In re Deepwater Horizon Belo Cases, — F.4th –, 2024 WL 4522690 (11th Cir. Oct. 18, 2024), is not a drug or device case. It is the Eleventh Circuit’s review of the Northern District of Florida’s exclusion of the plaintiffs’ general causation experts in a toxic tort exposure case arising from the
We receive emails from readers fairly regularly. They are usually from other attorneys, sometimes friends or acquaintances sharing their points of view or expanding on things that we may have underplayed or overlooked. Although we don’t spend much time (or really any time) trying to predict when we might hear from others, we have noticed
Anybody who has litigated a prescription medical product liability case knows about the learned intermediary rule, which is now followed in all fifty states. Just as prescription medical product warnings are routed through prescribing physicians, so necessarily is the causation aspect of such warnings. The details vary from state to state, but in all learned intermediary cases, correcting an allegedly inadequate warning must cause the learned intermediary physician to do something differently, and that “something” must prevent the plaintiff’s claimed injury.
At the same time, the Supreme Court’s TwIqbal decisions require that plaintiffs plead facts to support the elements of their causes of action. From the defense perspective, that means that complaints against our clients should be required to plead (at minimum): (1) the identity of the relevant prescriber, (2) what that prescriber would have done differently with a “better” warning, and (3) how that difference would have prevented the claimed harm. We don’t ask for a lot, but at least one fact supporting these essential causal elements should certainly be mandatory.Continue Reading Using TwIqbal To Enforce Warning Causation in Learned Intermediary Cases
In an earlier post, we discussed how the FDA, for over twenty years, from mid-1997 through mid-2019, created and operated an “alternative summary reporting (“ASR”) system for many (but not all) medical device-related adverse events. In June 2019 the FDA “formally ended” the ASR program, “revoked all . . . exemptions,” and opened “all” ASR reporting data to the public through “legacy files.”
One quirk of ASR reports is that they could not be included on the FDA’s public “MAUDE” (Manufacturer and User Facility Device Experience) database of medical device adverse events, because the FDA required an incompatible format for ASR submissions. Predictably, plaintiffs in any litigation where the defendant’s participation in the FDA ASR program was relevant started screaming about “coverups” despite the FDA itself receiving all the adverse report data that it wanted, in a form that made it easier for the Agency to use. Plaintiffs doubled down on already suspect “failure to report” claims. They’ve been claiming that, under state tort law, device manufacturers had a “duty” not only to comply with FDA reporting requirements, but to do so in the most public manner possible, even when the FDA preferred streamlined ASR reporting.Continue Reading Cutting Through the FDA Alternative Summary Reporting Fog
Speaking of the United States’ newly ratified Constitution, Benjamin Franklin wrote in 1789: “in this world nothing can be said to be certain, except death and taxes.” We would like to add to this list another certainty—summary judgment in a drug case without expert proof of general causation. So, when the court excluded all of
One of those experts was plaintiff himself—an emergency room doctor with a law degree. We all know what they say about lawyers who represent themselves. And that applies equally to doctors who try to act as their own causation experts. Add to that destructive testing after telling defendant no product existed and four more unreliable
This is our second go round with Vardouniotis v. Pfizer, Inc., Case No. 152029/2019 (N.Y. Sup.). When we posted about the court’s decision on defendant’s motion to dismiss, we were resigned to shrug our shoulders and accept that “nothing’s perfect.” It’s two years later and we’re still shrugging.
After the court allowed plaintiff’s negligence; gross
The California Supreme Court issued its widely anticipated opinion on the learned intermediary rule the other day, and the opinion is worth the wait. Based on the oral argument (which we reported on here), we did not expect the Supreme Court to enact a fundamental change to the learned intermediary doctrine, and the Court
This post is from the non-Reed Smith, non-Dechert, and non-Holland & Knight side of the blog.
We have covered the ranitidine litigation before. As we explained in prior posts (including here and here), plaintiffs allege that ranitidine, the active ingredient in Zantac, breaks down into N-Nitrosodimethylamine (“NDMA”), particularly at higher temperatures. NDMA is a known carcinogen and a ubiquitous substance present in the environment and in all manner of foods including bacon, beer, and cheese. Readers will remember that in a sweeping, 341-page opinion, the MDL court cut the head off the federal Zantac litigation by excluding plaintiffs’ experts. But other parts of the snake keep slithering. Continue Reading Delaware Zantac Court Fails to Keep the Gate