Bonnie Forman-Franco v. HHS - Influenza, shoulder injury related to vaccine administration (SIRVA) (2020)
Case summary [AI summaries can sometimes make mistakes]
Bonnie Forman-Franco, a 64-year-old woman, filed a petition on December 7, 2015, alleging that an influenza vaccine administered on December 30, 2013, caused a shoulder injury related to vaccine administration (SIRVA). Petitioner reported experiencing left shoulder pain within two hours of the vaccination, which worsened over time, leading to limited range of motion and subsequent surgery.
The respondent, the Secretary of Health and Human Services, initially concluded the case was not appropriate for compensation. SIRVA was later added to the Vaccine Injury Table for flu vaccines, but the petitioner's claim predated the effective date for Table claims, requiring her to prove causation-in-fact.
A fact hearing was held, and both parties submitted expert reports. Petitioner's expert, Dr.
G. Russell Huffman, a shoulder and elbow surgeon, opined that the vaccine caused a SIRVA injury, citing medical literature and the petitioner's asymptomatic status for seven years prior to the vaccination despite a 2007 rotator cuff surgery.
Respondent's expert, Dr. David Ring, an orthopedic surgeon specializing in upper limb disorders, argued that the injury was due to age-related changes and that the likelihood of a flu vaccine causing shoulder injury was "essentially zero." Dr.
Ring suggested that the petitioner's symptoms were coincident with age-appropriate changes. The Special Master, Nora Beth Dorsey, reviewed medical records, expert reports, and medical literature.
The Special Master found that the petitioner's prior shoulder injury did not preclude her claim, as she was asymptomatic for seven years before the vaccination and the injury became symptomatic only after the vaccine. The court determined that the rapid onset of pain and limited range of motion, confined to the vaccinated shoulder, established a logical sequence of cause and effect, satisfying the "Althen" prongs for off-Table claims.
Specifically, the Special Master found that the flu vaccine can cause SIRVA (general causation), that the petitioner's injury was caused by the vaccine (specific causation), and that there was a proximate temporal relationship between the vaccination and the injury. Therefore, Special Master Dorsey ruled that Bonnie Forman-Franco is entitled to compensation for her SIRVA injury, with damages to be determined.
Theory of causation
Petitioner Bonnie Forman-Franco, age 64, received an influenza vaccine on December 30, 2013, and subsequently developed left shoulder pain, limited range of motion, and required surgery, consistent with Shoulder Injury Related to Vaccine Administration (SIRVA). As this claim predates SIRVA's inclusion on the Vaccine Injury Table for flu vaccines, petitioner had to prove causation-in-fact under the "Althen" standard. Petitioner's expert, Dr. G. Russell Huffman, opined that the vaccine caused SIRVA, citing medical literature and the petitioner's seven-year asymptomatic period following a 2007 rotator cuff surgery. Respondent's expert, Dr. David Ring, argued the injury was due to age-related changes and that vaccine-induced shoulder injury is "essentially zero." Special Master Nora Beth Dorsey found that the petitioner's prior shoulder condition did not preclude her claim, as she was asymptomatic for seven years prior to vaccination. The Special Master found preponderant evidence satisfying the "Althen" prongs: (1) General causation was established by medical literature (Atanasoff, Bodor) and respondent's own recognition of SIRVA as a vaccine injury, with Dr. Huffman providing a specific mechanism of inflammatory response. (2) Specific causation was established by the logical sequence of cause and effect, with the petitioner's symptoms being confined to the vaccinated shoulder, occurring after a period of being asymptomatic, and not attributable to other conditions. (3) A proximate temporal relationship was established by the petitioner's reported onset of pain within two hours of vaccination, within the 48-hour window for SIRVA. Entitlement was granted, with damages pending. Attorneys for petitioner were Paul R. Brazil and Muller Brazil, LLP. Attorney for respondent was Adriana R. Teitel, U.S. Department of Justice.