October 8, 2008


FDA Drug Labeling Requirements: Floor or Ceiling?

McKenney v. Purepac Pharmaceutical Inc.

Pharmaceutical companies, attorneys, and other interested observers across the nation await the United States Supreme Court’s decision regarding federal preemption and drug labeling in Wyeth v. Levine, set for argument in November. In the meantime, however, California’s Fifth District Court of Appeals recently weighed in on the issue of the extent to which FDA regulations preempt state law claims related to drug labeling in McKenney v. Purepac Pharmaceutical Co.

In Fall 2007, Congress passed and the President signed into law the FDA Amendments Act of 2007 (FDAAA). FDAAA did not contain express guidance that would make clear whether Congress intended FDA regulations regarding drug labeling to preempt state law claims. The House Subcommittee on Health initially proposed language that expressly would have precluded FDAAA from preempting state law claims, but in its final form FDAAA omitted the proposed language.

In the absence of express preemption, courts across the nation have wrestled with the issue of whether and to what extent FDA regulations implicitly preempt state laws regarding drug labeling. Courts are called upon to determine whether FDA regulations constitute minimum standards which the states are free to enhance, or whether FDA should be held to be the best and only governmental entity equipped to balance risks and benefits of proposed drug labeling.

Essentially, the courts must determine if federal labeling requirements constitute a floor or ceiling for drug warnings. If the requirements are a floor—a minimum standard—then additional state law requirements would not inherently conflict with federal law. However, if the requirements are a ceiling—meaning the requirements are the final word on the adequacy of drug labels—then any state law requiring additional warnings would conflict with federal law and thus be preempted.

California’s Fifth District Court of Appeal Weighs In On The Debate

On September 25, 2008, the California Fifth District Appellate court weighed in on the issue of implied preemption of state law tort claims. In McKenney v. Purepac Pharmaceutical Company __ Cal. Rptr. 3d __, 2008 WL 4355425 (Cal. App. 5th Dist. Sept. 25, 2008), the appellate court analyzed whether federal preemption barred Carlyne McKenney’s state tort law claims that the label on Purepac’s generic prescription drug metoclopramide inadequately warned her of the dangers associated with the drug. Purepac contended that it could not simultaneously comply with both federal regulations and state law. The company asserted that it was not free to alter or deviate from the FDA-approved labeling.

In analyzing whether this preemption defense barred the plaintiff’s state tort claims, the court noted that federal law and regulations may preempt state law under three circumstances: when Congress expressly provided for preemption; when Congress implicitly preempted state claims by having the federal law dominate the field; or when simultaneous compliance with both federal and state law is impossible.

Here, the court noted that the FDA regulations did not expressly preempt state law claims. Likewise, it noted statements from the FDA itself indicating that the FDA did not intend to dominate the entire field. The court did recognize that, when state tort law required additional warnings on the label which would be expressly precluded by the FDA, there would then exist a conflict and the claims would be preempted. On the other hand, when compliance with FDA requirements did not specifically preclude a warning, the appellate court held that there is no conflict, and therefore no preemption.

On the facts before it, the court held that it was not clear from the complaint and other judicially noticed documents that FDA regulations expressly or impliedly preempted Purepac from warning of the alleged known risk of the generic drug in question. Reversing the lower court’s sustaining of Purepac’s demurrer to plaintiff’s fourth amended complaint, the court held that the FDA requirement that a generic drug and reference listed drug have the same label did not necessarily preempt plaintiff’s state law claim for failure to adequately warn of the risks of the generic drug.

Mc Kenney Decision Extends Ruling in Carlin

The appellate court’s decision in McKenney v. Purepac Pharmaceutical Company is an extension of an earlier ruling in Carlin v. Superior Court, 13 Cal. 4th 1104 (1996). In Carlin, the California Supreme Court held that Wilma Carlin, a prescription drug user, adequately stated causes of action based on Upjohn Company’s alleged failure to warn of known or reasonably scientifically knowable risks from its drug. The Court held that FDA regulations regarding drug labeling did not preempt state law claims for failure to warn of known or scientifically knowable risks.

United States Supreme Court Will Soon Weigh In On Federal Preemption Labeling Claims

The United States Supreme Court is expected to provide additional guidance regarding labeling requirements and federal preemption over the course of the next two months. This month, the Supreme Court will hear federal preemption arguments regarding tobacco labeling. In November, the Supreme Court will hear arguments regarding federal preemption of state law regarding prescription drug labeling in Wyeth v. Levine, Case No. 06-129.

It remains to be seen if the Supreme Court will definitively resolve preemption issues in these upcoming cases. For now, California courts appear to be resisting blanket federal preemption of state law claims by FDA-approved drug labels.