Labeling in Failure-to-Warn Case

NOVEMBER 01, 2006
Joseph L. Fink III, BSPharm, JD

Issue of the Case

If a patient is harmed by a medication when he or she experiences an adverse effect not mentioned in the official product labeling, may a lawsuit be maintained in state court for redress of those injuries? Or is such a state-level legal claim preempted by the fact that the FDA evaluated the information about the side effect and, in exercise of its informed expert decision making, permitted the product to be marketed with the approved labeling?

Facts of the Case

The lawsuit was filed by the surviving husband and the estate of a patient who had been prescribed a selective serotonin reuptake inhibitor (SSRI). The argument was that the wife's suicide was the result of the defendant manufacturers' failure to warn of the increased risk of suicidalbehavior on the part of patients taking the medication. The lawsuit named 2 defendants—the manufacturer of the brand name version of the medication; and the maker of the generic version. The record was unclear on the point of whether the prescriber indicated the brand name or generic name when issuing the prescription, but the generic version was used. Both firms were sued, because even if she had received only the generic version, the wording of the labeling was prepared by the brand name manufacturer at the time it initially applied for approval to market the product. The generic manufacturer had copied verbatim the original language that had already been approved by the FDA as part of its application to market the product.

The deceased patient had complained to her oncologist of mild fatigue and depression. She was started on the brand name version of the medication and later switched to the generic. After being on the medication for 22 days, she committed suicide at home.

The plaintiffs emphasized the fact that ample peer-reviewed scientific literature had appeared from the mid-1990s on, linking SSRIs to an increased risk of suicidal behavior. At the time of her death (October 2003), however, the FDAapproved labeling, consisting of the package label plus accompanying literature, did not warn of an association between the product and increased risk of personally harmful behavior. In June 2005, the FDA issued a public health advisory warning about the potential for antidepressant medications to cause suicidal thoughts and behavior in adults.

Before the trial began, the defendant manufacturers moved to have the judge dismiss the lawsuit. The manufacturers' position was that the FDA action abrogated the ability of injured plaintiffs to file state court-level lawsuits. Briefs were filed by parties on both sides of the issue, and the judge requested written answers to some specific questions he had. Oral arguments were also held on the issue. Following that, feeling that the preemption issues were so novel, the judge asked the FDA to file a brief in the case as amicus curiae (friend of the court). Such an "amicus brief" is submitted by a person or organization with special knowledge or insight in an attempt to enlighten the judge and illuminate the issues, thereby hopefully leading to a better, more informed decision from the court.

The Court's Ruling

The US district judge dismissed the failure-to-warn product liability lawsuit filed by the husband and the estate of the deceased patient, ruling that approval of labeling for the product by the FDA preempted any failure-to-warn claim arising under state law.

The Court's Reasoning

The judge looked at a policy statement released by the FDA in January 2006, 4 months before he announced his decision, that stated, "FDA approval of labeling under the Federal Food, Drug, and Cosmetic Act preempts conflicting or contrary state law." He made the direct ruling that "it is not the function of this Court, or for a jury empanelled to decide this case, to substitute its judgment for the FDA's about these medical issues. Congress has given the FDA broad power, the President has appointed its executives, some subject to the advice and consent of the Senate, and it has rendered its judgment on these issues."

This decision has been hailed in the health law literature as a "significant development for the product liability exposure profile of pharmaceutical manufacturers and should be used vigorously in efforts to dismiss failure-to-warn cases."

The plot thickened, however. Just 6 days after this decision was announced by the US District Court for the Eastern District of Pennsylvania, a federal district court in Nebraska reached exactly the opposite conclusion, denying a motion by defendant manufacturers to dismiss a lawsuit with a similar claim. In fact, both cases involved the same factual root—SSRIs and the increased risk of suicide. The manufacturers had argued that the FDA approval and the attendant labeling approved by the FDA preempted the ability in Nebraska to maintain a lawsuit based on common law claims based on strict liability and negligence for failure to warn. These differing opinions set the stage for the issue ultimately to be decided at the level of the US Supreme Court.

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