NEJM Volume 358:1883-1885, May 1, 2008, Number 18
Leonard H. Glantz, J.D., and George J. Annas, J.D., M.P.H.

Everyone would like to be immune from lawsuits. Legislatures sometimes provide immunity in order to advance important social policy goals. For example, by providing health care professionals with immunity under Good Samaritan statutes, legislatures hope to encourage voluntary medical assistance in emergencies. Similarly, Congress provided immunity to vaccine manufacturers who claimed they could not economically manufacture vaccines with the threat of liability hanging over them.

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If the [Supreme] Court expands the preemption doctrine and Congress does not rein it in, much closer scrutiny of the FDA's approval process will be required. Since the processes and judgments of drug and device manufacturers and the FDA will no longer be made public through litigation, all the documentation the FDA receives from manufacturers should be made available for scrutiny by the public and Congress. Safety data for drugs and devices should not be protected as trade secrets.