Drug & Device Law

JULY 24, 2023

What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co. 341 (2001). Second, as for superiority, PATDC82 II admitted that a class trial would face “enormous logistical hurdles,” but nonetheless found a nationwide class action “superior.” Plaintiffs Legal Committee , 531 U.S.

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Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

MARCH 31, 2022

In other words, the generic manufacturers are not allowed to change the FDA-approved label. Nor was a mere trial court free to invent new causes of action. “[I]t is not this Court’s role to adopt novel causes of action. 2001) (“irrespective of the theory of recovery. . . E.g. , Ford Motor Co. 2d 362, 370 (Md.

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Government Production FDA Approval FDA 52

Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. The court also assumed that physicians naturally would prescribe the “newer” TAF once the FDA approved it. at *48-*50.

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FDA Approval Drugs Production FDA 105