Drug & Device Law

JULY 24, 2023

2019) (“ PATDC82 I ”), because the third-party payor (“TPP”) plaintiffs were allowed to misuse RICO to pursue what was essentially a garden variety inadequate warning case – that the drug Actos increased the risk of bladder cancer. 341 (2001). Takeda Pharmaceuticals Co. , 3d 1243 (9th Cir. Indeed, that’s what the label says.

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Drug & Device Law

JUNE 6, 2022

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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Drug & Device Law

FEBRUARY 11, 2024

Considering the rigorousness of this process and the due process interests of drug sponsors, Congress also mandated by statute a process for withdrawal or suspension of an FDA approval decision − a process the Fifth Circuit circumvented. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v.

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Drug & Device Law

MAY 30, 2022

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. The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. 2d 349 (2d Cir.

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Drug & Device Law

DECEMBER 9, 2022

This is the doctrine: to prevail on a failure-to-warn claim in a prescription drug or medical device case, a plaintiff must prove both that the products warnings were inadequate and that the inadequate warning proximately caused the plaintiff’s injuries. 2001), aff’d sub nom. In Brennan v. Johnson & Johnson, et al., Pfizer Inc.

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