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In the consolidated Gilead Tenofovir 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.
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.
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