Laurie Bishara v. HHS - Tdap, scleroderma (2023)

Laurie Bishara, born in 1972, received a Tdap vaccine on February 8, 2016. Within two days, she reported exhaustion and achiness, and by February 23, 2016, she experienced swollen fingertips with color changes, leading to a diagnosis of Raynaud's phenomenon and a referral to a rheumatologist.

Subsequent evaluations confirmed a diagnosis of diffuse cutaneous scleroderma. Ms.

Bishara alleged that the Tdap vaccine caused her scleroderma, advancing the theory of molecular mimicry. She presented expert testimony from Dr.

Samar Gupta, who opined that molecular mimicry could explain the autoimmune response. The Secretary of Health and Human Services disputed this, presenting expert opinions from Dr.

Chester Oddis and Dr. You-Wen He.

Their reports argued that the etiology of scleroderma is unknown, challenged the reliability of molecular mimicry as a theory in this context, and noted the lack of published reports linking the Tdap vaccine to scleroderma. The court reviewed the evidence, including expert reports and testimony, and considered the legal precedents regarding molecular mimicry and the evidentiary value of case reports.

The court found that Ms. Bishara failed to present persuasive evidence that molecular mimicry is a reliable basis for connecting the Tdap vaccine to scleroderma, noting the absence of identified homology and the limited value of the case reports presented.

Consequently, the court concluded that Ms. Bishara did not meet her burden of proof for an off-Table injury.

Her claim for compensation was denied.