Under Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. § 314.70(c)(6)(iii)(A). Because the

Andrew Tauber
Federal Court Confirms that Anti-Vaxxers Do Not Have a Constitutional or Statutory Right to Endanger Everyone Else.
Last year we recounted a decision that denied a preliminary injunction to selfish New Mexicans who think that they have a right to endanger others by refusing to be vaccinated against the SARS-CoV-2 virus, which causes COVID-19. Specifically the court denied relief to a registered nurse who claimed that she has a right to treat…
An Offensive Application of Offensive Non-Mutual Collateral Estoppel by C.D. Cal.
Two weeks ago we reported on a case that refused to apply offensive non-mutual collateral estoppel, the doctrine that prevents a defendant from relitigating an issue that it lost in earlier litigation against a different plaintiff. Although we weren’t impressed by that decision’s analysis, its outcome was one we could endorse. Today we report on…
When Does Offensive Non-Mutual Collateral Estoppel Apply in MDLs?
Today’s post is for procedure geeks, especially those who litigate MDLs.
Offensive non-mutual collateral estoppel prevents a defendant from relitigating an issue that it lost in earlier litigation against a different plaintiff.
The issue is when offensive non-mutual collateral estoppel applies to a case that was part of an MDL. More specifically, the issue is…
Unhappy Elephant: New York’s Highest Court Holds that Animals Are Not Entitled to Writs of Habeas Corpus
Today we report on a case between Happy, an elephant, and the Bronx Zoo, where Happy has been held captive for the past 45 years. Represented by an animal-rights group, Happy filed a petition for a writ of habeas corpus, claiming that her captivity is unlawful and that she should be allowed to go to…
Washington Court of Appeals: Registering to Do Business Does Not Constitute Consent to Personal Jurisdiction
As we have previously observed, limits on personal jurisdiction matter because the outcome of litigation is heavily influenced by where a case is filed. Since the Supreme Court confirmed the narrow confines of general jurisdiction in Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011), and Daimler AG v. Bauman,…
No Personal Jurisdiction Over Component Supplier Under New York’s Long-Arm Statute
We’re pragmatic geeks. That means we love personal-jurisdiction issues. This year alone we’ve reported on personal-jurisdiction cases here, here, and here. And then yesterday we did it again. Although the decision we discussed yesterday, English v. Avon Products, Inc., — N.Y.S.3d —-, 2022 WL 1787160 (N.Y. App. 2022), was unfortunate in…
510(k) Devices, Compliance Presumptions, and the Long Shadow of Lohr
Several weeks ago, we reported on Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), in which the Third Circuit affirmed dismissal of a failure-to-warn claim because the plaintiff had failed to allege facts sufficient to overcome New Jersey’s “compliance presumption,” a statutory presumption (adopted by numerous states) under which a medical…
Applying the Helpful but Problematic New Jersey Statute Creating a Rebuttable Compliance Presumption, the Third Circuit Affirms Dismissal of a Failure-to-Warn Claim
A relatively short post about Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law.
The…
Twombly and Iqbal Taken Seriously: Express-Preemption Dismissal
Defendants love and plaintiffs hate Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009), which together stand for the proposition that to state a claim and avoid dismissal a plaintiff must allege facts that plausibly suggest that the defendant is liable. Today’s case, Poozhikala v.