R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Admin.

• Decision Date: 15 January 2016
• Docket Number: No. 14–5226.,14–5226.
• Citation: 810 F.3d 827
• Parties: R.J. REYNOLDS TOBACCO COMPANY, et al., Appellees v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Appellants.
• Court: U.S. Court of Appeals — District of Columbia Circuit

810 F.3d 827

R.J. REYNOLDS TOBACCO COMPANY, et al., Appellees

v.UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Appellants.

No. 14–5226.

United States Court of Appeals, District of Columbia Circuit.

Argued Oct. 7, 2015.

Decided Jan. 15, 2016.

Mark B. Stern, Attorney, U.S. Department of Justice, argued the cause for appellants. With him on the briefs were Benjamin C. Mizer, Acting Assistant Attorney General, Ronald C. Machen, Jr., U.S. Attorney at the time the brief was filed, and Alisa B. Klein and Patrick G. Nemeroff, Attorneys.

Carlos T. Angulo, Andrew N. Goldfarb, Hope M. Babcock, and Mark Greenwold were on the brief for amici curiae Public Health Groups in support of appellants.

Richard M. Cooper argued the cause for appellees. With him on the brief were Peter J. Anthony and Alan Mansfield. Laura M. Klaus entered an appearance.

William G. Kelly, Jr. was on the brief for amicus curiae Center for Regulatory Effectiveness in support of appellees.

Richard A. Samp was on the brief for amicus curiae Washington Legal Foundation in support of appellees.

Before: MILLETT and PILLARD, Circuit Judges, and WILLIAMS, Senior Circuit Judge.

Opinion for the Court filed by Senior Circuit Judge WILLIAMS.

WILLIAMS, Senior Circuit Judge:

With the Family Smoking Prevention and Tobacco Control Act of 2009, Pub.L. No. 111–31, § 101 (2009), Congress directed the Food and Drug Administration to establish a twelve-member Tobacco Products Scientific Advisory Committee, the duties of which included reporting on the safety of menthol cigarettes. 21 U.S.C. §§ 387g(e), 387q.¹ The Committee has now reported. While the FDA has issued a notice proposing adoption of special rules for such cigarettes, see Menthol in Cigarettes, Tobacco Products; Request for Comments, 78 Fed.Reg. 44,484 (July 24, 2013), it has not adopted a final rule. The plaintiffs, producers of menthol tobacco products or affiliates of such producers, claim that the FDA appointed to the Committee three members with pecuniary interests hostile to their products, in violation of relevant conflict-of-interests statutes and regulations, and that these appointments injured the plaintiffs.

Exact identification of the plaintiffs is complicated but largely irrelevant. R.J. Reynolds Tobacco Company and Lorillard Tobacco Company, together with Lorillard's parent, brought suit initially. They are now all wholly owned subsidiaries of Reynolds's parent, R.J. Reynolds Tobacco Holdings, Inc. We refer to the plaintiffs simply as plaintiffs except in describing events related only to a specific pre-merger company.

Plaintiffs allege, and in summary judgment proceedings the district court found, that three of the twelve members appointed to the Committee had unlawful conflicts of interest and that the FDA improperly failed to exclude those members or to grant conflict-of-interest waivers for them. (As we understand plaintiffs' position, they believe that a grant of waivers would have manifested acknowledgement of the conflicts of interest and thus adequately palliated their injuries. Oral Arg. Tr. at 39–40 ("[I]f they did a waiver we'd have to come up with a claim, and I don't know that we could.")) All three of the challenged members have testified in lawsuits against tobacco-product t manufacturers and had pending engagements to appear as expert witnesses in future suits; two of the three had hundreds of such engagements. Their individual billings for testimony have ranged as high as $50–60,000 per case. All three have also had financial relationships with pharmaceutical companies that manufacture smoking cessation products, which compete with tobacco products.

Plaintiffs claim that the FDA's appointments of these Committee members 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 menthol report to support the challenged members' consulting and expert witness businesses, with injuries flowing both from the report itself and from its use as support for their expert testimony and consulting. (Before the district court, plaintiff Lorillard also argued that it had been injured by a decline in its stock price, but the merged firm dropped that claim, and we do not consider it. Oral Arg. Tr. at 32.)

The district court granted summary judgment for plaintiffs and issued an order dissolving the Committee and enjoining use of the Committee's menthol report. Lorillard, Inc. v. FDA, 56 F.Supp.3d 37, 56–57 (D.D.C.2014).

We review the district court's grant of summary judgment de novo . Citizens for Responsibility & Ethics in Washington v. FEC, 711 F.3d 180, 184 (D.C.Cir.2013). We address first—and as it proves last—the government's defense that plaintiffs lack standing. Under the familiar threefold inquiry, plaintiffs must show an injury-in-fact that is "actual or imminent, not conjectural or hypothetical," and must show causation and redressability. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560–61, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992) (internal citations and quotation marks omitted). At summary judgment, plaintiffs cannot rest on " ‘mere allegations' but must ‘set forth’ by affidavit or other evidence ‘specific facts.’ " Id. at 561, 112 S.Ct. 2130 (quoting FED. R. CIV. P. 56(e) ).

Addressing the three alleged injuries in the order already presented, we conclude that all three are too remote and uncertain, or, to put the same thing another way, insufficiently imminent. We therefore vacate the district court's grant of summary judgment.

* * *

Risk of future FDA action. Since the FDA has not yet issued a rule, Lorillard's prospective injury from that rule remains remote. We assume without deciding that the appointment of the challenged Committee members without following statutorily mandatory conflict-of-interest waiver procedures violated a procedural right intended "to protect [plaintiffs'] concrete interests." Lujan, 504 U.S. at 572 n. 7, 112 S.Ct. 2130. A plaintiff who challenges the violation of such a right can establish standing "even though he cannot establish with any certainty that [provision of the right] will cause the [agency action] to be withheld or altered." Id. Although the Court did not explain the relaxation of the causation element, a failure to relax it would probably, because of the uncertain relationship between a procedural opportunity and success on the merits, eviscerate judicial enforcement of procedural mandates. In any event, despite this relaxation, the plaintiff must still demonstrate "a distinct risk to a particularized interest." Florida Audubon Soc'y v. Bentsen, 94 F.3d 658, 664 (D.C.Cir.1996) (en banc).

Although the government raised a standing and not a ripeness defense, we nonetheless treat ripeness cases as pertinent to whether the risk of injury is imminent enough. Both doctrines address the imminence issue, using the same focus on contingencies that may render the risk of harm too slight. (This is of course not to suggest that the doctrines are twins. Both have many distinctive facets, some even bearing on imminence of harm.) A claim is not adequately "ripe for adjudication," the Supreme Court has said, "if it rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all." Texas v. U.S., 523 U.S. 296, 300, 118 S.Ct. 1257, 140 L.Ed.2d 406 (1998) (citations and internal quotation marks omitted). We applied this aspect of ripeness doctrine in, for example, Atlantic States Legal Foundation v. EPA, 325 F.3d 281, 284–85 (D.C.Cir.2003), declining to hear a challenge to federal regulations that could adversely affect petitioners only after New York State adopted them through further notice-and-comment rulemaking. And very similar uncertainties led us to find a want of standing in Occidental Permian Ltd. v. FERC, 673 F.3d 1024, 1026 (D.C.Cir.2012), where a petitioner challenged FERC's grant of authority to negotiate rates for services of an as-yet unfinished interconnection facility; uncertainties relating (for example) to whether the potentially connecting transmission lines would ever be authorized and built made the injury too remote. Compare Chlorine Inst., Inc. v. Fed. R.R. Admin., 718 F.3d 922, 928–29 (D.C.Cir.2013), where like uncertainties defeated ripeness. On the overlap of the doctrines, see generally Louisiana Environmental Action Network v. Browner, 87 F.3d 1379, 1383–84 (D.C.Cir.1996).

Here, the appointment of the challenged committee members by no means rendered the risk of eventual adverse FDA action substantially probable or imminent. It remains unclear whether the FDA will issue a final rule, and what it would say. In particular, in any such rulemaking, the extent to which the FDA would be persuaded by the content of the Committee's report is quite speculative. The FDA need only "consider[ ]" the Committee's report, 21 U.S.C. § 387g(d)(1), along with the comments of persons responding to its notice of proposed rulemaking, id. § 387g(c), which of course the Administrative Procedure Act requires it to "consider[ ]," 5 U.S.C. § 553(c). And it is to adopt the proposed standard only if it finds, after "consider[ing] scientific evidence" on a range of issues, 21 U.S.C. § 387g(a)(3)(B)(i), that it "would be appropriate for the protection of the public health." 21 U.S.C. § 387g(d)(1)(A). If the report influences a proposed rule to plaintiffs' detriment in the way they anticipate, they will have an opportunity to raise concerns about the report's scientific claims, including assertions of bias. Review of any claims that the (still hypothetical) rule was in excess of statutory authority or arbitrary and capricious would proceed along conventional lines. Even if we were to assume arguendo that the FDA's selection of these committee members materially increased...