VVA 024544.
These requirements were codified in Army Regulation (AR) 70-25, which was promulgated on March 26,
1962 and later reissued in 1974. See Gardner Decl., Exs. 47, 48, Docket Nos. 496-55, 496-56. Both
versions set forth "[c]ertain basic principles" that "must be observed to satisfy moral, ethical, and legal
concepts." Gardner Decl., Ex. 47, Docket No. 496-55, 1; Gardner Decl., Ex. 48, Docket no. 496-56, 1. Like
the earlier memoranda, the regulations provided, "Voluntary consent is absolutely essential," and stated,
The volunteer will have legal capacity to give consent, and must give consent freely without
being subjected to any force or duress. He must have sufficient understanding of the
implications of his participation to enable him to make an informed decision, so far as such
knowledge does not compromise the experiment. He will be told as much of the nature,
duration, and purpose of the experiment, the method and means by which it is to be
conducted, and the inconveniences and hazards to be expected, as will not invalidate the
results. He will be fully informed of the effects upon his health or person which may possibly
come from his participation in the experiment.
Gardner Decl., Ex. 47, Docket No. 496-55, 1; Gardner Decl., Ex. 48, Docket No. 496-56, 1. The regulations
also mandated, "Required medical treatment and hospitalization will be provided for all casualties." Gardner
Decl., Ex. 47, Docket No. 496-55, 2; Gardner Decl., Ex. 48, Docket No. 496-56, 2.
On August 8, 1979, Army General Counsel Jill Wine-Volner issued a memorandum to various high-level
Army officials, entitled, "Notification of Participants in Drug or Chemical/Biological Agent Research."
Patterson Decl., Ex. 6, Docket No. 491-6, VET123-084994-95. In the memorandum, Wine-Vollner asked for
input regarding the creation of a program to "notify those individuals who were not fully informed
participants and may have suffered injury or be subject to a possible injury." Id. at VET123-084994. She
stated that "the legal necessity for a notification program is not open to dispute" and that the Army may be
held to have a legal obligation to notify those who are still adversely affected by their prior involvement in its
testing programs. Id. In a subsequent memorandum issued on September 24, 1979, Wine-Volner advised
the Director of the Army Staff, "If there is reason to believe that any participants in such research programs
face the risk of continuing injury, those participants should be notified of their participation and the
information known today concerning the substance they received." Patterson Decl., Ex. 7, Docket No. 491-
7, VET017-000279. This was to take place "regardless of whether the individuals were fully informed
volunteers at the time the research was undertaken." Id.
On October 25, 1979, John R. McGiffert, Director of the Army Staff, issued a memorandum to establish
"Army Staff responsibilities for review of past Army research involving possible military applications of drug
or chemical/biological agents," with the objective "to identity and notify those research participants who may
face the risk of continuing injury." Patterson Decl., Ex. 8, Docket No. 491-8, VET030-022686. The
memorandum provided, "In the event that long-term hazards of a substance are not known, The Surgeon
General (TSG) should continue to monitor research developments, and if at some future time more
information makes it necessary to take some action, TSG should recommend appropriate action, including
notification." Id. at VET030-022687. On November 2, 1979, the Army informed Congress of this notification
plan and the plan of the Surgeon General to ask the National Academy of Sciences to assist in reviewing
the effects of the drugs and agents. Patterson Decl., Ex. 9, Docket No. 491-9, VET030-022692-93.
On December 11, 1981, the Army published in the Federal Register a proposed amendment to a record
keeping system. 46 Fed. Reg. 60,639. The proposed system, to become effective on January 11, 1982,
was called the "Research and Experimental Case Files" and maintained records for individuals who were "
[v]olunteers (military members, Federal civilian employees, state prisoners) who participated in Army tests
of potential chemical agents and/or antidotes from the early 1950's until the program ended in 1975." Id.
The purpose of the system was for use by "the Department of the Army: (1) to follow up on individuals who
voluntarily participated in Army chemical/biological agent research projects for the purpose of assessing
risks/hazards to them, and (2) for retrospective medical/scientific evaluation and future scientific and legal
significance." Id.
On June 30, 1986, the Army proposed the creation of a new record system entitled the "Medical Research
Volunteer Registry." 51 Fed. Reg. 23,576. Included in the system were "[r]ecords of military members,
civilian employees, and non-DOD civilian volunteers participating in current and future research sponsored
by the U.S. Army Medical Research and Development Command." Id. Among the purposes of the system
were to "assure that the U.S. Army Medical Research and Development Command (USAMRDC) can
contact individuals who participated in research conducted/sponsored by the Command in order to provide
them with newly acquired information, which may have an impact on their health," and to "answer inquiries
concerning an individual's participation in research sponsored/conducted by USAMRDC." Id. AR 70-25 was
not listed among the authorities for the maintenance of the system.
Both record systems were amended several times during the 1980s. On May 10, 1988, the Army published
a proposed change, which changed the name of the "Medical Research Volunteer Registry" to "Research
Volunteer Registry" and expanded it to encompass research conducted by the U.S. Army Chemical
Research, Development and Engineering Center (CRDEC). 53 Fed. Reg. 16,575.
On August 8, 1988, the Army issued an updated version of AR 70-25, which became effective on
September 30, 1988.[2] Gardner Reply Decl., Ex. 87, Docket No. 513-13, 1. Among other changes, this
version added a provision stating,
Duty to warn. Commanders have an obligation to ensure that research volunteers are
adequately informed concerning the risks involved with their participation in research, and to
provide them with any newly acquired information that may affect their well-being when that
information becomes available. The duty to warn exists even after the individual volunteer has
completed his or her participation in research. To accomplish this, the MACOM [(major Army
Commands)] or agency conducting or sponsoring research must establish a system which will
permit the identification of volunteers who have participated in research conducted or
sponsored by that command or agency, and take actions to notify volunteers of newly acquired
information. (See a above.)
Id. at 5. Section a, which was referred to in this passage, requires that MACOM commanders and
organization heads "[p]ublish directives and regulations for . . . [t]he procedures to assure that the
organization can accomplish its `duty to warn.'" Id. at 5. The regulation also required the Army to create and
maintain a "volunteer database" so that it would be able "to readily answer questions concerning an
individual's participation in research" and "to ensure that the command can exercise its `duty to warn.'" Id.
at 18. It mandated, "The data base must contain items of personal information, for example, name, social
security number (SSN), etc., which subjects it to the provisions of The Privacy Act of 1974." Id. It further
provided, "Volunteers are authorized all necessary medical care for injury or disease that is a proximate
result of their participation in research." Id. at 4. The regulation also required that informed consent be
given in accordance with appendix E. Id. at 6, 20. Appendix E included, among other things:
E-3. Description of the study
A statement that the study involves research. An explanation of the purpose of the study and
the expected duration of the subject's participation. A description of the procedures to be
followed. An identification of any experimental procedures. A statement giving information
about prior, similar, or related studies that provide the rationale for this study.
E-4. Risks
A description of any reasonably foreseeable risks or discomforts to the subject.
E-5. Benefits
A description of the benefits, if any, to the subject or to others that may reasonably be
expected from the study. If there is no benefit to the subject, it should be so stated.
...
E-9. Subject's rights
A statement that —
a. Participation is voluntary.
...
Id. at 12. The definition for "human subject" included, with limited exceptions, a "living individual about
whom an investigator conducting research obtains data through interaction with the individual, including
both physical procedures and manipulations of the subject or the subject's environment." Id. at 20.
In 1989 and 1990, AR 70-25 was again updated. Gardner Decl., Ex. 49, Docket No. 496-57, i; Gardner
Reply Decl., Ex. 88, Docket No. 513-14, 1. The 1990 version added a provision stating that the regulation
applied to "Research involving deliberate exposure of human subjects to nuclear weapons effect, to
chemical warfare agents, or to biological warfare agents." Gardner Decl., Ex. 49, Docket No. 496-57, 1.
On November 21, 1990, the name of the "Research Volunteer Registry" was changed to the "Medical
Research Volunteer Registry." 55 Fed. Reg. 48,671. At that time, its system identification number was
changed to "A0070-25DASG." Id.
On September 24, 1991, the Army proposed changes to both the "Research and Experimental Case Files"
and the "Medical Research Volunteer Registry" record systems. 56 Fed. Reg. 48,179-81, 48,187. At that
time, both were kept materially the same as the earlier versions.
In 1991, the DOD issued regulations addressing the protection of human test subjects. 56 Fed. Reg.
28,003 (codified at 32 C.F.R. §§ 29.101-124). These regulations adopted some of the basic principles of
informed consent set forth in the Wilson Directive. See 32 C.F.R. § 219.116.
On December 1, 2000, the Army proposed the deletion of the "Research Volunteer Registry," stating that its
records "have been incorporated" into a new system of records, the "Medical Scientific Research Data
Files." 65 Fed. Reg. 75,249. This new records system was also given the system identifier of "A0070-25
DASG." Id. AR 70-25 was identified among the authorities for the maintenance of that records system. Id.
The purposes of the new data system included, "To answer inquiries and provide data on health issues of
individuals who participated in research conducted or sponsored by U.S. Army Medical Research Institute
of Infectious Diseases, U.S. Army Medical Research and Development Command, and U.S. Army
Chemical Research, Development, and Engineering Center," and to "provide individual participants with
newly acquired information that may impact their health." Id. Among the categories of people whose
records were included in the new system were "individuals who participate in research sponsored by the
U.S. Army Medical Research and Development Command and the U.S. Army Chemical Research,
Developments, and Engineering Center; and individuals at Fort Detrick who have been immunized with a
biological product or who fall under the Occupational Health and Safety Act or Radiologic Safety Program."
Id. Information in the database "may specifically be disclosed . . . [t]o the Department of Veteran Affairs to
assist in making determinations relative to claims for service connected disabilities; and other such
benefits." Id.
In 2002, Congress passed section 709 of the National Defense Authorization Act for Fiscal Year 2003
(NDAA), Pub. L. No. 107-314, Div. A, Title VII, Subtitle A, § 709(c), 116 Stat. 2458 (the "Bob Stump Act"),
which required the Secretary of Defense to work to identify projects or tests "conducted by the Department
of Defense that may have exposed members of the Armed Forces to chemical or biological agents."
The DOD has issued two memoranda releasing veterans in part or in full from secrecy oaths that they may
have taken in conjunction with testing. The first, issued by former Secretary of Defense William Perry in
March 1993, releases
any individuals who participated in testing, production, transportation or storage associated

with any chemical weapons research conducted prior to 1968 from any non-disclosure
restrictions or written or oral prohibitions (e.g., oaths of secrecy) that may have been placed on
them concerning their possible exposure to any chemical weapons agents.
Gardner Decl., Ex. 42, Docket No. 496-50, VVA XXXXXX-XX.
The second, issued by the Office of the Deputy Secretary of Defense on January 11, 2011, after the instant
litigation began, does not have a date restriction and states,
In the 1990s, several reviews of military human subject research programs from the World War
II and Cold War eras noted the common practice of research volunteers signing "secrecy
oaths" to preclude disclosure of research information. Such oaths or other non-disclosure
requirements have reportedly inhibited veterans from discussing health concerns with their
doctors or seeking compensation from the Department of Veterans Affairs for potential service-
related disabilities.
...
To assist veterans seeking care for health concerns related to their military service, chemical
or biological agent research volunteers are hereby released from non-disclosure restrictions,
including secrecy oaths, which may have been placed on them. This release pertains to
addressing health concerns and to seeking benefits from the Department of Veterans Affairs.
Veterans may discuss their involvement in chemical and biological agent research programs
for these purposes. This release does not affect the sharing of any technical reports or
operational information concerning research results, which should appropriately remain
classified.
...
This memorandum, which is effective immediately, does not affect classification or control of
information, consistent with applicable authority, relating to other requirements pertaining to
chemical or biological weapons.
Gardner Decl., Ex. 53, Docket No. 496-61, VET021-000001-02.
The DVA processes service-connected death or disability compensation (SCDDC) claims of class
members. To establish that a death or disability is connected to a veteran's participation in the testing
programs for the purposes of SCDDC claims, individuals seeking survivor or disability benefits must
establish that "it is at least as likely as not that such a relationship exists."
Plaintiffs contend that the DVA participated in some capacity in some of the other Defendants' testing
programs. Plaintiffs also argue that the DVA engaged in human testing of similar substances, including LSD
and Thorazine.
Defendants have undertaken some efforts to contact and provide notice to participants in the testing
programs. In 1990, the DVA contacted 128 veterans who participated in World War II mustard gas testing;
Defendants do not provide evidence of what information these individuals were provided then. Gardner
Decl., Ex. 15, DVA014 001257. In recent years, the DVA, using databases compiled by DOD and its
contractor, Batelle Memorial Institute, sent notice letters to certain individuals who participated in some
WWII and Cold War era testing programs. For the first round of letters related to WWII era testing, which
were sent in 2005, DOD identified approximately 6,400 individuals who had been exposed to mustard gas
or other agents during WWII and compiled a database with 4,618 entries. Starting in March 2005, the DVA
sent letters to approximately 319 individuals or their survivors for whom DVA could find current contact
information. These letters stated in part,
You may be concerned about discussing your participation in mustard agent or Lewisite tests
with VA or your health care provider.
On March 9, 1993 the Deputy Secretary of Defense released veterans who participated in the
testing, production, transportation or storage of chemical weapons prior to 1968 from any non-
disclosure restriction. Servicemembers who participated in such tests after 1968 are permitted
to discuss the chemical agents, locations, and circumstances of exposure only, because this
limited information has been declassified.
In response to the passage of the Bob Stump Act, DOD began in 2004 to search for Cold War era test
information. In addition, in April 2005, members of Congress on the House Veterans' Affairs Committee
requested that the DVA provide written notice to the living veterans who participated in the test programs at
Edgewood Arsenal and Fort Detrick. DOD created a database of information about Cold War era test
veterans with, among other things, information on the substances they were exposed to, the dose and the
route of administration, and where the information was available. The information came primarily from the
test participant files for each person. DOD provided this information to the DVA for use in making service-
connected health care and disabilities determinations. In December 2005, the DOD began providing DVA
with the names of test subjects and continued to do so after that when new information was located. As of
the present time, the DOD has given the DVA the names of 16,645 Cold War era test subjects. The DVA
has sent letters to each veteran in the database for whom it could locate current contact information, which
at present totals about 3,300 individuals.
Defendants did not include in the letters to Cold War era test subjects the names of the chemical or
biological agents to which the participants were exposed or information that was tailored to the individual
recipient. Defendants explain that they did not do so for several reasons, including that it would have taken
too long, the information provided by the DOD to the DVA was changing, the DVA did not want to send
veterans inaccurate information, alarm them or make them think they would suffer adverse effects if these
were unlikely.
The letters sent to the Cold War era test subjects by the DVA stated,
You may be concerned about releasing classified test information to your health care provider
when discussing your health concerns. To former service members who have participated in
these tests, DoD has stated:
"You may provide details that affect your health to your health care provider. For example, you
may discuss what you believe your exposure was at the time, reactions, treatment you sought
or received, and the general location and time of the tests. On the other hand, you should not
discuss anything that relates to operational information that might reveal chemical or biological
warfare vulnerabilities or capabilities."
...
If you have questions about chemical or biological agent tests, or concerns about releasing
classified information, contact DoD at (800) 497-6261, Monday through Friday, 7:30 a.m. to
4:00 p.m. Eastern Standard time.
The letter also provided information about obtaining a clinical examination from the DVA and contacting the
DVA to file a disability claim. If individuals called DOD's 1-800 number provided in the letter, they could
obtain further information about the tests and staff at the hotline would, at least sometimes, refer them to an
Army FOIA officer who had the authority to copy and send them their own individual test files; since
requests were tracked starting in 2006, the Army has received approximately 114 such requests. Gardner
Decl., Ex. 29, Docket No. 496-37, 16:18-17:4. The DVA also included a fact sheet from the DOD. The
DVA's expert in chemical agent exposures recognized that this fact sheet "has some significant
inaccuracies."
Defendants have also engaged in other types of outreach to past test participants. The DOD has placed
some information on its public website, including general information about the testing conducted, the
contents of the Perry memorandum and information about how to contact the DOD's 1-800 hotline for
additional information. DVA's website also contains some substantive information about the WWII and Cold
War era testing programs. The DOD and DVA have also held briefings for some veteran service
organizations.
LEGAL STANDARD
Summary judgment is properly granted when no genuine and disputed issues of material fact remain, and
when, viewing the evidence most favorably to the non-moving party, the movant is clearly entitled to prevail
as a matter of law. Fed. R. Civ. P. 56; Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986); Eisenberg v.
Ins. Co. of N. Am., 815 F.2d 1285, 1288-89 (9th Cir. 1987).
The moving party bears the burden of showing that there is no material factual dispute. Therefore, the court
must regard as true the opposing party's evidence, if supported by affidavits or other evidentiary material.
Celotex, 477 U.S. at 324; Eisenberg, 815 F.2d at 1289. The court must draw all reasonable inferences in
favor of the party against whom summary judgment is sought. Matsushita Elec. Indus. Co. v. Zenith Radio
Corp., 475 U.S. 574, 587 (1986); Intel Corp. v. Hartford Accident & Indem. Co., 952 F.2d 1551, 1558 (9th
Cir. 1991).
Material facts which would preclude entry of summary judgment are those which, under applicable
substantive law, may affect the outcome of the case. The substantive law will identify which facts are
material. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
Where the moving party does not bear the burden of proof on an issue at trial, the moving party may
discharge its burden of production by either of two methods:
The moving party may produce evidence negating an essential element of the nonmoving
party's case, or, after suitable discovery, the moving party may show that the nonmoving party
does not have enough evidence of an essential element of its claim or defense to carry its
ultimate burden of persuasion at trial.
Nissan Fire & Marine Ins. Co., Ltd., v. Fritz Cos., Inc., 210 F.3d 1099, 1106 (9th Cir. 2000).
If the moving party discharges its burden by showing an absence of evidence to support an essential
element of a claim or defense, it is not required to produce evidence showing the absence of a material fact
on such issues, or to support its motion with evidence negating the non-moving party's claim. Id.; see also
Lujan v. Nat'l Wildlife Fed'n, 497 U.S. 871, 885 (1990); Bhan v. NME Hosps., Inc., 929 F.2d 1404, 1409 (9th
Cir. 1991). If the moving party shows an absence of evidence to support the non-moving party's case, the
burden then shifts to the non-moving party to produce "specific evidence, through affidavits or admissible
discovery material, to show that the dispute exists." Bhan, 929 F.2d at 1409.
If the moving party discharges its burden by negating an essential element of the non-moving party's claim
or defense, it must produce affirmative evidence of such negation. Nissan, 210 F.3d at 1105. If the moving
party produces such evidence, the burden then shifts to the non-moving party to produce specific evidence
to show that a dispute of material fact exists. Id.
If the moving party does not meet its initial burden of production by either method, the non-moving party is
under no obligation to offer any evidence in support of its opposition. Id. This is true even though the non-
moving party bears the ultimate burden of persuasion at trial. Id. at 1107.
DISCUSSION
Defendants assert that there is no legally enforceable duty under the APA to provide notice to past test
subjects. They also argue that the Court lacks subject matter jurisdiction over Plaintiffs' APA claim for
medical care for class members and contend that there is no statutory authority for the DOD or the Army to
provide the care requested and no duty to do so created by the various memoranda or regulations. They
further argue that the class members have no constitutional entitlement to notice or health care.
Defendants also seek summary judgment on Plaintiffs' claims against the CIA and DOD regarding secrecy
oaths. Finally, they seek summary judgment on Plaintiffs' "biased adjudicator" claim against the DVA.
I. APA claims regarding notice and medical care
Title 5 U.S.C. § 702, the judicial review provision of the APA, "permits a citizen suit against an agency when
an individual has suffered à legal wrong because of agency action'. . . ." Rattlesnake Coalition v. United
States EPA, 509 F.3d 1095, 1103 (9th Cir. 2007) (quoting 5 U.S.C. § 702). For § 702 claims, 5 U.S.C. § 706
"prescribes standards for judicial review and demarcates what relief a court may (or must) order."
Rosemere Neighborhood Ass'n v. United States EPA, 581 F.3d 1169, 1172 n.2 (9th Cir. 2009). When a
plaintiff asserts an agency's failure to act, a court can grant relief by compelling "agency action unlawfully
withheld or unreasonably delayed." 5 U.S.C. § 706(1).
Plaintiffs' claims in the Fourth Amended Complaint against the DOD and the Army assert that, under the
APA, they are required to provide class members with notice of their exposures and known health effects,
and medical care as set forth in the agencies' own policies. By notice, Plaintiffs mean "notice to each test
participant regarding the substances to which he or she was exposed, the doses to which he or she was
exposed, the route of exposure (e.g., inhalation, injection, dermal, etc.) and the known or potential health
effects associated with those exposures or with participation in the tests." Mot. at 1 n.1.
https://scholar.google.com/scholar_case?case=16224867772468076932&q=Vietnam+Veterans+of+America+v.+Central+Intelligence+Agency&hl=e… 10/32
A. Claim for notice
1. Whether the regulations and memoranda have the "force of law"
Defendants contend that the Wilson Directive, CS: 385 and AR 70-25 "lack the force of law." Defs.'
Corrected Reply, Docket No. 513-1, 3.
A "`claim under § 706(1) can proceed only where a plaintiff asserts that an agency failed to take a discrete
agency action that it is required to take.'" Sea Hawk Seafoods, Inc. v. Locke, 568 F.3d 757, 766 (9th Cir.
2009) (quoting Norton v. S. Utah Wilderness Alliance, 542 U.S. 55, 64 (2004)) (emphasis in original).
"Discrete" actions include providing "rules, orders, licenses, sanctions, and relief." Hells Canyon, 593 F.3d
at 932. A discrete action is legally required when "the agency's legal obligation is so clearly set forth that it
could traditionally have been enforced through a writ of mandamus." Id. (citing Norton, 542 U.S. at 63).
"The limitation to required agency action rules out judicial direction of even discrete agency action that is
not demanded by law (which includes, of course, agency regulations that have the force of law)." Norton,
542 U.S. at 65 (emphasis in original).
In its January 19, 2010 and May 31, 2011 orders resolving Defendants' motions to dismiss, the Court
recognized that "Army regulations have the force of law." Docket No. 59, 15; Docket No. 233, 9; see also
Kern Copters, Inc. v. Allied Helicopter Serv., Inc., 277 F.2d 308, 310 (9th Cir. 1960) (stating that "Army
regulations have the force of law"). Defendants nonetheless contend that "not all regulations possess the
force of law" and that AR 70-25 was promulgated pursuant to 10 U.S.C. §§ 3013 and 4503, which are
"housekeeping" statutes, merely authorizing day to day internal operations, so this regulation cannot serve
as the basis for Plaintiffs' APA claims. Defs.' Opp. and Cross-Mot., Docket No. 495, 16-17; Defs.' Corrected
Reply, Docket No. 513-1, 4-5. Defendants have previously made similar arguments. In their motion to
dismiss Plaintiffs' third amended complaint, Defendants argued that the 1962 version of AR 70-25 was
promulgated pursuant to 5 U.S.C. § 301, which was a housekeeping statute, and thus could not create a
benefits entitlement. The Court rejected this argument, stating "there is nothing in AR 70-25 (1962) or
Plaintiffs' complaint to suggest that the regulation was issued pursuant to section 301." Docket No. 233, 10.
In support of their new argument, Defendants rely primarily on Chrysler Corporation v. Brown, 441 U.S. 281
(1979), in which the Supreme Court considered whether certain regulations promulgated by the
Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) had the force of law. In
that case, the Court said, "In order for a regulation to have the `force and effect of law,' it must have certain
substantive characteristics and be the product of certain procedural requisites." Id. at 302. It distinguished
between "substantive rules" that "affect[] individual rights and obligations" and "interpretive rules, general
statements of policy, or rules of agency organization, procedure, or practice." Id.; see also Vance v.
Hegstrom, 793 F.2d 1018, 1022 (9th Cir. 1986) (explaining that substantive rules "implement existing law,
imposing general, extrastatutory obligations pursuant to authority properly delegated by Congress,"
whereas "[i]nterpretive rules clarify and explain existing law or regulations" and "are issued without
delegated legislative power and go more to what the administrative officer thinks the statute or regulation
means") (internal quotation marks and citations omitted). The Court stated, "That an agency regulation is
substantive, however, does not by itself give it the `force and effect of law.'" Chrysler, 441 U.S. at 302.
Because the "legislative power of the United States is vested in the Congress, . . . the exercise of quasi-
legislative authority by governmental departments and agencies must be rooted in a grant of such power by
Congress and subject to limitations which that body imposes." Id. The Court rejected the argument that the
requisite grant of legislative authority for the regulations at issue in that case could be found in 5 U.S.C. §
301, which the Court labeled a "housekeeping statute." Id. at 309-10. A "housekeeping statute" is "simply a
grant of authority to the agency to regulate its own affairs . . . authorizing what the APA terms `rules of
agency organization, procedure or practice' as opposed to `substantive rules.'" Id.
Defendants concede that "AR 70-25 may appear to contain substantive rules." Defs.' Opp. and Cross-Mot.,
Docket No. 495, 16. They argue however that, because it was issued under 10 U.S.C. §§ 3013 and 4503,
which they contend are housekeeping statutes, AR 70-25 was not promulgated pursuant to a specific
statutory grant of authority sufficient to create enforceable rights.
Defendants are correct that AR 70-25 was promulgated under 10 U.S.C. §§ 3013 and 4503. The 1988,
1989 and 1990 versions state, in Appendix G under section G-1, titled "Authority,"
The Secretary of the Army is authorized to conduct research and development programs
including the procurement of services that are needed for these programs (10 USC 4503). The
Secretary has the authority to "assign detail and prescribe the duties" of the members of the
Army and civilian personnel (10 USC 3013).
Patterson Decl., Ex. 2, Docket No. 491-2, 13 (1990 version); Gardner Reply Decl., Ex. 88, Docket No. 513-
14, 17 (1989 version); Gardner Reply Decl., Ex. 87, Docket No. 513-13, 17 (1988 version). Appendices to
the 1962 and 1974 versions, which provided "opinions of The Judge Advocate General" to "furnish specific
guidance for all participants in research using volunteers," made similar statements. Gardner Decl., Ex. 47,
Docket No. 496-55, 4 (1962 version); Gardner Decl., Ex. 48, Docket No. 496-56, 4 (1974 version).[3]
The former § 4503, which was originally enacted in 1950 as section 104 of the Army and Air Force
Authorization Act of 1949, 64 Stat. 322, 5 U.S.C. § 235a and eventually repealed in 1993, provided in
relevant part, "The Secretary of the Army may conduct and participate in research and development
programs relating to the Army, and may procure or contract for the use of facilities, supplies, and services
that are needed for those programs." 10 U.S.C. § 4503 (1992). Section 3013 sets forth the responsibilities
and authority of the Secretary of the Army, including to "assign, detail, and prescribe the duties of members
of the Army and civilian personnel," and to "prescribe regulations to carry out his functions, powers, and
duties under this title." 10 U.S.C. § 3013(g).[4]
In their reply, Defendants represent that, in Schism v. United States, 316 F.3d 1259 (Fed. Cir. 2002), the
Federal Circuit "expressly" found that 10 U.S.C. § 3013 cannot serve as the "statutory basis authorizing
DoD to provide ongoing medical care for former service members because it would usurp Congress'
authority to control the purse strings for medical care." Defs.' Reply, Docket No. 513-1, 5.
However, the Federal Circuit did not so hold in Schism. In that case, the court considered the enforceability
of oral promises of military recruiters, made under the direction of supervisors, to new recruits that, if they
served on active duty for at least twenty years, they and their dependents would receive free lifetime
medical care. Id. at 1262. The principal question before the court was whether the oral promises made to
the plaintiffs were within the authority of the Air Force Secretary under 5 U.S.C. § 301. Id. at 1263. The
court held that, pursuant to Chrysler, § 301 "merely authorize[d] housekeeping" and not "the right to make
promises of lifetime health care." Id. at 1279-81. The court also addressed the plaintiffs' argument that "the
Commander-in-Chief's inherent power in combination with 10 U.S.C. §§ 3013, 5013, and 8013 — which
authorize the positions and enumerate the duties of the Secretaries of the Army, Navy, and Air Force
respectively — authorized the recruiters' promises." Id. at 1287-88. The court found that the President, as
Commander-in-Chief, did not have such inherent authority, because "[u]nder Article I, § 8, only Congress
has the power of the purse" and thus such a conclusion would encroach Congress's constitutional powers
to appropriate funding. Id. at 1288. The court did not apply this reasoning to 10 U.S.C. § 3013, which was
not applicable to the plaintiffs in that case, who were Air Force retirees. Id. at 1289. The court found that 10
U.S.C. § 8013, the corresponding statute for the Secretary of the Air Force, did not authorize the recruiters'
promises because the versions relevant to the plaintiffs there did not include "`recruiting' in the enumerated
powers" and, even if they did, "the Secretary's authority to conduct recruiting does not carry with it the
broad authority to make promises that bind future Congresses to appropriate funding for free lifetime care."
Id.
This case is distinguishable from Schism. Here, at the time that AR 70-25 was promulgated, there was a
statutory provision, 10 U.S.C. § 4503, that expressly authorized the Secretary of the Army to conduct
research and development and to "procure or contract for the use of facilities, supplies, and services that
are needed for those programs." 10 U.S.C. § 4503. Title 10 U.S.C. § 3013(g) gave the Secretary the power
to prescribe regulations to carry out his functions, powers and duties under that title, including § 4503.
Thus, Congress delegated to the Secretary of the Army the authority to contract for services needed to
carry out research and to implement regulations to do so. There is no reason that this would exclude
adopting a regulation promising to provide volunteers with medical treatment associated with injuries or
illnesses that result from participation in testing. Therefore, because AR 70-25 is a substantive rule and
was promulgated under 10 U.S.C. §§ 3013 and 4503, statutory grants of authority sufficient to create
enforceable rights, it created duties that are enforceable against the Army under the APA.
The parties also dispute whether the Wilson Directive and CS: 385 can create duties that are enforceable
under § 706(1) of the APA. The Ninth Circuit has created
a two-part test for determining when agency pronouncements have the force and effect of law:
"To have the force and effect of law, enforceable against an agency in federal court, the
agency pronouncement must (1) prescribe substantive rules — not interpretive rules, general
statements of policy or rules of agency organization, procedure or practice — and (2) conform
to certain procedural requirements. To satisfy the first requirement the rule must be legislative
in nature, affecting individual rights and obligations; to satisfy the second, it must have been
promulgated pursuant to a specific statutory grant of authority and in conformance with the
procedural requirements imposed by Congress."
River Runners for Wilderness v. Martin, 593 F.3d 1064, 1071 (9th Cir. 2010) (quoting United States v. Fifty-
Three (53) Eclectus Parrots, 685 F.2d 1131, 1136 (9th Cir. 1982)); see also Rank v. Nimmo, 677 F.2d 692,
698 (9th Cir. 1982) (same).
Defendants argue that these documents do not meet either of the requirements described in River
Runners. First, they contend that there is nothing in these documents that sets forth substantive rules that
demonstrate a binding obligation and that they were instead general statements of agency policy and
procedure. Defs.' Opp. and Cross-Mot., Docket No. 495, 14-16. In response, Plaintiffs point to the language
in the memoranda that they say "is indicative of a binding commitment (setting forth what the agency `will'
or `shall' do)." Pls.' Reply and Opp., Docket No. 502, 2-3. Both parties rely on Norton v. Southern Utah
Wilderness Alliance, 542 U.S. 55 (2004). Plaintiffs point out that, in Norton, the Supreme Court suggested
that even an agency's "plan," which is less formal than regulations, may "itself create[] a commitment
binding on the agency," at least where there is a "clear indication of binding commitment in the terms of the
plan." Id. at 69-70. Defendants respond that, in Norton, the Court found that the statement in the plan that
the agency "`will' take this, that, or the other action" was insufficient to create a binding commitment, absent
other supporting evidence.
As Plaintiffs point out, there is clear language in both memoranda that demonstrates that their dictates were
intended to be mandatory. In the Wilson Directive, the Secretary of Defense stated that the participation of
human volunteers in testing "shall be subject" to the conditions that he set forth in the memorandum, and
authorized the Secretaries of the Army, Navy and Air Force to conduct experiments using such subject only
"within the limits" that he had prescribed. Patterson Decl., Ex. 4, Docket No. 491-4, C-001-3. He also
informed the Secretaries of the Army, Navy and Air Force that they would be required to "insur[e]
compliance" with these dictates within their agencies. Id. at C-003. CS: 385 similarly stated that these
requirements "must be observed" and described obtaining of informed consent as a "duty and
responsibility." Patterson Decl., Ex. 5, Docket No. 491-5, VVA 024538. Unlike in River Runners, the dictates
of these policies and the conditions for the use of human subjects contained therein were not waivable and
could not be modified on a case-by-case basis. Cf. River Runners, 593 F.3d at 1071-72. Further, the
policies did not simply govern internal procedures. Instead, they proscribed obligations on the part of
Defendants toward individuals whom they used to test chemical and biological agents. As such, they
manifestly "affect[] individual rights." Chrysler, 441 U.S. at 302.
Second, Defendants argue that these memoranda were not promulgated pursuant to any specific grant of
authority from Congress. They state that "at least one court has expressly held that the Wilson
Memorandum lacks the force of law because `[t]here simply is no nexus between the [Wilson
Memorandum] and a corresponding delegation of legislative authority by the United States Congress."
Defs.' Reply, Docket No. 513-1, 4 (quoting In re Cincinnati Radiation Litig., 874 F. Supp. 796, 827 (S.D.
Ohio 1995)) (brackets in original). In Cincinnati, the plaintiffs cited two bases for the authority of the Wilson
Directive: the inherent authority of the President; and 5 U.S.C. § 301. 874 F. Supp. at 826-27. The court,
citing Chrysler, 441 U.S. at 304, rejected the proffered arguments and found no nexus with a grant of
authority from Congress. Cincinnati, 874 F. Supp. at 826-27. At the hearing on this motion, Defendants
argued that, because Plaintiffs had characterized CS: 385 as "a continuation" of the Wilson Directive, it
should fail on the same basis. Docket No. 523, 34:25-35:4.
Plaintiffs have not cited any statutory grant of power from Congress to the Secretary of Defense under
which he promulgated the Wilson Directive and none is apparent from the face of the document itself.
Accordingly, they have not met their burden to show that the Wilson Directive has the procedural requisites
to have the force and effect of law.
In contrast, CS: 385 clearly identifies its statutory authorization on its face. Like the 1962 and 1974 versions
of AR 70-25, CS: 385 contains an opinion from the Judge Advocate General pointing to 5 U.S.C. §§ 235a
and 181-4, the predecessors to 10 U.S.C. §§ 3013(g) and 4503, as granting the Secretary of the Army the
authority to conduct research and to make such assignments to Army and civilian personnel as he deems
proper. Patterson Decl., Ex. 5, Docket No. 491-5, VVA 024540. Accordingly, Plaintiffs have shown that the
requirements in River Runners are satisfied as to CS: 385 and therefore it, as well as AR 70-25, can be
enforced through the APA.
2. Content and nature of the duty to notify
Defendants contend that, even if they were binding, the Wilson Directive, CS: 385 and all versions of AR
70-25 do not compel them to issue the particular form of "notice" that Plaintiffs seek. They point out that the
memoranda and regulations do not mandate disclosure of the particular pieces of information that Plaintiffs
identify. Thus, they argue that no such legal obligation is set forth clearly enough to be legally binding upon
them. They also contend that any ongoing duty to warn created by the most recent iterations of AR 70-25 is
not owed to class members who participated in experiments before these versions were issued.
Each document, the Wilson Directive, CS: 385 and all versions of AR 70-25, contains similar language
providing that informed consent must be obtained from test subjects and that such consent includes being
told the "nature, duration, and purpose" of the testing, "the method and means by which it is to be
conducted," "all inconveniences and hazards reasonably to be expected," and the effects upon health or
person which may possibly come from participation. Although Defendants suggest that this does not
appear in the most recent versions of AR 70-25, it does appear in Appendix E thereof. See Gardner Reply
Decl., Ex. 87, Docket No. 513-13, 15; see also id. at 20 (setting forth definition of informed consent, which
"includes, when appropriate, those elements listed in appendix E of this regulation"). Defendants are
correct that the wording of the regulations does not support the exact definition of "notice" that Plaintiffs
have put forth here. However, this does not mean that the regulations do not support the duty to provide
some notice, specifically that listed in the first sentence of this paragraph.
The parties dispute whether Defendants have a "continuing duty to provide updated information as it is
acquired." Defendants argue that the regulations, except the most recent versions of AR 70-25, address
only the notice that researchers were required to provide to subjects in order to provide informed consent
before participating in a test and do not create any ongoing obligation to provide notice to test subjects after
testing was completed. As Defendants contend, the manner in which these documents are written does
support that they are directed at the provision of informed consent prior to participation in the experiments.
See First Order on Mot. to Dismiss, Docket No. 59 ("The 1962 version of AR 70-25 mandated the
disclosure of information so that volunteers could make informed decisions."). Further, Plaintiffs do not point
to anything in the regulations issued prior to 1988 that compels a contrary conclusion.
The most recent versions of AR 70-25 from 1988 through 1990 do contain a duty to warn that is manifestly
and unambiguously forward-looking in nature. In discussing the 1990 version of AR 70-25 in the order on
Plaintiffs' motion for class certification, the Court observed that, "by its terms, the section in the 1990
regulation regarding the duty to warn contemplates an ongoing duty to volunteers who have already
completed their participation in research." Class Cert. Order, Docket No. 485, 40; see also Gardner Reply
Decl., Ex. 87, Docket No. 513 13, 5 (1988 version of AR 70-25, with the provision regarding the "duty to
warn," which exists "even after the individual volunteer has completed his or her participation in the
research").
It is less clear whether this ongoing duty is owed to individuals who participated in experiments before 1988
or whether it is limited to only those who might have done so after AR 70-25 was revised in 1988. Although
the provision uses the past tense and addresses the creation of a system that will allow the "identification of
volunteers who have participated in research" so that they can be notified of newly acquired information, it
does not make clear whether it contemplates that the system would include the volunteers who participated
before it was created or if it would include only those who volunteered for research after it was created, to
allow them to be provided with additional information in the future, after they had completed their
participation. Gardner Decl., Ex. 49, Docket No. 496-57, 5. As the Court previously noted, there is nothing
in these documents that "limits these forward-looking provisions to those people who became test
volunteers after the regulation was created." Class Cert. Order, Docket No. 485, 39-40. However, there is
also nothing that clearly requires that these provisions apply to those who became test volunteers before
they were created. Although, as the Court also previously observed, "the definition for human subject or
experimental subject" contained in the 1988, 1989 and 1990 versions included, with limited exceptions, "a
living individual about whom an investigator conducting research obtains data through interaction with the
individual, including both physical procedures and manipulations of the subject or the subject's
environment," and did not explicitly "exclude individuals who were subjected to testing prior to the date of
the regulations," id. at 40, this definition also did not clearly include these individuals.
Defendants argue that, in the face of ambiguous regulations, the Court must defer to their reasonable
interpretation of their own regulations. The Rule 30(b)(6) witness for the Department of Defense and the
Army testified that "this change in AR 70-25 has an effective date of 1990, and it was not meant to
retroactively go back for all Army research conducted prior to that date primarily because the system to
effect duty to warn would have to be done at the time of research being conducted." Gardner Decl., Ex. 2,
Docket No. 496-4, 151:6-11.[5] He also testified that, in order "[t]o be able to effect a duty to warn at the
time a research program is established," the MACOM commander is required "to establish a system to do
that, to develop the roster and the location of those individuals." Id. at 139:19-140:1. He further testified that
this "has to be part of the informed consent process at the beginning of any research study" and "I do not
see how you can retrofit this requirement in completed studies." Id. at 143:1-14. He opined, "If there is no
such system in place, I don't see how it's possible for anyone to effect a duty to warn for events that
happened when such a system was not established. In other words, prior to 1990." Id. at 140: 8-12.
Generally, "agencies' interpretations of their own regulations are entitled to deference, even when their
interpretation of statutes is not." Price v. Stevedoring Servs. of Am., 697 F.3d 820, 828 (9th Cir. 2012); see
also Christopher v. SmithKline Beecham Corp., 132 S. Ct. 2156, 2166 (2012) (noting that, under Auer v.
Robbins, 519 U.S. 452 (1997), deference is "ordinarily" given to "an agency's interpretation of its own
ambiguous regulation"). However, "this general rule does not apply in all cases." Christopher, 132 S. Ct. at
2166. "Deference is undoubtedly inappropriate, for example, when the agency's interpretation is `plainly
erroneous or inconsistent with the regulation,'" or "when there is reason to suspect that the agency's
interpretation `does not reflect the agency's fair and considered judgment on the matter in question.'" Id.
(citations omitted). "This might occur when the agency's interpretation conflicts with a prior interpretation, . .
. or when it appears that the interpretation is nothing more than a convenient litigating position, . . . or a
post hoc rationalization advanced by an agency seeking to defend past agency action against attack." Id.
(internal quotation marks, citations and formatting omitted).
Where a court declines to give an interpretation Auer deference, it accords the agency's "interpretation a
measure of deference proportional to the `thoroughness evident in its consideration, the validity of its
reasoning, its consistency with earlier and later pronouncements, and all those factors which give it power
to persuade.'" Christopher, 132 S. Ct. at 2169 (quoting United States v. Mead Corp., 533 U.S. 218, 228
(2001)). This amount of consideration will "vary with circumstances" and may be "near indifference," such
as has been given in some cases when considering an "interpretation advanced for the first time in a
litigation brief." Mead, 533 U.S. at 228 (citing Bowen, 488 U.S. at 212-13).
Plaintiffs argue that the Court should not credit Defendants' explanation and testimony because it is a "post-
hoc rationalization" and a "litigation argument." Pls.' Reply and Opp. to Defs.' Cross-Mot., Docket No. 502,
16. Defendants respond that the reason they have advanced this explanation for the first time here is that
no one has attempted previously to interpret the regulation in the way that Plaintiffs do. Defendants also
argue that the creation of the separate Medical Research Volunteer Registry and Research and
Experimental Case Files systems supports their interpretation.
Defendants' arguments are not persuasive. As to their first point, that they have not previously interpreted
the regulation does not mean that whatever interpretation they put forward now must be adopted. Instead,
this simply means that there is no prior interpretation against which their current understanding can be
compared to determine whether they have maintained a consistent position or not. Further, there is
substantial reason to suspect that Defendants' current interpretation of AR 70-25 does not reflect the
Army's fair and considered judgment on the matter. According to their own briefs and admissions, they
have developed this interpretation only in the context of this litigation. See Bowen v. Georgetown Univ.
Hosp., 488 U.S. 204, 213 (1988) ("Deference to what appears to be nothing more than an agency's
convenient litigating position would be entirely inappropriate."); see also Fed. Labor Relations Auth. v.
United States Dep't of Treasury, 884 F.2d 1446, 1455 (D.C. Cir. 1989) (explaining reasons for reluctance to
defer to agency counsel's litigating positions, including that "a position established only in litigation may
have been developed hastily, or under special pressure, or without an adequate opportunity for
presentation of conflicting views"). They did so in a context that suggests that they were under special
pressure to take this position to further the defense of this action. Further, the record also suggests that
Defendants' position was developed quickly and without a careful consideration of AR 70-25 (1988) and the
context in which it was issued and developed. Notably, the agency representative upon whose
interpretation Defendants rely was mistaken about the date on which the operative parts of the regulation
were amended, suggesting that he did not have a clear understanding of the context in which these
changes were made.
Further, the explanation put forward by the DOD and Army's Rule 30(b)(6) witness is simply not accurate.
He reasons that the commander must develop the database containing the test subjects information at the
beginning of the research study in order to have the necessary information to carry out the duty to notify in
the future, if new information is uncovered later about the possible effects of a test. However, although it
may be easier to make such a database at the outset, it is also possible to create one after the fact, using
whatever information is available, as the DOD in fact attempted to do when it created the database for the
DVA's notice letters.
Finally, Defendants' argument regarding the file systems is flawed. Their explanation of the development of
the Medical Research Volunteer Registry supports that their proffered view is a post-hoc rationalization of
the development of AR 70-25 and its meaning. Defendants contend that "the Army intentionally created the
Medical Research Volunteer Registry required by AR 70-25 (1990) to contain information about volunteers
participating only in current or future research, not tests completed decades ago." Defs.' Opp. and Cross-
Mot., Docket No. 495, 21. They also argue that, in contrast, "in a separate notice published the same day,
the Army described" the Research and Experimental Case Files database as including the past volunteers;
Defendants suggest that this separate database was not created pursuant to AR 70-25. Id. at 20-21; Defs.'
Reply, Docket No. 513-1, 8-9. However, the Medical Research Volunteer Registry predated even the 1988
revision to AR 70-25 and thus was not created solely to fulfill the requirement of that regulation. AR 70-25
also was not cited as among the authorities for that Registry until it was replaced in 2000 by the Medical
Scientific Research Data Files system. The description for the new database created in 2000 removed the
language that referred to "current and future research" that had appeared in the description for the Medical
Research Volunteer Registry. Compare 58 F.R. 10,002, with 65 F.R. 75,250. Further, some stated purposes
of the new Medical Scientific Research Data Files system created in 2000 included "[t]o answer inquiries
and provide data on health issues of individuals who participated in research conducted or sponsored by"
the Army and to "provide individual participants with newly acquired information that may impact their
health." This language does not limit those included in the Medical Scientific Research Data Files to those
who would be test subjects in the future; instead, the use of the past tense suggests that it could
encompass individuals who participated in research in the past. In addition, nothing about AR 70-25
mandates that only one record system be created. A stated purpose of the Research and Experimental
Case Files database was "to follow up on individuals who voluntarily participated in Army
chemical/biological agent research projects for the purpose of assessing risks/hazards to them," which is
consistent with an ongoing duty to notify them of such risks and hazards.
Accordingly, under the circumstances described above, the Court finds that deference to Defendants'
position on this issue is not warranted.
Having considered the plain language of AR 70-25, the Court concludes that Plaintiffs' argument — that the
duty to warn is properly interpreted as applying on an on-going basis, not just as part of the pre-experiment
consent process, and is owed to service members who became test subjects before 1988 — is more
persuasive. This is consistent with the text itself, including the statement that this duty is owed to individuals
who have "participated" in research, not just to those who will participate in such research. This is also
supported by the addition to the 1990 version of AR 70-25, which made clear that the regulation applied to
research involving "deliberate exposure of human subjects to nuclear weapons effect, to chemical warfare
agents, or to biological warfare agents." The DOD, including the Army, represents that it does not "still
conduct human experimentation with chemical and biological warfare agents" and that its research
programs "involving human subjects do not involve the exposure of these subjects to chemical or biological
warfare agents" any longer. Gardner Reply Decl., Ex. 86, Docket No. 513-12, 2; see also Defs.' Opp. and
Cross-Mot., Docket No. 495, 2 (representing that the "Army suspended testing of chemical compounds on
human volunteers on July 28, 1976" and that the program involving testing of biological agents on humans
ended in 1973). Because the Army did not — and does not — engage in such ongoing testing, there would
have been no reason to add this language to AR 70-25 in 1990 if the regulation did not encompass those
who had already become such test subjects.
Accordingly, the Court concludes that Defendants' duty to warn test subjects of possible health effects is not
limited to the time that these individuals provide consent to participate in the experiments. Instead,
Defendants have an ongoing duty to warn about newly acquired information that may affect the well-being
of test subjects after they completed their participation in research. This ongoing duty is owed to individuals
who became test subjects prior to the time that the 1988 revision was issued.
3. Sufficiency of action versus failure to act
Defendants contend, because "it is undisputed that DoD has engaged in substantial outreach efforts to test
participants over the years," both alone and in collaboration with the DVA, it is "clear that Plaintiffs' true
complaint is with the sufficiency of action DoD has already taken," which is not cognizable under § 706(1)
of the APA. Defs.' Opp. and Cross-Mot., Docket No. 495, 12; Defs.' Reply, Docket No. 513-1, 2.
Plaintiffs respond that the Court should not "reverse its ruling that Plaintiffs have stated a cognizable notice
claim under APA section 706(1)." Id. at 16 (citing Order on First Mot. to Dismiss, Docket No. 59, 14-16).
They also contend that there is no dispute that the outreach actions were not taken "pursuant to the
applicable regulations," citing testimony by Defendants' witnesses that the outreach efforts were not
conducted in order to comply with AR 70-25. Pls.' Reply and Opp. to Defs.' Mot., Docket No. 502, 15 n.13.
They further argue that Defendants have made no showing that DVA's efforts can be substituted for those
of the Army or DOD, which have their own duty to provide notice. Finally, Plaintiffs contend that they are
challenging Defendants' failure to act and not the sufficiency of their outreach efforts.
Although the Court found when ruling on a motion to dismiss that Plaintiffs stated a cognizable claim,
Defendants have now made a summary judgment motion on this issue and Plaintiffs must raise a material
dispute of fact in support of their claim, not merely state a cognizable claim. Further, in the order cited by
Plaintiffs, the Court did not address the challenge raised by Defendants here. Plaintiffs' argument that
Defendants themselves did not identify AR 70-25 as the legal impetus for past outreach efforts is
unavailing. Under this logic, even if Defendants had taken all of the outreach steps that Plaintiffs maintain
that they should have, they could nonetheless be found to have failed to act and be compelled to make
redundant efforts.
Plaintiffs are correct that the notice letters were sent by the DVA to veterans for whom addresses could be
located, not by the DOD or the Army. As the Court noted in resolving the motion for class certification, the
DOD and the Army acknowledged that the letters were from the DVA and that they could advise the DVA
on the content but could not require the DVA to make particular changes to them. Class Cert. Order, Docket
No. 485, 23, 51. The Court concluded that, as a result, the class representatives' receipt of these letters did
not undermine their standing to challenge the DOD's and the Army's failure to notify. Id. at 23. The Court
found that this did not make certification under Rule 23(b)(2) inappropriate. Id. at 51. However, the Court
has not ruled on the current issue, whether Plaintiffs' challenge is to the sufficiency of agency action rather
than to a lack of agency action.
The APA limits judicial review to "[a]gency action made reviewable by statute and final agency action for
which there is no other adequate remedy in a court." 5 U.S.C. § 704. For an action to be "final" under the
APA, it "must mark the consummation of an agency's decision-making process" and "must be one by which
rights or obligations have been determined, or from which legal conclusions will flow." Bennett v. Spear, 520
U.S. 154, 177 (1997) (internal quotation marks and citations omitted). Review of an agency's failure to act
may be considered an exception to the final agency action requirement. See 5 U.S.C. § 706(1) (allowing a
reviewing court to "compel agency action unlawfully withheld or unreasonably delayed"). A claim under §
706(1) can be maintained "only where there has been a genuine failure to act." Ecology Ctr., Inc. v. United
States Forest Serv., 192 F.3d 922, 926 (9th Cir. 1999). The Ninth Circuit "has refused to allow plaintiffs to
evade the finality requirement with complaints about the sufficiency of an agency action `dressed up as an
agency's failure to act.'" Id. (quoting Nevada v. Watkins, 939 F.2d 710, 714 n.11 (9th Cir. 1991)).
Here, Plaintiffs challenge the decision of the DOD and Army to have the DVA send the notice letters to
former servicemen with information about their testing, in addition to arguing that the notice letters
themselves were insufficient for a variety of reasons. It is undisputed that the DOD and Army participated in
the preparation of the DVA's letters and accompanying information, although they did not have final say
over the content of the letters. Thus, the challenge here is to how Defendants carried out their duty, not
whether they did so at all. Accordingly, to the extent that Plaintiffs seek to require the DOD and Army to
provide notice to each class member which discloses on an individual basis the substances to which he or
she was exposed, the doses to which he or she was exposed, the route of exposure and the known effects
of the testing, this claim is not brought properly under § 706(1).
However, Plaintiffs also challenge the refusal of the Army to carry out its ongoing duty to warn, that is, after
the original notice, and in the future, to provide test subjects with information that is learned subsequently
that may affect their well-being. There is no material dispute of fact that the Army is not doing this on an
ongoing basis. Unlike the other aspects of their claim, here Plaintiffs do not challenge the sufficiency of
agency action and properly attack the Army's failure to act. Defendants have not provided evidence that
they have sent any updated information to test subjects since the DVA sent the notice letters and do not
acknowledge any intent or duty to do so.
4. Conclusion
For the reasons set forth above, the Court grants in part both Plaintiffs' motion for summary judgment and
Defendants' cross-motion in part and denies them in part. Because the Court dismissed the claim based on
the Wilson Directive and found no basis for enforcing CS: 385 and AR 90-75 against the DOD, the Court
grants judgment in favor of the DOD on this claim in its entirety. The Court also grants summary judgment
in favor of the Army to the extent that Plaintiffs seek to challenge its original notice efforts. However, the
Court summarily adjudicates in favor of Plaintiffs that the Army has an ongoing duty to warn and orders the
Army, through the DVA or otherwise, to provide test subjects with newly acquired information that may
affect their well-being that it has learned since its original notification, now and in the future as it becomes
available.
B. Claim for medical care
1. Monetary damages
Defendants argue that they are entitled to summary judgment on Plaintiffs' claim for medical care because
it is in fact a claim for money damages, not for equitable relief, and thus the APA's waiver of sovereign
immunity is inapplicable. Defendants acknowledge that the Court considered this argument previously and
rejected it, but argue that the prior decision should be reconsidered. They rely on two out-of-circuit cases
which they contend held that "claims similar to the medical care claim against DOD are essentially claims
for money damages and therefore not cognizable under the APA." See Defs.' Opp. and Cross-Mot. at 28-29
(citing Schism v. United States, 316 F.3d 1259, 1273 (Fed. Cir. 2002); Jaffee v. United States, 592 F.2d 712,
715 (3d Cir. 1979)). Defendants raised the same argument in the briefing related to their second motion to
dismiss and Plaintiffs' motion for class certification and cited the same cases therein.
As noted above, in Schism, the Federal Circuit held that compensation of members of the military, including
claims for benefits that were compensation for services rendered, was governed by statute and not
contract. 316 F.3d at 1273. There, the plaintiffs were seeking comprehensive free lifetime health care
coverage premised on an implied-in-fact contract based on oral promises for such coverage made at the
time that they were recruited. The Federal Circuit stated that "full free lifetime medical care is merely a form
of pension, a benefit received as deferred compensation upon retirement in lieu of additional cash," and
thus there was "no meaningful difference between the retirement benefits that the Supreme Court has
identified as beyond the reach of contracts and the full free medical care at issue" in that case. Id. at 1273.
On that basis, the court concluded that there were no valid contracts. Id. at 1274. The present case,
however, is not about a benefit as a form of deferred compensation for past military service. Instead, it is
about whether the government has a duty to pay for medical care to address ongoing suffering caused by
military testing.
Defendants also renew their argument that this case is "strikingly similar" to the claim brought in Jaffee. In
that case, the plaintiff alleged that, while he was serving in the Army in 1953, he was ordered to stand in a
field near the site of an explosion of a nuclear device, without any protection against the radiation, and
without his knowledge of or consent to the risks. Jaffee, 592 F.2d at 714. On behalf of himself and a
putative class of all soldiers who were ordered to be present at the explosion, he sought an order requiring
the United States to warn class members of the medical risks that they faced and to provide or subsidize
medical care for them. Id. The Third Circuit found that "the request for prompt medical examinations and all
medical care and necessary treatment, in fact, is a claim for money damages." Id. at 715. It noted that the
plaintiff "requests a traditional form of damages in tort compensation for medical expenses to be incurred in
the future." Id. It stated that "his complaint seeks an injunction ordering either the provision of medical
services by the Government or payment for the medical services," and that thus "payment of money would
fully satisfy Jaffee's èquitable' claim for medical care." Id. The court also found that the payment of money
could not satisfy the claim regarding warning of medical risks. Id. In another case, United States v. Price,
688 F.2d 204 (3d Cir. 1982), the Third Circuit found appropriate the funding of a diagnostic study to assess
the public health threat posed by contamination and abatement because, "though it would require monetary
payments," it "would be preventative rather than compensatory" and was intended as "the first step in the
remedial process of abating an existing but growing toxic hazard which, if left unchecked, will result in even
graver future injury." Id. at 212. The Third Circuit subsequently explained the principle derived from Jaffee
and Price to be "that an important factor in identifying a proceeding as one to enforce a money judgment is
whether the remedy would compensate for past wrongful acts resulting in injuries already suffered, or
protect against potential future harm." Penn Terra, Ltd. v. Dep't of Environmental Resources, 733 F.2d 267,
276-277 (3d Cir. 1984). Here, Plaintiffs have not conceded, as the plaintiff in Jaffe did, that their claim for
medical care could be fully remedied by money damages, and Defendants have not shown that it could be.
Further, they seek to end purported ongoing rights violations and harm, not compensation for harms that
took place completely in the past. Future medical treatment for ills suffered as a result of participation in
human experimentation can be seen as preventing future potential harm and suffering.
Accordingly, the Court denies Defendants' motion for summary judgment on this basis.
2. DVA medical care available to veterans
Plaintiffs seek a declaration that the DOD and the Army have a duty to provide them with medical care and
an injunction requiring these agencies to provide examinations, medical care and treatment and to
establish policies and procedures governing these. This Court has provided judicial review of Plaintiffs'
claims and found that AR 70-25 entitles them to medical care for disabilities, injuries or illnesses caused by
their participation in government experiments. The only remaining question is whether Plaintiffs are entitled
to choose which government agency ought to provide care.
The Court will not enjoin one government agency to provide health care when another agency has been
congressionally mandated to do so. The DVA, through its Veterans Health Administration, is charged with
providing "a complete medical and hospital service for the medical care and treatment of veterans." 38
U.S.C. § 7301(b). Congress has mandated that it provide hospital care and medical services "to any
veteran for a service-connected disability." 38 U.S.C. § 1710.[6] Thus, a "veteran who has a service-
connected disability will receive VA care provided for in the `medical benefits package' . . . for that service-
connected disability," even if that veteran is "not enrolled in the VA healthcare system." 38 C.F.R. §
17.37(b). When receiving care for service-connected disabilities, veterans are not subject to any copayment
or income eligibility requirements. 38 C.F.R. §§ 17.108(d)(1),(e)(1), 17.111(f)(1),(3). If a veteran disagrees

with a decision made by the DVA about benefits or service-connection, the veteran may appeal the decision
to the Board of Veterans' Appeals. 38 U.S.C. § 7105. Thereafter, decisions of the Board of Veterans'
Appeals can be appealed to the Court of Appeals for Veterans Claims. 38 U.S.C. § 7252.
Plaintiffs have not provided any evidence of a material dispute of fact that class members cannot access
the DVA health care system or that they are denied compensation for their service-connected injuries.
Plaintiffs assert in their response that the Court has previously noted that Plaintiffs' ability to seek health
care from the DVA "does not necessarily relieve the DOD and the Army from being required independently
to provide medical care, particularly because Plaintiffs may be able to establish that the scope of their duty
may be different than that of the DVA." Pls.' Reply, Docket No. 502, 18 (citing Class Cert. Order, Docket No.
485, 25). However, Plaintiffs have not offered any evidence to support that the duty of DOD and the Army is
in fact any broader than that of the DVA. Plaintiffs contend that, even if class members are eligible for
medical care from the DVA, "they are not receiving this medical care from the DVA." Pls.' Post-Hearing
Resp., Docket No. 519, 1. This, however, does not undermine the fact that class members can challenge
the DVA's failure to provide medical care through the statutorily-created appeals scheme. In addition,
although Plaintiffs suggest that the quality of medical care provided by the DVA is inferior to that of the DOD
and the Army, they have not shown any systematic exclusion or inadequate care of their class, or that the
class is unable to address any inadequacies through the DVA system.
To the extent that Plaintiffs argue that the DVA medical care is a "rationing system," apparently referring to
the fact that not all veterans may enroll in the DVA's comprehensive medical care program, no such
rationing is imposed on the duty of the DVA to provide no-cost care to veterans for service-connected
disabilities.[7] Plaintiffs also speculate, "It is possible that many class members are not even eligible for DVA
medical care," id. (citing 38 U.S.C. § 5303(a); 38 C.F.R. § 3.12), but provide no evidence that there are any
such class members.
To the extent that Plaintiffs argue that the organizational Plaintiffs are unable to bring their medical care
claims through the DVA system, this argument is unavailing. Plaintiffs have not shown that either of these
organizations has its own right to medical care. Further, to the extent that the organizational Plaintiffs are
asserting the rights of the members of their organizations, those members can seek care through the DVA
for any disabilities, injuries or illnesses suffered as a result of participation in the experimentation program.
The organizational Plaintiffs may not prevail on claims here that their members cannot prevail upon directly.
The Court has found that AR 70-25 entitles Plaintiffs to medical care for any disabilities, injuries or illnesses
suffered as a result of participation in the experimentation program. However, this Court will not enjoin the
DOD or the Army to provide health care, because the DVA is required to do so. Plaintiffs have not shown
that the DVA systematically fails to offer them care. Although there may be general dissatisfaction and
individual erroneous results, Plaintiffs and the class members can seek medical care through the DVA and
challenge denial of care through the statutory scheme prescribed by Congress.
II. Constitutional claims
In their cross-motion, Defendants also seek judgment on Plaintiffs' constitutional claims against the DOD
and the Army related to notice and health care. Plaintiffs have not moved for summary judgment on these
claims.
Defendants argue that there is no constitutional right for access to government information, so Plaintiffs'
constitutional claim for notice fails, and that there is no constitutional right to free health care, so Plaintiffs'
claim for health care fails. Defendants further contend that no court has ever granted a request for
continuing health care based on a violation of a substantive due process right to bodily integrity. In a
footnote, they also state, "Because Plaintiffs cannot identify any substantive entitlement to Notice or health
care under the APA or Constitution, their procedural due process claims regarding the alleged absence of
any procedures to challenge the deprivation of Notice and health care should be dismissed." Defs.' Opp.
and Cross-Mot. at 43.
Plaintiffs argue that Defendants did not move on their actual Constitutional claims and so the burden of
production never shifted to Plaintiffs. Thus, they contend Defendants should not be granted summary
judgment on those claims.
As summarized in the class certification order, Plaintiffs asserted the following constitutional claims against
the DOD and the Army in this case:
(2) under the Fifth Amendment, that these Defendants' failure to provide class members with
notice, medical care and a release from secrecy oaths violated their substantive due process
liberty rights, including their right to bodily integrity;
(3) under the Fifth Amendment, that these Defendants' failure to provide class members with
any procedures whatsoever to challenge this deprivation violated their procedural due process
rights;
(4) under the Fifth Amendment, that these Defendants' failure to comply with their own
regulations and procedures regarding notice and medical care deprived class members of
their due process rights; and
(5) under the First and Fifth Amendment, that the failure to provide a release from secrecy
oaths prevented class members from filing claims for benefits with the DVA and thereby
violated their right of access to the courts.
Docket No. 485, 10 (numbering in original). Of these claims, the Court certified only one claim, that brought
under the Fifth Amendment for Defendants' failure to comply with their own regulations, to proceed on a
class-wide basis. The Court denied certification as to the other constitutional claims.
In their motion, Defendants clearly address Plaintiffs' second claim for deprivation of substantive due
process rights, including the right to bodily integrity, the third claim for violation of their procedural due
process rights by depriving them of their protected interest without providing them with procedures by which
to challenge the deprivation, and the fifth claim regarding access to the courts. Defs.' Opp. and Cross-Mot.,
Docket No. 495, 41-43 & n.42, 49-50. Plaintiffs do not respond substantively to Defendants' challenges to
these claims, asserting incorrectly that Defendants ignore these claims. See, e.g., Pls.' Reply and Opp.,
Docket No. 502, 21, 23 n.22. Accordingly, the Court grants Defendants' motion for summary judgment on
the second, third and fifth claims against the Army and DOD.
Plaintiffs also dispute that Defendants properly moved on the fourth claim. Defendants made clear in the
notice of their motion that they moved "on all claims raised and remaining in Plaintiffs' Fourth Amended
Complaint." Defs.' Opp. and Cross-Mot., Docket No. 495; see also id. at 1 (arguing that "Plaintiffs'
constitutional claims," without any limitation, "are similarly baseless and should be dismissed"). Defendants
also argued that "Plaintiffs cannot identify any substantive entitlement to Notice or health care under the
APA or the Constitution" and thus "their procedural due process claim regarding the alleged absence of any
procedures to challenge the deprivation of Notice and health care should be dismissed." Defs.' Opp. and
Cross-Mot., Docket No. 495, 43 n.42. In their reply, they further explained that not "every violation of a
regulation amount[s] to a violation of an individual's due process rights," that Plaintiffs cannot show the
agency regulations at issue here have themselves created a constitutional right to those procedures and
thus that there is no constitutional claim for violation of those regulations. Defs.' Reply, Docket No. 513-1,
15.
In response, Plaintiffs rely on cases in which courts have held that agencies are bound to follow their own
regulations and that failure to do so may violate the due process clause. However, Defendants are correct
that such a failure does not always amount to a constitutional violation. See United States v. Caceres, 440
U.S. 741, 752-753 (1979) (finding no constitutional violation where the IRS "admittedly" failed to follow its
own regulations, on the basis that it was not "a case in which the Due Process Clause is implicated
because an individual has reasonably relied on agency regulations promulgated for his guidance or benefit
and has suffered substantially because of their violation by the agency"). Plaintiffs have not shown that
here.
Accordingly, Defendants' motion for summary judgment on Plaintiffs' constitutional claims is granted.
III. Secrecy oath claims
Defendants move for summary judgment on Plaintiffs' individual claims against the DOD, the Army and the
CIA based on secrecy oaths.
A. Claims against the CIA
Defendants argue that the CIA is entitled to summary judgment on Plaintiffs' individual secrecy oath claims
against that agency for a number of reasons. First, they contend that Plaintiffs can produce no evidence
that the CIA ever administered secrecy oaths to any individual Plaintiff or VVA member. Second, they
assert that the claims are moot because the CIA provided a sworn declaration in June 2011 attesting that
the individual Plaintiffs and identified VVA members did not give secrecy oaths to the CIA and releasing
them from any secrecy oath that they believed that they might have with the CIA. Finally, they argue that
the CIA cannot release individuals from a secrecy oath administered by the DOD or the Army.
Plaintiffs do not dispute that they cannot provide any evidence that the CIA administered secrecy oaths or
that declaratory relief against the CIA that addressed the validity of DOD or Army secrecy oaths would be
ineffective. They also concede that they have received all relief that they desired on this claim in relation to
the individuals released by the CIA through the June 2011 declaration. They state that this extends to their
entire claim against the CIA, "[i]n light of the CIA's statement that the secrecy oath release encompasses all
VVA members," and that they "submit that claim to the Court." Pls.' Reply and Opp., Docket No. 502, 36.
Defendants reply that Plaintiffs mischaracterized their response. They state that the 2011 declaration
encompassed only the VVA members who were identified by name therein and did not encompass an
additional twenty-seven VVA members whom Plaintiffs identified as having been test participants for the
first time six months after the close of discovery.
Irrespective of whether those additional twenty-seven VVA members were released from any possible
secrecy oaths through the 2011 declaration, the Court grants Defendants' motion for summary judgment on
the secrecy oath claim against the CIA. Plaintiffs have not produced any evidence that any secrecy oaths
were administered by the CIA, or are fairly traceable to the CIA, involving any Plaintiff or VVA member,
including those twenty-seven individuals who were identified later.
B. Claims against the DOD and the Army
Defendants also move for summary judgment on the secrecy oath claims against the DOD and Army.
Defendants argue that Plaintiffs have not presented any evidence that they or the VVA members currently
feel restrained by any such oath and that Defendants have issued two memoranda releasing them already.
They contend that, as a result, Plaintiffs lack standing to pursue this claim.
Plaintiffs respond that the Court already has rejected this argument when it refused to hold that certain
Plaintiffs and VVA members lacked standing at the class certification stage. However, as Defendants point
out, Plaintiffs presently have the burden to establish that there is at least a genuine issue of material fact as
to standing of each Plaintiff. See Dep't of Commerce v. U.S. House of Representatives, 525 U.S. 316, 329
(1999) ("To prevail on a Federal Rule of Civil Procedure 56 motion for summary judgment . . ., mere
allegations of injury are insufficient. Rather, a plaintiff must establish that there exists no genuine issue of
material fact as to justiciability or the merits.").
Plaintiffs assert that "it is clear that" they "`could benefit from equitable relief that would invalidate the
secrecy oaths altogether." Pls.' Reply and Opp., Docket No. 36. However, in the instant motion, they have
not cited any evidence to support that they or the VVA members still suffer ongoing effects of the oaths,
such as fear of prosecution. At the hearing, Plaintiffs cited the evidence regarding Dufrane relied upon by
the Court in the class certification order, but do not address the arguments raised by Defendants regarding
the other individuals.
In the class certification order, the Court noted that Plaintiffs had offered "evidence that Dufrane testified
that he continued to feel bound by the secrecy oath to some extent" and that there was no evidence cited
that showed that Defendants had communicated an unconditional release to him. Class Cert. Order, Docekt
No. 485, 28-29. Defendants again offer testimony from Dufrane's deposition, in which he stated he did not
think that he was allowed to talk about his experiences at Edgewood Arsenal "completely" because he had
been told not to talk about some aspects of what happened and that he still felt constrained by the secrecy.
See Docket No. 496-64, 92:1-94:16. He went on to state, however, that there was nothing in his memory
that he could identify that he wants to talk about but is unable to. Id. at 94:17-23. In addition, Defendants
have now offered evidence that Dufrane had seen the 1993 Perry memorandum prior to his deposition. As
quoted above, that memorandum provided a full and unconditional release from any secrecy oath that had
been given. In light of the facts that a full release was communicated to Dufrane, and that there is nothing
in particular that he presently feels that he is prevented from speaking about, although he feels generally
constrained, he will not receive a benefit from a further declaration "that Plaintiffs are released from any
obligations or penalties under their secrecy oaths." Fourth Am. Compl. ¶ 183. Finally, Plaintiffs do not offer
any response to Defendants' argument that there can be no showing of future threat of prosecution
because there have not been any such enforcement actions in the past.
Accordingly, the Court grants Defendants' motion for summary judgment on the secrecy oath claims against
the DOD and the Army.
IV. Claim that DVA is a biased adjudicator of benefits claims
Defendants seek summary judgment on Plaintiffs' claims against the DVA for biased adjudication of their
benefits claims. Defendants argue that 38 U.S.C. § 511 deprives this Court of jurisdiction over this claim
because it bars consideration of the relief that Plaintiffs seek. They also argue that Plaintiffs cannot
establish a genuine issue of material fact as to whether DVA was involved in the testing programs at issue
here. Finally, they contend that Plaintiffs cannot make a sufficient showing that the DVA was an inherently
biased adjudicator of their benefits claims.
A. Section 511
Defendants have previously argued on two occasions that § 511 deprives this Court of jurisdiction to hear
this claim, and on both occasions, the Court has rejected the argument. See Docket No. 177, 8-11; Docket
No. 485, 31-34. Defendants contend that they are now making a new argument, which the Court has not
addressed: that the relief sought by Plaintiffs cannot be granted under § 511. Plaintiffs respond simply that
the Court's prior decisions were correct and do not address Defendants' purportedly new argument.
Section 511 provides,
The Secretary shall decide all questions of law and fact necessary to a decision by the
Secretary under a law that affects the provision of benefits by the Secretary to veterans or the
dependents or survivors of veterans. Subject to subsection (b), the decision of the Secretary
as to any such question shall be final and conclusive and may not be reviewed by any other
official or by any court, whether by an action in the nature of mandamus or otherwise.
38 U.S.C. § 511(a).
In granting Plaintiffs leave to amend assert this claim against the DVA, the Court acknowledged that § 511
"precludes federal district courts from reviewing challenges to individual benefits determinations, even if
they are framed as constitutional challenges." Docket No. 177, 8. At that time, the effect of § 511 on claims
that "purport not to challenge individual benefits decisions, but rather the manner in which such decisions
are made," had not been addressed by the Ninth Circuit. Id. Thus, the Court reviewed several decisions
from other circuit courts of appeals that did address this issue. Id. at 9-11 (discussing in detail Broudy v.
Mather, 460 F.3d 106 (D.C. Cir. 2006); Beamon v. Brown, 125 F.3d 965, 972 (6th Cir. 1997)). Applying the
standards set forth in Broudy and Beamon, the Court held,
Section 511 does not bar Plaintiffs' claim under the Fifth Amendment. Under this theory, they
mount a facial attack on the DVA as the decision-maker. They do not challenge the DVA's
procedures or seek review of an individual benefits determination. Nor do they attack any
particular decision made by the Secretary. The crux of their claim is that, because the DVA
allegedly was involved in the testing programs at issue, the agency is incapable of making
neutral, unbiased benefits determinations for veterans who were test participants. This bias,
according to Plaintiffs, renders the benefits determination process constitutionally defective as
to them and other class members. Whether the DVA is an inherently biased adjudicator does
not implicate a question of law or fact "necessary to a decision by the Secretary" related to the
provision of veterans' benefits. See Thomas v. Principi, 394 F.3d 970, 975 (D.C. Cir. 2005).
Docket No. 177, 11.
Defendants later moved for leave to file a motion for reconsideration of this order, asserting that the Ninth
Circuit's recent decision in Veterans for Common Sense v. Shinseki, 678 F.3d 1013 (2012), compelled a
different result. The Court rejected this argument, finding that "Veterans for Common Sense does not
require reconsideration of the Court's prior conclusion." Docket No. 485, 33. This Court explained,
In that case, two nonprofit organizations challenged delays in the provision of care and
adjudication of claims by the DVA and the lack of adequate procedures during the claims
process. The court found that the challenges to delays were barred by § 511, because to
adjudicate those claims, the district court would have to examine the circumstances
surrounding the DVA's provisions of benefits to individual veterans and adjudication of
individual claims. Id. at 1027-30. However, after discussing the decisions reached by other
circuits in Broudy, Beamon and several other cases, the court concluded that it did have
jurisdiction over the claims seeking review of the DVA's procedures for handling benefits
claims at its regional offices. Id. at 1033-35. In so holding, the court stated that, unlike the
other claims, this claim "does not require us to review `decisions' affecting the provision of
benefits to any individual claimants" and noted that the plaintiff "does not challenge decisions
at all." Id. at 1034.
In Veterans for Common Sense, the Ninth Circuit explained,
A consideration of the constitutionality of the procedures in place, which frame the system by
which a veteran presents his claims to the VA, is different than a consideration of the decisions
that emanate through the course of the presentation of those claims. In this respect, VCS does
not ask us to review the decisions of the VA in the cases of individual veterans, but to
consider, in the "generality of cases," the risk of erroneous deprivation inherent in the existing
procedures compared to the probable value of the additional procedures requested by VCS. . .
. Evaluating under the Due Process Clause the need for subpoena power, the ability to obtain
discovery, or any of the other procedures VCS requests is sufficiently independent of any VA
decision as to an individual veteran's claim for benefits that § 511 does not bar our jurisdiction.
678 F.3d at 1034. In its prior order, this Court found that "the Ninth Circuit considered some of the same
authority and applied a similar standard as this Court did in its earlier order," and thus concluded that it
"would have reached the same conclusion if it had had the benefit of the decision in Veterans for Common
Sense at that time." Docket No. 485, 34.
Defendants now argue that the Court's assessment of the "manner in which the VA determines benefits
eligibility . . . plainly implicates `decisions that relate to benefits determination.'" Defs.' Opp. and Cross-Mot.
at 52. However, like the claim for which the Ninth Circuit found jurisdiction in Veterans for Common Sense,
evaluating whether the risk of actual bias is too high to be constitutionally tolerable is "sufficiently
independent of any VA decision as to an individual veteran's claim for benefits that § 511 does not bar" this
Court's jurisdiction. See 678 F.3d at 1034.
To the extent that Defendants now contend that Veterans for Common Sense does not allow the Court to
issue the relief that Plaintiffs seek, the Court rejects this argument. In that case, in addressing the plaintiff's
claim that delays in the provision of mental health care violated the APA and the Constitution, the Ninth
Circuit noted that
in order to provide the relief that VCS seeks, the district court would have to prescribe the
procedures for processing mental health claims and supervise the enforcement of its order. To
determine whether its order has been followed, the district court would have to look at
individual processing times. . . . [I]t would embroil the district court in the day-to-day operation
of the VA and, of necessity, require the district court to monitor individual benefits
determinations.
Id. at 1028.
Here, Plaintiffs seek a declaration that the DVA's decisions regarding entitlement to SCDDC and medical
care are "null and void" and an "injunction forbidding defendants from continuing to use biased decision
makers to decide their eligibility" for benefits. Fourth Am. Compl. ¶¶ 233-34; see also id. (seeking "a plan to
remedy denials of affected claims for SCDDC and/or eligibility for medical care based upon service
connection"). To the extent that Plaintiffs request that the Court reverse the past benefits determinations
made by the DVA — or at least the denials — their claims are not "sufficiently independent" of any VA
decision on an individual veteran's claim for benefits. Accordingly, to the extent that Plaintiffs seek an order
vacating all past benefits determinations and requiring that they be re-adjudicated, the Court finds that it
lacks jurisdiction to do so. However, Plaintiffs also ask that the Court issue "an order directing the DVA . . .
to devise procedures for resolving such claims that comply with the due process clause, which involve, at a
minimum, an independent decision maker, all to be submitted to the Court for advance approval." Id. at ¶
234. Monitoring compliance with such a plan as to adjudications of future claims would not require the
Court to look at individual benefits determinations, but rather to consider who will adjudicate the claims.
Plaintiffs' request is similar to that permitted by the Ninth Circuit in Veterans for Common Sense because it
involves the "consideration of the constitutionality of the procedures in place, which frame the system by
which a veteran presents his claims to the VA," and not the "consideration of the decisions that emanate
through the course of the presentation of those claims." 678 F.3d at 1034. Thus, the Court has jurisdiction
to consider Plaintiffs' claim for prospective injunctive and declaratory relief.
B. DVA's purported bias
"The crux of Plaintiffs' claim" against the DVA is that, "`because the DVA allegedly was involved in the
testing programs at issue, the agency is incapable of making neutral, unbiased benefits determinations for
veterans who were test participants,'" which "`renders the benefits determination process constitutionally
defective.'" Pls.' Reply and Opp., Docket No. 502, 23 (quoting Class Cert. Order, Docket No. 485, 32).
"There are two ways in which a plaintiff may establish that he has been denied his constitutional right to a
fair hearing before an impartial tribunal." Stivers v. Pierce, 71 F.3d 732, 741 (9th Cir. 1995). "In some cases,
the proceedings and surrounding circumstances may demonstrate actual bias on the part of the
adjudicator." Id. "In other cases, the adjudicator's pecuniary or personal interest in the outcome of the
proceedings may create an appearance of partiality that violates due process, even without any showing of
actual bias." Stivers, 71 F.3d at 741 (citations omitted); see also United States v. Oregon, 44 F.3d 758, 772
(9th Cir. 1994) (stating that the plaintiffs "must show an unacceptable probability of actual bias on the part
of those who have actual decisionmaking power over their claims"); Exxon Corp. v. Heinze, 32 F.3d 1399,
1403 (9th Cir. 1994) ("the Constitution is concerned not only with actual bias but also with `the appearance
of justice'"). "In attempting to make out a claim of unconstitutional bias, a plaintiff must òvercome a
presumption of honesty and integrity' on the part of decisionmakers." Stivers, 71 F.3d at 741. "He must
show that the adjudicator `has prejudged, or reasonably appears to have prejudged, an issue.'" Id.; see
also Caperton v. A. T. Massey Coal Co., 556 U.S. 868, 883-884 (2009) ("In defining these standards the
Court has asked whether, ùnder a realistic appraisal of psychological tendencies and human weakness,'
the interest `poses such a risk of actual bias or prejudgment that the practice must be forbidden if the
guarantee of due process is to be adequately implemented.'") (citation omitted).
Plaintiffs argue that the DVA as an agency appears to be biased because it was involved in the testing at
issue here. Plaintiffs have offered evidence that a CIA memorandum identified the DVA as among the
suppliers of chemicals used for tests, which, when conducted on humans, were carried out jointly with the
Army and Edgewood Arsenal. Plaintiffs also offer evidence, which Defendants do not dispute, that the DVA
separately carried out human testing using some of the same substances that were used in the testing
programs at issue here, including LSD, mescaline, thorazine, atropine and scopolamine. However,
accepting all of Plaintiffs' evidence as true, this is not sufficient to support a conclusion that the probability
of bias or prejudgment on the part of all of the DVA adjudicators was "intolerably high," so as to result in a
constitutional violation. Withrow v. Larkin, 421 U.S. 35, 57 (1975). Plaintiffs have not offered evidence to
show that the substances that the DVA provided to Defendants were actually used at all, much less that
they were used on humans who were service members. In addition, the DVA's involvement did not
necessarily mean that its adjudicators would have an interest in deciding claims in an inherently biased
fashion. As Defendants point out, Plaintiffs' evidence shows that, after the DVA began receiving claims for
benefits related to LSD testing, it proactively sought to learn more about the long-term effects of the drug in
order to adjudicate the claims. See Patterson Reply Decl., Ex. 22, Docket No. 503-9, DVA135 000062. This
suggests that the DVA sought to resolve such claims properly, not that it sought to avoid responsibility for
providing care. Further, Plaintiffs have not demonstrated that there is any connection between the DVA's
participation in the testing and the adjudicators at the agency who actually resolve their disability claims. As
Defendants point out, these claims are adjudicated by the Veterans Benefits Administration, an arm of the
DVA separate from the Veterans Health Administration, the arm of the agency which conducted research
into the same substances as used in the testing programs at issue. See United States v. Oregon, 44 F.3d at
772 (characterizing plaintiff's proffered evidence of bias by the Oregon Department of Justice as "fairly
weak" where, among other things, plaintiff had not shown that any officials involved in the prior actions it
contended showed bias would be involved in the challenged adjudication). The evidence Plaintiffs offer
here is too meager to support the existence of an appearance of bias that permeates the entire agency.
This conclusion is consistent with Ninth Circuit precedent, in which the court rejected claims of institutional
bias where there was insufficient evidence to support that the adjudicative body itself, as opposed to an
affiliated person or agency, was biased. In United States v. Oregon, the Klamath Tribe challenged the state
of Oregon's administrative procedures for determining water rights. 44 F.3d at 771. The Tribe argued that
the Oregon Department of Justice, which provided legal advice to the Oregon Water Resources
Department (OWRD), the agency charged with adjudicating their claims, had previously taken litigating
positions against the Tribe's water rights. Id. The Ninth Circuit rejected the claim, finding that the Tribe had
not shown that the ODOJ would have "any significant role to play in the adjudication or any impact on its
outcome" and thus had failed to show "an unacceptable probability of actual bias by the actual
decisionmakers." Id. at 772. Similarly, in a recent case, the court considered a claim by a landowner who
asserted that the hearing procedures employed by the Assessment Appeals Board for Orange County,
when considering his challenge to the County Assessor's valuation of his property and assessment of
property taxes, violated his due process rights. William Jefferson & Co. v. Bd. of Assessment & Appeals No.
3 for Orange Cnty., 695 F.3d 960, 961-62 (9th Cir. 2012). He argued that "the Board's procedures created
the appearance of unfairness" because the Board was advised by an attorney who worked in the same
office as the attorney representing the Assessor. Id. at 963-65. The court noted that, even if there were
evidence that the Board's attorney advisor "was biased in favor of the Assessor, which there is not," such
evidence was not necessarily sufficient by itself to "conclude that the adjudicating body — the Board itself
— was biased." Id. at 965. As in these cases, even if there were some evidence of bias by some
departments or individuals at the DVA, there is no evidence of bias by the DVA adjudicators of the claims at
issue here.
Plaintiffs also argue that the DVA "manifested its inherent bias." Pls.' Reply and Opp., Docket No. 502, 27.
Plaintiffs contend that the DVA has disseminated misinformation about the testing, which evidences its
inherent bias. They argue that various documents, including the letter and fact sheet that the DVA sent to
veterans about the substances and health effects, a training letter sent to DVA regional offices specifying
rules for adjudicating benefits claims and a letter sent to clinicians examining veterans, all included
inaccuracies and misrepresentations, including that a particular study "found no significant long term health
effects in Edgewood Arsenal test subjects." They also argue that there is evidence that the DVA deviated
from its own normal claim adjudication procedures in deciding these claims, and from the operative
regulations, by giving the DOD the sole authority to validate whether an individual participated in any
chemical or biological testing, instead of making a decision based on the entirety of the evidence in the
record. They contend that this evidences bias. They state that, because the DOD did not provide this
verification for many people, many claims for service connection were denied.
Defendants respond that Plaintiffs' purported evidence of bias in the DVA's adjudicatory system is irrelevant
because the Court allowed Plaintiffs to bring a claim alleging that the DVA was an inherently biased
adjudicator, not a claim of actual bias. They also argue that the evidence Plaintiffs submit cannot be
reviewed by the Court under § 511.
Plaintiffs reply that § 511 is not an evidentiary exclusionary rule. However, in Veterans for Common Sense,
the court did look at the type of inquiry that the district court would have to carry out in resolving the claims,
when deciding if the cause of action itself was barred under that section. For example, in resolving the
cause of action regarding delayed processing of mental health claims, the court said that "the district court
would have no basis for evaluating [the argument that the average processing time was too long] without
inquiring into the circumstances of at least a representative sample of the veterans whom VCS represents;
then the district court would have to decide whether the processing time was reasonable or not as to each
individual case." 678 F.3d at 1027. To the extent that Plaintiffs invite the Court to examine the reasons that
individual service members' claims were denied or the evidence that was submitted to show that an injury
was service-connected in particular cases, see e.g., Pls.' Reply and Opp., Docket No. 502, 30, such
evidence does fall into the category of which the Ninth Circuit disapproved.
Further, even if the Court could properly consider all of the evidence submitted by Plaintiffs, they have not
made a sufficient showing that these materials reveal that there is actual bias or a substantial appearance
of bias on the part of the DVA adjudicators. Plaintiffs argue that the DOD fact sheet that accompanied the
DVA notice letter showed bias because it included what a DVA representative believed to be an inaccuracy
and because the letter itself purportedly discouraged veterans from seeking care. However, although the
statement in the fact sheet may have been mistaken, it was the result of a reasonable difference of
scientific opinion and does not manifestly reveal a bias on behalf of the DVA, which was not its author, or of
the DVA's adjudicators. Further, the DVA's letter did not discourage veterans from coming to the DVA for
care; instead, it directly encouraged them to do so. Plaintiffs also argue that certain DVA training letters to
clinicians show bias because they stated that studies showed no "significant" long-term health or physical
effects from participation in testing. However, as with the DOD fact sheet, these statements reflect a
difference of scientific opinion as to what constitutes "significant" effects, a debate that is consistent with the
evidence that has been presented to the Court. Finally, to the extent that Plaintiffs contend that the DVA
diverged from its normal procedures by depending on the DOD to "to validate whether an individual
participated in any chemical or biological test," this argument is also unpersuasive. Defendants have
offered evidence that, in other contexts, the DVA does depend on the DOD to provide it with details of
veterans' service to be used in adjudicating claims, such as when and in what manner the individual
served, and this is sometimes specified in written DVA regulations. It is rational for the DVA to accept the
DOD's service records as reliable indicators of whether a person making a claim actually served in the
military and in what context. This is not inconsistent with, or an abdication of, the DVA's obligation to
consider "all pertinent medical and lay evidence" and to base its determination on "review of the entire
evidence of record" when resolving a claim of service-connection. 38 C.F.R. § 3.303(a).
Accordingly, because Plaintiffs have failed to raise a material dispute of fact that there was an appearance
of bias or an unconstitutionally high probability of actual bias on the part of the DVA adjudicators,
Defendants' motion for summary judgment on this claim is granted.
CONCLUSION
For the reasons set forth above, Plaintiffs' motion for partial summary judgment is GRANTED in part and
DENIED in part, and Defendants' cross-motion for summary judgment is GRANTED in part and DENIED in
part.
The Court rules as follows:
(1) The DOD and the Army are granted summary judgment on: (a) all APA claims for notice, except to the
extent that Plaintiffs seek to require the Army to warn class members of any information acquired after the
last notice that may affect their well-being when that information has become available and in the future; (b)
all APA claims for medical care; (c) the claim that, under the Fifth Amendment, these Defendants' failure to
provide Plaintiffs with notice, medical care and a release from secrecy oaths violated their substantive due
process liberty rights, including their right to bodily integrity; (d) the claim that, under the Fifth Amendment,
these Defendants' failure to provide Plaintiffs with any procedures whatsoever to challenge this deprivation
violated their procedural due process rights; (e) the claim that, under the Fifth Amendment, these
Defendants' failure to comply with their own regulations and procedures regarding notice and medical care
deprived Plaintiffs of their due process rights; and (f) the claim that, under the First and Fifth Amendment,
the failure to provide a release from secrecy oaths prevented Plaintiffs from filing claims for benefits with
the DVA and thereby violated their right of access to the courts.
(2) The DOD, the Army and the CIA are granted summary judgment on Plaintiffs' claims seeking a
declaration that the secrecy oaths are invalid and an injunction requiring Defendants to notify Plaintiffs that
they have been released from such oaths.
(3) Defendants' motion for summary judgment on Plaintiffs' claim against the DVA is granted.
(4) Plaintiffs' motion for summary judgment on the APA notice claim is granted to the extent that Plaintiffs
seek to require the Army to warn class members of any information acquired after the last notice was
provided, and in the future, that may affect their well-being, when that information becomes available.
The Court VACATES the final pretrial conference and trial dates. An injunction and judgment shall enter.
IT IS SO ORDERED.
[1] Pursuant to Federal Rule of Civil Procedure 25(d), the Court substitutes Director Brennan and Secretary Hagel in place of their
predecessors.
[2] Until Defendants filed their reply brief, the parties apparently did not realize that there were versions of AR 70-25 released in 1988
and 1989, and instead focused their analysis on the 1990 version. The parties have represented these versions were "substantively
identical for the purposes of the issues in this case." Defs.' Reply, Docket No. 513-1, 8 n.8; see also Hr'g Tr., Docket No. 523, 4:21-5:2.
[3] The Judge Advocate General opined that the authority for the regulation was 10 U.S.C. §§ 3012(a) and 4503. Gardner Decl., Ex. 47,
Docket No. 496-55, 4 (1962 version); Gardner Decl., Ex. 48, Docket No. 496-56, 4 (1974 version). In 1986, Public Law 99-433
redesignated 10 U.S.C. § 3012 as 10 U.S.C. § 3013.
[4] A predecessor version of this statute, which was enacted as section 101 of the Army Organization Act of 1950 and appeared at 5
U.S.C. § 181-4, provided in part that "the Secretary of the Army may make such assignments and details of members of the Army and
civilian personnel as he thinks proper, and may prescribe the duties of the members and civilian personnel so assigned; and such
members and civilian personnel shall be responsible for, and shall have the authority necessary to perform, such duties as may be so
prescribed for them."
[5] As previously noted, neither Plaintiffs nor Defendants were aware of the 1988 and 1989 versions of AR 70-25 until Defendants filed
the final brief on the instant cross-motions.
[6] "Disability" is defined as "a disease, injury, or other physical or mental defect." 38 U.S.C. § 1701(1).
[7] In addition to providing veterans with medical care for service-connected disabilities, the DVA offers eligible veterans a "medical
benefits package" of basic and preventive care that includes outpatient and inpatient medical, surgical, and mental health care,
prescription drugs coverage, emergency care, comprehensive rehabilitative care and other services. 38 C.F.R. § 1738(a). To receive the
medical benefits package, a veteran must generally be enrolled in the DVA health-care system. 38 C.F.R. §§ 17.36(a), 17.37. Veterans
who qualify for enrollment are placed into one of eight priority groups. 38 C.F.R. § 17.36(b). Assignment to a priority group involves a
consideration of factors including income and a percent rating that attempts to quantify the decrease in veterans' earning capacity based
on their service-connected disability. 38 C.F.R. §§ 4.1, 17.36(b). The Secretary determines, based on the "relevant internal and external
factors, e.g., economic changes, changes in medical practices, and waiting times to obtain an appointment for care," which priority
groups will actually be eligible for enrollment. 38 C.F.R. § 17.36(b),(c). Presently, the DVA enrolls veterans in all priority categories,
except those in subcategories (v) and (vi) of priority category eight, which consists of "Noncompensable zero percent service-connected
veterans" and "Nonservice-connected veterans" who do not meet certain income guidelines or moved from a higher priority category. 38
C.F.R. § 17.26(b)(8), (c)(2).

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1/1/2021 Murphy v. Implicito, 920 A. 2d 678 - NJ: Appellate Div.

2007 - Google Scholar

920 A.2d 678 (2007)

David MURPHY and Marilyn Murphy, Plaintiffs-Appellants,

Superior Court of New Jersey, Appellate Division.

Argued February 7, 2007.

Before Judges CUFF, WINKELSTEIN & FUENTES.

The opinion of the court was delivered by WINKELSTEIN, J.A.D.

II. Retrial Evidence

[66 N.J. at 272-73, 330 A.2d 355.]

[Murphy, supra, A-3172-03 (slip op. at 8-10) (internal citations omitted).]

C. Per Quod Claim

[1] All references in this opinion to plaintiff are to David Murphy.

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963 S.W.2d 726 (1998)

Donald R. SHADRICK and wife, Valerie Shadrick, Plaintiffs/Appellees,

Supreme Court of Tennessee, at Nashville.

February 17, 1998.

Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Cir.1972).

Cardwell, 724 S.W.2d at 751.

Benton, 825 S.W.2d at 414 (emphasis in original) (citations omitted).

ANDERSON, C.J., REID, BIRCH and HOLDER, JJ., concur.

[2] The "pedicle" is part of the vertebra.

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414 Pa. Superior Ct. 622 (1992)

Frederick FRITER and Sally Friter, Appellant,

Superior Court of Pennsylvania.

Argued September 18, 1991.

623 *623 Gerald A. McHugh, Jr., Philadelphia, for appellant.

Stephen A. Ryan, Bala Cynwyd, for appellees.

Before JOHNSON, FORD ELLIOTT, and HESTER, JJ.

FORD ELLIOTT, Judge:

no duty, in Pennsylvania, on a hospital to obtain consent from a patient prior to an operation.

A. For an investigational study.

Q. For an investigational study.

A. It's very important.

Q. Was that an ongoing function throughout the investigational study?

Trial transcript, 9/19/89 at 323-24.

Id., 388 Pa.Superior Ct. at 416-17, 565 A.2d at 1178.

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982 F.2d 1513 (1993)

Mildred ANDERSON, Plaintiff-Appellant,

Nos. 91-7522, 91-7731.

United States Court of Appeals, Eleventh Circuit.

February 12, 1993.

Before HATCHETT, EDMONDSON and BIRCH, Circuit Judges.

HATCHETT, Circuit Judge:

II. THE APPELLANTS

III. PROCEDURAL HISTORY

AFFIRMED IN PART, REVERSED IN PART.

[2] See 21 C.F.R. § 813, et seq. (1988).

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798 A.2d 742 (2002)

John MONTGOMERY and Marsha Montgomery, his Wife

Supreme Court of Pennsylvania.

Argued March 5, 2001.

Before FLAHERTY, C.J., ZAPPALA, CAPPY, CASTILLE and SAYLOR, JJ.

Justice SAYLOR files a concurring opinion.

Justice SAYLOR, concurring.

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VIETNAM VETERANS OF AMERICA; TIM MICHAEL JOSEPHS; and WILLIAM

No. C 09-0037 CW.