Donna S. Guillory v. HHS - Hepatitis B, neurological defects (2003)

Donna S. Guillory worked as an electroneurodiagnostic technologist at St.

Jude Medical Center in Kenner, Louisiana, and received three hepatitis B vaccinations as part of the Medical Center's employee immunization campaign. Her first vaccination was on July 10, 1992, after which she experienced brief chills, sweats, and site tenderness.

Her second vaccination was on August 10, 1992, causing similar transient symptoms. Shortly after the second vaccination, Ms.

Guillory underwent elective outpatient surgery to remove a wrist ganglion cyst on August 14. The following day she noticed facial numbness, and on August 17 her neurologist colleague, Dr.

Terence D'Souza, observed that she appeared unsteady with a slightly broad-based gait. An MRI was normal, and most symptoms subsided within a week; intermittent perioral tingling persisted for several months.

Ms. Guillory received her third hepatitis B vaccination on January 15, 1993, after which she experienced swelling in her feet and a rash covering her abdomen, chest, and neck.

On May 27, 1993, she awoke with severe pressure in her head and spinal pain radiating into both legs, and fell when she attempted to stand. She was referred to neurologist Dr.

Michael Wilensky, who found weakness in her legs, poor tandem gait, and peripheral ataxia, and initially diagnosed dizziness. On June 7, 1993, Dr.

Wilensky hospitalized Ms. Guillory.

He initially diagnosed acute transverse myelitis and began steroid therapy; as her motor weakness improved but cerebellar signs developed, he began to question whether her condition was post-vaccination encephalomyelitis. He discharged her with a diagnosis of "transverse myelitis with additional cerebellar signs suggestive of encephalomyelitis," and informed Ms.

Guillory that there "may be a relationship" between the hepatitis B vaccinations and her neurological condition based on the temporal history. In August 1993, Dr.

Wilensky told her he attributed her neurological condition to the vaccinations "basically by process of elimination." At the hearing before the special master, Ms. Guillory presented Dr.

D'Souza and Dr. Wilensky as witnesses, with Dr.

Wilensky providing both factual testimony and expert opinion. She also presented expert testimony from Dr.

Leon Weisberg, a neurologist who had evaluated her in connection with a Louisiana Workers' Compensation proceeding. The respondent presented Dr.

Kottil Rammohan as a rebuttal expert. The special master denied compensation, finding that petitioner had not carried her burden under the Shyface v.

HHS, 165 F.3d 1344 (Fed. Cir. 1999) standard of proving the vaccine was both a but-for cause of and a substantial factor in her neurological injury.

The special master found that neither Dr. Wilensky nor Dr.

Weisberg had provided reliable expert opinions supporting causation: Dr. Wilensky was not an immunologist, his opinion amounted to "subjective belief or unsupported speculation," and Dr.

Weisberg conceded under cross-examination that he "can't prove" his own theory. Judge Hewitt, writing for the Court of Federal Claims on August 28, 2003, denied the motion for review and sustained the special master's decision.

The court rejected petitioner's argument that the special master was required to apply the five-prong Stevens v. HHS, 2001 WL 387418 (Fed.

Cl. Spec.

Mstr. 2001) framework, holding that the argument had been waived: petitioner had not raised Stevens before the special master in briefing, evidence, or oral argument — even though more than a year had elapsed since Stevens was issued before the hearing concluded — and Vaccine Rule 8(f) bars reliance on facts or arguments not raised below. The court also noted that special masters' decisions are not precedential and the special master was not bound by Stevens.

The court rejected petitioner's res judicata argument based on a prior Louisiana Fifth Circuit Court of Appeals ruling, holding that the doctrine does not apply because the HHS respondent was not a party to the Louisiana proceedings. The court affirmed the special master's application of the Daubert reliability framework, finding no abuse of discretion in his determination that the testifying experts' opinions rested on subjective belief rather than reliable scientific methodology.

Finally, the court found no error in the special master's failure to specifically discuss the IOM Report and Dr. Waisbren's case reports in his written decision, noting that a special master is not required to reference every item of evidence, and that neither document would have compelled a different result.