Stacey Heinzelman v. HHS - Influenza, Guillain-Barré syndrome (GBS) (2011)

Stacey Heinzelman was born in 1971 and filed her petition on January 3, 2007, alleging that a flu vaccination she received on December 10, 2003, had caused her to develop Guillain-Barré syndrome (GBS). Approximately nine days after the vaccination, on December 19, 2003, Ms.

Heinzelman began showing signs of a gastrointestinal illness; the pathogen responsible for that illness was never identified. On December 30, 2003, she saw her primary care doctor with complaints of headache, tingling in her hands and feet, and stiff legs, and on December 31, 2003 she was hospitalized and diagnosed with GBS.

Both parties agreed on the GBS diagnosis and agreed that Ms. Heinzelman would never again be gainfully employed.

Her pre-vaccination gross earning capacity had been approximately $50,000 per year; she became eligible for Social Security Disability Insurance (SSDI) payments of approximately $20,000 per year as a result of her condition. This was an off-Table case — Ms.

Heinzelman did not allege a Table injury, and was required to prove causation-in-fact under the Althen three-prong test. Following an April 28, 2008 hearing at which both sides presented expert testimony, the special master issued a ruling on December 11, 2008 granting compensation.

Petitioner's expert, Dr. Marcel Kinsbourne, a trained neurologist, testified that in his opinion at a level of reasonable medical probability the flu vaccine had caused Ms.

Heinzelman's GBS, citing multiple medical articles with empirical studies. Her treating neurologist, Dr.

Darryl Prince, agreed with Dr. Kinsbourne's assessment.

The government's expert conceded that the flu vaccine has been implicated in the onset of GBS (prong 1) and that the twenty-day interval between the vaccination and GBS onset was a sufficient temporal relationship (prong 3); the dispute was confined to Althen prong 2, the logical sequence of cause and effect. The special master found the Althen test satisfied, granted compensation, and held that Ms.

Heinzelman had established a prima facie case, shifting the burden to the government to prove alternative causation. The government argued that Ms.

Heinzelman's GBS was statistically more likely caused by her GI illness, but the special master rejected that argument as predominantly statistical analysis, relying on Knudsen v. Secretary of HHS, 35 F.3d 543 (Fed.

Cir. 1994), which holds that bare statistical probabilities are insufficient to establish that a specific factor caused a specific individual's injury. During the damages phase, a dispute arose over whether Ms.

Heinzelman's anticipated SSDI payments should offset her compensation. On May 18, 2010, the special master ruled that SSDI should not reduce the award.

On December 7, 2010, the special master directed entry of final judgment based on the government's Proffer on Award of Compensation. The government filed a motion for review on January 6, 2011, raising two issues.

First, it argued that the special master had failed to consider the record as a whole before finding that petitioner established her prima facie case and had prematurely shifted the burden to the government, citing the statistical likelihood that the GI illness rather than the vaccine caused the GBS. Second, it argued that Ms.

Heinzelman's anticipated SSDI payments should reduce her compensation either as part of the "actual or anticipated loss of earnings" calculation under 42 U.S.C. § 300aa-15(a)(3)(A), or as a "Federal health benefits program" offset under § 300aa-15(g). Judge Damich, writing for the Court of Federal Claims on June 24, 2011, denied the government's motion for review.

On the first issue, the court held that the special master had properly considered the record as a whole, that Dr. Kinsbourne's testimony provided a reputable medical explanation sufficient to satisfy Althen prong 2, and that the government's statistical argument was properly rejected under Knudsen — the court rejected the government's effort to distinguish Knudsen as limited to on-Table cases, holding that once a petitioner establishes a prima facie off-Table case, she is on the same footing as an on-Table petitioner and the government may not rebut with bare statistics.

On the second issue, the court held that SSDI payments are not an offset. Under § 15(a)(3)(A), "loss of earnings" refers to the earning capacity lost due to the injury; SSDI is not "earnings," and the statute does not reduce the baseline calculation of lost earning capacity by the amount of government benefits received.

The court cited the House Report on the Vaccine Act, which stated that "the Committee did not intend that award be reduced because of other government benefits for which the injured person might be eligible." Under § 15(g), SSDI does not constitute a "Federal health benefits program" because SSDI compensates for loss of income rather than providing health insurance benefits, and other provisions of the Social Security Act that have nothing to do with health benefits are not thereby converted into health benefits programs.