Wednesday, March 14, 2012

Association Lacks Standing to Force FDA to Ban Mercury in Vaccines

The D.C. Circuit ruled in Coalition for Mercury-Free Drugs v. Sebelius that the plaintiff-organization lacked standing to force the FDA to ban the mercury-based preservative thimerosal from vaccines.

The case grows out of the Coalition's petition to the FDA and subsequent suit seeking an order forcing the FDA to ban thimerosal-preserved vaccines. The FDA moved to dismiss for lack of standing; the D.C. District dismissed; and the D.C. Circuit affirmed.

The D.C. Circuit ruled that the FDA did not force any member of the Coalition to take thimerosal-preserved vaccines--instead, the FDA only allowed them--and therefore no Coalition member could show actual and imminent harm.

The Circuit court also ruled that doctor-members did not have standing based on reputational harm, because the FDA did not force them to prescribe or to use thimerosal-preserved vaccines. (Those doctors could have used thimerosal-free vaccines.)

Finally, the court rejected the plaintiff's claim that the FDA's policy of allowing thimerosal-preserved vaccines made thimerosal-free vaccines prohibitively expensive. The court said that the plaintiffs could still reasonably obtain thimerosal-free vaccines, even if their price went up slightly becuase of the policy allowing thimerosal-free vaccines, and therefore no Coalition member alleged a sufficient injury based on lack of access to thimerosal-free vaccines.


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