Hellebrand v. Secretary of the Department of Health & Human Services

24 Cl. Ct. 756, 1991 U.S. Claims LEXIS 598, 1991 WL 280317
CourtUnited States Court of Claims
DecidedDecember 19, 1991
DocketNo. 90-372V
StatusPublished
Cited by3 cases

This text of 24 Cl. Ct. 756 (Hellebrand v. Secretary of the Department of Health & Human Services) is published on Counsel Stack Legal Research, covering United States Court of Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hellebrand v. Secretary of the Department of Health & Human Services, 24 Cl. Ct. 756, 1991 U.S. Claims LEXIS 598, 1991 WL 280317 (cc 1991).

Opinion

ORDER

HARKINS, Senior Judge:

Petitioners seek review in the United States Claims Court of the special master’s July 23, 1991, decision, which found petitioners were ineligible for compensation under the National Vaccine Injury Compensation Program (the Program) for the vaccine-related death of their daughter, Lacey Marie Hellebrand.1 Under the review stan[758]*758dards, the court is authorized to set aside any of the special master’s findings of fact or conclusions of law found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.2

Lacey Marie Hellebrand was bom on December 31, 1983, by a routine Ceasarean section that followed an uneventful pregnancy. Beginning in her second month, she was given phenobarbital (trade name Levsin PB) for colic. During the second month, she had a cold and took medication for congestion and wheezing. Those problems had stopped about a week before the vaccination. On March 7, 1984, between 3:30 and 4 p.m., Lacey received her first diphtheria-tetanus-pertussis (DTP) vaccination. At about 6 p.m., during her feeding Lacey began to cry and did not finish the bottle. She cried hard for about 2 hours and constantly kicked. She was given her usual dosage of Levsin PB at about 7:00-7:30 p.m., and eventually calmed down and fell asleep. She woke at 9:30 p.m. and took some, but not all, of her bottle and cereal. She was put to bed about 10 p.m. About midnight she was awake in her crib and not crying, but appeared drowsy or dazed. Sometime between 6:00-6:30 a.m., on March 8, 1984, Lacey Marie Hellebrand was found dead in her crib.

The cause of Lacey’s death is unknown. The medical examiner’s report listed the cause of death as bronchopneumonia, because of microscopic findings in his examination. Otherwise the examination indicated death from an unknown cause, or Sudden Infant Death Syndrome (SIDS). Two of respondent’s medical experts, although they did not know the cause of death, identified SIDS, as applicable.3 There are differences in medical opinion as to whether there is a causal connection between SIDS and the DTP vaccine. These differences are matters for the scientific community, and are not of concern in the disposition of this case.4

Petitioners’ medical expert was of the opinion that toxic components of the DTP vaccine activated a cascade of events that led to the death. The special master noted that petitioners’ medical expert did not know exactly what the DTP vaccine did in this case. Respondent’s medical experts were of the opinion that Lacey’s death was not causally connected to the DTP vaccination.

Petitioners point to evidence of depressed consciousness and non-responsiveness to stimuli, symptoms that are included in the aids to interpretation for a shock collapse or a hypotonic-hyporesponsive (HH) collapse.5 The record in this case supports a conclusion that the symptoms manifested by Lacey during the 15-hour period between the vaccination and death were compatible with descriptions of the effects of phenobarbital and with her normal symptoms of colic.

The special master concluded that a preponderance of the evidence did not demonstrate that Lacey Hellebrand suffered an on-Table injury after her DTP vaccination and prior to her death. The special master [759]*759concluded that the record did not show symptoms of an anaphylactic shock, and that the dramatic signs characteristic of an HHE were not present. The special master discounted the opinion of petitioners’ medical expert as support for causation in fact. He rejected the conclusion that a temporal relationship to an unexplained death alone yields causation in fact. He concluded that the evidence was insufficient to establish that the DTP vaccination was in fact the cause of the death.

The special master, however, did not absolve the DTP vaccination as the cause for the death. The special master did not make a finding of fact as to the actual cause of death. Nor did the special master find as a fact that DTP was not the actual; cause of death. Compensation under the Program was denied because statutory requirements, as interpreted by the special master, were not satisfied. The core of the special master’s statutory analysis is the concept that, for an on-table H-H collapse, the statute requires a showing that the death occurred as an acute complication or sequela of the H-H collapse.

The special master's decision is abbreviated and obscure. The evolution and structure of the special master’s statutory analysis, however, is traced in Part III of respondent’s response to the motion for review.6 The statutory analysis is the product of developing precedent in cases that examined the circumstances eligible for Program compensation as a Table injury after a SIDS autopsy.7

The Program is a unique effort to deal with a nationwide medical problem. It is designed to apply in a multitude of factual contexts that may be experienced by persons receiving vaccines in the United States or abroad. Compensation awards in the Program are particularly fact intensive. Application of precedent must be related to factual situations that truly are comparable. In this case the claim involves a death classified as SIDS that occurred 15 hours after a DTP vaccination. Other than the death, the factual context did not indicate an H-H collapse.

Compensation is awarded under the Program when the record as a whole shows that the petitioner has demonstrated by a preponderance of the evidence a death from the administration of a vaccine set forth on the Vaccine Injury Table, and the death occurred within the applicable time period,8 and there is not a preponderance of the evidence that the injury or death described in the petition is due to factors unrelated to the administration of the vaccine.9 Inasmuch as a SIDS death is a situation that is included in the term “factors unrelated to the administration of [760]*760the vaccine,” compensation for a SIDS death is authorized.10

With respect to shock collapse or H-H collapse, the Vaccine Injury Table provides a 3-day time period after the DTP vaccine is administered for first symptom or manifestation of onset or of significant aggravation.11 The Table recognizes that death may be an acute complication or sequela of a shock collapse or H-H collapse, which arose within the 3-day period. A time period for such acute complication or sequela is “not applicable.”12

To assist in identification of the injuries listed on the Table that entitle a petitioner to the presumption of causation, the statute provides qualifications and aids to interpretation, which “shall apply to” the Table. One of the indicia that may evidence a shock collapse or a H-H collapse is cardiovascular or respiratory arrest.13

The special master’s conclusion that a preponderance of the evidence in the record did not demonstrate an on-Table injury results from an analytical procedure that eliminates one of the indicia or symptoms listed in the aids to interpretation. In this analysis, death neither establishes nor precludes an H-H collapse, but death must be shown to be a sequela of a collapse that is evidenced by other symptoms in the aids to interpretation. A statement in the Allen

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24 Cl. Ct. 756, 1991 U.S. Claims LEXIS 598, 1991 WL 280317, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hellebrand-v-secretary-of-the-department-of-health-human-services-cc-1991.