v. - tobacco on trial · usca case #14-5226 document #1600816 filed: 02/25/2016 page 1 of 43[argued...

USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 of 43[ARGUED OCTOBER 7, 2015] No.14-5226

IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCillT

LORILLARD, INC., et al.,

Plaintiffs-Appellees

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION, et al.,

Defendants-Appellants

On Appeal from the United States District Court for the District of Columbia

PETITION OF APPELLEE, R.J. REYNOLDS TOBACCO COMPANY,

FOR REHEARING OR REHEARING EN BANC

Richard M. Cooper, DC Bar # 92817 Krista M. Anderson, DC Bar# 1020350 WILLIAMS & CONNOLLY LLP 725 Twelfth Street, N.W. Washington, DC 20005 Phone (202) 434-5466 Phone: (202) 434-5104 FAX: (202) 434-5029 [email protected] [email protected]

Attorneys for Appellee, R.J. Reynolds Tobacco Company

USCA Case #14-5226 Document #1601000 Filed: 02/26/2016 Page 1 of 43

USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 of 43

TABLE OF AUTHORITIES

CASES

Ass 'n of Am. Physicians & Surgeons, Inc. v. Clinton, 997 F .2d 898 (D.C. Cir. 1993) .................................................................................................. 13

Ass'n ofCmty. Orgs.for Reform Now v. Fowler, 178 F.3d 350 (5th Cir. 1999) ....................................................................................................... 11-12

At/. States Legal Found., Inc. v. EPA, 325 F.3d 281(D.C. Cir. 2003) .................... 15

Babbitt v. United Farm Workers Nat 'l Union, 442 U.S. 289 (1979) ........................ 7

Baur v. Veneman, 352 F.3d 625 (2d Cir. 2003) ............................................... 6-7, 14

Biotech. Indus. Org. v. District of Columbia, 496 F.3d 1362 (Fed. Cir. 2007) ..................................................................................................................... 6

Chamber of Commerce ofU S. v. EPA, 642 F.3d 192 (D.C. Cir. 2011) ............... 4-5

Chlorine Inst. v. Fed. R.R. Admin., 718 F.3d 922 (D.C. Cir. 2013) ........................ 15

Clapper v. Amnesty Int'/ USA, 133 S. Ct. 1138 (2013) .......................................... 10

CoxCom, Inc. v. Chafee, 536 F.3d 101 (1st Cir. 2008) .................................. 6

Crandon v. United States, 494 U.S. 152 (1990) ...................................................... 13

Digital Equip. Corp. v. Micro Tech, Inc., 142 F.R.D. 488 (D. Colo. 1992) ..................................................................................................................... 8

Franchise Tax Bd. of Cal. v. Alcon Aluminum Ltd., 493 U.S. 331 (1990 ................................................................................................................... 11

FTC v. Exxon Corp., 636 F.2d 1336 (D.C. Cir. 1980) .............................................. 7

IP Innovation L.L.C. v. Thomson, Inc., No. 1 :03-CV-0216-JDT-TAB, 2004 WL 771233 (S.D. Ind. Apr. 8, 2004) .......................................................... 8

Lockheed Martin Corp. v. Boeing Co., No. 6:03-CV-796-0RL28KRS, 2005 WL 5278461 (M.D. Fla. Jan. 26, 2005) ...................................................... 8

La. Envtl. Action Network v. Browner, 87 F.3d 1379 (D.C. Cir. 1996) .................. 15

11



Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) ................................................ 5

McBryde v. Comm. To Review Cir. Council Conduct & Disability Orders, 264 F.3d 52 (D.C. Cir. 2001) ................................................................ 13

Meese v. Keene, 481 U.S. 465 (1987) ............................................................... 12, 13

Metcalf v. Nat'! Petrol. Council, 553 F.2d 176 (D.C. Cir. 1977) ........................... 15

Nat'! Ass'n of Clean Air Agencies v. EPA, 489 F.3d 1221 (D.C. Cir. 2007) ................................................................................................................. 1, 4

Occidental Permian Ltd. v. FERC, 673 F.3d 1024 (D.C. Cir. 2012) ...................... 15

Pub. Citizen, Inc. v. Nat'! Highway Traffic Safley Admin., 489 F.3d 1279 (D.C. Cir. 2007) ....................................................................................... 5, 7

Rates Tech. Inc. v. Mediatrix Te/com Inc., No. CV 05-2755(JS)(AKT), 2007 W.L. 2581776 (E.D.N.Y. Sept. 5, 2007) ......................... 8

Raytheon v. Ashbom Agencies, Ltd., 372 F.3d 451 (D.C. Cir. 2004) .................... 11

Safe Flight Instrument Corp. v. Sundstrand Data Control Inc., 682 F. Supp. 20 (D. Del. 1988) ....................................................................................... 8

Sensormatic Elecs. Corp. v. Tag Co. US. LLC, No. 4:07-mc-181-TLW-TER, 2008 WL 217113 (D.S.C. Jan. 24, 2008) ......................................... 8

Sherley v. Sebelius, 610 F.3d 69 (D.C. Cir. 2010) ................................................ 1, 5

Sierra Club v. Jewell, 764 F.3d 1 (D.C. Cir. 2014) ..................................... 15

Stilwell v. Office of Thrift Supervision, 569 F.3d 514 (D.C. Cir. 2009) ................... 5

Tailored Lighting, Inc. v. Osram Sylvania Prods., Inc., 236 F.R.D. 146 (W.D.N.Y. 2006) ........................................................................................... 8

Texas v. United States, 523 U.S. 296 (1998) ............................................................. 5

Trs. of Bost. Univ. v. Everwright Elecs. Co., Nos. 12-cv-11935-PBS, 12-cv-12326-PBS, 12-cv-12330-PBS, 2014 WL 11030005 (D. Mass. July 8, 2014) .............................................................................................. 8

United States v. Irons, 640 F.2d 872 (7th Cir. 1981) .............................................. 13

111



United States v. Stadd, 636 F.3d 630 (D.C. Cir. 2011) ........................................... 13

Wyo. Outdoor Council v. U.S. Forest Serv., 165 F.3d 43 (D.C. Cir. 1999) ................................................................................................................... 15

STATUTES

18 u.s.c § 2 ........................................................................................................ 1, 13

18 U.S.C § 202(a) ................................................................................................ 1, 13

18 u.s.c § 208 .................................................................................................... 1, 13

18 U.S.C. § 208(a) ................................................................................................... 13

21 u.s.c. § 379d-1 .................................................................................................... 1

21 u.s.c. § 387d(b) ................................................................................................... 3

21 U.S.C. § 387g(e) ................................................................................................... 2

21 u.s.c. § 387g(f) ................................................................................................... 2

OTHER AUTHORITIES

5 C.F.R. pt. 2635 ................................................................................................. 1, 13

5 C.F.R. pt. 2640 ................................................................................................. 1, 13

Menthol in Cigarettes, Tobacco Products; Request for Comments, 78 Fed. Reg. 44,484 (July 24, 2013) ............................................................................................. 14

FDA, Guidance for Clinical Trial Sponsors[:] Establishment and Operation of Clinical Trial Data Monitoring Committees 9 (Mar. 2006), http://www.fda.gov/downloads/Regulatorylnformation/Guidances/ucm 127073.pdf ................................................................................................................. 4

Dep't of Health & Human Servs., Fiscal Year 2015 Food and Drug Administration Justification of Estimates for Appropriations Committees (undated), http://www.f<la.gov/ downloads/ AboutFDA/ReportsManuals F orms/Reports/BudgetReports/UCM3 883 09. pdf ......................................... 14-15, 15

IV



AR

Brief

challenged members

ethics rules

FDA

FDA Budget Justification

JA

Menthol Report

Panel Op.

GLOSSARY

Administrative Record

Corrected Brief for Appellees (#1549749 filed Apr. 28, 2015)

Drs. Neil Benowitz, Jack Henningfield, and Jonathan Samet

Conflict-of-interest statutes and regulations (18 U.S.C §§ 2, 202(a), 208; 21 U.S.C. § 379d-l; 5 C.F.R. pts. 2635, 2640

U.S. Food and Drug Administration

Dep't ofHealth & Human Servs., Fiscal Year 2015 Food and Drug Administration Justification of Estimates for Appropriations Committees (undated), http://www.fda.gov/ downloads/ AboutFDA/ReportsManu alsF orms/Reports/BudgetReports/UCM3 883 09. pdf

Joint Appendix

Menthol Cigarettes and Public Health: Review of the .Scientific Evidence and Recommendations (Mar. 23, 2011; final edits July 21, 2011 ), Administrative Record 19433-684, http://www.fda.gov/downloads/AdvisoryCommittees/Co mmitteesMeetingMaterials/TobaccoProductsScientificAd visoryCommittee/UCM269697 .pdf

R. J. Reynolds Tobacco Co. v. FDA, No. 14-5226 (D.C. Cir. Jan. 15, 2016), https://www.cadc.uscourts.gov/intemet/opinions.nsf/453 5A54A84 790EC685257F3B0054CC05/$file/14-5226-1593800.pdf

v



Pl. Sum. J. Mem.

Reynolds

Supp. Br.

TPSAC

Unredacted Memorandum In Support of Plaintiffs' Motion For Summary Judgment And In Opposition To Defendants' Motion For Summary Judgment (Doc. 67-1 July 19, 2013)

R.J. Reynolds Tobacco Company

Supplemental Brief for Appellee, R.J. Reynolds Tobacco Co. (#1582370 filed Nov. 6, 2015)

The Tobacco Products Scientific Advisory Committee

Vl



STATEMENT OF THE ISSUE AND ITS IMPORTANCE

The Panel decision ("Panel Op.") conflicts with decisions of this Court-

e.g., Sherley v. Sebelius, 610 F.3d 69, 74 (D.C. Cir. 2010); National Association of

Clean Air Agencies v. EPA, 489 F.3d 1221, 1227 (D.C. Cir. 2007). Although it

mentions the "substantial probability" standard for injury, Panel Op. 6, it makes

that standard impossible to satisfy in challenges to advisory committee members

with conflicting interests. Consideration by the full court is therefore necessary to

secure and maintain uniformity of the Court's decisions.

This case also involves an issue of exceptional and government-wide impor-

tance: whether a private party can have standing to challenge, under 18 U.S.C.

§§ 2, 202(a), and 208; 21 U.S.C. § 379d-1; 5 C.F.R. pts. 2635, 2640 (the "ethics

rules"), participation by advisory committee members in particular matters as to

which they have unwaived conflicting interests. The Panel Op.' s standing analysis

demands evidence that ordinarily is impossible to obtain, and consequently will

make it ordinarily impossible for any private party to have standing to make such a

challenge. This result is likely to be broadly harmful to private parties disfavored

in the political process, and thus lacking influence over committee appointments. 1

1 Panel Op. 3 states: "As we understand plaintiffs' position, they believe that a grant of waivers would have manifested acknowledgement of the conflicts of



STATEMENT OF THE CASE

Plaintiffs challenge the initial appointments by the Food and Drug Adminis-

tration ("FDA") of certain members of the agency's Tobacco Products Scientific

Advisory Committee ("TPSAC") and those members' participation in the develop-

ment of two statutorily mandated reports, one on menthol cigarettes, 21 U.S.C.

§ 387g(e), and the other on dissolvable tobacco products, 21 U.S.C. § 387g(f).

Corrected Brief for Appellees 2-3 & n.6 (#1549749 filed Apr. 28, 2015) ("Brief').2

Here, with meeting-by-meeting FDA approval, Brief 48 n.142, three TPSAC

members-Drs. Benowitz, Benningfield, and Samet (Committee Chair, Brief 18 &

n.77) (together, the "challenged members"}-helped write the Menthol Report, see

AR 19433-34 (Drs. Benowitz and Samet); JA 2532-37 (Dr. Benningfield); and two

interest and thus adequately palliated their injuries." That is not plaintiffs' position. Had waivers been granted, it is doubtful that plaintiffs could allege a violation of law. Acknowledgement of the conflicts would not have palliated any of plaintiffs' three types of injury, discussed infra. Waivers may remove the unlawfulness of the participation by committee members who have conflicting interests, but do not palliate the injuries that result from that participation.

2 The report on menthol cigarettes (Mar. 23, 2011; final edits, July 21, 2011) ("Menthol Report") is at Administrative Record ("AR") 19433-684 and at http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterial s/TobaccoProductsScientificAdvisoryCommittee/UCM269697. pdf. The report on dissolvable tobacco products (Mar. 1, 2012) is at AR 23495-503 and at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterial s/TobaccoProductsScientificAdvisoryCommittee/UCM295842.pdf.

2



of those members helped write the report on dissolvable tobacco products, see AR

21584-85, 21595-982, 24241-42, 24254-521 (Drs. Benowitz and Samet).

As part of that participation, those members received from FDA confidential

information that was submitted to FDA under 21 U.S.C. § 387d(b) by plaintiffs,

including R.J. Reynolds Tobacco Company ("Reynolds"), and that relates to the

design and other aspects of menthol cigarettes and dissolvable tobacco products

manufactured and sold by Reynolds.3 Those members consult on (i) product

design for manufacturers of nicotine-replacement-therapy products, which compete

with Reynolds's dissolvable tobacco products, and (ii) on other smoking-cessation

products, sales of which would increase if sales of menthol cigarettes and/or dis-

solvable tobacco products were banned or restricted. Brief 8-14. Those members

also testify against these plaintiffs/appellees in products-liability cases relating to

menthol cigarettes and other kinds of cigarettes, and were designated to testify in

hundreds of such cases. Id. at 5-8. Two of them so consulted, and one so testified,

even while serving on TPSAC. Brief 12 & n.48, 13 & n.53, 16 & n.68. These

3 Brief12 & n.47, 18 & nn.73-76, 55 & nn.167-69. The types of confidential information Reynolds was required to provide to FDA for use by TPSAC-e.g., product formulations, information on products in development, toxicological research, market research-are shown by document-request letters that FDA sent to Reynolds and other tobacco-product manufacturers. See JA 2386-88, 2448-55. FDA has never contended that Reynolds did not comply fully with these requests.

3



challenged members have relevant additional intellectual biases, id. at 15-16,

which FDA otherwise treats as potentially inconsistent with required impartiality.4

If the regulated plaintiffs here lack a substantial probability of injury, even

though (i) their confidential information was given to committee members who

consult for their competitors, and (ii) those members are paid to disparage in

testimony against these plaintiffs the very products about the regulation of which

they advise FDA, then almost certainly no private party ever has standing to

challenge participation by a committee member with a conflicting interest.

ARGUMENT

THE PANEL DECISION IS CONTRARY TO CIRCUIT PRECEDENT THAT A SUBSTANTIAL PROBABILITY OF HARM SUFFICES FOR INJURY IN FACT, AND THE DECISION REQUIRES EVIDENCE THAT GENERALLY IS IMPOSSIBLE TO OBTAIN.

It is settled law in this Circuit that, for injury in fact, a substantial probability

of injury suffices. Nat'l Ass 'n of Clean Air Agencies, 489 F.3d at 1227; Chamber

of Commerce of US. v. EPA, 642 F.3d 192, 200 (D.C. Cir. 2011) ("to 'shift[]

injury from "conjectural" to "imminent,"' the petitioners must show that there is a

4 See FDA, Guidance for Clinical Trial Sponsors[:] Establishment and Operation of Clinical Trial Data Monitoring Committees 9 (Mar. 2006) ("Individuals known to have strong views on the relative merits of the interventions under study may have an 'intellectual' conflict of interest and might not be able to review the data in a fully objective manner .... "), http://www.fda.gov/ downloads/Regulatorylnformation/Guidances/ucm 127073. pdf.

4



'substantial ... probability' of injury" (alterations in original) (citations omitted));

Sherley v. Sebelius, 610 at 7 4 ("the Doctors face a substantial enough probability to

deem the injury to them imminent"); Stilwell v. Office of Thrift Supervision, 569

F .3d 514, 518-19 (D.C. Cir. 2009) (citing cases). The purpose of the imminence

requirement "'is to ensure that the alleged injury is not too speculative for Article

III purposes."' Pub. Citizen, Inc. v. Nat'! Highway Traffic Safety Admin., 489 F.3d

1279, 1294 (D.C. Cir. 2007), quoting Lujan v. Defenders of Wildlife, 504 U.S. 555,

564-65 n.2 (1992).

As accurately summarized by the Panel, plaintiffs' three theories of injury

are: (i) the challenged members' possession of plaintiffs' confidential information;

(ii) the shaping of the Menthol Report to support testimony against plaintiffs; and

(iii) influencing FDA to take regulatory action adverse to plaintiffs. Panel Op. 4.

Each of these injuries plainly involves a substantial probability of harm. The

Panel's rationale-that standing nevertheless is defeated if a claim "rests upon

'contingent future events that may not occur as anticipated, or indeed may not

occur at all,"' Panel Op. 5-6 (quoting Texas v. United States, 523 U.S. 296, 300

(1998)}-as applied to these injuries, conflicts with established Circuit precedent.

I. POSSESSION OF PLAINTIFFS' CONFIDENTIAL INFORMATION.

In analyzing the imminence of injury from the challenged members' posses-

sion of plaintiffs' confidential information, which is relevant to their consulting

5



and testifying, Panel Op. 8-9 disregards the "substantial probability" standard and

calls for a type of evidence ordinarily impossible to obtain. Contrary to Panel Op.

8-9, plaintiffs' theory of injury does not depend on unlawful disclosure of the

confidential information, but, rather, on its influence on the challenged members'

consulting advice and testimony, even without disclosure. See Brief27-28.

For example, on the basis of such information but without disclosing it, a

TPSAC member could advise a consulting client to use (or not use) a particular

ingredient in a nicotine-replacement-therapy drug, or to do (or not do) a particular

test in a particular way, or to use (or not use) a particular marketing technique.

Similarly, as an expert witness, the TPSAC member could express opinions such

information supports or avoid expressing opinions it contradicts.

The Panel states that plaintiffs "have only presented evidence that the Com-

mittee members received such information ... not that they used it the way plain-

tiffs fear." Panel Op. 8. That criticism disregards the substantial-probability

standard.5 The confidential information is directly relevant to the subjects on

5 See Coxcom, Inc. v. Chafee, 536 F.3d 101, 108 (1st Cir. 2008) ("Even though ... there is no showing that any CoxCom subscriber actually used one of the filters purchased from appellants to cause financial harm to CoxCom, the chain of events that can result from the sale of filters in CoxCom's service area clearly encompasses a loss of remuneration to CoxCom."); Biotech. Indus. Org. v. District of Columbia, 496 F. 3d 1362, 1370 (Fed. Cir. 2007) ("The injury need not have been already manifested."); Baur v. Veneman, 352 F.3d 625, 641 (2d Cir. 2003) ("it is not the materialization of the feared risk itself that must be 'certainly impending.' .

6



which the challenged members consult and testify; and those members continued

to consult or testify while serving on TPSAC. See supra p. 3. Those facts create at

least a "substantial probability," a "realistic danger" or "credible threat," Babbitt v.

United Farm Workers Nat'/ Union, 442 U.S. 289, 298 (1979), that the information

will influence their consulting and/or the preparation of their testimony.6 A

substantial increase even in non-environmental risk suffices for injury. Pub.

Citizen, 489 F.3d at 1296.

"[I]t is very difficult for the human mind to compartmentalize and selec-

tively suppress information once learned, no matter how well-intentioned the effort

may be to do so." FTC v. Exxon Corp., 636 F.2d 1336, 1350 (D.C. Cir. 1980).

"Once [a party's] confidential and proprietary data is reviewed by [the expert], it

. . [T]he relevant 'injury' for standing purposes may be exposure to a sufficiently serious risk of medical harm-not the anticipated medical harm itself .... ").

6 While serving on TPSAC, JA 191 & Brief 5, on January 27, 2011, Dr. Henningfield was asked, on direct examination at a trial, JA 1830 (tr. at 930) (trial date), 1833 (tr. at 943) (witness), what kinds of things he "consult[ed] and rel[ied] on," JA 1844 (tr. at 988-89). His answer began: "Well, tobacco industry documents, because that goes to how we know in the scientific world about a lot of the design features that make cigarettes more addictive. So that's an important part of it that I've reviewed over the years." Id. (tr. at 988-89). He referred to menthol. JA 1850-51 (tr. at 1013-14). He testified the next day, JA 1888: "We are getting [present tense] information, some of it through [FDA] investigation that uncovered secret documents, some of it through the trials that uncovered more secret documents, and now the [FDA] oversight will cause the tobacco industry to provide more information." JA 1915 (tr. at 1343).

7



will become part of his general acquired knowledge, which cannot be 'unlearned'

or utilized only on a selective basis," Digital Equip. Corp. v. Micro Tech., Inc., 142

F.R.D. 488, 491-92 (D. Colo. 1992). The probability of improper influence of

such information given to an expert otherwise adverse to a producing party is

recognized as sufficiently substantial to justify protective orders to prevent it.7 In

Lockheed Martin Corp. v. Boeing Co., No. 6:03-CV-796-0RL28KRS, 2005 WL

5278461, at *3 (M.D. Fla. Jan. 26, 2005), the court protected against "intentional[]

7 See, e.g., Sensormatic Elecs. Corp. v. Tag Co. U.S. LLC, No. 4:07-mc-181-TLWTER, 2008 WL 217113, at *4 (D.S.C. Jan. 24, 2008) ("Based on his patents, teaching, writing, and vocational endeavors, I do not believe it is feasible for him to separate either his knowledge gained or him from future competitive endeavors."); Rates Tech. Inc. v. Mediatrix Telcom Inc., No. CV 05-2755(JS)(AKT), 2007 WL 2581776, at *3 (E.D.N.Y. Sept. 5, 2007) (actual misuse of confidential information not necessary to find actual risk of disclosure or misuse sufficient to warrant prophylactic judicial relief); Tailored Lighting, Inc. v. Osram Sylvania Prods., Inc., 236 F.R.D. 146, 149 (W.D.N.Y. 2006) ("this Court has no reason to question the integrity of plaintiffs president and patent inventor; nonetheless, it seems unreasonable to expect that anyone working to further his own scientific and technological interests would be able assuredly to avoid even the subconscious use of confidential information revealed through discovery that is relevant to those interests"); Safe Flight Instrument Corp. v. Sundstrand Data Control Inc., 682 F. Supp. 20, 22 (D. Del. 1988) ("accepting that Mr. Greene is a man of great moral fiber, we nonetheless question his human ability during future years of research to separate the applications he has extrapolated from Sundstrand's documents from those he develops from his own ideas"). See also Trs. of Bost. Univ. v. Everlight Elecs. Co., Nos. 12-cv-11935-PBS, 12-cv-12326-PBS, 12-cv-12330-PBS, 2014 WL 11030005, at *3 (D. Mass. July 8, 2014) ("Courts have generally denied an employee-inventor access to highly confidential materials of their adversary."); IP lnnovationL.L.C. v. Thomson, Inc., No. 1:03-CV-0216-JDT-TAB, 2004 WL 771233, at *3 (S.D. Ind. Apr. 8, 2004) ("The risk for abuse is real.").

8



or inadvertent[]" misuse of confidential information by an expert. The truth under-

lying this caselaw is captured in Russian folklore, where "'a man tells his younger

brother to sit in the comer and not think of a white bear, only to find later that the

sibling can think of nothing else."' JA 289 n.79. Plainly, there is a "substantial

probability" that the confidential information the challenged members received

influences their consulting advice and testimony, advertently or inadvertently.8

The Panel faults plaintiffs for not presenting "by affidavit or other evidence

specific facts suggesting that the challenged members have made or will make

improper use of confidential information." Panel Op. 8. Ordinarily, such evid-

ence cannot be obtained. Plaintiffs are not invited to attend the challenged

members' meetings with their consulting clients or their preparation sessions with

the lawyers for whom they testify; and influence without disclosure cannot reliably

be inferred from testimony. Yet, as the cases cited supra note 7 show, the situation

creates a substantial probability of actual influence.

The Panel states that it is "relatively hesitant to find standing when the

asserted injury depends on the unfettered choices made by independent actors not

8 FDA effectively acknowledged this substantial probability when it excluded from TPSAC's drafting of the Menthol Report TPSAC's industry-representative members on the ground that they were "not permitted access to trade secret or commercial confidential information." AR 10693-94, 11512-13. On this point, those members-who were subject to the same prohibition on improper disclosure as were other TPSAC members-were indistinguishable from the challenged members, who consult for competitors of the submitters of that information.

9



before the courts." Panel Op. 9 (internal quotation marks omitted). Yet, the

influence of the confidential information on thought, consulting, and testifying

does not depend on such "choices," as the caselaw and Russian folklore recognize.

Every time a challenged member consults about the design of a nicotine

replacement-therapy product or prepares or gives testimony about menthol ciga

rettes, what he says is very likely to be influenced by his knowledge of plaintiffs'

confidential information. Therefore, injury from that knowledge is "certainly

impending," Clapper v. Amnesty Int'l USA, 133 S. Ct. 1138, 1143 (2013).

II. SHAPING THE MENTHOL REPORT TO SUPPORT TESTIMONY.

FDA put the challenged members in positions to shape the Menthol Report,

and they did. Brief 18-20; Supplemental Brief for Appellee, R.J. Reynolds

Tobacco Co. 3 n.4 (#1582370 filed Nov. 6, 2015) ("Supp. Br.").

The Panel comments that plaintiffs did not rebut testimony in which Dr.

Henningfield mentioned the Menthol Report and stated that his testimony on

menthol would not be different from his prior testimony on menthol. Panel Op. 9-

10. Plaintiffs have no reason to rebut it. That testimony shows the injury. Two

challenged members recurrently disparaged menthol cigarettes in their testimony

and other public statements before their service on TPSAC. See, e.g., as to Dr.

Benowitz: JA 240, 273, 431-32, 441, 443-44, 453; as to Dr. Henningfield: JA 1814

& nn.6-10, 2001-02 (Tr. 1713-15), 2013 (Tr. 1759-60), 2456 (date), 2457 (parties),

10



2459 (witness), 2459-61 (testimony). As shown infra, the report matches Dr.

Henningfield's testimony during and after that service. Thus, the report was

shaped to match both Dr. Henningfield's prior and his subsequent testimony.

The Panel states that Dr. Henningfield "did not rely on [the Menthol Report]

to bolster his credibility." Panel Op. 10, citing J.A. 2461 (testimony on July 6,

2011, JA 2456). He did state that his opinions "are consistent with the TPSAC re

port .... " JA 2460. He also cited the report to support his credibility on Decem

ber 20, 2012 in testifying for a menthol smoker suing Reynolds. See, as filed in the

district court, Declaration of William E. Latham II, Ex.Bat Tr. 1 (parties, date),

Tr. 16-17 (Ms. Whitney became a menthol smoker), Tr. 92 ("This was a concern

that TPSAC raised. And actually if - what would be helpful, if you want, I could

quickly run through the TPSAC Report and point out a couple of the main find

ings."), Tr. 93 ("I think we can find a reasonable explanation for each of our opin

ions in there and I concur with those. So my opinions on this topic will essentially

be the TPSAC Report.") (Doc. 67-3 filed July 19, 2013). See also Supp. Br. 5.

Panel Op. 9 disparages the quantity of such cases plaintiffs cite. Where

there is some injury, however, its quantity is irrelevant to standing. Even the

"threat of relatively small financial injury" suffices. Raytheon v. Ashborn Agen

cies, Ltd., 372 F.3d 451, 454 (D.C. Cir. 2004) (citing Franchise Tax Bd. of Cal. v.

A/can Aluminum Ltd., 493 U.S. 331, 336 (1990)). See also, e.g., Ass 'n of Cmty.

11



Orgs.for Reform Now v. Fowler, 178 F.3d 350, 357-58 (5th Cir. 1999) ("Supreme

Court precedent teaches that the injury in fact requirement ... is qualitative, not

quantitative, in nature."). Here, there is a substantial probability of serious injury.

The Menthol Report injures the reputations of plaintiffs and their menthol

cigarettes. It has been relied on in calls for FDA to ban menthol cigarettes.9 It has

been cited against plaintiff Lorillard in litigation.10 It also is being widely cited in

the scientific literature, 11 which influences decisions in many forums (regulatory,

legislative, judicial, and private). The polling data in Meese v. Keene, 481 U.S.

465, 474-75 (1987), cited at Panel Op. 10, showed a "risk of injury" to reputation

9 See Tobacco Control Legal Consortium, Citizen Petition 3, 4, 8-13, 14, 16-17, 18, 19, 22, 24, 26, 28, 33 (Apr. 12, 2013), http://www.regulations.gov/#!document Detail;D-FDA-2013-P-0435-0001; Letter from Citizens' Comm'n to Protect the Truth to Caryn Cohen, M.S. [FDA], at 2d unnumbered page (Apr. 18, 2012), http://wll.peer360.com/content_document/44017.pdf; Aisha C. Moodie-Mills, Flavored Disease and Death for Minorities[:] Why the FDA Must Ban Menthol Cigarettes 1n.2,2 n.4, 3 n.8, 4 n.13, 6 n.20 (Ctr. for Am. Progress May 2011), http://www.amer icanprogress.org/wp-content/uploads/issues/2011 /05/pdf/menthol _ban. pdf.

10 Brief of Amici Curiae, Am. Legacy Found., 7-8, 14-15, 17, 33, Evans v. Lorillard Tobacco Co., No. SJC-11179 (Mass. Sup. Jud. Ct. filed Oct. 26, 2012), Memorandum in Support of Plaintiffs' Motion for Summary Judgment and in Opposition to Defendants' Motion for Summary Judgment ("Pl. Sum. J. Mem."), Ex. 1 (Doc. 67-1 filed July 19, 2013).

11 Eight scientific articles that cite the report (issued in 2011) and that were published as of July 19, 2013 are cited in Pl. Sum. J. Mem. 14-15 n.18. Google Scholar lists 48 publications that cite it: http://scholar.google.com/scholar?cites=149346 3 l 712423875113&as_sdt=20005&sciodt=l,9&hl=en (last visited Feb. 18, 2016).

12



sufficient for injury in fact, 481 U.S. at 475. See McBryde v. Comm. To Review

Cir. Council Conduct & Disability Orders, 264 F.3d 52, 56-57 (D.C. Cir. 2001)

(analyzing Meese; finding injury to "reputation generally" from "stigmatizing re

ports"). These citations to the report similarly show reputational injury in fact.

III. INFLUENCING FDA TO ACT AGAINST MENTHOL CIGARETTES.

"Advisory committees not only provide ideas to the government, they also

often bestow political legitimacy on that advice." Ass 'n of Am. Physicians & Sur

geons, Inc. v. Clinton, 997 F.2d 898, 913 (D.C. Cir. 1993). Plainly, Congress

required TPSAC reports on menthol cigarettes and dissolvable tobacco products to

provide FDA unbiased advice about those products. The challenged members'

participation in those reports defeated that purpose; Indeed, an obvious purpose of

the ethics rules, as applied to advisory committees, is to prevent the kinds of inju

ries at issue here-to prevent the giving of committee advice that is biased by con

flicting interests, and to prevent committee members from using their official roles

to further private interests, to the harm of the public interest and private parties.

Title 18 U.S.C. § 208(a) is prophylactic. United States v. Irons, 640 F.2d

872, 876-78 (7th Cir. 1981); cf Crandon v. United States, 494 U.S. 152, 164

(1990). Actual corruption or misconduct is not an element. United States v. Stadd,

636 F.3d 630, 636 (D.C. Cir. 2011) (listing elements). Congress determined that

the probability, risk, threat, or danger created by the existence of a conflicting

13



interest on the part of a participating government employee, by itself, suffices for

criminal prohibition. The same probability, risk, threat, or danger to a party situ-

ated adversely to a conflicted government employee and within the range of that

employee's ability to inflict injury should also suffice for injury in fact. "Thus, in

this case, there is a tight connection between the type of injury [the plaintiffs]

allege[] and the fundamental goals of the statutes which [they] sue[] under-

reinforcing [plaintiffs'] claim of cognizable injury." Baur, 352 F.3d at 635.

TPSAC's Menthol Report unanimously concluded: "Removal of menthol

cigarettes from the marketplace would benefit public health in the United States."

Menthol R~port 225, AR 19660. FDA generally follows its advisory committees'

advice; in one study, it followed 92% of unanimous views. Brief20. Here, FDA

has already invested scarce resources in an advance notice of proposed rulemaking

and in its own scientific review12-actions it certainly would not have taken if it

did not believe that final regulatory action as to menthol cigarettes is substantially

probable.13 Later, referring to that advance notice and scientific review, FDA

12 Menthol in Cigarettes, Tobacco Products; Request for Comments, 78 Fed. Reg. 44,484, 44,484 (July 24, 2013). FDA referred to TPSAC's Menthol Report. Id.

13 FDA's resources are scarce. In presenting FDA's proposed 2015 budget, Commissioner Margaret A. Hamburg, M.D., stated: "the magnitude of the new responsibilities we have been asked to take on urgently requires additional resources ... . " Dep't of Health & Human Servs., Fiscal Year 2015 [FDA] Justification ofEstimates for Appropriations Committees i (undated) ("FDA Budget Justification"), http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/Budget

14



stated: "FDA is committed to a science-based approach that addresses the public

health issues raised by menthol cigarettes." FDA Budget Justification 130. That is

a public commitment to "address[]," i.e., to act as to, menthol cigarettes. 14

Under this Court's "substantial probability" decisions, these circumstances

create an injury to plaintiffs' economic interests that, even if not certain, is

substantially probable, not merely speculative, hypothetical, abstract, remote, or

contingent on a tenuous, multi-step causal chain. 15

CONCLUSION

For the foregoing reasons, the Court should grant re-hearing by the Panel or

en bane.

Respectfully submitted,

Reports/UCM388309.pdf. Among FDA's requested increases were increases in user fees for tobacco products. Id. at 8, 132.

14 In contributing to a substantial probability, these FDA actions are similar to the factors in Wyoming Outdoor Council v. United States Forest Service, 165 F.3d 43 (D.C. Cir. 1999), discussed at Panel Op. 7-8. Cf Sierra Club v. Jewell, 764 F.3d 1, 7 (D.C. Cir. 2014) (related actions and stated expectation established substantial probability). Plaintiffs' injuries result from violations of a procedural right, challenges to which are subject to a less rigorous standard of injury. Brief 29-34.

15 A multi-step causal chain was the decisive factor in Chlorine Institute, Inc. v. Federal Railroad Administration, 718 F.3d 922, 928 (D.C. Cir. 2013); Occidental Permian Ltd. v. FERC, 673 F.3d 1024, 1026-27 (D.C. Cir. 2012); Atlantic States Legal Foundation, Inc. v. EPA, 325 F.3d 281, 283 (D.C. Cir. 2003); Louisiana Environmental Action Network v. Browner, 87 F.3d 1379, 1383 (D.C. Cir. 1996); andMetcalfv. National Petroleum Council, 553 F.2d 176, 184 (D.C. Cir. 1977).

15



February 25, 2016.

725 Twelfth Street, N.W. Washington, DC 20005 Phone: (202) 434-5466

(202) 434-5104 FAX: (202) 434-5029 [email protected] [email protected]

Attorneys for Appellee, R.J. Reynolds Tobacco Company



CERTIFICATE AS TOP ARTIES, RULINGS, AND RELATED CASES

A. Parties and Amici.

1. Plaintiffs/ Appellees.

The original plaintiffs/appellees were Lorillard, Inc., now known as

Lorillard, LLC ("Lorillard"); Lorillard Tobacco Company ("LTC"); and R. J.

Reynolds Tobacco Company ("RJRT").

On June 12, 2015, Lantern Acquisition Co. ("LAC"), a direct, wholly-owned

subsidiary of Reynolds American Inc. ("RAI"), merged with and into Lorillard,

with Lorillard surviving as a wholly-owned subsidiary of RAI. Such transaction is

referred to as the Lorillard merger. Following the Lorillard merger: RAI

contributed the stock of Lorillard to its subsidiary, R. J. Reynolds Tobacco

Holdings, Inc.; Lorillard converted into a limited liability company, named

Lorillard, LLC; and Lorillard Tobacco Company, LLC (formerly known as

Lorillard Tobacco Company) merged with and into RJRT, with RJRT continuing

as the surviving corporation (such transaction is referred to as the Lorillard

Tobacco merger).

A more detailed description of the Lorillard merger, Lorillard Tobacco

merger, and related transactions follows:



a. Structure of the Companies Immediately Before the Lorillard Merger.

Immediately before the Lorillard merger, (i) Lorillard and RAI were wholly

separate and independent companies; (ii) L TC was a direct, wholly-owned

subsidiary of Lorillard; and RJRT was a direct, wholly-owned subsidiary ofR.J.

Reynolds Tobacco Holdings, Inc. ("RJRH"), which was, itself, a direct, wholly-

owned subsidiary ofRAI. Neither RAI nor RJRH is a party in this litigation. Just

prior to the closing of the Lorillard merger, Lorillard converted L TC to a limited

liability company ("LLC").

b. The Lorillard Merger.

The Lorillard merger proceeded as follows:

(i) LAC merged with and into Lorillard, with

Lorillard continuing as the surviving corporation. Lorillard retains the Lorillard

name, and will not engage in the design, manufacture, distribution, marketing, or

sale of any tobacco products. Rather, as described below, those functions remain

with Plaintiff/ Appellee L TC, which, in tum, was merged into Defendant RJR T.

(ii) Immediately prior to the Lorillard merger, certain

assets then owned by Lorillard subsidiaries, including Lorillard's Greensboro, NC

manufacturing facility, and other liabilities were sold and transferred to ITG

Brands, LLC (formerly known as Lignum-2, L.L.C., a company unaffiliated with

Lorillard, RAI, or any of their affiliates) ("ITG"). Immediately after the closing of



the Lorillard merger, RAI subsidiaries or affiliates sold certain assets and

transferred certain liabilities to ITG, including assets and liabilities relating to the

Winston, Salem, and Kool cigarette brands previously designed, manufactured,

distributed, marketed, and sold by RJRT; the Maverick cigarette brand previously

designed, manufactured, distributed, marketed, and sold by L TC; and the blu e

cigarette brand.

(iii) After the Lorillard merger, RAI contributed all of

the outstanding stock of Lorillard to RJRH. As noted above, Lorillard was

subsequently converted into a limited liability company, and, like RJRT, is a

wholly-owned subsidiary ofRJRH.

(iv) Immediately after the Lorillard merger, LTC was

merged with and into RJRT, with RJRT continuing as the surviving corporation.

Following the Lorillard Tobacco merger, RJRT retains the same name and the

same position in RAI' s corporate structure, as it had before the Lorillard Tobacco

merger. As a result of the Lorillard Tobacco merger, LTC's subsidiaries became

subsidiaries ofRJRT.

2. Defendants/ Appellants.

The original defendants/appellants were the United States Food and Drug

Administration ("FDA"); the United States Department of Health and Human

Services ("DHHS"); Kathleen Sebelius, Secretary of Health and Human Services



(in her official capacity); Margaret A. Hamburg. M.D., Commissioner of Food and

Drugs (in her official capacity); and Lawrence R. Deyton, M.S.P.H., M.D.,

Director, Center for Tobacco Products, FDA (in his official capacity).

FDA and DHHS remain defendants/appellees. The current individual

defendants/appellees are Sylvia M. Burwell, Secretary of Health and Human

Services (in her official capacity); Stephen Ostroff, M.D., Acting Commissioner of

Food and Drugs (in his official capacity); and Mitch Zeller, J.D., Director, Center

for Tobacco Products, FDA (in his official capacity).

3. Amici Curiae.

In the district court, the American Academy of Pediatrics, the American

Association of Cancer Research, the American Heart Association, the American

Cancer Society, the American Cancer Society Cancer Action Network, the

American Lung Association, the American Medical Association, the American

Society of Preventive Oncology, the American Thoracic Society, the Association

of Schools of Public Health, the Campaign for Tobacco Free Kids, the Center for

Science in the Public Interest, and the Oncology Nursing Society joined in an

amicus brief in support of the Defendants.

In this Court, the American Academy of Otolaryngology-Head and Neck

Surgery, the American Academy of Pediatrics, the American Association for

Respiratory Care, the American Cancer Society Cancer Action Network, the



American College of Cardiology, the American Heart Association, the American

Legacy Foundation, the American Lung Association, the American Medical

Association, the American Thoracic Society, the Campaign for Tobacco-Free Kids,

the General Board of Church and Society of the United Methodist Church, the

National African American Tobacco Prevention Network, the National Association

of County and City Health Officials, the National Latino Alliance for Health

Equity, the Partnership for Prevention, the Society for Research on Nicotine and

Tobacco, and the Tobacco Control Legal Consortium have joined in an amicus

brief in support of Appellants.

Also in this Court, the Center for Regulatory Effectiveness has filed an

amicus brief in support of affirmance or remand, and the Washington Legal

Foundation has filed an amicus brief in support of affirmance.

C. Rulings Under Review.

The Brief for Appellants states: "The defendants-appellants seek[] review of

the July 21, 2014 judgment and decision, issued by the Honorable Richard J. Leon,

United States District Judge for the District of Columbia, in case No. 11-cv-440,

ECF Nos. 83, 84. The district court's opinion and order are reproduced in the Joint

Appendix at JA120 and JA155 respectively. No citation is yet available in the

Federal Supplement. The district court's opinion can be found at 2014 WL



3585883." The district court's decision subsequently has been reported at 56 F.

Supp. 3d 37.

D. Related Cases.

This case has not previously been before this or any other court. We are not

aware of any related case.



CORPORATE DISCLOSURE STATEMENT

Plaintiff/appellee, R. J. Reynolds Tobacco Company ("RJRT"), a North

Carolina corporation, is successor by merger to R.J. Reynolds Tobacco Company,

a New Jersey corporation. The existing RJRT is a wholly owned indirect

subsidiary of Reynolds American Inc. ("RAI"), a publicly held corporation.

Brown & Williamson Holdings, Inc. (formerly known as Brown & Williamson

Tobacco Corporation) and Louisville Securities Limited each hold more than 10%

of the stock ofReynolds American Inc.

Effective July 30, 2004, a transaction was completed whereby RJRT became

successor in interest to Brown & Williamson Tobacco Corporation's U.S. tobacco

business. Effective August 2, 2004, Brown & Williamson Tobacco Corporation, a

Delaware corporation, changed its name to Brown & Williamson Holdings, Inc.

Brown & Williamson Holdings, Inc. and Louisville Securities Limited are indirect

wholly owned subsidiary of British American Tobacco, p.l.c., a publicly held

corporation.

During the pendency of this appeal, the other two plaintiffs/appellees

Lorillard, Inc. (now known as Lorillard, LLC) was acquired by RAI and Lorillard

Tobacco Company, LLC (formerly known as Lorillard Tobacco Company) was

merged with and into RJRT, as described in the Certificate as to Parties, Rulings,

and Related Cases.




~nit£n ~tai£s Olnurt nf J\pp£als 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.



USCA Case #14-5226 Document #1593800 Filed: 01/15/2016

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., I Food and Drug Administration § 4:15 (4th ed. 2015) (describing management review process for FDA rules).

Page 2of11




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 premerger 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.

Page 3of11



USCA Case #14-5226 Document#1593800 Filed: 01/15/2016

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

Page 4of11




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 bane).

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. US., 523 U.S. 296,

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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-andcomment 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)(l), 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)(l)(A). If the report influences a proposed

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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.

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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

Page 8of11




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 plaintiffs 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 m3ury. 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

Page 9of11




10

has come up." J.A. 2460. Plaintiffs have not sought to refute this. Benningfield 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

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11

menthol report and ordering the reconstitution of the Committee.

So ordered.



CERTIFICATE OF SERVICE

I HEREBY CERTIFY that, on February 25, 2016, I caused to be filed the

foregoing petition with the Clerk of the United States Court of Appeals for the

District of Columbia Circuit by using the CM/ECF system and hand delivery of

paper copies. I further certify that all parties required to be served were served via

the CM/ECF system, e-mail, and first class mail at the following addresses:

MarkB. Stem Adam D. Kirschner Patrick George Nemeroff U.S. Department of Justice 20 Massachusetts A venue NW Room 5381 Washington, DC 20530 [email protected] [email protected] [email protected]

Attorneys for Appellants United States Food and Drug Administration, United States Department of Health and Human Se-rvices, Kathleen Sebelius, Margaret A. Hamburg, and Lawrence R. Deyton

Carlos T. Angulo Andrew N. Goldfarb Zuckerman Spaeder LLP 1800 M Street, NW, Suite 1000 Washington, DC 20036 [email protected] [email protected]

Justin M. Gundlach Hope M. Babcock Institute for Public Representation Georgetown University Law Center 600 New Jersey Ave. NW, Suite 312



Washington, D.C. 20001 [email protected] [email protected]

Attorneys for American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Pediatrics, American Association for Respiratory Care, American Cancer Society Cancer Action Network; American College of Cardiology, American Heart Association, American Legacy Foundation, American Lung Association, American Medical Association, American Thoracic Society, Campaign for Tobacco-Free Kids, General Board of Church and Society of the United Methodist Church, National African American Tobacco Prevention Network, National Association of City and County Health Officials, National Latino Alliance for Health Equity, Partnership for Prevention, Society for Research on Nicotine and Tobacco, and Tobacco Control Legal Consortium

Scott Lawrence Nelson Public Citizen Litigation Group 1600 20th Street, NW Washington, DC 20009-1001

Attorney for Public Citizen, Inc., American Academy of Pediatrics, American Association For Cancer Research, American Heart Association, American Cancer Society, American Cancer Society, Cancer Action Network, American Lung Association, American Medical Association, American Society of Preventive Oncology, American Thoracic Society, Association of Schools of Public Health, Center For Science In The Public Interest, and Oncology Nursing Society

William G. Kelly, Jr. Multinational Legal Services, PLLC 1850 Fall Line Dr. Driggs, ID 83422 Attorney for Center for Regulatory Effectiveness [email protected]



Richard A. Sarnp Mark S. Chenoweth Washington Legal Foundation 2009 Massachusetts Avenue, NW Washington, DC 20036 Attorneys for Washington Legal Foundation [email protected]


v. - tobacco on trial · usca case #14-5226 document #1600816 filed: 02/25/2016 page 1 of 43[argued...

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