The Federal Food, Drug, and Cosmetic Act requires drug and medical device manufacturers to investigate and report to the U.S. Food and Drug Administration incidents involving their products, even though personal injuries may not have resulted. These reports are available to the public through the Freedom of Information Act (FOA) and can be used against drug and medical device defendants in civil litigation. To encourage candid reporting, some commentators have suggested the application of the self-critical analysis privilege to this industry. The author reviews the historical development of the privilege, arguing both that application of the privilege is federally preempted by the FOA and that "strong public interests of liberal discovery and the right of access to government records do not justify expansion of the self-critical analysis privilege to product safety analyzes submitted to the FDA by the drug and medical device industry."
Patricia L. Andel,
Inapplicability of the Self-Critical Analysis Privilege to the Drug and Medical Device Industry,
San Diego L. Rev.
Available at: https://digital.sandiego.edu/sdlr/vol34/iss1/3