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

40 Fed. Cl. 440, 1998 U.S. Claims LEXIS 26, 1998 WL 64115
CourtUnited States Court of Federal Claims
DecidedFebruary 3, 1998
DocketNo. 95-295V
StatusPublished
Cited by1 cases

This text of 40 Fed. Cl. 440 (Riggs v. Secretary of the Department of Health & Human Services) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Riggs v. Secretary of the Department of Health & Human Services, 40 Fed. Cl. 440, 1998 U.S. Claims LEXIS 26, 1998 WL 64115 (uscfc 1998).

Opinion

OPINION

MEROW, Judge.

Petitioner Amanda Riggs seeks review of the August 5, 1997 decision denying her claim under the National Childhood Vaccine Compensation Act of 1986, 42 U.S.C. §§ 300aa-l to 300aa-34 (1994) (“Vaccine Act” or “Act”), for the death of her two-month old son, Gabriel Lucas. Riggs v. Secretary of the Dep’t of Health & Human Servs., No. 95-0295V, 1997 WL 523900 (Fed.Cl.Spec.Mstr.). Petitioner alleged that Gabriel suffered an encephalopathy (ie., a significant impairment of brain function) as a result of a diphtheria-pertussis-tetanus (“DPT”) vaccination administered on April 16, 1993. Proof of an encephalopathy within 72 hours of a DPT vaccination raises a presumption that the occurrence was caused by the vaccine and, if that presumption is left unrebutted, gives rise to an entitlement to compensation under the Act for resulting injury or death. In this case, petitioner alleged that an encephalopathy was evidenced by, among other things, the fact that Gabriel slept almost continuously for approximately 60 out of the 72 hours between the administration of the DPT vaccine and his death on April 19,1993.

Relying upon new Department of Health and Human Services (“HHS”) vaccine regulations, 42 C.F.R. § 100.3 (1995), the special master determined that this evidence, alone or in combination with other factors, failed to establish an encephalopathy under the Vaccine Act. The special master found that these new regulations “severely limit the signs that can be considered encephalopathie,” 1997 WL 523900, * 3, and more particularly that under those regulations “[sjleepiness is specifically disqualified,” id. at * 4, as such a sign. On review here, petitioner alleges that the special master misapplied the new regulations, and that this misapplication led to the denial of her claim.

As explained more fully below, while HHS considered eliminating the statutory presumption relating to encephalopathy during the above-referenced rulemaking, it ultimately maintained that presumption in favor of clarifying the clinical signs and symptoms which demonstrate an encephalopathy. Those regulatory changes neither eliminate the statutory presumption, nor carry the proscriptive legal import ascribed to them by the special master below. Most importantly, the regulations do not provide that sleep, alone or in combination with other factors, is insufficient to demonstrate an encephalopathy under the Vaccine Act as matter of law.

Rather, the regulations provide that an encephalopathy is indicated by “a significantly decreased level of consciousness lasting for at least 24 hours” during the 72 hours following a DPT vaccination. 42 C.F.R. § 100.3(b)(2)(i)(A). Sixty hours of almost continuous sleeping during the 72 hours following a DPT vaccination meets this regulatory standard and, taken together with the other clinical signs consistent with an encephalopathy that were present in this case, is sufficient to establish an encephalopathy under the Act. Since respondent did not demonstrate that Gabriel’s death was, more likely than not, caused by factors unrelated to the vaccine, petitioner is entitled to compensation. The decision below is therefore reversed and remanded for an award of compensation to petitioner. 42 U.S.C. § 300aa-12(e)(2)(C).

FACTS

A hearing was held in this matter on July 8, 1997, in Norfolk, Virginia. Petitioner, Amanda Riggs, petitioner’s parents, Nina and Bret Lucas, and petitioner’s roommate, Linda Pitcock, testified. Also testifying for petitioner were Dr. Larry White, a pediatric neurologist, and Dr. Mark Geier. Dr. Russell D. Snyder, a neurologist, and Dr. Virginia M. Anderson, a pathologist, testified on behalf of respondent. While respondent argued that the testimony for petitioner should be discounted because it was not documented in contemporaneous medical records, the special master found that petitioner and her witnesses were both credible and forthright, and therefore accepted their factual description of Gabriel’s clinical course as accurate and truthful. [442]*442According to that description, prior to his vaccination, Gabriel was a happy, healthy baby with a voracious appetite. Although Gabriel had suffered from a cold for approximately two weeks before his vaccination, he was described as “healthy as a horse” by his pediatrician directly prior to receiving his DPT shot. See Hr’g Tr. at 16. Petitioner testified that Gabriel had, in fact, maintained his normal sleeping and eating patterns during that two-week time period. Id. Those normal patterns included feeding approximately every three hours; overnight, Gabriel would regularly awaken for these feedings on his own accord. Hr’g Tr. at 14.

Following his vaccination on Friday, April 16,1993, Gabriel fell asleep, slept through his feeding, fed less than usual when awakened for it, and went back to sleep, sleeping through the night for 12 hours. He awoke Saturday morning only when roused by petitioner, but spent the day almost continuously asleep. Gabriel slept through his feedings, a trip to the local mall, a trip to the supermarket and a visit to friends Saturday evening. He again slept through the night for approximately 12 hours. He awoke for a feeding on Sunday when roused by petitioner, and again ate less than usual, slept through a trip to McDonald’s, and again slept through the night. Gabriel awoke on his own accord Monday morning, fed, and fell back asleep. Shortly thereafter, petitioner discovered that Gabriel was not breathing and took him to the hospital, where he was pronounced dead. Approximately 72 hours had elapsed between Gabriel’s vaccination and his death on Monday, April 19, 1993. Gabriel had spent roughly 60 of those hours asleep.

Testimony delivered at the July 8, 1997 hearing reflected that during the brief time Gabriel was awake during that 72 hour period, he fed less than usual, was irritable, cried inconsolably and sometimes appeared disengaged. Gabriel did, however, smile at his care givers on at least two occasions, and made eye contact with petitioner at least once. Hr’g Tr. at 95. Although petitioner and her witnesses remarked that they were concerned that Gabriel was sleeping too much, petitioner testified that it was against her natural inclination to wake him up from sleep. Hr’g Tr. at 30. Experts for both sides testified that Gabriel’s condition warranted medical attention. Hr’g Tr. at 73, 228, 239.

Petitioner’s experts testified that Gabriel’s death was, more likely than not, caused by an encephalopathy. In their view, Gabriel’s extended period of sleep indicated an acute abnormality or impairment of brain function, and that this together with his irritability, inconsolable crying, disinterest in food, and periodic disengagement when awake, were sufficient to demonstrate an encephalopathy. Hr’g Tr. at 71-73, 148-49, 151. Respondent’s experts disagreed, and testified that the cause of death was sudden infant death syndrome (“SIDS”). Experts for petitioner described SIDS as the otherwise unexplainable death of a healthy infant. Hr’g Tr. at 79.

ANALYSIS

This court has jurisdiction to review the decision below pursuant to 42 U.S.C. § 300a

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40 Fed. Cl. 440, 1998 U.S. Claims LEXIS 26, 1998 WL 64115, Counsel Stack Legal Research, https://law.counselstack.com/opinion/riggs-v-secretary-of-the-department-of-health-human-services-uscfc-1998.