Bailey Day v. HHS - Influenza, neuromyelitis optica (NMO) or Devic’s Syndrome (2017)

On September 24, 2012, Laura Day, as the parent and natural guardian of her daughter Bailey Day, filed a petition under the National Vaccine Injury Compensation Program. The petition alleged that the Gardasil and FluMist vaccinations administered on September 28, 2011, caused Bailey to develop multiple sclerosis (MS).

It was later discovered that Bailey actually suffers from neuromyelitis optica (NMO), also known as Devic's Syndrome. The respondent, the Secretary of Health and Human Services, argued that the petitioner had not provided adequate evidence that the vaccinations caused B.K.D.'s NMO.

An entitlement hearing was held on June 10-11, 2015, with testimony from the petitioner, B.K.D., and their respective experts. On November 13, 2015, Chief Special Master Nora Beth Dorsey issued a ruling on entitlement, finding that the petitioner was entitled to compensation.

The public decision does not detail the specific symptoms, medical tests, or treatments B.K.D. experienced prior to the diagnosis of NMO, beyond what is described in the factual background. The decision does not name petitioner's counsel or respondent's counsel in the entitlement ruling, but later documents identify Anne Carrion Toale of Maglio, Christopher & Toale as petitioner's counsel and Gordon Elliot Shemin of the U.S.

Department of Justice as respondent's counsel. Dr.

Carlo Tornatore testified as petitioner's expert, and Dr. Thomas Leist testified as respondent's expert.

Dr. Tornatore proposed three theories of causation: molecular mimicry, immune system imbalance, and a misdirected immune response.

Dr. Leist disputed these theories, arguing that sequence homologies alone were insufficient to cause autoimmune disease and citing the Institute of Medicine's finding of insufficient evidence to assess an association between the HPV vaccine and NMO.

Chief Special Master Dorsey found that the petitioner had provided preponderant evidence that the Gardasil and FluMist vaccinations could cause NMO via molecular mimicry, satisfying Althen Prong One. She also found that the petitioner had shown a logical sequence of cause and effect, satisfying Althen Prong Two, and that the timing of B.K.D.'s symptom onset (three days post-vaccination) was medically appropriate, satisfying Althen Prong Three.

The ruling on entitlement was issued on November 13, 2015. On January 27, 2016, the parties filed a stipulation for interim attorneys' fees and costs, and Chief Special Master Dorsey awarded $112,500.00 to petitioner's attorney, Anne Toale.

On May 31, 2016, Chief Special Master Dorsey awarded interim damages of $250,000.00 for past pain and suffering, noting the extreme financial hardship faced by B.K.D.'s family. This interim award was affirmed by Judge Victor J.

Wolski on December 7, 2016, and judgment was entered on January 18, 2017. On March 6, 2017, Chief Special Master Dorsey issued a final decision awarding compensation based on a stipulation/proffer.

The total award was $1,361,412.88, comprising a lump sum of $1,283,828.14 for life care expenses (first year), lost earnings, and past unreimbursable expenses; a lump sum of $7,584.74 to satisfy the Indiana Medicaid lien; and an amount sufficient to purchase an annuity for future life care expenses. The $250,000.00 for past pain and suffering had already been paid.

The annuity was to include a 4% growth rate for non-medical items and a 5% growth rate for medical items. The final decision was issued on March 31, 2017.