Very similar to the placement of a comma, variations in capitalization can have an effect on that means fairly a bit. Take PrEP and PREP. The previous refers to using sure antiviral medicines for pre-exposure prophylaxis to HIV, which has been hailed as a paradigm shift in treating HIV. We recall that FDA was so impressed with the primary revealed research supporting PrEP that it requested the producer of the research medication—a three-in-one tablet—to use for the novel indication. A type of drug substances, tenofovir, has for the previous few years been the topic of a really weird concept of legal responsibility that the producer ought to have switched from the unique chemical, tenofovir disoproxil fumarate, to an allegedly higher model it developed, tenofovir alafenamide, prior to it did. Whereas many courts have rejected these claims, together with primarily based on preemption, not too long ago each a California state appellate court docket and a California federal court docket have endorsed the novel “responsibility to innovate” in these circumstances. Along with being basically inconsistent with product legal responsibility rules and public coverage, the appliance to a drug that has been key in addressing a decades-long pandemic is distasteful, to place it mildly.
PREP, at the very least on these pages, usually refers back to the sweeping immunity for COVID-19 counter-measures pursuant to the Public Readiness and Emergency Preparedness Act of 2005. The producer of tenofovir and the unique PrEP medication additionally manufactures remdesivir, which has been one of many predominant antivirals to deal with COVID-19. In Fust v. Gilead Sciences, Inc., No. 2:23-cv-2853 WBS DB, 2024 WL 732965 (E.D. Cal. Feb. 22, 2024), two plaintiffs filed a purported nationwide class motion in California state court docket that asserted a variety of client safety claims on behalf of individuals allegedly injured by way of remdesivir, together with the survivors of individuals allegedly killed by way of remdesivir. Of word, California has expansive client safety legal guidelines, particularly as utilized by its state courts, and these plaintiffs elected to not pursue them as a substitute of product legal responsibility claims, apart from negligent misrepresentation, which may slot in both bucket. The defendant eliminated and moved to dismiss primarily underneath the PREP Act; in the meantime, plaintiffs moved to remand.
First up was the movement to remand. The elimination was primarily based on CAFA, the Class Motion Equity Act, which was supposed to offer material jurisdiction in federal court docket for just about this precise state of affairs—a category that will cross state traces and contain substantial cures even when introduced within the state the place the defendant is predicated. The plaintiffs made some borderline frivolous arguments in help of remand, so we’ll handle solely the least frivolous one. Plaintiffs argued that its proposed nationwide class was not well worth the $5 million minimal underneath CAFA although it sought compensatory and punitive damages and reduction that included a corrective advert marketing campaign and disgorgement of the income from the sale of the drug. The Fust court docket didn’t should look previous the corrective advert marketing campaign price, as a result of a number of circumstances estimated the price of equal or cheaper campaigns at nicely above $5 million. Id. at *1.
That meant that the federal court docket additionally bought to resolve if PREP Act immunity worn out all of plaintiffs’ claims. (To us, they might even have been preempted had the case proceeded.) The PREP Act immunity evaluation has three components, the primary two of which have been mainly walkovers right here. A drug accepted to deal with COVID-19—remdesivir acquired an emergency use authorization in March 2020 and an approval for its SNDA in April 2022—was clearly a coated countermeasure and its producer was clearly a coated particular person. Id. at *5. All that was left was whether or not the claims within the swimsuit associated to “loss brought on by, arising out of, regarding, or ensuing from the administration of” the drug. Extra particularly, claims for loss allegedly brought on by the “manufacture, labeling, distribution . . . packaging, advertising and marketing, promotion, [and] sale” of the drug would set off immunity. Not surprisingly, the buyer safety, false promoting, and misrepresentation claims concerning the alleged over-statement of the advantages and under-statement of the dangers of a prescription drug walked proper into immunity. The court docket perused the criticism and concluded “[e]very main noun and verb comprising plaintiffs’ allegations concerning act, damage, and causation manifestly implication the broad protections” of the PREP Act. Id. at *6. This was according to different selections we’ve got mentioned and customary sense.
Talking of frequent sense, we might be remiss if we didn’t word that indication for remdesivir was restricted to sufferers hospitalized for COVID-19. The proposed class was equally restricted. So, had it caught round lengthy sufficient, each member within the class would needed to have been hospitalized because of the results of a virus that induced a pandemic and acquired the antiviral that was the primary—and, for a very long time, solely—to obtain FDA authorization to deal with their life-threatening situation. The reduction requested by that class would have included that the producer disgorge the income from the sale of the drug to everybody, together with these whose lives have been saved by its use. As a convicted felon turned boxing promoter used to say, “Solely in America.” Nicely, apart from the PREP Act and its software in circumstances like Fust. Even in California.
