We reported a couple of months ago on important decisions in the Fourth Circuit that invalidated state laws in West Virginia and Maryland purporting to compel pharmaceutical manufacturers to deliver steeply discounted prescription medicines to unlimited numbers of pharmacies under the federal 340B drug discount program. Because the opinions created a circuit split on a
Can states compel prescription drug manufacturers to deliver steeply discounted medicines to unlimited numbers of pharmacies? That is the issue that has been kicking around federal courts for a few years now, and the Fourth Circuit has now weighed in by answering “no.”
We are talking here about drugs purchased under the federal government’s 340B
This post is from the non-Dechert and non-RS side of the Blog.
Depending on the time, issue, and players, the supposed epithets of “judicial activism” or “activist judge” can be thrown in just about every juridical direction. If we were to try to parse out the most common reason for the use of these terms
For design defect claims, a key issue is whether the relevant jurisdiction requires evidence that a suitable alternative design existed that would have allowed the plaintiff to dodge the alleged injury. This blog has posted at length about alternative design requirements and their nuances. These posts address everything from the existential question of “What
The 2024 Annual Meeting of the American Law Institute (“ALI”) got under way yesterday. Therefore, based on what happened last year (described in detail here), we assume we are on the brink of the ALI taking the monumentally non-restating step of recognizing no-injury medical monitoring. In a case of twisted timing, as we await
Our work on “hard goods” (automobile, appliance, fire) product liability cases is greatly outnumbered by our drug and device cases (and probably also outnumbered these days by website privacy cases). But the history of product liability has often been driven by such hard goods cases. Think of Cardozo’s famous opinion in MacPherson v. Buick.
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
Shortly after we recently posted our 50-state survey of state law concerning expert “gatekeeping,” we received a thoughtful email from friend-of-the-Blog Tom Hurney, of Jackson Kelly, informing us that there were additional gatekeeping-related issues in West Virginia that our search – limited to cases using the word “gatekeeping” – did not reflect. His
Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. A draft of this article is now available on SSRN.
The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying “no” and trying to ban that same FDA-approved drug. It doesn’t matter whether that drug is morphine, methadone, minoxidil – or mifepristone.
Continue Reading Mifepristone Manufacturer Wins First Round in West Virginia
Quick – when’s the last time that a federal court of appeals certified a pro-plaintiff ruling to the relevant state supreme court?
We don’t remember either.
Continue Reading Alternative Design Issue Certified to West Virginia High Court