Seth Answer

Michael K Jeanes, Clerk of Court
*** Electronically Filed ***

M. King, Deputy
10/17/2017 3:37:00 PM
Filing ID 8760776
1 Barry Mitchell (#013975)

barry@mscclaw.com
2
Anna H. Finn (#026738)
3 anna@mscclaw.com
MITCHELL | STEIN | CAREY | CHAPMAN, PC
4
One Renaissance Square
5 2 North Central Avenue, Suite 1450
Phoenix, AZ 85004
6
Telephone: (602) 358-0293
7 Facsimile: (602) 358-0291
8 Attorneys for Defendant Nikesh Seth
9 IN THE SUPERIOR COURT OF THE STATE OF ARIZONA
10 IN AND FOR THE COUNTY OF MARICOPA
11
STATE OF ARIZONA, EX REL. MARK ) No. CV2017-012008
12 BRNOVICH, ATTORNEY GENERAL, )
13 )
Plaintiff, ) ANSWER OF DEFENDANT NIKESH
14 ) SETH, M.D.
15 v. )
)
16 INSYS THERAPEUTICS, INC.; ALEC ) (Honorable Rosa Mroz)
17 BURLAKOFF, INDIVIDUALLY; ALEC )
BURLAKOFF AND JANE DOE )
18 BURLAKOFF, AS A MARITAL )
19 COMMUNITY; ELIZABETH GURRIERI, )
INDIVIDUALLY; AELIZABETH )
20 GURRIERI AND JOHN DO GURRIERI, )
21 AS A MARITAL COMMUNIT; STEVE )
FANTO, INDIVIDUALLY; STEVE )
22 FANTO AND JANE DOE FANTO, AS A )
23 MARITAL COMMUNITY; NIKESH )
SETH, INDIVIDUALLY; NIKESH SETH )
24 AND JANE DOE SETH, AS A MARITAL )
25 COMMUNITY; SHELDON GINGERICH, )
INDIVIDUALLY; SHELDON )
26 GINGERICH AND JANE DOE )
27 GINGERICH, AS A MARITAL )
COMMUNITY, )
28 )
Defendants. )
1 Defendant Nikesh Seth, M.D. (Dr. Seth) by and through his attorneys of record,
2 hereby answers the Complaint. Any allegations not specifically admitted are denied. In
3 answering the allegations of the Complaint, Dr. Seth admits, denies and affirmatively
4 alleges as follows:
5 1. Dr. Seth lacks knowledge or information sufficient to form a belief about
6 the truth of the allegations contained in Paragraph 1 and therefore denies them.
7 2. Dr. Seth lacks knowledge or information sufficient form a belief about the
8 truth of the allegations contained in Paragraph 2 and therefore denies them.
9 3. Dr. Seth admits that between 2014 and early 2017, he was paid by Insys in
10 exchange for speaking to medical providers about his experience prescribing the drug
11 Subsys. Dr. Seth denies the remaining allegations in Paragraph 3.
14 5. In response to the allegations in Paragraph 5, Dr. Seth states that the
15 Complaint speaks for itself and therefore no response is required.
16
JURISDICTION AND VENUE
17
18 6. Admit.
19 7. Admit.
20 PARTIES
21
8. Admit.
22
9. Dr. Seth lacks knowledge or information sufficient to form a belief about
23
the truth of the allegations contained in Paragraph 9 and therefore denies them.
24
25
26
27
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13 18. Admit.
14 19. Admit that Dr. Seth is married. Deny all remaining allegations in
15 Paragraph 19.
20 22. Admit only that Dr. Seth is a medical doctor who was in practice in
21 Maricopa County Arizona between 2011 and 2017, during which time he treated patients
22 and prescribed medications, including occasionally Subsys. Deny all remaining
23 allegations in Paragraph 22.
24 ALLEGATIONS
25
26
27
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3 26. Admit only that Subsys contains fentanyl, which is a highly addictive drug.
4 Deny all remaining allegations in Paragraph 26.
5 27. Admit.
6 28. Admit.
7 29. Admit.
8 30. Admit.
9 31. In response to the allegations contained in Paragraph 31, Dr. Seth states that
10 the FDA label for Subsys speaks for itself and therefore no response is required.
11 32. Admit.
17 the FDA TIRF REMS speaks for itself and therefore no response is required.
28
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1 41. Admit only that health insurers and pharmacy benefit managers (PBMs)
2 often require prior authorization before paying for Subsys. Deny the remaining
3 allegations in Paragraph 41.
8 44. Admit only that it is not an uncommon practice for a healthcare providers
9 office to submit prior authorization requests for drugs such as Subsys. Affirmatively
10 allege that it is a common practice for manufacturers of specialty drugs to assist in the
11 prior authorization process. Deny the remaining allegations in Paragraph 44.
12 45. Admit.
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17 76. In response to the allegations in Paragraph 76, Dr. Seth states that the FBI
18 Agent Affidavit speaks for itself and therefore no response is required. Any remaining
19 allegations in Paragraph 76 are denied.
28
-7-
10 Agent Affidavit speaks for itself and therefore no response is required. Any remaining
11 allegations in Paragraph 85 are denied.
17 Agent Affidavit speaks for itself and therefore no response is required.
20 90. Admit.
25 93. Admit only that Dr. Seth used a slide deck prepared by Insys when he
26 spoke to healthcare providers between 2014 and 2016 regarding his experiences
27 prescribing Subsys. Deny all other allegations in Paragraph 93.
28
-8-
7 97. Deny.
15 cited document speaks for itself and therefore no response is required.
28
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5 110. Admit only that, during the referenced timeframe, Dr. Seth prescribed
6 Subsys to a small subset of his patients where it was his medical judgment that such a
7 prescription was in the patients best interest. Dr. Seth lacks knowledge or information
8 sufficient to form a belief as to the remaining allegations in Paragraph 110 and therefore
9 denies them. Affirmatively allege that Dr. Seths prescribing of Subsys was within the
10 standard of care and absolutely unrelated to his receipt of speaker fees.
13 112. Deny the allegations with respect to Dr. Seth. Dr. Seth lacks knowledge or
14 information sufficient to form a belief about the truth of the remaining allegations
15 contained in Paragraph 112 and therefore denies them.
16 113. Admit only that Dr. Seth was compensated by Insys for speaking
17 engagements between 2014 and 2016 and was paid a contractually fixed amount for each
18 speaking engagement. Deny the remaining allegations in Paragraph 113. Affirmatively
19 allege that the aggregate total for the entire time period Dr. Seth spoke on behalf of Insys
20 was approximately $200,000.
21 114. Admit only that Dr. Seth prescribed Subsys before he began speaking on
22 behalf of Insys. Deny the remaining allegations in Paragraph 114. Affirmatively allege
23 that Dr. Seths patient population fluctuated in size and varied in diagnosis makeup
24 during the years 2011 to present and that his use of TIRF products, including Subsys, also
25 varied. Affirmatively allege that Dr. Seth only prescribed Subsys to a small subset of his
26 patients where it was his medical judgment that such a prescription was in the patients
27 best interest. Affirmatively allege that Dr. Seths prescribing of Subsys was within the
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1 115. Admit only that Dr. Seth prescribed Subsys after he began speaking on
2 behalf of Insys. Deny the remaining allegations in Paragraph 115. Affirmatively allege
3 that Dr. Seths patient population fluctuated in size and varied in diagnosis makeup
4 during the years 2011 to present and that his use of TIRF products, including Subsys, also
5 varied. Affirmatively allege that Dr. Seth only prescribed Subsys to a small subset of his
6 patients where it was his medical judgment that such a prescription was in the patients
7 best interest. Affirmatively allege that Dr. Seths prescribing of Subsys was within the
15 119. Admit only that Dr. Seth was compensated a contractually fixed amount for
16 each of the times he spoke to other healthcare providers about his experience prescribing
17 Subsys. Dr. Seth lacks knowledge or information sufficient to form a belief about the
18 truth of the remaining allegations contained in Paragraph 119 and therefore denies them.
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1 Affirmatively allege that Dr. Seth was paid significantly less than $2400 for each of his
2 speaking engagements.
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13 186. Admit only that Dr. Fanto signed an interim consent Agreement with the
14 Arizona Medical Board. Dr. Seth lacks knowledge or information sufficient to form a
15 belief about the truth of the remaining allegations contained in Paragraph 186 and
16 therefore denies them.
18 Consent Agreement speaks for itself and therefore no response is required.
20 Subsys FDA label speaks for itself and therefore no response is required.
22 Prescriber Enrollment Form speaks for itself and therefore no response is required.
-16-
9 197. Admit only that Dr. Seth prescribed Subsys to a small subset of his patients
10 between the referenced dates when it was his medical judgment that such a prescription
11 was in the patients best interest. Dr. Seth lacks knowledge or information sufficient to
12 form a belief about the truth of the remaining allegations contained in Paragraph 197 and
13 therefore denies them. Affirmatively allege that Dr. Seths prescribing of Subsys was
14 within the standard of care and absolutely unrelated to his receipt of speaker fees.
15 198. Admit.
20 therefore denies them. Affirmatively allege that Dr. Seths patient population fluctuated
21 in size and varied in diagnosis makeup during the years 2011 to present and that his use
22 of TIRF products, including Subsys, also varied. Affirmatively allege that Dr. Seths
23 prescribing of Subsys was within the standard of care and absolutely unrelated to his
24 receipt of speaker fees.
25 200. Admit.
28
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1 Affirmatively allege that Dr. Seth did not accept speaker fees in exchange for writing
2 prescriptions for Subsys.
9 of TIRF products, including Subsys, also varied.
28
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3 Affirmatively allege that Dr. Seths prescribing of Subsys was within the standard of care
4 and absolutely unrelated to his receipt of speaker fees.
7 Affirmatively allege that Dr. Seths prescribing of Subsys was within the standard of care
8 and absolutely unrelated to his receipt of speaker fees.
11 211. Admit.
12 212. Admit.
24 Affirmatively allege that Dr. Seths patient population fluctuated in size and varied in
25 diagnosis makeup during the years 2011 to present and that his use of TIRF products,
26 including Subsys, also varied.
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7 233. Admit only that Dr. Seth was compensated an aggregate amount of
8 approximately $200,000, based on a contractually fixed rate for each speaking
9 engagement he performed between 2014 and 2016. Dr. Seth lacks knowledge or
10 information sufficient to form a belief about the truth of the remaining allegations
11 contained in Paragraph 233 and therefore denies them.
16 236. Admit only that Dr. Seth received a civil investigative demand from the
17 State in July 2017. Dr. Seth lacks knowledge or information sufficient to form a belief
18 about the truth of the remaining allegations contained in Paragraph 236 and therefore
19 denies them.
20 237. Admit only that Dr. Seth has not responded to the civil investigative
21 demand. Dr. Seth lacks knowledge or information sufficient to form a belief about the
22 truth of the remaining allegations contained in Paragraph 237 and therefore denies them.
23 238. Deny the allegations in Paragraph 238 with regard to Dr. Seth. Dr. Seth
24 lacks knowledge or information sufficient to form a belief about the truth of the
25 remaining allegations contained in Paragraph 238 and therefore denies them.
26 Affirmatively allege that before he prescribed Subsys to any patient, Dr. Seth disclosed
27 that he was a paid speaker on behalf of Insys.
28
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3 remaining allegations contained in Paragraph 239 and therefore denies them.
6 remaining allegations contained in Paragraph 240 and therefore denies them. To the
7 extent the allegations in Paragraph 240 assert a legal conclusion, no answer is required.
10 remaining allegations contained in Paragraph 241 and therefore denies them. To the
11 extent the allegations in Paragraph 241 assert a legal conclusion, no answer is required.
28
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7 VIOLATIONS OF LAW
8
267. Dr. Seth realleges and incorporates his response to all preceding paragraphs
9
as if set forth fully herein.
10
268. The allegations in Paragraph 268 assert a legal conclusion to which no
11
response is required. To the extent a response is required, Dr. Seth lacks knowledge or
12
information sufficient to form a belief about the truth of the allegations contained in
13
Paragraph 268 and therefore denies them.
14
15
response is required. To the extent a response is required, Dr. Seth lacks knowledge or
16
information sufficient to form a belief about the truth of the allegations contained in
17
Paragraph 269 and therefore denies them.
18
19
response is required. To the extent a response is required, deny.
20
21
response is required. To the extent a response is required, deny.
22
23 PRAYER FOR RELIEF
24 272. Dr. Seth denies that the State is entitled to the relief sought, or to any relief.
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2 AFFIRMATIVE DEFENSES
3
1. The Complaint fails to state facts sufficient to constitute any claim upon
4
which relief can be granted against Dr. Seth.
5
2. Dr. Seth did not violate any law of the State of Arizona, including those
6
cited in the Complaint, nor did he violate any federal or municipal law or other
7
regulation.
8
3. If any liability exists on the part of Dr. Seth, such liability is to be
9
completely indemnified by Insys.
10
4. Dr. Seths investigation into the issues raised in the Complaint is in its
11
preliminary stages, and therefore Dr. Seth reserves the right to amend this Answer to add
12
further affirmative defenses and allege any counterclaims when they are discovered.
13
14 WHEREFORE, Dr. Seth requests judgment as follows:
15 1. That the State take nothing by the Complaint, which will be dismissed with
16 prejudice.
17 2. That Dr. Seth recover from the State any appropriate costs and fees,
18 including but not limited to attorneys fees as authorized by A.R.S. 12-348 and/or 12-
19 349.
20 3. That the Court order any such further and other relief as it deems
21 appropriate.
22
23
///
24
///
25
///
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1 RESPECTFULLY SUBMITTED this 17th day of October, 2017.
MITCHELL | STEIN | CAREY | CHAPMAN, PC
2
3
By: s/ Anna H. Finn
4
Barry Mitchell
5 Anna H. Finn
6 Attorneys for Defendant
7 ORIGINAL of the foregoing E-FILED

8 this 17th day of October, 2017, with:
9 Clerk of the Superior Court

10 Maricopa County Superior Court
201 W. Jefferson
11 Phoenix, AZ 85003
12
COPY of the foregoing
13 EMAILED AND MAILED this 17th
14 day of October, 2017, to:
15 MARK BRNOVICH
16 Attorney General
Matthew du Me
17 Office of the Attorney General
18 1275 W. Washington Street
Phoenix, AZ 85003
19 consumer@azag.gov
20 Attorneys for Plaintiff
21
s/ Julie Greenwood
22
23
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25
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Michael K Jeanes, Clerk of Court

* Electronically Filed *

1 Barry Mitchell (#013975)

7 ORIGINAL of the foregoing E-FILED

9 Clerk of the Superior Court

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