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
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
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.
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
A federal judge in DC has reminded us that the government does not operate in secret, at least not always and usually not completely in connection with prescription drug approval. The case is Vanda Pharmaceuticals, Inc. v. FDA, No. 22-cv-938, 2023 U.S. Dist. LEXIS 51853 (D.D.C. Mar. 27, 2023), and the plaintiff was a
We know the real quote attributable to Bill Gates is “content is king,” But as communications continue to become shorter and more compressed, context can get lost in the shuffle; and context as much as content, drives our knowledge and interactions. So, when the court in Henry v. Nissin Foods (U.S.A.) Co., opined that
In our first appellate oral argument we found ourselves in front of a very hot Ninth Circuit panel (that means lots of questions). We danced our hardest to affirm the district court’s denial of a criminal defendant’s motion to suppress. The problem was that the lower court had wandered onto shaky ground. We knew it.
Starting with our comprehensive post lambasting Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448 (W.D. Pa. 2019), for ignoring 75 years of hitherto unbroken Pennsylvania precedent and allowing a “strict liability” design defect claim against an FDA-regulated prescription medical product, we have both chronicled and opposed the other side’s attempt to infiltrate strict liability into Pennsylvania litigation involving such products (primarily medical devices). That attempt disregards seven Pennsylvania Supreme Court decisions between 1948 (Henderson) and 2014 (Lance), as well as the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) (Creazzo), all rejecting application of strict liability principles to prescription medical products. For the gory details, see the prior post.
Continue Reading Pennsylvania Law, Federal Rules, and FDA Standards
The FDA recently published its Final Guidance on REMS programs for prescription drugs, which we thought might interest our readers. The document is formally called “Format and Content of a REMS Document: Guidance for Industry” and you can download and review the Final Guidance here. You might be thinking two things at this moment:
We disagree with plenty of courts on plenty of things, but most of the time it’s at least arguably just a conflict with one of our pro-defense views. But occasionally, very occasionally, we run into a decision that’s just plain wrong on some factual or legal aspect. Blackburn v. Shire U.S., Inc., 2022 WL 16729466 (11th Cir. Nov. 7, 2022) (thankfully unpublished), is such a decision.