Sometimes there are decisions that we begin to read with an expectation—perhaps based on a thumbnail from Bexis—that we will have a strong impression. Not surprisingly, the expected impression is usually negative. This was the case with Apter v. HHS, No. 22-40802, 2023 U.S. App. LEXIS 23401 (5th Cir. Sept. 1, 2023), which concerned
FDA
Another Update on Medical Abortion Litigation
When we last commented on the Alliance for Hippocratic Medicine v. FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.”…
Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic
We’ve finished reading through the New Jersey Supreme Court’s unanimous decision in Hrymoc v. Ethicon, Inc., ___ A.3d ___, 2023 WL 4714042 (N.J. July 25, 2023) (which should really be captioned “McGinnis” because plaintiff Hrymoc settled, see n.1). The good – really good – news is that an abusively obtained nuclear ($68 million+) verdict goes bye-bye. That alone is grounds for celebration.Continue Reading Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic
Third Circuit Tosses Criminal Charge that Unauthorized Ingredient Source was Introduction of a “New Drug”
Med-Mal Plaintiff Expert Standard of Care Opinion Unnecessary Due to FDA Warnings
Law school taught us that design defect, manufacturing defect, and failure to warn are the big troika of product liability theories. Real life practice taught us that failure to warn is far and away the most common and dangerous claim we face. It is easy for plaintiffs to allege and easy for juries to follow…
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…
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…
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…
This Is Why FDA Is Not a Black Box
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…