Statute
FDCA
242 published works
Drug & Device Law
DiToto Is a Total Mess
By Bexis
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…
Marler Blog
Nara’s German Manufacturer Just Failed an FDA Inspection — But That’s Not Where the Botulism Came From
By Bill Marler
My friend Phyllis Entis, the FoodBugLady over at eFoodAlert, broke a story today that anyone following the Nara Organics infant botulism outbreak needs to read. Let me add some context from…
Regulatory Oversight
FDA Proposes Foreign Manufacturing Establishment Registration and Product Listing Requirements
By Bryan Haynes, Agustin Rodriguez, Zie Alere, Val Fesenko*
On June 29, 2026, the U.S. Food and Drug Administration (FDA) published a notice of proposed rulemaking (NPRM) titled "Establishment Registration and Product Listing for Tobacco Products," which would, for…
Drug & Device Law
Half-Squeezed: S.D.N.Y Splits the Difference on Heavy Metal Toothpaste Claims
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.…
Drug & Device Law
Off-Label Prescribing Is Not A Crime
By Lisa Baird
Today’s post is about one of our favorite topics, off-label use. This time, it isn't about what manufacturers can say about unapproved uses. It's about whether the DOJ can wield…
Drug & Device Law
CGMPs: Changing Good Manufacturing Practices (and Preemption)
By Lisa Baird
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…
Drug & Device Law
Hardly a Shock – PMA Preemption Prevails in New Mexico
By Bexis
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…
Regulatory Oversight
Federal Court Bars Enforcement of Virginia Vapor Directory, Pending Fourth Circuit Ruling
By Bryan Haynes, Agustin Rodriguez, Zie Alere
We recently covered this case here, in which a small manufacturer and retailer sued the Virginia attorney general (AG) and tax commissioner in the U.S. District Court for the Eastern…
Drug & Device Law
Nevada Court Rejects Purported Parallel Claim Based On A Purported Violation Based On A Purported Defect Based On Market Withdrawal
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…
Drug & Device Law
Preemption, Plausibility, and Parallel Claims
By Bexis
We’ve bashed the horrible decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), more times than we care to count. This time we’re taking a look precedent…