After recent posts on the AHM (or Hippo) litigation, we read the excellent FDA reply brief and considered yet another post on the subject. With the oral argument before the Fifth Circuit yesterday and more briefs and decisions to come, we elected to deal with a topic that was not quite so weighty. In
Eric Alexander
FDA’s Brief To The Fifth Circuit in the AHM Case Is Worth A Read
Attempting to stay up on every filing in every medication abortion case could be a full-time job these days. We have one of those already, so we tend to stick to court rulings. The filings in the Fifth Circuit on the AHM appeal are something of an exception. In addition to party briefs, the…
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…
Wrinkles In Time In The Acetaminophen ASD-ADHD MDL
Last November, we offered well-deserved criticisms of a really bad MDL-wide preemption decision in In re Acetaminophen − ASD-ADHD Products Liability Litigation, MDL No. 3043, 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022) (“ASD-ADHD I”). One of its huge gaffes was not citing the Supreme Court’s decision in Merck Sharp & Dohme Corp.
Partial Update On Medical Abortion Litigation
Lawyers really like to be right. This dive into the latest on reproductive rights in the context of challenges to FDA’s regulation of a prescription medication is an instance where we wish we had not been right with some of our predictions. Back when the Dobbs decision had been leaked but not yet issued, we…
One Step Closer To Having Unanimity On The Learned Intermediary Doctrine
For much of the sixteen and a half years of this Blog, we have been tracking the acceptance and rejection of the learned intermediary doctrine. The first year that we compiled a worst decisions of the year list it was topped by a case that still holds the title for worst, most thinly veiled legislation…
Not An Early April Fools’ Day Joke: State Still Pushes Its Dumb Ivermectin Law
About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. We probably should not have been surprised by the persistence of frivolous litigation. After all, our day job entails defending litigations that can last years longer than they…
Pelvic Mesh Remand Case Fizzles Out Again
Stop us if you have heard us say “stop us if you have heard this before.” Pelvic mesh cases on remand have often faced the harsh realities of procedural requirements and burdens of proof because transferee judges have treated them like individual cases rather than items in an inventory. Decisions about the impact of failure…
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…
Plaintiffs Cannot Turn Their Burden To Prove Causation Into Partial Summary Judgment
Duh. We apologize for the depth of our profundity, but there are some legal principles we think are really obvious. So obvious, in fact, that we might respond to question about these principles with this most dismissive of (clean) interjections. (We were somewhat surprised to learn from the interwebs that duh was supposedly first used…