We know that any federal court analysis that starts with Although the state has not recognized the duty . . . is going to be followed by a “prediction” of state law that instead creates unprecedented liability according to the federal court’s personal predilections. Which is precisely what the court did in CLF v. Coopersurgical
We recently discussed how “failure-to-recall” claims essentially don’t exist – outside of a couple of limited fact patterns that plaintiffs asserting such claims in litigation involving FDA-regulated products can almost never allege. Today’s post adds the constitutional defense of preemption to good, old-fashioned state-law failure to state a claim.Continue Reading Bartlett Pairs – “Failure To Recall” As a “Stop-Selling” Variant
Today’s case, Ganz v. Grifols Therapeutics LLC, 2023 WL 5437356 (S.D. Fla. 2023), involves a biologic but also speaks to drugs and medical devices. The mixed decision dismisses design-defect and failure-to warn claims but allows manufacturing-defect and failure-to-recall claims to proceed. Although we’ll briefly summarize those rulings, the decision is more interesting for noting
We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. When we say long-held, we mean it, because we had a few of the first cases where this theory was put