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On February 21, 2011, Lorillard Tobacco Company and R.J. Reynolds Tobacco Company filed a complaint[1] against the FDA in the United States District Court for the District of Columbia challenging the composition of the Tobacco Products Scientific Advisory Committee (“TPSAC”) and alleging that TPSAC failed to comply with the Federal Advisory Committee Act (“FACA”). TPSAC was formed immediately following the passage of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”). TPSAC was charged with researching the health effects of menthol in cigarettes and reported to the FDA that mentholated cigarettes adversely affected public health, and that their removal from the market would benefit public health.[2]
In their complaint, the tobacco companies allege that three members of TPSAC have financial and appearance conflicts of interest stemming from their continued service as paid expert witnesses in anti-tobacco litigation, as well as their continued employment for pharmaceutical companies that manufacture smoking-cessation products.[3] The tobacco companies argue that this creates an unbalanced committee representing only one set of viewpoints that are against smokeless tobacco products and menthol in cigarettes.[4]
Lorillard and R.J. Reynolds alleged injuries include disclosure of confidential information to conflicted committee members who could use it to testify for parties adverse to them, that the conflicted members have the ability to shape the TPSAC report to help with their work as expert witnesses, that Lorillard lost 2 billion in shareholder value, and that their procedural right to fair decision making was violated.[5] The companies are seeking declaratory relief that the three committee members violated FACA, as well as an injunction preventing the FDA from receiving or considering any suggestions from TPSAC pending the result of this litigation.[6]
On April 29, 2011, the FDA moved to dismiss the suit for lack of subject matter jurisdiction and failure to state a claim. The FDA argued that the tobacco companies lacked standing to challenge the committee’s composition because their alleged injuries were speculative, not traceable to the FDA, and were unlikely to be redressed by the court.[7] Furthermore, the FDA argued that any conflicts of interest are within FDA discretion and are not subject to judicial review.
On August 1, 2012, the U.S. District Court for the District of Columbia denied the FDA’s motion in its entirety.[8] The court held that Lorillard and R.J. Reynolds pled sufficient injuries and that the conflicts of interest were justifiable by the court. [9] Due to the limited number of viewpoints regarding tobacco issues and the scientific, rather than political, nature of the issues, the court determined they are equipped with sufficient standards against which it can assess the committee’s objectiveness.[10] With the denial of the FDA’s motion to dismiss, the tobacco companies can proceed with their suit.
On July 21, 2014, Judge Richard Leon granted Lorillard’s Motion for Summary Judgment to bar the Committee’s menthol report from consideration and ordered the agency to reconstitute the Committee. The judge found that “the Committee’s findings and recommendations, including reports such as the Menthol Report, are, at a minimum, suspect, and, at worst, untrustworthy.” [11]
The FDA appealed Judge Leon’s ruling to the U.S. Court of Appeals for the DC Circuit which reversed the District Court’s ruling in a January 16, 2016 decision. [12] The Court considered the plaintiff/appellee’s three alleged injuries and found none of them to be imminent enough to confer standing. It, therefore, vacated the District Court’s judgment for lack of standing and dissolved Judge Leon\’s injunction preventing the agency from utilizing the Menthol Report issued by the Tobacco Products Scientific Advisory Committee.
2012 Summary by Katelyn Blaney, updated by Mark Gottlieb in 2016.
[1] Online Copy of Initial Complaint: http://www.hpm.com/pdf/LORILLARD%20Adv%20Cmte%20-%20Complaint.pdf.
[2] The Tobacco Products Scientific Advisory Committee, Menthol Cigarettes and Public Health: Review of the Scientific Evidence and Recommendations, Chapter 8, p. 220 (March, 2011).
[3] 2d Amended Complaint at ¶ 2, Lorillard, Inc. v. U.S. Food & Drug Admin., No. 11-440 (RJL), 2012 WL 3542228 (D.D.C. 2012).
[4] Id. at ¶ 3.
[5] Lorillard, Inc v. United States Food & Drug Admin., No. 11-440 (RJL), 2012 WL 3542228, at *2 (D.D.C. 2012).
[6] Id. at ¶ 4.
[7] Lorillard, No. 11-440 (RJL), 2012 WL 3542228, at *2 (D.D.C. 2012).
[8] Id. at *1.
[9] Id. at *2.
[10] Id. at *2.
[11] Lorillard Inc v. United States Food and Drug Administration, Civil Action No. 2011-0440 (D.C. 2014) District Court, District of Columbia.
[12] RJ Reynolds Tobacco v. US FOOD AND DRUG ADMIN. 810 F. 3d 827 – Court of Appeals, Dist. of Columbia Circuit 2016.