MEMORANDUM DECISION AND ORDER The following e-filed documents listed on NYSCEF (Motion #001) numbered 9-101 were read on this motion. Upon the foregoing documents, and after oral argument completed on November 2, 2023, on Motion Sequence #001, Motion Sequence #001 is resolved and therefore, it is hereby, ORDERED, that the Defendants’ request for dismissal of Plaintiff’s complaint pursuant to CPLR §3211 [a] [7] upon the ground that Defendant is immune from liability under New York’s Emergency or Disaster Treatment Protection Act, N.Y. Pub. Health Law §§3080-82 is DENIED with prejudice, and it is further; ORDERED, that the Defendants’ request for the dismissal of the complaint pursuant to CPLR §3211 [a] [2] and CPLR §3211 [a] [7] on the ground that Defendant is immune from suit and liability under the federal Public Readiness and Emergency Preparedness Act, 42 U.S.C. §247d-6d, et seq, and the court thus lacks subject matter jurisdiction is DENIED with prejudice, and it is further; ORDERED, that the Clerk of the Court shall enter judgment accordingly. Memorandum Decision I. Procedural History On or about November 1, 2022, Plaintiff, as Proposed Administrator of the Estate of the Decedent, Maryanne Pierro, commenced this action to recover for violations of New York Public Health Law; negligence; conscious pain and suffering; wrongful death; gross negligence; and medical and nursing malpractice, with regards to the death of the Decedent on April 2, 2020. Defendant filed Motion Sequence #001 on August 18, 2023, seeking (a) dismissal of Plaintiff’s complaint pursuant to CPLR §3211 [a] [7] upon the ground that Defendant is immune from liability under New York’s Emergency or Disaster Treatment Protection Act, N.Y. Pub. Health Law §§3080-82; (b) dismissal of the complaint pursuant to CPLR §3211 [a] [2] and CPLR §3211 [a] [7] on the ground that Defendant is immune from suit and liability under the federal Public Readiness and Emergency Preparedness Act, 42 U.S.C. §247d-6d, et seq, and the court thus lacks subject matter jurisdiction as the cause of action is defensively preempted by federal law; and (c) for such other and further relief as this the Court deems just and proper. On October 16, 2023, Plaintiff filed opposition to Motion Sequence #001. Defendant filed reply on November 1, 2023. Oral argument was heard on November 2, 2023. II. Facts Decedent was a resident at Defendant’s facility from on or around 2015, until April 2, 2020, with intermittent hospitalizations in between. (NY St Cts Filing [NYSCEF] Doc Nos. 1; 14-17). Plaintiff alleges that during the Decedent’s time in the care of the Defendants, Defendants were neglectful and failed to provide the Decedent with appropriate care, failed to provide her such nursing and rehabilitation services as are customarily provided in a nursing home and rehabilitation facility, and was otherwise negligent in the care provided to plaintiff’s decedent. (NY St Cts Filing [NYSCEF] Doc No. 1). Decedent contracted COVID-19 while in the Defendants’ care. (see id). Plaintiff contends that Decedent’s medical chart is devoid of any mention regarding isolation precautions, infection protocols, or any other mention of the COVID-19 virus at Defendants’ facility and the measures taken with respect to Decedent. On or around April 2, 2020, per her medical chart, Decedent tested positive for COVID-19 and passed away that same day. (NY St Cts Filing [NYSCEF] Doc No. 17). Her medical chart has conflicting notes as to when she died and when her family was informed. (see id). COVID-19 was a novel virus caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that was first identified in China in December 2019. The global population had no natural immunity from this respiratory virus and initial efforts to contain its spread amongst the population failed. On January 30, 2020, the World Health Organization (“WHO”) declared the outbreak a public health emergency of international concern and a global pandemic on March 11, 2020. In early 2020, the emergence of the novel coronavirus in the United States made nursing homes a prime target for the spread of the deadly virus. The CDC cautioned that older adults, people with medical conditions, and people living in nursing homes and longer-term care facilities are at an increased risk for severe illness and need to take extra precautions against COVID-19 (People at Increased Risk, Centers for Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html (last updated Jan. 4, 2021). State and Federal legislatures swiftly responded to the numerous COVID-19 outbreaks and subsequent deaths in nursing homes by enacting liability shields and regulations granting immunity to protect health care providers from litigations arising out of their conduct in response to the novel coronavirus1. In March 2020, the New York metropolitan region was severely impacted by this global pandemic. Plaintiff contends that prior to the pandemic, Defendants failed to have the appropriate policies, procedures, staffing and otherwise failed to be prepared for a foreseeable event such as an infectious disease exposure and outbreak, and after the pandemic begun and throughout the time periods referenced herein, and that Defendants failed to properly respond to the pandemic. Defendants contend that the Complaint does not and cannot plead a sustainable cause of action under the law because the allegations therein directly trigger the immunity conferred upon Defendants by New York’s Emergency or Disaster Treatment Protection Act, N.Y. Pub. Health Law §§3080-82 and the federal Public Readiness and Emergency Preparedness Act. III. Emergency or Disaster Treatment Protection Act CPLR §3211 [a] [7] provides that a “party may move for judgment dismissing one or more causes of action asserted against him on the ground that the pleading fails to state a cause of action[.]” “ In considering a motion pursuant to CPLR 3211 [a] [7] to dismiss a complaint for failure to state a cause of action, the court must accept the facts as alleged in the complaint as true, accord the plaintiff the benefit of every possible favorable inference, and determine only whether the facts as alleged fit within any cognizable legal theory” (see Green 333 Corp. v. RNL Life Science, Inc., 186 AD3d 1334 [2d Dept 2020] citing Cortlandt St. Recovery Corp. v. Bonderman, 31 NY3d 30 [2018]; Korsinsky v. Rose, 120 AD3d 1307 [2d Dept 2014]). Where “evidentiary material is submitted and considered on a motion pursuant to CPLR §3211 [a] [7], and the motion is not converted into one for summary judgment, the question becomes whether the plaintiff has a cause of action, not whether the plaintiff has stated one, and unless it has been shown that a material fact claimed by the plaintiff to be one is not a fact at all, and unless it can be said that no significant dispute exists regarding it, dismissal should not eventuate” (see Graphic Arts Mut. Ins. Co. v. Pine Bush Cent. Sch. Dist., 159 AD3d 769 [2d Dept 2018] citing Guggenheimer v. Ginzburg, 43 NY2d 268 [1977]; Sposato v. Paboojian, 110 AD3d 979 [2d Dept 2013]; Constructamax, Inc. v. Dodge Chamberlin Luzine Weber, Assoc. Architects, LLP, 109 AD3d 574 [2d Dept 2013]). “A court is, of course, permitted to consider evidentiary material submitted by a defendant in support of a motion to dismiss pursuant to CPLR §3211 [a] [7]” (see Mera v. New York City Health & Hosps. Corp., 2023 NY App Div LEXIS 4951 [2d Dept 2023] quoting Cordell Marble Falls, LLC v. Kelly, 191 AD3d 760 [2d Dept 2021] quoting Sokol v. Leader, 74 AD3d 1180 [2d Dept 2010] citing CPLR §3211 [c]). “If the court considers evidentiary material, the criterion then becomes ‘whether the proponent of the pleading has a cause of action, not whether he [or she] has stated one’” (see id quoting Sokol v. Leader, 74 AD3d 1180 [2d Dept 2010] quoting Guggenheimer v. Ginzburg, 43 NY2d 268 [1977] citing Cordell Marble Falls, LLC v. Kelly, 191 AD3d 760 [2d Dept 2021]). At the outset of the COVID-19 pandemic the New York State Legislature enacted the Emergency or Disaster Treatment Protection Act (Public Health Law former art 30-D, §§3080-3082 [repealed by L 2021, ch 96, §1]; hereinafter the EDTPA) with the stated purpose of “promot[ing] the public health, safety and welfare of all citizens by broadly protecting the health care facilities and health care professionals in this state from liability that may result from treatment of individuals with COVID-19 under conditions resulting from circumstances associated with the public health emergency” (see id quoting Public Health Law former §3080). [T]he EDTPA initially provided, with certain exceptions, that a health care facility “shall have immunity from any liability, civil or criminal, for any harm or damages alleged to have been sustained as a result of an act or omission in the course of arranging for or providing health care services” as long as three conditions were met: [1] the services were arranged for or provided pursuant to a COVID-19 emergency rule or otherwise in accordance with applicable law; [2] the act or omission was impacted by decisions or activities that were in response to or as a result of the COVID-19 outbreak and in support of the State’s directives; and [3] the services were arranged or provided in good faith (see id quoting former PHL §3082 [1]). The health care services covered by the immunity provision included those related to the diagnosis, prevention, or treatment of COVID-19; the assessment or care of an individual with a confirmed or suspected case of COVID-19; and the care of any other individual who presented at a health care facility or to a health care professional during the period of the COVID-19 emergency declaration (see id former PHL §3081 [5]). The only exception under the statute is for injuries caused by “willful or intentional criminal misconduct, gross negligence, reckless misconduct, or intentional infliction of harm” (see former PHL §3082 [2]). The “Court of Appeals has held that the failure to exercise even ‘slight care’ or ‘slight diligence’ constitutes gross negligence (see Gentile v. Garden City Alarm Co., 147 AD2d 124 [2d Dept 1989] citing Food Pageant, Inc. v. Consolidated Edison Co., 54 NY2d 167 [1981]; Dalton v. Hamilton Hotel Operating Co., 242 NY. 481 [1926]; Weld v. Postal Tel. Cable Co., 210 N.Y. 59 [1913]). “To constitute gross negligence, a party’s conduct must ‘smack[ ] of intentional wrongdoing’ or ‘evince[ ] a reckless indifference to the rights of others’” (see Bennett v. State Farm Fire & Cas. Co., 161 AD3d 926 [2d Dept] quoting Ryan v. IM Kapco, Inc., 88 AD3d 682 [2d Dept 2011] quoting Sommer v. Federal Signal Corp., 79 N.Y.2d 540 [1992]; citing Skywest, Inc. v. Ground Handling, Inc., 150 AD3d 922 [2d Dept 2017]; J. Petrocelli Contr., Inc. v. Morganti Group, Inc., 137 AD3d 1082 [2d Dept 2016]). “Generally, the question of gross negligence is a matter to be determined by the trier of fact” (see id citing Food Pageant, Inc. v. Consolidated Edison Co., 54 NY2d 167 [1981]; Dolphin Holdings, Ltd. v. Gander & White Shipping, Inc., 122 A.D.3d 901 [2d Dept 2014]). Plaintiff’s allegations that Defendants, as a skilled nursing facility under state and federal statutory obligations regarding infections controls and policies, did not adequately and/or timely implement infection control procedures and prevention safeguards created a foreseeable situation in which residents of the facility, including the Decedent, would suffer from serious medical complications and death when there was an outbreak of a highly contagious and communicable respiratory illness. The Plaintiff’s allegations include, but are not limited to the following: Defendant, through its actual, implied, and/or apparent agents, servants, and employees, engaged in the following acts and/or omissions: a) Failed to develop appropriate infection control and prevention policies and procedures; b) Failed to develop and implement COVID-19 isolation and infection control and prevention procedures that were specifically tailored to facility; c) Failed to implement appropriate interventions related to infection control and prevention; d) Failed to screen all residents, including Decedent, for COVID-19 symptoms and elevated temperature, heart rate, respirations, and pulse oximetry; e) Negligently instructed one or more members of the Defendant’s nursing staff to continue to come into facility and provide direct care to elderly residents, including Decedent; f) Failed to frequently obtain vitals for all residents, including Decedent, for signs/symptoms of a respiratory distress, fever, cough, all of which are known signs/symptoms of COVID-19; g) Failed to timely isolate residents suspected and/or symptomatic of COVID-19 from the general resident population; h) Failed to provide, maintain, monitor and/or employ standard contact and droplet precautions and PPE; i) Failed to ensure sufficient levels of staff to provide skilled nursing care and treatment to all residents, including JOSEPH STAZZONE, in accordance with their care plans; j) Failed to ensure sufficient levels of staff to limit the nursing staff caring and/or assigned to positive or symptomatic residents from providing any care to negative or asymptomatic residents; k) Failed to provide positive or symptomatic patients with surgical masks and other protective interventions to help reduce transmission; l) Failed to immediately isolate residents identified with symptoms of fever and lower respiratory illness, including, but not limited to cough, shortness of breath, and sore throat; m) Failed to maintain isolation protocols for residents identified with symptoms of fever and lower respiratory illness up to and until staff obtained a physician order that discontinued isolation protocol; n) Failed to provide all resident services, including, but not limited to meals, physical and occupational therapy, social service activities, and personal hygiene in residents’ designated rooms with the door closed for both suspected and confirmed COVID-19 residents, and/or any resident displaying acute respiratory symptoms; (NY St Cts Filing [NYSCEF] Doc No. 1). In considering a motion pursuant to CPLR 3211 [a] [7], the court must accept the facts as alleged in the complaint as true, accord the plaintiff the benefit of every possible favorable inference, and determine only whether the facts as alleged fit within any cognizable legal theory, in doing so the complaint sets forth the requisite elements that would permit the trier of fact to determine whether the Defendants’ conduct rose to the levels to constitute gross negligence, thus exempting the Defendants from the immunity under EDTPA. Accordingly, Defendants’ request for dismissal of Plaintiff’s complaint pursuant to CPLR §3211 [a] [7] upon the ground that Defendant is immune from liability under New York’s Emergency or Disaster Treatment Protection Act, N.Y. Pub. Health Law §§3080-82 is DENIED with prejudice. IV. Public Readiness and Emergency Preparedness Act 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 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.” 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]). When enacting the PREP Act, which can cut off an injured individual’s ability to seek recourse through the courts, Congress recognized the need to include an alternative form of relief for individuals injured by covered countermeasures. 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.” The PREP Act provides that “[s]ubject to the other provisions of this section, a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.” (see 42 USC §247d-6d [a] [1]). The immunity provided under the PREP Act “applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.” (see 42 USC §247d-6d [a] [2] [B]). 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.” 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 USC §247d-6e[a]) (See Whitehead v. Pinehead Operating, LLC, 75 Misc3d 985 [Sup Ct Columbia County 2022]). The only exception to the PREP Act’s grant of immunity is “for death or serious physical injury proximately caused by willful misconduct” (see 42 USC §247d-6d [d] [1]), defined as an act or omission that is taken (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit (see 42 USC §247d-6d [c] [1] [A]). Under 42 USC §247d-6d(d)(1), immunity is not available when willful misconduct is the proximate cause of death or serious physical injury. Any such case must be brought in the District Court for the District of Columbia, no matter where the harm occurred. The burden of proving proximate cause is on the plaintiff. The standard is clear and convincing evidence. The advisory opinion notes that the PREP Act does not confer immunity against federal enforcement actions, whether civil, criminal, or administrative. For activities undertaken under a federal contract, the period of immunity lasts until October 1, 2024. Once the declaration expires, covered entities have 12 months of liability protection to dispose of Covered Countermeasures. Here, Defendants contend that: Covered countermeasures are broadly defined under the PREP Act Declaration to include, among other things, any drug, diagnostic, or other device that is approved, cleared, or licensed by the FDA and is used to diagnose, mitigate, prevent, treat, cure, or limit the harm of COVID-19. HHS has advised that the number of “covered countermeasures” are “too numerous to list,” and include various forms of PPE, hand sanitizers, COVID-19 tests, oxygen and its delivery systems, and medical devices used for determining whether an individual is symptomatic for COVID-19, such as thermometers and pulse oximeters. (NY St Cts Filing [NYSCEF] Doc No. 11). Defendants further contends that the administration of covered countermeasures includes not only the physical provision of a covered countermeasure, but also extends to activities and decisions directly relating to dispensing of countermeasures, and activities related to management and operation of programs and locations for providing countermeasures to recipients. (see id). While Defendants argue that Plaintiff’s claims involve Defendants’ protocols for preventing COVID-19 which would include the use and administration of covered countermeasures, among the Plaintiff’s claims for loss are claims arising from Defendants’ alleged failure to implement an effective infection control program and effectively isolate persons exhibiting symptoms. Accepting the Plaintiff’s facts as alleged in the complaint as true and according those facts the benefit of every possible favorable inference, these claims would fall outside the scope of the PREP Act and rendering any immunity provided by it inapplicable. The Court further questions the Defendants’ expansiveness of the term “covered countermeasure”. Discovery would be the appropriate vehicle to determine (i) which “countermeasures” fall under these definitions, if these alleged “covered countermeasures” are at play in plaintiff’s claims, and if so, whether these are countermeasures that would not have been manufactured, administered, used, designed, developed, modified, licensed, or procured but for the COVID-19 pandemic. 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 [EDNY 2021]). It is important to note that the PREP Act is, at its core, an immunity statute; it does not create rights, duties, or obligations. See 42 USC §247d-6d(a)(1). Accordingly, in providing immunity from suit to certain covered persons for certain types of claims, the PREP Act confers primary jurisdiction over most claims within its scope not to the federal courts but to the Secretary, who has the sole authority to administer and provide compensation from a “Covered Countermeasure Process Fund.” See 42 USC §§247d-6e(a), 247d-6e(b). Even with PREP Act claims involving “willful misconduct,” which may be brought exclusively in the United States District Court for the District of Columbia, the plaintiff must first exhaust administrative remedies, and may elect to accept compensation from the Process Fund instead of filing suit in federal court [See 42 USC §§247d-6e(d)(1), 247d-6e(d)(5); see also 42 USC §§247d-6d(d)(1), 247d-6d(e)(1)]. Thus, except for one narrow exception, PREP Act claims cannot be brought in federal court. Accordingly, the Defendants’ request for the dismissal of the complaint pursuant to CPLR §3211 [a] [2] and CPLR §3211 [a] [7] on the ground that Defendant is immune from suit and liability under the federal Public Readiness and Emergency Preparedness Act, 42 USC §247d-6d, et seq, and the court thus lacks subject matter jurisdiction as the cause of action is defensively preempted by federal law is DENIED with prejudice. Decretal Paragraphs ORDERED, that the Defendants’ request for dismissal of Plaintiff’s complaint pursuant to CPLR §3211 [a] [7] upon the ground that Defendant is immune from liability under New York’s Emergency or Disaster Treatment Protection Act, N.Y. Pub. Health Law §§3080-82 is DENIED with prejudice, and it is further; ORDERED, that the Defendants’ request for the dismissal of the complaint pursuant to CPLR §3211 [a] [2] and CPLR §3211 [a] [7] on the ground that Defendant is immune from suit and liability under the federal Public Readiness and Emergency Preparedness Act, 42 USC §247d-6d, et seq, and the court thus lacks subject matter jurisdiction is DENIED with prejudice, and it is further; ORDERED, that the Clerk of the Court shall enter judgment accordingly. The foregoing shall constitute the Decision and Order of this Court. Dated: November 15, 2023
