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

Maybe we have been doing this too long.  Or maybe, like the prequels, spinoffs, and reboots that are so prevalent among streaming entertainment options, there is just a lot of repetition.  In serial product liability cases, we hope that repetition leads to consistency of results or at least predictable rules of the game.  Consider the

This post is from the non-Reed Smith side of the blog only.

Mismatch your socks – you’re bold.  Mismatch your shoes – you’re frazzled.  Mismatch plates on a dining table – your creating ambience.  Mismatch your pizza with pineapple – well don’t knock it until you’ve tried it.  Treat the law like it’s your socks

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

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.

Multidistrict litigations are big piles of wrong. Wrong incentives invite the wrong cases, the wrong rulings, and the wrong results. Plaintiff lawyers park weak cases in MDLs, counting on ultimately collecting money for cases into which they invested virtually no work. Courts encourage that dysfunctional conduct by doing everything possible to force settlements, even if