Learned Intermediary

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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

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On its face, Osos v. Nuvasive, Inc., 2024 WL 3585092 (E.D. Mich. July 30, 2024), is a fairly routine medical implant product liability lawsuit, involving allegations of metallosis that have already been around the block quite a few times in hip implant cases.  Osos involves a somewhat different device, but the legal principles are no different.

But Osos involves Michigan law, and Michigan (as we first mentioned at the end of last year, and discussed more thoroughly here) only recently repealed a longstanding conclusive presumption of non-defectiveness based on FDA drug approvals.  That presumption, which “functionally foreclosed” most product liability claims against, such products, White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023, 1029 (W.D. Mich. 2008), undoubtedly reduced litigation by Michigan plaintiffs.  See Our “Michigan Diaspora” post.  The repeal will equally undoubtedly cause Michigan prescription medical product litigation to rebound.Continue Reading Possible Learned Intermediary Showdown in Michigan

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We have often characterized judicial options as mixed bags, and a recent example of such a mixed bag can be found in Muldoon v. DePuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 130020 (N.D. Cal. July 23, 2024). The plaintiff claimed injuries from a ceramic-on-metal hip implant.  He alleged that friction and wear caused the…

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Smith v. Angiodynamics, Inc., 2024 U.S. Dist. LEXIS 73561 (M.D. Alabama April 23, 2024), offers the veritable mixed bag of rulings. The plaintiff alleged that an implanted vascular device fractured, resulting in pieces of the device migrating to the plaintiff’s heart. The plaintiff underwent surgery to remove the fragments.  The plaintiff’s lawsuit included claims…

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We observed oral argument the other day before the California Supreme Court in Himes v. Somatics, a case that places California’s learned intermediary doctrine squarely in the spotlight.  A learned intermediary case before the California Supreme Court?  For your ever-vigilant DDL bloggers, that is like Thanksgiving and Christmas wrapped into one! 

Who will be…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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