Drug & Device Law

AUGUST 28, 2023

In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions.

FDA 52

FDA FDA Approval Doctors Production 52

Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. That’s why Buckman Co.

FDA Approval 59

FDA Approval FDA Doctors Production 59

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). But the FDA has concluded just the opposite. Without any consideration of what actual doctors did for actual patients with actual diseases, all that was proven was the maxim “garbage in, garbage out.”

Testimonials 52

Testimonials Pharmacy FDA Doctors 52