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We’ve discussed decisions applying preemption under the Public Readiness & Emergency Preparedness Act (hereafter “PREP Act”), 42 U.S.C. §247d-6d, on several occasions since the COVID-19 pandemic began.  At this point, some four years after the COVID-19 pandemic declaration, we believe that sufficient PREP Act preemption precedent has accumulated, and that the caselaw is sufficiently favorable to the defense position in product liability litigation, that we should start scorecard for PREP Act preemption in the product liability context.

This favorable state of legal precedent is not surprising, given the PREP Act’s broadly preemptive language concerning products used to combat COVID-19.  That language becomes effective upon a federal declaration of public health emergency.  42 U.S.C. §§247d(a), 247d-6d(a)(1), which in this instance occurred on March 17, 2020.  85 Fed. Reg. 15191 (HHS 2020).  Under the PREP Act, a “qualified countermeasure” includes any “biological product” (such as vaccines) used “to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease).”  42 U.S.C. §247d-6d(a)(2)(A)(i).  The PREP Act also contains strong “liability protections” for “covered countermeasures” and “covered persons,” which are defined terms:

(1) Covered countermeasure

The term “covered countermeasure” means −

(A) a qualified pandemic or epidemic product (as defined in paragraph (7));. . . . [or]

(C) a . . . biological product . . . that is authorized for emergency use in accordance with [pertinent portions of the FDCA.]

42 U.S.C. §247d-6d(i)(1). The term “biological product” includes vaccines.  42 U.S.C. §262(i)(1).

(2) Covered person

The term “covered person”, when used with respect to the administration or use of a covered countermeasure, means −. . .

(B) a person or entity that is −

(i) a manufacturer of such countermeasure;

(ii) a distributor of such countermeasure;. . . or

(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).

42 U.S.C. §247d-6d(i)(2).  Obviously, a vaccine manufacturer is a “covered person.”

For both “covered persons” and “covered countermeasures” the Act provides extensive preemption:

(8) Preemption of State law

During the effective period of a declaration . . ., or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that −

(A) is different from, or is in conflict with, any requirement applicable under this section; and

(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, Drug, and Cosmetic Act.

42 U.S.C. §247d-6d(b)(8).

This language reflects “clear congressional intent that the prescribed remedies be exclusive.”  Mitchell v. Advanced HCS, L.L.C., 28 F.4th 580, 587 (5th Cir. 2022).  “To encourage voluntary participation in the distribution of these countermeasures, the Secretary of [HHS] invoked the [PREP Act], to provide legal immunity for the individuals and organizations who provided these countermeasures to the public.”  Leonard v. Alabama State Board of Pharmacy, 61 F.4th 902, 905 (11th Cir. 2023).  The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005:

To encourage the expeditious development and deployment of medical countermeasures during a public health emergency . . . [by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . .  In the PREP Act, Congress made the judgment that, in the context of a public health emergency, immunizing certain persons and entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered.

“The PREP Act & COVID-19, Part 1: Statutory Authority to Limit Liability for Medical Countermeasures” 1, 1 (Cong. Res. Serv. April 13, 2022) (available here) (emphasis added).  See, e.g., Cannon v. Watermark Retirement Communities, Inc., 45 F.4th 137, 139 (D.C. Cir. 2022) (quoting this publication).. “The purpose of the PREP Act, as supplemented by the amended PREP Act declaration, was to encourage covered providers to implement covered countermeasures as quickly and broadly as reasonably possible without fear of liability.”  Mills v. Hartford Healthcare Corp., 298 A.3d 605, 630 (Conn. 2023) (citation omitted).  “Under this plain, clear, and unambiguous language, the PREP Act was designed to prevent lawsuits that would arise from the physical provision of covered countermeasures to the end-user.”  Pugh v. Okuley’s Pharmacy & Home Medical, 224 N.E.3d 619, 2023 WL 5862281, at *3 (Ohio App. Sept. 11, 2023).

To be clear, many of the cases just cited will not appear in our scorecard because they do not involve product liability at all – or, as stated in the statute, the “administration” of any “countermeasures.”  PREP Act preemption has not been extended to, for example, nursing homes allegedly failing to use countermeasures (e.g., Cannon, supra); doctors claimed to have committed malpractice in non-COVID-19 aspects of treating patients who also happened to have the disease (Mills, supra); or workplace injury litigation concerning the production, but not administration, COVID-19 countermeasures (Pugh, supra).  None of those situations involves the type of claims that our clients retain us to defend.

In litigation against a “covered person” over a “covered countermeasure,” the PREP Act has one exception to its preemptive scope, a statutory cause of action for intentional misconduct.  42 U.S.C. §247d-6d(d)(1).  We’re not aware of anyone purporting to try that yet, since it’s quite difficult to pursue.  In case someone does, here are the prerequisites to bringing such a claim.  First, a plaintiff must seek recovery for “death or serious physical injury” − no medical monitoring garbage allowed – “proximately caused by willful misconduct.”  Id.  “Willful misconduct means “an act or omission” done:  “(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.”  Id. §247d-6d(c)(1)(A).  Second, the claim can only be filed in the United States District Court for the District of Columbia before a special three-judge panel.  Id. §247d-6d(d)(5), (e)(1).  Third, the government must have already brought an enforcement action against the defendant for the claimed conduct.  Id. §247d-6d(c)(5)(A).  Fourth, any private action for willful misconduct claim must be accompanied by both (i) specified sworn verifications signed by both the plaintiff and a plaintiff’s expert and (ii) “certified” medical records supporting causation.  Id. §247d-6d(e)(4).  Fifth, before filing, a plaintiff must have sought and been denied compensation through the PREP Act’s administrative alternative to litigation (Countermeasures Injury Compensation Program (“CICP”)).  Id. §247d-6e(d)(1).  Sixth, the willful misconduct allegations must be pleaded with specificity.  Id. §§247d-6d(c)(1)(A), (e)(3).  Seventh, plaintiffs are not entitled to discovery until after motions to dismiss have been decided.  Id. §247d-6d(e)(6).

With that, here is our scorecard:

  • Kehler v. Hood, 2012 WL 1945952 (E.D. Mo. May 30, 2012).  Motion to dismiss third-party indemnification claims granted.  PREP Act immunity bars claims related to vaccinations.  Pre-COVID.
  • Parker v. St. Lawrence County Public Health Dep’t, 954 N.Y.S.2d 259 (N.Y. App. Div. Nov. 1, 2012).  Dismissal of all claims affirmed.  Lack of parental consent to vaccination preempted.  Pre-COVID.
  • Casabianca v. Mount Sinai Medical Center, 2014 WL 10413521 (N.Y. Sup. Dec. 2, 2014).  Motion to dismiss denied.  The decedent was never administered a vaccine or received any other influenza countermeasure.  Therefore, his malpractice claim would not be dismissed.  Pre-COVID.
  • Avicolli v. BJ’s Wholesale Club, Inc., 2023 WL 5862281 (E.D. Pa. April 7, 2021).  Summary judgment denied.  An issue of fact remained whether that product (hand sanitizer) allegedly causing harm had been manufactured and sold after the HHS declaration of emergency, and thus not in response to the emergency.
  • Perez v. Oxford University, 2022 WL 1446543 (Mag. S.D.N.Y. April 11, 2022), adopted, 2022 WL 1468438 (S.D.N.Y. May 10, 2022).  Motion to dismiss granted.  The only possible claim for alleged complications of vaccination under the PREP Act is for willful misconduct.  Since plaintiff has not brought such a claim, the action must be dismissed, because this court has no jurisdiction.
  • Arbor Management Services, LLC v. Hendrix, 875 S.E.2d 392 (Ga. App. June 22, 2022).  Denial of motion to dismiss affirmed.  Plaintiffs’ allegations solely concerned nursing home visitation, staffing, recreation, and socialization, rather than the administration of a “covered countermeasure” such as a drug, device, or other object as identified in the PREP Act emergency declarations.
  • Storment v. Walgreen, Co., 2022 WL 2966607 (D.N.M. July 27, 2022).  Motion to dismiss granted.  Vaccines are covered countermeasures.  An allegation that the plaintiff fainted after receiving a vaccine is preempted, since it cannot be divorced from the process of  administering the vaccine.  Plaintiff may seek recovery through the federal countermeasures fund.
  • T.C. v. Pfizer, Inc., 2022 WL 17578871 (S.D. Cal. Nov. 9, 2022), aff’d, 2024 WL 511872 (9th Cir. Feb. 9, 2024). Motion to dismiss granted.  Vaccines are covered countermeasures.  Defendant is facially immune from suit in this Court under the PREP Act.
  • Iannelli v. Citrus Memorial Hospital, Inc., 2022 WL 20690949 (Fla. Cir. Nov. 15, 2022).  Motion to dismiss denied.  PREP Act preemption requires covered injuries caused by use or administration of covered countermeasures, not the failure to use countermeasures.
  • Goins v. Saint Elizabeth Medical Center, 640 F. Supp.3d 745 (E.D. Ky. Nov. 19, 2022).  Motions to dismiss granted and denied.  All claims against manufacturers and pharmacies distributing COVID-19 vaccines, including battery, are preempted.  Vaccines are covered countermeasures.  “Administration” of a vaccine thus refers to the logistical work it takes to provide it.  Absent allegations that the physician and hospital defendant were involved with the vaccination, those claims are not dismissed and are remanded.  Claims concerning post-vaccination medical treatment are not preempted.  Affirmed in part and reversed in part, 2024 WL 229568, below.
  • Cowen v. Walgreens Co., 2022 WL 17640208 (N.D. Okla. Dec. 13, 2022).  Motion to dismiss granted.  Vaccines are covered countermeasures.  That plaintiff intended to get a flu, not a COVID-19, vaccine does not change that the claimed injuries are related to the COVID-19 vaccine plaintiff allegedly received by mistake.  Plaintiff’s it-could-have-been-a-different-vaccine argument is rejected.
  • Politella v. Windham Southeast School Dist., 2022 WL 18143866 (Vt. Super. Dec. 28, 2022).  Motion for judgment on the pleadings granted.  Clams that the plaintiff’s child was vaccinated without parental consent are related to and dependent on the vaccination and within the scope of PREP Act preemption.
  • Wilhelms v. ProMedica Health Systems, Inc., 205 N.E.3d 1159 (Ohio App. Jan. 18, 2023).  Grant of motion to dismiss reversed.  A factual question remained whether plaintiff’s bedsores were causally related to the defendants’ use of a respirator as a COVID-19 countermeasure, or whether the cause was unrelated general medical care.
  • Hansen v. Brandywine Nursing & Rehabilitation Center, Inc., 2023 WL 587950 (Del. Super. Jan. 23, 2023).  Motion to dismiss denied.  Plaintiff did not allege administration of a countermeasure, which would have been preempted, but only basic infectious disease prevention, which would be necessary whether or not COVID-19 was involved.
  • M.T. v. Walmart Stores, Inc., 528 P.3d 1067 (Kan. App. April 28, 2023).  Partial denial of motion to dismiss reversed and all claims dismissed.  Vaccines are covered countermeasures, and all persons involved in administration of vaccines are covered persons.  Plaintiff cannot allege that an approved COVID-19 vaccine was not actually a vaccine.  Judicial notice supplies the facts plaintiff failed to plead.  Negligence claims, including those of action and those of omission, are covered by the PREP Act when they are causally related to the administration or use of a covered countermeasure.  No exception to PREP Act preemption exists for informed consent claims.  Claims alleging violation of parental consent rights are preempted since they are causally related to the vaccination.  Complete preemption cases have no bearing on the defensive preemption at issue here.
  • Santo v. Genesis Healthcare, Inc., 2023 WL 3493880 (Del. Super. May 16, 2023).  Motion to dismiss denied.  Except for one allegation relating to personal protective equipment, plaintiff’s complaint relates to general nursing home infection prevention unrelated to COVID-19.  Defendant can seek summary judgment against the one claim if plaintiff pursues it.
  • Gibson v. Johnson & Johnson, 2023 WL 4851413 (E.D. Pa. July 28, 2023).  Motion to dismiss granted.  All claims against the manufacturer of the COVID-19 vaccine administered to the plaintiff prisoner are dismissed.  PREP Act immunity precludes federal False Claims Act claims.  PREP Act preemption extends to affiliated corporations of vaccine manufacturers.
  • Maupin v. Klein’s Pharmacy & Orthopedic Appliances, 2023 WL 5334034 (Ohio C.P. Aug. 7, 2023).  Motion to dismiss denied.  Although a dispensing pharmacy is a PREP Act distributor, the pleadings do not establish whether the administering employees had the training and certifications necessary to be “qualified persons” under relevant PREP Act declaration amendments.
  • Bird v. State, 537 P.3d 332 (Wyo. October 26, 2023).  Summary judgment affirmed.  All claims brought by state prisoners are preempted.  The state could order vaccination, and vaccines are covered countermeasures.  Conduct that is negligent or reckless in administering a COVID-19 vaccine is immune from suit and liability for both federal and state law claims.
  • Estate of Carter v. Cambridge Sierra Holdings, LLC, 2023 WL 8351512 (C.D. Cal. Oct. 20, 2023).  Motion to dismiss denied as to PREP Act preemption.  Pleadings did not establish that nursing home was a covered person making a choice to allocate or administer countermeasures.
  • Garcia v. Welltower OpCo Group LLC, 2023 WL 8047821 (C.D. Cal. Nov. 15, 2023).  Motion to dismiss denied.  Plaintiffs do not allege the administration of any government-identified form of COVID-19 countermeasures, therefore the claims are not preempted.
  • Perez v. Ransome, 2024 WL 198908 (M.D. Pa. Jan. 18, 2024).  Motion to dismiss granted.  Vaccines are covered countermeasures.  All claims against vaccine manufacturer and prison vaccine administrator are preempted, including allegations of synergistic injury.
  • Goins v. Saint Elizabeth Medical Center, Inc., 2024 WL 229568 (6th Cir. Jan. 22, 2024).  Dismissal affirmed in part and reversed in part.  PREP Act preemption bars all claims concerning the decedent’s vaccination.  Claims involving other allegedly negligent treatment not involving COVID-19-related medical care not preempted.  Partially reversing 640 F. Supp.3d 745, above.
  • Baghikian v. Providence Health & Services, __ F. Supp.3d __, 2024 WL 487769 (C.D. Cal. Feb. 6, 2024).  Motion to dismiss granted.  All claims against manufacturers of antiviral medicines used to treat COVID-19 are preempted.  Just as vaccines are covered countermeasures, so are antivirals.  Informed consent claims are preempted.  Plaintiffs fail to state a willful misconduct claim, and could not bring it in this court.
  • Fust v. Gilead Sciences, Inc., 2024 WL 732965 (E.D. Cal. Feb. 22, 2024).  Motion to dismiss granted.  All claims against manufacturers of antiviral medicines used to treat COVID-19 are preempted.
  • Happel v. Guilford County Board of Education, ___ S.E.2d ___, 2024 WL 925471 (N.C. App. March 5, 2024).  Grant of motion to dismiss all claims affirmed.  Preemption extends to all claims relating to vaccinations, including informed consent claims.  Plaintiffs have not brought a willful misconduct claim.
  • Willsey v. United States, 2024 WL 1012956 (S.D. Ind. March 8, 2024).  Motion to dismiss granted.  The United States is also a covered person against which all claims relating to vaccination are preempted.  Claims that the government collaborated with pharmaceutical companies during the COVID-19 pandemic to develop vaccines and encouraged Americans to take them relate to vaccines and their rollout and are preempted.  The PREP Act applies regardless of good faith.
  • Coleman v. Sharp Memorial Hospital, 2024 Cal. Super. Lexis 10893 (Cal. Super. March 29, 2024). Demurrer overruled. Because the complaint might be read as “not based on the countermeasure, but rather on the alleged concealment of facts,” an allegation that the defendants fraudulently concealed a different, off-label treatment for COVID, and instead treated the decedent with a covered countermeasure could escape preemption.
  • Gieser v. Moderna Corp., 2024 WL 3077100 (Mag. E.D. Cal. June 20, 2024). Motion to dismiss granted.  All of pro se prisoner’s claims against a COVID-19 vaccine manufacturer for claimed personal injuries are preempted. Willful misconduct requirements are lacking and such an action would be in the wrong court.