The Supreme Court on Wednesday issued its decision in the much-watched case of Wyeth v. Levine—the underlying lawsuit that inspired it is based on a fairly simple idea: Diana Levine was severely injured when she was given Wyeth’s Phenergan by a physician’s assistant who was attempting to inject the drug directly into the vein but instead either got it into the artery or injected it in such a way that it leaked out of the vein (”perivascular extravasation”) and mixed with arterial blood.
The Court held that the labeling approval by the FDA does not preempt state laws or shield companies from legal damages as part of liability claims.
From the opinion, the Supreme Court noted what many saw as a practical reality about the FDA:
"The [FDA] lacks the resources needed to accomplish its large and complex mission . . . .There is widespread agreement that resources for post marketing drug safety work are especially inadequate and that resource limitations have hobbled the agency’s ability to improve and expand this essential component of its mission”); GAO, Drug Safety: Improvement Needed inFDA’s Post market Decision-making and Oversight Process 5 (GAO–06–402, 2006), http://www.gao.gov/new.items/d06402.pdf."
"The FDA lacks a clear and effective process for making decisions about, and providing management oversight of, post market safety issues."