The “fraud on the FDA” claim that the Supreme Court held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was actually the most extreme form of a private plaintiff second-guessing the result of an FDA process classifying a regulated product. Plaintiffs claimed that, because of purported “fraud” in the §510(k)
No FDCA-Based Negligence Per Se in Texas
Back during the Orthopedic Bone Screw mass tort litigation, one of major avenues of attack on the plaintiffs’ novel claims was to pursue every state-law avenue for rejecting the assertion of negligence per se predicated on supposed violations of the Food, Drug & Cosmetic Act (“FDCA”). That approach originally led us to 21 U.S.C. §337(a),
Post-Albrecht Preemption Pummels Pradaxa Plaintiffs
Two of longest recent entries in our Post-Levine Drug/Vaccine Preemption Cheat Sheet are Pradaxa wins. Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., slip op., 2020 WL 1704646 (Conn. Super. March 13, 2020) (#106), and Ridings v. Maurice, ___ F. Supp.3d ___, 2020 WL 1264178 (Mag. W.D. Mo. March 16, 2020) (#108). There’s also
Spanish Plaintiffs’ Sad Song – I Can’t Get No Jurisdiction
With apologies to Mick Jagger and Keith Richards (who wouldn’t have jurisdiction either, being UK citizens), that is what the Sixth Circuit told a pack of Spanish plaintiffs recently in In Re DePuy Orthopædics, Inc. ASR Hip Implant Products Liability Litigation, ___ F.3d ___, 2020 WL 1482384 (6th Cir. March 27, 2020).
All companies
Complete Summary Judgment in Remanded Pelvic Mesh Case
The remanded pelvic mesh case, Sherer-Smith v. C.R. Bard, Inc., was recently wiped from the docket by summary judgment. See 2020 WL 1470962 (W.D. Wis. March 26, 2020). That’s news because, except for a couple of odd-ball cases (see Gray v. C. R. Bard, Inc., 2019 WL 6521972 (S.D.W. Va. Dec. 3,
Report From the Front – The Federal Government’s Battle To Reassert Control of FCA Filings Ostensibly in its Name
We’ve long believed that False Claims Act (“FCA”) cases – particularly in the health sciences area – are out of control. Twenty-first century lawyers, and their solicitation techniques, have turned Abraham Lincoln’s Nineteenth Century law aimed at corrupt government contractors into its own form of corruption. Today’s FCA racket is complete with professional relators, deceit
On Promoting Off-Label Use II
Not too long ago we commented on the President of the United States promoting the unproven off-label use of a prescription drug, hydroxychloroquine, for treatment of COVID-19, on nationwide TV, in the presence of the Commissioner of the FDA, no less. As we pointed out in the prior post, this drug has serious potential side
The Next Personal Jurisdiction Issue for the Supreme Court
We’ve blogged several times before how the logic of the United States Supreme Court’s decision in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), dooms nationwide class actions against corporations – except in jurisdictions where they are “at home.” BMS held, essentially, that a non-resident plaintiff could not sue a non-resident
Guest Post – Is Artificial Intelligence a “Product”? The Third Circuit Says, “No.”
Today’s guest post is by Corinne Fierro, Mildred Segura, and Farah Tabibkhoei, all of Reed Smith. These three are all part of the firm’s left-coast, techno side of the product liability practice, and bring our readers a recent appellate decision that addresses the intersection of 21st Century high technology and 20th Century
Notice to Clients Monitoring Pennsylvania Dockets
The Pennsylvania Supreme Court entered an emergency COVID-19-related order on March 24, 2020 – copy here – that should be of interest to our clients who engage in removal before service (so-called “snap removal”). As we reported at the time, the Third Circuit upheld removal before service in Encompass Insurance Co. v. Stone Mansion