Jerry Masoudi, former Chief Counsel for the Food and Drug Administration (FDA), highlighted the importance of assuring that inappropriate warnings are not included on drug labeling--and the importance of maintaining a national system, so "we don't have 50 different labels" for a drug.
Moderator: Sandi Dennis, Deputy General Counsel for Healthcare, BIO Panelists: Gerald Masoudi, partner at Covington & Burling; Brian Wolfman, Director, Public Citizen Litigation Group, Erika Lietzan, Partner, Covington & Burling; Paul Schmidt, Partner, Covington & Burling
This panel presented focused on the meaning of the Supreme Court decision in Wyeth v. Levine, a groundbreaking decision that "has radically changed the landscape" of preemption of drugs, according to panelist Erika Lietzan. The decision, issued in March, held that plaintiff Diana Levine's claim that the labeling of Wyeth's Phenergan did not adequately warn against the risk of the IV-push method of adminitration employed by Levine's health care provider. Jerry Masoudi, former Chief Counsel for the Food and Drug Administration (FDA), highlighted the importance of assuring that inappropriate warnings are not included on drug labeling--and the importance of maintaining a national system, so "we don't have 50 different labels" for a drug. He also highlighted concerns regarding new burdens on FDA in reviewing an influx of labeling supplements. Jerry Masoudi and Erika Lietzan both noted concern with the subjective nature of the Wyeth's decison "test" as to "whether FDA would have rejected" a labeling change. How could one know that, or have clear evidence of what FDA might have rejected, queried Lietzan. Brian Wolfman, one of Levine's lawyers, noted the importance that the system compensates injured parties, which the regulatory system cannot do. He stated that "regulation generally involves minimum standards, and manufacturers can add to that." He said that he does not agree with concerns that a lack of preemption will adversely impact innovation, as there has not been any such effect previously, and "no appellate court ever ruled in favor of preemption." In contrast, Paul Schmidt said that an increase in product liability litigation is a relatively new and significant burden on industry. He highlighted the increase in product liability litigation in the last decade, stating that trial lawyers who had focused on tobacco and asbestos have now turned to drugs, including mass tort litigation against products like vioxx and bextra. Schmidt said that cases now often focus on not whether there is a warning, but what the exact wording of a warning is--eg, whether and when to alter language from "association" to "possible or probable." In terms of where preemption may still exist, Wolfman stated that there should be preemption if there is a conflict--FDA decides one thing, and a state jury decides the exact opposite. Both Schmidt and Wolfman agreed that the next tier of litigation post-Wyeth will likley play out in SSRI litigation, where several cases in the next few months will address warnings related to a link to risk of suicide. In terms of advice for companies going forward, Lietzan noted the importance of documenting discussions with FDA regarding potential changes to warnings. She stated that while some may predict dense lebels and over-warning in the future, as a result of Wyeth, that may be less likely given the need to consider not just legal objectives in developing labeling, but medical, regulatory, and science as well. She added that perhaps we can all find common goals in this arena--considering FDA's workload, making FDA review more efficient, and asuring that drug labeling is clear and uncluttered. --Sandi Dennis
Sandi Dennis is BIO's General Counsel for Healthcare in the Legal & Intellectual Property Division