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). The unstated premise here was fraud on the market – an assumption that every class member always has perfect information. Plaintiffs Legal Committee , 531 U.S. You can see where this is going.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. 3d , 2023 WL 2825871 (N.D.

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59

FDA FDA Approval Testimonials Vaccine 59