R.J. Reynolds Tobacco Co. v. United States Food & Drug Administration ( 2016 )

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued October 7, 2015 Decided January 15, 2016
No. 14-5226
R. J. REYNOLDS TOBACCO COMPANY, ET AL.,
APPELLEES
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION, ET AL.,
APPELLANTS
Appeal from the United States District Court
for the District of Columbia
(No. 1:11-cv-00440)
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.
2
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
1
Although the enabling statute (cited in the text below) grants
the relevant authority to the Secretary of Health and Human
Services, see 46 Fed. Reg. 26,052-01 (May 11, 1981); FDA Staff
Manual Guide 1410.10 (May 18, 2005), the custom followed
generally and in the briefs before us is to refer to the FDA where
(as here) it is the acting component of that Department. See, e.g., 1
Food and Drug Administration § 4:15 (4th ed. 2015) (describing
management review process for FDA rules).
3
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 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.
4
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 (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 (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
5
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.
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,
6
300 (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
7
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 the risk of its adoption of a rule
more adverse to plaintiffs than the rule it might otherwise
have adopted (or no rule at all), that would still fall short of
saying that the selection rendered adoption of a more adverse
rule imminent. For similar reasons, we held that plaintiffs in
Metcalf v. National Petroleum Council, 553 F.2d 176, 184,
188 (D.C. Cir. 1977), lacked standing to challenge the
composition of an advisory committee where, among other
things, there was “no allegation that [the agency] took action
based on” one of the committee’s recommendations.
Ripeness concerns underscore this point: part of the reason
the injury is too remote is that, if the FDA chooses not to
issue a rule, this case “may not require adjudication at all.”
Friends of Keeseville, Inc. v. FERC, 859 F.2d 230, 235 (D.C.
Cir. 1988).
Plaintiffs cite our decision in Wyoming Outdoor Council
v. U.S. Forest Service, 165 F.3d 43 (D.C. Cir. 1999), for its
recognition of the general proposition that the constitutional
minima of standing are somewhat relaxed when applied to
procedural violations, Appellee Br. 29, a point we noted in
some detail above. Wyoming Outdoor Council is in fact
somewhat unusual in finding standing where the ultimate
agency action threatening harm to plaintiffs—there, issuance
of oil and gas leases—had not occurred when they brought
suit. Although the lack of final leases obviously left
uncertainty, we found that the Forest Service’s failure to make
each of the required predicate findings put plaintiffs’
environmental interests “in genuine danger.” Id. at 51.
8
Crucially, however, leases had been issued by the time of
decision, id. at 47, and, unlike the situation as to NEPA
claims in the case, the record on the issue was complete, id.See also Center for Biological Diversity v. U.S. Dep’t of the
Interior, 563 F.3d 466, 473, 479 (D.C. Cir. 2009) (finding
standing to challenge violation of certain procedural
prerequisites to approval of a leasing program, even though
leases had not been issued). Neither of these cases is brought
into play here, and accordingly we find the alleged increased
risk of an FDA rule on menthol cigarettes too uncertain for
standing.
Confidential information. Plaintiffs assert that they have
been injured by the challenged Committee members’ access
to confidential information, which they could disclose to
plaintiffs’ competitors or could use in their expert witness
work. Yet plaintiffs have not set forth by affidavit or other
evidence specific facts suggesting that the challenged
members have made or will make improper use of
confidential information. They have only presented evidence
that the Committee members received such information in the
course of their time on the Committee—not that they used it
the way plaintiffs fear. See, e.g., Mem. in Supp. of
Defendants’ Motion for Summary Judgment 11 n.5 (Doc. 65
June 21, 2013) (acknowledging that confidential information
was presented to the Menthol Report writing group, of which
Drs. Benowitz and Samet were members, J.A. 2436); J.A.
2545-85 (a draft chapter of the subcommittee report showing
Dr. Henningfield’s tracked changes and (through redactions)
the presence of confidential information in the report at J.A.
2554).
There is considerable reason to believe that the
challenged members will not disclose such information.
Disclosure would subject them to criminal and civil penalties.
See 18 U.S.C. § 1905 (prescribing fines and imprisonment of
9
up to a year); 5 C.F.R. § 2635.801(d) (incorporating 18
U.S.C. § 1905 by reference to Subpart I of the regulation; see
5 C.F.R. § 2635.902(aa)). We have rejected assertions of
imminent injury where the prospective injury depends on
future illegal activity, finding, for example, that a sheriff
lacked standing to challenge President Obama’s immigration
policy partly because the plaintiff’s theory depended on
immigrants’ committing crimes in the future. Arpaio v.
Obama, 797 F.3d 11, 22 (D.C. Cir. 2015). More generally,
we are relatively hesitant to find standing when the asserted
injury “depends on the unfettered choices made by
independent actors not before the courts.” Lujan, 504 U.S. at
562 (citation and internal quotation marks omitted). Plaintiffs
have not presented evidence—or at least evidence sufficient
to support summary judgment—that the challenged members’
access to confidential information poses an imminent risk of
injury.
Shaping of the Menthol Report. Plaintiffs’ evidence that
they have been injured by any shaping of the report by the
challenged Committee members to support their expert
testimony is similarly weak. Although they note hundreds of
pending tobacco cases in which the challenged Committee
members are identified as prospective witnesses, Appellee Br.
6-7; J.A. 273, 278-79, they have presented no evidence on
how many of the cases concern menthol tobacco products.
They cite only a handful of mentions of the menthol report in
challenged members’ testimony and are only able to point to
two cases that involved a menthol smoker. Appellee Supp.
Br. 5. Moreover, their examples of such testimony do not
support their contention that the shaping of the report caused
any injury. For example, Dr. Henningfield, one of the
challenged Committee members, mentioned the report when
deposed in a case against (pre-merger) R.J. Reynolds (J.A.
2460-61), but he said that “[m]y testimony on menthol would
not be different than it has been in earlier cases when menthol
10
has come up.” J.A. 2460. Plaintiffs have not sought to refute
this. Henningfield described his testimony as consistent with
the report, but did not rely on it to bolster his credibility, and
in fact suggested that its findings on how menthol influences
the transition from use to dependence were not relevant to the
plaintiff in that case, as he had allegedly become addicted to
cigarettes before he started smoking menthols. J.A. 2461.
Plaintiffs have also presented no facts supporting their
contention that the challenged members shaped the report to
support their testimony, or used the report’s concurrence in
their views to validate those views. Of course plaintiffs can
press their objections to the report during cross-examination
of the expert witnesses in pending cases.
Finally, the challenged members’ opportunity to shape
the menthol report to characterize menthol tobacco products
as unsafe did not give rise to an imminent reputational injury.
Plaintiffs’ reliance on Meese v. Keene, 481 U.S. 465, 473-76
(1987), is misplaced. There a congressional statute identified
certain foreign films as “political propaganda,” and the Court
found standing for a politician who wanted to show the films
but claimed that doing so, in the face of the congressional
characterization, would damage his professional reputation
and impair his chances of securing reelection to the California
State Senate. He backed the claim up with powerful
supportive polling data. Id. at 472-75 & 473-74 n.7.
Plaintiffs offer no comparable evidence that the Committee’s
report is likely to inflict such an injury on their reputations.
* * *
In sum, plaintiffs have not demonstrated that any of their
three injuries is sufficiently imminent to confer standing. We
therefore vacate the judgment of the district court for lack of
jurisdiction and dissolve its injunction barring the use of the
11
menthol report and ordering the reconstitution of the
Committee.
So ordered.