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Coalition For Mercury-Free Drugs (Comed, Inc.), A Non-Profit v. Kathleen Sebelius

March 13, 2012

COALITION FOR MERCURY-FREE DRUGS (COMED, INC.), A NON-PROFIT ORGANIZATION, ET AL., APPELLANTS
v.
KATHLEEN SEBELIUS, SECRETARY OF HEALTH AND HUMAN SERVICES, AND MARGARET HAMBURG, COMMISSIONER OF FOOD AND DRUGS, APPELLEES



Appeal from the United States District Court for the District of Columbia (No. 1:09-cv-00015)

The opinion of the court was delivered by: Kavanaugh, Circuit Judge:

Argued November 2, 2011

Before: ROGERS and KAVANAUGH, Circuit Judges, and WILLIAMS, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge KAVANAUGH.

The Coalition for Mercury- Free Drugs opposes the use of vaccines that contain thimerosal, a mercury-based preservative. The Coalition believes that vaccines containing mercury harm young children and pregnant women. The Coalition and several of its members sued to suspend Food and Drug Administration approval of thimerosal-preserved vaccines. The District Court dismissed plaintiffs' suit for lack of standing.

We recognize plaintiffs' genuine concern about thimerosal-preserved vaccines. But plaintiffs are not required to receive thimerosal-preserved vaccines; they can readily obtain thimerosal-free vaccines. They do not have standing to challenge FDA's decision to allow other people to receive thimerosal-preserved vaccines. Plaintiffs may, of course, advocate that the Legislative and Executive Branches ban all thimerosal-preserved vaccines. But because plaintiffs are suffering no cognizable injury as a result of FDA's decision to allow thimerosal-preserved vaccines, their lawsuit is not a proper subject for the Judiciary. We affirm the judgment of the District Court.

I

A

Vaccine manufacturers often distribute vaccines in vials containing multiple doses. Under federal law, multiple-dose vials must contain a preservative so as to prevent bacterial and fungal contamination. See 21 C.F.R. § 610.15(a).

Preservatives are important because injection with a contaminated vaccine can be fatal. See FDA, THIMEROSAL IN VACCINES, available at http://www.fda.gov.

Thimerosal is a mercury-based compound that FDA has found to be safe and effective as a vaccine preservative. See 42 U.S.C. § 262(a)(2)(C)(i); FDA Response to Coalition Citizen Petition at 4-5. FDA has explained that "thimerosal has been the subject of several studies . . . and has a long record of safe and effective use preventing bacterial and fungal contamination of vaccines, with no ill effects established other than minor local reactions at the site of injection." FDA, THIMEROSAL IN VACCINES.

Despite FDA's approval, some members of the public have expressed concern about thimerosal-preserved vaccines. And in 1999, "as a precautionary measure," the Public Health Service (an entity within HHS) established the goal of removing thimerosal from early childhood vaccines. FDA Response to Coalition Citizen Petition at 18.*fn1 Since 2001, most vaccines routinely recommended for children younger than six or for pregnant women have contained no thimerosal or only trace amounts. The significant exception is the flu vaccine: Thimerosal-preserved flu vaccines are necessary to ensure sufficient supply at a reasonable price. Therefore, flu vaccines with thimerosal remain on the market and are approved not just for adults but also for young children and pregnant women.

B

The Coalition for Mercury-Free Drugs and its members believe vaccines containing thimerosal are unsafe. They are especially concerned about the possible effects of thimerosal- preserved vaccines on young children and pregnant women. Exposure to thimerosal, plaintiffs ...


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