Lorillard, Inc. v. Food & Drug Administration

Cigarette companies Lorillard and R.J. Reynolds sued the FDA, claiming that the FDA’s Tobacco Products Scientific Advisory Committee violates the Federal Advisory Committee Act (FACA) because some of the scientists appointed to the panel have taken views of scientific issues that the tobacco companies disagree with and have given expert testimony in lawsuits against tobacco companies. According to the tobacco companies, the involvement of scientists who have opinions on scientific matters relevant to the Committee’s work violates FACA’s requirement that advisory committees be fairly balanced, unless those members’ opinions are balanced by pro-tobacco opinions of other members.

Public Citizen, on behalf of itself and 13 other organizations interested in public health and the proper functioning of federal advisory committees, filed a memorandum as amicus curiae supporting the FDA’s motion to dismiss the lawsuit. Our memorandum argues that FACA does not require, or permit, a court to assess the scientific views of expert members of advisory committees to determine whether they are fairly balanced. In August 2012, the district court denied the motion to dismiss. In July 2014, the court granted the companies’ motion for summary judgment, finding that three members of the advisory committee had financial conflicts of interest and that their activities as consultants and expert witnesses created the appearance of conflicts of interest. The court ordered the FDA to reconstitute the committee and enjoined the FDA from using the committee’s report on the use of menthol in cigarettes.

In January 2016, the U.S. Court of Appeals for the D.C. Circuit threw out the tobacco companies’ lawsuit on the ground that it would not be ripe unless and until the FDA took some action based on the advisory committee’s report.