Anjanette Welch v. HHS - Influenza, neuropathy (2019)

Anjanette Welch filed a petition on April 4, 2018, seeking compensation under the National Vaccine Injury Compensation Program, alleging that the influenza vaccine she received on October 18, 2016, caused Guillain-Barré syndrome (GBS) and other neurological injuries. Ms.

Welch, who was fifty-two years old at the time of vaccination, had a significant medical history including type 2 diabetes mellitus, hypertension, obesity, arteriosclerosis, pancreatitis, and frequent urinary tract infections. She did not report any neurological or muscular symptoms prior to the vaccination.

Ms. Welch reported experiencing symptoms of weakness, poor balance, tingling in her hands and feet, and pain starting in December 2016, which was more than six weeks after her vaccination.

She sought treatment from her primary care physician, Dr. Regina Velarde, on February 21, 2017, and subsequently saw neurologist Dr.

Fredric Schoen on March 9, 2017. Dr.

Schoen's initial assessment included a balance problem and skin sensation disturbance, considering possibilities such as post-infection neuropathy or neuropathy related to diabetes. Electrodiagnostic testing showed no definitive evidence of generalized neuropathy but suggested carpal tunnel syndrome.

Dr. Schoen noted Ms.

Welch had received a flu shot in the fall but did not recall when. Further evaluations, including a lumbar puncture and brain MRI, were performed.

On April 27, 2017, Dr. Schoen noted her symptoms were improving slightly and recorded that she had a flu shot "2 weeks before onset of symptoms," a statement that conflicted with her earlier reports.

He theorized her condition might be postinfectious or small fiber neuropathy. In July 2017, rheumatologist Dr.

Neal Greenstein noted she was positive for antinuclear antibodies but did not provide a definitive diagnosis, opining her condition might be a mild case of GBS or a virus. On August 7, 2017, Dr.

Schoen recorded that she "likely had postvaccination neuropathy i.e. very mild Guillain-Barré syndrome," noting her numbness began "probably 4 weeks later." Her reflexes had returned in her knees and ankles but remained absent in her arms. By August 16, 2017, she reported to Dr.

Velarde that she had been diagnosed with GBS. Petitioner filed no subsequent medical records.

Ms. Welch submitted an affidavit detailing her symptoms and their impact on her life, stating symptoms began in the days following vaccination and intensified weekly, but also averred symptoms worsened between December 2016 and April 2017.

Petitioner's expert, Dr. Schoen, provided two reports.

In his first report, he stated he "felt that she had probable postvaccination neuropathy" and considered a "presumed etiology of postvaccination neuropathy," but did not definitively diagnose GBS. In his second report, Dr.

Schoen noted Petitioner "did not show evidence of typical findings of [GBS]" but still suspected "extremely mild" GBS. He stated GBS symptoms usually begin one to three weeks after the inciting illness, but deemed Petitioner's onset time "still unclear," with some notes indicating weeks and others up to a month.

He acknowledged diabetes as a common cause of neuropathy but found Petitioner's symptom course inconsistent with it. Crucially, Dr.

Schoen concluded his second report by stating he "CAN NOT state within a reasonable degree of medical certainty that the flu vaccine was the competent producing cause of her very mild symptoms." Respondent did not file an expert report. Special Master Brian H.

Corcoran reviewed the filings and determined that Ms. Welch failed to establish a Table claim, as her symptom onset in December 2016 was outside the forty-two-day timeframe for GBS following flu vaccination, and her condition did not fit the acute progression of GBS.

He also found that Ms. Welch did not establish a non-Table claim under the Althen test.

The Special Master noted that Dr. Schoen's ultimate conclusion that he could not state to a reasonable medical certainty that the vaccine caused the injury undermined Petitioner's case.

The Special Master found that Petitioner's reliance on Dr. Schoen's earlier statements was insufficient, especially given the conflicting information regarding symptom onset and Dr.

Schoen's inability to confirm causation. The Special Master also found that Petitioner failed to establish a medically acceptable timeframe for onset and that her expert's opinion was not persuasive due to its reliance on potentially erroneous factual assumptions and lack of a clear causation theory.

Consequently, the Special Master dismissed Ms. Welch's claim for lack of preponderant evidence.

Petitioner was represented by Robert P. Goodwin of Walsh Roberts & Grace, and Respondent was represented by Voris E.

Johnson of the U.S. Department of Justice.

The decision was issued on August 1, 2019.