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

Happy Star Wars Day. May the Fourth be with you.

If all FDA approved medicines enjoyed the preemption protection that vaccines do, the DDL product liability litigation landscape would be leaner and less nonsensical. Flores v. Merck & Co., 2022 U.S. Dist. LEXIS 46442 (D. Nev. March 16, 2022), shows why that is so.

A few years ago we did a couple of posts about the learned intermediary decision that arose from the Zimmer Nexgen Knee Implant MDL, and was subsequently affirmed by the Seventh Circuit Court of appeals.  We designated the opinion In re Zimmer Nexgen Knee Implant Products Liability Litigation, 218 F. Supp. 3d 700 (N.D.

A federal court applying Florida law has refused to dismiss fraud and misrepresentation claims brought by a patient against a medical-device manufacturer, rejecting the manufacturer’s contention that such claims are categorically barred by the learned-intermediary doctrine.

It is perhaps telling that the decision, Pirlein v. Ethicon, Inc., Med. Devices Rep. ¶ 24,799 (S.D. Fla.

We have promised ourselves that we will stream this week’s “This Is Us” episode when we finish this blog post.  We love this series beyond reason, and we dread its imminent demise, notwithstanding the title’s grammatical transgression.  (We generally condition any sort of allegiance on correct use of predicate nominatives.)  We are struck, over and