With Gilead’s Reasonableness Standard, Side Effects May Vary
Adrug manufacturer’s research pipeline is many things: a bet on science, a bet on regulators, a bet on patents, and a very expensive bet against failure. What it has not traditionally been—at least until now—is a standing invitation for tort plaintiffs to argue, years later, that the company should have bet differently.
That is the question now before the California Supreme Court, which heard oral argument yesterday in Gilead Tenofovir Cases (S283862). The case asks whether California law recognizes a previously unheard-of “duty to commercialize a safer alternative drug.” Under the First Appellate District Court of Appeal’s rule, that duty arises whenever a pharmaceutical manufacturer allegedly “knows” that another formulation in its pipeline is at least as effective, and safer, than the product currently on the market.
The International Center for Law & Economics (ICLE) filed an amicus brief in the case urging reversal. The brief argues that the appellate court’s rule effectively eliminates the longstanding product-defect requirement, rests on a misreading of Brown v. Superior Court, and—most interestingly from a law & economics perspective—would invite courts and juries to second-guess R&D decisions that the patent system and U.S. Food and Drug Administration already heavily structure.
Oral argument, of course, is no oracle of case disposition. Even so, two lines of questioning stood out to me, and both, I think, vindicated concerns we raised in the brief.