Long ago, it seemed that large-scale drug or device litigation was usually spurred on by a recall, market withdrawal, or major labeling change describing a new risk or limiting the scope of product use. The plaintiff lawyers these days seem to be more willing to put their energy into attacking currently marketed products without triggering
There is a well-worn saying in electrical engineering — if you want to break a circuit, you can cut the wire or trip the breaker. Plaintiffs in several consolidated spinal-cord stimulator cases recently tried something more creative — they attempted to rewire the entire regulatory grid by suing the FDA itself, hoping to knock out
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
There’s an old joke about a guy who keeps banging his head against the wall. When asked why, he says: Because it feels so good when I stop. That’s roughly how we feel about watching defendants in medical device cases make preemption arguments under the shadow of Medtronic, Inc. v. Lohr, 518 U.S. 470
If preemption were an independent basis for federal subject matter jurisdiction, almost all of our drug, device, and vaccine product liability litigation would be in federal court. We’ve long been resigned that preemption is a defense, not grounds for jurisdiction. E.g., Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 811 (1986). A
Gadolinium is a heavy metal. Sounds ominous. But it is also the active component in contrast agents used in more than 100 million MRI procedures — and its accumulated safety record is, in the words of plaintiff’s own literature, “extraordinarily positive.” Combs v. Bayer AG, 2026 WL 1693470, at *11 n.19 (Okla. App. Ct.
The now well-known requirement from the TwIqbal cases that a complaint contains factual allegations that establish that relief is plausible derives from Rule 8(a)(2) requirement that each pleading contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” One recurring point of contention in drug and device litigation
This post is from the non-RS side of the Blog.
Consider the following scenario. A fifty-two-year-old woman has end-stage left ventricular heart failure despite medical care and the latest medications. Her prospects for a heart transplant or the implantation of a left-ventricular assist device to prolong her life are limited, including by financial considerations. She
Back in 2006, people were still carrying around Motorola Razrs, “YouTube” was barely a year old, and nobody had heard of an iPhone. That is when the device in Aceste v. Stryker Corp., 2026 Ohio Misc. LEXIS 1215 (Lucas Cty. C.P. Feb. 4, 2016),was implanted. By the time the case was filed in 2015
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