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
Failure to Recall
Bartlett Pairs – “Failure To Recall” As a “Stop-Selling” Variant

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
Litigation Posture Leaves Important Issues Unresolved In Biologics Case As Some Claims Are Dismissed While Others Survive

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…
Pro Se Plaintiff Tries and Fails To Plead Claims For Failure To Withdraw And Failure To Warn

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…