Having clerked for a federal district judge and cut our litigation teeth in MDLs, federal court practice has burrowed deep. When we think of procedural issues, our brains reflexively think in FRCP terms, and sometimes in state court the mental shift takes a beat.
Most of the time, it is a pretty short beat. Sometimes
Today’s guest post comes from three Reed Smith colleagues and fellow European Union Product Liability Directive nerds, Jamie Lanphear, Greg Speier, and Wim Vandenberghe. As always, our guest posters get all the cheers for their work along with any jeers, though those are hardly likely.
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The Blog has been sounding the
News about the long‑running talc MDL has developed since, but the opinion we discuss today (In re Johnson & Johnson Talcum Powder Prods. Mktg., Sales Pracs., & Prods. Liab. Litig., 2026 U.S. Dist. LEXIS 162870, 2026 LX 335455, 2026 WL 2111340 (D.N.J. July 22, 2026)) is worth a look. It is a prime
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
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
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
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
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
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 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