Group Lacks Standing to Prevent FDA from Approving Vaccines Feared to Cause Autism

An advocacy group concerned with the potential future effect of certain vaccinations does not have standing to sue the FDA to suspend approval of the vaccinations. Certain vaccinations routinely given to very young children are preserved with a mercury-based agent, thimerosal, to prevent bacterial and fungal growth. The advocacy group believes that giving these vaccinations to young children can cause autism. It petitioned the FDA to stop approving the vaccines. The FDA denied the petition, based on its claim that sound scientific evaluation has repeatedly found these vaccines to be safe.


The group filed a lawsuit alleging that the FDA was in violation of its statutory duty to ensure these vaccines are safe. It requested an order requiring the FDA to prohibit the administration of vaccines containing more than a trace level of thimerosal to young children and pregnant women. They also sought to force the FDA to remove thimerosal-preserved vaccines from the market.


The district court granted the FDA’s motion to dismiss for lack of standing and failure to state a claim.


The circuit court affirmed. The plaintiffs based their claim to standing on their fear that future exposure to thimerosal would cause injury, and alleged several past injuries resulting from thimerosal exposure in vaccines. However, since all the plaintiffs claimed they would refuse vaccinations containing thimerosal in the future, none of them could establish a real and immediate threat of injury that the relief sought would address.


See: Coalition for Mercury-Free Drugs v. Sebelius, 2012 WL 811521 (D.C.Cir.  Mar 13, 2012) (not designated for publication).