The U.S. House of Representatives, 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.(1)Chairman Waxman's Opening Statement states in part:
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... This morning we will have two expert panels to help us understand the implications of this legal doctrine of preemption. ....
FDA's "Statement for the Record" (2) expresses their concern that state liability lawsuits which challenge FDA's determination of safety, efficacy and appropriate labeling have detrimental effects on public health (e.g. limiting patient doctor choices, descreased patient access to beneficial products, increased confusion over warnings or statements that can deter use of beneficial medical products). FDA observes that if there is a failure to meet the conditions of FDA's approval for a drug, biologic, or device, then state law liability on that basis would not interfere with Federal law and so manufacturers would get no protection from such claims. FDA's statement describes FDA's legal basis for Federal preemption of state law in this context.
In addition to important testimony given by other experts, testimony from David C. Vladeck, Professor of Law at Georgetown University Law Center and Scholar Center for Progressive Reform, includes his urging Congress to act swiftly to overrule the Supreme Court's recent ruling in Riegel v. Medtronic, Inc. He notes that:
...premarket approval is an important process intended to put an end to the marketing of devices without meaningful testing and with no assurance of safety, but that by itself, it cannot replace the continuous and comprehensive safety incentives, information disclosure and victim compensations that state liability law has traditionally provided.He quotes Sen. Kennedy's statement that even with FDAAA resources,
[t]he resources of the drug industry to collect and analyze ..safety data vastly exceed the resources of the FDA and no matter what we do, they will always have vastly greater resources to monitor the safety of their products than the FDA does.(4)
(1) http://oversight.house.gov/story.asp?ID=1943
(2) http://oversight.house.gov/story.asp?ID=1947
(3)
(4) http://oversight.house.gov/documents/20080514123701.pdf
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