U.S. Food & Drug Administration v. Lorillard, Inc., No. 14-5226 (U.S. Ct. Appeals for D.C. Circuit 2015)

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Status: Closed

Legal Issue 

Whether the district court erred in holding that three of the world’s foremost authorities on nicotine addiction should be disqualified altogether from the U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee because of purported conflicts of interest and that the FDA should be barred from using a March 2011 report on menthol cigarettes issued by this committee.

Overview

On July 21, 2014, U.S. District Court Judge Richard Leon ruled that three members of the U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) had conflicts of interest (or the appearance of conflicts of interest), disqualified them from the committee, and barred the FDA from using a March 2011 report on menthol cigarettes issued by the committee. The FDA’s report, issued in July 2013, concluded that menthol cigarettes pose a greater public health risk than regular cigarettes because they lead to increased youth initiation.
 
This ruling by Judge Leon was based on an interpretation of the conflict of interest provisions governing federal employees found in 18 U.S.C. § 208 and related regulations.  Contrary to well-established principles of statutory interpretation, the court’s analysis failed to consider the effect of the specific, later-enacted conflicts provisions of the Family Smoking Prevention and Tobacco Control Act of 2009 that are applicable specifically to the TPSAC, or of the overall policy priorities that Congress stated explicitly in the TCA, on the general conflicts provisions on which it relied.

On March 26, 2015, the Tobacco Control Legal Consortium and seventeen other national non-profit organizations filed an amicus brief at the U.S. Court of Appeals for the District of Columbia Circuit in support of the U.S. Food and Drug Administration. The brief urged the appellate court to uphold the FDA’s carefully considered determination that the experts were not precluded from participating on the TPSAC, and pointed out that the district court’s ruling will not only deprive the tobacco advisory committee of the best scientific minds available, but could also impact the FDA’s broader ability to carry out its mission and protect public health. 

Outcome

On January 15, 2016, a three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit unanimously reversed the lower court’s ruling, finding that the plaintiffs had not shown imminent injury from the appointment or actions of challenged TPSAC members.

Case Documents & Information

Case Documents