Michael Hanlon v. HHS - DPT, residual seizure disorder with tuberous sclerosis found to be the unrelated actual cause (1997)

Filed 1990-09-25Decided 1997-09-15Vaccine DPT
deniedcognitive/developmental

Case summary [AI summaries can sometimes make mistakes]

Michael Hanlon, born March 30, 1978, received his first diphtheria-pertussis-tetanus (DPT) vaccination on June 1, 1978. The following day, he experienced his first seizure.

He subsequently received three more DPT vaccinations on July 28, 1978, October 3, 1978, and October 1, 1979. Michael continued to experience afebrile complex partial, or focal, seizures for years.

He was diagnosed with both a seizure disorder and tuberous sclerosis (TS), a genetic brain disorder known to cause seizures and intellectual disability. On September 25, 1990, Michael's parents filed a petition under the National Vaccine Injury Compensation Program, alleging that the DPT vaccine caused his residual seizure disorder.

Special Master Laura Millman initially ruled in favor of the petitioners on May 31, 1994, finding that Michael's injuries fit the Vaccine Injury Table in type and timing. However, before damages were determined, the respondent moved for reconsideration and presented additional evidence.

The special master then received further medical proof and conducted omnibus hearings in 1996 and 1997, involving over twenty tuberous sclerosis cases. In her final entitlement decision on September 15, 1997, Special Master Millman concluded that while petitioners had established a prima facie Table case, the respondent had successfully rebutted the presumption of causation.

The respondent's evidence, particularly from pediatric neurologist Dr. Manuel Gomez, who was described as the world's leading expert on tuberous sclerosis, along with other medical testimony and research, indicated that tuberous sclerosis itself overwhelmingly causes seizures in affected children and that DPT does not initiate the type of afebrile focal seizures Michael experienced.

Special Master Millman found that Michael's seizures were coincidental to the timing of his first DPT shot and were actually caused by tuberous sclerosis, which she determined to be a factor unrelated to vaccine administration. Michael's parents sought review of this decision.

On September 15, 1997, Judge Turner affirmed the special master's denial of compensation. The court held that the special master did not abuse her discretion by reconsidering the initial entitlement ruling before a final judgment, properly admitted the government's expert proof, and permissibly relied on evidence showing tuberous sclerosis was the true cause of Michael's seizures.

The court therefore upheld the denial of compensation. The public opinion does not name the petitioners' counsel or respondent's counsel.

Theory of causation

Petitioners alleged that the DPT vaccine administered on June 1, 1978, to Michael Hanlon, then approximately 63 days old, caused residual seizure disorder (RSD), a condition listed in the Vaccine Injury Table. Michael experienced his first seizure the day after vaccination, and subsequent DPT doses were given on July 28, 1978, October 3, 1978, and October 1, 1979. Petitioners also alleged significant aggravation of Michael's pre-existing tuberous sclerosis (TS), a condition not listed in the Table. Special Master Laura Millman initially found a prima facie Table case for RSD, establishing a presumption of causation. However, the Special Master ultimately found that respondent successfully rebutted this presumption by proving that TS, a genetic disorder, was the actual cause of Michael's seizures and current condition. Respondent's expert, Dr. Manuel Gomez, and other evidence established that TS overwhelmingly causes seizures in affected children and that DPT does not initiate the specific type of afebrile focal seizures Michael experienced. Judge Turner affirmed the Special Master's decision on September 15, 1997, holding that the Special Master did not abuse her discretion in reconsidering the entitlement issue and that the rebuttal evidence was sufficient to establish TS as the unrelated factor principally responsible for Michael's condition. Petitioners' counsel and respondent's counsel are not named in the public decision. No compensation was awarded.

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