Committee Holds Hearing on Whether FDA Regulation Should Bar Liability Claims

The Committee on Oversight and Government Reform held a hearing titled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” on Wednesday, May 14, 2008, in 2154 Rayburn House Office Building. A preliminary transcript of this hearing is now available.

FDA approval of drugs and high-risk medical devices before they are marketed does not necessarily guarantee safety. Patients harmed by medical products have traditionally sought compensation under state law for damages, such as medical expense incurred, and lost wages. The hearing will examine the implications of “preemption” of state liability laws in the FDA context and whether FDA regulation of drugs and medical devices should bar injured patients from seeking compensation under state law.

The following witnesses are expected to testify:

• Panel 1
• Dennis and Kimberly Quaid, parents of newborn twins, Thomas Boone Quaid and Zoe Grace Quaid, who were victims of a heparin overdose
• William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston
• Aaron S. Kesselheim, M.D., J.D., Harvard Medical School, Division of Pharmacoepidemiology
• David A. Kessler, M.D., J.D., Professor of Pediatrics and Epidemiology and Biostatistics, School of Medicine, University of California, San Francisco
• Panel 2
• David Vladeck, J.D., Professor of Law, Georgetown University Law Center
• Gregory Curfman, M.D., Editor, New England Journal of Medicine
• Christine Ruther, President & Chief Engineer, C&R; Engineering, Inc.
• State Representative David Clark (R-Utah), National Conference of State Legislatures (NCSL)
• John E. Calfee, Ph.D., American Enterprise Institute
• Panel 3
• Randall Lutter, Ph.D., Deputy Commissioner for Policy, Food and Drug Administration