M.W. v. HHS - Hepatitis A, Sudden Unexplained Infant Death (SUID) / Sudden Unexplained Death in Childhood (SUDC) (2022)

Cheyenne Whitesell, on behalf of her deceased son M.W., filed a petition for compensation on October 18, 2017, alleging that the hepatitis A, influenza, measles, mumps, and rubella (MMR), and varicella vaccines M.W. received on October 19, 2015, caused his death on October 22, 2015. M.W. was approximately one year and one month old at the time of vaccination.

The petitioner argued that the vaccines caused a "cytokine storm" leading to vascular congestion and death, and that M.W. was "primed" for an enhanced immune response due to a prior ear infection and amoxicillin treatment. The respondent argued that the petitioner failed to establish a medically accepted theory connecting the vaccines to the death, a logical sequence of cause and effect, or a proximate temporal relationship.

Special Master Christian J. Moran reviewed expert reports from Dr.

Alan Levin for the petitioner and Dr. Christine McCusker and Dr.

Brent Harris for the respondent. The Special Master found Dr.

McCusker and Dr. Harris to be more qualified than Dr.

Levin, noting Dr. Levin's lack of current clinical practice and past criticisms in Vaccine Program cases, while highlighting Dr.

McCusker's extensive pediatric immunology experience and Dr. Harris's pathology expertise.

Regarding the "cytokine storm" theory, the Special Master found that Dr. McCusker credibly refuted it, stating that vaccine-induced cytokine levels are insufficient to cause massive vascular congestion and that M.W.'s condition the night before his death was inconsistent with such a storm.

The Special Master also found Dr. Levin's "priming" theories, related to M.W.'s ear infection and amoxicillin treatment, to be unsupported by relevant medical literature.

The autopsy findings were also contested; while Dr. Levin interpreted the congestion as "significant" or "massive," Dr.

Harris reviewed the slides and found only "minimal" congestion, noting the autopsy was incomplete and other causes of death, such as suffocation or cardiac arrhythmia, could not be ruled out. The Special Master found Dr.

Harris's assessment of the autopsy findings persuasive. Furthermore, the Special Master found that M.W.'s condition the night before his death, including a resolving fever and normal behavior, was inconsistent with a cytokine storm.

The petitioner did not provide a medically supported timeframe for vaccine causation, relying on Dr. Levin's vague assertion that four days was acceptable, which was countered by Dr.

McCusker's analysis of vaccine timing literature. The Special Master concluded that the petitioner failed to meet her burden of proof under the three prongs of the Althen standard for an off-Table claim.

Therefore, the petition was denied. Petitioner's counsel was Patricia A.

Finn. Respondent's counsel was Benjamin P.

Warder. The decision was issued by Special Master Christian J.

Moran on July 12, 2022.