When a plaintiff alleges injury from the consumption of a generic drug

QUESTION PRESENTED The Supreme Court of California has created the tort of “warning-label liability,” also known as “innovator liability,” which lets users of a generic drug bring failure-to-warn claims against the manufacturer of the brand-name drug—even though the manufacturer had no role in making, marketing, or selling the generic. The rationale for the tort is that because a generic drug’s label must mirror the branded drug’s label, the brand-name manufacturer’s labeling decisions are a proper basis for liability. Regardless of the merits of this novel theory as a matter of state law, the Due Process Clause forbids California from haling an out-of-state brand-name manufacturer into court when generic-drug users claim they were injured by products that a competitor sold in the State. Specific jurisdiction is absent because a warning-label claim against a brand-name manufacturer does not “arise out of or relate to the defendant’s contacts with the forum”’—it relates to labeling decisions the defendant made in its home state. Ford Motor Co. v. Mont. Kighth Jud. Dist. Ct., 592 U.S. 351, 359 (2021). And forcing a brand-name manufacturer to defend claims in California when it did not profit from generic sales in California is anything but “fair[]” or “reciprocal.” Jd. at 367-68. Not only does the manufacturer lose twice—a missed sale, and a lawsuit based on a competitor’s sale—but it has no ability to “structure [its] primary conduct” to avoid claims based on a generic competitor’s sales in California. Id. The question presented is: ii When a plaintiff alleges injury from the consumption of a generic drug, can the consumer’s home state assert specific personal jurisdiction over an out-of-state brand-name manufacturer?