MER-L-000049-23 05/03/2023 5:26:58 PM Pg 1 of 1 Trans ID: LCV20231449007

CJ Griffin
Partner
cgriffin@pashmanstein.com
Direct: 201.270.4930

May 3, 2023

VIA NJ ECOURTS
Honorable Douglas H. Hurd P.J.Civ.
Mercer County Civil Courthouse
175 South Broad Street, Floor 3
Trenton, New Jersey 08650-0068

Re: LifeVac LLC v. States Newsroom, Inc., et al.

Docket No: MER-L-49-23

Dear Judge Hurd:

This firm represents Defendants in the above-referenced matter. On May 14, 2023,
Defendants filed a Motion to Dismiss Plaintiff’s Complaint for Failure to State a Claim, arguing,
among other things, that the alleged defamatory statements in a news story that form the basis of
Plaintiff’s claims were neither false nor defamatory.

We write now to advise the Court that the Director of the New Jersey Department of Health
Office of Emergency Medical Services released a statement on May 2, 2023 concerning Plaintiff’s
product, the LifeVac device, which was partly the subject of the news story at issue. A copy of
the statement is enclosed herewith for the Court’s reference. The Director states, among other
things, that the LifeVac device is not approved by the United States Food and Drug Administration
and that there is insufficient research documenting safety and efficacy in the use of the LifeVac
Device. The statement goes on to disapprove of the utilization of the LifeVac Device by pre-
hospital health care providers (e.g., EMTs, paramedics, etc.) in pre-hospital settings or during non-
emergency medical transports.

This statement, an official government document, of which the Court may take judicial
notice, further supports Defendants’ position that the subject news article did not contain any false
or defamatory statements relating to Plaintiff’s device, and that the statements made in the news
story were, in fact, true or substantially true.

We thank the Court for its attention to this matter.

Respectfully submitted,

/s/ CJ Griffin
CJ Griffin

cc: Counsel of Record (via NJ eCourts)

Encl.

Court Plaza South Phone: 201.488.8200

21 Main Street, Suite 200 Fax: 201.488.5556
Hackensack, NJ 07601 www.pashmanstein.com
 MER-L-000049-23 05/03/2023 5:26:58 PM Pg 1 of 2 Trans ID: LCV20231449007

DEPA RTMENT OF HEALTH

OFFICE OF EMERGENCY MEDICAL SERVICES
PO BOX 360
PHILIP D. MURPHY TRENTON, N.J. 08625-0360
Governor
www.nj.gov/health
SHEILA Y. OLIVER JUDITH M. PERSICHILLI, RN, BSN, MA
Lt. Governor Commissioner

To: New Jersey EMS Community

From: Candace Gardner, Director, Office of Emergency Medical Services

Date: May 2, 2023

Subject: Anti-Choking Devices

The New Jersey Department of Health (Department) Office of Emergency Medical

Services (OEMS) recognizes that there are several devices marketed to be used in the case of
a foreign body airway obstruction (choking) in the community setting. Such devices include but
are not limited to, Lifevac® and Dechoker®.

After a detailed review of the aforementioned marketed products, OEMS was able to
make the following determinations:

• These devices are not approved by the United States Food and Drug Administration.

• Use of this type of device is not within the National EMS Scope of Practice for the
management of airway obstruction at any provider level.

• These types of devices are not endorsed for use by healthcare organizations, such as
the American Heart Association (AHA).

• There is currently insufficient research documenting safety and efficacy in the use of this
device (Dunne et al., 2020; Dunne, Osman, et al., 2022; Dunne, Queiroga, et al., 2022).

The Department is vested with the responsibility of carrying out the provisions of the
Health Care Facilities Planning Act, N.J.S.A. 26:2H-1 et seq., which was enacted, in part, to
ensure that hospital and related health care services rendered in New Jersey are of the highest
quality.

As defined at N.J.S.A. 26:2H-2b, health care services include pre-hospital Basic Life
Support (BLS) ambulance services and any pre-hospital care rendered by Advanced Life
Support (ALS) services. Furthermore, N.J.S.A. 26:2H5 grants the Commissioner of Health the
power to inquire into health care services and to conduct periodic inspections with respect to the
fitness and adequacy of the equipment and personnel employed by those services. As such, in
furtherance of each of the aforementioned statutory objectives, the Department adopted
regulations that govern the licensure and inspection of BLS and ALS service providers and their
vehicles. Those regulations are set forth in their entirety at N.J.A.C. 8:40, N.J.A.C. 8:41,
N.J.A.C. 8:41A, and N.J.A.C. 8:40A.

In conclusion, OEMS does not endorse, nor approve of the utilization of these devices
by pre-hospital health care providers (EMTs, paramedics, etc.) in pre-hospital settings or during
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non-emergency medical transports. As such, OEMS continues to endorse that pre-hospital

providers follow AHA guidelines and the National EMS Scope of Practice for the management of
foreign body airway obstruction appropriate to their level of training.

References

Dechoker. (n.d.). Dechoker - choking airway clearing device. Retrieved March 8, 2023, from
https://www.dechoker.com/

Dunne, C. I., Peden, A. E., Queiroga, A. C., Gomez Gonzalez, C., Valesco, B., & Szpilman, D.
(2020). A systematic review on the effectiveness of anti-choking suction devices and
identification of research gaps. Resuscitation, 153, 219–226.
https://doi.org/10.1016/j.resuscitation.2020.02.021

Dunne, C. L., Osman, S., Viguers, K., Queiroga, A., Szpilman, D., & Peden, A. E. (2022). Phase
one of a global evaluation of suction-based airway clearance devices in foreign body
airway obstructions: A retrospective descriptive analysis. International Journal of
Environmental Research and Public Health, 19(7), 3846.
https://doi.org/10.3390/ijerph19073846

Dunne, C. L., Queiroga, C., Szpiman, D., Viguers, K., Osman, S., & Peden, A. E. (2022). A
protocol for the prospective evaluation of novel suction-based airway clearance devices
in the treatment of foreign body airway obstructions. Cureus.
https://doi.org/10.7759/cureus.20918

Food and Drug Administration. (n.d.). Devices@fda. U.S. Food and Drug Administration.
https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm

Lifevac. (n.d.). Official site of lifevac. LifeVac. Retrieved March 8, 2023, from https://lifevac.net/

U.S. Department of Transportation National Highway Traffic Safety Administration. (2021,

August). National EMS Scope of Practice Model 2019: Including change notices 1.0 and
2.0 [PDF].
https://www.ems.gov/assets/National_EMS_Scope_of_Practice_Model_2019_Change_
Notices_1_and-
_www.ems.gov/assets/National_EMS_Scope_of_Practice_Model_2019_Change_Notice
s_1_and-_2_August_2021.pdf2_August_2021.pdf