“Off label use” is a bit of an odd thing. The FDA does not regulate the practice of medicine, but it does get involved in the labeling of medical devices and pharmaceuticals through the applicable pre-marketing review processes, and those labels identify the use (or uses) intended for that medical product. That use (or
Benchslapped!
Although Mark Herrmann co-founded the Drug and Device Law Blog (with Bexis) way back in the day, he now writes for Above the Law. Unlike Above the Law, the Drug and Device Law Blog generally does not feature benchslaps—judicial opinions that take a swipe at counsel for their professional misdeeds. Though we may
The New EU Product Liability Directive
A long time ago, in a mass tort far, far away, the plaintiffs’ lawyers were not content with collecting plaintiffs from within the US. They also brought a putative product liability class action in federal court in the U.S. on behalf of European plaintiffs. As a result, your bloggers learned a little bit (a very
RICO Madness, Part II: The Oral Argument in Medical Marijuana, Inc. v. Horn
Almost a year ago (how time flies!), we brought you our first Rico Madness post, regarding the cert petition in Medical Marijuana, Inc. v. Horn, and promised to keep you updated if the Supreme Court took the case. Well, they did and we are.
In our prior post, we noted that we are
We Applaud The Preemption Analysis And Outcome In Mack v. CooperSurgical, Inc. (2024) While Bemoaning Those In Mack v. CooperSurgical, Inc. (2023)
Note: There is a table in this post that may be easier to view on a phone than on a computer.
Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”).
These devices are a very small subset of FDA-regulated medical devices – around 1% — and they
Florida Pure Bill of Discovery and the Medicare Secondary Payer Act
This post is from the non-Butler Snow side of the blog.
When a news article starts with “Florida man…” you know you are in for a bit of crazy. Usually crazy and funny, but in a smack-my-head kinda way.
The lawsuit resulting in the decision in MSP Recovery Claims, Series LLC v. Ethicon Inc.
Another Preemption Win Involving An Economic Loss Class Action And An OTC Drug
As regular blog readers know, we love a clean grant of a motion to dismiss on preemption grounds. They are relatively common, so it sometimes puzzles us that the plaintiffs’ bar keeps filing plainly preempted claims.
Perhaps some of these plainly preempted lawsuits get filed because the express preemption provision of the FDCA related to
California, There You Go, Right Back Where You Started From: Expanding Liability ViaNegligent Infliction of Emotional Distress
Decades ago, California had a well-deserved reputation for inventing new varieties of tort liability. California would hatch an idea to expand liability; law professors would churn out thought-pieces taking the theory in new and further directions; judges across the country would struggle with whether to adopt the concept or constrain it in some fashion; eventually
No Alternative Design, No Design Defect Claim In West Virginia
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
Federal Government Website Resources
Every once in a while, we find ourselves on a federal government corner of the internet, and we usually are surprised to discover (or are reminded) that these webpages often have materials that are worth knowing about, even downright useful, for our type of practice.
These sites are not always easy to navigate, however, so