Ass'n of Am. Physicians v. Food Drug Admin.

Full title: ASS'N OF AM. PHYSICIANS SURGEONS, INC., ET AL., Petitioners, v. FOOD DRUG…

Court: U.S.

Date published: May 4, 2010

No. 09-1354 (U.S. May. 4, 2010)

Opinion

On Petition for Writ of Certiorari to the U.S. Court of Appeals for the District of Columbia Circuit.

No. 09-1354.

May 4, 2010.

Lawrence J. Joseph, Washington, DC. PGPage i

PETITION FOR WRIT OF CERTIORARI QUESTIONS PRESENTED

Whether petitioners have standing to challenge approval by the Food Drug Administration ("FDA") of the "Plan B" morning-after pill for distribution simultaneously as both a prescription drug and an over-the-counter drug?

Whether FDA lawfully may, by rule, compel administrative exhaustion before a plaintiff can challenge an FDA drug approval in court and, if so, which party bears the burden of proof on exhaustion?

Whether administrative exhaustion — if required — is satisfied by participation in FDA proceedings on the drug approval or is excused as futile based on FDA's consideration of the relevant issues in its drug approval or based on its opposition on the merits to petitioners' position during the litigation?

Whether, if petitioners lack standing, the courts below had subject-matter jurisdiction to reach the exhaustion issue?

Whether and how three-judge panels are bound by the prior decisions of three-judge or en banc panels in their circuits and how to address instances of intra-circuit splits in authority? PGPage ii

PARTIES TO THE PROCEEDING

Petitioners are the Association of American Physicians Surgeons, Inc. ("AAPS"), Concerned Women for America ("CWA"), and Safe Drugs for Women ("SDW"). AAPS is a membership group primarily of physicians, and SDW is a membership group primarily of medical caregivers including physicians, pharmacists, and nurses. Although CWA also has members, CWA's members are not germane to this litigation because their non-informational injuries are too speculative to support standing, and CWA ( i.e., itself as a corporation) shares its members' informational injuries.

Respondents are the federal Food Drug Administration ("FDA"), FDA's Commissioner in her official capacity and individual capacity under color of legal authority, the United States, and intervener Duramed Pharmaceuticals, Inc. ("Duramed"). Duramed manufactures the challenged drug.

Pursuant to this Court's Rule 29.6, petitioners state that AAPS, CWA, and SDW are non-profit corporations, and no publicly held company owns any interest in AAPS, CWA, or SDW. PGPage iii

TABLE OF CONTENTS

Ultra Vires Dicta

APPENDIX

Ass'n of Am. Physicians Surgeons, Inc. v. FDA Ass'n of Am. Physicians Surgeons, Inc. v. FDA 539 F.Supp.2d 4 Ass'n of Am. Physicians Surgeons, Inc. v. FDA Ass'n of Am. Physicians Surgeons, Inc. v. FDA Ass'n of Am. Physicians Surgeons, Inc. v. FDA 5 U.S.C. § 704 21 U.S.C. § 353 21 U.S.C. § 355c 21 U.S.C. § 355c 110-85 21 C.F.R. § 10.3 21 C.F.R. § 10.25 21 C.F.R. § 10.35 21 C.F.R. § 10.45 21 C.F.R. § 10.85 21 C.F.R. § 310.200

TABLE OF AUTHORITIES

Cases Adams v. Watson 10 F.3d 915 ^st Alston v. Countrywide Financial Corp. ^rd Alton R. Co. v. U.S. 315 U.S. 15 Ass'n of Am. Physicians Surgeons, Inc. v. FDA Ass'n of Am. Physicians Surgeons, Inc. v. FDA 539 F.Supp.2d 4 Am. Bioscience, Inc. v. Thompson 243 F.3d 579 American Canoe Ass'n, Inc. v. City of Louisa Water Sewer Comm'n 389 F.3d 536 ^th Animal Legal Def. Fund v. Glickman en banc Arnold Tours, Inc. v. Camp 400 U.S. 45 Ass'n of Data Processing Serv. Org'ns v. Camp 397 U.S. 150 Assoc. Gas Distribs. v. FERC 899 F.2d 1250 Atonio v. Wards Cove Packing Co., Inc. 810 F.2d 1477 en banc Bangura v. Hansen 434 F.3d 487 ^th Bristol-Myers Squibb Co. v. Shalala 91 F.3d 1493 Bryant v. Rich 530 F.3d 1368 ^th Canadian Lumber Trade Alliance v. U.S. Cantrell v. City of Long Beach 241 F.3d 674 ^th Carey v. Population Serv., Int'l 431 U.S. 678 Chiles v. Thornburgh 865 F.2d 1197 Clarke v. Securities Industry Ass'n 479 U.S. 388 Coit Independence Joint Venture v. Federal Sav. Loan Ins. Corp. 489 U.S. 561 Craig v. Boren 429 U.S. 190 Ctr. for Auto Safety v. NHTSA 793 F.2d 1322 DaimlerChrysler Corp. v. Cuno 547 U.S. 332 Dalton v. City of Las Vegas ^th Darby v. Cisneros 509 U.S. 137 Doe v. Oberweis Dairy 456 F.3d 704 ^th Duke Power Co. v. Carolina Envtl. Study Group Inc. 438 U.S. 59 FEC v. Akins 524 U.S. 11 First Nat'l Bank Trust Co. v. N.C. U.A. 988 F.2d 1272 Fox Tel. Stations, Inc. v. F. C. C. 280 F.3d 1027 FW/PBS, Inc. v. City of Dallas 493 U.S. 215 Graham v. Collins 506 U.S. 461 Haitian Refugee Ctr. v. Gracey 809 F.2d 794 Hall v. Sebelius ___ F.Supp.2d ___ 2009 WL 3088821 Havens Realty Corp. v. Coleman 455 U.S. 363 Heartwood, Inc. v. U.S. Forest Service ^th Hiller v. Oklahoma ex rel. Used Motor Vehicle Parts Comm'n 327 F.3d 1247 Honeywell Int'l, Inc. v. EPA 374 F.3d 1363 393 F.3d 1315 Indep. Cmty. Bankers of Am. v. Bd. of Govs. Reserve Sys. 195 F.3d 28 Insurance Corp. of Ireland, Ltd. v. des Bauxites de Guinee 456 U.S. 694 Jones v. Bock 549 U.S. 199 La. Energy Power Auth. v. FERC 141 F.3d 364 Lujan v. Defenders of Wildlife 504 U.S. 555 Mahon v. U.S. Dept. of Agriculture 485 F.3d 1247 ^th McCarthy v. Madigan 503 U.S. 140 McKart v. U.S. 395 U.S. 185 McMellon v. United States 387 F.3d 329 en banc Metro. Washington Airports Auth. v. Citizens for the Abatement of Aircraft Noise 501 U.S. 252 Michael Reese Hosp. Medical Ctr. v. Thompson 427 F.3d 436 443 ^th Morrison v. Amway Corp. 323 F.3d 920 929 Motor Veh. Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co. 463 U.S. 29 N.C.U.A. v. First Nat'l Bank Trust, Co. 522 U.S. 479 N.Y. State Club Ass'n, Inc. v. New York 487 U.S. 1 NRDC v. EPA 824 F.2d 1146 en banc NRDC v. SEC 606 F.2d 1031 Nulankeyutmonen Nkihtaqmikon v. Impson 503 F.3d 18 ^st Peoples Gas, Light Coke Co. v. U. S. Postal Service 658 F.2d 1182 ^th Pub. Citizen v. Dep't of Justice 491 U.S. 440 Rosebud Sioux Tribe v. McDivitt 286 F.3d 1031 ^th Ryan v. Johnson 115 F.3d 193 Salmi v. Sec'y of Health Human Servs. 774 F.2d 685 Scheduled Airlines Traffic Offices, Inc. v. D.O.D. 87 F.3d 1356 Seven-Up Co. v. Coca-Cola Co. 86 F.3d 1379 ^th Shays v. F.E.C. 414 F.3d 76 Simon v. E.K.W.R.O. 426 U.S. 26 Southwestern Bell Tel. Co. v. City of El Paso 243 F.3d 936 Stauber v. Shalala 895 F.Supp. 1178 Steel Co. v. Citizens for a Better Environment 523 U.S. 83 Sugar Cane Growers Co-op. of Fla. v. Veneman 289 F.3d 89 Summers v. Earth Island Institute 129 S.Ct. 1142 Tel. Data Sys., Inc. v. FCC 19 F.3d 42 Toua Hong Chang v. Minnesota 521 F.3d 828 Tummino v. Torti U.S. v. Students Challenging Regulatory Agency Procedures 412 U.S. 669 U.S. v. Western Pac. R. Co. 352 U.S. 59 U.S. v. Wilson 290 F.3d 347 Weinberger v. Salfi 422 U.S. 749 Western Radio Services Co. v. Qwest Corp. 530 F.3d 1186 ^th Statutes 5 U.S.C. § 704 21 U.S.C. § 352 21 U.S.C. § 353 21 U.S.C. § 353 21 U.S.C. § 353 21 U.S.C. § 353 21 U.S.C. § 355c 21 U.S.C. § 355c 21 U.S.C. § 355c 21 U.S.C. § 355c 21 U.S.C. § 371 28 U.S.C. § 1254 28 U.S.C. § 1291 28 U.S.C. § 1331 28 U.S.C. § 1651 42 U.S.C. § 3604 117 Stat. 1936 121 Stat. 866 121 Stat. 823 866-76 110-85 121 Stat. 866 875 333.16215 333.17708 333.17745 333.17764 Legislative History 97 Cong. Rec. 9321 97 Cong. Rec. 9328 97 Cong. Rec. 9328 97 Cong. Rec. 9330 97 Cong. Rec. 9336 97 Cong. Rec. 9343 97 Cong. Rec. 9344-45 Rules, Regulations and Orders 21 C.F.R. § 10.3 21 C.F.R. § 10.3 21 C.F.R. § 10.25 21 C.F.R. § 10.25 21 C.F.R. § 10.25 21 C.F.R. § 10.30 21 C.F.R. § 10.35 21 C.F.R. § 10.35 21 C.F.R. § 10.45 21 C.F.R. § 10.45 21 C.F.R. § 10.85 21 C.F.R. § 10.85 21 C.F.R. § 10.85 21 C.F.R. § 310.200 21 C F.R. § 310.200 21 C.F.R. § 310.200 21 C.F.R. § 310.200 21 C.F.R. § 310.200 21 C.F.R. § 314.50 21 C.F.R. § 330.13 21 C.F.R. § 310.200 19 Fed. Reg. 7347 28 Fed. Reg. 1449 28 Fed. Reg. 6377 39 Fed. Reg. 11,680 40 Fed. Reg. 40,682 40 Fed. Reg. 40,689 41 Fed. Reg. 32,580 42 Fed. Reg. 4680 42 Fed. Reg. 4688 42 Fed. Reg. 15,673 43 Fed. Reg. 4214 44 Fed. Reg. 37,434 63 Fed. Reg. 66,632 68 Fed. Reg. 66,113 70 Fed. Reg. 52,050 72 Fed. Reg. 15,043 12 12 15 52 59 60 Questions Presented ............................... i Parties to the Proceeding ........................ ii Table of Contents ............................... iii Appendix .......................................... V Table of Authorities ............................. vi Petition for Writ of Certiorari ................... 1 Opinions Below .................................... 1 Jurisdiction ...................................... 1 Authorities Involved .............................. 1 Statement of the Case ............................. 3 Factual Background ............................. 6 Regulatory Background .......................... 7 Reasons to Grant the Writ ........................ 11 I. Petitioners Have Standing ..................... 12 A. Constitutional Standing .................... 12 1. Informational Standing .................. 13 2. Competitive Standing .................... 16 3. Authorizing Illegal Conduct ............. 18 4. Procedural Standing ..................... 19 B. Prudential Standing ........................ 21 1. FDA Waived the Zone Test ................ 21 2. Petitioners Meet Zone Test .............. 21 3. Zone for Acts ............... 23 4. Suitable Challengers .................... 24 II. FDA Cannot Require or Prove Exhaustion ....... 25 A. FDA Cannot Require Exhaustion ............. 26 B. FDA Did Not Prove Exhaustion .............. 28 III. Lack of Exhaustion Does Not Require Dismissal .............................................. 30 A. Petitioners Satisfied Exhaustion .......... 30 B. Consideration of Petitioners' Issues in SNDA Makes Exhaustion Futile ................... 32 C. Rule 12(b)(6) Motion on Petitioners' Positions Makes Exhaustion Futile ................... 33 IV. If Petitioners Lack Standing, Ruling on Exhaustion Is ........................... 33 V. Lower Courts Must Follow Precedent and First- Decided Cases in Intra-Circuit Splits ......... 35 Conclusion ....................................... 36 , No. 08-5458 (D.C. Cir. Nov. 27, 2009) (decision) .................................... 1a , (D.D.C. 2009) (decision) ...... 5a , No. 07-0668-JDB (D.D.C. Aug. 22, 2009) (order denying post-judgment motions) ........ 38a , No. 08-5458 (D.C. Cir. Apr. 6, 2009) (order denying dispositive motions) ................. 44a , No. 08-5458 (D.C. Cir. Feb. 3, 2010) (order denying petition for rehearing en banc) ...... 45a .................................. 46a FFDCA § 503(b), (b) .............. 46a FFDCA § 505c(g)(2), (g)(2) ...... 48a FFDCA § 505c(h)(1)-(2), (h)(1)-(2) ..................... 48a Pediatric Research Equity Act of 2007, Pub.L. No. , § 402(b)(2), 121 Stat. 866, 875 (Sept. 27, 2007) ...................... 49a (a) .............................. 49a (a) ............................. 50a (d) ............................. 50a (a)-(b), (e) .................... 50a ................................ 51a .............................. 52a , (1 Cir. 1993) ..... 17 , 585 F.3d 753 (3 Cir. 2009) ........................... 14 , (1942) ......... 18 , No. 08-5458 (D.C. Cir. Nov. 27, 2009) .......... 1 , (D.D.C. 2009) ..............passim , (D.C. Cir. 2001) ................. 29 , (6 Cir. 2004) .................. 15 , 154 F.3d 426 (D.C. Cir. 1998) () ................ 19 , (1970) 18 , (1970) ........................... 24 , (D.C. Cir. 1990) ................ 17 , (9th Cir. 1987) () ....... 35 , (6 Cir. 2006) .. 30 , (D.C. Cir. 1996) ................. 17 , (11 Cir. 2008) ... 29 , 517 F.3d 1319 (Fed. Cir. 2008) .................... 17 , (9 Cir. 2001) .................. 20 , (1977) ........................... 13 , (11th Cir. 1989) ................ 23 , (1987) ........................... 22 , (1989) ........... 28 , (1976) .............. 13 , (D.C. Cir. 1986) ................ 21 , (2006) ........................... 13 , 282 Fed.Appx. 652 (10 Cir. 2008) .......................... 29 , (1993) ........... 27 , (7 Cir. 2006) .................. 30 , , (1978) ...................... 13 , (1998) ............. 16, 21 , (D.C. Cir. 1993) ................ 24 , (D.C. Cir. 2002) ................ 33 , (1990) ........................... 34 , (1993) ........... 35 , (D.C. Cir. 1987) ................. 23 , , (D.D.C. 2009) ................. 29 , (1982) ........................... 14 , 230 F.3d 947 (7 Cir. 2000) ........................... 15 , (10th Cir. 2003) ................ 36 , (D.C. Cir. 2004), withdrawn on part on other grounds, (D.C. Cir. 2005) ....... 25 , Fed. , (D.C. Cir. 1999) .... 36 , (1982) ................... 34 , (2007) ............... 28 , (D.C. Cir. 1998) .............................. 17 , (1992) ....................... 12, 20 , (11 Cir. 2007) ................ 30 , (1992) ......... 33 , (1969) .............. 26 , (4th Cir. 2004) () ........ 36 , (1991) ........................... 24 , , (7 Cir. 2005) ............. 29 , , (11th Cir. 2003) .............................. 36 , (1983) .................. 10 , (1998) ........................... 21 , (1988) ............................. 13 , (D.C. Cir. 1987) () ................. 32-33 , (D.C. Cir. 1979) ...... 15 , (1 Cir. 2007) ............... 20, 30 , (7 Cir. 1981) ........ 17 , (1989) ........................... 15 , (8 Cir. 2002) ................. 20 , (3rd Cir. 1997) .... 36 , (6th Cir. 1985) .................. 36 , (D.C. Cir. 1996) ................. 25 , (5 Cir. 1996) .................. 17 , (D.C. Cir. 2005) .... 17 , (1976) .......... 19 , (5th Cir. 2001) .................. 36 , (W.D. Wise. 1995) ............................. 31 , (1998) ............................ 34 , (D.C. Cir. 2002) .................. 20 , (2009) .......................... 5 , (D.C. Cir. 1994) ................... 19 , (8th Cir. 2008) .................. 36 , 603 F.Supp.2d 519 (E.D.N.Y. 2009) ............................ 5 (SCRAP), (1973) ....... 12 , (1956) .. 26 , (D.C. Cir. 2002) ..... 9 , (1975) ......... 28 , (9 Cir. 2008) ................. 29 ................................ 1, 27 (a) ............................... 14 ................................ 1, 2 (b)(1) ......................... 2, 19 (b)(3) ............................. 2 (b)(4) ......................... 2, 19 ................................. 16 (g)(2) ........................ 3, 16 (h)(1) ........................ 3, 16 (h)(2) ........................... 16 (a) ............................... 21 (1) ............................... 1 .................................. 1 .................................. 1 (a) .............................. 26 (d) .............................. 14 Pediatric Research Equity Act of 2003, PUB. L. No. 108-155, (2003) ............. 2 Pediatric Research Equity Act of 2007, Pub.L. No. 110-85, (Sept. 27, 2007) ..... 1 Pediatric Research Equity Act of 2007, PUB. L. No. 110-85, Title IV, , (2007) ......................................... 2 PUB. L. No. , § 402(b)(2), , (Sept. 27, 2007) .............................. 16 M.C.L.A. § ............................. 19 M.C.L.A. § (2)-(3) ...................... 19 M.C.L.A. § (12) ......................... 19 M.C.L.A. § ............................. 19 H.R. REP. 82-700 (1951) ...................... 20, 22 S. REP. NO. 82-946 (1951) ................. 2, 20, 22 (1951) ........................ 22 (1951) ........................ 23 (1951) ........................ 22 (1951) ........................ 23 (1951) ........................ 23 (1951) ........................ 23 (1951) ..................... 23 .................................. 2 (a) .......................... 30, 31 ................................. 2 (a) ..................... 25, 30, 31 (a)(1) .......................... 30 (h)(3) .......................... 31 ................................. 2 (d) ............................. 27 ................................. 2 (b) ............................. 25 ................................. 2 (d)(1) ...................... 10, 21 (e) ......................... 10, 21 ........................... 2, 10 (a) ........................... 10 (b) ..................... 7-10, 30 (d) ........................... 11 (e) ............................ 9 ............................ 30-31 ............................... 10 21 C.F.R. § 1.108(c) (1955) ....................... 8 21 C.F.R. § 130.101(b) (1964) ..................... 8 (b) (1976) ................. 8, 10 (1954) .......................... 7 (1963) .......................... 7 (1963) .......................... 7 (1974)......................... 8 (1975)......................... 8 (1975)..................... 9, 21 (1976)........................ 10 (1977)........................... 8 (1977).......................... 21 (1977)......................... 9 (1978).......................... 14 (1979)........................ 14 (1998)......................... 3 (2003)........................ 31 (2005)........................ 31 (2007)......................... 9 FED. R. CIV. P. (b)(1)...................... 28, 29 FED. R. CIV. P. (b)(6).................. 28, 29, 33 FED. R. CIV. P. ................................. 5 FED. R. CIV. P. (c).............................. 5 FED. R. CIV. P. (e).............................. 5 FED. R. CIV. P. (b).............................. 5

PETITION FOR WRIT OF CERTIORARI

The Association of American Physicians Surgeons, Inc. ("AAPS"), Concerned Women for America ("CWA"), and Safe Drugs for Women ("SDW") respectfully petition this Court to issue a writ of certiorari to review the judgment of the U.S. Court of Appeals for the District of Columbia Circuit, which affirmed the district court's dismissal for lack of constitutional and prudential standing and for failure to exhaust the administrative remedy that regulations of respondent Food Drug Administration ("FDA") purport to make mandatory.

OPINIONS BELOW

The court of appeals' unreported decision is reprinted in the Appendix ("App.") at la, and its unreported order denying cross dispositive motions is reprinted at App. 44a. The district court's decision is reported at 539 F.Supp.2d 4 and reprinted at App. 5a. The district court's unreported order denying the plaintiffs' post-judgment motions is reprinted at App. 38a.

JURISDICTION

The court of appeals issued its decision on November 27, 2009, and denied a timely filed petition for rehearing en banc on February 3, 2010 (order reprinted at App. 45a). The district court had jurisdiction under 28 U.S.C. § 1331, and the court of appeals had jurisdiction under 28 U.S.C. § 1291. This Court has jurisdiction under 28 U.S.C. § 1254(1).

AUTHORITIES INVOLVED

The Appendix quotes 5 U.S.C. § 704 and relevant excerpts from 21 U.S.C. §§ 353 and 355c, the Pediatric Research Equity Act of 2007, Pub.L. No. 110-85, 121 Stat. 866 (Sept. 27, 2007), FDA's procedural regulations ( 21 C.F.R. §§ 10.3, .25, .35, .45, .85), and the regulations implementing 21 U.S.C. § 353 ( 21 C.F.R. § 310.200). The authorities fall into three primary areas:

1. Rx-OTC Dichotomy. In 1951, the Durham-Humphrey Amendments ("DHA") to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301- 399a ("FFDCA"), resolved confusion between the drugs eligible for sale only by prescription ("Rx") and those eligible for sale over the counter ("OTC"). In pertinent part, the amendments added FFDCA § 353(b)(4) to create a strict dichotomy between Rx drugs on the one hand, and OTC drugs on the other. 21 U.S.C. § 353(b)(4). The legislative history confirms the statute's plain text: "over-the-counter drugs are forbidden to bear a label containing [the Rx] caution statement." S. REP. NO. 82-946, at 10 (1951). This litigation challenges FDA's first-ever approval for a drug for dual Rx-OTC distribution.

2. Rulemaking to Remove Drug from Rx Requirements. The DHA also added FFDCA § 353(b)(3) to establish the regulatory process for moving Rx drugs to OTC status by rulemaking, 21 U.S.C. § 353(b)(3), and added FFDCA § 353(b)(1) to provide that holding a drug limited to Rx use for dispensing without a prescription constitutes misbranding. 21 U.S.C. § 353(b)(1).

3. Data Required for Adolescent Uses. The Pediatric Research Equity Act of 2003, PUB. L. No. 108-155, 117 Stat. 1936 (2003), and the Pediatric Research Equity Act of 2007, PUB. L. No. 110-85, Title IV, 121 Stat. 823, 866-76 (2007) ("PREA"), supplement the data that drug manufacturers must submit to support their products when those products will be used by "pediatric" populations. The term "pediatric" includes adolescents both above and below eighteen years of age. First Am. Compl. ¶ 92.¹ Like the other data that manufacturers submit to support drug approvals, these data guide the label language, 21 U.S.C. § 355c(g)(2), and result in informational postings on FDA's website. 21 U.S.C. § 355c(h)(1).

1 Like FDA's Pediatrics Rule, 63 Fed. Reg. 66,632 (1998), on which PREA is based, PREA does not specify or define rigid age ranges for "pediatric" subpopulations. In promulgating its final rule, FDA accepted comments that opposed the rigid age ranges of the proposed rule and adopted a flexible approach that considers stages of development. 63 Fed. Reg. at 66,650-51. In addition to considering pediatric populations aged up to 21 years old in its rulemaking, 63 Fed. Reg. at 66,651, the Pediatrics Rule expressly covered adolescents as well as neonates, infants, and children. 63 Fed. Reg. at 66,668 (former 21 C.F.R. § 201.23(a)). Moreover, puberty extends beyond the eighteenth birthday for a significant pediatric subpopulation. First Am. Compl. ¶ 92 ( citing Leon Speroff Mark A. Fritz, Clinical Gynecologic Endocrinology and Infertility, at 370 (Lippincott Williams Wilkins 7th ed. 2005); FDA, "International Conference on Harmonisation; Ell: Clinical Investigation of Medicinal Products in the Pediatric Population," 65 Fed. Reg. 19,777, 19,780 (2000); FDA, "International Conference on Harmonisation; Ell: Clinical Investigation of Medicinal Products in the Pediatric Population; Availability," 65 Fed. Reg. 78,493 (2000); FDA, "Guidance for Industry: Ell Clinical Investigation of Medicinal Products in the Pediatric Population," at 9 ( Dec. 2000)).

STATEMENT OF THE CASE

Petitioners filed this action to challenge both the substance and procedure of FDA's approval of a Supplemental New Drug Application ("SNDA") for age-bifurcated, dual Rx-OTC distribution of levonorgestrel tablets, 0.75 mg (hereinafter "Plan B"). The operative complaint includes eight counts:

I Plan B violates FFDCA's safety and efficacy requirements for OTC drugs;

II Plan B unlawfully bears dual Rx-OTC labeling;

III Plan B is unlawfully bifurcated by age and lacks the data required by PREA;

IV Plan B's dual Rx-OTC labeling unlawfully creates a third "behind-the-counter" drug category;

V FDA failed to convene an APA rulemaking for its changed drug policies;

VI FDA failed to convene an FFDCA rulemaking to remove Plan B from Rx requirements;

VII FDA approved Plan B under unlawful senatorial pressure; and

VIII FDA's exhaustion rule is unlawful.

First Am. Compl. at ¶¶ 96-136 (Court of Appeal Joint Appendix ("CAJA") 121-29). Petitioners seek vacatur of FDA's SNDA and related declaratory relief.

Because FDA declined to certify the administrative record, petitioners moved the district court to compel FDA to do so and filed a notice of the availability of portions of the record on FDA and Government Printing Office websites. CAJA 199-206. Without requiring FDA to certify the record, the district court granted the FDA and Duramed motions to dismiss for lack of standing and failure to exhaust administrative remedies. App. at 6a. In doing so, the district judge relied on representations by Duramed's counsel that "no administrative record of the FDA's consideration of [petitioners"] arguments exists . . . because [petitioners] have never submitted those challenges to the FDA." App. at 33a-34a. On August 22, 2008, the district court denied petitioners' timely filed motion under Rules 15, 52(c), 59(e), and 60(b), and this appeal followed.

This action concerns the same FDA approval at issue in Tummino v. Hamburg, No. 05-0366-ERK-VVP (E.D.N.Y.), where the new administration declined to appeal the court's order to extend OTC status for Plan B from "18 and older" to "17 and older." Tummino v. Torti, 603 F.Supp.2d 519 (E.D.N.Y. 2009). The relief that petitioners seek here is consistent with the Tummino order to treat 17-year-olds the same as those 18 or older, except that petitioners here would remove OTC distribution for everyone, whereas Tummino seeks to extend OTC distribution downward. Significantly, the Tummino plaintiffs ultimately seek to extend Plan B's OTC status to all ages, without regard for PREA compliance. Perhaps even more significantly, the Tummino judgment that FDA declined to appeal was entered without subject-matter jurisdiction under the standards of Summers v. Earth Island Institute, 129 S.Ct. 1142, 1151 (2009). Specifically, the Court denied FDA's motion to dismiss (filed under the previous administration) on standing based on pleadings, but never found that the plaintiffs had standing on the merits. Tummino, 603 F.Supp.2d at 539 ("plaintiffs are responding to a motion to dismiss, so their allegations in the complaint must be accepted as true for purposes of standing"). As a result of FDA's unexplainable decision not to appeal an obviously baseless ruling, minors are exposed to a powerful hormonal drug, with abortifacient properties, notwithstanding the lack of required safety data.

Factual Background

In 1999, FDA approved an Rx-only NDA for Plan B, in which FDA granted a one-time waiver to the then-applicable requirements for pediatric data. First Am. Compl. ¶ 67 (CAJA 112). In 2003, Plan B's sponsor (now Duramed) sought to switch Plan B to OTC distribution, but FDA had safety concerns about young women. CAJA 66-67, In response to FDA "not-approvable letters" based on safety concerns for younger women, Duramed proposed age bifurcation ( i.e., Rx for younger women, OTC for older women), and FDA found that approach to present "difficult and novel issues," on which it issued an advance notice of proposed rulemaking ("ANPRM") in which petitioners and their members filed comments that covered the issues raised in this litigation. CAJA 66, 404-34; First Am. Compl. ¶ 72 (CAJA 114).

During this process, two Senators publicly announced a hold on Acting Commissioner von Eschenbach's nomination as FDA Commissioner until FDA took final action on Plan B, First Am. Compl. ¶ 73 (CAJA 114); CAJA 436-37 (¶ 8), and one of them conditioned release of her hold on FDA's approving Plan B for OTC distribution. CAJA 436-37 (¶ 8). Because FDA could not approve Plan B for OTC distribution without additional data on younger women, and Duramed had serially declined to submit such data, FDA had only two options: capitulation or an extended rulemaking (delaying Senate confirmation).

On the eve of the confirmation hearing, FDA suddenly and without reasoned explanation resolved the "difficult and novel issues" and approved Plan B for age-bifurcated Rx-OTC distribution. In his testimony to Congress that day, Dr. von Eschenbach acknowledged that FDA had considered the public comments in approving Duramed's SNDA and, indeed, could not have approved the SNDA without the public comments. CAJA 441-44 (¶¶ 3-9).

Regulatory Background

In 1954, FDA promulgated § 310.200(b)'s first predecessor (former 21 C.F.R. § 1.108(c)) expressly pursuant to § 503(b)(3). 19 Fed. Reg. 7347, 7347-48 (1954). In 1963, FDA proposed and finalized § 311.200(b)'s direct predecessor (former 21 C.F.R. § 130.101(b)) expressly pursuant to § 503(b)(1) and § 503(b)(3). 28 Fed. Reg. 1449 (1963); 28 Fed. Reg. 6377 (1963). In pertinent part, and consistent with the plain statutory text, the 1954 and 1963 versions both expressly required a rulemaking to remove a new drug from prescription requirements under § 503(b)(1), even if the "petition" that triggered the rulemaking came to FDA via an SNDA or on FDA's own initiative. See 19 Fed. Reg. at 7347-48 (promulgated 21 C.F.R. § 1.108(c)); 28 Fed. Reg. at 6385 (promulgated 21 C.F.R. § 130.101). Specifically, in both 1954 and 1963, the final regulation provided as follows:

A proposal to exempt a drug from the prescription-dispensing requirements of section 503(b) (1) (C) [now § 503(b)(1)(B)] of the act may be initiated by the Commissioner or by any interested person. Any interested person may file a petition seeking such exemption, stating reasonable grounds therefor, which petition may be in the form of a supplement to an approved new-drug application. Upon receipt of such a petition, or on his own initiative at any time, the Commissioner will publish a notice of proposed rule making and invite written comments. After consideration of all available data, including any comments submitted, the Commissioner may issue a regulation granting or refusing the exemption[.] Whenever the Commissioner concludes . . . that granting or refusing the exemption requires a more thorough development of the facts than is possible in a written presentation, he may call a public hearing for that purpose. . . . As soon as practicable after the completion of the hearing, the final regulation granting or refusing the exemption shall be issued[.]

21 C.F.R. § 130.101(b) (1964); accord 21 C.F.R. § 1.108(c) (1955); accord 21 C.F.R. § 310.200(b) (1976). Thus, from 1954 through 1976, FDA could not tenable interpret § 310.200(b) as it does not to allow amending an SNDA via order, rather than rulemaking.

In the interval, FDA has adopted only one substantive amendment to § 310.200(b), as part of its rulemaking in the mid-1970s to adopt its uniform rules of administrative practice. 40 Fed. Reg. 40,682, 40,769 (1975) (proposed amendment to § 310.200(b)); 42 Fed. Reg. 4680, 4714 (1977) (promulgated amendment to § 310.200(b)).² As FDA's rulemaking record demonstrates, adopting the uniform rules for administrative practice did not alter the type of administrative action required to remove drugs from the Rx requirements of § 503(b)(1). Instead, the notice of proposed rulemaking merely provided that "Section 310.200(b) would be revised to replace the procedure now set out in that provision with a reference to Part 2." 40 Fed. Reg. at 40,716. The mere elimination of § 310.200(b)'s rulemaking process in deference to the new general-purpose Part 2 process does not suggest a sub silentio intent to do away with rulemakings altogether. U.S. v. Wilson, 290 F.3d 347, 359-60 (D.C. Cir. 2002) (drafter "unlikely to intend any radical departures from past practice without making a point of saying so"). Instead, FDA would simply convene § 503(b)(3)'s required rulemakings under the general provisions of Part 2, not the specific provisions of § 310.200(b).

2 When it recodified its regulations in 1974, FDA plainly designated "Old section" § 130.101 as "New section" § 310.200. 39 Fed. Reg. 11,680 (Mar. 29, 1974). In a 1977 recodification, FDA amended § 310.200(b) to change the reference from the original rules of practice (former 21 C.F.R. pt. 2) to the recodified ones (current 21 C.F.R. pt. 10). 42 Fed. Reg. 15,673, 15,674 (Mar. 22, 1977) ("Section 310.200(b) is amended by changing the reference to 'Part 2' to read 'Part 10"'). Technical amendments in 2007 changed citations to § 505(b)(1)(C) to the now-current § 505(b)(1)(B). 72 Fed. Reg. 15,043 (Mar. 30, 2007).

FDA's rulemaking to add § 310.200(e) on OTC-panel procedures confirms that, in 1976, FDA interpreted § 310.200(b) consistently with the statute (and opposite its current position):

[T]he Commissioner described the two procedures by which a prescription drug ingredient may lawfully be marketed for OTC use. Ingredients limited to prescription use under section 503(b)(1)(C) of the [FFDCA] may acquire OTC status by a petition submitted pursuant to the procedures set forth in § 310.200 []; the OTC drug review process provides another procedure.

41 Fed. Reg. 32,580, 32,581 (1976) (citations omitted). As indicated, "the procedures set forth in § 310.200" clearly contemplated that FDA would act "by regulation," even if the "petition" came to FDA in the form of an SNDA or if FDA acted on its own initiative. 21 C.F.R. § 310.200(b) (1976). Moreover, the regulations expressly and currently limit Rx-to-OTC switches to § 310.200(b)'s petition process and § 330.13's monograph process: "Any drug limited to prescription use under section 503(b)(1)(B) of the act remains so limited until it is exempted as provided in paragraph (b) or (e) of this section." 21 C.F.R. § 310.200(a). To change either its interpretation of its regulation (i.e., to switch the required procedures from a rulemaking to an order) or its regulations themselves, FDA would need to undertake a rulemaking. 21 C.F.R. § 10.85(d)(1), (e); Motor Veh. Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42 (1983) (course change requires reasoned analysis beyond that required to act in the first instance). FDA has not taken any lawful final action to amend its procedures.

Consistent with the DHA's plain text and legislative history, FDA's implementing regulations also provide that "Prescription legend not allowed on exempted drugs. The use of the prescription caution statement quoted in [ § ]503(b)(4) of the act, in the labeling of a drug exempted under the provisions of this section, constitutes misbranding." 21 C.F.R. § 310.200(d) (emphasis in original).

REASONS TO GRANT THE WRIT

The writ of certiorari should be granted both to resolve splits among the courts of appeal on jurisdictional issues and to exercise this Court's supervisory authority in matters of importance both to review of FDA drug approvals and to the lower courts' exercise of their authority:

(1) To address the lower courts' deviation from this Court's and other circuits' decisions on informational, competitive, and procedural standing (Sections I.A.1, I.A.2, and I.A.4, respectively);

(2) To address a split in circuit authority on the jurisdictional versus non-jurisdictional basis of dismissal for failure to exhaust administrative remedies and the allocation of the burden of proof (Section II.B);

(3) To exercise this Court's supervisory authority over the lower courts' improper exercise of jurisdiction to reach a merits issue (the validity of FDA's rule requiring administrative exhaustion), if indeed the petitioners lack standing (Section IV); and

(4) To address a split in circuit authority and to exercise this Court's supervisory authority over the extent to which three-judge panels are bound by the holdings of prior three-judge panels in intra-circuit splits (Section V).

In addition to these important legal issues, this litigation also presents important policy issues on the review of FDA action and has important safety implications on the exposure of minors to a powerful and untested hormonal drug with abortifacient properties.

I. PETITIONERS HAVE STANDING

As in any federal litigation, constitutional and prudential standing are threshold issues here. Given that the lower courts also reached the merits on FDA's exhaustion regulation, however, the Court should grant the writ of certiorari even if petitioners lack standing. Thus, in addition to being a threshold issue, standing is also a fork in the road. If petitioners have standing, the Court should consider whether FDA can require exhaustion and whether petitioners have satisfied exhaustion (Sections II-III, infra). If petitioners lack standing, the Court should consider why (and on what jurisdiction) the lower courts upheld FDA's exhaustion rule (Section IV, infra). A. Constitutional Standing

At its constitutional minimum, standing involves a tripartite test of a cognizable injury to the plaintiff, caused by the defendant, and redressable by the court. Lujan v. Defenders of Wildlife, 504 U.S. 555, 561-62 (1992). Injury need not be to economic or comparably tangible because an "identifiable trifle" suffices. U.S. v. Students Challenging Regulatory Agency Procedures (SCRAP), 412 U.S. 669, 690 n. 14 (1973). While direct injuries pose "little question" of causation or redressability, plaintiffs have a heightened showing when government action affects third parties, who then cause injury. Defenders of Wildlife, 504 U.S. at 561-62. Standing can be expanded by third-party or associational standing and narrowed by prudential concerns such as the zone-of-interests test. Associations — including associations of associations — can litigate on behalf of individual members if those members have standing, their interests are germane to the association, and nothing requires individual participation. N.Y. State Club Ass'n, Inc. v. New York, 487 U.S. 1, 9 (1988). Further, associations can assert third-party standing based on the relationships between members and third parties, and the plaintiff need not identify a specific third party because potential customers suffice. Craig v. Boren, 429 U.S. 190, 194-95 (1976); Carey v. Population Serv., Int'l, 431 U.S. 678, 683 (1977). Once a plaintiff has established constitutional standing, that plaintiff may rely on third-party standing to satisfy the merely prudential zone-of-interest test. Carey, 431 U.S. at 682-86.

If petitioners establish standing for any one substantive count for vacating the SNDA ( e.g., Counts I-IV, VI, and VII), that would suffice for all six substantive counts. Duke Power Co. v. Carolina Envtl. Study Group, Inc., 438 U.S. 59, 78-81 (1978) (standing doctrine has no nexus requirement outside taxpayer standing); Daimler Chrysler Corp. v. Cuno, 547 U.S. 332, 353 n. 5 (2006) ("once a litigant has standing to request invalidation of a particular agency action, it may do so by identifying all grounds on which the agency may have failed to comply with its statutory mandate"). Finally, if they have substantive standing, petitioners also have procedural standing (Counts V and VIII).

1. Informational Standing

The lower courts denied informational standing for several reasons, including remarkably that FFDCA does not create a right in accurate drug labeling information. App. 19a. The courts failed to conform their reasoning to this Court's precedents and the cases from other circuits.

FFDCA creates rights in accurate labeling information by criminalizing misbranding, defined as "labeling [that] is false or misleading in any particular." 21 U.S.C. § 352(a). Petitioners have an even greater claim to informational standing than the tester who had standing in Havens Realty Corp. v. Coleman, 455 U.S. 363, 373 (1982). The statutes are parallel in their requiring truthful information, compare 21 U.S.C. § 352(a) with 42 U.S.C. § 3604(d), but she "expected to receive false information regarding the availability of homes for purchase," "had no intention of buying a home," and still "was held to have standing." Alston v. Countrywide Financial Corp., 585 F.3d 753, 763 (3^rd Cir. 2009). In any event, FDA's binding preambles foreclose FDA's denying that physicians have rights in labeling. 44 Fed. Reg. 37,434, 37,435 (1979) ("prescription drug labeling is intended to provide physicians with a clear and concise statement of the data and information necessary for safe and effective use of the drug").³ Medical professionals plainly have informational rights in drug information. Cf. Heartwood, Inc. v. U.S. Forest Service, 230 F.3d 947, 952 n. 5 (7^th Cir. 2000) (National Environmental Policy Act provides process to "provide stakeholders with information necessary to monitor agency activity"); American Canoe Ass'n, Inc. v. City of Louisa Water Sewer Comm'n, 389 F.3d 536, 542 (6^th Cir. 2004). The lower court's contrary reasoning is baseless.

3 See also id. at 37,436 ("This statutory scheme for drug labeling is intended to provide physicians . . . with the information they need to prescribe a drug under conditions that maximize the drug's effectiveness and minimize its risks"); 43 Fed. Reg. 4214, 4213 (1978) ("When a pharmacist, physician, nurse, or other person dispenses the drug . . . to the patient, he . . . bears the responsibility for providing . . . the [patient] labeling. . . . [L]abeling serves primarily as an informational adjunct to the physician-patient encounter and is intended to reinforce and augment oral information given by the physician").

Statutorily required labeling is particularly germane to pharmacists, whose lot the DHA intended to improve by eliminating the ambiguity between Rx and OTC drugs. Here, Plan B's unprecedented dual Rx-OTC labeling falsely suggests that pharmacists lawfully may dispense that product OTC to adults, notwithstanding § 503(b)(1)'s prohibition. As regulated professionals, the standing doctrine does not require pharmacists to violate their profession's ethical requirements by dispensing a misbranded drug. See NRDC v. SEC, 606 F.2d 1031, 1042 (D.C. Cir. 1979) (investors who wish to behave in "ethically sound manner" have standing to redress "arguabl[e] impair[ment]" from "lack of [allegedly required] information"). The courts below have no basis for declining to follow this circuit precedent.

The lower courts also incorrectly reasoned that the information-providing statute must have a cause of action for denial of information, compare App. at 19a with Pub. Citizen v. Dep't of Justice, 491 U.S. 440, 449-51 (1989) (finding informational standing under Federal Advisory Committee Act, which lacks any cause of action). That is not required.

The lower courts also incorrectly reasoned that petitioners could not show redressability because vacatur would leave them without any label changes. Compare App. at 21a with FEC v. Akins, 524 U.S. 11, 25 (1998). As Akins recognized, vacatur would put the parties back in the position they should have been in all along, which provides enough redress even if FDA (or Duramed) potentially could take action on remand that would leave plaintiffs no better off. Remand redresses injury "even though the agency (like a new jury after a mistrial) might later, in the exercise of its lawful discretion, reach the same result for a different reason." Id.; see also Section I.A.4, infra (relaxed showing of redressability for procedural injuries). Specifically, vacatur would mean that Duramed again has a pending SNDA, which (if petitioners prevail) FDA can approve only by rulemaking.

Similarly, vacatur would make the Plan B SNDA subject to PREA, which FDA inappropriately waived: "[a]n assessment pending on or after the date that is 1 year prior to the date of the enactment of this Act shall be subject to the tracking and disclosure requirements established under [ 21 U.S.C. § 355c], as in effect on or after such date of enactment." PUB. L. NO. 110-85, § 402(b)(2), 121 Stat. 866, 875 (Sept. 27, 2007). That would open up even more information that petitioners seek. 21 U.S.C. (1951) § 355c(g)(2), (h)(1)-(2). That too provides sufficient basis for informational standing.

2. Competitive Standing

Although the complaint frames physicians' injury as exposure to unlawful competition, First Am. Compl. ¶¶ 19-20 (CAJA 96), the district court required proof of lost revenue. App. at 23a. Under the unambiguous law of the D.C. Circuit, plaintiffs can plead exposure to competition as an injury distinct from lost sales: the "injury claimed here is not lost sales, per se; . . . [r]ather the injury claimed is exposure to competition," Bristol-Myers Squibb Co. v. Shalala, 91 F.3d 1493, 1499 (D.C. Cir. 1996); Shays v. F.E.C., 414 F.3d 76, 86 (D.C. Cir. 2005) ("increased competition represents a cognizable Article III injury"); La. Energy Power Auth. v. FERC, 141 F.3d 364, 367 (D.C. Cir. 1998) ("[courts] have not required litigants to wait until increased competition actually occurs"). "[Plaintiffs] sufficiently establish their constitutional standing by showing that the challenged action authorizes allegedly illegal transactions that have the clear and immediate potential to compete with petitioners' own sales." Assoc. Gas Distribs. v. FERC, 899 F.2d 1250, 1259 (D.C. Cir. 1990). To rule otherwise the courts below had to ignore the foregoing binding precedent. See Section V, infra, on three-judge panels' obligation to follow circuit precedent.

The circuits are in agreement with the law of the D.C. Circuit as stated by the foregoing decisions. See, e.g., Canadian Lumber Trade Alliance v. U.S., 517 F.3d 1319, 1333-34 (Fed. Cir. 2008) (analyzing competitive standing even when plaintiff is not "textbook candidate"); Peoples Gas, Light Coke Co. v. U.S. Postal Service, 658 F.2d 1182, 1194 (7^th Cir. 1981) (recognizing competition between gas and electric power); Adams v. Watson, 10 F.3d 915, 920-25 (1^st Cir. 1993); cf. Seven-Up Co. v. Coca-Cola Co., 86 F.3d 1379, 1383 (5^th Cir. 1996) ("indirect or even non-competitors may also have standing under the Lanham Act"). The decisions below conflicted not only with binding circuit law, but also with the law in the other circuits. Whatever a "textbook candidate" might mean to the Federal Circuit, it does not mean that competitive standing applies only to like entities such as physician-to-physician or manufacturer-to-manufacturer competition.⁴ Any economic textbook recognizes both supplementary and complimentary goods. Physicians give away access to Plan B prescriptions, but charge for office visits. With OTC Plan B, pharmacists allow free visits to their offices, but charge a markup for access to Plan B ( i.e., they charge customers more than Duramed charges the pharmacist). The market is "access to Plan B," and physicians and pharmacists compete in it.

4 This Court's precedents long ago foreclosed limiting competitive standing to like entities. Arnold Tours, Inc. v. Camp, 400 U.S. 45, 46 (1970) ("[w]hen national banks begin to provide travel services for their customers, they compete with travel agents no less than they compete with data processors when they provide data-processing services to their customers"); Alton R. Co. v. U.S., 315 U.S. 15, 18-20 (1942) (railroads versus truckers).

3. Authorizing Illegal Conduct

Petitioners argue (and for standing, courts must accept) that dual Rx-OTC Plan B is misbranded when held for OTC sales. Even if petitioners are wrong about the Rx-OTC merits, the prior Rx-only Plan B certainly could not lawfully be sold OTC. The courts below reasoned that the challenged competition and patient activity is not traceable to FDA's approval because it depends on unfettered third-party choices. App. at 23a. But patients' actions are not truly unfettered when FDA's challenged approval is the action that makes those choices possible. Without FDA's approval, that conduct would be unlawful, and no pharmacist would offer Plan B for OTC distribution.

Under binding D.C. Circuit precedent, injury is "fairly traceable to the administrative action contested . . . if that action authorized the conduct or established its legality." Tel. Data Sys., Inc. v. FCC, 19 F.3d 42, 47 (D.C. Cir. 1994) (emphasis added); Animal Legal Def. Fund v. Glickman, 154 F.3d 426, 441-42 (D.C. Cir. 1998) (en banc). On the merits it is indisputable that Plan B's OTC distribution is unlawful because dual Rx-OTC Plan B is misbranded when held for OTC sale. 21 U.S.C. § 353(b)(1), (4); 21 C.F.R. § 310.200(d). Even if Plan B were not misbranded when held for OTC sale, FDA's SNDA authorized pharmacists to distribute Plan B without a prescription, which they previously could not lawfully do. Simon v. E.K.W.R.O., 426 U.S. 26, 45 n. 25 (1976) (private injury traceable to agency action if injurious conduct "would have been illegal without that action"); see, e.g., M.C.L.A. §§ 333.16215, 333.17708(2)-(3), 333.17745(12) (limiting the dispensing of prescription drugs in Michigan to various types of physicians and dentists and to staff under their supervision); M.C.L.A. § 333.17764 (criminalizing sale of misbranded drug). This is another example of the larger issue addressed in Section V, infra, of lower courts' nullifying circuit precedent.

4. Procedural Standing

The decisions below conflict with another important aspect of constitutional standing: the relaxation of immediacy and redressability for plaintiffs who suffer procedural injury where the procedure is "designed to protect [the] threatened concrete interest of his that is the basis of [such plaintiffs'] standing." Defenders of Wildlife, 504 U.S. at 573 n. 8; Defenders of Wildlife, 504 U.S. at 572 n. 7. Here, Congress recognized that the Rx-OTC distinction affects consumers, pharmacists, physicians, and drug manufacturers, S. REP. NO. 82-946, at 2 (quoted supra); H.R. REP. 82-700, at 9 (same), so § 503(b)(3)'s required rulemaking obviously is a procedure designed to protect petitioners' interests.

Consistent with this Court's holdings, the circuits recognize the relaxed showing on immediacy and redressability. See, e.g., Cantrell v. City of Long Beach, 241 F.3d 674, 682 (9^th Cir. 2001); Nulankeyutmonen Nkihtaqmikon v. Impson, 503 F.3d 18, 27-28 (1^st Cir. 2007); cf. Rosebud Sioux Tribe v. McDivitt, 286 F.3d 1031, 1040 (8^th Cir. 2002) ("procedural standing can substitute for constitutional standing"). Indeed, even the D.C. Circuit recognizes that "[i]f a party claiming the deprivation of a right to notice-and-comment rulemaking under the APA had to show that its comment would have altered the agency's rule, section 553 would be a dead letter." Sugar Cane Growers Co-op. of Fla. v. Veneman, 289 F.3d 89, 95 (D.C. Cir. 2002). Nonetheless, the decisions below relaxed neither immediacy nor redressability. Instead (and contrary precedent under both procedural and competitive standing), the courts required a showing of actual loss, App. 23a, and faulted petitioners for not showing that vacatur of the SNDA would redress their labeling concerns. App 21a. Of course, forcing FDA and Duramed into the rulemaking that the DHA require in the first place would provide an opportunity to raise petitioners' issues with FDA. Akins, 524 U.S. at 25. Procedural standing does not require more.

B. Prudential Standing

Standing's "zone of interest" test is a prudential doctrine that asks "whether the interest sought to be protected by the complainant is arguably within the zone of interests to be protected . . . by the statute." N.C.U.A. v. First Nat'l Bank Trust, Co., 522 U.S. 479, 492 (1998) (emphasis and alteration in original). Petitioners are within the zone of interests, which is inapposite to ultra vires actions, and are "suitable challengers" even if outside the zone. At the outset, however, the merely prudential zone is irrelevant because FDA legislatively waived it.

1. FDA Waived the Zone Test

Unlike constitutional standing, prudential tests are subject to legislative waiver, Ctr. for Auto Safety v. NHTSA, 793 F.2d 1322, 1335-36 (D.C. Cir. 1986), and FDA's legislative rulemakings waive standing: "It is the opinion of the Commissioner that every citizen has standing in the courts to contest any action of the agency, and that no objection relating to such standing will be interposed by the agency in such cases." 40 Fed. Reg. 40,689 (1975); accord 42 Fed. Reg. 4688 (1977). Because FDA unquestionably has authority for legislative rules, 21 U.S.C. § 371(a), and unquestionably binds itself to its preambles, 21 C.F.R. § 10.85(d)(1), (e), any sub-constitutional limit on standing is waived.

2. Petitioners Meet Zone Test

The courts below held physicians' competitive and economic injuries outside the zone, App. at 25a n. 4, without recognizing that the test "struck the balance in a manner favoring review, but excluding those would-be plaintiffs not even arguably within the zone of interests to be protected or regulated by the statute." Clarke v. Securities Industry Ass'n, 479 U.S. 388, 396-97 (1987). "[N]ot meant to be especially demanding," "it suffic[es] to establish reviewability" under the test if "the general policy implicit in the [relevant statutes] was 'apparent' and that 'those whose interests are directly affected by a broad or narrow interpretation of the Acts are easily identifiable.'" Clarke, 479 U.S. at 399-400 n. 14.

Physicians' competitive interests vis-à-vis pharmacists are plainly "affected by a broad or narrow interpretation" of the DHA. NCUA, 522 U.S. at 499 ("Although . . . respondents' objectives in this action are not eleemosynary in nature, . . . that, too, is beside the point"). Indeed, Congress expressly considered physicians beneficiaries of relaxing Rx requirements when truly not required ( e.g., for aspirin), 97 Cong. Rec. 9328 (1951) (Reps. Gwinn and O'Hara), and both committee reports recognized physicians among those affected. See S. REP. No. 82-946, at 2 (quoted supra); H.R. REP. 82-700, at 9 (same). Thus, physicians' injuries are in the zone.

More significantly, Plan B's dual Rx-OTC labeling denies pharmacists their statutory right to labeling that clearly indicates "which drugs may be sold on prescription and which drugs may be sold freely over the counter," which the House floor manager considered the first question behind the DHA legislation. 97 Cong. Rec. at 9321 (Rep. Wolverton).⁵ That right is the dead center of the DHA's zone of interests, which FDA violated by approving a label that falsely suggests that Plan B is lawful for OTC sales. By denying pharmacists the single most important information that the DHA required, FDA puts pharmacists in the untenable position of violating state and federal law and their professional obligations, which Congress expressly intended to spare them.

5 See id. at 9328 ("druggists throughout this country have figuratively been swinging on the jailhouse door, because . . . the druggist oftentimes is unable to know whether he is violating the law by selling a drug . . . without a prescription") (Rep. Carlyle); id. at 9330 ("druggists of this country want this thing nailed down so that they will not be slammed in jail" and calling clear Rx vs. OTC labeling "belling the cat") (Rep. Roberts); id. at 9336 (report lists over 100 druggists "convicted for over-the-counter sales of drugs, many . . . selling them innocently") (Rep. Beckworth); id. at 9343 (same); id. ("Under the present law he does not know whether the drugs he sells over the counter are in violation of the law") (Rep. Thornberry); id. at 9344-45 ("he does not know whether he is violating the law if he sells the drug over the counter . . . What the druggist is seeking is certainty") (Rep. Williams).

3. Zone for Ultra Vires Acts

Because standing assumes plaintiffs' merits views — here, that FDA lacks authority for a dual Rx-OTC product, which is misbranded — Circuit law should have either held the zone-of-interest test inapplicable or applied the zone from the overriding constitutional issues raised by a lawless agency. Haitian Refugee Ctr. v. Gracey, 809 F.2d 794, 812 (D.C. Cir. 1987); accord Chiles v. Thornburgh, 865 F.2d 1197, 1211 (11^th Cir. 1989). By acting outside its delegation, FDA makes law without the constitutional process for making law, violating "the separation-of-powers principle, the aim of which is to protect . . . the whole people from improvident laws." Metro. Washington Airports Auth. v. Citizens for the Abatement of Aircraft Noise, 501 U.S. 252, 271 (1991); Ass'n of Data Processing Serv. Org'ns v. Camp, 397 U.S. 150, 153 (1970) (test asks whether plaintiff is "arguably within the zone of interests to be protected or regulated by the statute or constitutional guarantee in question"). Because FDA acted outside its statute and its own regulations, the narrow zone considered by the courts below should not shield FDA's unlawful conduct.

This Court has not addressed the theory in the D.C. and Eleventh Circuits that agencies' ultra vires conduct either renders the zone of interests inapposite or raises the zone of larger constitutional protections than the narrow laws under which agencies take their challenged actions. It should.

4. Suitable Challengers

Even if not the intended beneficiaries, petitioners can satisfy the zone of interests as "suitable challengers" if their "interests . . . [are] sufficiently congruent with those of the intended beneficiaries that [they] are not more likely to frustrate than to further the statutory objectives." First Nat'l Bank Trust Co. v. N.C.U.A., 988 F.2d 1272, 1275 (D.C. Cir. 1993). Although the district court found physicians' competitive injuries contrary to the statutory purpose, App. 25 n. 4, that finding could preclude suitable-challenger standing only for the safety issue, not for the various bright-line statutory violations ( e.g., § 503(b)'s Rx-OTC dichotomy/rulemaking requirement and PREA's data requirements) under binding Circuit precedent: "the Hazardous Waste Treatment Council line of cases is inapposite when a competitor sues to enforce a statutory demarcation, such as an entry restriction, because the potentially limitless incentives of competitors [are] channeled by the terms of the statute into suits of a limited nature brought to enforce the statutory demarcation." Honeywell Int'l, Inc. v. EPA, 374 F.3d 1363, 1370 (D.C. Cir. 2004) (citing cases) (emphasis added, alteration in original), withdrawn on part on other grounds, 393 F.3d 1315 (D.C. Cir. 2005); N.C.U.A., 988 F.2d at 1278; Scheduled Airlines Traffic Offices, Inc. v. D.O.D., 87 F.3d 1356, 1360-61 (D.C. Cir. 1996) ("Sato's interests cannot diverge from the . . . statute[: . . . ] Either the funds at issue in this case are covered by the statute or they are not"). Under binding Circuit precedent, if physicians have constitutional standing, they also have prudential standing because "entry-like restrictions" are not subject to manipulation.

This is another example of the larger issue addressed in Section V, infra, of district judges and three-judge panels nullifying circuit precedent.

II. FDA CANNOT REQUIRE OR PROVE EXHAUSTION

Although its optional citizen-petition process is commendable, 21 C.F.R. § 10.25(a) ("interested person may petition [FDA] to issue, amend, or revoke a regulation or order"), FDA's mandatory exhaustion regulation is unlawful. Id. § 10.45(b) ("request that [FDA] take or refrain from taking any . . . action must first be the subject of a final administrative decision based on a petition submitted under § 10.25(a)"). Moreover, even if lawful, FDA should bear the burden of proof, which it did not meet here.

A. FDA Cannot Require Exhaustion

Assuming arguendo that FDA has authority to require exhaustion by rule, notwithstanding that FFDCA does not require exhaustion, the FDA rule cannot insulate any and all FDA action from review. For example, exhaustion does not apply for the issues that are "solely one[s] of statutory interpretation" where "the proper interpretation [was] certainly not a matter of [agency] discretion." McKart v. U.S., 395 U.S. 185, 197-99 (1969). Similarly, the rule that "courts ordinarily should not interfere with an agency until it has completed its action" does not apply where the agency "has clearly exceeded its jurisdiction." McKart, 395 U.S. at 194. Because the DHA, the DHA's legislative history, and FDA's own regulations prohibit dual Rx-OTC labeling, for example, FDA lacks jurisdiction to approve a dual Rx-OTC label.

Technically, "'[e]xhaustion' applies where a claim is cognizable in the first instance by an administrative agency alone." U.S. v. Western Pac. R. Co., 352 U.S. 59, 63 (1956). While that includes the decision on whether to approve a drug or what the labeling should say, it does not apply to how FDA approves a drug. If § 503(b)(3) requires a rulemaking, petitioners need not first ask FDA to follow the law. Cf. 28 U.S.C. § 1651(a). On FDA's duty to act by rulemaking, courts are the first and final arbiter.

To the extent that FDA has authority to require exhaustion by rule, FDA cannot require it unless the disputed agency action remains inoperative during any intra-agency appeals. 5 U.S.C. § 704. Far from meeting § 704, FDA regulations expressly provide the opposite. 21 C.F.R. § 10.35(d) ("action taken by an interested person . . . will [not] stay or otherwise delay any [FDA] administrative action").

When challenging "final agency action," an APA plaintiff has no duty to exhaust optional administrative remedies unless the disputed agency action remains inoperative during that further administrative process. 5 U.S.C. § 704 ( "Except as otherwise expressly required by statute, agency action otherwise final is final for the purposes of this section . . . unless the agency otherwise requires by rule and provides that the action meanwhile is inoperative, for an appeal to superior agency authority") (emphasis added).

Agencies may avoid the finality of an initial decision, first, by adopting a rule that an agency appeal be taken before judicial review is available, and, second, by providing that the initial decision would be "inoperative" pending appeal. Otherwise, the initial decision becomes final and the aggrieved party is entitled to judicial review.

Darby v. Cisneros, 509 U.S. 137, 152 (1993) (emphasis added). "Courts are not free to impose an exhaustion requirement as a rule of judicial administration where the agency action has already become 'final' under [ § 704]." Darby, 509 U.S. at 153-54. If the D.C. Circuit has trouble with this clear restriction, then circuits with a lighter APA caseload also would benefit from this Court's clarification. B. FDA Did Not Prove Exhaustion

Separate from the question of whether FDA can require exhaustion is the question of which party bears the burden of proof. This also relates to the question of whether exhaustion is an affirmative defense under FED. R. CIV. P. 12(b)(6) or an element of jurisdiction under FED. R. Civ. P. 12(b)(1). If the former, defendants bear the burden of proof; if the latter, plaintiffs bear the burden of proof.

When a statute does not require exhaustion, "courts are guided by congressional intent in determining whether application of the [exhaustion] doctrine would be consistent with the statutory scheme" and "should not defer the exercise of jurisdiction under a federal statute unless it is consistent with that intent." Coit Independence Joint Venture v. Federal Sav. Loan Ins. Corp., 489 U.S. 561, 579-80 (1989) (interior quotations omitted); Weinberger v. Salfi, 422 U.S. 749, 765 (1975) ("doctrine of administrative exhaustion should be applied with a regard for the particular administrative scheme at issue"). Here, nothing in FFDCA counsels for deferring jurisdiction to review FDA's procedural and substantive violations of DHA and PREA. Accordingly, as with other instances where the statute is silent, courts should follow "the usual practice under the Federal Rules [, which] is to regard exhaustion as an affirmative defense." Jones v. Bock, 549 U.S. 199, 212 (2007). That usual practice allocates the burden of proof to defendants under FED. R. CIV. P. 12(b)(6).

Relying on the unsworn statements of defendants' counsel that the SNDA and public processes were not joined, the district court committed clear error in holding (without the record) that "FDA has [not] ha[d] the opportunity to apply its expertise and [develop] a record." App. at 34a. That plainly violates the law of the D.C. Circuit:

[T]he district court appears to have relied on the parties' written or oral representations to discern the basis on which the FDA acted. Surely that was not sufficient.

Am. Bioscience, Inc. v. Thompson, 243 F.3d 579, 582 (D.C. Cir. 2001). But "[t]here is some uncertainty regarding whether a failure to exhaust administrative remedies is properly brought in a Rule 12(b)(1) motion, as a jurisdictional defect, or in a Rule 12(b)(6) motion for failure to state a claim." Hall v. Sebelius, ___ F.Supp.2d ___, 2009 WL 3088821, 6-7 (D.D.C. 2009) (citing cases);⁶ compare Michael Reese Hosp. Medical Ctr. v. Thompson, 427 F.3d 436, 443 (7^th Cir. 2005) ("exhaustion of administrative remedies is a prerequisite of subject matter jurisdiction") and Dalton v. City of Las Vegas, 282 Fed.Appx. 652, 656 (10^th Cir. 2008) ("APA requires exhaustion of administrative remedies before federal jurisdiction will lie") with Western Radio Services Co. v. Qwest Corp., 530 F.3d 1186, 1196 (9^th Cir. 2008) ("[APA] finality is a jurisdictional requirement, while some statutory exhaustion requirements may not be jurisdictional").⁷ This Court should clarify the issue.

6 Failure to exhaust administrative remedies resembles "a defense for lack of jurisdiction in one important sense: Exhaustion of administrative remedies is a matter[ ] in abatement, and ordinarily [does] not deal with the merits." Bryant v. Rich, 530 F.3d 1368, 1374 (11^th Cir. 2008) (alterations in original, interior quotations omitted).

7 See also Bangura v. Hansen, 434 F.3d 487, 493-94 (6^th Cir. 2006) (exhaustion is jurisdictional if mandated by Congress); Doe v. Oberweis Dairy, 456 F.3d 704, 711-12 (7^th Cir. 2006) (same); Mahon v. U.S. Dept. of Agriculture, 485 F.3d 1247, 1262 (11^th Cir. 2007) (distinguishing between statutes that require exhaustion jurisdictionally and statutes that merely codify the common law); Impson, 503 F.3d at 33-34 (distinguishing mandatory statutory exhaustion from jurisdiction).

III. LACK OF EXHAUSTION DOES NOT REQUIRE DISMISSAL

Assuming arguendo that FDA's exhaustion rule validly applies, that still would not justify dismissal. First, petitioners exhausted FDA's administrative remedy. Second, exhaustion would be futile, both because FDA in fact considered petitioners' issues and because FDA opposed them on the merits in this litigation.

A. Petitioners Satisfied Exhaustion

FDA defines "[i]nterested person" as "a person who submits a petition or comment or objection . . . in an informal or formal administrative proceeding." 21 C.F.R. § 10.3(a) (emphasis added).⁸ Consistent with § 503(b)(3), a manufacturer's SNDA for an Rx-to-OTC switch is a "petition" under § 10.25(a). 21 C.F.R. §§ 10.25(a)(1) (including forms under 21 C.F.R. § 314.50 among the forms that constitute a "petition"), 310.200(b) ("Any interested person may file a petition seeking such exemption, which petition may be pursuant to Part 10 of this chapter, or in the form of a supplement to an approved new drug application"), 314.50 ("Applications and supplements to approved applications are required to be submitted in the form . . . required under this section") (emphases added). Duramed's § 314.50 application unquestionably is a petition under § 10.25(a).

8 The suggestion that a party may seek review only of " its challenge," App. at 34a (emphasis in original), would create the anomaly that commenters opposing a petition cannot challenge FDA's granting the petition without re-petitioning for vacatur.

Moreover, the "procedures" that FDA may take "[i]n reviewing a petition" expressly include "[a] Federal Register notice requesting information and views." 21 C.F.R. § 10.30(h)(3). FDA requested comments in two notices here, 68 Fed. Reg. 66,113 (2003); 70 Fed. Reg. 52,050 (2005), and petitioners participated in both. Because both notices qualify as a "Federal Register notice requesting information and views" about issues raised by Duramed's SNDA, petitioners unquestionably are "interested persons" under § 10.3(a). Cf. Stauber v. Shalala, 895 F.Supp. 1178, 1188-89 (W.D. Wise. 1995) (finding response to FDA request for comments on NDA satisfies exhaustion).

Because they commented on Federal Register notices that FDA issued on Duramed's SNDA "petition" — and because FDA considered the comments⁹ in deciding to proceed with Duramed's SNDA, Section III.B, infra — petitioners satisfy both the letter and the spirit of FDA's regulations. By rejecting this argument, the courts below split with Stauber, the only other relevant authority.

9 Petitioners raised all of the relevant issues presented here. CAJA 405-30 (safety, efficacy, Rx-OTC dichotomy with no "third drug" category, age restrictions unlawful, PREA, APA rulemaking), 432 (§ 503(b)(3) rulemaking).

B. Consideration of Petitioners' Issues in SNDA Makes Exhaustion Futile

Assuming arguendo that exhaustion applies and is not satisfied, exhaustion still would provide no basis for dismissal. FDA considered the issues that petitioners want to raise here, so requiring FDA to re-consider them again would be futile.

Then-Acting Commissioner von Eschenbach testified to Congress that: (1) FDA analyzed the public comments with "an internal process;" (2) he "engaged in the analysis of that [internal process];" (3) both he and career FDA staff concluded that the public comments provided "overwhelming evidence" that FDA could proceed without rulemaking and could "accommodate the bifurcation" within FDA's "current regulatory framework;" (4) the public comments made it possible to decide the SNDA ( i.e., the SNDA was unapprovable without the public comments); and (5) the public comments helped set the bifurcation age at 18 on both enforceability and safety. CAJA 442-44 (¶¶ 6-9), 447-51; see also 340-41 (74:24-75:4, FDA admission at oral argument); 68 (FDA acknowledges SNDA's reliance on public comments). Thus, contrary to the district court's baseless findings, App. 34a, FDA did apply its expertise, a written record exists, and the SNDA and public processes clearly were "joined."

Under an en banc decision of the D.C. Circuit, that should suffice because courts "should not dismiss [ nonparticipating plaintiffs if] the agency in fact considered the statutory issue raised in the [complaint]." NRDC v. EPA, 824 F.2d 1146, 1150-1152 (D.C. Cir. 1987) ( en banc). It "obviously would have been futile for [plaintiff] to have petitioned the agency . . . to repeal" agency actions "where [agency] had just determined that the [actions] in question were still necessary in the public interest." Fox Tel. Stations, Inc. v. F.C.C., 280 F.3d 1027, 1040 (D.C. Cir. 2002). In summary, the law in the D.C. Circuit is clear that exhaustion does not require petitioning an agency to re-reject an argument, and this is another example of the larger issue addressed in Section V, infra, of lower courts' nullifying circuit precedent.

C. Rule 12(b)(6) Motion on Petitioners' Positions Makes Exhaustion Futile

Assuming arguendo that exhaustion applies, is not satisfied, and was not otherwise futile, exhaustion still would provide no basis for dismissal. In the district court, FDA opposed petitioners on the merits under FED. R. CIV. P. 12(b)(6), which means that FDA has "predetermined the issues," even if FDA's SNDA did not. As the McCarthy Court stated, "in view of Attorney General's submission that the challenged rules of the prison were 'validly and correctly applied to petitioner,' requiring administrative review through a process culminating with the Attorney General 'would be to demand a futile act.'" McCarthy v. Madigan, 503 U.S. 140, 148 (1992) (quoting Houghton v. Shafer, 392 U.S. 639, 640 (1968)). Again, exhaustion does not require petitioning agencies to re-reject an argument.

IV. IF PETITIONS RS LACK STANDING, RULING ON EXHAUSTION IS DICTA

Even when the parties below do not dispute jurisdiction, "no action of the parties can confer subject-matter jurisdiction upon a federal court." Insurance Corp. of Ireland, Ltd. v. Compagnie des Bauxites de Guinee, 456 U.S. 694, 702 (1982). Indeed, "every federal appellate court has a special obligation to satisfy itself not only of its own jurisdiction, but also that of the lower courts in a cause under review, even though the parties are prepared to concede it." FW/PBS, Inc. v. City of Dallas, 493 U.S. 215, 231 (1990) (interior quotations omitted). "And if the record discloses that the lower court was without jurisdiction [an appellate] court will notice the defect." Id. (interior quotations omitted). In such cases, appellate courts "have jurisdiction on appeal, not of the merits but merely for the purpose of correcting the error of the lower court in entertaining the suit." Steel Co. v. Citizens for a Better Environment, 523 U.S. 83, 95 (1998) (interior quotations omitted).

Technically, of course, this is not a case where "action of the parties [purports to] confer subject-matter jurisdiction upon a federal court." Bauxites de Guinee, 456 U.S. at 702. The petitioners insist that there is jurisdiction, and the respondents insist that there is not. But petitioners also insist that — if indeed there is no jurisdiction for the DHA-PREA-FFDCA claims — then the lower courts simply had no business reaching the exhaustion issue. Clearly if petitioners had standing on the DHA-PREA-FFDCA claims, they would have had procedural standing for Count VIII to challenge FDA's exhaustion rule. Reaching the exhaustion issue necessarily — albeit implicitly — decides the disputed merits issue of the lawfulness of FDA's regulation.

Unfortunately, the need to review unlawful FDA action arises far more often than the isolated context of this one drug. The health professionals represented by AAPS and SDW consider the need to review unlawful FDA action a critical protection of our government system. If it lacks jurisdiction, this litigation should not bar future litigation by plaintiffs with standing. Accordingly, if this Court is not inclined to take up the standing issue in this case — or if it takes this case and affirms for lack of standing — this Court should vacate the portion of the decisions below that purport to uphold FDA's regulatory exhaustion regime.

V. LOWER COURTS MUST FOLLOW PRECEDENT AND FIRST-DECIDED CASES IN INTRA-CIRCUIT SPLITS

The circuits are split on how to address intra-circuit splits, an issue that was decisive in this litigation.¹⁰ In the criminal-justice context, this Court has recognized the "raw power of [jury] nullification." Graham v. Collins, 506 U.S. 461, 487 (1993) (alteration in original, interior quotation omitted) (Thomas, J., concurring). This Court's supervisory power over the lower courts requires the Court to address the judicial variety: nullification by selective application of otherwise-binding precedent.

10 Under D.C. Circuit authority, physicians plainly have competitive standing (Section I.A.2), pharmacists plainly have informational standing (Section I.A.1), the zone of interests is either inapposite (Section I.B.3) or satisfied (Section I.B.4), and exhaustion is FDA's burden (Section II.B) and is satisfied if FDA considered petitioners' issues (Section III.A).

The Ninth Circuit elevates intra-circuit splits to the en banc court. Atonio v. Wards Cove Packing Co., Inc., 810 F.2d 1477, 1478-79 (9th Cir. 1987) ( en banc). By contrast, the weight of circuit authority (including the D.C. Circuit) calls for disregarding the second decision in the intra-circuit split, reasoning that the second three-judge panel lacked authority to overrule the decision of the initial three-judge panel. See, e.g., Ryan v. Johnson, 115 F.3d 193, 198 (3rd Cir. 1997); McMellon v. United States, 387 F.3d 329, 333 (4th Cir. 2004) ( en banc); Southwestern Bell Tel. Co. v. City of El Paso, 243 F.3d 936, 940 (5th Cir. 2001); Salmi v. Sec'y of Health Human Servs., 774 F.2d 685, 689 (6th Cir. 1985); Hiller v. Oklahoma ex rel. Used Motor Vehicle Parts Comm'n, 327 F.3d 1247, 1251 (10th Cir. 2003); Morrison v. Amway Corp., 323 F.3d 920, 929 (11th Cir. 2003); Indep. Cmty. Bankers of Am. v. Bd. of Govs., Fed. Reserve Sys., 195 F.3d 28, 34 (D.C. Cir. 1999). Finally, the Eighth Circuit takes a less disciplined approach to stare decisis and the authority of three-judge panels: "[w]hen there is an intra-circuit split, we are free to choose which line of cases to follow." Toua Hong Chang v. Minnesota, 521 F.3d 828, 832 n. 3 (8th Cir. 2008).

Given the importance of stare decisis and judicial authority to litigants generally and to the resolution of this litigation specifically, the Court should recognize and hold that lower courts are not free to reject circuit precedent. Stare decisis in the lower courts is critical for the public to believe that the courts are impartial and fair.

CONCLUSION

The petition for writ of certiorari should be granted.

Respectfully submitted,

Lawrence J. Joseph 1250 Connecticut Av, NW Suite 200 Washington, DC 20036 Tel: (202) 669-5135 Fax: (202) 318-2254 Email ljj@larryjoseph.com