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Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are. While we know that a late-breaking holiday horror, such as T.H.

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Ruling On Motion To Dismiss In A Pennsylvania (Prescription) Device Case Takes Us Back

Drug & Device Law

On appeal, the plaintiff was allowed to carve out a previously unrecognized claim for what is generously called “negligent design” but is more accurately called “negligent failure to withdraw a legally marketed prescription medical product.” (We will skip the massive preemption issues with such a claim, but feel free to peruse some posts.)

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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” Plaintiff] has not identified any testimony from [the prescriber] that. . .

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The FDA and Feasible Alternative Designs

Drug & Device Law

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

FDA 59
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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d

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No Expert Do-Overs

Drug & Device Law

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” Fru-Con Inc. , 3d 734 (7th Cir. at 743 (citation and quotation marks omitted).

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Guest Post – Defendant Pitches A Shut Out And Hits A Home Run In Securing Summary Judgment In A Fosamax Case

Drug & Device Law

Though the Redbirds are having a rough season, few sports franchises have enjoyed such sustained periods of excellence and perennial playoff contention , a laudable accomplishment for a midsized market team without the seemingly bottomless pockets of the New York and Los Angeles teams. at *3 (internal quotation marks and citations omitted).