PAULINE NEWMAN, Circuit Judge.
This case concerns proof of causation of a Table Injury
Gary G. Bunting, as representative of his son Bradley Bunting, appeals the decision of the United States Claims Court denying compensation under the Act. Bunting v. Secretary of the Dep't of Health and Human Services, 19 Cl.Ct. 738 (1990). We reverse on the issue of entitlement, and remand for determination of quantum.
The Bunting Injury
That Bradley Bunting was injured is not disputed. Nor is it disputed that the injuries (encephalopathy and seizure disorder) are listed on the Vaccine Injury Table of the National Childhood Vaccine Injury Act. 42 U.S.C. § 300aa-14(a). The history of Bradley's injury is summarized as follows, as presented by his parents and physicians, by deposition and by live testimony at the hearing before the special master. This history is described in greater detail by the Claims Court, 19 Cl.Ct. at 742-50.
When Bradley Bunting was born, on December 29, 1983, the attending physician recorded no abnormality. The first of two diphtheria-pertussis-tetanus (DPT) vaccinations was administered on March 2, 1984. At that time Bradley's parents were told by the pediatrician that side effects of the vaccine included drowsiness, irritability, and fever. Bradley's parents testified that Bradley fell into a deep sleep that lasted the rest of March 2 and part of March 3, and had a slight fever. His parents were not alarmed because they had been told to expect such effects. The day after the vaccination Bradley was listless and drowsy, and exhibited a staring episode, which lasted between 15 and 20 minutes. A week later Bradley began favoring the use of his left arm, whereas he had previously favored his right arm. On March 27, 1984 Bradley was seen by his pediatrician, at which time Bradley's mother mentioned that Bradley was favoring his left arm.
On May 7, 1984 Bradley received the second DPT vaccination. The pediatrician's record for that date states that Bradley had otitis media (ear pain). His parents immediately noticed swelling and tenderness at the site of the inoculation. On the following day Bradley cried inconsolably for two to three hours, and his right leg twitched rhythmically about every five seconds. The twitching subsided, but resumed on May 24, 1984. In early June, while on vacation in Jacksonville, Bradley's mother noticed a bending type behavior.
Bradley's parents stated that "jackknife" seizures occurred about 10 times before June 29, 1984. The seizures became more frequent, and on July 3, 1984 Bradley was admitted to the Humana Hospital, where tests were conducted including an electroencephalogram (EEG). On the hospital's form requesting the EEG it was recorded that Bradley "1 wk ago began having seizure like episodes". The report on the EEG, dated July 10, 1984, was: "Impression: Abnormal EEG with bilateral spike and wave activities occurring independently consistent with seizure disorder." The hospital records state that the pediatrician concluded at the June 29th examination that the behavior was due to ear pain.
On July 16 the pediatrician recorded that three afebrile seizures
Bradley is now seven years old. His encephalopathy is manifested by psychomotor retardation, seizures, and weakness in all four limbs. It is deemed permanent, with no expectation of recovery. He requires constant custodial care, and physical and speech therapy.
The Compensation Proceedings
In November 1988 Gary Bunting filed a petition in the United States Claims Court on behalf of Bradley, for compensation under the National Childhood Vaccine Injury Act. The Act authorizes compensation for specified injuries, 42 U.S.C. § 300aa-10(a), including encephalopathy and residual seizure disorder, 42 U.S.C. § 300aa-14(a), when caused by a covered vaccine, 42 U.S.C. § 300aa-11(c)(1).
Compensation proceedings are conducted by a special master. 42 U.S.C. §§ 300aa-12(d)(1) and (3). The proceedings are designed to be informal and non-adversarial. See H.R.Rep. No. 908, 99th Cong., 2d Sess. 3, reprinted in 1986 U.S.Code Cong. & Admin.News 6287, 6344 (establishing a procedure to administer awards "quickly, easily, and with certainty and generosity"). Shortly after Bradley's petition was filed, counsel for the Department of Health and Human Services (HHS) moved to suspend
Two days before the hearing in Miami, HHS delivered to the Claims Court in Washington a document entitled Vaccine Injury Compensation Program Medical Review (the Medical Review). The record is silent as to when or how this document was provided to the Buntings, but it is undisputed that it was not provided before or at the hearing. The special master later rejected this document as untimely.
The hearing before the special master took place without representation of HHS.
During the hearing the parents and the medical expert Dr. Morrell testified in person, and deposition and documentary evidence were presented. The special master questioned the witnesses extensively. For example, the record contains sixteen pages of transcript wherein the master interrogated the medical expert. The master's report contains twenty-three pages of findings of fact and conclusions of law. The master summarized his conclusion that causation had been shown by the preponderance of the evidence, as follows:
The master referred to the absence of any other known cause of the injury:
The master found that the pattern of symptoms the parents observed supported a finding of causation:
HHS requested de novo review by the Claims Court, on the basis that the special master erred in finding that Bradley's injury was caused by the vaccine, and that the master's failure to admit the Medical Review into evidence after the hearing was error. The Claims Court granted de novo review, admitted the Medical Review into evidence, and denied compensation.
Bunting objects to the de novo review. However, at that time the Claims Court had statutory authority to redecide, on the record, any aspect of the decision of the special master, without deference to the findings or conclusions of the master. 42 U.S.C. § 300aa-12(d)(1) provided that "the [Claims] court shall undertake a review of the record of the proceedings and may thereafter make a de novo determination of any matter."
Bunting argues that the Claims Court erred in accepting the Medical Review into evidence. Bunting points out that although the Medical Review is dated June 12, 1989, and thus was apparently available before and during the hearing before the special master on July 13, 1989, it was not produced, as required by the pretrial order of May 2, 1989.
Bunting states that this withholding of the government's evidence prejudiced his case because the medical expert Dr. Morrell was not able to address the contents of the Medical Review during his testimony before the special master. The Buntings state that their financial situation precluded calling Dr. Morrell to testify again before the Claims Court. Indeed, it is not clear whether such a procedure was available, for the Claims Court's review was based entirely on the record before the master plus the Medical Review. There was no de novo evidentiary hearing.
However, since the substance of the Medical Review does not defeat entitlement, as we shall discuss, and since the law authorizing de novo review has now been changed, we need not decide whether the Medical Review should have been admitted by the Claims Court under these circumstances of its prior availability and failure of production. We shall review the Claims Court's decision on its merits in light of all the evidence considered by the court.
Proof of Causation
42 U.S.C. § 300aa-11(c)(1) states the requirements for compensation for a vaccine-related injury:
When the time period set in the Vaccine Injury Table for the first symptom or manifestation
H.R.Rep. No. 908, 99th Cong., 2d Sess. 15, reprinted in 1986 U.S.Code Cong. & Admin.News 6344, 6356. Substantiating medical evidence is required:
42 U.S.C. § 300aa-13(a)(1).
It is undisputed that Bradley suffers from an encephalopathy. The hearing record contains Dr. Morrell's testimony that the physician and hospital records placed Bradley's symptoms and diagnosis in medically recognized chronology to the administration of the vaccine. He testified with respect to the symptoms described by the parents or in the contemporaneous medical records, and that the symptoms were consistent with the diagnosis of encephalopathy. He identified known alternative causes of encephalopathy such as tuberculosis, prenatal abnormalities, and various causes of cerebral palsy, and testified that the medical records showed that tests for these causes were negative. He concluded that the cause of the encephalopathy was the DPT vaccine, especially the second inoculation. He stated:
In addition, the Nemours Childrens Hospital neurologist who treated Bradley testified by deposition as to the symptoms and diagnosis. He reported the extensive efforts to find a correctable cause:
The Act also requires that there must not be a preponderance of evidence that the injury was caused by factors unrelated to the administration of the vaccine. 42 U.S.C. § 300aa-13(a)(1)(B). The Claims Court did not find that any such evidence was of record. The lack of evidence of other possible causes is also a factor to be weighed in determining causation due to the vaccine. Tinnerholm v. Parke, Davis & Co., 411 F.2d 48, 53 (2d Cir.1969) ("The trial court was also justified in finding and giving weight to the facts that Quadrigen [a DPT and polio vaccine] is capable of causing exactly the symptoms that occurred to the infant plaintiff and that no other apparent cause of these symptoms was ever brought to light.")
The master, interrogating Dr. Morrell, asked him to define "reasonable medical certainty" as applied to his conclusion that the vaccine was the cause of Bradley's disorder:
Although the conclusions of a medical expert are not binding on the decision-maker, 42 U.S.C. § 300aa-13(b)(1); Sternberger v. United States, 401 F.2d 1012, 1016, 185 Ct.Cl. 528 (1968), we discern no support for the Claims Court's statement that Dr. Morrell's testimony "at best is speculative".
The authors of the Medical Review agreed with the diagnosis of Bradley's encephalopathy, and agreed that DPT vaccination has been a suspected cause, but characterized the association as "controversial":
Encephalopathy and seizure disorder are listed on the Injury Table of the statute. The association of the administration of the DPT vaccine with the onset of these illnesses is not negated by the Medical Review's assertion of the absence of a "controlled study". A petitioner's burden is not to show a generalized "cause and effect relationship" with listed illnesses, but only to show causation in the particular case. The Medical Review, and the Claims Court, would place a different and greater burden on petitioners than was enacted by Congress.
Dr. Morrell testified that Bradley's symptoms are
He testified that parents are, since 1986, routinely warned of the symptoms associated with encephalopathy following immunization. The Medical Review, at best relying in broad brush on a "controversial" state of medical knowledge, does not suggest an alternative cause in Bradley's case, or suggest any inconsistency in the observed symptoms, or error in this particular diagnosis.
The standard of proof required by the Act is simple preponderance of evidence; not scientific certainty. As in Tinnerholm v. Parke Davis & Co., 285 F.Supp. 432, 440 (S.D.N.Y.1968), aff'd, 411 F.2d 48 (2d Cir.1969), "[i]t is not plaintiff's burden to disprove every possible ground of causation suggested by defendant nor must the findings of the Court meet the standards of the laboratorian".
The Claims Court found that causation had not been shown. We deem this finding to be in clear error. Bunting has met the statutory burdens, and is entitled to compensation in accordance with the Act.
Costs under Federal Circuit Rule 39 are taxed in favor of Bunting.
REVERSED AND REMANDED.
The actions of HHS herein are illustrative of this criticism.