Much like the placement of a comma, differences in capitalization can affect meaning quite a bit.  Take PrEP and PREP.  The former refers to the use of certain antiviral medications 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 first published studies supporting PrEP that it asked the manufacturer of the study drugs—a three-in-one pill—to apply for the novel indication.  One of those drug substances, tenofovir, has for the last few years been the subject of a truly bizarre theory of liability that the manufacturer should have switched from the original chemical, tenofovir disoproxil fumarate, to an allegedly better version it developed, tenofovir alafenamide, sooner than it did.  While many courts have rejected these claims, including based on preemption, recently both a California state appellate court and a California federal court  have endorsed the novel “duty to innovate” in these cases.  In addition to being fundamentally inconsistent with product liability principles and public policy, the application to a drug that has been key in addressing a decades-long pandemic is distasteful, to put it mildly.

PREP, at least on these pages, generally refers to the sweeping immunity for COVID-19 counter-measures pursuant to the Public Readiness and Emergency Preparedness Act of 2005.  The manufacturer of tenofovir and the original PrEP drugs also manufactures remdesivir, which has been one of the main antivirals to treat 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 action in California state court that asserted a number of consumer protection claims on behalf of people allegedly injured by the use of remdesivir, including the survivors of people allegedly killed by the use of remdesivir.  Of note, California has expansive consumer protection laws, especially as applied by its state courts, and these plaintiffs elected not to pursue them instead of product liability claims, except for negligent misrepresentation, which could fit in either bucket.  The defendant removed and moved to dismiss primarily under the PREP Act; meanwhile, plaintiffs moved to remand.

First up was the motion to remand.  The removal was based on CAFA, the Class Action Fairness Act, which was intended to provide subject matter jurisdiction in federal court for pretty much this exact situation—a class that would cross state lines and involve substantial remedies even when brought in the state where the defendant is based.  The plaintiffs made some borderline frivolous arguments in support of remand, so we will address only the least frivolous one.  Plaintiffs argued that its proposed nationwide class was not worth the $5 million minimum under CAFA even though it sought compensatory and punitive damages and relief that included a corrective ad campaign and disgorgement of the profits from the sale of the drug.  The Fust court did not have to look past the corrective ad campaign cost, because multiple cases estimated the cost of equivalent or cheaper campaigns at well above $5 million.  Id. at *1.

That meant that the federal court also got to decide if PREP Act immunity wiped out all of plaintiffs’ claims.  (To us, they would also have been preempted had the case proceeded.)  The PREP Act immunity analysis has three parts, the first two of which were basically walkovers here.  A drug approved to treat COVID-19—remdesivir received an emergency use authorization in March 2020 and an approval for its SNDA in April 2022—was clearly a covered countermeasure and its manufacturer was clearly a covered person.  Id. at *5.  All that was left was whether the claims in the suit related to “loss caused by, arising out of, relating to, or resulting from the administration of” the drug.  More specifically, claims for loss allegedly caused by the “manufacture, labeling, distribution . . . packaging, marketing, promotion, [and] sale” of the drug would trigger immunity.  Not surprisingly, the consumer protection, false advertising, and misrepresentation claims about the alleged over-statement of the benefits and under-statement of the risks of a prescription drug walked right into immunity.  The court perused the complaint and concluded “[e]very major noun and verb comprising plaintiffs’ allegations regarding act, injury, and causation manifestly implication the broad protections” of the PREP Act.  Id. at *6.  This was consistent with other decisions we have discussed and common sense.

Speaking of common sense, we would be remiss if we did not note that indication for remdesivir was limited to patients hospitalized for COVID-19.  The proposed class was similarly limited.  So, had it stuck around long enough, every member in the class would had to have been hospitalized due to the effects of a virus that caused a pandemic and received the antiviral that was the first—and, for a long time, only—to receive FDA authorization to treat their life-threatening condition.  The relief requested by that class would have included that the manufacturer disgorge the profits from the sale of the drug to everyone, including those whose lives were saved by its use.  As a convicted felon turned boxing promoter used to say, “Only in America.”  Well, except for the PREP Act and its application in cases like Fust.  Even in California.