Kathleen Wyatt v. HHS - Influenza, Guillain-Barré Syndrome (2019)

On August 5, 2014, Kathleen Wyatt filed a petition under the National Vaccine Injury Compensation Program, alleging that she developed joint pain in her lower and upper extremities, radiating to her upper torso, after receiving the Fluarix influenza vaccine on October 1, 2012. Ms.

Wyatt, who was 60 years old at the time, claimed her symptoms began within a week of vaccination. Her primary care physician, Dr.

Charles MacCallum, noted her symptoms on October 16, 2012, prescribed prednisone, and referred her to a rheumatologist. Ms.

Wyatt also reported her symptoms to a corporate nurse who filed a Vaccine Adverse Event Reporting System (VAERS) report on October 16, 2012, stating the onset of symptoms was October 10, 2012. On October 28, 2012, Ms.

Wyatt fell down stairs, fracturing her left ankle. She reported to an orthopedist that she missed steps, but later informed Dr.

Corn in a letter that she continued to experience joint pain since her flu vaccine. Her rheumatologist, Dr.

Aminda Lumapas, saw her on January 3, 2013, and noted a positive ANA and a possible reactive arthritis process that had resolved. Dr.

Lumapas was unsure if the vaccine caused the symptoms and stated the symptoms had resolved by January 17, 2013. Ms.

Wyatt returned to work on a limited basis on January 11, 2013, and was cleared for full duty by Dr. Corn on February 1, 2013.

She continued to see Dr. MacCallum for other issues, but did not complain of joint or extremity pain related to the vaccine until December 8, 2015, when she saw neurologist Dr.

Lawrence Saltis. Dr.

Saltis noted a positive ANA and elevated CRP but did not associate her complaints with the flu vaccine. EMGs in January 2016 showed mild axonal peripheral neuropathy and mild right carpal tunnel syndrome.

Dr. MacCallum provided opinion letters in February and June 2016, suggesting an autoimmune reaction to the vaccine was the most plausible explanation for her symptoms, but acknowledged that evaluations by rheumatology failed to find significant autoimmune disease and that his opinion was based solely on temporal relationship.

He also stated that Ms. Wyatt did not have Guillain-Barré Syndrome (GBS).

Petitioner's expert, Dr. Phillip DeMio, diagnosed Ms.

Wyatt with "autoimmunity with a minimally improved Guillain-Barré Syndrome, with severe persisting sequelae" and later "autoimmunity, inflammation, polyneuropathy, and arthritis," attributing these to the flu vaccine. However, the Special Master found Dr.

DeMio lacked the requisite expertise in autoimmune or neurological disorders and that his opinions were unsupported by objective evidence. The Special Master denied entitlement, finding that Ms.

Wyatt failed to prove a defined and recognized injury, that her symptoms resolved within three months post-vaccination, thus not meeting the six-month duration requirement, and that she failed to satisfy the Althen criteria for causation. On September 4, 2019, the Court of Federal Claims affirmed the Special Master's decision, denying Ms.

Wyatt's motion for review and sustaining the dismissal.