Jeffrey David Simmons v. HHS - Tdap, anaphylactoid response; immune problems; Addison’s-like disease (2019)

Jeffrey David Simmons, a 38-year-old adult, filed a petition on April 7, 2011, alleging that the Tdap vaccine he received on April 11, 2008, caused him anaphylaxis, immune dysregulation, and autoimmune disease leading to Addison's disease. The respondent is the Secretary of Health and Human Services.

Petitioner's counsel was Clifford J. Shoemaker, and respondent's counsel was Justine E.

Walters for the entitlement ruling, and later Lynn C. Schlie for the damages decision.

Special Master Laura D. Millman issued the rulings.

Petitioner's medical history included childhood issues with digestion, asthma, and sensitivities to gluten and casein. Following the Tdap vaccination, he experienced an immediate reaction including redness, swelling, fever, chills, muscle pain, headache, hives, and chest tightness.

Over the subsequent months, he developed persistent symptoms such as flank pain, headaches, fatigue, diarrhea, skin darkening, and joint pain. He was eventually diagnosed with adrenal insufficiency, requiring hormone replacement therapy, described as Addison's-like disease.

Petitioner's wife testified about his symptoms and his improved health when avoiding gluten and dairy. Petitioner testified about his childhood health issues and how avoiding gluten and dairy improved his condition.

He stated that after the Tdap vaccine, his symptoms worsened significantly, leading to his inability to continue working as an insurance agent and his dismissal from his partnership in October 2009. Petitioner's expert, immunologist Dr.

Joseph A. Bellanti, opined that the Tdap vaccine, containing casein to which petitioner was sensitive, triggered an immunologically-mediated disease.

He believed the vaccine exacerbated petitioner's genetic susceptibility to allergies and set in motion a cascade of immune-mediated tissue-injuring reactions affecting the neurologic, endocrine, and immunologic systems, leading to his chronic symptoms and adrenal insufficiency. Respondent's expert, immunologist Dr.

Arnold I. Levinson, agreed that petitioner had a reaction to the Tdap vaccine, which he termed a hypersensitivity reaction, but opined that the reaction did not last beyond six months and that petitioner's Addison's disease was not related to the vaccine reaction.

He also stated he did not know how long the reaction lasted or the basis for petitioner's persisting symptoms. In a ruling on entitlement dated October 30, 2015, Special Master Millman found that petitioner had a vaccine reaction that lasted more than six months and that his Addison's disease was part of that sequelae.

The Special Master accepted Dr. Bellanti's theory that the Tdap vaccine's casein component caused further sensitization, leading to adrenal insufficiency, and concluded that petitioner was entitled to compensation.

The Special Master noted that the field of vaccine causation often lacks complete and direct proof of biological mechanisms and that close calls should be resolved in favor of petitioners. A subsequent decision on damages was issued on June 24, 2019.

The parties engaged in resolving damages, with economists Dr. Robert W.

Cook for the petitioner and Dr. Patrick F.

Kennedy for the respondent providing conflicting reports on lost wages. The Special Master addressed disputes regarding lost wages, ownership income, and the present value methodology, largely ruling in favor of the respondent on the calculation of W-2 income and present value methodology due to insufficient supporting documentation for petitioner's claims.

However, the Special Master found an award for petitioner's loss of ownership income reasonable. The Special Master also denied petitioner's claim for past health insurance premiums due to insufficient proof.

The Special Master awarded compensation for projected life care expenses, wage loss, loss of ownership income, pain and suffering, and reimbursement of Medicaid liens. The total award included a lump sum payment of $1,631,128.03 for first-year life care expenses, lost wages, lost ownership income, pain and suffering, and past unreimbursable expenses.

Additionally, lump sum payments of $252.77 and $465.36 were made for Medicaid liens. Future compensation for life care items was to be provided through an annuity.

The total award, including the lump sum and the value of the annuity, was over $1.6 million.