Pharmacy Law: State Failure-to-Warn Claims Preempted by Approved Labeling?

NOVEMBER 01, 2007
Joseph L. Fink III, BSPharm, JD

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.

Issue of the Case

When a manufacturer has submitted the draft labeling (package insert) to accompany a new product that it proposes to market to the FDA for approval and it has secured that approval, does the fact that the FDA approved the wording about warnings mean that an injured patient who used the medication is foreclosed from pursuing, in state court, a legal claim that the warnings were inadequate, thereby contributing to the injuries suffered? Does the action by the federal agency preempt a state-level lawsuit?

Facts of the Case

Two lawsuits were under consideration by the US District Court serving a southern state, in which it was alleged that a prescription medication had caused the plaintiffs to suffer heart attacks. As the case proceeded, the attorneys representing the defendant manufacturer moved for summary judgment, and the presiding judge heard oral arguments on the motion. These arguments indicated that the defendant did not feel that the plaintiffs' cases would succeed and that the proceedings should end right there. The FDA had approved the wording of the warnings, and, in the view of the manufacturer, this agency decision eliminated the opportunity for the patients to sue because they had taken the medication after the labeling had been modified to reflect an increased chance of cardiac problems associated with the use of the pharmaceutical.

The Court's Ruling

The defendant manufacturer's motion for a summary judgment was denied, and so the cases will continue to proceed through the federal court system.

The Court's Reasoning

The judge in the case looked closely at the manufacturer's reliance on policy statements from the FDA reflecting the agency's view that its standards for prescription-drug product labeling set the limits for what is required. Under this perspective provided by the agency, and so long as the product is labeled in accordance with the FDAmandated language, there can be no lawsuits in state courts using failureto- warn products-liability legal theory and arguing that the drug producer failed-to-warn users of the danger. The FDA stated its perspective in a 2006 announcement in the Federal Register:

"Under the Federal Food, Drug, and Cosmetic Act, FDA is the expert federal public health agency charged by Congress with ensuring that drugs are safe and effective, and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading."

The judge considering these issues in the 2 cases reached an opposite conclusion. The FDA approval of the wording used in product labeling to warn prescribers, pharmacists, and patients about potential risks with the use of the medication does not eliminate the possibility of an injured patient suing because the warnings were inadequate. In fact, the judge included in his decision the rather straightforward conclusion that "the FDA's current view on the question of immunity for prescription drug manufacturers is entirely unpersuasive."

A failure-to-warn claim is based on state law and is usually pursued in state courts. There is no parallel to a failure-to-warn products-liability legal claim in the federal court system. Thus, when such cases end up in federal court because the parties are citizens of different states—the so-called diversity jurisdiction—the federal courts are bound to apply the law of the state where the claim originated.

This fact appeared to weigh heavily in the judge's decision. He indicated that:

"Because there are no federal remedies for individuals harmed by prescription drugs, a finding of implied preemption in these cases would abolish state law remedies and would, in effect, render legally impotent those who sustain injuries from defective prescription drugs."

One commentator has pointed out that the FDA has not been alone in taking the position that its decisions on a topic or issue are the final word. Both the Consumer Product Safety Commission, the agency that enforces the child-resistant closure provisions of the Poison Prevention Packaging Act that pharmacists work with every day, and the National Highway Traffic Safety Administration have taken similar policy positions.

The manufacturer is considering whether to pursue an appeal of this decision. In its view, this is an issue ultimately requiring the attention of the US Supreme Court to clarify the law in this area. Courts have had opportunities to rule on the position taken by the FDA in more than 20 cases to date, and that has resulted in a fairly even split in the decisions.