No, your DDL bloggers are not offering a money-back guarantee—although we suppose offering one would not cost us anything, since reading the blog is free. For enterprises that actually sell products though, the story is sometimes different, and many product sellers do guarantee satisfaction—or your money back. Moreover, when those guarantees are unrestricted, we
A mere two weeks ago, we praised a California federal court for dismissing preempted claims against a prescription drug manufacturer and not giving the plaintiff a third chance to plead a non-preempted claim. We noted that allowing three strikes seems to be the default rule on serial amendments in response to motions to dismiss or
The plaintiff in Kha v. Tilray Brands, Inc. tried to use California’s Sherman Law to do an end run around the Food, Drug, and Cosmetic Act in a case involving hemp products, but it did not work. The district court correctly saw the case as an attempt to impose additional, state-law requirements on food labeling
[T]esting conducted by FDA laboratories and a toxicological risk assessment related to metals found in tampons . . . found that, while trace metals are present in
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