Supreme Court, Columbia County, June 8, 2022

Phelan, Phelan & Danek, LLP, Albany (Marie Flynn Danek of counsel), for defendants.

Napoli Shkolnik, PLLC, Melville (Joseph Ciaccio of counsel), for plaintiff.

In this negligence action, the plaintiff, Thomas Whitehead, as executor of the estate of Janis Tipple, alleges negligence, negligence per se, wrongful death, and nursing home malpractice against the defendants, Pine Haven Operating LLC, doing business as Pine Haven Nursing and [*2]Rehabilitation Center, Pine Haven Nursing and Rehabilitation Center, ABC Corporation and ABC Partnership, which led to the death from COVID-19 of the deceased Janis Tipple. The defendants now move pre-answer to dismiss the complaint, asserting the defenses of lack of subject matter jurisdiction (CPLR 3211 [a] [2]); or, in the alternative, that the complaint fails to state a cause of action (CPLR 3211 [a] [7]); or to dismiss the plaintiff's cause of action for negligence per se (CPLR 3211 [a] [7]). The defendants assert that the plaintiff's allegations distill into claims{**75 Misc 3d at 987} that are barred under both state and federal law by the Public Readiness and Emergency Preparedness Act (PREP Act) (42 USC § 247d-6d [a] [1]); Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (85 Fed Reg 15198 [Mar. 10, 2020]); New York Emergency or Disaster Treatment Protection Act (EDTPA) (Public Health Law art 30-D, §§ 3080-3082); and New York Executive Order (A. Cuomo) No. 202.10 (9 NYCRR 8.202.10)—all of which granted nursing homes and medical providers immunity from suit in cases where damages and death occurred as a result of COVID-19, and its countermeasures and treatments. With respect to the plaintiff's allegations of negligence per se (third cause of action), the defendants argue, albeit a violation of a state statute may constitute negligence per se, a violation of an ordinance or regulations is only some evidence of negligence and not negligence per se.

The plaintiff opposes, asserting that the complaint is not preempted by the PREP Act, because it does not allege damages arising from, or related to, "the administration of" a "covered countermeasure" for COVID-19 or the selective administration of a "covered countermeasure." According to the plaintiff, the claims in the complaint relate to defendants' glaring omissions in failing to act to prevent injury and death to the decedent. The plaintiff further argues that a nursing home is not a "covered person-program planner" under the PREP Act and therefore the act is not applicable. More particularly, the complaint alleges that the defendants "failed to take proper steps to protect the residents and/or patients at their facilities from the COVID-19 virus" (paras 261-262) and lists 11 COVID-19 countermeasures which the defendants failed to undertake (paras 263-273). The plaintiff asserts that the decedent's death was a "direct result of the defendants' failure to take measures to protect her at the nursing home from the deadly COVID-19 virus, and their negligence, gross negligence, and nursing home malpractice" (para 275). The complaint seeks damages, including punitive damages, for violations of Public Health Law §§ 2801-d and 2803-c, negligent medical care, negligence per se, conscious pain and suffering, as well as wrongful death.

Also in opposition to the motion to dismiss, the plaintiff argues that Public Health Law article 30-D, §§ 3080-3082, was repealed within 11 months of its enactment due in part to an investigation and resulting report from the New York State Attorney General which found that not-for-profit nursing homes{**75 Misc 3d at 988} were incentivizing profits rather than investing in personal protective equipment, staffing and other preventive measures.^[FN1] The short life of the statute, with its preemptive repeal, signifies that the legislative intent was that Public Health Law article 30-D have no retroactive effect. The plaintiff further argues, to the extent that the defendants' motion to dismiss is based upon this repealed statute, the motion must fail.

On a CPLR 3211 motion to dismiss, the court is required to "afford the complaint a liberal construction, accept the facts alleged as true, accord the plaintiff the benefit of every favorable [*3]inference and determine only whether the alleged facts fit within any cognizable legal theory" (Gagnon v Village of Cooperstown, N.Y., 189 AD3d 1724, 1725 [3d Dept 2020] [citations omitted]). In addition to the pleadings, the court may "take judicial notice of facts [that amount to common knowledge or may be determined] by resort to easily accessible sources of indisputable accuracy" (Hamilton v Miller, 23 NY3d 592, 603 [2014], quoting People v Jones, 73 NY2d 427, 431 [1989]). This said, "where the pleaded facts state a cause of action, documentary evidence may result in dismissal only where it has been shown that a material fact as claimed by the pleader . . . is not a fact at all and . . . no significant dispute exists regarding it" (Acquista v New York Life Ins. Co., 285 AD2d 73, 76 [1st Dept 2001] [internal quotation marks and citations omitted]).

The PREP Act was enacted in 2005, and is invoked when the Secretary of the U.S. Department of Health and Human Services determines that a disease or health condition exists that constitutes a public health emergency (42 USC § 247d-6d [b]). Thereafter, the Secretary "may make a declaration, through publication in the Federal Register, recommending . . . the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures." (Id. § 247d-6d [b] [1].) This was done to address the COVID-19 pandemic (Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed Reg 15198 [Mar. 10, 2020]). Under the PREP Act, a "covered countermeasure" is a drug, biological product, or device that is a "qualified pandemic or epidemic product" or a "security countermeasure" or is "authorized for emergency use [by the] Federal Food, Drug, and Cosmetic Act." (42 USC § 247d-6d [i] [1] [a]-[c].) The PREP Act does not define{**75 Misc 3d at 989} "administration" and "use," but the Secretary's Declaration states that "[a]dministration" of covered countermeasures "means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution, and dispensing of the countermeasures to recipients; management and operation of countermeasure programs; or management and operation of locations for purpose of distributing and dispensing countermeasures." (85 Fed Reg 15198.)

Immunity under the PREP Act applies to any loss or claim that has a causal relationship to the administration to or use by a "covered person" arising out of or relating to the administration of a covered countermeasure (42 USC § 247d-6d [a] [1]), with the exception to immunity being "death or serious physical injury proximately caused by willful misconduct." (Id. § 247d-6d [d] [1].) A claim falling under the PREP Act must be filed in federal court, and the act creates a fund known as the Covered Countermeasure Process Fund for "purposes of providing timely, uniform, and adequate compensation to eligible individuals for covered injuries" (42 USC § 247d-6e [a]).

The PREP Act was clarified on April 17, 2020, by U.S. Department of Health and Human Services Advisory Opinion No. 20-01, to provide that a person did not lose immunity (even if the person or entity was not a covered person) if that person could have reasonably believed that it was a covered person, or the product administered was a covered countermeasure. Since then, the Secretary's Declaration has been amended five times. On June 4, 2020, the Secretary amended the Declaration for a second time to clarify retroactively the definition of "covered countermeasures" to include products that are used "to limit the harm that COVID-19 . . . might otherwise cause." The third clarification included who may meet the definition of a "covered person" as a "program planner" and that the "use" and "administration" of countermeasures extends beyond physical distribution of countermeasures to recipients to include all program planning decisions and activities. The fourth clarification stated [*4]that the act must be construed in accordance with these advisory opinions and acknowledged that there can be situations where not administering a covered countermeasure to a particular individual falls within the PREP Act, particularly where it involves a product in limited supply. A fifth U.S. Department of Health and Human Services advisory opinion (Advisory Op No. 21-01) again confirmed that the act can apply to allegations of failure to act or inaction.{**75 Misc 3d at 990}

For the reasons that follow the court grants the motion to dismiss to the extent of dismissing the plaintiff's third cause of action (negligence per se) and denies the motion to dismiss in all other respects.

Turning first to the defendants' defense of lack of subject matter jurisdiction, the court is mindful that "[p]arties have been litigating similar disputes throughout the ongoing COVID-19 pandemic and district courts . . . have consistently held that they do not have jurisdiction over them" and there is a "broad consensus of district courts in this circuit and nationwide" on the issue of subject matter jurisdiction (Rivera -Zayas v Our Lady of Consolation Geriatric Care Ctr., 2021 WL 4776610, *2-3, 2021 US Dist LEXIS 197444, *5-6 [ED NY, Oct. 12, 2021, 20-CV-5153 (NGG) (JMW)] [citations omitted]). All said, the PREP Act does not afford federal courts exclusive subject matter jurisdiction over what has been pleaded here as a state claim (Dupervil v Alliance Health Operations, LCC, 516 F Supp 3d 238 [ED NY 2021]).^[FN2]

[1] Turning next to the defendants' claim of immunity under New York's EDTPA (Public Health Law art 30-D, §§ 3080-3082), and New York Executive Order 202.10, the EDTPA has been repealed, and the court finds the repeal to be retroactive. The EDTPA was repealed less than a year after it was enacted, and there is the clear indication, as stated in the legislative debate on the bill and the commentary (including the affidavit presented of Member of Assembly Ron Kim, one of the sponsors of the bill), that the repeal was to be "retroactively applied to the unfair immunity bill so as to afford nursing home residents and their families their day in court." Further, the plain language of the statute must be interpreted in a manner "so as to avoid an unreasonable or absurd application of the law" (People v Garson, 6 NY3d 604, 614 [2006] [internal quotation marks omitted]). However viewed, if the repeal was not retroactive, its remedial nature would be undermined (Lubonty v U.S. Bank N.A., 34 NY3d 250, 255 [2019]).

[2] As to any claim of immunity by defendants as a result of Governor Cuomo's temporary executive order—9 NYCRR 8.202.10 ("Continuing Temporary Suspension and Modification {**75 Misc 3d at 991}of Laws Relating to the Disaster Emergency" [Mar. 21, 2020])—the court is not persuaded that the executive order supports the proposition that the operators of residential nursing homes were granted any type of immunity for injury or death to their residents in the wake of the COVID-19 pandemic. Certainly, there is no language in the order that provides for the same. Nor is the court inclined to infer any grant of immunity in the order—which would be an "extraordinary interpretation" of the order (Scheja v Sosa, 4 AD3d 410, 411 [2d Dept 2004]). However viewed, the executive order was temporary, made during a public health emergency, and not intended to be binding after its expiration.

The parties fundamentally disagree on the interpretation of the PREP Act's immunity [*5]provision, and its applicability to the plaintiff's complaint. According to the defendants, their use of covered countermeasures within the nursing home grants them immunity from these negligence claims, as they are "administrators," "program planners," and "covered persons." Because they managed the COVID-19 protocols advanced by the health departments and various governmental agencies, they assert they are covered by the immunity provisions provided by the act. And, because they are covered persons and entitled to this immunity, there can be no state claims for negligence against them. All said, the court rejects these "complete preemption" arguments, for the same, universal, reasoning in the federal courts (Eaton v Big Blue Healthcare, Inc., 480 F Supp 3d 1184 [D Kan 2020]; Khalek v South Denver Rehabilitation, LLC, 543 F Supp 3d 1019 [D Colo 2021]).

[3] The PREP Act applies, and preempts state claims and confers immunity, only where the allegations are that the defendant dispensed or administered countermeasures improperly, causing injury (Parker v St. Lawrence County Pub. Health Dept., 102 AD3d 140, 141-142 [3d Dept 2012]). The act provides immunity for the "administration or use of a . . . countermeasure" and "administration" is defined as the "physical provision of a countermeasure to a recipient" (Casabianca v Mount Sinai Med. Ctr., 2014 NY Slip Op 33583[U], *7-8 [Sup Ct, NY County 2014] [emphasis omitted]). Allegations such as those set forth in this complaint (failing to enforce social distancing, failing to timely restrict visitors, failing to insure all residents and staff wore face coverings, failure to screen staff and visitors, and failing to discontinue group activities) do not amount to the administration of countermeasures under the PREP Act. Here,{**75 Misc 3d at 992} there are no allegations that the decedent was injured by administration of the vaccine, or the administration of treatment, or the use of a diagnostic test, or use of any personal protective equipment, all of which would fall under the act.

Surely, the PREP Act's immunity provisions, in the context of the COVID-19 pandemic, were meant to protect pharmaceutical companies who rapidly developed the COVID-19 vaccine,^[FN3] and now cannot be read to afford a free pass to residential nursing homes who failed to adequately protect their residents from illness and death during the pandemic. The court is simply not persuaded, as argued by the defendants, that "[a]s long as the covered person offered a site for the distribution of a covered countermeasure," "without regard to whether there was a 'direct relationship' between the injury and the use of a covered countermeasure," immunity is provided (Shapnik v Hebrew Home for Aged at Riverdale, 535 F Supp 3d 301, 321 [SD NY 2021]). The plaintiff's complaint, read in the light most favorable to the plaintiff, reveals that the "decedent died from COVID-19 based on a negligent failure to protect her rather than from any affirmative efforts to treat the disease or administer countermeasures as would be required to fall under the Act's rubric" (Tercero v Orinda Care Ctr., LLC., 2022 WL 256511,*2, 2022 US Dist LEXIS 17386, *4 [ND Cal, Jan. 3, 2022, Case No. 21-cv-05563-JSW]). As clearly stated in the complaint, the decedent died because the defendants negligently failed to protect her from contracting the disease by "failing to enforce social distancing," "fail[ing] to cancel group activities," "fail[ing] to timely restrict visitors," "fail[ing] to adequately screen visitors," and more (Dupervil, 516 F Supp 3d [*6]238). The complaint does not allege that the defendants failed to properly administer vaccines, or biological agents, or drugs or devices, which would have therefore triggered the PREP Act's immunity provisions.

Valerie Lattrell, RN, in support of the motion to dismiss, states in her affidavit that countermeasures were taken; that the decedent's care was impacted by the nursing home's decisions and activities in response the COVID-19 outbreak; and that all services rendered to the decedent were rendered in "good faith" (Lattrell aff para 17). This said, her affidavit can be read to actually support the plaintiff's negligence claims, as{**75 Misc 3d at 993} she fails to allege that the decedent was specifically administered any covered countermeasure (drug, biologic or even any specific respiratory protection)—which, if that had occurred, could have fallen under the PREP Act.

Lastly, the court turns to the defendants' argument for dismissal of the cause of action for negligence per se (third cause of action). The allegations which comprise the same amount only to violations of state and federal regulations—with the exception of alleged violations of Public Health Law §§ 2801-d and 2803-c. Mindful that in "the absence of a violation of a statutorily imposed duty [of care] a negligence per se finding [is] unwarranted" (Elliott v City of New York, 95 NY2d 730, 736 [2001]), the court dismisses the plaintiff's third cause of action. The court also notes that the cited sections of the Public Health Law do not impose a "specific duty" of care or standard of conduct, and do not support a claim of negligence per se (Elliott at 734).

The defendants' pre-answer motion to dismiss is granted to the extent of dismissal of the plaintiff's third cause of action and as to all other respects is denied. The defendants are directed to file a verified answer within 30 days. A mandatory compliance conference is scheduled for August 24, 2022, at 1:30 p.m., to be conducted by Microsoft Teams.

Accordingly, it is ordered, the defendants' motion to dismiss is granted to the extent of dismissing the plaintiff's third cause of action (negligence per se); and is denied in all other respects.