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Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

2006) – a precedential holding that the same Pennsylvania rule barring strict liability claims against prescription drugs also applied to prescription medical devices − should not be followed because the plaintiffs in Creazzo were supposedly “pro se.” Janssen Pharmaceuticals, Inc. , Medtronic, Inc. , but see Hahn v. Richter , 543 Pa.

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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. That “common and widely known side effect” of many “chemotherapy drugs,” id.

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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 3d 75 (Fla.

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Pro Se Plaintiff Tries and Fails To Plead Claims For Failure To Withdraw And Failure To Warn

Drug & Device Law

Back during the diet drug litigation, we had cases with very significant alleged injuries and a colorable argument that the label was inaccurate as to the risk of the plaintiffs’ injuries. If the drug had not been sold at the time, then it did not matter what the prescribers thought.

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On Expert “Adulteration” and “Misbranding” Opinions

Drug & Device Law

Ferring Pharmaceuticals, Inc. A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug. High on the list was Tsao v. 2018 WL 3649714 (S.D. April 19, 2018).