Not quite three years ago, we co-authored a chapter in a Digital Health guide put out by International Comparative Legal Guides. It bore the pithy title “Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health.” We continue to tinker with the principles of product liability law
Class II Medical Devices
Time to Chuck Lohr Out The Window and Start Over With Riegel?
We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption.
Yes, we need a life, but let’s put that aside for the moment.
In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval…
Personal Responsibility and Products Liability: Broken Doesn’t Mean Defective
Plaintiffs bring product liability suits against medical device manufacturers when outcomes fall short of expectations. Such as when a bone plate—a device surgically implanted to stabilize broken bones and enable proper healing—breaks. Now indulge us for a moment because Bexis and Yeary learned a lot about bone screws and orthopedic devices back in the day.
New York Appellate Court Reverses Denial of Summary Judgement and Holds No Duty to Warn of Someone Else’s Product
The Butler Snow contingent on the DDL blogging team had nothing to do with this post.
New York law is surprisingly good for defendants. Or maybe we’re jaded by bad experiences in other jurisdictions, and New York law manages to seem fair only by comparison. Certainly, we’d rather be in a courtroom in New York…
Device Recall Notice Turned Into Plaintiff Lawyer Advertising?
When we tell people what we do, we often get a response, from lawyers and non-lawyers alike, to the effect of, “so you do class actions.” The somewhat canned response is that “serial product liability litigations” or “mass torts” rarely involve certified classes other than settlement classes because individual factors in personal injury cases almost…
Doctors Without Burdens: Another Mesh Court Goes Backwards
Maybe we have been doing this too long. Or maybe, like the prequels, spinoffs, and reboots that are so prevalent among streaming entertainment options, there is just a lot of repetition. In serial product liability cases, we hope that repetition leads to consistency of results or at least predictable rules of the game. Consider the…
E.D. Pa. Trims Pelvic Mesh Claims
Bostic v. Ethicon, Inc., 2022 WL 952129 (E.D. Pa. March 29, 2022), is a Pennsylvania mesh case raising a host of familiar issues in a motion to dismiss context. The complaint is of the typically overpleaded (14-count) variety. Dickens was not really paid by the word, but plaintiff lawyers seem to think they might…
Fifth Circuit Affirms Dismissals and Summary Judgment in Defibrillator Case out of the Eastern District of Louisiana
This post is from the non-Winston & Strawn side of the blog.
As we write today, we are nine days from an event, two years in the planning, that we have mentioned in these pages before. We are taking the Drug and Device Law Dowager Countess (nearly 88) and her slightly younger sister to see…
Evidence of 510(k) Clearance Is Relevant and Admissible, Says E.D. Pa. IVC Filter Judge
As we write this, it is a glorious Labor Day Monday in the suburbs of Philadelphia. We are pleased to confirm that the Drug and Device Law Rock Climber retrieved her dogs last week, though not before we rushed to the vet one last time, this time to address the Pom’s allergic skin reaction to…
Wrong Court and Wrong-er Reasoning − Ignoring 75 Years of Controlling Precedent
The opinion, Schrecengost v. Coloplast Corp., 2019 WL 6465398 (W.D. Pa. Dec. 2, 2019), recently “predicted” that Pennsylvania would allow strict liability design and warning defect claims in cases involving prescription medical products. Id. at *11-13. In so doing Schrecengost was not only wrong, but loud wrong. First, without even a serious discussion, Schrecengost…