Drug & Device Law

FEBRUARY 20, 2023

Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. to determine whether a proposed alternative drug would have received FDA approval.” 2003), aff’d , 810 N.Y.S.2d For physicians to prescribe such a safer drug, it must reach the market.

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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. 2003 WL 1785795, at *13 (D. One certainly doesn’t find this distinction at the Zimmer Nexgen language that Rennick cited.

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Drug & Device Law

MAY 30, 2022

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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Drug & Device Law

MARCH 28, 2022

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).

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Drug & Device Law

JUNE 13, 2023

In the “ 50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping ,” the Drug & Device Law Blog (the Best Blog on the Planet) describes West Virginia as a “gatekeeper” state because of cases reflecting adoption of the Daubert analysis of W. 2003) (citation and quotation marks omitted); see also State v.

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