We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption.
Yes, we need a life, but let’s put that aside for the moment.
In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval
We’ve been defending drug and device litigation for a long time, and we’ve seen many plaintiffs who experienced real injuries. Those of us at the blog, our colleagues at other defense firms, and our clients are genuinely sympathetic to injuries a plaintiff actually experienced. Many plaintiffs we’ve encountered also endured terrible circumstances earlier in their lives. Some of those can be heartbreaking. Defending cases on the basis that our clients’ products did not cause the injury or that the injury was a known and warned of risk doesn’t mean the defense bar looks askance at plaintiffs and their experiences. But, when we see a case involving a syringe needle purportedly propelled into a plaintiff’s derrière, some of us might exhibit a moment of minor moral weakness and include the above title in a blog post. Mea culpa.
Today’s case, Rudzinskas v. Retractable Techs., Inc., 2025 U.S. Dist. LEXIS 191860 (S.D. Ga. Sept. 29, 2025), involves a type of syringe that automatically retracts once the plunger handle is fully depressed. Plaintiff’s husband regularly administered vitamin B-12 shots to her and had been doing so for six or seven years. Plaintiff claimed that, on one of those occasions, the needle from defendant’s syringe “shot into [her] like a slingshot.” Id. at *4. Plaintiff went to the hospital and an ultrasound suggested the needle was embedded in the plaintiff’s buttock. Plaintiff underwent surgery to have the needle removed, but the surgeon was not able to extract it. Continue Reading A Real Pain in the . . .
The preemption case du jour is Gregory v. Boston Sci. Corp., 2025 U.S. Dist. LEXIS 164801, 2025 WL 2452382 (E.D.N.Y. Aug. 25, 2025), in which the Eastern District of New York granted summary judgment on federal preemption grounds.
Every time we see a case that does that—upholds preemption on summary judgment—we wonder
Today’s decision, Croci v. Zoll Medical Corp., 2025 WL 2307728 (S.D.N.Y. Aug. 11, 2025), is a straightforward, preemption-based 12(b)(6) dismissal of a complaint involving a Class III medical device. The case involves claims about a Life Vest, which is worn externally and monitors the wearer’s heart rate. The device is able to detect ventricular tachycardia and ventricular fibrillation, and it can deliver a therapeutic shock to restore the wearer’s heart rate to a normal rhythm. The complaint alleged that the decedent experienced problems with the Life Vest, and that a representative of the Life Vest’s manufacturer visited the decedent’s home to “desensitize the device.” Id. at *1. Shortly after the alleged visit from the representative, the decedent experienced a cardiac arrest and died.Continue Reading PMA Preemption in the Southern District of New York
Today’s post is our second installment about a case in the District of Massachusetts alleging injury from a Class III medical device. We blogged about it this spring when the court dismissed plaintiff’s claim that an implanted defibrillator and associated leads caused her numerous, unnecessary shocks. The court dismissed that complaint based on straightforward, premarket approval preemption. But the court granted plaintiff leave to amend, and she moved to file an amended complaint. Today’s decision, Summers v. Medtronic, Inc., 2025 WL 2201110 (D. Mass. Aug. 1, 2025), denied plaintiff’s motion for leave based on the learned intermediary rule in Massachusetts. It’s a helpful decision because it applies the learned intermediary rule at the 12(b)(6) stage in the context of a device recall.Continue Reading Summers Round 2: Learned Intermediary Rule Applies to Claim Based on Device Recall
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