Warnings

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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

Photo of Eric Alexander

Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”  In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions.  In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support…

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We do not care much about car racing.  Sure, we have seen some parts of some races on television, had toy racecars in our remote youth, and have craned our necks to see a few fancy “street legal” versions zooming past.  However, we have never attended a race in person and do not follow any…

Photo of Andrew Tauber

A relatively short post about Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law.

The…

Photo of Steven Boranian

The Ninth Circuit has certified a question to the California Supreme Court on the learned intermediary doctrine that immediately caught our attention:  In a failure-to-warn claim against a prescription medical product manufacturer, is the plaintiff required to show that a stronger warning would have altered the physician’s decision to prescribe the product?  Or can the…

Photo of Rachel B. Weil

For the first time in two years, we write from the confines of our office in downtown Philadelphia.  While we loved the full-time “work from home” regime, we have fondly re-embraced the near-forgotten view from our 30th-floor window, along with our Dancing Barney doll, our RBG action figure, and our solar-powered effigy of…

Photo of Eric Alexander

In the coming weeks, there are sure to be many articles looking at what Judge Brown Jackson has written and what that might suggest about the future jurisprudence of the United States Supreme Court if she is confirmed.  We will not predict what will happen in confirmation.  We will, however, weigh in on what Judge…

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If the concept behind Multidistrict Litigations is centralized, efficient management of common issues in large numbers of lawsuits, with remand of trial-ready cases, then MDLs are less than successful on those grounds, and certainly not successful enough to justify the asymmetric discovery and bad rulings (or nonrulings) that come as part and parcel of the…

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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