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We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug.  Wilkins v. Genzyme Corp., 2022 WL 4237528 (D. Mass. Sept. 14, 2022), is an even stranger claim, with the plaintiff seeking to hold the defendant liable for not manufacturing a prescription drug.  Fortunately, in Wilkins, those claims (several theories alleging essentially the same thing) did not state a claim.

Continue Reading No Liability for Not Manufacturing a Product
Photo of Eric Alexander

Maybe we have been doing this too long.  Or maybe, like the prequels, spinoffs, and reboots that are so prevalent among streaming entertainment options, there is just a lot of repetition.  In serial product liability cases, we hope that repetition leads to consistency of results or at least predictable rules of the game.  Consider the…

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If the concept behind Multidistrict Litigations is centralized, efficient management of common issues in large numbers of lawsuits, with remand of trial-ready cases, then MDLs are less than successful on those grounds, and certainly not successful enough to justify the asymmetric discovery and bad rulings (or nonrulings) that come as part and parcel of the…

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If drugs and medical devices undergo a product life cycle, so do drug and medical device litigations. We are currently laboring in the relatively early stage of a Multidistrict Litigation, where the court seems terrified of making any substantive decisions. We get no rulings. Rather, the parties are forced to listen to lectures about the…

Photo of Eric Alexander

A long time ago in a law school relatively far away, we took torts as a first year law student.  Many of the cases about which we learned (or were supposed to have learned) were from even longer ago and we had no idea how much some of those old cases would inform our practice. …

Photo of Michelle Yeary

When it comes to medical device preemption, having Pre-Market Approval (“PMA”) is like being dealt pocket aces in Texas Hold’Em Poker.  It’s the strongest starting hand you can have; a 4:1 favorite over any other two card combo.  It means you’re starting in the power position.  Since the Supreme Court’s decision in Riegel v. Medtronic…

Photo of Michelle Yeary

We’ve all had cases where plaintiffs try to use their prescribers and treaters as their experts on everything from failure to warn and causation to design defect and company conduct. Even on the medical aspects of the case, a treater needs to offer more than just an unsupported general conclusion in order to withstand scrutiny…

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.
Learn more about this book