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). 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives. His testimony is thus irrelevant and inadmissible.

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Drug & Device Law

DECEMBER 27, 2022

Reliance on “animal data” – another notorious and frequent error common in unreliable expert testimony. Relying on the grossly excessive ranitidine exposure lab tests previously excluded for their bizarre results and shoddy methodologies. Peculiar methodology (not results) that is not “generally accepted.”. at *167 (quoting Glastetter v.

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Drug & Device Law

DECEMBER 9, 2022

2001), aff’d sub nom. Here, the court confronted the question directly, turning for guidance to one of our all-time favorite warnings causation decisions, Motus v. Pfizer, Inc ,196 F. 2d 984 (C.D. Pfizer Inc. Roerig Div.) 3d 659 (9th Cir. at *18 (citations omitted).

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Drug & Device Law

NOVEMBER 28, 2022

2001) (Kilburn); and Wade-Greaux v. Because the facts of [plaintiff’s] case paralleled the description of [the pseudonym] in Dr. Moline’s congressional testimony, [defendant] suspected that [she] was one of the thirty-three anonymous individuals that the article had studied. I-Flow Corp. , 2d 1092, 1119-25 (D. 3d 244 (6th Cir.

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Drug & Device Law

AUGUST 26, 2022

Instead, it looked to Pennsylvania’s ultimate requirement of proof of expert testimony to prove a prescription drug (!!!) Without deciding whether 9(b)’s heightened pleading standards apply to a negligent misrepresentation claim, the court cited 2001 and 2007 Eastern District of Pennsylvania cases for a “degree of specificity” standard.

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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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