In its recent ruling the U.S. Supreme Court ruled that premarket approval from the Food & Drug Administration (FDA) does not preempt pharmaceutical companies from being held liable when their drug fails to meet state standards. In Wyeth v. Levine the court held that drug manufacturers can be sued in state courts even when they follow the rules and standards set out by the FDA.
Wyeth v. Levine involves a female, Vermont musician who lost part of her right arm after Wyeth’s drug Phenergan was injected into one of her arteries. The drug’s FDA-approved warning label warned against administering the drug this way, but did not prohibit it.
Wyeth argued that they were not required to change their labels to comply with Vermont regulations and that meeting the federal standards was enough. Levine argued that she was able to bring a liability claim under Vermont law even though Wyeth complied with federal standards.
The key issue of the case was whether or not Levine’s claim was preempted since Wyeth met the federal standards. The Supreme Court ruled that the case was not preempted and that Levine is able to bring a claim under Vermont law.
Legal and medical practitioners have been keeping a close eye on Wyeth and several lawyers and law associations. Prior to the court’s decision several physicians independently advised the court on their views of the FDA’s approval process and whether it adequately protected patients.
The legal community was interested to see if Wyeth went the same way as the Supreme Court’s recent decision in Riegel v. Medtronic, Inc. in which they held that FDA approval preempted medical devices from liability under state standards. Congress is currently working to soften the blow of the Riegel decision and restore the rights of patients to sue under state law.
The Wyeth case is a win for patients’ rights and hopefully marks a new trend in FDA preemption cases of putting patients first.
Kreisman Law Offices has been handling Illinois product liability and pharmaceutical litigation for over 30 years, serving Chicago and its surrounding areas such as Evanston, Oak Park, and Tinley Park.