Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , 341 (2001). Takeda Pharmaceutical Co. , 3d 1243 (9th Cir. Plaintiffs Legal Committee , 531 U.S.

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Drug & Device Law

DECEMBER 27, 2022

Reliance on “animal data” – another notorious and frequent error common in unreliable expert testimony. Novartis Pharmaceuticals Corp. , Relying on the grossly excessive ranitidine exposure lab tests previously excluded for their bizarre results and shoddy methodologies. at *167 (quoting Glastetter v. 3d 986, 991 (8th Cir.

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Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

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Drug & Device Law

FEBRUARY 20, 2023

151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. His testimony is thus irrelevant and inadmissible. Ethicon, Inc. ,

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Drug & Device Law

FEBRUARY 11, 2024

Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court: The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations. Buckman Co.

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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

MAY 30, 2022

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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