Eighth Circuit Allows Proposed Class Action for Drug Manufacturing Defects – LeFaivre v. KV Pharmaceutical et al.

By October 12, 2011 July 18th, 2019 Dangerous Drugs

As a dangerous drug attorney in St. Louis, I have followed the trials and tribulations of local pharmaceutical company KV Pharmaceutical. KV and its subsidiaries, Ethex Corp. and Ther-Rx Corp., were heavily disciplined and even shut down for major manufacturing defects that posed a risk to consumers, such as oversized pills that could create an accidental painkiller overdose. That situation led to several lawsuits, including LeFaivre v. KV Pharmaceutical et al, a proposed class action that found its way to the Eighth U.S. Circuit Court of Appeals. LeFaivre did not claim any injuries, but rather, breach of implied warranty of merchantability and violation of the Missouri Merchantability Practices Act. The companies argued that because the claims stem from federal regulatory compliance, they were federally preempted; but the Eighth Circuit ultimately disagreed.
The drug underlying the dispute is the generic metoprolol succinate ER, for treating high blood pressure. LeFaivre purchased and used it several times in his home state of Rhode Island. In 2009, KV signed a consent decree and recalled many months’ worth of drugs to settle FDA claims that it had violated manufacturing standards. LeFaivre sued KV in Missouri federal court, alleging that KV sold “unmerchantable” drugs and failed to disclose that the drug was adulterated as a matter of federal law. He sought damages for the difference between the price of drugs that were up to standards and the price of the adulterated drugs. KV moved to dismiss, arguing that because LeFaivre’s claims rested on violations of FDA law, they were essentially an attempt to privately enforce federal drug laws, a right that does not exist. The federal district court agreed and dismissed the case. LeFaivre appealed to the Eighth Circuit.
That court reversed, finding that federal preemption did not apply. Any preemption would be implied preemption, the court said, since there is no express preemption in the relevant statute. And on implied preemption, the Eighth was able to rely on the Supreme Court’s recent ruling in Wyeth v. Levine, which found express Congressional intent not to preempt state laws. The appeals court found that the federal district court was wrong when it relied on the 2001 U.S. Supreme Court ruling in Buckman Co. v. Plaintiffs’ Legal Committee. That case sought to hold a company responsible for making fraudulent representations to the FDA about another company’s products, but the Supreme Court ruled that the claims were preempted by federal law. A concurrence in that case specifically distinguished its facts, which included no FDA enforcement action, from a hypothetical case in which the FDA did take enforcement action and a plaintiff brought state-law claims on the same issues afterward. This is basically that hypothetical case, the Eighth said. Furthermore, Buckman concerned fraud on the FDA, whereas this case alleges fraud against consumers. Thus, the Eighth reversed the dismissal and sent the case back to district court.
As a defective drug lawyer, I applaud the Eighth Circuit for giving this plaintiff a chance to prove his case. As the plaintiff argued, a contrary ruling would leave people who have suffered economic injuries from dangerous drugs without a legal recourse. This may seem like a small matter compared to people who have suffered serious health consequence or even death. But as a pharmaceutical liability attorney, I know those injuries and illnesses often go hand in hand with serious financial problems. Someone who develops even a mild chronic condition can expect medical bills for a lifetime. And even those who suffered no health injury should have a remedy against a manufacturer that intentionally deceived them.


If you or someone in your family suffered serious health consequences after taking a drug you thought you could trust, you should call Carey, Danis & Lowe to discuss how we can help. For a free consultation, you can send us a message online or call 1-877-678-3400 today.
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