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Coalition for Mercury-Free Drugs v. Sebelius

July 15, 2010

THE COALITION FOR MERCURY-FREE DRUGS, ET AL., PLAINTIFFS,
v.
KATHLEEN SEBELIUS, *FN1 SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Reggie B. Walton United States District Judge

AMENDED MEMORANDUM OPINION*fn2

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.*fn3 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");*fn4 (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.*fn5 FDA, Thimerosal in Vaccines (March 31, 2010).*fn6 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_CoMeDCitizenPetitionPart2.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 (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 (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 (1992)).

A. The Plaintiffs' Request for Leave to File Supplemental Declarations in Support of Standing

Subsequent to the defendants moving for dismissal of this action, the plaintiffs filed multiple motions for leave to submit supplemental information in the form of declarations by members of Mercury-Free in their effort to demonstrate that at least one plaintiff, if not all of them, possess the requisite standing to maintain this action. See Pls.' Mot. to Supplement I; Pls.' Mot. to Supplement II; Pls.' Mot. to Supplement III. The defendants oppose these motions, contending that the plaintiffs must demonstrate standing "based on the complaint at the time the complaint was filed." Defs.' Opp'n Re: Leave to Supplement at 3. The defendants' position is inaccurate because the law in this Circuit does, in fact, permit plaintiffs to submit post-complaint affidavits to demonstrate standing. See, e.g., Am. Library Ass'n v. FCC, 401 F.3d 489, 494 (D.C. Cir. 2005) (indicating that where jurisdictional questions exist, a court may seek supplemental briefing); D&F Alfonso Realty Trust v. Garvey, 216 F.3d 1191, 1194 (D.C. Cir. 2000) (indicating that the petitioners overcame a standing challenge when "afforded . . . the opportunity [after oral argument] to submit affidavits supporting its allegations"). Moreover, the Court can also look outside the four corners of the complaint to determine its jurisdiction. Jerome Stevens Pharms., 402 F.3d at 1253. Accordingly, the Court will grant the plaintiffs' three motions for leave to supplement the record and consider the additional information in assessing whether the Court has Article III jurisdiction to consider their claims.

B. The National Vaccine Injury Compensation Act Does Not Confer Standing in the Absence of Satisfying the Traditional Standing Requirements

The plaintiffs contend that they have standing to bring this action because the National Vaccine Injury Compensation Act ("Vaccine Act"), 42 U.S.C. §§ 300aa-10--300aa-34 (2006), through its citizen suit provision, states that "[a]ny person may commence in a district court of the United States a civil action on such person's own behalf against the Secretary where there is alleged a failure of the Secretary to perform any act or duty upon this part." 42 U.S.C. § 300aa-31; see also Pls.' Mem. Re: Discovery at 8. On the other hand, the defendants, relying upon Lujan, 504 U.S. 555, contend that the traditional requirements of standing are not present in this case, and the statutory provision relied upon by the plaintiffs does not confer standing in the absence of satisfying the traditional standing requirements. See Defs.' Opp'n Re: Discovery at 19-20. The Court finds that the defendants have the stronger position.

In Lujan, the Supreme Court determined that the plaintiffs lacked standing despite their reliance on a citizen suit provision similar to the one relied upon by the plaintiffs here. 504 U.S. at 571-74; see also Common Cause v. FEC, 108 F.3d 413, 419 (D.C. Cir. 1997) (indicating that a "citizen suit" provision "does not confer standing; it confers a right to sue upon parties who otherwise already have standing"). Similar to the citizen suit provision in Lujan, 42 U.S.C. ยง 300aa-31 authorizes suits against the government for violations of the Vaccine Act, but it does not dispense ...


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