The Supreme Court of the United States recently announced its ruling in the Wyeth v. Levine case. The principal question before the Court was whether FDA approval of a drug’s label overrides (or preempts) state-law claims of inadequate warning. The argument made by the drug company was that it would be impossible to comply with both state and federal laws if the state’s law provides for a stronger warning label than the FDA labeling regulation. The Supreme Court rightly rejected that argument, finding that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” By issuing this ruling, the Court will allow consumers more protection from drug injuries that could have been prevented if the drug label had included proper warnings.
In this case, Diane Levine, a professional musician being treated for migraine headaches was injected with Phenergan, a drug manufactured by Wyeth. Because of the direct IV administration (IV push) of the drug, Ms. Levine’s artery in her arm died, ultimately resulting in amputation of that arm. Wyeth was aware of the dangers of the IV push method for administering Phenergan, but never included any warnings to prohibit IV push administration on the label. The FDA had not determined whether the label should have included the warning. However, the FDA’s labeling rules require that a prescription drug manufacturer change warning labels as soon as there is reasonable evidence that the drug causes adverse reactions without waiting for FDA approval of the label change.
Government regulations are intended to set minimum safety standards, but cannot guarantee safety. The preamble of regulations was intended to define the agency’s interpretation. Beginning in 2005, Federal agencies started adding to the preamble of regulations without Congressional approval. With these additions, the agencies claimed that federal standards overrule any state safety standards and that state tort claims should be discarded. By adding preemption language to the agency preamble, the agencies bypassed Congress in determining if or when state law should be overruled. In 2007, however, Congress passed the Food and Drug Administration Act of 2007 (FDAAA), forcing the FDA to require drug manufacturers to update their labels when the manufacturers become aware of potential hazards.
If you or a family member has been injured as a result of a drug error or other product defect, please contact us on-line at Regan Zambri & Long or call us at (202) 753-4272 for a free consultation.