The U.S. Court of Appeals for the Federal Circuit denied omnibus claims for compensation from the Vaccine Injury Compensation Fund that were based on the theory that the measles, mumps and rubella (MMR) vaccine alone can cause childhood autism. Three test cases were used to posit the facts that would determine the outcome for the omnibus claimants, with each exploring different theories of causation for an alleged link between vaccines and autism. The special masters and the Court of Federal Claims rejected the theories proposed by plaintiffs in all three cases, and two of the cases were appealed to ultimate decision-maker on the claims, the Federal Circuit. Hazelhurst v. HHS is the first of the two to reach the decision stage.
The other case still on appeal, Cedillo v. HHS, was slated for oral argument on June 10. Cedillo contends that MMR vaccine and thimerosal-based vaccines in combination can cause autism.
Approximately 5,000 claimants' interests are subject to determination in the omnibus claim proceedings.
The discovery of the persistent measles virus in certain autistic children formed the underpinnings of Hazelhust's claim that the MMR virus alone can cause autism. Hazelhurst relied on research from three sources: British doctor Andrew Wakefield, the Irish for-profit Unigenetics lab and Dr. Stephen Walker of Wake Forest University School of Medicine.
The special master found the work of Wakefield, Unigenetics and Walker to be flawed, and both the Court of Federal Claims and the Federal Circuit upheld the findings. Under applicable law, the Court of Federal Claims or the Federal Circuit could have reversed the special master's decision only upon a determination that the special master's findings were arbitrary and capricious, its legal conclusions were not in accordance with law, or its discretionary rulings were an abuse of discretion.
With respect to Unigenetics, the government presented testimony by molecular biologist Dr. Stephen Bustin, who analyzed the Unigenetics lab findings. Bustin concluded that the lab failed to follow its own protocols and the standards set forth by the manufacturers of their laboratory equipment, rendering their conclusions unreliable. Unigenetics has ceased operations.
On appeal before the Federal Circuit, Hazelhurst challenged the special master's and Federal Claims Court's reliance on Bustin's conclusion as a matter of fundamental fairness. They asserted that Unigenetics' records were not available to them on three alternate theories: destruction of the records, court sealing of the records and the impracticality of obtaining them from a foreign government. The Federal Circuit rejected this challenge, noting that it was the plaintiff who introduced the Unigenetics findings into the proceeding, opening the door to the government's challenge of those findings' validity.
The Federal Circuit also noted that the special master's decision affirmed by the Federal Claims Court based its conclusions concerning flaws in the Unigenetics data on several sources, not solely the Bustin evidence.
Wakefield's conclusions were rejected because other scientists had been unable to replicate them, and the scientific community itself had rejected his research as methodologically unsound. Dr. Wakefield's study was published in the respected medical journal The Lancet, but 10 of the 12 co-authors later repudiated the findings.
The Walker evidence was deemed unsatisfactory based on its preliminary status and based on its reliance on a "wild-type" measles virus rather than the less virulent and reproducible vaccine-strain measles virus.
With respect to the plaintiff's argument that the special master and Federal Claims Court disregarded genetic sequencing evidence supplied by the Walker group, the Federal Circuit disagreed. The court pointed out that the special master referenced the supposedly ignored evidence in her decision. The Walker research was preliminary and incomplete, the court said, as well as of minimal significance due to the small number of cases in which vaccine-strain genetic material was found in bowel biopsies.
With the Hazelhurst case behind them, the omnibus claimants are nearing the end of the road in the claims process. Their last chance in linking their children's autism with vaccine administration is the upcoming appeal of Cedillo.