Nearly a decade ago we published the blogpost “Pre-Approval Design Defects – No Such Thing.” As we discussed, “pre-approval” design (later joined by warning) claims were a transparent preemption dodge. No such claims had ever been advanced before the Supreme Court’s holdings in the generic drug preemption cases (Mensing/Bartlett)
Negligent Design
Two Strikes Was Enough In California Federal Court
Over the life of the Blog, there have been many posts taking issue with the pro-plaintiff leanings of California courts, which have resulted in many questionable decisions on issues ranging from expanding personal jurisdiction to shrinking preemption to re-writing the duties of medical product manufacturers under California law. We have also thrown more than a…
No Duty to Innovate: California Supreme Court Rejects New Negligence Theory
The California Supreme Court handed down its long-awaited decision in Gilead Tenofovir Cases yesterday, and as we hoped, the Court held that a drug manufacturer owes no duty of care when deciding whether and when to develop an allegedly safer alternative drug to replace an admittedly non-defective product. The decision is a significant win for…
California Supreme Court Hears Argument On The “Duty to Innovate”
We observed arguments last week in the California Supreme Court in Gilead Tenofovir Cases, and quality advocates on both sides put on a great performance. As we previewed last week, the case presents a question with potentially sweeping consequences for product liability law: Does a pharmaceutical manufacturer owe a duty of reasonable care…
The “Duty to Innovate” Arrives at the California Supreme Court: Oral Argument Set for May 6, 2026
After nearly three years of litigation winding through California’s appellate courts, the closely watched Gilead Tenofovir Cases is finally set for oral argument before the California Supreme Court on Wednesday, May 6, 2026, at 9:00 a.m. in San Francisco. The case presents a question with potentially sweeping consequences for product liability law: Does a pharmaceutical…
More Than A Feeling Required In Psych Drug Case
This post comes from the non-RS side of the Blog.
Prescription medications for psychiatric conditions fill an important role in modern healthcare. They tend to have labels with lots of information about the risks of various emotional, psychological, and neuroreceptor-mediated conditions, including worsening of the underlying conditions being treated, interactions with other medications or substances…
W.D. Pa. Dismisses Design Defect Claims with Prejudice Based on Comment k; Dismisses Manufacturing and Warning Claims without Prejudice Based on Pleading Deficiencies
Blair v. Abbvie Inc., 2025 WL. 57198 (W.D. Pa. Jan. 9, 2025), is, from the defense perspective, a favorable opinion dismissing (some with prejudice, some with leave to amend) all counts of the plaintiff’s complaint. The opinion is a bit odd, in a semi, unintentionally-ironic sort of way, because it faults the plaintiff for…
Duty to Innovate Before The California Supreme Court: The Briefs Are In
Both sides in Gilead v. Superior Court have filed their opening briefs in the California Supreme Court, and the extreme nature of the California Court of Appeal’s opinion extending a manufacturer’s duties has been laid bare. As expected, the defendant convincingly argued that the California Court of Appeal has imposed potentially unlimited liability on product…
California Supreme Court Grants Review on “Duty to Innovate”
The California Supreme Court has granted review in Gilead Life Sciences v. Superior Court, the case in which the California Court of Appeal ruled that the defendant could be liable to users of one drug for alleged negligence in connection with a different drug, even while admitting that the drug they actually used…
Life-Saving Drugs and Chicken Bones: California Court Expands Innovator Duties of Care
We reported a few months ago on oral argument in the California Court of Appeal in Gilead Life Sciences v. Superior Court, where the parties argued about whether California law recognizes a broad “duty to innovate.” At issue was whether a product manufacturer could be liable to patients taking one drug for failing to…
