Fulbright partner Lance Shea and associates Andre Hanson, Tiffany Guglielmetti and Kimberly Levy published the lead article in the Food & Drug Law Journal’s recent symposium on drug and medical device safety surveillance: Cause and Effect? Assessing Postmarketing Safety Studies as Evidence of Causation in Products Liability Cases", 62 Food & Drug L.J. 445 (2007). The article reviews the types of causation evidence potentially generated by drug and medical device safety surveillance activities and issues in proving causation in products liability cases. Also, the article discusses factors that should be considered in assessing whether the results of human health studies are sufficient evidence of causation.

Drug and device safety surveillance is one of the hottest issues for pharmaceutical and medical device manufacturers in litigation and regulatory matters. To cover key litigation issues, the Food & Drug Law Institute invited Shea to address drug safety surveillance from a litigation perspective in the Journal’s symposium. The symposium included other contributors such as Dr. Daniel Schultz, Director of the FDA’s Center for Devices and Radiological Health.

SOURCE: Fulbright & Jaworski L.L.P.