Rehearing Denied; Suggestion for Rehearing In Banc Declined June 26, 1996.
CLEVENGER, Circuit Judge.
This case returns to us on remand from the Supreme Court which reversed our decision awarding Margaret Whitecotton compensation under the Vaccine Act. Shalala v. Whitecotton, ___ U.S. ___, 115 S.Ct. 1477, 131 L.Ed.2d 374 (1995). The Supreme Court left open several issues for us to decide on remand. As a result of our decision on the remaining issues, we affirm-in-part and reverse-in-part the decision of the United States Court of Federal Claims
Margaret Whitecotton (Maggie) was born on April 22, 1975. Maggie was borderline microcephalic
On August 18, 1975, Maggie received her third Diphtheria-Pertussis-Tetanus (DPT) vaccination. Following the shot, Maggie suffered a series of clonic
Other contemporaneous evidence, however, counterbalances the symptomology described above. Specifically, Maggie's discharge diagnosis at the conclusion of her hospitalization included the following physical examination results:
In the several months following her vaccination, Maggie's development was slow but steady. During this period, for example, Maggie learned to sit, crawl and, to some
Notwithstanding this development, Maggie was not an ordinary healthy baby. In February 1976, she was hospitalized for ten days with a possible seizure disorder after she became still, flaccid, and pale. Her EEG, however, was normal, and she did not suffer from any seizures while in the hospital. At around this time, Maggie was formally diagnosed with microcephaly and cerebral palsy.
Today, Maggie is severely disabled both mentally and physically. She has cerebral palsy and is non-ambulatory. Her vocabulary is very limited. She is, for all practical purposes, totally dependent on others for her needs.
The National Childhood Vaccine Injury Act of 1986 (Vaccine Act) provides an alternative to the traditional tort system for individuals who have suffered vaccine-related injuries. The Act permits petitioners to recover compensation for their vaccine-related injuries under two distinct legal theories. The first is actual causation. If petitioner can show to a preponderance that the vaccine was the cause of her injuries, then she is entitled to compensation under the Act. 42 U.S.C. §§ 300aa-11(c)(1)(c)(ii), 300aa-13(a)(1)(A).
The burden of showing causation, however, is heavy. Therefore, Congress provided a second method of obtaining compensation. The Act provides a "Vaccine Injury Table" which lists various injuries associated with each vaccine, and provides a time period with respect to each injury associated with each vaccine. 42 U.S.C. § 300aa-14. To prevail under this second theory, a petitioner must show that she experienced the first "symptom or manifestation" of a table injury, within the table time period following the vaccination. See 42 U.S.C. § 300aa-11(c)(1)(C)(i). If petitioner can make such a showing, causation is presumed and petitioner is deemed to have made out a prima facie case of entitlement to compensation under the Act. See 42 U.S.C. § 300aa-13(a)(1)(A). The burden of going forward then shifts to the government which must pay compensation unless it can show to a preponderance that a "factor unrelated" to the vaccine was the actual cause of petitioner's injuries. See 42 U.S.C. § 300aa-13(a)(1)(B).
In addition to providing compensation for those who suffer the initial onset of a table injury within the table time period following a vaccination, the statute also permits recovery if an individual suffers a significant aggravation of a table injury within the statutory time period. Congress provided for compensation in such cases:
H.R. Rep. 908, 99th Cong.2d Sess. 1, reprinted in 1986 USCCAN 6287, 6356. The statutory requirements to make out a prima facie significant aggravation claim are analogous to those required to make out a prima facie initial onset claim. Petitioner must show that she suffered the first symptom or manifestation of the significant aggravation of a table injury within the table time period following her vaccination. 42 U.S.C. § 300aa-11(c)(1)(C)(i).
On July 24, 1990, petitioners Kay and Michael Whitecotton, Maggie's parents, filed a claim under the Vaccine Act in the United States Court of Federal Claims seeking compensation for injuries allegedly suffered by Maggie as a result of her DPT vaccination. The court referred Maggie's case to a special master who conducted a hearing at which both petitioners and respondents presented evidence including the testimony of experts.
Before the special master, petitioners asserted that Maggie had suffered the initial onset of a table encephalopathy
The special master denied Maggie's claim under both the initial onset and significant aggravation theories. With respect to the initial onset theory, the special master denied Maggie's claim because her small head size indicated that she was already encephalopathic at the time of her vaccination. At the hearing, the experts disputed the point below which a person with a small head should be formally diagnosed as microcephalic. Most of the testimony indicated that a head size at or below two standard deviations from the mean warrants a diagnosis of microcephaly. Some of the testimony supported a looser standard which would define a patient as microcephalic only if the patient's head was more than three standard deviations below the mean. The special master adopted the more commonly accepted definition of two standard deviations below the mean, and under that definition found that Maggie was "at least borderline microcephalic at birth and ... clearly microcephalic by the time she received her third DPT shot on August 18, 1975." The special master further found, on the basis of expert testimony, that Maggie's microcephaly indicated that Maggie was already encephalopathic prior to August 18, 1975, the date of her third DPT shot. Since she was already brain damaged on the day of the shot, the post-vaccination symptoms could not constitute the "first symptom or manifestation" of her encephalopathy, as required by the statute.
With respect to the significant aggravation theory, the special master denied Maggie compensation on the basis of the analysis which had only recently been developed by the Court of Federal Claims in the case of Misasi v. Secretary of Department of Health & Human Services, 23 Cl.Ct. 322 (1991). In
Applying the Misasi framework to the facts of Maggie's case, the special master concluded that even absent the vaccine, Maggie would have been mentally retarded and might have suffered from cerebral palsy. As a result, the special master concluded that there was no reason to believe that Maggie's condition would have been any different had the vaccine not been administered, and he consequently denied Maggie's significant aggravation claim.
After the Court of Federal Claims affirmed the special master's decision, the Whitecottons appealed to this court. Unlike the Court of Federal Claims, we concluded from our analysis of the statutory scheme that a petitioner could make out an initial onset table injury claim even if petitioner had exhibited a symptom or manifestation of a table injury prior to the vaccination. Whitecotton v. Secretary of Dep't of Health & Human Servs., 17 F.3d 374, 376-77 (Fed.Cir.1994). As a result, we found that Maggie's post-vaccination symptoms entitled her to compensation notwithstanding her preexisting microcephaly.
The Supreme Court granted certiorari, and reversed. Whitecotton, ___ U.S. at ___, 115 S.Ct. at 1481. Writing for the majority, Justice Souter disagreed with our assertion that a petitioner may recover on an initial onset theory if she had exhibited symptoms or manifestations of her post-vaccination injury prior to vaccination. See id. at ___, 115 S.Ct. at 1480. Consequently, the Court held, demonstration of symptoms within the table time period is insufficient, in itself, to make out a prima facie case of entitlement under the Act. In addition, the petitioner must show that she exhibited no symptom or manifestation of the injury before the vaccination. See id.
In her concurring opinion, Justice O'Connor highlighted the scope of the Supreme Court's decision. Justice O'Connor noted that the Court's decision articulated the essential elements of a prima facie initial onset table case. It did not, however, address the Whitecotton's challenges to the special master's fact findings with respect to whether Maggie's microcephaly indeed constituted a first manifestation of her encephalopathy. Id. at ___, 115 S.Ct. at 1482 (O'Connor, J., concurring). Nor did it address any legal or factual challenges to the special master's denial of Maggie's significant aggravation claim. Id. at ___-___, 115 S.Ct. at 1482-83. We consider these unresolved issues on remand.
Our review of the special master's findings of fact is very limited. As we have recognized in the past, "Congress assigned to a group of specialists, the Special Masters ..., the unenviable job of sorting through these painful cases and, based upon their accumulated expertise in the field, judging the merits of the individual claims." Hodges v. Secretary of Dep't of Health & Human Servs., 9 F.3d 958, 961 (Fed.Cir.1993). For this reason, Congress has instructed us to affirm a special master's factual findings unless they are arbitrary, capricious, or an abuse of discretion. See Knudsen v. Secretary of Dep't of Health & Human Servs., 35 F.3d 543, 546-47 (Fed.Cir.1994).
We also note that in deciding this case, we may consider only the record developed in the proceedings below. Hodges, 9 F.3d at 962. Thus, studies that were not
The special master denied the initial onset prong of Maggie's petition because he found that Maggie's microcephaly constituted a pre-vaccination manifestation of an encephalopathy. In reaching this conclusion, the special master relied on substantial expert testimony as well as the medical literature available to him at the time of the hearing. Indeed, it was the opinion of the Whitecottons' own expert witness, Dr. Slater, that:
Based on the evidence presented at the hearing, the special master concluded that the preponderance of the evidence indicated that Maggie was already encephalopathic before her third DPT shot. Supported, as it was, by substantial expert testimony, this finding is not arbitrary and capricious, nor does it constitute an abuse of discretion. We therefore affirm the special master's denial of Maggie's initial onset claim.
Before examining the special master's denial of Maggie's significant aggravation claim, we pause to review the state of the law with respect to this difficult concept. The Vaccine Act created an entirely new area of law just 10 years ago. Of the concepts embodied in the Vaccine Act, one of the most slippery and difficult to apply is that of "significant aggravation." It is therefore not surprising that the jurisprudential development of significant aggravation has not been without complication. Instead, the concept has evolved fitfully as the Court of Federal Claims has struggled to come to grips with this new and not-well-developed legal notion.
Misasi constituted the Court of Federal Claims' initial attempt to formulate a legal construct for deciding claims of significant aggravation. That opinion recognized that the primary difficulty in adjudicating the significant aggravation claims of children with a pre-existing condition, is that it is very difficult to know at the age when a child is vaccinated what symptoms would have naturally manifested themselves as the child matured and what symptoms might have remained latent absent the vaccination. See id. at 327 ("One conclusion that is apparent from a study of the medical testimony is that even in the absence of a DPT inoculation, it is very difficult to predict the ultimate physical and mental status of a hypotonic OCD child less than two months old."). In order to deal with this difficulty, Misasi articulated the four-part inquiry described above in Part III of this opinion. That inquiry compares the actual condition of the child after the vaccination with the child's predicted condition had the vaccine not been administered. If the child's current condition represents a significant aggravation of the child's expected condition, then the child is entitled to the presumption of compensation under a significant aggravation theory. In this way, Misasi reasoned, it is possible to distinguish cases in which the vaccination caused the significant aggravation from cases in which the vaccination had no detrimental effect.
Rather than discard Misasi entirely, however, the Court of Federal Claims instead shifted its application from petitioners' prima facie case, where Misasi improperly denied petitioners the benefit of the statutory presumption of causation, to petitioners' rebuttal case, where petitioners properly bear the burden of showing causation. For example, in O'Connor v. Secretary of Department of Health & Human Services, 24 Cl.Ct. 428, 429 n. 2 (1991), aff'd, 975 F.2d 868 (Fed.Cir.1992) (citations omitted), the court applied Misasi, but noted in a footnote:
Similarly, in Reusser v. Secretary of Department of Health & Human Services, 28 Fed. Cl. 516, 527-28 (1993), the court perceptively explained:
With respect to questions of law, our review of the Court of Federal Claims' judgment is de novo. See Euken v. Secretary of Dep't of Health & Human Servs., 34 F.3d 1045, 1047 (Fed.Cir.1994). We agree with the court's analysis in Reusser and O'Connor that, as originally conceived, the Misasi test improperly required a petitioner to prove, as part of her prima facie case, that petitioner's significant aggravation was not caused by a pre-existing injury. We therefore decline to adopt and follow the original Misasi test in evaluating whether a petitioner has made out a prima facie case for recovery under the Act. In so doing, we conclude that the special master, and the Court of Federal Claims, erred as a matter of law in applying the original Misasi standard to this case. We therefore reverse the
As a result, this case requires us to articulate the proper test for evaluating whether a petitioner has made out a prima facie significant aggravation claim under the Act. We note that the skeleton of the proper test was expressed by the court in Reusser. Therefore, we seek here merely to articulate those aspects of the test which Reusser did not make explicit. As Reusser recognized, to make out a prima facie case under the statute, a petitioner must prove two things: First, "that the claimant ... significantly aggravated an injury listed on the Vaccine Injury Table," and second, "that the ... significant aggravation of the injury occurred within the time period prescribed by the Table." Reusser, 28 Fed. Cl. at 527.
The statute defines "significant aggravation" as:
42 U.S.C. § 300aa-33(4). By its use of the phrase "change for the worse in a pre-existing condition," the statute implicitly requires a comparison of the person's pre-vaccination condition with the person's current, post-vaccination condition. Indeed, such a comparison is inherent in the plain meaning of the word "aggravation" itself. Therefore, the first of Reusser's two steps requires, in fact, a three-part inquiry during which the special master must: (1) assess the person's condition prior to administration of the vaccine, (2) assess the person's current condition, and (3) determine if the person's current condition constitutes a "significant aggravation" of the person's condition prior to vaccination within the meaning of the statute. If the special master concludes that the person has suffered a significant aggravation, the special master must then proceed to Reusser's second step and: (4) determine whether the first symptom or manifestation of the significant aggravation occurred within the time period prescribed by the Table. Thus, in our four-step articulation of the test, the first three steps correspond to Reusser's first step, and the fourth step corresponds to Reusser's second step.
A comparison of our four-step test with the original Misasi four-step test is illuminating. The first two steps of the tests are analogous. Each requires that the special master evaluate the person's pre-vaccination condition and current, post-vaccination condition. This is not surprising because, as noted above, these two steps are practically inherent in the term "aggravation." In contrast, with respect to steps three and four, the two tests differ substantially. Instead of asking whether the person's symptoms would have occurred absent the vaccine, our test hoves close to the statutory mandate, and relieves a petitioner of the burden of proving causation if she can show that the first symptom or manifestation of the significant aggravation of her condition occurred within the table time period provided in the statute. Of course, as the court pointed out in Reusser, once a petitioner has made a prima facie case, the government may still prevail if it can show, to a preponderance of the evidence, that the pre-existing condition was, in fact, the cause of the individual's post-vaccination significant aggravation.
Finally, we note that in applying the above-described framework, the permissible scope of the special master's inquiry is virtually unlimited. Congress desired the special masters to have very wide discretion with respect to the evidence they would consider and the weight to be assigned that evidence. The statute therefore provides:
42 U.S.C. § 300aa-13(b).
Thus, the special master is free to consider evidence from outside the table time period in determining whether an individual suffered the first symptom or manifestation of a significant aggravation of an injury within the table time period. We mention this primarily because the special master does not seem to have considered Maggie's first abnormal EEG, taken four days after the table
For the reasons described above, the decision of the Court of Federal Claims is
AFFIRMED-IN-PART, REVERSED-IN-PART, and REMANDED.