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We write a lot about the learned intermediary rule. There are 50 state surveys and  summaries of helpful decisions, as well as numerous posts on state-specific decisions. We tracked the development of the rule in jurisdictions like West Virginia and Arizona, and we’ve generally been pleased to report positive developments. At the end of 2024, though, we flagged the Himes case from California as one of the ten worst decisions of the year based on its novel approach to warnings causation.  Given our criticisms of Himes, we found it both bizarre and troubling to see the case cited recently by an MDL court in Massachusetts applying Pennsylvania law. Our colleagues in the plaintiffs’ bar are clearly advocating to expand Himes into other jurisdictions, and the defense bar should be ready to counter those efforts.Continue Reading Himes Makes a Sneak Appearance on the East Coast

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May the holidays treat you well.  We trust that none of you got burnt by any of the many hot things loitering around this time of year: yule logs, candles, figgy puddings, overloaded electrical outlets, and Aunt Sally’s line dancing after she downs a third eggnog. 

Today’s case is not exactly hot, but it’s got

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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

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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

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Our prior TwIqbal post concerning learned intermediary causation was well received by our readers, so we’re back with a second, related (and, as it turned out, even longer) discussion of pleading in prescription medical product warning litigation.

In addition to pleading causation, a product liability plaintiff alleging an inadequate warning must plead how the warning was inadequate.  Sounds rather obvious, but never underestimate the capacity of plaintiffs in our sandbox for failing to plead their cases.  The amount of precedent bouncing lazy plaintiffs for not bothering to allege what (they claim) is wrong with prescription medical product  warnings is surprisingly (or maybe not) extensive.Continue Reading Using TwIqbal To Require Plaintiffs To Identify Claimed Warning Inadequacy

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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

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In Clemens v. DaimlerChrysler Corp., 534 F.3d 1017 (9th Cir. 2008), the court, applying California law, correctly “decline[d plaintiff’s] invitation to create a new exception” to that state’s privity requirement “that would permit [plaintiff’s] action to proceed.”  Id. at 1023-24.  “[A] federal court sitting in diversity is not free to create new exceptions” to state law limiting liability.  Id. at 1024 (citing Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).  D&Z held, as we’ve discussed many times:

A federal court in a diversity case is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

423 U.S. at 4.  And the Supreme Court has kept on saying this.  Erie principles prohibit “federal judges” from “displac[ing] the state law that would ordinarily govern with their own rules.”  Boyle v. United Technologies Corp., 487 U.S. 500, 517 (1988).  “[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.”  Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).

But when updating the learned intermediary section of his treatise, Bexis came across a peculiar MDL holding, that because a defendant supposedly “cite[d] no cases” for the proposition “that the learned intermediary doctrine should apply to Plaintiffs’ . . . consumer protection claims” under the laws of California, Maryland, Illinois, and Florida, then “the learned intermediary doctrine should not apply” to claims brought by plaintiffs in any of these states.  In re Natera Prenatal Testing Litigation, 664 F. Supp.3d 995, 1007-08 (N.D. Cal. 2023).  The decision did not cite any precedent from any of these states (not even a trial court decision) affirmatively creating any exception to the learned intermediary rule for consumer fraud claims.  Id.Continue Reading Debunking Another Stunningly Wrong MDL Expansion of Liability