Coalition for Mercury-Free Drugs Fails to Prove Standing in Thimerosal Case

July 5, 2010

By Alexander J. Varond* & Kurt R. Karst

Recently, the U.S. District Court for the District of Columbia dismissed a case brought by the Coalition for Mercury-Free Drugs (“Coalition”). Judge Reggie B. Walton ruled that the Coalition lacked standing to ask the court to ban vaccines containing the mercury-based preservative Thimerosal.


Beginning on August 10, 2007, the Coalition pursued a Citizen Petition against the use of Thimerosal under the belief that it causes the onset of autism and other brain disorders in children.

Though the preservative has been used in vaccines in the United States since the 1930s and has been proven safe, FDA supports a policy to remove Thimerosal from vaccines that are commonly administered to children. Regardless, FDA denied the 2007 Citizen Petition citing its lack of a legal or scientific basis to support the Coalition’s proposition.

The Case: The Coalition for Mercury-Free Drugs v. Kathleen Sebelius

Following the denial of its Citizen Petition, the Coalition filed a petition for injunctive relief in the United States District Court for the District of Columbia. Specifically, the complaint sought to suspend all approval and licenses as well as recall the preservative unless manufacturers could positively prove that it did not cause neurological damage in susceptible populations.

The court first addressed whether the National Vaccine Injury Compensation Act (“Vaccine Act”) provided sufficient, independent standing. Judge Watson held that although the Vaccine Act contains a citizen petition clause which 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, “it does not dispense with the requirement that the plaintiffs must demonstrate that they have standing to bring such an action in federal court.” Opinion at 8.

Thus, to bring the action before the federal court, plaintiffs had to prove standing “which requires the presence [of]: (1) injury in fact, (2) causation, and (3) redressability.” Opinion at 6. The court noted that the group would have to prove that at least one individual in the group had “standing to sue in their own right,” as required under Hunt v. Wash. State Apple Advertising Comm’n, 432 U.S. 333 (1977).

First, Judge Walton ruled that fear of the effects of Thimerosal was an insufficient basis for standing since there was adequate availability of mercury-free vaccines. The court noted that these mercury-vaccines were ample alternatives for anyone fearing the potential harms of Thimerosal. Moreover, even if there was an increased burden for those people that preferred mercury-free vaccines, plaintiffs did not prove that the burden or delay caused sufficient harm.

The court also held that the potential for healthcare providers to become confused whether a vaccine contained Thimerosal was too abstract of a potential harm. This was particularly true because Thimerosal packaging clearly indicated the preservative’s presence. Moreover, the potential for mix-ups as a result of repackaging and  “blatant mislabeling and deception by a pharmacist cannot be deemed ‘fairly traceable’ to the actions of the named defendants . . . .” Opinion at 17 (citing Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992)).

Finally, the court rejected the coalition’s claim that doctors and other medical professionals would suffer a loss of reputation from an alleged inability to guarantee the safety of vaccines. In these terms, the court held that this potential harm to doctors merely constituted an insufficient and generalized grievance, not the concrete and imminent injury.  Thus, the Coalition’s suit was dismissed for a lack of standing because the Coalition was unable to prove adequate harm.

* Law Student

Categories: Drug Development