In Gilead Tenofovir Cases, the California Supreme Court held that drug manufacturers do not owe a duty of care to users of a nondefective drug when deciding whether and when to develop and market a potentially safer alternative. We previously covered Gilead’s appeal of lower court decisions permitting novel negligence claims to proceed in a 23,000 case coordinated proceeding. In a 6-1 decision on August 3, 2026, the California Supreme Court reversed and rejected a “duty-to-innovate” […]

In Yousefzadeh v. Johnson & Johnson Consumer Inc., 184 F.4th 130 (2d Cir. 2026), the Second Circuit largely affirmed dismissal of consumer claims against manufacturers of over-the-counter oral phenylephrine (“PE”) decongestants, holding that the Food, Drug, and Cosmetic Act (“FDCA”) express preemption provision, 21 U.S.C. § 379r, bars most state-law claims against monograph-regulated PE products. Yousefzadeh, 184 F.4th at 138–39. The court found its analysis “consistent with” Monsanto Co. v. Durnell, 146 S. Ct. […]