Before Mayer, Chief Judge, Newman and Clevenger, Circuit Judges.
The opinion of the court was delivered by: Newman, Circuit Judge.
Appealed from: United States Court of Federal Claims Judge Christine O. C. Miller
June and Patricia Shyface, grandmother and mother of Cheyenne Michael Shyface, appeal the judgment of the United States Court of Federal Claims *fn1 denying compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. '300aa-1 et seq., for the death of Cheyenne. Because the Shyfaces established that Cheyenne's death was a vaccine injury in terms of '300aa-11(c)(1)(C)(ii), we reverse.
Cheyenne was born on February 8, 1993. He received a combination Diphtheria-Pertussis-Tetanus (DPT) vaccine on April 1, 1993. His mother and grandmother testified as to the ensuing events. *fn2 On April 2 Cheyenne was less responsive and would not cry. On April 3 Cheyenne did not respond to his caregivers or to his environment; he did not move his head, grasp, vocalize, smile, or cuddle as before; he took no nourishment and very little water; he simply lay without response with glazed and staring eyes. When his diaper was changed, the leg in which the vaccine was injected jerked uncontrollably. On the evening of April 4, Cheyenne did move his eyes to some extent. However, Cheyenne developed a fever which rose precipitously in the early hours of the next day. On April 5, at 5:23 A.M., Cheyenne was brought to the emergency room with a temperature of 109 degrees Fahrenheit. He went into respiratory arrest immediately upon arrival. Despite ice applications and attempts at cardio-pulmonary resuscitation, Cheyenne was pronounced dead at 6:38 A.M. The death certificate listed cause of death as respiratory arrest due to 110 degree fever with dehydration and infection. An autopsy produced cultures demonstrating a modest growth of E.coli bacteria. June and Patricia Shyface claimed compensation under the Vaccine Act, relying upon either of the two methods of establishing entitlement under the Act. Under the Table method, the Shyfaces alleged that encephalopathy (an injury listed in the Vaccine Injury Table) occurred within the requisite 72-hour period, and that Cheyenne's death was a sequela of the encephalopathy. See '300aa-14(a)(I). Under the non-Table method, the Shyfaces alleged that Cheyenne's death was caused by the DPT vaccination. See '300aa-11(c)(1)(C)(ii). The Secretary of Health and Human Services recommended denial of the claim, on the ground that the E.coli infection (sepsis) was the principal cause of Cheyenne's death and was unrelated to the DPT vaccine.
An evidentiary hearing before the special master was held on September 16, 1996. William Torch, M.D., a pediatric neurologist, testified for the Shyfaces. Dr. Torch testified that Cheyenne's death was caused by the high fever, resulting from a combination of the DPT vaccination and the E.coli infection. Dr. Torch testified that Cheyenne would not have died but for the DPT vaccination, that he would not have died but for the E.coli infection, and that it was the combination of the two that caused his death. Dr. Torch testified that he could not determine whether the DPT vaccination or the E.coli infection was the predominant cause of Cheyenne's death.
Lucy P. Rorke, M.D., a pathologist, and John McDonald, M.D., a pediatric neurologist, testified for the Secretary. Dr. Rorke testified that although there was no pneumonia evident in Cheyenne's air passages, it existed in the cell linings. Dr. Rorke acknowledged that Cheyenne's temperature was very unusual and that in her experience, infants with bacterial infections do not have a temperature of 110 degrees. Dr. McDonald opined that when one observes sepsis, whether at mild or moderate levels, one need look no further for another cause of death. Dr. McDonald testified that it has not been proven that DPT can cause permanent injury or death. Thus both Dr. Rorke and Dr. McDonald testified that an E.coli pneumonia caused Cheyenne's death.
The special master, considering this testimony, found that a preponderance of the evidence showed that Cheyenne sustained an encephalopathy, a Table injury, within the requisite 72-hour period. The special master also found that Cheyenne's death was causally related to the administration of the DPT vaccine, and that it was less likely that the E.coli infection alone caused Cheyenne's death:
"Dr. Torch argues persuasively that sepsis alone could not have caused Cheyenne's death; his temperature was much higher than would be expected in the case of an E.coli infection alone, particularly at the moderate levels of infection indicated by test cultures. The ultimate cause of death, hyperpyrexia, more likely was brought on by a combination of the two factors, E.coli and the pertussis vaccine both of which are known pyrogens (capable of causing fever). . . ."
The special master determined that contrary to the Secretary's position, Cheyenne did not suffer an "overwhelming" and "fulminating" sepsis, since the levels of E.coli found during autopsy were "quite modest" and "far less" than expected in a case of overwhelming sepsis:
"The court gives weight to the fact that the levels of bacteria found on autopsy were quite modest, far less than expected in an overwhelming E.coli infection. Only a small number of bacteria were found in the bladder and the lung--certainly not an overwhelming condition. Dr. McDonald described one case of fatal E.coli infection observed in his own professional experience, but admitted that unlike this present case, "quite a bit" of E.coli bacteria was found in the lungs and blood samples. No other organisms were confirmed in Cheyenne's case. . . ."
The special master determined that the Secretary failed to prove that an overwhelming sepsis was the principal cause of death, and that the findings of the pathologist who performed the initial autopsy supported Dr. Torch's testimony that sepsis alone could not explain Cheyenne's death:
"Respondent's claim that the infection was "fulminating" or "overwhelming" is without sufficient foundation. When asked, Dr. Rorke admitted that the primary reason she suspects an "overwhelming" sepsis is not based on the pathological findings, but on the fact that the child died. Dr. McDonald also admitted as much. Reliance on such basis amounts to impermissible speculation.
The court also gives weight to the fact that the pathologist who actually performed the initial autopsy, Dr. McKinley, is in apparent agreement with petitioners' expert, Dr. Torch. Dr. McKinley concluded that the autopsy findings were insufficient to explain Cheyenne's death. He was puzzled that the infant's reaction was out of proportion with what was found on autopsy."
The special master concluded that the Shyfaces proved by a preponderance of the evidence that Cheyenne suffered an encephalopathy within three days of his vaccination and that this Table injury was the cause of his death. The special master also concluded that the Shyfaces proved that "Cheyenne's death was, in fact, causally related to the administration of the vaccine." The statutory compensation was awarded to the Shyfaces.
The Court of Federal Claims reviewed the special master's decision. The court noted that the Secretary "[did] not challenge the special master's factual determinations regarding the existence of an encephalopathy and fever, both of which were based on the credibility of testimony given by Patricia and June Shyface and their expert, Dr. Torch." Instead, the Secretary objected to the special master's decision on the legal grounds that the Shyfaces had not proven an encephalopathy under the recently revised Vaccine Injury Table regulations, see 42 C.F.R. '100(b)(2), *fn3 and had not proven that the vaccine had actually caused Cheyenne's death.
The Court of Federal Claims remanded for further findings of fact and Conclusions of law. Referring to the Table and non-Table methods, the court ruled that "the special master must ascertain whether and exactly how petitioners sustained their burden under either method, or both." The court determined that the special master had failed to apply the recently revised Vaccine Injury Table regulations, 42 C.F.R. '100.3(b)(2), to determine whether the severity and durational elements of encephalopathy were present. The court also held that the special master, in addressing the actual causation, non-Table injury method, did not explain "how, on the basis of Dr. Torch's testimony, petitioners have shown actual causation, or a direct nexus between the vaccine and Cheyenne's death."
On remand, the special master applied the revised regulations and determined that the Shyfaces did not prove that Cheyenne met the recently revised requirements of a Table injury of encephalopathy, and that the Shyfaces did not prove that the vaccine was the predominant cause of Cheyenne's death. The special master reviewed Dr. Torch's testimony:
Dr. Torch does not retreat from his opinion that the vaccine carries the weight of the blame for Cheyenne's death. However, his testimony, as a whole, supports both sources as cause:
"[Q] Is there any way of telling . . . any scientific way of determining which of those two is more responsible for the high temperature. [A] I don't believe so. I don't know how much you could attribute to each etiology. I cannot go so far that one predominated over the other in terms of the death itself. But he would not have died without the vaccine." Tr. at 100-101.
The special master determined that the Shyfaces had not met their burden of proving causation, in view of the evidence that both the vaccine and the infection contributed to Cheyenne's death:
In reading the printed text of the transcript, one does not sense fully the level of conviction with which Dr. Torch presented his opinion that "but for" the vaccine, Cheyenne would not have died. Upon review, however, I now find that Dr. Torch's testimony is insufficiently persuasive to establish that death, in fact, was caused by the vaccine. Petitioners evidence of a vaccine-related cause stands possibly in equipoise, but no better. As even Dr. Torch conceded, it is impossible to know with any degree of confidence, which source is the predominant cause of death.
Respondent's evidence is equally persuasive. Without the benefit of the statutory presumption conferred by the presence of a Table injury, and because petitioners have the burden of affirmatively proving a vaccine-related cause, it is my opinion that petitioners cannot prevail on the record as it stands. I base my Conclusion on my determination that petitioners have failed to carry their burden of proof.
The Court of Federal Claims, sustaining the special master's denial of compensation, held that it must be shown that the vaccine was the actual cause of death, and ...