The Coal. For Mercury-free Drugs v. Sebelius

• Decision Date: 01 July 2010
• Docket Number: Civil Action No. 09-0015 (RBW).
• Citation: 725 F.Supp.2d 1
• Parties: The COALITION FOR MERCURY-FREE DRUGS, et al., Plaintiffs, v. Kathleen SEBELIUS, 1 Secretary of Health and Human Services, et al., Defendants.
• Court: U.S. District Court — District of Columbia

725 F.Supp.2d 1

The COALITION FOR MERCURY-FREE DRUGS, et al., Plaintiffs,

v.Kathleen SEBELIUS, ¹ Secretary of Health and Human Services, et al., Defendants.

Civil Action No. 09-0015 (RBW).

United States District Court,District of Columbia.

July 1, 2010.

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COPYRIGHT MATERIAL OMITTED.

Clifford John Shoemaker, Shoemaker & Associates, Vienna, VA, John F. McHugh, John F. McHugh, P.C., New York, NY, for Plaintiffs.

Drake S. Cutini, Department of Justice, Office of Consumer Litigation, Washington, DC, for Defendants.

AMENDED MEMORANDUM OPINION ²

REGGIE B. WALTON, District Judge.

The plaintiffs, the Coalition for Mercury-Free Drugs (“Mercury-Free”), and several named individuals who are also the principal officers of Mercury-Free, bring this action against the Secretary of Health and Human Services and the Commissioner of the Food and Drug Administration (“FDA”) in their official capacities, alleging injuries arising from the defendants' approval of the use of Thimerosal, a mercury-based chemical compound used in pharmaceutical products, such as vaccines, to prevent the growth of bacteria or fungi. See Complaint (“Compl.”) ¶¶ 3-7, 83-100. Currently before the Court are several motions, including the defendants' motion to dismiss the plaintiffs' complaint pursuant to Federal Rule of Civil Procedure 12(b)(1) on the ground that the plaintiffs cannot allege a concrete, imminent injury caused by the defendants' actions sufficient to invoke the Article III jurisdiction of this Court, see Memorandum in Support of Motion to Dismiss (“Defs.' Mem.”) at 2, which the plaintiffs oppose. ³ See Plaintiffs' Memorandum of Law in Opposition to the Defendants' Motion to Dismiss (“Pls.' Opp'n”). In addition to the defendants' motion to dismiss, the Court also considered the following pending motions and related filings in resolving the defendants' motion to dismiss: (1) the plaintiffs' motion to conduct jurisdictional discovery, see Plaintiffs' Motion for Leave to Conduct Jurisdictional Discovery (“Pls.' Mot. Re: Discovery”); Plaintiffs' Memorandum of Points and Authorities in Support of its Motion for Leave to Conduct Discovery Limited to the Issue of Jurisdiction (“Pls.' Mem. Re: Discovery”), which the defendants oppose, see Defendants' Opposition to Plaintiffs' Motion for Leave to Conduct Discovery Limited to the Issue of Jurisdiction (“Defs.' Opp'n Re: Discovery”); ⁴ (2) the defendants' motion for a protective order, see Motion for a Protective Order; Memorandum in Support of Defendants' Motion for Protective Order; and (3) three motions by the plaintiff seeking leave to supplement the record, see Motion for Leave to Supplement Record [Oct. 9, 2009] (“Pls.' Mot. to Supplement I”), Motion for Leave to Supplement Record [Oct. 19, 2009] (“Pls.' Mot. to Supplement II”), Motion for Leave to Supplement Record [March 17, 2010] (“Pls.' Mot. to Supplement III”), which the defendants oppose, see Defendants' Opposition to Plaintiffs' Motions for Leave to Supplement the Record (“Defs.' Opp'n Re: Leave to Supplement”). For the reasons that follow, the Court finds that the plaintiffs do not have standing to bring this lawsuit and accordingly must grant the defendants' motion to dismiss the plaintiffs' complaint under Federal Rule of Civil Procedure 12(b)(1). In concluding that the plaintiffs lack standing, the Court considered their three motions for leave to supplement the record over the defendants' objection. The Court also concludes that the plaintiffs' request for jurisdictional discovery was not narrowly tailored to produce information relevant to the issue of standing and thus ordering jurisdiction discovery is not warranted. And because the plaintiffs' lack of standing, the Court finds that the issuance of a protective order is unnecessary.

I. BACKGROUND

Thimerosal has been used in the United States since the 1930s and was subsequently determined by the FDA to be safe and effective when used as a vaccine preservative. ⁵ FDA, Thimerosal in Vaccines (March 31, 2010). ⁶ Nevertheless, in 1999, in furtherance of its overall aim to reduce all human exposure to mercury, the Public Health Service established a goal to remove Thimerosal from vaccines routinely recommended for children. See Defs.' Mem. at 4. Consequently, there are now mercury-free alternatives for all vaccines routinely recommended for both children and adults. Id.

The plaintiffs oppose any use of mercury-based preservatives, such as Thimerosal, in vaccines contending that it is the cause of a variety of health problems, including the development of autism and other brain development disorders in children when either children or pregnant mothers are exposed to it. Compl. ¶¶ 68-73. On August 10, 2007, Mercury-Free filed a citizen petition seeking to have the FDA: (1) proscribe the use of Thimerosal-containing vaccines or other similarly preserved medical products for certain “susceptible” classes; (2) withdraw its approval of or revoke the license for the use of these vaccines; (3) issue an immediate recall and destruction of these vaccines; (4) alter the warning labels and informed consent policies for these vaccines; and (5) alter the FDA's policy stance on these vaccines as a whole. See generally, Defs.' Mem. at 1 (referring to the citizen petition, see Paul King, PhD, et al., Citizen Petition Requesting Certain Actions with Respect to Vaccines and Other Drug Products, Containing Added Mercury, in Order to Reduce the Health Risk to Susceptible Fetuses, Newborns, Children, Adolescents and Adults (Aug. 24, 2007), http:// mercury freedrugs. org/ docs/ 070824_ Co Me DCitizen Petition Part 2. pdf). The FDA denied the petition on November 21, 2008, asserting that Mercury-Free's contentions were supportable by neither law nor science and the pharmaceutical products currently on the market containing mercury preservatives are safe. Defs.' Mem. at 1. Seeking to challenge the FDA's denial of their petition, the plaintiffs filed their complaint with this Court.

The plaintiffs' complaint “reiterates the arguments presented by [the p]laintiffs to the FDA and [the Department of Health and Human Services]” in Mercury-Free's citizen petition and asserts that the defendants are in violation of federal law by not recalling or banning the use of mercury-based compounds in vaccines and other pharmaceutical products. Compl. ¶¶ 13, 87. The plaintiffs seek a prospective injunction requiring the defendants to suspend the approval and licensing of all products that contain mercury-based compounds, and requiring a recall of all batches of vaccines that contain Thimerosal unless its manufacturer can prove that its product does not cause adverse neurological outcomes in any group of susceptible individuals. Id. ¶ 29-30. The defendants responded to the complaint with their motion to dismiss for lack of subject-matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1), on the basis that the plaintiffs lack standing to maintain their complaint. Defs.' Mem. at 2. Alternatively, the defendants seek dismissal under Federal Rule of Civil Procedure 12(b)(6) on the basis that their denial of the plaintiffs' citizen petition was neither arbitrary nor capricious and therefore was not in violation of the Administrative Procedure Act. Id.

After the defendants' motion to dismiss was filed, the plaintiffs sought a preliminary injunction to compel the defendants to ensure that Thimerosal-preserved influenza vaccines were not administered to pregnant women during the 2009-2010 flu season. Pls.' Mem. Re: Injunction at 3. The Court held a hearing on the plaintiffs' request on August 26, 2009, and ultimately denied the request for injunctive relief. See Aug. 27, 2009 Order. Thereafter, the plaintiffs moved for leave to conduct jurisdictional discovery, see Pls.' Mot. Re: Discovery, which the defendants oppose, see Defs.' Opp'n Re: Discovery. The plaintiffs also filed multiple motions for leave to file supplemental declarations of various plaintiffs in an effort to establish standing. See Pls.' Mot. to Supplement I, Pls.' Mot. to Supplement II, and Pls.' Mot. to Supplement III. The defendants have moved unopposed for a protective order to be entered in this case. See Motion for a Protective Order.

II. STANDARD OF REVIEW

In deciding a motion to dismiss for lack of subject-matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1), a court must “accept all factual allegations in the complaint as true.” Jerome Stevens Pharms., Inc. v. FDA, 402 F.3d 1249, 1253 (D.C.Cir.2005) (quoting United States v. Gaubert, 499 U.S. 315, 327, 111 S.Ct. 1267, 113 L.Ed.2d 335 (1991)). A court is not limited to the allegations set forth in the complaint when assessing a Rule 12(b)(1) motion, but “may consider materials outside of the pleadings in deciding whether to grant a motion to dismiss for lack of jurisdiction[.]” Id. Moreover, under Rule 12(b)(1), “[i]t is to be presumed that a cause lies outside [a federal courts'] limited jurisdiction,” Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377, 114 S.Ct. 1673, 128 L.Ed.2d 391 (1994) (citations omitted), unless the plaintiffs establish by a preponderance of the evidence that the Court has jurisdiction, see Hollingsworth v. Duff, 444 F.Supp.2d 61, 63 (D.D.C.2006).

III. LEGAL ANALYSIS

Article III of the federal Constitution extends judicial power to courts only in situations involving “Cases” or “Controversies.” U.S. Const. art. III, § 2. This jurisdictional limitation imposes the requirement that a plaintiff must have standing to pursue a matter in federal court, Nat'l Treasury Employees Union v. United States, 101 F.3d 1423, 1427 (D.C.Cir.1996), which requires the presence of the following three prerequisites: “(1) injury in fact, (2) causation, and (3) redressability,” Young America's Foundation v. Gates, 573 F.3d 797, 799 (D.C.Cir.2009) (citing Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61, 112 S.Ct. 2130, ...