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JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

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Particularly in economic loss class actions, we occasionally have to deal with claims involving the Magnuson Moss Warranty Act (“MMWA”).  Thus, we have covered MMWA issues before.  Here’s another one.  In In Re Hill’s Pet Nutrition, Inc., Dog Food Products Liability Litigation, 2022 WL 1641291 (D. Kan. May 24, 2022), the court held…

Summary judgment was affirmed in Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues.  Vesoulis was a one-off suit under Louisiana law against the manufacturer of a pre-market (“PMA”)-approved medical device and the implanting – or, more properly, explanting – surgeon.  Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility.  Id. at *1.

The device being PMA approved, one might think that the chief defense was express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  It wasn’t.  Rather, plaintiff’s central warning claim fell under the Louisiana product liability statute (“LPLA”) because the surgeon was “experienced.”  Id. at *2.  Instead the case turned on implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). Continue Reading FDCA-Based Negligence Per Se & Informed Consent Don’t Mix

An amendment to the FDCA, called the “Verifying Accurate Leading-edge IVCT Development Act” – or VALID Act (cute) for short – has been wending its way through Congress.  It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on…

We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.”  21 C.F.R. §801.109(c).  That requirement comes…

Confident prescribing physicians and implanting surgeons are the best “learned” intermediaries.  They’re experienced at what they do and aren’t intimidated by plaintiffs’ counsel and their threats of malpractice claims if they don’t testify the way plaintiffs want them to.  Confident learned intermediaries stand by their medical decisions.  Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different.  Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases.Continue Reading Confident Learned Intermediaries Defeat Warning Causation

There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.  The law presumes that licensed doctors know what they are doing.  That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need.  As part of that process, such physicians necessarily also evaluate what risks they should tell – and not tell − their patients.

One consequence of a physician’s presumed medical competence is that a learned intermediary is within his/her rights to disregard a manufacturer’s warning altogether, to decide that a particular risk was not severe enough to make a difference, or to conclude that such a risk did not exist or was not material in the context of a particular patient’s medical needs.  In all of these situations, the prescriber’s independent evaluation of what risks to credit, which to ignore, and which to omit in counseling patients breaks the causal chain of , entitling a manufacturer defendant to judgment on a warning claim concerning such risks.  This scenario was the “third hypothetical” in our “Learned Intermediary Rule 201” post back in 2008.Continue Reading Unimpressed Learned Intermediaries Defeat Warning Causation

Not too long ago we blogged about the value that the Product Liability Advisory Council (“PLAC”) brings to the table – particularly to drug and device manufacturers faced with relentless product liability claims.  For the third time, we urged our corporate readers to support PLAC’s pro-defense advocacy by joining and becoming members.

Still not…

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