Diane Lifton and Danielle Rosen co-authored an article in Bloomberg BNA entitled "Seufert v. Merck and Cerveny v. Aventis: The Intersection of Science and Federal Preemption in Pharmaceutical Product Liability Litigation."
The article examines two recent cases that illustrate when federal law preempts state product liability failure-to-warn claims. The authors observed that a showing that the Food and Drug Administration (FDA) reviewed "the science of the alleged causal association between the drug and the specific risk at issue, post-product use, remains the key to a successful preemption defense."
In Seufert, plaintiffs claimed that Merck failed to warn that diabetes drug Ongylza and Kombiglyze increased the risk of pancreatic cancer. In Cerveny, plaintiffs brought state law claims for strict liability and negligent failure to warn in connection with the use of fertility drug Clomid, arguing that the Clomid labeling should have included a warning regarding the possibility of birth defects in connection with use of the drug prior to pregnancy.
In both cases, the FDA's issuance of a new label post-citizen petition, which did not include new warnings, along with affirmative conclusions by the FDA that scientific data did not show cause and effect between use of the drugs and risk of pancreatic cancer or birth defects, respectively, indicated that the FDA had addressed such risks and found no evidence requiring it to apply the warnings suggested by plaintiffs.
Although Seufert and Cerveny are currently on appeal, the authors said both cases suggest that "a regulatory record reflecting the FDA's review of the science regarding the risk at issue, without a label change, ultimately can result in a finding that the FDA would have rejected plaintiffs' proposed warning, and, thus, that federal law preempts plaintiffs' state law product liability failure to warn claim."