Papers considered: 1. Notice of Motion dated April 19, 2024; Attorney Affirmation in Support of Steven V. Debraccio, Esq., dated April 19, 2024, with Exhibits A-FF; and Memorandum of Law in Support. 2. Affirmation in Opposition of Joseph L. Ciaccio, Esq., dated May 23, 2024, with Exhibits 1-26; and Memorandum of Law in Opposition. 3. Reply Affirmation of Steven V. DeBraccio, Esq., dated May 29, 2024. 4. Letter to the Court from Wilbert Mendez Mazzero, Esq., dated July 20, 2024, with Exhibits 1-3, providing post-submission caselaw. 5. Letter to the Court from Steven V. DeBraccio, Esq., dated July 25, 2024, in response to the post-submission letter. DECISION/ORDER In this action arising out of the Plaintiff’s Decedent’s death from COVID-19, Defendant, Hudson Valley Care Partners, LLC d/b/a Hudson Valley Rehabilitation & Extended Care Center, (“HVCP”), moves pre-answer for dismissal of the Complaint pursuant to CPLR §3211(a)(1), (2), and (7). Plaintiff, Sarah S. Foster, in her capacity as Administrator of the Estate of Jean D. Saltmarsh, opposes. BACKGROUND Plaintiff’s Decedent, Jean D. Saltmarsh, was a resident of HVCP’s nursing home from June 18, 2018, until her death from COVID-19 on December 11, 2020. Foster asserts claims pursuant to New York Public Health Law §§2801-d and 2803-c, along with claims based upon negligence pre-pandemic, negligence during the pandemic, negligence per se, conscious pain and suffering prior to death, wrongful death, gross negligence, nursing home malpractice resulting in wrongful death, and nursing home malpractice resulting in conscious pain and suffering. Defendant’s motion seeks dismissal based upon documentary evidence; for failure to state a cause of action; and pursuant to the immunity provided by the Emergency Disaster Treatment and Prevention Act, (“EDTPA”), Article 30-D of the Public Health Law, (now repealed), and the Public Readiness and Emergency Preparedness Act (“PREP Act”), 42 USC §247d-6d. HVCP asserts that the Court lacks subject matter jurisdiction to hear Foster’s PREP Act claim pursuant to 42 USC §247d-6d(a)(1); (d)(1); and (e)(1). DEFENDANT’S CONTENTIONS At age 93, Jean Saltmarsh was admitted to HVCP’s nursing home facility on June 18, 2018. At the time of admission, she had been diagnosed with hypertension, chronic obstructive pulmonary disease, dementia, Alzheimer’s disease, peripheral vascular disease, and major depressive disorder. When the COVID-19 pandemic struck in March of 2020, her care was impacted by the implementation of various policies and countermeasures introduced to combat the virus. All in-person visitation was prohibited, group activities were cancelled and contact was limited to essential staff wearing personal protection equipment (“PPE”). In addition to PPE, the facility utilized such other countermeasures as thermometers, pulse oximeters, supplemental oxygen, prescription medication and COVID-19 testing. Furthermore, full-time staff members were permitted to work 12-hour shifts and RN unit managers 20-hour shifts, with a 4-hour allotted break, as deemed necessary. Those licensed professionals working in other capacities were re-assigned to resident care duties. Policy was implemented which allowed the facility to designate staff members who would be required to remain on premises with provision of rest areas, meals and cleaning facilities. HVCP provided health care services in accordance with applicable law and in good faith. Accordingly, it is entitled to dismissal based upon the immunity granted by the EDTPA. Alternatively, HVCP claims entitlement to immunity pursuant to the PREP Act, which protects covered persons or entities from claims related to the administration or use of covered COVID-19 countermeasures. HVCP is a covered “person” under the statute because it is a State-licensed nursing home following the guidance of State authorities having jurisdiction, using covered COVID-19 countermeasures in accordance with a COVID-19 countermeasure program plan. HVCP also argues that Plaintiff’s second cause of action, alleging pre-pandemic negligence, fails to state a cause of action, as Saltmarsh died from COVID-19 nine months after the start of the pandemic and thus her estate cannot demonstrate proximate cause from pre-pandemic acts or omissions. Finally, HVCP seeks dismissal of Plaintiff’s fourth cause of action, based upon negligence per se, because negligence per se may not be based upon an alleged violation of State regulations, as a statutory violation is required. PLAINTIFF’S CONTENTIONS In opposition, Foster argues that the EDTPA is inapplicable to her claims regarding infection prevention and control failures. Defendant failed to meet its burden of proving conclusively that the Decedent’s care was impacted by its response to the pandemic or inability to properly respond to same or that the care provided was rendered in good faith. Additionally, even if some of her claims are barred by the EDTPA, Foster’s claims based upon gross negligence and recklessness, which are exceptions to EDTPA’s protections are properly pleaded. Finally, Foster has asserted no claim that the administration of any product or drug led to Saltmarsh’s death therefore her claims are outside the scope of the PREP Act and, thus, not preempted by same. More particularly, Foster contends that Saltmarsh contracted the COVID-19 virus but was never transferred to a hospital, resulting in her death. HVCP failed to prepare for and protect Saltmarsh before and during the outbreak. Foster refers to the January 30, 2021, report from New York State Attorney General Letitia James entitled “Nursing Home Response to COVID-19 Pandemic”, (hereinafter “the Attorney General’s report”), which found a lack of compliance with infection control protocols, an insufficient supply of PPE and insufficient testing of residents and staff placed residents at increased risk of harm. The Attorney General’s report further found that New York State’s reimbursement model provided financial incentives to owners of for-profit nursing homes to transfer funds to related parties for the purpose of increasing their own profits rather than investing in higher levels of staffing and/or purchasing PPE. The Attorney General’s report found preliminarily that the “immunity provisions [of the EDPTA] may have “allowed facilities to make financially-motivated decisions”. The Complaint alleges specific failures by HVCP including failure to timely implement and/or execute infection control protocols; inadequate staffing levels; failure to effectively separate residents in accordance with applicable regulations; failure to enforce social distancing; failure to provide face masks to all residents and health care professionals; failure to screen people entering the facility for fever or other symptoms of infection; failure to monitor governmental health guidance; and failure to provide appropriate care, including such nursing and rehabilitation services as are customarily provided in such a facility. DISCUSSION/STANDARD ON CPLR 3211(a)(1) MOTION TO DISMISS When a motion to dismiss is premised upon documentary evidence, “such motion may be appropriately granted only where the documentary evidence utterly refutes plaintiff’s factual allegations, conclusively establishing a defense as a matter of law” (Goshen v. Mutual Life Ins. Co. of N.Y., 98 NY2d 314, 326, 774 NE2d 1190, 746 NYS2d 858 [2002]). While factual affidavits submitted by a plaintiff may be considered to remedy defects in the complaint (see Leon v. Martinez, 84 NY2d 83, 88, 638 NE2d 511, 614 NYS2d 972 [1994]), affidavits submitted by a defendant do not constitute documentary evidence upon which a proponent of dismissal can rely. See, Realty Invs. of USA v. Bhaidaswala, 254 AD2d 603, 604-605 (3d Dept., 1998); Crepin v. Fogarty, 59 A.D.3d 837, 838 (3d Dept., 2009); State of N.Y. Workers Comp. Bd. v. Madden, 119 AD3d 1022, 1029 (3d Dept., 2014). As HVCP’s CPLR §3211(a)(1) motion to dismiss is based upon the averments of Kathryn A. Costello, rather than the type of documents which undeniably and conclusively establish its defense1, that portion of the motion which is pursuant to CPLR §3211(a)(1) is denied. DISCUSSION/STANDARD ON CPLR §3211(a)(7) MOTION TO DISMISS In deciding a motion pursuant to CPLR §3211(a)(7), the Court must “accept the facts as alleged in the complaint as true, accord Plaintiff ‘the benefit of every possible favorable inference’” and “determine only whether the facts as alleged fit into any cognizable legal theory”. Nonnon v. City of New York, 9 NY3d 825, 874 NE2d 720, 842 NYS2d 756 (2007); quoting Leon v. Martinez, 84 NY2d 83, 87-88, 638 NE2d 511, 614 NYS2d 972 (1994). The scope of a court’s inquiry on such a motion is narrowly circumscribed to determine if, assuming the truth of the facts alleged, the complaint states the elements of a legally cognizable cause of action. See, Rovello v. Orofino Realty Co., 40 NY2d 633, 634, 357 N.E.2d 970, 389 NYS2d 314 (1976). The grounds for dismissal under CPLR §3211(a)(7) are strictly limited; the court is not allowed to render a determination upon a thorough review of the relevant facts adduced by both parties, but rather is substantially more constrained in its review, examining only the plaintiff’s pleadings and affidavits (see Rovello v. Orofino Realty Co., 40 NY2d 633, 635, 357 NE2d 970, 389 NYS2d 314 [1976]; Sokol v. Leader, 74 AD3d 1180, 1181, 904 NYS2d 153 [2d Dept., 2010]). In this regard, the Third Department has explained: “In contrast to a motion for summary judgment, a court resolving a motion to dismiss for failure to state a claim cannot base the determination upon submissions by the defendant — without regard to how compelling claims made in such submissions may appear (see Miglino v. Bally Total Fitness of Greater N.Y., Inc., 20 NY3d 342, 351, 985 NE2d 128, 961 NYS2d 364 [2013]; see also Marston v. General Elec. Co., 121 AD3d 1457, 1458-1459, 995 NYS2d 646 [3d Dept., 2014]). Indeed, upon a motion pursuant to CPLR §3211(a)(7), the party opposing dismissal is allowed a remedy not available to the party seeking dismissal; the court ‘may freely consider affidavits submitted by the plaintiff to remedy any defects in the complaint, since the ultimate criterion is whether the proponent of the pleading has a cause of action, not whether he or she has stated one’ (Schmidt & Schmidt, Inc. v. Town of Charlton, 68 AD3d 1314, 1315 [3d Dept., 2009]; see Leon v. Martinez, 84 NY2d 83, 88, 638 NE2d 511, 614 NYS2d 972 [1994]; Guggenheimer v. Ginzburg, 43 NY2d 268, 275, 372 NE2d 17, 401 NYS2d 182 [1977]; Chenango Contr., Inc. v. Hughes Assoc., 128 AD3d 1150, 1151, 8 NYS3d 724 [3d Dept., 2015])”. Carr v. Wegman’s Food Mkts., Inc., 182 AD3d 667, 668-669 (3d Dept., 2020); Bennett v. Bennett, 223 AD3d 1013, 1014 (3d Dept., 2024). “[U]nless the motion to dismiss is converted by the court to a motion for summary judgment” (Rovello v. Orofino Realty Co., supra, 40 NY2d at 635), a motion to dismiss is not “in a posture to be resolved as a matter of law.”. Miglino v. Bally Total Fitness of Greater N.Y., Inc., supra, 20 NY3d at 351; Carr v. Wegmans Food Mkts., Inc., supra, 182 AD3d at 669. Nonetheless, “where the movant provides evidence extrinsic to the complaint in support of the motion, a court ‘need not assume the truthfulness of the pleaded allegations. Instead, the criterion is whether the proponent of the pleading actually has a cause of action, not whether he [or she] has properly stated one’ (Henderson v. United Parcel Serv., 252 AD2d 865, 866, 675 N.Y.S.2d 715 [3d Dept 1998] [internal quotation marks, ellipsis, brackets and citations omitted]; see Matter of Parvaz v. Public Serv. Commn., 201 AD3d 1211, 1213-1214, 162 N.Y.S.3d 511 [3d Dept., 2022], lv dismissed & denied 38 NY3d 1029 [2022]). In such instance, the plaintiff ‘no longer can rely only on the unsupported factual allegations of the pleading but must submit evidence demonstrating the existence of a cause of action’ (Matter of La Barbera v. Town of Woodstock, 29 AD3d 1054, 1055, 814 N.Y.S.2d 376 [3d Dept 2006], lv dismissed 7 NY3d 844 [2006]).” Whitehead v. Pine Haven Operating LLC, 222 A.D.3d 104, 109-110 (3d Dept., 2023). The parties herein have submitted affirmations and exhibits but this Court has not converted this motion to one for summary judgment. Accordingly, the standard herein is whether Foster has a cause of action, not whether she has stated one and HVCP’s submissions must establish its defense “conclusively”. See, Lawrence v. Miller, 11 NY3d 588, 595 (2008). DISCUSSION/THE EMERGENCY OR DISASTER TREATMENT PROTECTION ACT The EDPTA provides immunity from liability for any harm or injury alleged to have been sustained as a result of an act or omission undertaken in the course of arranging for or providing health care services where the treatment provided to the individual was “impacted by the health care facility’s…decisions or activities in response to or as a result of the COVID-19 outbreak and in support of the state’s directives” (PHL §3082[1][b]) and the health care facility “is arranging for or providing health care services in good faith”. (PHL §3082[1][c]). Immunity is not applicable where, as relevant herein, the harm alleged is “caused by an act or omission constituting…gross negligence [or] reckless misconduct”. (PHL §3082[2]). This law took effect on March 7, 2020. On August 3, 2020, the EDPTA was amended, removing “arranging for” treatment from the immunity protection, resulting in the immunity provisions of the law being applicable only to “providing health care services in accordance with applicable law or where appropriate pursuant to a COVID-19 emergency rule”. (L 2020, ch 134, §2). The August 3, 2020, amendment to the EDPTA also removed “prevention” from the definition of “health care services”. On January 30, 2021, the Attorney General’s Office issued a report which found that there had been widespread lack of compliance with infection protocols by health care facilities during the height of the pandemic and that for-profit nursing homes had misappropriated public funds to increase their own profits instead of investing in higher levels of staffing. In response to those findings, the EDPTA was repealed on April 6, 2021. The Third Department has held that the repeal does not have retroactive effect. Whitehead v. Pine Haven Operating LLC, supra, 222 AD3d at 109. Accordingly, the EDPTA was in effect during the period of March 7, 2020, through Saltmarsh’s death on December 11, 2020. Therefore, to be entitled to immunity from liability related to treatment of Saltmarsh’s post-amendment (post-August 3, 2020), COVID-19 infection, Defendant must establish (a) that the treatment provided to Saltmarsh occurred in the course of providing health care services in response to the COVID-19 pandemic; (b) her treatment was impacted by the health care facility’s or health care professional’s decisions or activities in response to the COVID-19 outbreak and in support of the state’s directives; and, further, (c) that such health care services were provided in good faith. Where a decedent’s infection and death occurred after the August 3, 2020, amendment to EDPTA, which removed “prevention” from the definition of “health care services”, the immunity provisions do not apply to claims based on failure to prevent the resident from acquiring COVID-19. See, Labianca v. Waterview Acquisition I, LLC, (Sup. Ct., Westchester Co., Index # 68088/2023). Accordingly, Foster’s claim for failing to prevent Saltmarsh’s COVID-19 infection, which occurred on or about November 30, 2020, is not precluded by the EDPTA. Furthermore, PHL §3082(1)(b) requires that “the treatment of the individual [be] impacted by the health care facility’s decisions or activities in response to or as a result of the COVID-19 outbreak” (emphasis supplied). To meet its burden on this motion, HVCP must conclusively demonstrate that Saltmarsh’s individual care was impacted by decisions or activities in response to or as a result of the COVID-19 outbreak and in support of the State’s directives; and that such care was rendered in good faith. Whitehead, supra, 222 AD3d at 110-111. In this regard, HVCP’s submissions demonstrate that Saltmarsh was seen only by essential staff wearing PPE, her vital signs were monitored daily, her communal activities were cancelled and she was screened for signs and symptoms of COVID-19. Staffing levels were adjusted to ensure adequate coverage. Hours were extended and professionals working in other capacities were directed to patient care. All decision-making was completely guided or mandated by the information and directives it received from the local, state, and federal governments. HVCP avers that all of its actions were undertaken in good faith. These averments are sufficient to demonstrate HVCP’s entitlement to immunity from civil liability on Foster’s claims regarding failure to provide proper treatment for Saltmarsh’s COVID-19 infection, shifting the burden to Plaintiff to demonstrate that she has a cause of action. Whitehead, supra, 222 AD3d at 110-111. Foster’s submission of the Attorney General’s report supports her contention that HVCP made staffing and admission decisions which favored profit-making over patient safety, thereby questioning the good faith of Defendant’s efforts. This submission provides a factual basis refuting HVCP’s sworn allegation of good faith. Cf., Whitehead, supra (wherein the plaintiff submitted only a “two-page excerpt of decedent’s medical chart”, held to be insufficient to refute the defendant’s sworn allegations that care had been impacted and provided in good-faith). Therefore, Foster has demonstrated that she has a negligence cause of action regarding Saltmarsh’s diagnosis and treatment which is not precluded by EDPTA immunity and a Public Health Law §§2801-d, 2803-c cause of action. Accordingly, HVCP’s motion to dismiss Foster’s First and Third Causes of Action is denied. Regarding Foster’s cause of action for gross negligence, HVCP claims the Complaint lacks sufficient factual averments. The Seventh Cause of Action alleges that HVCP acted in so careless a manner as to show complete disregard for Saltmarsh. Factual allegations incorporated therein include failing to appropriately separate residents in accordance with governmental guidance; failing to enforce social distancing among residents and staff; failing to cancel all group activities and communal dining; failing to timely restrict all visitors; failing to ensure all residents and health care professionals wear face coverings/masks; failing to ensure appropriate staffing levels; failing to actively screen everyone entering the building for fever and symptoms of COVID-19; and failing to monitor governmental guidance for maintaining the safety of its residents. The Complaint further states that these deficiencies occurred despite HVCP knowing such conduct would probably result in injury or damage to Saltmarsh and that same was undertaken with complete disregard of the consequences of their actions and/or inactions. These specific factual allegations are virtually identical to the “bare legal conclusions with no factual specificity” found to be insufficient to assert a gross negligence claim in Whitehead, supra. Here, however, Foster’s submission of the Attorney General’s report supports the plausible conclusion that HVCP, emboldened by the immunity granted it by the EDPTA, wantonly placed profits over patient safety. Such conduct evinces a reckless disregard for the residents and “smacks of intentional wrongdoing” (see, Colnaghi, USA v. Jewelers Protection Services, 81 NY2d 821, 823-824 [1993]; Finsel v. Wachala, 79 AD3d 1402, 1404 [3d Dept., 2010]). This submission establishes a factual basis for the allegations, provides a remedy to Foster’s pleading defect and thereby distinguishes this case from Whitehead, supra. Consequently, the Court finds that Foster, at this stage, has a cause of action for gross negligence and denies HVCP’s motion to dismiss the Seventh Cause of Action. Foster’s Second Cause of Action alleges that HVCP’s pre-pandemic negligent actions and/or omissions caused Saltmarsh’s injuries and death. HVCP’s motion asserts that Plaintiff’s Second Cause of Action fails to state a cause of action because Foster has not pleaded any facts to support the conclusion that defendant’s pre-pandemic conduct proximately caused Saltmarsh’s death. Foster alleges that HVCP owed a duty of care to Saltmarsh, and breached that duty by rendering pre-pandemic care that was careless, unskillful, negligent and not in accordance with accepted standards of care, practice, treatment, and services; by failing, pre-pandemic, to have policies or preparations in place, such as staffing levels, infectious disease procedures, available PPE, and other measures which would have mitigated or avoided the effects of COVID-19; by failing to appropriately separate residents and by other means. The Complaint alleges that these acts and/or omissions “wholly and solely” caused Saltmarsh’s injuries and death. In support of her pleading, Foster submits the CMS Emergency Preparedness Rule, issued on February 1, 2019, and alleges that HVCP failed to prepare accordingly for the known threat of the COVID-19 virus, SARS-CoV-2. As EDPTA immunity is inapplicable to pre-pandemic negligence, Foster’s factual allegations establish duty, breach, and proximately-caused injuries, and are thus sufficient to state a negligence cause of action. See, Esterbrooks v. Schenectady County, 218 AD3d 969, 970 (3d Dept., 2023). Whether Foster can ultimately prove that pre-pandemic negligence was the proximate cause of Saltmarsh’s injuries and death is not relevant on this pre-answer motion to dismiss. Id.; see also, Crepin v. Fogarty, 59 AD3d 837, 838 (3d Dept., 2009) (“[W]hether a plaintiff can ultimately establish its allegations is not part of the calculus in determining a motion to dismiss”). Therefore, the Court denies HVCP’s motion to dismiss Foster’s Second Cause of Action alleging pre-pandemic negligence. Regarding Foster’s Fourth Cause of Action, alleging negligence per se, HVCP argues that Foster’s reliance upon the provisions of the Omnibus Budget Reconciliation Act (“OBRA”) and New York State regulations are insufficient as a matter of law to state a cause of action. This is because, “[A]s a rule, violation of a state statute that imposes a specific duty constitutes negligence per se, or may even create absolute liability” (Elliott v. City of New York, 95 NY2d 730, 734 [2001]), whereas “[B]y contrast, violation of a municipal ordinance [or administrative rule or regulation] constitutes only evidence of negligence.” Id. As the Fourth Cause of Action alleges negligence per se based upon violations of 42 CFR 483.25 of the OBRA regulations and 10 NYCRR 415 and other New York State and County rules and regulations, the Court finds that Foster fails to state a cause of action of negligence per se. To the extent the Fourth Cause of Action alleges negligence per se based upon other, unspecified “federal statutes, New York State statutes, and Public Health Law §§2801-d, 2803-c”, Foster has failed to identify any statute which she claims was violated other than the Public Health Law sections which comprise her First Cause of Action. Accordingly, the Court grants the motion to dismiss the Fourth Cause of Action for failure to state a cause of action. DISCUSSION/MOTION TO DISMISS BASED ON PREP ACT IMMUNITY Under the PREP Act, the Secretary of Health and Human Services (“HHS”) is empowered to declare a public health emergency and take various actions in response to same. The Secretary’s authority includes providing civil immunity to “covered persons” from “suit and liability under Federal and state law with respect to claims for loss caused by, arising out of, relating to, or resulting from the administration” or “use” of a “covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure”. (42 USC §247d-6d[a][1]). Such immunity “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”. (42 USC §247d-6d[a][2][B]). In the event the Secretary of HHS issues a declaration that a disease constitutes a public health emergency, as with COVID-19, the Secretary may, through publication in the Federal Register, recommend the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures, and provide that the immunity provisions of the PREP Act apply thereto. On March 10, 2020, the Secretary issued a declaration under the PREP Act regarding the COVID-19 pandemic. (Federal Register, Vol. 85, No. 15, pg. 198). On June 8, 2020, the Secretary declared that “covered countermeasures” include: “(1) any antiviral, any other drug, any biologic, any diagnostic, any other device, any respiratory device, or any vaccine, used (a) to treat, diagnose, cure, prevent, mitigate or limit the harm from COVID-19, or the transmission of SARS-Cov-2 or a virus mutating therefrom, or (b) to limit the harm that COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, might cause; or (2) any device used in the administration of any such product, and all components and constituent materials of any such product.” (Federal Register, Vol. 85, No. 110, pg. 35102). Additionally, “covered countermeasures” must be “qualified pandemic or epidemic products” or “security countermeasures” or “drugs, biological products, or devices authorized for investigational or emergency use” or a “respiratory protective device” as those terms are defined in the PREP Act and elsewhere. Id; 42 USC §247d-6d(i)(1)(A-D). Furthermore, “qualified pandemic or epidemic products that limit the harm that COVID-19 might otherwise cause” are “those that would not have been manufactured, administered, used, designed, developed, modified, licensed, or procured but for the COVID-19 pandemic, even when the products are manufactured, administered, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure threats or conditions other than COVID-19″. (Federal Register, Vol. 85, No. 110, pg. 35101). Here, HVCP asserts that it is a “covered person” “with respect to the administration or use of a covered countermeasure” under the PREP Act as a “program planner” (42 USC §247d-6d[i][2][B][iii]) and that it is entitled to immunity because it administered and/or used covered countermeasures in its efforts to address the COVID-19 pandemic. Foster’s claims “relate to” HVCP’s use or failure to use the covered countermeasures. HVCP asserts the covered countermeasures it utilized include PPE, N95 masks, thermometers, pulse oximeters, COVID-19 testing, and supplemental oxygen. Of these alleged “covered countermeasures”, the Court finds that COVID-19 testing fits the definition of “qualified pandemic or epidemic products that limit the harm that COVID-19 might otherwise cause” because it “would not have been manufactured, administered, used, designed, developed, modified, licensed, or procured but for the COVID-19 pandemic”. Additionally, N95 masks fit the definition of a “respiratory protective device” and is thus a “covered countermeasure”. Foster’s assertion that PREP Act immunity does not apply because she has not made a claim “for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure” is without merit. Under the PREP Act, the scope of immunity “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, as relevant herein, a causal relationship with the “dispensing,…, administration,…, or use of such countermeasure”. 42 USC §247d-6d(a)(2)(B); Kluska v. Montifiore St. Luke’s Cornwall, 227 AD3d 690, 692 (2d Dept., 2024). Foster’s claims regarding the failure to prevent Saltmarsh’s COVID-19 infection “relate to” the use or non-use of COVID-19 testing and/or N95 masks. Furthermore, the PREP Act’s immunity provisions extend to “program planners” (42 USC §247d-6d[i][2][B][iii]), those who “supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use…of a qualified pandemic product…or provides a facility to administer or use a covered countermeasure”. As such, PREP Act immunity is available to HVCP as a defense to Foster’s claims of loss, where administration or use of the covered countermeasure(s) occurred during the effective period of the Secretary’s declaration. 42 USC §247d-6d(a)(3)(A). Accordingly, the issue is whether HVCP’s submissions demonstrate conclusively that Saltmarsh’s injuries bear a causal relationship with its administration or use of COVID-19 testing or N95 masks. (See, Kluska, supra, where the injured plaintiff alleged that his pressure ulcers arose from the use of a respirator, conceded to be a covered countermeasure, dismissal for failure to state a cause of action was denied because the defendant’s “evidentiary submissions, which included the injured plaintiff’s medical records, failed to establish that there is no significant dispute as to whether the…pressure ulcers arose from the use of the ventilator”; id., at 692). The affidavit of Kathryn A. Costello, HVCP’s Administrator, establishes that it had an infection control program prior to the pandemic. Upon the declaration of the public health emergency, HVCP implemented a program to prevent, mitigate and treat COVID-19, in view of guidance provided by the CDC and WHO, for the purpose of administering, allocating and using covered countermeasures, including COVID-19 testing as it became available. Additionally, Costello avers that Saltmarsh was tested for COVID-19 on July 20, 2020, and on several occasions in November 2020, testing negative on each occasion until her positive test on November 30, 2020. Thereafter treatment measures were employed but were ultimately unsuccessful, resulting in Saltmarsh’s death on December 11, 2020. HVCP also submits Saltmarsh’s medical records, copies of its COVID-19 policies and procedures, along with various advisories and guidances. These submissions, if not rebutted, are sufficient to conclusively demonstrate HVCP’s immunity defense. In opposition, Foster submits the Attorney General’s report, a copy of CMS Emergency Preparedness Requirements, Saltmarsh’s death certificate, a copy of the law which repealed the EDTPA, and a series of court decisions. These submissions are insufficient to rebut HVCP’s demonstration of entitlement to immunity under the PREP Act. Accordingly, the Court grants HVCP’s motion, pursuant to CPLR §3211(a)(7), to dismiss Foster’s First Cause of Action (Public Health Law claim); Third Cause of Action (negligence during the pandemic); Sixth Cause of Action (wrongful death); Seventh Cause of Action (gross negligence); Eighth Cause of Action (nursing home malpractice); and the Ninth Cause of Action (nursing home malpractice resulting in Conscious pain and suffering. Plaintiff’s Fourth Cause of Action, dismissed herein for failure to state a cause of action, is also subject to dismissal on the ground of PREP Act immunity. The Court denies HVCP’s motion to dismiss Foster’s Second Cause of Action, based on pre-pandemic negligence, because PREP Act immunity applies only to the administration or use of a covered countermeasure “during the effective period of the declaration”. Thus, any claim of negligence on the part of HVCP which occurred prior to February 4, 2020, the effective date of the Secretary’s declaration, is not precluded by PREP Act immunity. HVCP’s motion to dismiss Plaintiff’s Fifth Cause of Action, seeking damages for conscious pain and suffering, is denied to the extent such damages were proximately caused by pre-pandemic negligence. Finally, as there is no cause of action asserted by Foster for willful misconduct under the PREP Act (42 USC §247d-6d[c]), HVCP’s motion pursuant to CPLR §3211(a)(2), for lack of subject matter jurisdiction, is denied. Accordingly, it is hereby ORDERED, that HVCP’s motion to dismiss pursuant to CPLR §3211(a)(7) is granted as to Plaintiff’s First, Third, Fourth, Sixth, Seventh, Eighth and Ninth Causes of Action; and it is further ORDERED, that the motion to dismiss pursuant to CPLR §3211(a)(7) is denied as to Plaintiff’s Second Cause of Action; and it is further ORDERED, that the motion to dismiss the Fifth Cause of Action, for conscious pain and suffering, is denied solely as to Foster’s claim based upon pre-pandemic negligence, and is otherwise granted; ORDERED, that HVCP’s motion to dismiss pursuant to CPLR §3211(a)(1) is denied in its entirety; and it is further ORDERED, that HVCP’s motion to dismiss pursuant to CPLR §3211(a)(2) for lack of subject matter jurisdiction is denied; and it is further ORDERED, that HVCP is directed to serve its Answer within 20 days of the date of this Decision/Order. The Court will conduct a preliminary conference at the Ulster County Courthouse on October 21, 2024, at 10:00 AM. This shall constitute the Decision/Order of the Court. The Court is e-filing the original of this Decision/Order, relieving the parties of their obligations, pursuant to CPLR §2220, regarding filing and entry of same but that does not relieve the parties of their obligations regarding service of same with notice of entry thereon. Dated: September 23, 2024
