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Warner-Lambert Co. v. Kent

Issues

1.� According to the conflict-of-laws standard established in Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), does federal law preempt state law that requires a fact-finder to determine the validity of allegations of fraud-based federal agency product approval, if the agency has not detected fraud and state-court determination of the issue would thus intrude upon the agency's congressionally-mandated responsibilities?

2.� Under Buckman, is a Michigan provision permitting product liability suits against manufacturers of FDA-approved drugs only if the approval was premised on fraudulent dealings with the FDA preempted by federal law, in that it requires the state court to determine whether the fraud occurred and whether FDA approval depended upon such fraud?

Court below

United States Court of Appeals for the Second Circuit

Under Michigan law, individuals may bring personal injury suits against manufacturers of FDA-approved prescription drugs only if the plaintiffs can show that FDA approval depended on fraudulent submission or withholding of information. 27 Michigan residents sued Warner-Lambert Co., claiming personal injury arising from using Rezulin, Warner-Lambert's FDA-approved drug for diabetes treatment. Warner-Lambert argues that Michigan law is preempted by federal law because permitting state courts to second-guess the FDA's product-approval and fraud-detection processes interferes with the agency's essential functions and promotes regulatory uncertainty. The Michigan plaintiffs respond that federal preemption does not apply to traditional state tort claims. The decision in this case will clarify the scope of FDA autonomy in policing the drug-approval process and plaintiffs' freedom to assert state tort claims in areas regulated by federal entities.

Questions as Framed for the Court by the Parties

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.

In 1996, Warner-Lambert Co., a pharmaceutical manufacturer now owned by Pfizer Inc., sought federal Food and Drug Administration ("FDA") approval of Rezulin (troglitazone), a prescription drug intended to treat type 2 diabetes mellitus. Brief of Petitioners&nb

Additional Resources

American Journal of Law and Medicine: Medical Devices: Food, Drug, and Cosmetic Act Preempts State Law Fraud Claims- Buckman Co. v. Plaintiff's Legal Comm.
Reed Smith: Supreme Court's Two Fraud-On-The-FDA Cases Have Dramatically Different Reasoning
LII Law about . . . Food and Drug Law
LII Law about . . . Administrative Law

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