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Tummino v. Hamburg

August 27, 2009

ANNIE TUMMINO ET AL., PLAINTIFFS,
v.
MARGARET HAMBURG,*FN1 IN HER OFFICIAL CAPACITY AS COMMISSIONER OF THE FOOD AND DRUG ADMINISTRATION, DEFENDANT, AND CONCERNED WOMEN FOR AMERICA, CHRISTIAN PHARMACISTS FELLOWSHIP INTERNATIONAL, AND CHRISTIAN MEDICAL & DENTAL ASSOCIATIONS, PROPOSED-INTERVENORS.



The opinion of the court was delivered by: Edward R. Korman United States District Judge

MEMORANDUM & ORDER

KORMAN, J.

Concerned Women for America ("CWA"), Christian Medical & Dental Associations ("CMDA"), and Christian Pharmacists Fellowship International ("CPFI"), referred to for the sake of convenience as "intervenors," although they are seeking merely to leave to intervene, are three non-profit membership organizations whose members oppose abortion. CWA is "public policy women's organization" that works for "'the protection of all innocent human life from conception until natural death.'" (Intervenors' Mem. at 3.) CMDA is an "organization of Christian physicians and allied healthcare professionals" who "oppose[] the practice of abortion as contrary to Scripture, a respect for the sanctity of human life, and traditional, historical and Judeo-Christian medical ethics." (Id.) CPFI is an organization of Christian pharmacists who "oppose[] abortion for religious, moral and ethical reasons, and are committed to the sanctity of human life." (Id.) They seek leave to intervene in order to appeal from the judgment, entered March 24, 2009. See Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y. 2009). They also seek an extension of time to file a notice of appeal.

The present litigation began in January 2005 when plaintiffs -- individuals and organizations advocating wider distribution and access to emergency contraceptives, as well as parents and their minor children seeking the same -- filed a complaint challenging the Food and Drug Administration's ("FDA") denial of a Citizen Petition, which had requested that the FDA make Plan B, a prescription-only emergency oral contraceptive, available over-the-counter to women of all ages. The underlying facts concerning the FDA's consideration of and final determinations regarding both the Citizen Petition and a number of parallel proposals submitted by the Plan B drug sponsor -- referred to as supplemental new drugs applications ("SNDAs") -- are exhaustively detailed in Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y. 2009). Briefly, after denying the Citizen Petition and rejecting two SNDAs -- the first, proposing that Plan B be made available without a prescription to women of all ages and the second, proposing it be made available without a prescription to women 16 and older -- the FDA, in August 2006, approved a third SNDA for Plan B, and permitted Plan B's manufacturer to market Plan B to women 18 and older without a prescription. As approved, Plan B's point-of-sale was restricted to pharmacies and certain health clinics.

Plaintiffs in Tummino alleged that "the FDA's decisions regarding Plan B -- on the Citizen Petition and the SNDAs -- were arbitrary and capricious [under the Administrative Procedure Act]" and "made in bad faith because they were improperly influenced by political considerations wholly outside the scope of the FDA's statutory authority." Id. at 523, 538. On March 23, 2009, I vacated the denial of the Citizen Petition, and ordered the FDA to permit Plan B's manufacturer "to make Plan B available to 17 year olds without a prescription, under the same conditions as Plan B is now available to women over the age of 18." Id. at 550. I remanded to the FDA the issue of whether Plan B should be made available without a prescription to women younger than 17. Id. The judgment was entered on March 24, 2009 and, pursuant to Fed. R. App. P. 4(a)(1)(B), a notice of appeal had to have been filed within 60 days of the entry of judgment. If, as here, the last day of the 60 day period falls on a weekend or "legal holiday," a party seeking to appeal has until the next business day to file. Fed. R. App. P. 26(a)(3). Here, the last day fell on a Saturday, May 23, 2009 and the next Monday, May 25, 2006, was Memorial Day, a "legal holiday" under Fed. R. App. P. 26(a)(4). Thus, intervenors had until Tuesday, May 26, 2009 to file their notice of appeal.

On April 22, 2009, the FDA announced that "[t]he government will not appeal this decision." FDA Statement, Updated FDA Action on Plan B (levonorgestrel) Tablets (Apr. 22, 2009), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149568.htm. On the same day, CWA President, Wendy Wright, who submitted a declaration in support of the instant motion, issued a statement criticizing the decision: "'This decision is driven by politics, not what is good for patients or minors. . . . The FDA should have challenged the decision.'" CWA, FDA Caves to Pressure, Plans to Endanger 17-Year-Olds, Christian Newswire, April 22, 2009, 3:33 pm. GMT. The FDA's decision was also widely covered by the national media. See, e.g., Rob Stein, U.S. Would Allow Sale of `Morning-After' Pill to Minors, Washington Post, Apr. 22, 2009, available at 2009 WLNR 7528441; Noam N. Levey, FDA Signals Shift in Birth-Control Debate; Morning-After Pill Will Be Sold to 17-Year-Olds Over the Counter, Los Angeles Times, Apr. 23, 2009, at A1; Gardiner Harris, Agency Agrees to Ease Access to Emergency Contraceptive for 17-Year-Olds, New York Times, Apr. 23, 2009, at A14; Jennifer Corbett Dooren, FDA Expands Access to Morning-After Pill, Wall Street Journal, Apr. 23, 2009, at B11. Nevertheless, intervenors, who argue that "the need . . . to intervene at all was occasioned by the new administration's decision to allow" the judgment "to stand without appeal" (Intervenors' Mem. at 13), did not move to intervene and appeal within 60 days of the March 24, 2009 judgment. Instead, they waited until June 25, 2009 to file a motion (1) to intervene, pursuant to Fed. R. Civ. P. 24(a), (b), for the purpose of filing a notice of appeal to challenge plaintiffs' standing and (2) for an extension of time to file that appeal, pursuant to Fed. R. App. P. 4(a)(5).

Discussion

Because intervenors are not parties to the underlying action, "the threshold (and ultimately dispositive) question" is whether they may properly intervene. Farmland Dairies v. Comm'r of New York State Dep't of Agric and Mkts., 847 F.2d 1038, 1043 (2d Cir. 1988). They clearly cannot because they do not have standing to intervene and because the motion to intervene was not timely filed. Their motion for extension of time to file a notice of appeal is also denied for this reason and because they have not made the showing otherwise necessary to obtain such relief.

I. Motion to Intervene

While the Second Circuit does not ordinarily require intervenors to establish their own standing, U.S. Postal Serv. v. Brennan, 579 F.2d 188, 190 (2d Cir. 1978), "an intervenor's right to continue a suit in the absence of the party on whose side intervention was permitted is contingent upon a showing by the intervenor that he fulfills the requirements of Art. III." Diamond v. Charles, 476 U.S. 54, 68 (1986) (emphasis added). Of course in this case, intervention was never permitted. Nevertheless, because the party on whose side intervention could have been sought during the course of the litigation has decided not to appeal, intervenors must establish that they are sufficiently harmed by the judgment to give them independent standing.

A. Intervenors Lack Standing To Intervene

Intervenors bear the burden of proving each element of standing: (1) that they have "suffered an 'injury in fact' -- an invasion of a legally protected interest which is (a) concrete and particularized . . . and (b) 'actual or imminent, not "conjectural" or "hypothetical;"'" (2) that there is a "causal connection between the injury and the conduct complained of," and (3) that it is "'likely,' as opposed to merely 'speculative,' that the injury will be 'redressed by a favorable decision.'" Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992). Moreover, intervenors may establish their representational or associational standing if: (1) at least one of its members has standing to sue in his or her own right; (2) the interests the association seeks to protect are germane to its purpose; and (3) neither the claim asserted nor the relief requested requires the participation of an individual member in the lawsuit. Bldg. & Const. Trades Council of Buffalo, N.Y. and Vicinity v. Downtown Dev., Inc., 448 F.3d 138, 144 (2d Cir. 2006) (quoting Hunt v. Wash. State Apple Adver. Com'n, 432 U.S. 333, 343 (1977)).

Intervenors present a number of theories in support of standing. All are without merit.

1. Informational Standing

By way of background, under certain circumstances the Pediatric Research Equity Act ("PREA") requires a person who submits a drug application to the FDA to submit along with that application data "to assess the safety and effectiveness of the drug . . . for the claimed indications in all relevant pediatric subpopulations" and "to support dosing and administration for each pediatric subpopulation for which the drug . . . is safe and effective." 21 U.S.C. § 355c(2)(A). Unless an assessment has been deferred until after approval, id. § 355c(a)(3), waived, id. § 355c(a)(4), or has been deemed unnecessary by the FDA, id. §§ 355c(a)(2)(B) (FDA may conclude that pediatric effectiveness and safety can be extrapolated from studies in adults), the FDA must review the pediatric safety assessment prior to approval of the drug application. Id. § 355c(f). When a pediatric safety assessment is required, the FDA "shall make available to the public . . . the reviews of such pediatric assessments." Id. § 355c(h).

Intervenors argue that they have suffered an informational injury because the judgment, which ordered the FDA to permit Plan B to be marketed to 17 year olds without a prescription, deprived them of access to pediatric safety information that the FDA otherwise would have been required to consider and make available to the public before approving such use by 17 year olds. There is little support, however, for the proposition that a plaintiff's (or in this case a proposed-intervenor's) interest in access to information compiled during agency proceedings is, in and of itself, sufficient to confer standing. Indeed, in the United States v. Richardson, 418 U.S. 166 (1974), the Supreme Court rejected a similar claim for ...


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