In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. Our position has been clear, and the same from the Blog’s beginning
The FDA has taken recent steps that may, or may not, affect product liability litigation. We’re discussing the “may” aspect. For purely regulatory analysis, plenty of other commentary is available.
These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices. Any litigator with even passing knowledge of medical device preemption knows that this − more properly, a prior (1982) version − is the process that the Supreme Court stated, was “focused on equivalence, not safety” in Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) (emphasis original).
Continue Reading Tort-Related Implications of Recent FDA Device Draft Guidances
Lately, there seems to be an overdose of OTC (Over the Counter) drug cases. Everywhere we look, we see more and more lawsuits centered on OTC’s, both in the areas of product liability and consumer fraud. Is it because OTC litigation offers plaintiff lawyers the prospect of a huge potential plaintiff population? Is it because
Our best college era summer job was working as a staffer for the New Jersey State Senate. The Abscam investigation was ongoing, and it seemed that every week there’d be another empty seat in the Senate chamber courtesy of the FBI. Good times. We doubt we personally performed any services that were useful for Garden
We have posted a few times (here, here, and here) about the Alliance for Hippocratic Medicine v. FDA/Alliance for Hippocratic Medicine v. Danco Labs., LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone, a pharmaceutical FDA-approved for use
We don’t write a lot on criminal cases, but published opinions in the Ninth Circuit involving the Food Drug and Cosmetic Act always catch our eye. In United States v. Marschall, No. 22-30048, 2023 WL 6135771 (9th Cir. Sept. 20, 2023) (to be published in F.4th), the Ninth Circuit held last week that some
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
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.”
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
When Bexis sends around the weekly list of cases, we jump on the ones where the United States is the first listed party. It returns us to our salad days at the U.S. Attorney’s Office way back at the end of the 20th century. (We had more fun, more authority, more hair, and less insomnia