We’ve posted twice recently about the potential jurisdictional benefits of the congressionally expanded “federal officer” basis for federal jurisdiction in tort litigation: 28 U.S.C. §1442 (a)(1). Our first post cited in passing Griffin v. Optum, Inc., ___ F.4th ___, 2026 WL 1239289 (8th Cir. May 6, 2026), as an example of courts already applying
OT – Bexis’ Hawai’ian Adventure
This post is off-topic – it has nothing to do with prescription medical product liability litigation, or even the law. Bexis recently took a vacation on the island of Kauai, in Hawai’i, for the sixteenth time. He hiked, for the tenth time, the first two miles of the Kalalau Trail, to Hanakapiai Beach. That’s nice
Say Good-Bye to CGMPs and Hello to ISO 13485
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
FDA – Make My FAS the PFAS
Some of us of a certain age were fans of Parliament/Funkadelic back in the day. The group even released an album entitled “Medicaid Fraud Dogg.” That was the most drug/device adjacent rock-and-roll since the Rolling Stones released “Mother’s Little Helper.” One classic Parliament line was “make my funk the p-funk
Off-Label Notes
The Blog has always been interested in off-label use issues. We hope our readers are as well. Here are a couple of recent developments that have nothing in common except that they involve off-label issues.
The first is regulatory. On May 12, 2023, the FDA actually did something smart, a relative rarity for the current
One Headcount To Learned Intermediary Rule Them All – Part 3
Here at the Blog, we love the learned intermediary rule. We’ve chronicled the rule’s steady expansion as it now has precedential support in all fifty states. “Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration.” Dearinger v. Eli Lilly & Co.
One Headcount To Learned Intermediary Rule Them All – Part 2
Here at the Blog, we love the learned intermediary rule. We’ve chronicled the rule’s steady expansion as it now has precedential support in all fifty states. “Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration.” Dearinger v. Eli Lilly & Co.
It Is Indeed Time To Reconsider Federal Officer Removal
Back in 2020, we published a post, “Is It Time To Reconsider Federal Officer Removal?” It discussed a Fifth Circuit asbestos case, Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286 (5th Cir. 2020), overruled prior precedent in light of a congressional amendment to the federal officer removal statute, 28 U.S.C. §1442(a), that
One Headcount To Learned Intermediary Rule Them All – Complete 50-State Survey
Here at the Blog, we love the learned intermediary rule. We’ve chronicled the rule’s steady expansion as it now has precedential support in all fifty states. “Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration.” Dearinger v. Eli Lilly &
An Expert Weighs in on Privilege and TPLF Discovery
Bexis has been working with Lawyers for Civil Justice on a number of projects, including the currently pending initiative to enact a federal rules amendment that requires meaningful disclosure of third-party litigation funding (“TPLF”) on essentially the same rationale that insurance policies are routinely disclosed under Fed. R. Civ. P. 26 (a)(1)(A)(iv). As part of