Roberta Pek v. HHS - Influenza, multiple sclerosis (2020)

Roberta Pek, a 35-year-old adult, received an influenza vaccine on October 10, 2014, and a Tdap vaccine on November 14, 2014. She alleged that she developed multiple sclerosis (MS) as a result of these vaccinations.

Her symptoms, including numbness and tingling in her lower extremities, began around January 7, 2015, approximately 89 days after the flu shot and 54 days after the Tdap shot. Medical records indicated a diagnosis of MS, supported by MRI findings of lesions disseminated in time and space, and a positive CSF study for oligoclonal bands.

Petitioner's expert, Dr. Lawrence Steinman, argued that the flu vaccine could trigger an immune response to myelin proteins via molecular mimicry, and the Tdap vaccine's adjuvant could further propagate the autoimmune process.

Respondent's expert, Dr. Peter Donofrio, agreed that Ms.

Pek had MS but concluded that existing literature does not support a causal link between the Tdap vaccine and MS, and that the onset of symptoms was too far removed from vaccination to establish causation. The court found that Petitioner failed to establish a medically plausible theory that the vaccines could cause MS, did not prove a logical sequence of cause and effect linking the vaccines to her MS, and did not demonstrate a medically acceptable temporal relationship between vaccination and onset.

The court noted that while MS is a demyelinating injury, it is chronic and relapsing-remitting, unlike acute injuries more commonly linked to vaccines in the program. The court also found Dr.

Steinman's reliance on molecular mimicry and cytokine stimulation to be insufficiently supported by evidence specific to MS. Ultimately, the court denied Ms.

Pek's claim for compensation due to insufficient evidence to establish causation.