Federal Circuit Affirms Rejection Of Vaccine-Autism Link

Federal Circuit Affirms Rejection Of Vaccine-Autism Link

WASHINGTON, D.C. — (Mealey’s) In the first appeal to be considered of the Vaccine Court’s rejection of a connection between childhood vaccines and autism, the Federal Circuit U.S. Court of Appeals affirmed May 13 that the petitioners’ evidence was unreliable and insufficient (Rolf Hazlehurst, et al. v. Secretary, No. 2009-5128, Fed. Cir.).

The petition on behalf of Yates Hazlehurst, 10, was the second in a group of three brought to test the claim that neuroinflammation created by entry of the vaccine-strain measles virus into the brain caused the children's autism. The panel said the petition was undermined by reliance on the work of Dr. Andrew Wakefield and Unigenetics, a for-profit laboratory established in Dublin, Ireland, to develop evidence supporting a vaccines-autism causation theory, and that of Dr. Stephen Walker and colleagues at the Wake Forest University School of Medicine.

“The special master found that Dr. Wakefield’s work had been largely discredited within the scientific community and that none of the studies indicating the presence of measles virus in autistic children had been successfully replicated by an accredited laboratory independent of Dr. Wakefield or Unigenetics,” the panel said.  “In particular, the special master found that Dr. Wakefield’s early 1990s research on persistent measles infections was reviewed by the Medical Research Council of the United Kingdom and found to lack important controls and sufficiently specific reagents for detecting measles virus.  She also found that Dr. Wakefield’s subsequent research was dismissed by the scientific community as methodologically unsound.  In that regard, she noted that 10 of 12 co-authors on Dr. Wakefield’s controversial 1998 article in the medical journal The Lancet subsequently retracted their support for the article’s conclusion that there is a potential causal link between the MMR vaccine and autism.”

The Hazlehursts’ key witness was Yates’ pediatric neurologist, Dr. Jean-Ronel Corbier, who, according to the panel, relied heavily on the results of the Unigenetics and Walker studies as support for his opinion that Yates’ MMR vaccination played a substantial role in causing his autism.

The petitioners complained that the government obtained an unfair advantage by introducing Dr. Stephen Bustin to undercut the petitioners’ reliance on the Unigenetics findings because the materials on which Bustin relied in the British litigation no longer exist or are under seal.  The complaint, the panel said, was self-inflicted.

“The special master’s decision to admit and consider Dr. Bustin’s testimony and reports was in full accord with the principle of fundamental fairness,” the panel said.  “Although not obligated to do so, the petitioners chose to introduce the Unigenetics data and thus placed its validity squarely in issue.  Fairness dictated that the government be given an opportunity to refute that critical evidence.”

“In any event, we agree with the Court of Federal Claims that the special master would have reached the same conclusion regarding the reliability of the Unigenetics data even in the absence of Dr. Bustin’s evidence,” the panel said.

The case was considered by the Office of Special Masters along with Cedillo v. Secretary of Health and Human Services (No. 98-916V) and Snyder v. Secretary of Health and Human Services (No. 01-162V), presenting a theory that the combined effect of the MMR vaccine and vaccines containing thimerosal caused their children’s autism, the panel said. The Hazlehursts abandoned that theory in post-hearing briefing, the panel said, and relied on the theory that Yates’ autism was caused by the MMR vaccine alone.

According to the panel, Yates developed normally during his first year of life. On Feb. 8, 2001, three days before his first birthday, he received an MMR vaccination. Within a month after his MMR vaccination, according to his family, Yates became “wild,” “very hyperactive,” and “out of control.” By the summer of 2001, Yates had lost all meaningful speech, although he had previously used words such as “mama,” “please,” and “thank you.” At about the same time, he developed chronic diarrhea and abdominal pain, the panel said.

Circuit Judge William C. Bryson wrote for the court. Circuit Judge Pauline Newman concurred, as did U.S. Judge Andrew J. Guilford of the Central District of California, sitting by designation.

[Editor's Note:  Full coverage will be in the May issue of Mealey’s Litigation Report: Thimerosal & Vaccines.  In the meantime, the opinion is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844.  Document #56-100519-015Z.  For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]

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