Over the life of the Blog, there have been many posts taking issue with the pro-plaintiff leanings of California courts, which have resulted in many questionable decisions on issues ranging from expanding personal jurisdiction to shrinking preemption to re-writing the duties of medical product manufacturers under California law. We have also thrown more than a
The Supreme Court decided Buckman in the context of a fairly large product liability litigation about implanted medical devices. In the years that followed, the plaintiffs in drug and device product liability litigation tried a number of arguments to cabin the impact of Buckman. For instance, they argued that it 1) did not apply
[T]esting conducted by FDA laboratories and a toxicological risk assessment related to metals found in tampons . . . found that, while trace metals are present in
Our initial inclination was not to blog about DiToto v. Nevro Corp., 2026 WL 1425041 (D. Md. May 21, 2026), given that it was an adverse, poorly reasoned trial court level decision. But then we received an updated citation indicating that – for reasons that totally escape us – Thompson-Reuters/West had decided to publish
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
As we have said before, the Blog is unabashedly pro-science. There is a difference between good science and bad science, and reliance on the latter to make any important decision—be it in everyday life, litigation, or public policy—is not smart. We are also unabashedly in favor of strict application of the Rules of Evidence
We reported a couple of months ago on important decisions in the Fourth Circuit that invalidated state laws in West Virginia and Maryland purporting to compel pharmaceutical manufacturers to deliver steeply discounted prescription medicines to unlimited numbers of pharmacies under the federal 340B drug discount program. Because the opinions created a circuit split on a
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
That title might be overblown, because we are discussing only two cases. But one of them is the Roundup case, and we could not resist the cheesy wordplay.
Roundup is neither a drug nor device. It is regulated by the Environmental Protection Agency (EPA), not the Food and Drug Administration (FDA). Nevertheless, the Federal Insecticide