W.C. v. HHS - Influenza, multiple sclerosis (2011)

W.C. filed his petition in June 2007, alleging that a flu vaccine he received on December 13, 2004 had caused the onset of multiple sclerosis or, in the alternative, had significantly aggravated a pre-existing but asymptomatic form of the disease. He was approximately thirty-four years old at the time of the vaccination, and before December 13, 2004, he had no clinical symptoms of neurological problems.

Eleven days after the vaccination, on December 24, 2004, W.C. experienced numbness in his left arm, hand, head, and face. He saw his family physician, Dr.

Deborah Darrington, who referred him for an MRI performed on December 30, 2004. That MRI revealed six lesions, none of which was enhanced by contrast agent — an observation bearing heavily on the subsequent dispute over when the lesions had formed.

After a hunting expedition on January 8, 2005, W.C. lost most motor function in his left hand and arm and saw neurologist Dr. John Hannam, who noted the MRI findings were consistent with a possible first clinical attack of multiple sclerosis.

A lumbar puncture showed no oligoclonal bands. In March and June 2005, multiple sclerosis specialist Dr.

Rifaat Bashir evaluated W.C.; after a June 28, 2005 MRI showed a new enhancing lesion, Dr. Bashir concluded that a diagnosis of clinically supported multiple sclerosis could be made and began treating him for that condition.

Petitioner's expert, Dr. Carlo Tornatore, the director of the Multiple Sclerosis Center at Georgetown University Hospital, testified that the flu vaccine caused W.C.'s multiple sclerosis through the mechanism of molecular mimicry — vaccine peptides structurally similar to myelin basic protein (MBP) could cause the immune system to attack MBP in the central nervous system.

Dr. Tornatore relied on the Wucherpfennig study (1995), which identified influenza A peptides with structural similarities to MBP, and on case reports documenting demyelinating conditions following flu vaccination.

The government's expert, Dr. Arun Venkatesan of Johns Hopkins, contended that W.C. had pre-existing subclinical multiple sclerosis before his vaccination.

Dr. Venkatesan's key argument was statistical: the December 30, 2004 MRI showed six lesions, none of which was enhanced.

According to the Cotton study (2003), new multiple sclerosis lesions typically enhance for a mean of three weeks; if the six lesions had all formed after the December 13 vaccination, the probability that all six would have fully healed within the seventeen-day interval before the MRI was extremely low, suggesting they had existed before the vaccination. Dr.

Tornatore responded that the Cotton study's median enhancement duration was two weeks, making rapid healing plausible, and that lesions were likely enhancing on December 24, when W.C. became symptomatic. The special master issued the Entitlement Decision on February 22, 2011, denying compensation.

He found W.C.'s lesions had predated the vaccination based on Dr. Venkatesan's probability argument, which the special master found persuasive.

Because the pre-existing MS finding disposed of the direct-causation theory (a vaccine cannot be the but-for cause of a disease that already existed), the special master applied the six-prong Loving test for off-table significant aggravation claims. He found that W.C. had not established the first Althen/Loving element — a medical theory causally connecting the aggravation to the vaccination — because the Wucherpfennig study had tested influenza A virus rather than the vaccine itself, was conducted in vitro, and a subsequent study by Moriabadi (2001) found no increased T-cell reactivity to MBP in multiple sclerosis patients following flu vaccination.

Three large clinical studies (Confavreux 2001, DeStephano 2003, Miller 1997) found no statistically significant increase in multiple sclerosis relapses following flu vaccination. The special master separately denied W.C.'s motion to redact his name from the decision on March 16, 2011, relying on Ninth Circuit precedent addressing anonymous civil plaintiffs.

Judge Lettow, writing for the Court of Federal Claims on July 22, 2011, affirmed the special master's Entitlement Decision but reversed the Redaction Decision. On entitlement, the court held that the special master's finding of pre-existing subclinical multiple sclerosis could not be deemed arbitrary or capricious, even though the court described the question as "a close call." Although the special master had invoked Broekelschen in support of a diagnosis-first approach — a case that required resolving two competing diagnoses with different etiologies — the court held that his error was harmless because the parties agreed that W.C. had multiple sclerosis; the disputed question was only when it began and whether the vaccine caused or aggravated it.

The pre-existing MS finding implicitly disposed of both Althen prongs two and three: if the disease predated the vaccine, there could be no logical sequence of cause and effect and no medically acceptable temporal relationship establishing causation. The special master's analysis of the significant aggravation claim under the Loving test was also upheld.

On the redaction issue, the court reversed the special master's denial. The court held that the privacy provisions of the Vaccine Act — 42 U.S.C. § 300aa-12(d)(4)(B) — mirror the language of FOIA Exemption 6 and should be interpreted consistently with the body of FOIA privacy law rather than the civil-case anonymous-plaintiff doctrine applied by the special master.

Applying FOIA Exemption 6 balancing — weighing the individual's privacy interest against the public interest in disclosure — the court found no public interest in disclosing W.C.'s identity. His identity had no bearing on the public's awareness of vaccines and their risks; the medical condition information served that interest adequately without naming him.

W.C. had expressed a specific, rational concern that disclosure of his identity linked to his multiple sclerosis diagnosis could be used to discredit testimony he provided on behalf of the government in immigration proceedings. The case was remanded to the special master with instructions to redact W.C.'s name from the published decisions.