Ala Mohamad v. HHS - Tdap, Guillain-Barré syndrome (2024)
Case summary [AI summaries can sometimes make mistakes]
Ala Mohamad, a 45-year-old man born in 1970, filed a petition on August 29, 2016, alleging that a Tdap vaccine administered on September 18, 2015, caused him to develop Guillain-Barré Syndrome (GBS). Mr.
Mohamad, who immigrated to the United States in 1999, had worked in various jobs before his illness. He reported being in good health prior to the vaccination.
Within two weeks of receiving the Tdap vaccine during a routine physical, he experienced numbness in his hands, feet, and lower back, which began around September 28, 2015. This led to falls and a diagnosis of GBS.
His treating physicians at the Medical Center of Aurora, including Drs. Dennis Keselman, Kenneth Tompkins Jr., Janice Brenneman, Heather Katz, and Jeffrey Zamarripa, noted in his medical records that his GBS was likely triggered by the tetanus injection or was secondary to the tetanus vaccination.
He was hospitalized from October 2 to October 30, 2015, receiving treatments including IVIG and plasmapheresis. His condition also involved kidney issues, with doctors considering nephritis and glomerulonephritis.
Throughout his hospitalization, he was not tested for C. jejuni or cytomegalovirus, which are associated with GBS. The public decision does not detail the specific onset of symptoms beyond the reported numbness, nor does it describe all diagnostic tests performed or the specific mechanism of GBS causation.
The Secretary of Health and Human Services contested entitlement, arguing that persuasive evidence did not show a Tdap vaccination can cause GBS, questioning the onset of symptoms, and raising CIDP as an alternative diagnosis. The case proceeded through extensive briefing and expert reports.
Petitioner's expert, neurologist Dr. Yuval Shafrir, opined that the Tdap vaccine can cause GBS and did cause Mr.
Mohamad's GBS, relying on case reports, temporal association, and treating physician statements. Respondent's expert, neuro-immunologist Dr.
Thomas Leist, disagreed, citing the 2012 Institute of Medicine (IOM) report and suggesting a possible strep infection as an alternative cause. Dr.
Neal Halsey also testified for the respondent. Special Master Christian J.
Moran issued a Ruling on Entitlement on January 27, 2022, finding that Mr. Mohamad was entitled to compensation.
The Special Master found that government publications, including the 2019 ACIP Best Practices, constituted strong evidence that a tetanus vaccine can cause GBS in rare cases, satisfying the first prong of the Althen test for off-Table injuries. He found a proximate temporal relationship between the vaccination and the onset of GBS on September 28, 2015 (ten days post-vaccination), satisfying the third prong.
He also found a logical sequence of cause and effect, supported by the treating physicians' statements, satisfying the second prong. The Special Master concluded that the Secretary had not established an alternative cause for Mr.
Mohamad's GBS. Following the entitlement ruling, the parties engaged in settlement discussions for damages.
On May 24, 2024, respondent filed a Proffer on Award of Compensation, which petitioner accepted. On June 21, 2024, Special Master Moran issued a decision awarding Mr.
Mohamad a total of $919,494.53. This award included $561,869.00 for past and future lost earnings, $225,000.00 for pain and suffering (reduced to present value), funds to satisfy a Colorado Medicaid lien of $92,602.13, and compensation for life care items detailed in a life care plan, to be paid via a lump sum and an annuity.
The lump sum payment was $794,823.40, covering the first year of life care items, lost earnings, and pain and suffering. The Medicaid lien was paid jointly.
Future life care items were to be funded through an annuity with a 4% annual growth rate, paid to Mr. Mohamad for his lifetime.
The Secretary sought review of the entitlement ruling. On December 2, 2024, Judge Philip S.
Hadji of the U.S. Court of Federal Claims denied the motion for review, sustaining the Special Master's decision.
The court found that the Special Master properly considered the evidence, including government publications and treating physician statements, and did not improperly shift the burden of proof. The court affirmed that the Special Master's findings were not arbitrary or capricious.
Theory of causation
Ala Mohamad, age 45, received a Tdap vaccine on September 18, 2015. He developed Guillain-Barré Syndrome (GBS) with onset of numbness on September 28, 2015, ten days post-vaccination. This case was litigated as an off-Table claim. Petitioner's expert, Dr. Yuval Shafrir, opined that the Tdap vaccine caused Mr. Mohamad's GBS, relying on case reports, temporal association, and treating physician statements. Respondent's experts, Dr. Thomas Leist and Dr. Neal Halsey, disagreed, citing the 2012 IOM report and suggesting alternative causes like strep infection. Special Master Christian J. Moran found entitlement, determining that government publications, including the 2019 ACIP Best Practices, provided strong evidence that tetanus vaccines can cause GBS in rare cases (Althen prong 1). He found a proximate temporal relationship (Althen prong 3) and a logical sequence of cause and effect supported by treating physicians' statements (Althen prong 2). The Secretary did not establish an alternative cause. The Special Master awarded $919,494.53, comprising $561,869.00 for lost earnings, $225,000.00 for pain and suffering, $92,602.13 for a Medicaid lien, and life care items via lump sum and annuity. The Court of Federal Claims denied the Secretary's motion for review, sustaining the Special Master's decision.