In this, the Year of Our Lord 2025, that title could apply to so, so, so many things. Soooooo many things.
But this is the Drug and Device Law Blog, product liability is our niche, and what we are referring to is the new, 2024 European Union Product Liability Directive (the “PLD”), also known as
This post is from the non-Butler Snow side of the blog.
When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you will encounter both experts and “experts” (scare quotes intended) in materials science.
Materials science
“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
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
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
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
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
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.
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
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