Recently, towards the end of a post about preemption and the FDA’s Current Good Manufacturing Practices (“cGMPs”) – also known as Quality Management System Regulations (“QMSRs”) − we noted a “significant change” last February. “[T]he FDA issued a final rule” that replaced all existing cGMPs “by incorporating by reference an international standard specific for device
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
Every so often a summary judgment decision comes along that makes you wonder whether the plaintiff thought the rules of civil procedure were more like suggestions. Neal v. Smith & Nephew Inc., 2026 WL 87302 (W.D. LA Jan. 12, 2026), is one of those cases.
The facts are familiar product liability territory. Plaintiff
In case our title was too subtle, we think that a stack of purported inferences should neither state a claim for strict liability with a prescription medical device nor sidestep express preemption in the case of a Class III device. We have long been dubious of the idea of a true parallel claim as articulated
It’s the most wonderful time of year, or at least Sirius channel 79 keeps telling us that. Too much food, too much drink, too much family, and not quite enough presents. Or, at least, not enough of the right presents. Or, maybe, lots of those veritable mixed bags. You know – a six pack of
Not long ago we published a blogpost, “New California Ranitidine Litigation Order Makes A Huge Mess Of Everything” about a California trial court decision that created, out of whole cloth, what it called a “hybrid theory” of strict liability that jumbled together elements of the long-established – and long separate – concepts of design and manufacturing defect, while sprinkling in the negligence concept of intent. See In re Rantidine Cases, 2025 WL 2796831 (Cal. Super. Sept. 15, 2025). As a result, the court allowed a “manufacturing” defect that was uniform across all units of the product, because it construed plaintiffs’ attack on the defendants’ manufacturing processes as a manufacturing defect.
In this post we will attempt to describe just how far out of bounds this “hybrid theory” really is.
Continue Reading California Design vs. Manufacturing Defects – Neer the Twain Shall Meet
This week we could not resist writing about a good result from an always interesting jurisdiction (Louisiana) involving one of our all-time favorite defense lawyers (Hi, Lori Cohen).
In McGuire v. B. Braun Med. Inc., 2025 U.S. Dist. LEXIS 184172, 2025 WL 2689205 (E.D. Louisiana Sept. 19, 2025), the district court granted the defendants’ motion to
This is from the non-RS side of the Blog.
We admit that the use of “everything” in our title may be excessive. The order in In re Rantidine [sic] Cases, JCCP 5150 (Cal. Super. Ct. Sept. 15, 2025) (“Cali Ranitidine”), slip op. here, did not cause climate change, poverty, hunger, air
Federal preemption of tort claims involving medical devices receiving premarket approval (PMA) is a powerful defense. But for some reason, there are plaintiff lawyers who think it does not apply, or barely applies, to claims for manufacturing defect. That is bad enough. When courts buy into that misconception, it is even worse. It takes clear