This week, as the US Supreme Court hears the case of Wyeth v. Levine, centered around the FDA’s continued approval of the Wyeth migraine drug Phenergan for intravenous use via the IV push method, despite the drug’s tendency to cause gangrene when administered using this particular method (this is what happened to plaintiff Diana Levine), attorneys all over the country are keeping a keen eye on the discussion surrounding issues of preemption.
Ultimately, the question the Supreme Court will decide is whether or not Wyeth should be liable for Levine’s gangrene and subsequent arm amputation because the company knew of the risks of gangrene from the IV push method, and nevertheless marketed the drug to be used this way. Along the road to this final decision, however, are the many questions surrounding the FDA’s role in the approval and labeling of Phenergan. The FDA has ostensibly known about the drug’s gangrene risks for many years, and despite the over 50 amputations that have resulted from the IV push method of administration, has continued to approve the drug for IV push use, including only a mild warning on the label to advise doctors of the risk. (Because Wyeth has never been remiss in reporting incidents of gangrene from Phenergan via IV push, this is not the kind of Merck/Vioxx-type case in which a drug company deliberately withheld risks from the FDA.)
Given that a Vermont court awarded $7.4 million in damages to Levine on the basis of her argument that Phenergan’s label did not adequately address the gangrene risks, and the Supreme Court may find that the FDA, not Wyeth, is ultimately responsible for the nature of the labeling—having decided after risk-benefit analyses that the risk of gangrene was not sufficient to ban the IV push method of Phenergan—the apparent contradiction between state and federal law must be resolved. If the Supreme Court sides with Wyeth, the preemption victory will certainly take states’ rights down a notch. But since we will soon have a new president in the White House who will likely appoint new justices to the Supreme Court, will any kind of preemption decision made now just be overturned later?
To answer these questions and provide an in-depth analysis of the preemption matter at hand, Mike Ferrara of the Ferrara Law Firm and James Beck of Dechert LLP met on the Legal Talk Network this week to discuss the potential impact of Wyeth v. Levine on the future of our legal landscape. Click here to listen to their commentary online, or visit the Ferrara Law Firm.