Hazlehurst v. Sec'y Of Health And Human Serv.

• Decision Date: 13 May 2010
• Docket Number: No. 2009-5128.,2009-5128.
• Citation: 604 F.3d 1343
• Parties: Rolf HAZLEHURST and Angela Hazlehurst, parents of William Yates Hazlehurst, Petitioners-Appellants,v.SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

604 F.3d 1343

Rolf HAZLEHURST and Angela Hazlehurst, parents of William Yates Hazlehurst, Petitioners-Appellants,v.SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.

No. 2009-5128.

United States Court of Appeals Federal Circuit.

May 13, 2010.

Curtis R. Webb, Webb, Webb & Guerry, of Twin Falls, ID, argued for petitioners-appellants.

Lynn E. Ricciardella, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, of Washington, DC argued for respondent-appellee. With her on the brief were Tony West, Assistant Attorney General, Timothy P. Garren, Director, Mark W. Rogers, Deputy Director, and Gabrielle M. Fielding, Assistant Director.

Before NEWMAN and BRYSON, Circuit Judges, and GUILFORD, District Judge.^*

BRYSON, Circuit Judge.

This is one of a large number of cases involving claims for compensation on behalf of autistic children whose condition is alleged to have been caused by childhood vaccinations. In this case, Rolf and Angela Hazlehurst filed a claim for their son, Yates Hazlehurst, seeking compensation under the National Childhood Vaccine Injury Act of 1986 (“the Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34. The Hazlehursts alleged that the measles, mumps, and rubella (“MMR”) vaccine, which was administered to Yates shortly before his first birthday, caused him to develop regressive autism. A special master denied the Hazlehursts' petition, and the Court of Federal Claims affirmed. Hazlehurst v. Sec'y of Heath & Human Servs., 88 Fed.Cl. 473 (2009). On appeal to this court, the Hazlehursts argue that the special master improperly relied on certain evidence that should have been excluded and disregarded other evidence that should have been considered. We affirm.

I

The Office of Special Masters consolidated this case with several others as part of what was termed the Omnibus Autism Proceeding, an effort by the Office of Special Masters to identify and adjudicate certain test cases as a means of addressing the principal issues in approximately 5,000 autism claims that have been filed under the Vaccine Act. The objective of the omnibus proceeding was to determine the relationship, if any, between vaccines and autism spectrum disorders. This case was considered together with two others Cedillo v. Secretary of Health and Human Services, No. 98-916V, and Snyder v. Secretary of Health and Human Services, No. 01-162V, in one of the groups of test cases. In the Cedillo and Snyder cases, the petitioners presented a theory of causation based on the combined effect of the MMR vaccine and vaccines containing thimerosal, a vaccine preservative. The Hazlehursts initially presented that theory of causation, but in post-hearing briefing they relied on the theory that Yates's autism was caused by the MMR vaccine alone. Although each of the three cases was decided by a different special master, the record in this case includes all of the general causation evidence admitted in Cedillo and Snyder. The full record encompasses tens of thousands of pages of medical literature, more than four thousand pages of hearing testimony, and fifty expert reports containing the opinions of seven experts for the petitioners and eighteen experts for the government.

The evidence at the hearing showed that Yates Hazlehurst was born on February 11, 2000, and developed normally during his first year of life. On February 8, 2001, three days before his first birthday, Yates 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, even though he had previously used words such as “mama,” “please,” and “thank you.” At about the same time, he developed chronic diarrhea and abdominal pain. Following a series of evaluations in July 2002, Yates was diagnosed as exhibiting a pattern of behavior consistent with autism.

In 2003, the Hazlehursts filed a petition for vaccine injury compensation under the Vaccine Act. The special master summarized their theory of causation as follows:

[P]etitioners assert that the measles component of the MMR vaccine causes an immune dysfunction that impairs the vaccinee's ability to clear the measles virus. Unable to properly clear the measles virus from the body, the vaccinee experiences measles virus persistence which leads to chronic inflammation in the gastrointestinal system and, in turn, chronic inflammation in the brain. Petitioners argue that the inflammation in the brain causes neurological damage that manifests as autism.

Hazlehurst v. Sec'y of Health & Human Servs., No. 03-654V, 2009 WL 332306, at *86 (Fed.Cl. Feb. 12, 2009). The Hazlehursts acknowledged that the linchpin of their theory was the discovery of persistent measles virus in certain autistic children who had received the MMR vaccine. That evidence derived from the research of Dr. Andrew Wakefield of the Royal Free Hospital in London and his colleagues at the Unigenetics laboratory in Dublin, and the research of Dr. Stephen Walker and his colleagues at the Wake Forest University School of Medicine.

Dr. Wakefield was the primary proponent of the hypothesis that the MMR vaccine could cause autism in certain children. His work led to civil litigation against certain vaccine manufacturers in the United Kingdom (“the UK litigation”). The Unigenetics laboratory was a for-profit, non-accredited institution that was established to support the UK litigation by testing children for the presence of measles virus in certain body tissues. The Unigenetics research, which reported successful use of the polymerase chain reaction technique (“PCR”) to identify and amplify measles virus genetic material in the blood and intestinal tissues of autistic children, formed the basis for a 2002 article co-authored by Dr. Wakefield (the Uhlmann article) on which the Hazlehursts primarily rely. In addition, the Hazlehursts rely on preliminary research results reported by the Walker group. In an abstract and poster presentation delivered at the June 2006 International Meeting for Autism Research (“IMFAR”), the Walker group claimed to have replicated the positive results reported by Unigenetics.

The Hazlehursts' key witness at their hearing was Yates's pediatric neurologist, Dr. Jean-Ronel Corbier. Dr. Corbier relied heavily on the results of the Unigenetics and Walker studies as support for his opinion that Yates's February 8, 2001, MMR vaccination played a substantial role in causing Yates's autism. Dr. Corbier testified that those studies suggested that the MMR vaccine may contribute to the development of regressive autism in children who fit a particular clinical profile, including normal development prior to receipt of the MMR vaccination, display of symptoms of regressive autism within one to nine months after receipt of the MMR vaccination, and development of gastrointestinal problems during that period.

The special master also heard testimony from Dr. Karin Hepner and Dr. Arthur Krigsman, two of the researchers in the Walker group. Drs. Hepner and Krigsman cited their own work as evidence of the reliability and reproducibility of the Unigenetics test results. They also stated that the Walker group had confirmed its results through genetic sequencing. Dr. Krigsman testified that the group had verified, at least for some samples, that the genetic material identified and amplified by PCR contained the same nucleotide sequence as the targeted product, i.e., vaccine-strain measles virus.

In response to the petitioners' evidence concerning the presence of measles virus in autistic children, the government offered expert testimony and reports from, among others, Dr. Stephen Bustin, a molecular biologist who had appeared as an expert in the UK litigation. In connection with the UK proceedings, Dr. Bustin had been hired by vaccine manufacturers to evaluate the testing methods of the Unigenetics laboratory. After analyzing Unigenetics' equipment and notebooks, Dr. Bustin concluded that the Unigenetics researchers had failed to follow their own standard operating procedures, had failed to abide by certain standard laboratory practices, and had failed to comply with standards set forth by the manufacturers of the laboratory testing equipment, all of which undermined the reliability of the laboratory's test results. Dr. Bustin memorialized his conclusions in reports that were filed under seal in the UK litigation and later released to the government in the Omnibus Autism Proceeding.

Over objection, the government sought to introduce Dr. Bustin's reports and testimony regarding the Unigenetics laboratory, which, by that time, had gone out of business.¹ The special master in the Cedillo case provisionally admitted the evidence. The three special masters in the omnibus proceeding then deferred decision on whether to rely on that evidence and stated that they would “favorably consider joining in a request” by the petitioners “for the release of relevant reports” from the UK litigation. The record remained open for more than a year following the Cedillo hearing to afford the petitioners sufficient time to present rebuttal evidence, to conduct additional cross-examination of Dr. Bustin, and to obtain documents from the British court. However, none of the petitioners recalled Dr. Bustin for further questioning or applied for access to any of the materials from the UK litigation.

The special master subsequently denied the Hazlehursts' motion to strike Dr. Bustin's reports and testimony. She explained that Dr. Bustin's evidence was highly relevant and that fairness had been achieved by affording the petitioners a generous period of time in which to obtain any additional relevant information.

In her decision on the merits, the special master concluded that the Hazlehursts had failed to prove that Yates's MMR vaccination had caused his autism. In a lengthy opinion, the special master analyzed the...