Victoria Mager v. HHS - HPV, significant aggravation of preexisting seizure disorder leading to sudden unexpected death in epilepsy (SUDEP) (2023)

On September 5, 2014, Michael Mager filed a petition under the National Childhood Vaccine Injury Compensation Program on behalf of his daughter, Victoria Mager, who died on January 11, 2014. The petition alleged that the human papillomavirus (HPV) vaccine administered on September 11, 2012, caused or significantly aggravated a pre-existing seizure disorder, leading to her death from Sudden Unexpected Death in Epilepsy (SUDEP).

Victoria Mager was born on July 29, 1995. Her medical history prior to the HPV vaccinations was generally normal, though she experienced bed-wetting around age eight, received speech therapy, and had some reported school performance and attention issues.

She received meningococcal and Tdap vaccines on September 4, 2007, and her first HPV vaccine on October 2, 2007. Approximately 43 days later, on November 14, 2007, she had a seizure, followed by another seizure four minutes later.

An EEG showed epileptiform discharges indicating focal sites of cerebral hyperexcitability. She was prescribed Depakote.

At a December 2007 follow-up, her parents reported possible earlier seizure episodes, and her bed-wetting had stopped after starting Depakote. A neurologist noted focal onset epilepsy by EEG and frontal lobe dysfunction.

In February 2008, her parents requested she be weaned off Depakote due to side effects, and a subsequent neuropsychological evaluation noted focal language findings and a maternal family history of epilepsy. From April 2008 to October 2012, Victoria appeared to function normally, with no reported seizure activity for four years.

She received her second HPV vaccination on September 11, 2012. Twenty-nine days later, on October 10, 2012, she suffered another seizure, diagnosed as a probable seizure.

She reported two more seizures in October and November 2012 and was again prescribed Depakote. In January 2013, a neurologist assessed a primary generalized seizure disorder, possibly juvenile myoclonic epilepsy (JME), and switched her medication to Keppra.

By July 2013, her Keppra compliance was noted as "less than ideal." On January 11, 2014, Victoria was found unresponsive and pronounced dead on arrival at a hospital. An autopsy revealed brain changes consistent with a seizure disorder, including focal subpial gliosis.

The death certificate listed "seizure disorder" as the cause of death. The parties agreed Victoria had a seizure disorder that caused her death but disputed the diagnosis and vaccine causation.

Petitioner's expert, Dr. Michael Shafrir, argued for autoimmune epilepsy and a challenge-rechallenge pattern, suggesting the second HPV dose aggravated her condition.

Respondent's experts, Dr. Douglas Kohrman and Dr.

Robert Fujinami, argued for JME, citing pre-vaccination seizure signs and lack of autoimmune markers. Special Master Christian J.

Moran initially denied compensation, finding insufficient evidence of autoimmune epilepsy. The Court of Federal Claims vacated this decision, remanding for further analysis under the Althen standard.

On remand, the Special Master granted entitlement, finding the second HPV dose medically acceptable within a plausible timeframe and sufficient to satisfy the challenge-rechallenge framework for significant aggravation. The Special Master rejected a molecular mimicry theory but concluded the sequence of events satisfied causation requirements.

Respondent's motion for review was denied by Judge Ryan T. Holte on June 20, 2023.

Judgment was entered for $365,593.02.