We’re medical machine and pharmaceutical attorneys, so preemption is our factor. It could not make for scintillating cocktail dialog, however we discover the intersection between Constitutional regulation (the Supremacy Clause and the federal/state steadiness of energy) and public coverage points (well being and security, and regulation versus litigation as the easiest way to advertise similar) to be a fairly fascinating subject.
To not point out, it’s a highly effective protection for our shoppers in product legal responsibility issues as a result of it could possibly foreclose legal responsibility and plaintiffs’ use of tort lawsuits (invariably creatures of state regulation origin) to impose necessities on medical gadgets or prescribed drugs that the federal FDA didn’t.
What might be higher than preemption? How about “immunity”? Or is it that the identical factor by a unique identify?
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 consideration earlier than, however not too long ago, in Baghikian v. Windfall Well being & Companies, 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 regarded on the PREP Act within the common context during which we take care of preemption: A tort lawsuit (involving product legal responsibility and associated state regulation tort claims) towards a medical product producer (right here, the producers of the COVID 19 antiviral drugs remdesivir and tocilizumab).
A Primer on the PREP Act. By means of the PREP Act, Congress hoped to facilitate the short deployment of essential medical assets throughout public well being emergencies, partially by releasing “lined particular person[s]” from the specter of civil litigation and legal responsibility. In related half, it supplies that:
“a lined particular person shall be immune from swimsuit and legal responsibility below Federal and State regulation with respect to all claims for loss attributable to, arising out of, regarding, or ensuing from the administration to or the use by a person of a lined countermeasure.”
42 U.S.C. § 247d-6d(a)(1) (emphasis added).
The one exception to this broad grant of immunity is a fairly explicit “unique Federal reason behind motion towards a lined particular person for demise or severe bodily harm proximately attributable to willful misconduct,” though that treatment is just out there (1) in the USA District Court docket for the District of Columbia; (2) requires pleading with particularity, a criticism supported by a verification below oath, a health care provider’s affidavit, and authorized medical information; (3) requires conduct extra harmful than negligence or recklessness; (4) may be pursued solely after the plaintiff first pursues an administrative declare; and (5) should be confirmed by clear and convincing proof. 42 U.S.C. §§ 247d-6d & 247d-6e.
Different key PREP Act provisions:
- “Coated particular person[s]” embody producers and distributors of “lined countermeasures.” 42 U.S.C. § 247d-6d(i)(2)(B)(i)–(ii).
- “Coated countermeasures” embody “certified pandemic or epidemic product[s]” so designated by a declaration of the Secretary of Well being and Human Companies. 42 U.S.C. § 247d-6d(i)(7).
- “All claims” within the PREP Act’s immunity clause means all claims with “a causal relationship” to the lined countermeasure’s “design, growth, scientific testing or investigation, manufacture, labeling, distribution, formulation, packaging, advertising and marketing, promotion, sale, buy, donation, allotting, prescribing, administration, licensing, or use.” 42 U.S.C. § 247d-6d(a)(2)(B).
- Paying homage to the Vaccine Harm Compensation Act, 42 USC §300aa-22(b-c), the PREP Act additionally created another no-fault system for people to hunt restoration in the event that they consider they’ve been injured by a lined countermeasure. See 42 U.S.C. § 247d-6e(a) (creating the “Coated Countermeasure Course of Fund”).
The Baghikian Opinion. Not all that lengthy after the PREP Act handed, the COVID-19 pandemic began, shortly confirming the significance of releasing authorities and trade to work collectively to deploy each sort of desperately wanted medical useful resource. The federal government issued the required “public well being emergency” declaration in March 2020, and the PREP Act kicked in.
The Baghikian defendants’ antiviral drugs had been and are an essential a part of the battle towards COVID-19. One defendant developed and manufactures remdesivir, lined by an Emergency Use Authorization issued by the FDA in Might 2020 and full approval in October 2020. The opposite defendant manufactures a rheumatoid arthritis medication, tocilizumab, however contracted with the federal authorities to conduct scientific trials relating to its use in treating COVID-19 resulting in 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 handled with the defendants’ antivirals with out enough knowledgeable consent, and handed away after three weeks. They didn’t, nevertheless, contest that defendants had been “lined particular person[s]” or that the antiviral drugs had been “lined countermeasures.”
As an alternative, the plaintiffs argued that an allegedly inadequate knowledgeable consent in regards to the remedies vitiated the PREP Act’s immunity provision—a rivalry the Baghikian court docket shortly rejected as unfounded within the statute’s language and unsupported by any caselaw.
The plaintiffs additionally took a shot at arguing for utility of the “willful misconduct” exception to PREP Act immunity. However even setting apart the procedural issues (just like the requirement that such claims be pursued solely within the District of Columbia), the plaintiffs’ assertions of strict legal responsibility or, at most, recklessness, fell in need of the “willful misconduct” wanted below the PREP Act.
As the primary case straight addressing the PREP Act in a product legal responsibility case towards producers, Baghikian is critical, and its rejection of legal responsibility was clearly the proper outcome. Baghikian already has been adopted 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 closing merchandise of notice in regards to the PREP Act:
Defendants shouldn’t get carried away making an attempt to take away PREP Act claims to federal court docket, probably hurting themselves on the principle problem (immunity) over a skirmish about jurisdiction. In Saldana v. Glenhaven Healthcare LLC, 27 F.4th 679, 686 (ninth Cir. 2022), the Ninth Circuit held that the PREP Act doesn’t end in “full” preemption. Full preemption is just not a protection to legal responsibility and isn’t the identical as area preemption; it’s a jurisdictional doctrine. Full preemption permits elimination of a case to federal court docket, based mostly on the understanding that any try to state a declare on the related topic is deemed to be based mostly on federal regulation as a substitute. See Retail Prop. Tr. v. United Bhd. of Carpenters & Joiners of Am., 768 F.3d 938, 941 (ninth Cir. 2014). Full preemption will get you into federal court docket, however not dismissed from the case, and Saldana says it doesn’t apply to PREP Act claims in any occasion.
That mentioned, Baghikian does spotlight one potential, albeit uncommon, path to federal court docket: the federal officer elimination statute, 28 U.S.C. § 1442(a)(1), out there as a result of the claims had been based mostly on actions the tocilizumab producer took on the route of a federal officer.
