Term: 2007
Docket: 06-1498
Warner-lambert Co., Llc, Et Al. v. Kimberly Kent Et Al.
- Pro
06-1498 WARNER-LAMBERT CO. V. KENT DECISION BELOW: 467 F3d 85 CHIEF JUSTICE ROBERTS TOOK NO PART EXPEDITED BRIEFING SCHEDULE CERT. GRANTED 9/25/2007 QUESTION PRESENTED: 1. Whether, under the conflict preemption principles in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), federal law preempts state law to the extent that it requires the fact-finder to determine whether the defendant committed fraud on a federal agency that impacted the agency’s product approval, where the agency— which is authorized by Congress to investigate and determine fraud—has not found any such fraud, and thus—as in Buckman—the state requirement would interfere with the agency’s critical functions. 2. Whether, under the conflict preemption principles in Buckman, federal law preempts the provision in a Michigan statute that allows a product liability claim to be maintained against a manufacturer of an FDA approved drug where, without an FDA finding of fraud on that agency, the fact-finder is required to make a finding under state law as to whether the manufacturer committed fraud-on-the-FDA and whether, in the absence of that fraud, the FDA would not have approved the drug. LOWER COURT CASE NUMBER: 05-1705, 05-1743, 05-1745
In the case of Warner-Lambert Co., LLC, et al. v. Kimberly Kent et al., 2007, the U.S Supreme Court was asked to decide whether federal law preempts state-law claims based on allegations that a drug manufacturer made false statements to the Food and Drug Administration (FDA) during a new-drug application process. The plaintiffs alleged that Warner-Lambert's predecessor had fraudulently represented information about its diabetes medication Rezulin’s safety profile in order to secure FDA approval for marketing it. They sought damages under Michigan law which allows such lawsuits if evidence of fraud is presented against FDA regulations. The court split evenly 4-4 (Justice Roberts took no part), thus affirming lower court rulings without setting any national precedent or providing an opinion explaining their reasoning behind this decision.
In the dissenting opinion for Warner-Lambert Co., LLC, et al. v. Kimberly Kent et al., Justice John Paul Stevens argued that federal law does not preempt state law claims based on fraud-on-the-FDA theories. He contended that the majority's interpretation of FDA regulations was overly broad and failed to consider Congress' intent in enacting those laws. According to him, there is no evidence that Congress intended to shield drug manufacturers from liability under state tort laws when they knowingly provide false information to the FDA or fail to disclose adverse effects of their drugs as required by federal law. Therefore, he believed consumers should be allowed to sue drug companies under state law for injuries caused by such fraudulent conduct.
