The following e-filed documents listed on NYSCEF (Motion No. 002) numbered 17-63 were read on this motion. MEMORANDUM DECISION AND ORDER Upon the foregoing documents, and after oral argument completed on February 29, 2024, on Motion Sequence No. 002, Motion Sequence No. 002 is resolved and therefore, it is hereby, ORDERED, that the Defendant’s request for dismissal of Plaintiff’s Summons, and Verified Complaint pursuant to CPLR §3211 [a] [1], and CPLR §3211 [a] [7] based 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 (“EDTPA”); and New York Executive Order 202.10, and the federal Public Readiness and Emergency Preparedness Act, 42 U.S.C. §247d-6d, and U.S.C. §247d-6e (“PREP Act”) is DENIED with prejudice; and it is further, ORDERED, that any relief requested, and not specifically addressed in this Decision and Order has been considered by the court and is DENIED, without prejudice to renew; and it is further, ORDERED, that the Clerk of the Court shall enter judgment accordingly. Memorandum Decision I. Procedural History On or about March 20, 2023, Plaintiff, Cassandra Moody Murray, commenced this lawsuit as attorney-in-fact on behalf of Karen Moody Etchison, hereinafter referred to as Resident, by filing a Summons and Verified Complaint. Plaintiff contends that this action stems from alleged instances of willful, intentional, reckless, and grossly negligent acts and omissions that occurred leading up to and during Resident’s admission to Defendant’s facility from on or about February 1, 2020, through on or about March 28, 2020. During that time, Resident, was in the exclusive care and control of the Defendant. Plaintiff contends Resident was caused, by no fault of her own, to suffer severe personal injuries due to the acts and omissions referred to above and the deprivation of Resident’s statutory rights. Defendant filed Motion Sequence No. 002 on January 31, 2024, seeking (a) dismissal of the summons, and verified complaint pursuant to CPLR §3211 [a] [1], and CPLR §3211 [a] [7] based 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 (“EDTPA”); and New York Executive Order 202.10, and the federal Public Readiness and Emergency Preparedness Act, 42 U.S.C. §247d-6d, and U.S.C. §247d-6e (“PREP Act”); or alternatively (b) an extension of time to serve a responsive pleading until 30 days after service of a decision on the motion, and (c) such other and further relief as this Court deems just, proper and equitable. On February 15, 2024, Plaintiff filed opposition to Motion Sequence No. 002. Defendant filed reply on February 26, 2024. Oral argument was heard on February 29, 2024. II. Facts Plaintiff Cassandra Moody Murray is the daughter of Karen Moody Etchison (Resident). Defendant is a residential healthcare facility located in Staten Island, New York. In late January 2020, COV1D-19 was declared a global health emergency by the World Health Organization. (NY St Cts Filing [NYSCEF] Doc No. 19). On March 2, 2020, New York State declared a State Disaster Emergency due to COV1D-19. (see id). On or about February 1, 2020, through on or about March 28, 2020, Resident was admitted to Defendant’s facility (NY St Cts Filing [NYSCEF] Doc No. 41). During Resident’s admission, Resident was allegedly infected with SARS-CoV-2 and COVID-19, and developed respiratory distress and hypoxia, which resulted in her untimely death on March 28, 2020. (NY St Cts Filing [NYSCEF] Doc No. 1). Plaintiff alleges that prior to the arrival of coronavirus, Defendant had a longstanding history of failing to provide proper infection prevention and control procedures, and despite being armed with knowledge of prior public health infection events, failed to take steps to prepare to prevent the spread of future infections. (see id). Plaintiff further contends that Resident’s injuries were substantially contributed to by the negligent acts and/or omissions, willful and intentional criminal misconduct, gross negligence, reckless misconduct and intentional infliction of harm of the Defendants as well as the violation of the resident’s rights pursuant to New York Public Health Law §2801-d and enumerated in New York Public Health Law §2803-c. (see id). Plaintiff maintains that the Resident’s COVID-19 infection, was caused, or contributed to by Defendant’s infection control policies, and/or Defendant’s acts or omissions related to Defendant’s infection control policies. Plaintiff alleges in their complaint that Resident’s death was the direct result of Defendant’s negligent acts and/or omissions, willful and wanton acts, gross negligence, reckless misconduct, which was a circumstance that existed prior to the COVID-19 pandemic. III. Emergency or Disaster Treatment Protection Act CPLR §3211 [a] provides that a “party may move for judgment dismissing one or more causes of action asserted against him on the ground that a defense is founded upon documentary evidence; (see CPLR 3211 [a] [1]) or the pleading fails to state a cause of action[.]” (see CPLR 3211 [a] [7]). “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 provided, [A]ny health care facility or health care professional 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, if: (a) the health care facility or health care professional is arranging for or providing health care services pursuant to a COVID-19 emergency rule or otherwise in accordance with applicable law; (b) the act or omission occurs in the course of arranging for or providing health care services and the treatment of the individual is impacted by the health care facility’s or health care professional’s decisions or activities in response to or as a result of the COVID-19 outbreak and in support of the state’s directives; and (c) the health care facility or health care professional is arranging for or providing health care services in good faith. (see id quoting former PHL §3082 [1]). The health care service covered by the immunity provision included [S]ervices provided by a health care facility or health care professional, regardless of the location where those services are provided, that relate to: (a) the diagnosis, prevention, or treatment of COVID-19; (b) the assessment or care of an individual with a confirmed or suspected case of COVID-19; or (c) the care of any other individual who presents 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]). Plaintiff alleges in their complaint that: That on or about February 1, 2020, through on or about March 28, 2020, [Resident] was admitted to and was a resident at Defendant['s]…facility, and during her admission, was infected with SARS-CoV-2 and COVID-19. [During] her admission, [Resident] was caused to sustain injury due to the negligent acts or omissions of Defendant…, resulting in severe and permanent personal injuries, and untimely death. (NY St Cts Filing [NYSCEF] Doc No. 1 at page 16). [D]uring [Resident]‘s stay at Defendant…nursing homes she was infected with SARS-CoV-2 and contracted COVID-19, and suffered respiratory distress, hypoxia, and other injuries, caused by the negligence of Defendant…and violation of Defendant…contract with [Resident], laws, rules, statutes and ordinances without any negligence on the part of the [Resident]. [D]uring [Resident]‘s stay at Defendant…nursing homes she was infected with SARS-CoV-2 and contracted COVID-19, and suffered respiratory distress, hypoxia, and other injuries, caused by the negligence of Defendant…and violation of Defendant…contract with [Resident], laws, rules, statutes and ordinances without any negligence on the part of the [Resident], which caused her death. (see id at page 17). [Resident]‘s injuries were substantially contributed to by the negligent acts and/or omissions, willful and intentional criminal misconduct, gross negligence, reckless misconduct and intentional infliction of harm of the Defendants as well as the violation of the resident’s rights pursuant to New York Public Health Law §2801-d and enumerated in New York Public Health Law §2803-c. (see id at page 18). That at all times hereinafter mentioned, and at all times before the COVID-19 pandemic, despite medical best practices, existing regulations, and specific COVID-19 guidance from CDC, CMS, and DOH, Defendants failed to plan and take proper infection control measures. That at all times hereinafter mentioned, and at all times before the COVID-19 pandemic, Defendant failed to maintain an infection control program with policies designed to provide a safe, sanitary, and comfortable environment in which residents vulnerable to infection reside and where their health care providers work. That at all times hereinafter mentioned, and at all times before the COVID-19 pandemic, Defendant failed to have an infection control program which investigated, controlled and took action to prevent infections in the facility and to determine what procedures, such as isolation, should be utilized for an individual resident to prevent continued transmission of disease. That at all times hereinafter mentioned, and at all times before the COVID-19 pandemic, Defendant failed to isolate residents and properly sterilize and store all equipment to prevent the spread of infection. (see id at page 19). That at all times hereinafter mentioned, the Defendant acted willfully, intentionally, recklessly and with gross negligence by knowingly by implementing policies, including accepting COVID-19 positive patients and residents, failing to test patients, residents and staff, etc. with the knowledge that the policies implemented would increase the risk of contracting disease, causing sickness and death in patients and residents. (see id at pages 19-20). That at all times hereinafter mentioned, the Defendant, its servants, agents, and/or employees, failed to safely and properly move, monitor, supervise, assist, and/or treat [Resident]. As a result of the negligence of the Defendant, [Resident] was caused to sustain severe personal injuries to her head, face and body, obliging her to incur expenses for medical care and resulted in pain, suffering and loss of enjoyment of life. The aforementioned injuries suffered were caused by the sole negligence of the Defendant and without any negligence on the part of the [Resident] contributing thereto. (see id at page 20). That at all times hereinafter mentioned, as a result of the foregoing acts and/or omissions, [Resident] was subject to the negligence of Defendants, causing [Resident] to be forced to undergo medical treatment, incur medical expenses, suffer permanent disfigurement, disability, pain and suffering, mental anguish, loss of enjoyment of life, loss of dignity, and death. That at all times hereinafter mentioned, the Defendant…acted in so careless a manner as to show complete disregard for the rights and safety of others. That at all times hereinafter mentioned, the Defendant…acted or failed to act knowing that their conduct would probably result in injury or damage. That at all times hereinafter mentioned, the Defendant…acted or failed to act knowing that their conduct would probably result in injury or damage. (see id at page 25). That at all times hereinafter mentioned, the Defendant…acted in so reckless a manner or failed to act in circumstances where an act was clearly required, so as to indicate disregard of the consequences of their actions or inactions. That at all times hereinafter mentioned, the Defendant…conduct, as outlined above, was willful. That at all times hereinafter mentioned, the Defendant…conduct, as outlined above, was in reckless disregard. (see id at page 25). “On a motion to dismiss a complaint pursuant to CPLR §3211 [a] [7] for failure to state a cause of action, the complaint is to be afforded a liberal construction, the facts alleged are presumed to be true, the plaintiff is afforded the benefit of every favorable inference, and the court is to determine only whether the facts as alleged fit within any cognizable legal theory” (see Martinez v. NYC Health & Hosps. Corp., 2024 NY App Div LEXIS 183 [2d Dept 2024] quoting Watts v. City of New York, 186 AD3d 1577 [2d Dept 2020]; citing CPLR §3026; Leon v. Martinez, 84 N.Y.2d 83 [1994]). In Martinez, the plaintiff alleged that the decedent was diagnosed with COVID-19 after arriving at the hospital on March 30, 2020, and he died from COVID-19 on April 9, 2020. (see id). The defendants’ submissions in Martinez, included the complaint and the transcript of the plaintiff’s hearing pursuant to General Municipal Law §50-h, and conclusively established that the defendants were entitled to immunity under the EDTPA (see id citing Public Health Law former §3082; Mera v. New York City Health & Hosps. Corp., 220 AD3d 668 [2d Dept 2023]; Ruth v. Elderwood At Amherst, 209 AD3d 1281 [4th Dept 2022]). The Second Department held that as the complaint in Martinez made “no allegations that the defendants’ acts or omissions constituted willful or intentional criminal misconduct, gross negligence, reckless misconduct, or intentional infliction of harm, none of the exceptions to the immunity provisions of EDTPA apply” (see id citing Public Health Law former §3082 [2]). Defendant maintains in the affidavit of its Assistant Director of Nursing Services, who was a registered nurse at the Staten Island Care Center (SICC) during March 2020, All infection control activities and policies at the facility were the product of informed decision making based on many factors, including the availability of, perceived efficacy, and anticipated future availability of the above-listed products as well as efforts to comply with CDC and DOH guidelines. For example, the present and future availability and perceived efficacy of PPE was a critical factor in determining who received PPE to wear; the degree of social distancing to be implemented within the facility and the circumstances under which social distancing would be implemented; who would be permitted to enter the facility and under what circumstances; and the degree of contact that residents would have with staff, visitors, and other residents on a daily basis. (NY St Cts Filing [NYSCEF] Doc No. 19 at pages 5-6). The development of infection control protocols and activities within the facility necessarily required that decisions be made to balance the practical need for the close physical contact between individuals against the risk of human-to-human transmission of a disease with limited scientific information available. These decisions required consideration of the present and future availability and perceived efficacy of, among other things, COVID-19 tests, PPE, hand sanitizers, thermometers, pulse oximeters, and supplemental oxygen. (NY St Cts Filing [NYSCEF] Doc No. 19 at page 6). The physician’s affirmation provided by Plaintiff contends that “[t]here are questions as to the sufficiency of the Defendant facility’s prepandemic stockpiles of personal protection equipment and whether the supplies were in compliance with rules and regulations existing at that time.” (NY St Cts Filing [NYSCEF] Doc No. 51 at page 3). Plaintiff further maintains that the affidavit of Defendant’s Assistant Director of Nursing Services is silent as to the adequacy of the defendant facility’s pre-pandemic staffing levels. (see id at pages 3-4). New York law imposes on nursing home operators a special obligation to care for their residents specifically as follows: (1) New York’s residential health care facilities are responsible for the health and well-being of more than 100,000 residents ranging from infants with multiple impairments to young adults suffering from the sequelae of traumatic brain injury to the frail elderly with chronic disabilities. For the vast majority of residents, the residential health care facility is their last home. A license to operate a nursing home carries with it a special obligation to the residents who depend upon the facility to meet every basic human need. (2) Each resident comes to the nursing home with unique life experiences, values, attitudes and desires, and a singular combination of clinical and psychological needs. In order to assure the highest practicable quality of life, the individuality of the nursing home resident must be recognized, and the exercise of self-determination protected and promoted, by the operator and staff of the facility. The physical environment, care policies and staff behavior must at once acknowledge the dependence of the residents while fostering their highest possible level of independence. (see 10 NYCRR §415.1 [a] [1]; [2]) Nursing homes are also required to maintain sufficient staffing to provide required care. (see 10 NYCRR §415.13). The omission from the Defendant’s evidence regarding the adequacy of its staffing levels prior to and during the pandemic raises an issue of fact. If the Defendant did not have adequate healthy staff, it would have been a departure from good and accepted medical practice to continue to admit additional residents and not seek to transfer all residents that it could not safely and adequately care for. Decisions made by the Defendant, as to staffing, etc., would have impacted the care rendered to the Resident. Such decisions having been made prior to the pandemic and maintained during the crisis would defeat the intent of the EDTPA, which was enacted to support health care professionals making impossible heath care decisions in good faith during the unprecedented crisis. Plaintiff further contends, According to the Center for Medicare Services, in 2018 until the present, STATEN ISLAND CARE CENTER, has maintained “below average” staffing levels. (NY St Cts Filing [NYSCEF] Doc No. 51 at page 6). According to the investigative findings of the New York State Attorney General, dated January 30, 2021, nursing homes with low CMS staffing ratings had higher COVID-19 fatality ratings. The Attorney General determined that pre-existing insufficient staffing levels in many nursing homes put residents at increased risk of harm during the COVID-19 pandemic. As nursing home resident and staff COVID-19 infections rose during the initial wave of the pandemic, staffing absences increased at many nursing homes. As a result, preexisting low staffing levels decreased further to especially dangerous levels in some homes, even as the need for care increased due to the need to comply with COVID-19 infection control protocols and the loss of assistance from family members. (NY St Cts Filing [NYSCEF] Doc No. 49). 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 NY 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]). In considering a motion pursuant to CPLR §3211 [a] [1] and 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] [1], and 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. New York Executive Order 202.10 On March 23, 2020, among a deluge of executive orders promulgated during the COVID-19 pandemic by then Governor Andrew M. Cuomo, Executive Order 202.10 was issued and stated in part: to the extent necessary to provide that all physicians, physician assistants, specialist assistants, nurse practitioners, licensed registered professional nurses and licensed practical nurses shall be immune from civil liability for any injury or death alleged to have been sustained directly as a result of an act or omission by such medical professional in the course of providing medical services in support of the State’s response to the COVID-19 outbreak, unless it is established that such injury or death was caused by the gross negligence of such medical professional[.] (see 9 NYCRR §8.202.10). On or about April 6, 2020, Governor Cuomo and the New York State Legislature enacted the Emergency or Disaster Treatment Prevention Act (“the EDTPA”), which codified the protections granted within Executive Order 202.10. Plaintiff contends Resident was admitted to the Defendant’s facility on February 20, 2020 from Staten Island University Hospital North due to various conditions such as cerebral infarction and hypertension and not for the purpose of arranging for or receiving health care services pursuant to the COVID-19 emergency rule. Plaintiff further maintains that Resident’s admission to Defendant’s facility was prior to the decree of Executive Order 202.10 and the enactment of the EDPTA. Plaintiff contends that Resident’s injuries were substantially contributed to by the negligent acts and/or omissions, willful and intentional criminal misconduct, gross negligence, reckless misconduct and intentional infliction of harm of the Defendants as well as the violation of the resident’s rights pursuant to New York Public Health Law §2801-d and enumerated in New York Public Health Law §2803-c. 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]). In considering a motion pursuant to CPLR §3211 [a] [1] and 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 Executive Order 202.10. Accordingly, Defendants’ request for dismissal of Plaintiff’s complaint pursuant to CPLR §3211 [a] [1], and CPLR §3211 [a] [7] upon the ground that Defendant is immune from liability under Executive Order 202.10 is DENIED with prejudice. V. 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. Plaintiff’s claims are not encompassed by the PREP Act. Here, the Plaintiff’s claims do not allege loss “caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.” (see 42 USC §247d-6d(a)(1); NY St Cts Filing [NYSCEF] Doc No. 1). Plaintiff alleges that Resident suffered severe and permanent personal injuries due to the negligence, recklessness, and carelessness of Defendant. (NY St Cts Filing [NYSCEF] Doc No. 1). Defendant contends that: [SICC] falls squarely within the definition of “program planner” insofar as they would have “provide[d] a facility to administer or use a covered countermeasure,” “established requirements” for the use and administration of covered countermeasures within that facility, and “administered a program with respect to the administration, dispensing, distribution, provision, or use” of covered countermeasures within its facility. (NY St Cts Filing [NYSCEF] Doc No. 21). The acts and omissions listed in the complaint are unrelated to the administration, prioritizing, or purposeful allocation of a drug, biological product, or device to an individual within the meaning of the PREP Act. There are no allegations in the Complaint that allege causal connection between the Resident’s injuries and the administration of a covered countermeasure. 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. (see Estate of Pierro v. Carmel Richmond Healthcare & Rehabilitation Ctr., 2023 NY Misc. LEXIS 20278 [Sup Ct Richmond County 2023] [Castorina, J.]). 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] [1] 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 Defendant’s request for dismissal of Plaintiff’s summons, and verified complaint pursuant to CPLR §3211 [a] [1], and CPLR §3211 [a] [7] based 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 (“EDTPA”); and New York Executive Order 202.10, and the federal Public Readiness and Emergency Preparedness Act, 42 U.S.C. §247d-6d, and U.S.C. §247d-6e (“PREP Act”) is DENIED with prejudice; and it is further, ORDERED, that any relief requested, and not specifically addressed in this Decision and Order has been considered by the court and is DENIED, without prejudice to renew; 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: March 22, 2024
