NEWMAN, Circuit Judge.
June and Patricia Shyface, grandmother and mother of Cheyenne Michael Shyface, appeal the judgment of the United States Court of Federal Claims
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.
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
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:
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 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:
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
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),
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:
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:
(Citations omitted.) The trial court entered judgment for the Secretary, and the Shyfaces appealed their non-Table claim.
The issue is whether the Shyfaces established entitlement to compensation by proving that Cheyenne's DPT vaccine was a but-for cause of his death. Because the Shyfaces established that the DPT vaccine was a but-for cause of and a substantial factor in Cheyenne's death, we conclude that the Shyfaces are entitled to compensation.
The Shyfaces argue that there was a preponderance of evidence that the DPT vaccine "caused" Cheyenne's death as contemplated in the words of the statute:
The Shyfaces state that the Court of Federal Claims erred in ruling that this causation required that the DPT vaccination was the "predominant cause" of Cheyenne's death. According to the Shyfaces, the law of torts is the source of the statute's rule of causation, and tort law does not require that the DPT vaccine was the "predominant cause" of Cheyenne's death, but only that the DPT vaccine was a "but for" cause of Cheyenne's death.
The Shyfaces cite Grant v. Secretary of Health and Human Servs., 956 F.2d 1144 (Fed.Cir.1992) as supporting the position that the statutory causation requirement is drawn from tort law. The Grant court, in discussing the required showing of causation in non-Table injuries, cited Hasler v. United States, 718 F.2d 202, 205 (6th Cir.1983), a Federal Tort Claims Act decision arising from vaccination against swine flu. Hasler applied the law of Michigan, the state in which Grant could have pursued a traditional tort claim. Accordingly, the Shyfaces argue that in the case at bar, the court should look to Montana law to determine whether there was a sufficient showing of causation. Montana applies the "but for" test for causation. See Busta v. Columbus Hosp. Corp., 276 Mont. 342, 370,
The Secretary disagrees, citing our decisions in Grant, supra, and Munn v. Secretary of Department of Health and Human Servs., 970 F.2d 863 (Fed.Cir.1992). In Grant we stated that the Vaccine Act "does not relax proof of causation in fact for non-Table injuries." 956 F.2d at 1147. In Munn we stated: "The claimant must prove by a preponderance of the evidence that the vaccine, and not some other agent, was the actual cause of the injury. Given the vagaries of human illnesses, particularly in young children, that is not always an easy burden to carry." 970 F.2d at 865. The Secretary states that the Shyfaces had to demonstrate that the vaccine caused the injury, applying the preponderance of the evidence standard, meaning that they had to demonstrate "that the vaccine is more likely than any other factor to have been directly responsible for the injury." That is, the Secretary argues that precedent requires more than showing that the injury would not have occurred but for the vaccination. In Abbott v. Secretary of Department of Health and Human Servs., 27 Fed. Cl. 792 (1993), aff'd in part, rev'd in part and remanded, 19 F.3d 39 (Fed.Cir. 1994), when a child drowned in a bathtub after suffering a seizure that was presumptively vaccine-related, the Court of Federal Claims held, and the Federal Circuit affirmed, that:
Similarly, the Secretary argues, Cheyenne's death was not due to forces set in motion by the vaccine, but rather by an existing and overwhelming sepsis. The Secretary argues that Cheyenne's death was not the "medical consequence" of a vaccine injury, even if he suffered a vaccine-associated fever from which he died.
The Secretary adds that application of the "but for" test would fundamentally undercut the Vaccine Act's framework as established by Congress. The Secretary argues that the Shyfaces reliance on Montana law and the Restatement is misplaced, since the Vaccine Act is not a negligence-based system and does not employ negligence-based standards. The Secretary argues that the petitioners should be held to the same standard of proof as the Secretary in the rebuttal case. The statute provides that the petitioner must establish causation by a preponderance of the evidence, and compensation may be awarded only if there is not a preponderance of the evidence that the injury was due to factors unrelated to the administration of the vaccine:
The Secretary points out that in rebutting with evidence of factors unrelated to the vaccine, it is not enough for the Secretary to establish that other factors merely contributed to producing the injury. Instead, the Secretary must prove that the "factors unrelated" were "principally responsible" for causing the injury:
(Emphases added.) The Secretary argues that the statutory use of "preponderance of the evidence" in both '300aa-13(a)(1)(A) (referring to the petitioner's burden) and '300aa-13(a)(1)(B) (referring to the Secretary's burden) indicates that the petitioners should be held to the same burden in proving causation as the Secretary is held in proving "factors unrelated." The Secretary states that the statute is not satisfied if the petitioner shows only that the vaccine contributed equally to the injury and was a "but-for" cause of death.
There is a dearth of precedent discussing the requirements for prima facie causation. The court in Grant stated that "the Vaccine Act does not relax proof of causation in non-Table injuries." The Shyfaces state that in accordance with Munn they proved "by a preponderance of the evidence that the vaccine, and not some other agent, was the actual cause" of Cheyenne's death. Addressing the Secretary's argument that petitioners should be held to the same burden of proof when proving causation as the Secretary is held when proving "factors unrelated", the Shyfaces argue that the elevated burden placed on the Secretary in proving a "factor unrelated" is imposed by statute and is unique to the Secretary's proof of a "factor unrelated". The Shyfaces argue that the statute requires that petitioners "demonstrate by a preponderance of the evidence", '300aa-13(a)(1)(A), that the injury "was caused by a vaccine", '300aa-11(c)(1)(C)(ii). In contrast, the statute requires that in rebutting prima facie causation, the Secretary must prove by a "preponderance of the evidence", '300aa-13(a)(1)(B), that agents other than the vaccine are "principally responsible for causing the petitioner's illness", '300aa-13(a)(2)(B). Thus, according to the Shyfaces, the statute in formulating the Secretary's burden combines "principally responsible" with the term "causing" to yield a higher standard than "causation" alone.
In Knudsen v. Secretary of Department of Health and Human Servs., 35 F.3d 543 (Fed. Cir.1994), this court stated:
Id. at 549. The Shyfaces argue that notwithstanding this language, Knudsen did not hold broadly that the standard for a petitioner's proof of actual causation in non-Table cases should be the same as the standard for the Secretary's proof of alternative actual causation; Knudsen turned on whether the Secretary, in proving "factors unrelated", '300aa-13(a)(2), was required to identify the specific virus that was principally responsible for causing the petitioner's encephalopathy. According to the Shyfaces, the "standards" referred to in the quoted portion of Knudsen refer to the level of detail or specificity required concerning how the vaccine or other agent caused an injury. Thus the Shyfaces argue that Knudsen did not establish the burden of proof for all cases.
The Vaccine Act allows a petitioner to establish prima facie entitlement to compensation using the non-Table method, i.e., by showing that the injury was "caused" by the vaccine. See '300aa-11(c)(1)(C)(ii). The parties offer divergent interpretations of the statutory word "cause". This issue of statutory interpretation receives plenary review. Because the statute does not elaborate on the
The legislative history provides some guidance in ascertaining Congressional intent with respect to the "but for" standard proposed by the Shyfaces and the "predominant cause" standard proposed by the Secretary. The House Report concerning '300aa-11 states:
H.R.Rep. No. 99-908 at 15 (1986) U.S.Code Cong. & Admin.News 1986, at 6287, 6356 (emphases added). The legislative history of '300aa-13, the provision relating to the Secretary's rebuttal of a prima facie case, is also helpful, for although it does not deal with all of the legal nuances of causation, it reaffirms the burden on the Secretary:
Id. at 18, U.S.Code Cong. & Admin.News 1986, at 6359 (emphases added).
As we have mentioned, the Shyfaces argue that determination of causation in non-Table cases invokes the law of the state in which the tort claim would have been brought, and that in Montana the "but for" test controls causation. The Secretary replies that in a non-Table case involving concurrent causes, unless the petitioner can prove that the vaccine was the predominant or principal cause of injury, the petitioner has not presented the requisite prima facie case and the Secretary need not demonstrate an alternate cause.
The absence of elaboration of the law of causation in the legislative history leads us to conclude that the Vaccine Act's requirement of causation in non-Table cases was not viewed as distinct from causation in the tort law. However, at the threshold, we do not agree with the Shyfaces that the applicable law is the law of the state in which the tort claim could have been brought. The purpose of the Vaccine Act was to establish a compensation program under which awards could be made to vaccine-injured persons "quickly, easily, and with certainty and generosity." H.R.Rep. No. 99-908 at 3, U.S.Code Cong. & Admin.News 1986, at 6344. National uniformity in administration is implicit in the statutory scheme. This purpose would not be served by requiring recourse to varying state negligence laws in determining causation.
A uniform approach, one which implements the statutory purpose, is that of the Restatement (Second) of Torts. The general provision for the requirement of causation in establishing tort liability provides useful
'430 (emphasis added). The Restatement then defines "legal cause":
Thus the Restatement provides that the "but for" criterion is necessary, but not sufficient, to establish causation due to a negligent action; that action must also be a substantial factor in causing the injury. See '431 cmt. a ("In order to be a legal cause of another's harm, it is not enough that the harm would not have occurred had the actor not been negligent. Except as stated in '432(2), this is necessary, but it is not of itself sufficient. The negligence must also be a substantial factor in bringing about the plaintiff's harm.") On this definition, we disagree with the Shyfaces that but-for causation is sufficient to establish liability, for as the Court of Federal Claims observed, "the standard of `actual causation' is more stringent than the `but for' standard."
We adopt the Restatement rule for purposes of determining vaccine injury, that an action is the "legal cause" of harm if that action is a "substantial factor" in bringing about the harm, and that the harm would not have occurred but for the action. See '431. The Restatement recognizes that concurrent forces may bring about a single harm, requiring weighing the contributing factors:
'433 cmt. d. The Restatement further provides:
'430 cmt. d (emphasis in original).
This rule that the vaccine must be a substantial factor in bringing about the harm accords with the legislative history of the Vaccine Act. Implementing this principle in terms of the Vaccine Act statutory provisions, establishment of prima facie entitlement to compensation according to the non-Table method would require the petitioner to prove, by a preponderance of the evidence, that the vaccine was not only a but-for cause of the injury but also a substantial factor in bringing about the injury. As discussed in Grant, 956 F.2d at 1148, in order to show
The Shyfaces established, by a preponderance of evidence, that the DPT vaccination was a substantial factor contributing to and bringing about Cheyenne's death. The facts are undisputed. The special master found that Cheyenne would not have died but for the DPT vaccination, and that the DPT vaccine contributed to Cheyenne's death by causing him to experience an exceptionally high fever. The special master also found that the sepsis was not the predominant cause of his death. Thus although the Shyfaces did not prove that the DPT vaccine was the only or predominant cause of his death, the requirements of the Vaccine Act are met prima facie upon proof of the substantial factor criterion. We have not been shown reversible error in the special master's finding that the Secretary failed to prove that factors unrelated to the vaccine were principally responsible for Cheyenne's death. See '300aa-13(a)(2)(B). Therefore, the Shyfaces established entitlement to compensation by showing that the DPT vaccine was both a but-for cause of and a substantial factor in Cheyenne's death. The petitioners shall be awarded the statutory compensation for the vaccine-related death of Cheyenne. The decision of the Court of Federal Claims is reversed.
Costs to petitioners.