v. - Tobacco On Trial

1 USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 Page 1 of 43[ARGUED OCTOBER 7, 2015] 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, 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, Washington, DC 20005 Phone (202) 434-5466 Phone: (202) 434-5104 FAX: (202) 434-5029 Attorneys for Appellee, 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 Page 2 of 43 TABLE OF AUTHORITIES CASES Ass 'n of Am. Physicians & Surgeons, Inc.

2 V. Clinton, 997 F .2d 898 ( Cir. 1993) .. 13 Ass'n ofCmty. Reform Now v. Fowler, 178 350 (5th Cir. 1999) .. 11-12 At/. States Legal Found., Inc. v. EPA, 325 281( Cir. 2003) .. 15 Babbitt v. United Farm Workers Nat 'l Union, 442 289 (1979) .. 7 Baur v. Veneman, 352 625 (2d Cir. 2003) .. 6-7, 14 Biotech. Indus. Org. v. District of Columbia, 496 1362 (Fed. Cir. 2007) .. 6 Chamber of Commerce ofU S. v. EPA, 642 192 ( Cir. 2011) .. 4-5 Chlorine Inst. v. Fed. Admin., 718 922 ( Cir. 2013) .. 15 Clapper v. Amnesty Int'/ USA, 133 S. Ct. 1138 (2013) .. 10 CoxCom, Inc. v. Chafee, 536 101 (1st Cir. 2008) .. 6 Crandon v. United States, 494 152 (1990) .. 13 Digital Equip. Corp. v. Micro Tech, Inc., 142 488 (D. Colo. 1992) .. 8 Franchise Tax Bd. of Cal. v. Alcon Aluminum Ltd., 493 331 (1990 .. 11 FTC v. Exxon Corp., 636 1336 ( Cir. 1980) .. 7 IP Innovation v. Thomson, Inc., No. 1 :03-CV-0216-JDT-TAB, 2004 WL 771233 ( Ind. Apr.))

3 8, 2004) .. 8 Lockheed Martin Corp. v. Boeing Co., No. 6:03-CV-796-0RL28 KRS, 2005 WL 5278461 ( Fla. Jan. 26, 2005) .. 8 La. Envtl. Action Network v. Browner, 87 1379 ( Cir. 1996) .. 15 11 USCA Case #14-5226 Document #1601000 Filed: 02/26/2016 Page 2 of 43 USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 Page 3 of 43 Lujan v. Defenders of Wildlife, 504 555 (1992) .. 5 McBryde v. Comm. To Review Cir. Council Conduct & Disability Orders, 264 52 ( Cir. 2001) .. 13 Meese v. Keene, 481 465 (1987) .. 12, 13 Metcalf v. Nat'! Petrol. Council, 553 176 ( Cir. 1977) .. 15 Nat'! Ass'n of Clean Air Agencies v. EPA, 489 1221 ( Cir. 2007) .. 1, 4 Occidental Permian Ltd. v. FERC, 673 1024 ( Cir. 2012) .. 15 Pub. Citizen, Inc. v. Nat'! Highway Traffic Safley Admin., 489 1279 ( Cir. 2007) .. 5, 7 Rates Tech. Inc. v. Mediatrix Te/com Inc., No. CV 05-2755(JS)(AKT), 2007 2581776 ( Sept. 5, 2007).

4 8 Raytheon v. Ashbom Agencies, Ltd., 372 451 ( 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 ( Jan. 24, 2008) .. 8 Sherley v. Sebelius, 610 69 ( Cir. 2010) .. 1, 5 Sierra Club v. Jewell, 764 1 ( Cir. 2014) .. 15 Stilwell v. Office of Thrift Supervision, 569 514 ( Cir. 2009) .. 5 Tailored Lighting, Inc. v. Osram Sylvania Prods., Inc., 236 146 ( 2006) .. 8 Texas v. United States, 523 296 (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, 640 872 (7th Cir. 1981) .. 13 111 USCA Case #14-5226 Document #1601000 Filed: 02/26/2016 Page 3 of 43 USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 Page 4 of 43 United States v.

5 Stadd, 636 630 ( Cir. 2011) .. 13 Wyo. Outdoor Council v. Forest Serv., 165 43 ( Cir. 1999) .. 15 STATUTES 18 2 .. 1, 13 18 202(a) .. 1, 13 18 208 .. 1, 13 18 208(a) .. 13 21 379d-1 .. 1 21 387d(b) .. 3 21 387g(e) .. 2 21 387g(f) .. 2 OTHER AUTHORITIES 5 pt. 2635 .. 1, 13 5 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), .. 4 Dep't of Health & Human Servs., Fiscal Year 2015 Food and Drug Administration Justification of Estimates for Appropriations Committees (undated), < downloads/ AboutFDA/ReportsManuals F orms/Reports/BudgetReports/UCM3 883 09. pdf .. 14-15, 15 IV USCA Case #14-5226 Document #1601000 Filed: 02/26/2016 Page 4 of 43 USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 Page 5 of 43AR Brief challenged members ethics rules FDA FDA Budget Justification JA Menthol Report Panel Op.

6 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 2, 202(a), 208; 21 379d-l; 5 pts. 2635, 2640 Food and Drug Administration Dep't ofHealth & Human Servs., Fiscal Year 2015 Food and Drug Administration Justification of Estimates for Appropriations Committees (undated), 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, mmitteesMeetingMaterials/TobaccoProducts ScientificAd visoryCommittee/UCM269697 .pdf R. J. Reynolds Tobacco Co. v. FDA, No. 14-5226 ( Cir. Jan. 15, 2016), 5A54A84 790EC685257F3B0054CC05/$ v USCA Case #14-5226 Document #1601000 Filed: 02/26/2016 Page 5 of 43 USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 Page 6 of 43Pl.)

7 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) Reynolds Tobacco Company Supplemental Brief for Appellee, Reynolds Tobacco Co. (#1582370 filed Nov. 6, 2015) The Tobacco Products Scientific Advisory Committee Vl USCA Case #14-5226 Document #1601000 Filed: 02/26/2016 Page 6 of 43 USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 Page 7 of 43 STATEMENT OF THE ISSUE AND ITS IMPORTANCE The Panel decision ("Panel Op.") conflicts with decisions of this , Sherley v. Sebelius, 610 69, 74 ( Cir. 2010); National Association of Clean Air Agencies v. EPA, 489 1221, 1227 ( 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.

8 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 2, 202(a), and 208; 21 379d-1; 5 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 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 USCA Case #14-5226 Document #1601000 Filed: 02/26/2016 Page 7 of 43 USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 Page 8 of 43 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 387g(e), and the other on dissolvable Tobacco products, 21 387g(f).

9 Corrected Brief for Appellees 2-3 & (#1549749 filed Apr. 28, 2015) ("Brief').2 Here, with meeting-by-meeting FDA approval, Brief 48 , three TPSAC members-Drs. Benowitz, Benningfield, and Samet (Committee Chair, Brief 18 & ) (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' posi-tion. Had waivers been granted, it is doubtful that plaintiffs could allege a viola-tion 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 AdvisoryCommittees/CommitteesMeetingMate rial s/TobaccoProductsScientificAdvisoryCommi ttee/UCM269697.)

10 Pdf. The report on dissolvable Tobacco products (Mar. 1, 2012) is at AR 23495-503 and at s/ 2 USCA Case #14-5226 Document #1601000 Filed: 02/26/2016 Page 8 of 43 USCA Case #14-5226 Document #1600816 Filed: 02/25/2016 Page 9 of 43of 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 387d(b) by plaintiffs, including Reynolds Tobacco Company ("Reynolds"), and that relates to the design and other aspects of menthol cigarettes and dissolvable Tobacco products manufactured and sold by 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.