Search heeding presumption

Legal problems are often multi-faceted.  Turned one way, the problem looks like one issue.  Turn it around, and a different issue glimmers in your eye.

For example, in Saulsby v. Amphastar Pharm., Inc., __ S.E.2d ___, 2025 N.C. App. LEXIS 420, 2025 WL 1812450 (N.C. App. July 2, 2025), the North Carolina Court of…

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.

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

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

It’s that time of year again – time to review drug and medical device product liability litigation during 2022 and select the year’s ten worst decisions.  Frankly, it’s not that hard to do – they reek to high heaven, so they are pretty easy to find.  What’s harder is finding the motivation to write about decisions that we find profoundly distasteful for one reason or another.  It’s fun to write about wins, but not about losses, so watch for decisions we might not have addressed previously.Continue Reading The Agony of Defeat -The Ten Worst Prescription Drug/Medical Device Decisions of 2022

To anyone who needs a few more CLE hours before the end of the 2022, we wanted to let you know that sessions from Reed Smith’s recent Life Sciences CLE Week are now available on demand. Here are descriptions of the topics, and registration links.

The Ebb and Flow of the Law – A Year…

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.
Learn more about this book