Labeling in Failure-to-Warn Case

Issue of the Case

If a patient is harmed by a medicationwhen he or she experiences an adverseeffect not mentioned in the official productlabeling, may a lawsuit be maintainedin state court for redress of those injuries?Or is such a state-level legal claim preemptedby the fact that the FDA evaluatedthe information about the side effectand, in exercise of its informed expertdecision making, permitted the product tobe marketed with the approved labeling?

Facts of the Case

The lawsuit was filed by the survivinghusband and the estate of a patient whohad been prescribed a selective serotoninreuptake inhibitor (SSRI). The argumentwas that the wife's suicide was the resultof the defendant manufacturers' failure towarn of the increased risk of suicidalbehavioron the part of patients taking themedication. The lawsuit named 2 defendants—the manufacturer of the brandname version of the medication; and themaker of the generic version. The recordwas unclear on the point of whether theprescriber indicated the brand name orgeneric name when issuing the prescription,but the generic version was used.Both firms were sued, because even if shehad received only the generic version, thewording of the labeling was prepared bythe brand name manufacturer at the timeit initially applied for approval to marketthe product. The generic manufacturerhad copied verbatim the original languagethat had already been approved by theFDA as part of its application to marketthe product.

The deceased patient had complainedto her oncologist of mild fatigue anddepression. She was started on thebrand name version of the medicationand later switched to the generic. Afterbeing on the medication for 22 days, shecommitted suicide at home.

The plaintiffs emphasized the fact thatample peer-reviewed scientific literaturehad appeared from the mid-1990s on,linking SSRIs to an increased risk of suicidalbehavior. At the time of her death(October 2003), however, the FDAapprovedlabeling, consisting of thepackage label plus accompanying literature,did not warn of an associationbetween the product and increased riskof personally harmful behavior. In June2005, the FDA issued a public healthadvisory warning about the potential forantidepressant medications to cause suicidalthoughts and behavior in adults.

Before the trial began, the defendantmanufacturers moved to have the judgedismiss the lawsuit. The manufacturers' position was that the FDA action abrogatedthe ability of injured plaintiffs to filestate court-level lawsuits. Briefs werefiled by parties on both sides of the issue,and the judge requested written answersto some specific questions he had. Oralarguments were also held on the issue.Following that, feeling that the preemptionissues were so novel, the judgeasked the FDA to file a brief in the case asamicus curiae (friend of the court). Suchan "amicus brief" is submitted by a personor organization with special knowledgeor insight in an attempt to enlightenthe judge and illuminate the issues, therebyhopefully leading to a better, moreinformed decision from the court.

The Court's Ruling

The US district judge dismissed thefailure-to-warn product liability lawsuitfiled by the husband and the estate ofthe deceased patient, ruling that approvalof labeling for the product by theFDA preempted any failure-to-warnclaim arising under state law.

The Court's Reasoning

The judge looked at a policy statementreleased by the FDA in January 2006, 4months before he announced his decision,that stated, "FDA approval of labelingunder the Federal Food, Drug, andCosmetic Act preempts conflicting orcontrary state law." He made the directruling that "it is not the function of thisCourt, or for a jury empanelled to decidethis case, to substitute its judgment forthe FDA's about these medical issues.Congress has given the FDA broadpower, the President has appointed itsexecutives, some subject to the adviceand consent of the Senate, and it hasrendered its judgment on these issues."

This decision has been hailed in thehealth law literature as a "significantdevelopment for the product liabilityexposure profile of pharmaceutical manufacturersand should be used vigorously inefforts to dismiss failure-to-warn cases."

The plot thickened, however. Just 6days after this decision was announcedby the US District Court for the EasternDistrict of Pennsylvania, a federal districtcourt in Nebraska reached exactly theopposite conclusion, denying a motion bydefendant manufacturers to dismiss alawsuit with a similar claim. In fact, bothcases involved the same factual root—SSRIs and the increased risk of suicide.The manufacturers had argued that theFDA approval and the attendant labelingapproved by the FDA preempted the abilityin Nebraska to maintain a lawsuitbased on common law claims based onstrict liability and negligence for failure towarn. These differing opinions set thestage for the issue ultimately to be decidedat the level of the US Supreme Court.

Dr. Fink is professor ofpharmacy law and policy atthe University of KentuckyCollege of Pharmacy,Lexington.