FDA Dodges a Bullet: D.C. Circuit Vacates District Court's Ruling in Lorillard v. FDA

3 min

Agency May Rely On TPSAC Menthol Report and Need Not Reconstitute Advisory Panel

On January 15, 2016, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) vacated the decision of the U.S. District Court for the District of Columbia (district court) in Lorillard, et al. v. FDA,1 which had dissolved the U.S. Food and Drug Administration's (FDA) Tobacco Products Scientific Advisory Committee (TPSAC or the Committee) and enjoined the Agency from using the Committee's report on the safety of menthol cigarettes (Menthol Report or the Report). FDA may now rely on the Report and need not reconstitute TPSAC's membership.

Plaintiffs alleged, and the district court found, that three of the twelve Committee members had unlawful conflicts of interest and that the Agency improperly failed to exclude those members or grant conflict-of-interest waivers for them. Plaintiffs asserted that these conflicts of interest existed because all three of the challenged members had testified in lawsuits against tobacco-product manufacturers and had then-pending engagements to appear as expert witnesses in future suits. In addition, plaintiffs argued, all three challenged members also had financial relationships with pharmaceutical companies that manufacture smoking cessation products, which, plaintiffs asserted, compete with tobacco products.

Plaintiffs asserted that, because of these conflicts of interest, FDA's appointments of the TPSAC members at issue caused them three injuries: (1) an increased risk that the FDA will regulate menthol tobacco products adversely to plaintiffs' interests; (2) access by the challenged Committee members to plaintiffs' confidential information, with a probability of their using the information to plaintiffs' detriment; and (3) the shaping of the Report to support the challenged members' consulting and expert witness businesses. Plaintiffs alleged that these injuries resulted both from the Menthol Report itself and from its use as support for the challenged members' expert testimony and consulting.

The D.C. Circuit determined that each of the alleged injuries is too remote and uncertain (i.e., "insufficiently imminent") to provide standing. With regard to issuance of menthol regulations, the D.C. Circuit opined that FDA need only "consider[]" TPSAC's Menthol Report (i.e., the Agency is not compelled to rely on the Report), along with public comments on future proposed regulations. See 21 U.S.C. §§ 387g(d)(1) and 387g(c). As long as FDA does so, and finds, after "consider[ing] scientific evidence" on a range of issues, that it "would be appropriate for the protection of the public health" to regulate menthol cigarettes, the Agency may so regulate. See 21 U.S.C. §§ 387g(a)(3)(B)(i) and 387g(d)(1)(A).

The D.C. Circuit's decision left open the possibility of future standing if the Menthol Report informs a proposed menthol rule in a way that is detrimental to plaintiffs. Plaintiffs might in this context raise concerns about the Report's scientific claims, including any assertions of Committee member bias.

If you have questions regarding the issues raised in this alert, please contact one of the authors.

[1] R.J. Reynolds Tobacco Company and Lorillard Tobacco Company, together with Lorillard's parent company, initially brought this suit against the Agency (Lorillard, et al. v. FDA). These entities are now wholly owned subsidiaries of Reynolds's parent company, R. J. Reynolds Tobacco Holdings, Inc. The case recently decided by the D.C. Circuit is captioned R.J. Reynolds Tobacco Company, et al. v. FDA.