Sharkey v. FDA and Merck
This was a FOIA case challenging the FDA's refusal to produce documents reflecting the net number of doses in each lot of hepatitis B vaccine distributed in the United States. Release of the information would have aided research on vaccine safety and provided greater understanding of vaccine adverse reaction data. FDA invoked FOIA Exemption 4 as its basis for withholding the requested documents, claiming that the records contain confidential commercial information the release of which could cause competitive harm to the two vaccine manufacturers. The district court ruled for the FDA and the decision was affirmed on appeal.