Guest Blogger: Perry Court Gets it Right: Why FDA Approval of Drug Labels Should Not Bar Victims From Having Their Day in Court
by Leslie A. Bailey, Brayton-Baron Fellow, Trial Lawyers for Public Justice
The scenario is not uncommon. A prescription drug is approved by the U.S. Food and Drug Administration ("FDA") as safe and effective, but after it has been on the market for some time, new data shows that the drug may increase the risk of a dangerous side effect. In light of this new safety data, the drug manufacturer is faced with a choice: hide the information from the public by continuing to market the drug with its existing label, or change the label. Too often, drug companies make the wrong choice, and fail to strengthen the warning. In cases like these, state tort law provides an essential means for injured individuals and their families to hold drug makers accountable, and thus to encourage responsible behavior by the industry.
This may seem like an uncontroversial proposition, but lawsuits by patients against drug makers for failure to warn of known risks are under attack these days-not only by Big Pharma, but by the FDA itself. Since 2001, the Bush-controlled agency has been filing amicus curiae briefs on behalf of drug manufacturers, arguing that many state law failure-to-warn claims conflict with-and thus are preempted by-the FDA's approval of the drug's label. In January of this year, the FDA took its new, pro-business preemption position one step further, inserting it-without congressional approval, without notice or comment, and in contradiction to previous official statements-into the preamble to a new prescription drug regulation. Since then, a growing number of drug makers have relied on the preamble to argue that injured victims cannot hold them accountable for failing to warn of known risks.
On October 16, 2006, in a critical victory for consumers, a federal court in Philadelphia emphatically rejected this preemption argument. In Perry v. Novartis Pharma. Corp., --- F. Supp. 2d ----, 2006 WL 2979388, the U.S. District Court for the Eastern District of Pennsylvania held that the FDA's approval of a drug label does not preempt suits against drug makers who fail to warn consumers of known risks. The Center for Constitutional Litigation and Trial Lawyers for Public Justice, along with trial counsel Scott Liotta and Larry Roth, represented the parents of a two-year-old boy, Andreas Perry, who developed lymphoma after he was prescribed the topical immunosuppressant Elidel to treat his eczema.1 His parents were not warned that Elidel would increase their son's risk of developing cancer. However, the FDA ultimately required Novartis to add to Elidel's label a clear and prominent "black-box" warning of the cancer risks.
The Perrys sued Novartis, alleging that the company had failed to adequately warn of Elidel's known cancer risks. Novartis moved to dismiss the case, arguing that the claims conflict with-and thus are preempted by-the FDA's approval of Elidel's label.
In denying Novartis' preemption motion, Judge Stewart Dalzell reasoned that the Perrys' claim would neither compel the drug maker to violate federal law nor disrupt any statutory or regulatory scheme. The court emphasized that, because FDA regulations already permit manufacturers to supplement labels with warnings of newly discovered risks without prior FDA approval, state law tort suits do not conflict with FDA regulations. Thus, the court reasoned, a failure-to-warn claim cannot be preempted by federal law unless the FDA has rejected the specific warning proposed by the plaintiffs-not the case with Elidel. Judge Dalzell dismissed the FDA's preamble, which states that the agency has "exclusive authority" to regulate drug labels, as a mere "advisory opinion" that "need not affect" the court's preemption analysis, and rejected the FDA's position as "overstat[ing] the scope of preemption."
Perhaps most significantly, the court emphasized that, "given the recent concerns about the effectiveness of the FDA's safety monitoring of recently approved drugs, . . . the availability of state law tort suits provides an important backstop to the federal regulatory scheme."
The importance of this "backstop" cannot be overstated. Unfortunately, by the time the FDA gets around to requiring a stronger warning on the label of a dangerous drug-or, as in the case of Vioxx, pulling it from the market-it's often too late for many patients. Recent reports by the General Accounting Office and the National Academies' Institute of Medicine ("IOM") confirm that the FDA's approval process is dangerously ineffective and impaired by resource constraints. See GAO, Improvement Needed in FDA's Postmarket Decision-making and Oversight Process, Highlights, (GAO-06-402 March 2006); IOM, The Future of Drug Safety: Promoting and Protecting the Health of the Public at S-4 (Sept. 22, 2006), available at http://newton.nap.edu/execsumm_pdf/11750. The Perry decision-and others like it-keep in place a critical incentive for drug makers to propose stronger label warnings to the FDA as soon as they learn of risks associated with the drug, or face accountability under state law. This incentive preserves crucial protections for consumers of prescription drugs.
1 TLPJ's and CCL's brief and the Perry decision are posted on http://www.tlpj.org/briefs_documents.htm