William R. Miller v. HHS - MMR, seizure disorder, possible pervasive developmental disorder, attention deficit/hyperactive disorder, intractable epilepsy, developmental delay, autistic disorder, global developmental delays, mixed expressive-receptive language disorder, seizure disorder, Severely Autistic (2016)

On November 6, 2006, Tara and Bruce Miller, as parents and next friends of William R. Miller, a minor, filed a petition for compensation under the National Vaccine Injury Compensation Program.

They alleged that William suffered a "table injury" known as encephalitis, or alternatively, that his injuries were caused-in-fact by the DTaP and MMR vaccinations he received on November 10, 2003. William was born on July 19, 2002.

During his first fifteen months, he received recommended childhood immunizations without noted developmental abnormalities, though he did have ear infections and upper respiratory illnesses. On November 10, 2003, at approximately sixteen months old, William received his fourth DTaP and first MMR vaccinations.

Eight days later, on November 18, 2003, he developed a fever and subsequently had a seizure lasting about three minutes. He was taken to St.

Cloud Hospital, where he was diagnosed with acute seizure and acute febrile illness, likely viral. He was discharged the next morning, noted to be acting playful and smiling.

His mother reported he was "doing well" the following day, and his pediatrician, Dr. Weining Hu, examined him on November 20, 2003, finding him afebrile, seizure-free, and active.

An influenza vaccine was administered that day. Three weeks later, on December 12, 2003, William experienced episodes of unresponsiveness and was admitted to the hospital, treated with Dilantin, and discharged.

He had further seizure activity on December 31, 2003, and again on January 3, 2004, with a temperature of 104°F. He was hospitalized multiple times, with EEGs and other tests performed.

Pediatric neurologist Dr. Jhablall Balmakund evaluated William in January and February 2004, diagnosing possible pervasive developmental disorder and ADHD, and changing his medication.

By August 2004, Dr. Michael Frost, an epilepsy specialist, diagnosed intractable epilepsy and developmental delay.

Neuropsychological evaluations in March 2005 and August 2006 led to diagnoses of autistic disorder, global developmental delays, mixed expressive-receptive language disorder, and severe autism. The case was transferred to the Omnibus Autism Proceeding.

In March 2011, the petitioners elected to proceed with a ruling on the written record, relying on medical records and the affidavit of their expert, Dr. Leon Charash.

The respondent submitted an expert report from Dr. Catherine M.

Shaer. The primary issue for the "table injury" claim was whether William's seizure on November 18, 2003, qualified as an acute encephalopathy under the Vaccine Injury Table's definition.

The Table requires that for children under 18 months who present following a seizure, an acute encephalopathy is established only if there is a significantly decreased level of consciousness persisting beyond 24 hours, not attributable to the postictal state or medication. The medical records indicated that William was discharged the morning after his seizure "acting playful, walking about the room, and smiling," and was reported to be "doing well" and active and playful by his pediatrician the following day.

There was no documented evidence of a decreased level of consciousness persisting beyond the immediate postictal period. Special Master George L.

Hastings, Jr. noted that Dr. Charash applied a lay definition of encephalopathy ("brain damage") rather than the specific regulatory definition, which states that seizures alone are insufficient.

The off-Table causation-in-fact claim also failed, as Dr. Charash's affidavit offered only a conclusion without a medical theory or explanation of the causal chain.

Respondent's expert, Dr. Shaer, concluded that the record evidence did not establish an acute or chronic encephalopathy.

Special Master Hastings denied the petition on January 7, 2016, finding no Table injury and no proven off-Table causation. Petitioners did not seek review of the decision.

The public decision does not describe the specific clinical signs of William's later developmental issues or autism, nor does it name the attorneys involved.