A potentially landmark case regarding federal "preemption" of state law claims will be heard by the U.S. Supreme Court in the upcoming term. In November, the Court will hear arguments regarding whether a patient will be allowed to keep the approximately $6 million judgment that a Vermont jury ordered Wyeth to pay her for failing to adequately warn about the risks of one of its drugs. The case could be significant in the ongoing battle over "preemption," a doctrine that can prohibit injured consumers from suing in state court when the product that allegedly caused injury has satisfied federal standards and requirements. The threshold issue in this line of cases is whether FDA approval of a drug preempts state law claims challenging safety, efficacy or labeling. Manufacturers have long argued that the FDA's actions are the final wor d on safety and effectiveness as provided by federal statute, but many states disagree. Thus, the Supreme Court's decision is being closely monitored by industry and the plaintiff's bar. This case ultimately could determine whether injured patients will be able to sue manufacturers under state law when the allegedly offending product has already been approved by the FDA. A decision by the Court in the last term held that a lawsuit concerning injuries caused by medical devices was preempted by a 1976 federal law.
In the current case, the patient, a Vermont resident, received Phenergan, which carries the warning: "inadvertent intra-arterial injection can result in gangrene requiring amputation." The patient received the drug via "IV push." The physician administering the drug missed the vein, eventually resulting in the amputation of the patient's arm. Because Phenergan's label did not rule out administration of the drug by IV push, the patient sued, arguing that the drug should have carried a stronger warning regarding IV push administration. Wyeth argued that it could not change Phenergan's labeling to comply with Vermont law without violating federal law. A jury disagreed and awarded the patient approximately $6 million, a verdict upheld by the Vermont Supreme Court. Access the respondent's brief here and Wyeth's initial and reply briefs here and here.