Drug & Device Law

DECEMBER 21, 2023

Takeda Pharmaceutical Co. , Remember Riegel ( 2008+1 )? Luitpold Pharmaceuticals, Inc. Rather than examine the actual bases of those opinions, as Rule 702(b) required, Crockett waved the testimony through with the single observation that the expert claimed to have “conducted a “detailed review of the literature.”

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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

APRIL 18, 2022

The surgeon’s testimony supported two grounds for non-causation: lack of reliance, and that a warning would not have changed how the prescription product was used. Wyeth Pharmaceuticals , 471 F. 2008); Herzog v. March 30, 2021) (“Where the learned intermediary doctrine applies, the plaintiff must prove that. . .

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Drug & Device Law

FEBRUARY 20, 2023

Lederle Laboratories , 2008 WL 972657 (W. March 19, 2008) (“It is very difficult to see what else these defendants could have done” when one claimed alternative “was never licensed by the FDA” and the other “was not approved by the FDA until” nearly a decade after plaintiff’s vaccination). 1992) (plaintiff failed “to establish. . .

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Drug & Device Law

JUNE 23, 2023

All of them had very stale claims – with that injury occurring before 2008, which was seven years before the critical 2015 label change that added “reports of permanent hair loss” to the drug’s label. Plaintiff Adams’ “sworn testimony and plaintiff fact sheet” established that she blew the statute of limitations by some eight years.

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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

This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Plaintiff] has not identified any testimony from [the prescriber] that. . . Bayer HealthCare Pharmaceuticals, Inc. ,

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