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We are medical device and pharmaceutical lawyers, so preemption is our thing.  It may not make for scintillating cocktail conversation, but we find the intersection between Constitutional law (the Supremacy Clause and the federal/state balance of power) and public policy issues (health and safety, and regulation versus litigation as the best way to promote same) to be a pretty interesting topic. 

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not.

What could be better than preemption?  How about “immunity”?  Or is it that the same thing by a different name?

And that brings us to the Public Readiness and Emergency Preparedness Act (or “PREP Act”), 42 U.S.C. §§ 247d-6d, 247d-6e.  The PREP Act has captured our attention before, but recently, in Baghikian v. Providence Health & Services, No. CV 23-9082-JFW(JPRX), __ F.Supp.3d __, 2024 U.S. Dist. LEXIS 22420, 2024 WL 487769 (C.D. Cal. Feb. 6, 2024), the Central District of California looked at the PREP Act in the usual context in which we deal with preemption:  A tort lawsuit (involving product liability and related state law tort claims) against a medical product manufacturer (here, the manufacturers of the COVID 19 antiviral medications remdesivir and tocilizumab).

A Primer on the PREP Act.  Through the PREP Act, Congress hoped to facilitate the quick deployment of crucial medical resources during public health emergencies, in part by freeing “covered person[s]” from the threat of civil litigation and liability.  In relevant part, it provides that:

“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.”

42 U.S.C. § 247d-6d(a)(1) (emphasis added). 

The only exception to this broad grant of immunity is a quite particular “exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct,” although that remedy is only available (1) in the United States District Court for the District of Columbia; (2) requires pleading with particularity, a complaint supported by a verification under oath, a doctor’s affidavit, and certified medical records; (3) requires conduct more dangerous than negligence or recklessness; (4) can be pursued only after the plaintiff first pursues an administrative claim; and (5) must be proven by clear and convincing evidence.  42 U.S.C. §§ 247d-6d & 247d-6e.

Other key PREP Act provisions:

  • “Covered person[s]” include manufacturers and distributors of “covered countermeasures.”  42 U.S.C. § 247d-6d(i)(2)(B)(i)–(ii). 
  • “Covered countermeasures” include “qualified pandemic or epidemic product[s]” so designated by a declaration of the Secretary of Health and Human Services. 42 U.S.C. § 247d-6d(i)(7). 
  • “All claims” in the PREP Act’s immunity clause means all claims with “a causal relationship” to the covered countermeasure’s “design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use.” 42 U.S.C. § 247d-6d(a)(2)(B).
  • Reminiscent of the Vaccine Injury Compensation Act, 42 USC §300aa-22(b-c), the PREP Act also created an alternative no-fault system for individuals to seek recovery if they believe they have been injured by a covered countermeasure.  See 42 U.S.C. § 247d-6e(a) (creating the “Covered Countermeasure Process Fund”).

The Baghikian Opinion.  Not all that long after the PREP Act passed, the COVID-19 pandemic started, quickly confirming the importance of freeing government and industry to work together to deploy every type of desperately needed medical resource.  The government issued the necessary “public health emergency” declaration in March 2020, and the PREP Act kicked in.

The Baghikian defendants’ antiviral medications were and are an important part of the battle against COVID-19.  One defendant developed and manufactures remdesivir, covered by an Emergency Use Authorization issued by the FDA in May 2020 and full approval in October 2020.  The other defendant manufactures a rheumatoid arthritis medicine, tocilizumab, but contracted with the federal government to conduct clinical trials regarding its use in treating COVID-19 leading to an Emergency Use Authorization in June 2021 and full approval for COVID-19 use in December 2022.

The plaintiffs alleged that the decedent had been hospitalized for COVID-19 and treated with the defendants’ antivirals without adequate informed consent, and passed away after three weeks.  They did not, however, contest that defendants were “covered person[s]” or that the antiviral medications were “covered countermeasures.” 

Instead, the plaintiffs argued that an allegedly insufficient informed consent about the treatments vitiated the PREP Act’s immunity provision—a contention the Baghikian court quickly rejected as unfounded in the statute’s language and unsupported by any caselaw.

The plaintiffs also took a shot at arguing for application of the “willful misconduct” exception to PREP Act immunity.  But even setting aside the procedural problems (like the requirement that such claims be pursued only in the District of Columbia), the plaintiffs’ assertions of strict liability or, at most, recklessness, fell short of the “willful misconduct” needed under the PREP Act.

As the first case directly addressing the PREP Act in a product liability case against manufacturers, Baghikian is significant, and its rejection of liability was clearly the right result.  Baghikian already has been followed in Fust v. Gilead Sciences, Inc., No. 2:23-cv-2853 WBS DB, 2024 U.S. Dist. LEXIS 30894 (E.D. Cal. Feb. 21, 2024)).

One final item of note about the PREP Act:

Defendants should not get carried away trying to remove PREP Act claims to federal court, potentially hurting themselves on the main issue (immunity) over a skirmish about jurisdiction.  In Saldana v. Glenhaven Healthcare LLC, 27 F.4th 679, 686 (9th Cir. 2022), the Ninth Circuit held that the PREP Act does not result in “complete” preemption.  Complete preemption is not a defense to liability and is not the same as field preemption;  it is a jurisdictional doctrine.  Complete preemption allows removal of a case to federal court, based on the understanding that any attempt to state a claim on the relevant subject is deemed to be based on federal law instead.  See Retail Prop. Tr. v. United Bhd. of Carpenters & Joiners of Am., 768 F.3d 938, 941 (9th Cir. 2014).  Complete preemption gets you into federal court, but not dismissed from the case, and Saldana says it doesn’t apply to PREP Act claims in any event.

That said, Baghikian does highlight one potential, albeit unusual, path to federal court: the federal officer removal statute, 28 U.S.C. § 1442(a)(1), available because the claims were based on actions the tocilizumab manufacturer took at the direction of a federal officer.