Federal Claims Court: Vaccines Don't Cause Autism

Three federal judges have ruled in three separate cases that there is no association between vaccines and autism.

The rulings, which were issued Feb. 12, represent a victory for immunization proponents, but the legal battle is far from over. According to published reports, lawyers for the plaintiffs have indicated they will appeal.

A background document (2-page PDF; About PDFs) from the U.S. Court of Federal Claims Office of Special Masters states that the plaintiffs have 30 days to seek reviews.

"There is a chance for appeal, but to have three cases settled in a similar manner is significant," said Jonathan Temte, M.D., Ph.D., an associate professor in the department of family medicine at the University of Wisconsin, Madison, and a member of the CDC's Advisory Committee on Immunization Practices, or ACIP. "These were test cases ahead of 5,000 other cases. These have a strong bearing on where things are likely to go."

More than 5,500 cases alleging that vaccines cause autism have been filed with the National Vaccine Injury Compensation Program. Anti-immunization groups have advanced the following three theories of causation:

The Feb. 12 rulings stemmed from three cases -- based on the first causation theory -- for which hearings started in 2007. More than 5,000 pages of transcripts resulted from the three hearings, which also produced 700 pages of post-hearing briefs.

According to the U.S. Court of Federal Claims, evidentiary hearings on cases related to the second theory of causation concluded in July 2008, but posthearing briefs are still being filed. That process, the court said, will conclude in the spring or summer, after which the Special Masters -- judges assigned to the court -- will issue their opinions.

The third theory was dropped by the Petitioners' Steering Committee because evidence pertaining to that theory was presented in a case included in the first theory group.

In that case, Cedillo vs. Secretary of Health and Human Services, the plaintiff argued that thimerosal-containing vaccines can cause immune dysfunction, that the MMR vaccine can cause autism and that the MMR vaccine can cause chronic gastrointestinal dysfunction.

Special Master George Hastings wrote in his ruling that "the evidence was overwhelmingly contrary to the petitioners’ contentions" on each issue.

"The expert witnesses presented by the respondent were far better qualified, far more experienced and far more persuasive than the petitioners' experts concerning most of the key points," he wrote.

Doug Campos-Outcalt, M.D., M.P.A., who serves as the AAFP's liaison to ACIP and is associate head of the Department of Family and Community Medicine and assistant dean for outreach and multicultural affairs at the University of Arizona College of Medicine, Phoenix, said he hopes the rulings will counter the "onslaught of false claims" by anti-immunization organizations.

"If you read the judgments, they're pretty critical of the experts used by the plaintiffs," he said. "They're basically saying they're not credible, and their evidence isn't credible. They're using studies that have been discredited."

However, Campos-Outcalt said the rulings likely won't stop anti-immunization groups, which have blamed vaccines for other health problems in infants and children, including sudden infant death syndrome.

Temte said he hopes the rulings will ease people's minds. A growing number of parents are rejecting vaccinations for their children or have sought to lengthen the vaccination schedule so that their children do not receive several antigens at once, CDC and other reports suggest.

"Safety continues to be a very important driver of concern about vaccines for both patients and physicians," said Temte. "Anything out there that alleviates concern is a real benefit, especially at a time when there is avoidance of vaccines for personal reasons and a time when there is an increase of preventable illness."

Temte's statement is right on target. In January, Minnesota public health officials reported that a nationwide shortage of Haemophilus influenzae type b, or Hib, vaccine and the refusal by some parents to vaccinate their children may have sparked a re-emergence of invasive Hib disease in that state.

Five cases of invasive Hib disease in children younger than age 5 years were reported last year to the Minnesota Department of Health. Three of the five children were completely unvaccinated against the disease. One child died.

Meanwhile, 131 measles cases were reported to the CDC from Jan. 1, 2008 through July 31 from 15 states and Washington, D.C. Seventy-six percent of the reported illnesses were in people younger than age 20, and 91 percent were in people who were unvaccinated or of unknown vaccination status.

Campos-Outcalt said the anti-vaccination movement is lowering overall immunity levels in the nation's children.

"There's no doubt we'll see outbreaks," he said, "and some children will die from preventable illness because of these false claims."

HHS has scheduled a public hearing of the Advisory Commission on Childhood Vaccines next month to discuss these and related issues. Interested parties can phone in to hear the proceedings by calling (888) 790-3149. The hearing is scheduled to run from 1-5:30 p.m. ET on March 5 and from 9 a.m.-12:30 p.m. on March 6. The call leader is Geoffrey Evans, M.D., and the password is ACCV.