In law school, many students struggle with the distinctions between personal jurisdiction, venue, and forum non conveniens (aka, FNC). In the real world of product liability, FNC is definitely viewed as a less effective tool in the defense litigation toolbox than the other two. Part of the reason is that the showing required for a
Sometimes opinions go entirely in favor of the defense, analyzing numerous, independent bases for the dismissal of a complaint. Today’s decision, Doyle v. Bayer Corp., 2025 WL 1666261 (W.D. Wash. June 12, 2025), is definitely one of those. It is a perfect example of what should happen when a plaintiff files a generic, bare-bones complaint in a prescription medical product case.
Plaintiff had an intrauterine device (IUD) implanted, and after about two years was informed that the IUD had likely been expelled from her body. More than ten years after that, plaintiff obtained an x-ray for a persistent cough. Doctors suspected that a shadow shown on the x-ray in the plaintiff’s abdomen was the IUD. Plaintiff subsequently had surgery to remove the IUD, and she and her husband then filed suit against the manufacturer. Plaintiffs asserted five common law product liability claims and a sixth for unfair business practices.Continue Reading Belt and Suspenders – Dismissal in the Western District of Washington
This is from the non-Butler Snow side of the Blog.
Readers of the Blog know that we believe in strictly applying the requirements of Federal Rules of Evidence 702 and 703. Long before the 2023 amendments to Rule 702 were a twinkle in the advisory committee’s collective eye, we were pounding the proverbial drum that
Not too long ago we saw a story in the legal press about a newly filed case in Minnesota where the plaintiff claimed that the FDA was going easy on the defendant because it approved “hundreds of premarket supplements” rather than requiring “a new PMA application.” Supposedly “[b]y utilizing the [premarket approval] supplement process instead of filing a new PMA application, [the defendant] avoided the rigorous scientific review, public comment and clinical trial requirements.”
That’s barnyard excrement. This plaintiff isn’t just wrong s/he is loud wrong – which, for plaintiffs, is unfortunately rather common.Continue Reading Supplemental Authority
A month or so ago, we castigated some extremely poorly reasoned expert exclusion decisions in the Bulox v. Coopersurgical litigation. The end results weren’t horrible (p-side motions were denied), but th0se Rule 702 opinions completely ignored the changes wrought by the 2023 amendments to that Rule. It was so striking that we went on PACER to see whether defense counsel was to blame for any of that – they weren’t.
Well, today we’re cheering the latest decision(s) in the same litigation. Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 56370 (Mag. S.D. Tex. March 6, 2005) (“Bulox I”), adopted, 2025 U.S. Dist. Lexis 54755 (S.D. Tex. March 25, 2025) (“Bulox II”), is as good a PMA medical device preemption decision as a defendant has a right to expect. This Bulox decision should go a long way towards defeating the other side’s latest campaign to deprive women of contraceptive choice.Continue Reading Clip, Clip Hooray
This post is from the non-Butler Snow side of the blog.
When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you will encounter both experts and “experts” (scare quotes intended) in materials science.
Materials science
We consistently defend the ability of physicians to engage in off-label use. Bexis helped lay the scholarly foundation for courts to utilize the term “off label use,” and two of his law review articles remain go-to reads on the subject. Not surprisingly, we follow medical malpractice decisions that address off label use. Back in 2009, Mark Herrmann (the Blog’s co-founder with Bexis), published a law review article articulating the reasons why package inserts should not be admitted as standard of care evidence in medical malpractice actions. More recently, we wrote a comprehensive post collecting case law rejecting the admission of package insert evidence to establish a violation of the standard of care by physicians who used drugs or devices off label. Today’s case is a detailed opinion from the Iowa Supreme Court joining what is now the majority view—that package inserts should not be admitted as substantive evidence of the standard of care.Continue Reading Package Inserts Are Not Admissible to Establish Standard of Care
[This post is from the non-Reed Smith side of the blog.]
Today we report on Dickson v. Dexcom, Inc, 2024 WL 4291511 (W.D. La. 2024), an important medical-device preemption case that started with a doctrinal bang but ended on a factual whimper.
Committed to nationally uniform standards based on good science, we believe that
Recently we discussed the latest opinion in the ongoing “controversy” over the application of Pennsylvania’s comment k across-the-board rule to cases involving medical devices. Douglas v. Atrium Medical Corp., 2024 WL 4364950 (M.D. Pa. Sept. 20, 2024). We use “controversy” advisedly, because as Douglas held, there is “no substantial ground for difference of opinion
Note: There is a table in this post that may be easier to view on a phone than on a computer.
Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”).
These devices are a very small subset of FDA-regulated medical devices – around 1% — and they