ALF Argues New Drug Tort Violates Sound Science & Harms The Public Interest
In the consolidated GileadTenofovir Cases, the California Court of Appeal held that “the legal duty of a manufacturer to exercise reasonable care can, in appropriate circumstances, extend beyond the duty not to market a defective product” (emphasis added). More specifically, the court held that “a drug manufacturer, having invented what it knows is a safer, and at least equally effective, alternative to a prescription drug that it is currently selling and that is not shown to be defective, has a duty of reasonable care to users of the current drug when making decisions about the commercialization of the alternative drug.”
Gilead Sciences, Inc., the defendant in mass product liability litigation involving one of its prescription tenofovir HIV/AIDS drugs, has appealed this unprecedented ruling to the California Supreme Court.
ALF long has been one of the nation’s foremost advocates for sound science in the courtroom. In March 2024 ALF submitted an amicus curiae letter urging the California Supreme Court to review and reverse the Court of Appeal’s holding. The California Supreme Court granted review. ALF now has submitted an amicus brief on the merits, arguing that the new tort duty imposed by the Court of Appeal conflicts with sound science as well as free enterprise, and harms the public interest.
ALF’s amicus brief was authored by Executive Vice President & General Counsel Larry Ebner and Board & Executive Committee member Ana Tagvoryan of Blank Rome’s Los Angeles office.
1. When a plaintiff sues a manufacturer claiming injury from the manufacturer’s product, must the plaintiff prove that the product is defective?
2. Does a manufacturer of a non-defective, FDA-approved pharmaceutical product has a duty to develop and commecialize, without delay, a different pharmaceutical product that is allegedly safer for some consumers?
Additional Background:
The Court of Appeal indicated in its widely publicized, certified-for-publication Opinion that Gilead “developed and sold one of the first medications to treat HIV/AIDS”—TDF, which the Food and Drug Administration (FDA) approved in 2001, even though “its use carried a risk of skeletal and kidney damage.” Op. at 1 (filed Jan. 9, 2024). Although “[t]he 24,000 plaintiffs in this coordinated proceeding allege that they suffered these and other adverse effects . . . they do not assert any claim seeking to prove that TDF is defective.” Id. at 1-2. Instead, the plaintiffs allege that “[w]hile Gilead was developing TDF, it discovered a similar, but chemically distinct, potential drug,” TAF; that “Gilead’s early testing indicated TAF could be as effective as TDF at treating HIV/AIDS, while carrying a lower risk of adverse effects”; that “Gilead elected to defer development of TAF because it was concerned that the immediate development of TAF would reduce its financial return from TDF”; and that “[y]ears later, Gilead resumed the development of TAF and obtained FDA approval for its sale in 2015.” Id. at 2. The plaintiffs “characterize their claim as one for ordinary negligence, contending that Gilead’s decision to defer development of TAF to maximize its profits breached its duty of reasonable care to users of TDF.” Id.
ALF’s Amicus Brief:
ALF’s amicus brief argues that the unprecedented tort duty created by the Court of Appeal not only destroys the traditional, well-defined boundaries of product liability, but also clashes with sound science and free enterprise. The brief urges the California Supreme Court to hold that an innovative pharmaceutical company cannot be held liable for postponing, or even terminating, research & development of a new drug that a subset of consumers (here in hindsight) allege is safer than the non-defective, efficacious, FDA-approved drug that they have been using.
The amicus brief explains that attaching liability at an early stage of new drug development based on a pharmaceutical manufacturer’s supposed “actual knowledge” that a candidate drug is safer than an existing drug is contrary to the fundamental nature of continually evolving scientific knowledge. It is incompatible with the multi-stage scientific method by which potential new drugs are explored, tested, submitted for FDA review and approval, and eventually made available to the public. The duty imposed by the Court of Appeal not only is irreconcilable with sound science and the scientific method, but also would suppress vital innovative activity in the pharmaceutical industry, and thus, would harm the pubic interest.
Status:
The appeal is awaiting the scheduling of a hearing.
Contact:
Email ALF Executive Vice President & General Counsel Larry Ebner.
