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
June 25, 2026 was a very good day for preemption. While one hand of the judiciary was busy with the Supreme Court handing down its 7-2 ruling in Monsanto Co. v. Durnell — establishing that FIFRA expressly preempts Roundup state-law failure-to-warn claims, the other hand was quietly doing the same thing with toothpaste. Specifically, the
Ever since we reviewed the Environmental Protection Administration’s (“EPA”) 2019 decision reaffirming its prior conclusion that glyphosate does not cause cancer and, therefore, the “Roundup” herbicide did not warrant any cancer warnings, we have been convinced that state-law claims demanding such warnings were (or should be) preempted – regardless of how pro-plaintiff decisions might seek
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
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
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
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
As we have discussed more times than we like, the plaintiffs’ class action cabal, in conjunction with their running-dog Valisure “if it doesn’t have it, we’ll cook it until it does” “testing” laboratory, has targeted various products supposedly containing benzene contaminants. The result has been a plethora of no-injury class actions by plaintiffs who
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 is from the non-Reed Smith side of the blog.
They say it’s better to be lucky than good. But in Luckey v. Abbott Laboratories, Inc., 2026 WL 836122 (E.D. Ky. Mar. 26, 2026), plaintiff was neither.
This is a straightforward—and satisfying—PMA preemption decision involving a heart valve allegedly marketed to last at