We’ve re-read Monsanto Co. v. Durnell, No. 24-1068, 609 U.S. ___, 2026 LX 336645, 2026 WL 1825691 (June 25, 2026) (“Durnell”), a few times over the past few weeks. As Bexis noted in his quick-out-of-the gate (and great) analysis, there is a lot in there to use in our medical device
Making It Easier For Injured People To Prove Liability And Get Full Compensation: More On The New European Union Product Liability Directive
If you are a regular blog reader, you may have seen some of our prior posts about the new Product Liability Directive adopted by the European Union and going into force this December.
Two weeks ago, we had the pleasure of Co-Chairing the inaugural forum on Life Sciences Product Liability Europe in Brussels
The Clock Is Still Ticking On The European Union’s Product Liability Directive
For about 18 months now, we’ve been feeling a bit like Chicken Little (or Henny Penny for those in Europe).
We have been posting about the dangers hidden in the impending implementation of the European Union’s Product Liability Directive (“EU PLD”), and bending the ear of any in house lawyer in reach about taking
Off-Label Prescribing Is Not A Crime
Today’s post is about one of our favorite topics, off-label use. This time, it isn’t about what manufacturers can say about unapproved uses. It’s about whether the DOJ can wield the FDCA’s misbranding provisions to criminally investigate hospitals whose physicians prescribe FDA-approved drugs for off-label purposes.
In In re Administrative Subpoena 25-1431-032 to Rhode
CGMPs: Changing Good Manufacturing Practices (and Preemption)
In the drug and device product liability world, we love our acronyms and our short-hand phrases. The MDAs to the FDCA. Class III. PMA. 510(k).
Today’s acronym is CGMP, which sometimes you will see written as “cGMP”. The GMP stands for Good Manufacturing Practices, and the “C” (or “c”) has, since a 1996 Final Rule
Fourth Circuit Reverses Vaccine Mandate Injunction
Can we all agree that as between vaccines and [checks notes] “snort[ing] cocaine off of toilet seats”, it is the vaccines that should make us “not scared of a germ”?
Ok, maybe the [checks notes] Secretary of Health and Human Services wouldn’t agree, but c’mon—the evidence that vaccines save lives is overwhelming.
As Perry
The Narrow Gap Is Not Wide Enough For Wieder
The latest medical device express preemption decision, Wieder v. Advanced Bionics LLC, 2026 U.S. Dist. LEXIS 70645, 2026 WL 880370 (S.D.N.Y. Mar. 31, 2026), comes out of the Southern District of New York and involves a Class III, PMA‑approved cochlear implant.
Fluid allegedly worked its way into the device and caused a short‑circuit and device
FDA Launching Unified Adverse Event Monitoring System
- FAERS (FDA Adverse Event Reporting System) — containing reports for drugs, biologics, cosmetic products, and color additives.
The Drug and Device Law Blog’s Shark Week Continues
It must be bad plaintiff lawyer week here at the Drug and Device Law Blog. Yesterday, we brought you a review of The Pain Brokers (One Signal Publishers 2026) and the sordid tale of ginned-up damages in the vaginal mesh litigation.
Today we bring you The American Tort Reform Association’s 2026 report, The Junk
Litigation Funding in the European Union
Here in the United States, Lawyers for Civil Justice (LCJ) encourages lawyers to Ask About TPLF, also known as third party litigation funding.
LCJ and others are advocating for an addition to the Federal Rules of Civil Procedure that would require litigants to disclose the involvement of litigation funders in cases, just like