Summary
nursing home COVID-19 protocols, such as social distancing, restricting visitors, requiring residents and staff to wear face coverings, screening staff and visitors, and discontinuing group activities, did "not amount to the administration of countermeasures under the PREP Act"
Summary of this case from Mills v. Hartford HealthCare Corp.Opinion
Index No. E012022017995
06-08-2022
Thomas N. WHITEHEAD, as Executor of the Estate of Janis H. Tipple, Deceased, Plaintiff, v. PINE HAVEN OPERATING LLC d/b/a Pine Haven Nursing and Rehabilitation Center, Pine Haven Nursing and Rehabilitation Center, ABC Corporation and ABC Partnership, Defendants.
Napoli Shkolnik, PLLC, Attorneys For Plaintiff, Joseph Ciaccio, Esq., of counsel, 400 Broadhollow Road, Melville, New York 11747 Phelan, Phelan & Danek, LLP, Attorneys For Defendant, Marie Flynn Danek, Esq., of counsel, 300 Great Oaks Boulevard, Albany, New York 12203
Napoli Shkolnik, PLLC, Attorneys For Plaintiff, Joseph Ciaccio, Esq., of counsel, 400 Broadhollow Road, Melville, New York 11747
Phelan, Phelan & Danek, LLP, Attorneys For Defendant, Marie Flynn Danek, Esq., of counsel, 300 Great Oaks Boulevard, Albany, New York 12203
Henry F. Zwack, J. 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 Have Operating, LLC d/b/a Pine Haven Nursing and Rehabilitation Center, Pine Haven Nursing and Rehabilitation Center, ABC Corporation and ABC Partnership, which lead 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 that are barred under both state and federal law by the Public Readiness and Emergency Preparedness Act ("PREP Act"), 85 Fed Reg. 15198, 42 USC 247 - 69 [a][1]; the New York Emergency or Disaster Treatment Protection Act ("EDTPA"); Public Health Law Article 30, 3080-3082), and New York Executive Order 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 pre-empted 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" (paragraphs 261-262) and lists eleven COVID-19 countermeasures which the defendants failed to undertake (paragraphs 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" (paragraph 275). The complaint seeks damages, including punitive damages, for violations of the PHL §§ 2801-d and 2803, 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 PHL Article 30, § 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 that found not-for-profit nursing homes were incentivizing profits rather than investing in personal protective equipment, staffing and other preventive measures . The short life of the statute, with its pre-emptive repeal, signifies that the Legislative intent was that PHL Article 30 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 as true, accord the plaintiff the benefit of every favorable inference and determine only whether the alleged facts fit within any cognizable legal theory ( Gagnon v. Village of Cooperstown, N.Y., 189 A.D.3d 1724, 1725, 137 N.Y.S.3d 193 [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 N.Y.3d 592, 603, 992 N.Y.S.2d 190, 15 N.E.3d 1199 [2014], quoting People v. Jones, 73 N.Y.2d 427, 431, 541 N.Y.S.2d 340, 539 N.E.2d 96 [1989] ). This said, "where the pleaded facts state a cause of action, documentary evidence may result in a 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 A.D.2d 73, 76, 730 N.Y.S.2d 272 [1st Dept. 2001], internal quotations and citations omitted).
The report was entitled "Nursing Home Response to COVID-19 Pandemic."
The PREP Act was enacted in 2005, and is invoked when the Secretary of Health and Human Services determines that a disease or health condition exists that constitutes a public health emergency ( 42 U.S.C. § 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.." 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.15. 198 [March 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. The PREP Act does not define "administration" and "use," but the Secretary's Declaration states that "administration" of covered countermeasures "means physical provision of countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures."
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 U.S.C § 247d-6d(a)(1), with the exception to immunity being "death or serious physical injury proximately caused by willful misconduct." 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 ("CCPF") for "purposes of providing timely, uniform, and adequate compensation to eligible individuals for covered injuries" ( 42 U.S.C.A. § 247d-6e [a]).
The PREP Act was clarified on April 17, 2020, by Advisory Opinion 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 not 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 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 is involves a product in limited supply. A fifth HHS Advisory Opinion (21-01) again confirmed that the Act can apply to allegations of failure to act or inaction. 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 "parties have been litigating similar disputes throughout the ongoing 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 Center , 2021 WL 4776610 [E.D.N.Y. October 12, 2021, 20-CV-5153] citations omitted). All said, the PREP Act does not afford federal courts exclusive subject matter jurisdiction over what has been pled here as a state claim ( Dupervil v. Alliance Health Operations , LLC , 516 F.Supp. 3d 238 [E.D.N.Y. 2021] ).
It is notable that these defendants have not moved pursuant to 28 USC 1441 (a) to remove this case to federal court, which has been done in all the reported caselaw to date, and which would be consistent with their argument that the federal court has subject matter jurisdiction through the PREP Act.
Turning next to the defendants’ claim of immunity under New York's EDTPA (Public Health Law Article 30, 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 N.Y.3d 604, 614, 815 N.Y.S.2d 887, 848 N.E.2d 1264 [2006] ). However viewed, if the repeal was not retroactive, its remedial nature would be undermined ( LaBounty v. U.S. Bank N.A., 34 N.Y.3d 250, 255, 116 N.Y.S.3d 642, 139 N.E.3d 1222 [2019] ).
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 of Laws Relating to the Disaster Emergency", March 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 A.D.3d 410, 411, 771 N.Y.S.2d 554 [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 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] ; Kahlek v. South Denver Rehabilitation, LLC. , 543 F.Supp.3d 1019 [D.Colo.2021] ).
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 A.D.3d 140, 141-42, 954 N.Y.S.2d 259 [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" ( Casablanca v. Mount Sinai Medical Center , 2014 WL 10413521 [Sup.Ct.,N.Y. County 2014] ). 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, 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, 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 "as long as a 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’ that immunity is provided" ( Shapnik v. Hebrew Home for the Aged at Riverdale , 535 F.Supp.3d 301 [S.D.N.Y.2021] ). The plaintiff's complaint, read in the light most favorable to the plaintiff, reveals that the "decedent died from COVID-19 based on negligent failure to protect her rather than from any affirmative efforts to treat the disease or administer countermeasures as would be required under the Act's rubric" ( Tereco by and through Silva v. Orinda Care Center, LLC. 2022 WL 256511, [ N.D.Cal., January 3, 2022, No. 21-cv-05563-JSW, 2022 WL 256511 ]). 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," "failed to cancel group activities," "failed to timely restrict visitors," "failed to adequately screen visitors," and more ( Dupervil, 516 F Si[[ 3d 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.
Ruan Meintjes, The Art of Dodging Bullets: How COVID-19 Drug Manufacturers and Providers Plan to Escape Tort Liability , 24 SMULR 113 [Spring Summer 2021]).
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 affidavit, paragraph 17). This said, her affidavit can be read to actually support the plaintiff's negligence claims, as 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 N.Y.2d 730, 736, 724 N.Y.S.2d 397, 747 N.E.2d 760 [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 defendant's pre-answer motion to dismiss is granted to the extent of dismissal of the plaintiff's Third Cause of Action and as to all respect 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.
This constitutes the Decision and Order of the Court.