Since before the Dobbs decision reversed decades of precedent on reproductive rights, we have been looking at the implications for drug and device manufacturers. See here and here. Our posts have, of course, followed the ins and outs of the notorious AHM (or Hippo) litigation as it makes its way up to the
Implied Preemption
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…
“Shaky Foundation” Brings Down Failure to Report Claim in Pennsylvania
Sometimes we read an opinion and think to ourselves, we couldn’t have said it better ourselves. That is true of the analysis of failure to report claims in McGee v. Johnson & Johnson, 2023 WL 4765454 (W.D. Pa. Jul. 26, 2023). We’ve been railing against Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th…
Third Circuit Affirms Mass Dismissal In Throwback Decision
Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. We introduced ourselves with some rare first personal singular statements before proceeding to trash a Louisiana intermediate appellate court’s affirmance of a large verdict under Louisiana’s Medical Assistance Programs Integrity Law. Among our criticisms was the lack of detail on…
PMA Preemption Guts Ohio Case Down to Narrow Failure to Warn Claim
As evidenced by our PMA Preemption Score Card, on which today’s case became the 651st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions. But plaintiffs keep filing PMA medical device complaints, so we’ll keep posting about them.
Which brings us to today’s case, Arnold v.
Express Preemption Based On Forceful Agency Action Pursuant To Law
When we have given talks on preemption, whether to law firm personnel, attendees of professional conferences, or new FDA employees, we have tended to start with the Supremacy Clause and then break up the types of preemption and the issues related to them into different buckets. We have not had to name those buckets or…
Pro Se Plaintiff Twiqballed in D. Conn., But Claim Would Have Failed Anyway
We are back “stateside,” after a trip to London and Florence. We loved both, especially the Tower of London, Highclere Castle (used for the filming of Downton Abbey – how very cool to walk through the rooms we watched with such pleasure for six seasons) and, of course, the breathtaking David. But this is pretty…
North Carolina Court Dismisses Surgical Stapler Lawsuit
A plaintiff lawyer recently filed a case against our client in North Carolina. He has made a settlement demand that any rational observer would regard as ambitious to the point of outrageous. Despite that crazy number, we are on fairly friendly terms with the plaintiff lawyer. We jawbone at each other in a generally good…
Implied Preemption and A Lack of Evidence Strips Plaintiff’s Case Under Nebraska Law
Today’s case is Thelen v. Somatics, LLC, 2023 WL 3338221 (M.D. Fla. May 5, 2023). It is a straightforward products liability case involving a medical device used in electro-convulsive therapy. Plaintiff alleges the device caused a permanent neurological injury, memory loss, and brain damage and that the manufacturer is liable for failure to warn…
Pretty Potent Mix In A Prescription Painkiller Preemption Decision
If we have said it once, we have said it a hundred times: medical product manufacturers are not insurers of their products. Almost as frequently uttered would be that strict liability is not the same thing as absolute liability. In the show position might be that the temporal relationship between a new medical condition and…