A class action lawsuit against KV Pharmaceutical Co. is being allowed to go forward thanks to a decision by the 8th Circuit Court of Appeals. The lawsuit claims that Missouri-based KV Pharmaceutical put a defective drug on the market, causing economic damages to consumers.
In March 2009, Ethex Corp., a division of KV, stipulated in a federal consent decree that it had not used proper quality control procedures when making the hypertension medicine, Metoprolol Succinate ER, and that some of its tablets may have been oversized and delivered higher than labeled doses. The company also issued a recall for the tablets.
The suit was filed in April 2009 on behalf of Allen Lefaivre, a resident of Rhode Island, and other consumers of Metoprolol Succinate ER made by Ethex. According to the complaint, Lefaivre had a prescription for the drug, which he purchased several times at retail pharmacies in Rhode Island. The defective drug lawsuit, which sought economic damages for purchasing the medicine, was filed under Missouri’s Merchantability Practices Act, which deals with fraud and deceptive business practices.
A federal district judge in St. Louis, Missouri had held that Lefaivre’s state claims were preempted by federal law because it was based on violations of federal law. The lower court said allowing the suit to go forward would interfere with the U.S. Food and Drug Administration’s (FDA) authority to regulate the manufacture and sale of prescription drugs.
In an appeal to the 8th Circuit, Lefaivre’s lawyers argued that the lower court’s decision to bar the lawsuit would leave purchasers of the defective drug without a legal remedy for their economic injuries.
A three-judge panel of the 8th Circuit ruled in Lefaivre’s favor, citing, among other things the U.S. Supreme Court’s Wyeth vs. Levine decision , and writing that the High Court’s comments regarding drugs and drug labeling “strongly imply that field preemption does not apply in the present case.”
“Specifically, in relating the history of federal regulation of drugs and drug labeling, the Court recognized that when Congress first enacted the Federal Food and Drugs Act, Congress ‘supplemented the protection for consumers already proved by state regulation and common-law liability,'” the panel said. “Furthermore, when Congress enacted an express preemption provision for medical devices, it declined to do so for prescription drugs. . . . Nor has Congress ever provided a federal remedy for consumers harmed by ineffective drugs.”