Drug & Device Law

AUGUST 26, 2022

After more than a month away at trial, we probably should not have picked a case that hit so close to home, so to speak. 2003) (“[C]ourts are to assist the plaintiff by allowing jurisdictional discovery unless the plaintiff’s claim is ‘clearly frivolous.’ ”).” 2014), a prescription drug case. Atrium Medical Corp. , — F.

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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 trial court granted summary judgment based on evidence that the implanting surgeon “would have used the clips in the surgery even if he had received such a warning” and thus plaintiff “could not prove the cause element of his claims.” 2003 WL 1785795, at *13 (D. Nothing about what does or does not “inform” prescribers.

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Drug & Device Law

MARCH 28, 2022

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. Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach.

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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. As the Blog noted , later cases affirmed the gatekeeping role. “The

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