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Another RICOdiculous Decision

Drug & Device Law

What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co. 341 (2001). the relationship between [plaintiff] and its pharmacy benefit manager. . . Apparently, massive loss of evidence was merely a “usual and customary service” of pharmacy benefit mangers nationwide.

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The FDA and Feasible Alternative Designs

Drug & Device Law

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA 59