Failure to Recall

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Photo of Andrew Tauber

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…

Photo of Eric Alexander

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…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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