The word of the day is targeted. Targeted discovery on a targeting device and a district court laser-focused on the failure to warn causation target. The end result is a decisive defense win on failure to warn. See In re Biozorb Device Prods. Liab. Litig., 1:23-cv-10599-ADB, No. 1:22-CV-11895-ADB, 2025 WL 509834 (D. Mass. Feb.
Defendant in Beavan v. Allergan U.S.A., Inc., 2014 N.J. Super. Unpub. LEXIS 2898 (N.J. App. Nov. 21, 2024) made two solid arguments for summary judgment – preemption based on the FDCA’s recall regulations and plaintiff’s lack of admissible expert testimony. The trial court rejected both. The appellate court, however, saw the merit in the
The last time we looked into Bueno v. Merck, it was anything but bueno. Taking the position that, “if there is a cause of action, there must be jurisdiction,” a misguided decision had held that a branded drug manufacturer could be haled to court under an innovator liability claim, despite the defendant having never sold anything to the plaintiff in the state. See Bueno v. Merck & Co., 626 F. Supp.3d 1154 (S.D. Cal. 2022). That decision made our bottom ten list in in 2022.
Two years later – and who knows how many $$$ spent in the interim – the result on the merits was incomparably better. All claims dismissed with prejudice for a variety of excellent reasons. Bueno v. Merck & Co., ___ F. Supp.3d ___, 2024 WL 3974754 (S.D. Cal. Aug. 27, 2024). Ditto for a companion case decided the same day. See Parker v. Merck & Co., 2024 WL 3974764 (S.D. Cal. Aug. 27, 2024).
Here’s what happened.Continue Reading Bueno and More Bueno
We posted earlier this year about the failure to warn causation decision from the California Supreme Court in Himes v. Somatics, 549 P.3d 916 (Cal. 2024), and the potential parade of horribles that might ensue. Here comes the grand marshal of the parade.Continue Reading California District Court Punts on Learned Intermediary Causation Post-Himes
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