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
About a year ago we blogged about a strong preemption decision from the Eastern District of New York, Gallego v. Tandem Diabetes Care, Inc., 2025 WL 948282 (E.D.N.Y. March 28, 2025). Gallego involved a Class III insulin injection pump that sent a warning alarm to its user that insulin was no longer being delivered. The diabetic using the pump then spoke with a representative of the manufacturer who confirmed that the pump was not delivering insulin and that the user should replace the insulin cartridge. The user of the pump died later the same day, and his estate filed a lawsuit. As discussed in our prior post, the court dismissed with prejudice most of the estate’s claims, but it granted plaintiff leave to file a second amended complaint (SAC) that included a claim for negligent defective design and wrongful death. Today’s decision, Gallego v. Tandem Diabetes Care, Inc., 2026 WL 1130316 (E.D.N.Y. Apr. 27, 2026), applies another robust preemption analysis and dismisses the plaintiff’s remaining claims with prejudice.
Continue Reading Preemption Round Two in the Eastern District of New York
No, not that case. The appeal of the FIFRA preemption rulings in glyphosate litigation is still pending. This decision is Hencely v. Fluor Corp., No. 24-924, 2026 U.S. Lexis 1868 (U.S. Apr. 22, 2026), which involves the preemption of negligence claims against a military contractor in connection with a terrorist attack on the Bagram
Our PMA Preemption Scorecard now collects 729 opinions, the vast majority of which find preemption (which is why it’s a “scorecard”). Only three of them are from the Land of Enchantment, New Mexico – with two of them being in the same case. The third is Yusnukis v. Nevro Corp., 2026 WL 509227 (D.N.M.
Benzene-based consumer class actions are becoming almost routine. So are their dismissals on preemption grounds. It takes something a little different to make one stand out. The plaintiff in Leonard v. CVS Pharmacy, 2026 WL 986311 (N.D. Cal. Apr. 13, 2026), tried just that, invoking a res ipsa loquitur–type theory to plead “parallel”
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
This post comes from the non-RS side of the Blog.
Prescription medications for psychiatric conditions fill an important role in modern healthcare. They tend to have labels with lots of information about the risks of various emotional, psychological, and neuroreceptor-mediated conditions, including worsening of the underlying conditions being treated, interactions with other medications or substances