Drug & Device Law

JULY 24, 2023

The drug is still on the market, and it has other risks that the FDA has found significantly more serious – requiring a boxed warning – than a three-one hundredths-of one-percent (0.0003) increase in absolute incidence of bladder cancer. But the FDA has concluded just the opposite. PATDC82 I , 943 F.3d 3d at 1251.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

FEBRUARY 16, 2023

Plaintiffs claimed that “surgical treatments that do not use [bone] screws should be considered alternative designs,” and lost. The problem with this argument is that it really takes issue with the choice of treatment made by [plaintiff’s] physician, not with a specific fault of the [bone] screws sold by [the defendant]. 3d 760 (Tex.

FDA 59

FDA Production FDA Approval Treatment 59

Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp.

Production 72

Production FDA Approval Packaging Doctors 72