Court Opinion

ID: 9493255
Source: CourtListenerOpinion
Date Created: 2023-08-05 15:02:39.475974+00
Date Added: 2024-06-11T17:55:44.360993
License: Public Domain

PLAGER, Circuit Judge,
dissenting.
While I commend the majority for its dedication to our deferential standard of review in Vaccine Act cases, see Hodges v. Secretary of Dep’t of Health & Human Servs., 9 F.3d 958 (Fed.Cir.1993) (Plager, J.); Bradley v. Secretary of Dep’t of Health & Human Servs., 991 F.2d 1570 (Fed.Cir.1993) (Plager, J., concurring in part and dissenting in part), even under the most rigorous application of that standard the decision of the Court of Federal Claims in this case requires reversal; the Special Master’s decision, left standing by that court, is both arbitrary and capricious, and not in accordance with governing law. I therefore respectfully dissent.
The majority has done an excellent job in laying out the facts in Rachael Lampe’s tragic case, and I shall not waste space recounting them here. I will emphasize *1369those facts I find of particular importance as they are relevant to my analysis.
I. Standard of Review
The Court of Federal Claims reviews the decision of the Special Master under the arbitrary, capricious, abuse of discretion, or not in accordance with law standard. See 42 U.S.C. § 300aa-12(e)(2)(B). On appeal to this court, we review the decision of the Court of Federal Claims to determine whether that court correctly evaluated the Special Master’s decision under that standard. See Bradley v. Secretary of Dep’t of Health & Human Servs., 991 F.2d 1570, 1574 (Fed.Cir.1993). Thus, although we are reviewing as a matter of law the decision of the Court of Federal Claims under a non-deferential standard, we are in effect reviewing the decision of the Special Master under the deferential arbitrary and capricious standard on factual issues, and independently, that is, without deference, on legal issues. See Hines v. Secretary of Dep’t of Health & Human Servs., 940 F.2d 1518, 1524 (Fed.Cir.1991); Whitecotton v. Secretary of Health & Human Servs., 81 F.3d 1099, 1106 (Fed.Cir.1996) (no deference to Court of Federal Claims or Special Master with regard to legal issues). I will therefore address my analysis, as the majority did, directly to the decision of the Special Master (cited hereinafter as “Special Master’s decision”).
II. Legal Errors
The Special Master’s primary error of law was in interpreting the Vaccine Act as requiring that Rachael’s injury be linked to one particular injection in order to show actual causation, which led him to attempt to identify a single vaccination as the proverbial “smoking gun.” For example, the structure of the Special Master’s discussion of the case was organized around the following headings: “B. Have petitioners demonstrated ... that Rachael suffered from a preexisting seizure disorder prior to her third DPT vaccination?”; “C .... have petitioners demonstrated ... that Rachael’s second DPT vaccination caused-in-fact her seizure condition?”; “D .... have petitioners demonstrated ... that Rachael’s third DPT vaccination caused-in-fact a significant aggravation of her preexisting seizure condition?” See Special Master’s decision at 11,14, 16; see also id. at 25 (criticizing Rachael’s expert because she “did not specify which vaccination of the three should be considered the cause of Rachael’s problems”).
This interpretation was a clear misreading of the statutes governing Vaccine Act cases, and it was extremely prejudicial to the causation theory of Rachael’s case, that her seizure disorder was the result of a severe, progressive allergic reaction to the cumulative series of administrations of the DPT vaccine. The Special Master’s misreading of the Vaccine Act and concomitant search for the “smoking gun” led him into a series of other errors that ultimately resulted in an improper denial of Rachael’s petition.
An examination of the relevant statutes regarding the requirements for demonstrating actual causation reveals no requirement that an injury alleged to be the result of a vaccine must be linked to one particular administration of that vaccine. The basic requirement for the initial petition in an actual causation case like the present one is set forth in 42 U.S.C. § 300aa-ll(c)(l)(C)(ii)(II):
A petition for compensation under the Program for a vaccine-related injury or death shall contain ... an affidavit, and supporting documentation, demonstrating that the person who suffered such injury or who died ... sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine [listed in the Vaccine Injury Table],
Section 300aa-13(a) then spells out how such a petition is to be analyzed to determine eligibility for compensation:
*1370(1) Compensation shall be awarded under the Program to a petitioner if the special master or court finds on the record as a whole—
(A) that the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition by section 300aa-ll(c)(l) of this title, and
(B) that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition.
Section 300aa-13(b) explains that, in making such a determination, the Special Master is to consider:
in addition to all other relevant medical and scientific evidence contained in the record' — •
(A) any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury, condition, or death, and
(B) the results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.
Any such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court. In evaluating the weight to be afforded to any such diagnosis, conclusion, judgment, test result, report, or summary, the special master or court shall consider the entire record and the course of the injury, disability, illness, or condition until the date of the judgment of the special master or court.
Nowhere does this scheme require or even suggest that causation must be tied to one particular administration of a vaccine. The key phrase in § 300aa-ll(c)(l)(C)(ii)(II) is that the injury must be “caused by a vaccine [listed in the Vaccine Injury Table].” Causation is thus linked to the vaccine, not to a particular administration of the vaccine. Furthermore, § 300aa-13(b) states that the Special Master “shall consider the entire record and the course of the injury, disability, illness, or condition.” Cf. Bunting, 931 F.2d at 872-73 (implicitly attributing actual causation to series of two DPT vaccine administrations).
In contrast, linkage to a particular administration of the vaccine is required for demonstrating an injury under the Vaccine Injury Table. See 42 U.S.C. § 300aa-14. Table injuries must occur within a specified time frame, and so each condition in the table has associated with it a “Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration.” See id. Thus, table injuries are by definition linked to particular administrations. However, the clear meaning of the cited statutes demonstrates that the requirement for this linkage does not carry over to the analysis of actual causation, contrary to what the Special Master apparently believed. The Special Master’s decision was incorrect as a matter of law because he limited his analysis to each administration of the DPT vaccine as a separate potential instance of causation, rather than considering causation by the series of vaccine administrations as a whole.
The consequence of the Special Master’s incorrect reading of the statute was his requiring the Lampes to prove that Rachael’s seizure after the third vaccination represented a “significant aggravation” of her preexisting seizure disorder. Because the Special Master treated each administration of the vaccine separately, he decided that the bicycle pedaling movements she demonstrated after receiving the second vaccine were a “preexisting condition” at the time of her third vaccination. Therefore, the full seizure she suffered after the third vaccination could not be viewed as the onset of her seizure disorder, but could only be compensated, if at all, if it was a “significant aggravation” of her “preexisting” seizure disorder. Because he found the’ full seizure to be merely a culmination *1371of her “preexisting” seizure disorder, and therefore not a significant aggravation, he denied compensation.
As discussed above, Rachael’s theory was based on a cumulative reaction to the series of vaccinations. When the Special Master forced Rachael into a significant aggravation case, thus precluding her from establishing her cumulative reaction theory, he effectively foreclosed her from demonstrating her eligibility for compensation. The testimony of her doctors was properly directed to her theory of causation, not to the significant aggravation theory created by the Special Master, and not surprisingly she was therefore unable to establish her case to the satisfaction of the Special Master under his theory. Indeed, the vast majority of the Special Master’s opinion is dedicated to this issue, and it is filled with extensive criticisms of Rachael’s experts because they did not address the issue in the way he wanted it addressed. This fundamental misreading of the law, and the consequent error in decision that it caused, should have led the Court of Federal Claims to vacate the decision of the Special Master; the court’s failure to do so is itself reversible error.
The Lampes make the further point that, as a matter of law (and logic), the preexisting condition analysis should apply only when the condition predated any introduction of the vaccine into the body of the vaccinee, which was not the case here. Although I believe this argument has substantial merit, my conclusion that Rachael need not show that her injuries were linked to one particular administration of the vaccine subsumes this argument, and I therefore will not address it further. However, I note that much of the Special Master’s opinion is irrelevant under the correct analysis.
Having established as a legal matter that the series of vaccinations should be viewed as a whole, I now turn to the proper legal analysis of actual causation, as set forth in Grant v. Secretary of Dep’t of Health & Human Servs., 956 F.2d 1144 (Fed.Cir.1992). Under Grant, the petitioner must demonstrate, by the preponderance of the evidence, a logical sequence of cause and effect showing that the vaccination is the “cause” of the injury. See id. at 1148. This logical sequence must be supported by a reputable medical or scientific explanation. See id. The lack of alternative causation is a necessary part of this showing, not a separate showing in response to evidence of alternative causation presented by the Secretary (as it is in table injury cases). See Bunting v. Secretary of Dep’t of Health & Human Servs., 931 F.2d 867, 872 (Fed.Cir.1991); Johnson v. Secretary of Health & Human Servs., 33 Fed. Cl. 712, 721 (1995), aff'd 99 F.3d 1160 (Fed.Cir.1996) (table); Williams v. Secretary of Dep’t of Health & Human Servs., 1998 WL 156967 at *10 (Fed.Cl. March 18, 1998) (Special Master).
It is important to keep in mind what is meant by establishing that the vaccine is the “cause” of the injury. “The standard of proof required by the Act is simple preponderance of the evidence; not scientific certainty.” Bunting, 931 F.2d at 873. “The determination of causation in fact under the Vaccine Act involves ascertaining whether a sequence of cause and effect is ‘logical’ and legally probable, not medically or scientifically certain.” Knudsen v. Secretary of Dep’t of Health & Human Servs., 35 F.3d 543, 548-49 (Fed.Cir.1994). Furthermore, “close questions of causation must be resolved in favor of the petitioners.” McClendon v. Secretary of Dep’t of Health & Human Servs., 24 Cl.Ct. 329, 334 (1991).
III. Fact-Based Errors
Given that understanding of Rachael’s burden, this case presents two extraordinary facts that separate it from the vast majority of Vaccine Act cases, and the Special Master acted arbitrarily and capriciously when he failed to appreciate the significance of these facts.
The first extraordinary fact comes from a review of the full course of the injury, as related to the series of vaccinations. *1372Rachael’s theory of causation was her developing allergic reaction to the DPT vaccine. See Special Master’s decision at 14 (discussing testimony of Rachael’s expert that “her injuries were a result of an allergic reaction to all three of the inoculations”); id. at 24 (discussing second expert’s testimony that Rachael’s “allergen hypersensitivity ... grew as she was repeatedly exposed to the allergen, here the DPT vaccine”). After the initial vaccination on November 10, 1975, she had no observable response, but this vaccination “primed” her system. After the second vaccination on December 18, 1975, she had a minor reaction, as exhibited by her “bicycle pedaling” motions. After the third vaccination on January 19, 1976, she had a full-blown seizure, followed by regular seizures thereafter. Such a picture strongly suggests the asserted theory of an allergic reaction as a result of the cumulative effect of the DPT vaccinations.
Scientifically, the best way to test such a theory would be to administer the vaccine again and observe the effects on Rachael. For obvious moral and ethical reasons, such experiments are of course never done intentionally. Indeed, under modern practice, the normal procedure after a reaction such as that exhibited by Rachael is to place a note in the patient’s medical record that the patient should avoid all future exposure to the DPT vaccine. See Sharpnack v. Secretary of Dep’t of Health & Human Servs., 27 Fed.Cl. 457, 461 (1993) (quoting Special Master’s citation to 1988 report establishing guidelines that states that an encephalopathy within 7 days of receiving the DPT vaccination is an “absolute contraindication” to future administration of the vaccine).
However, at the time Rachael received her vaccinations, this was not standard practice and thus no such notation was made. As a consequence, Rachael received a fourth DPT booster vaccination one year later, on January 26, 1977. By this time, her seizure activity had been brought under some measure of control through the use of drugs, and she was experiencing light seizures only rarely. Rachael’s reaction to the fourth vaccination was exactly what would have been predicted under the allergic reaction theory: she experienced a severe seizure the next day and the frequency and severity of her seizures again increased.
It would be hard to imagine a clearer demonstration of the strength of the theory of causation by the cumulative effect of an allergic reaction to the DPT vaccination. As the majority points out, maj. op. at 1362-63, the Special Master recognized that Rachael’s bicycling movements, which began during the course of the vaccine series, were seizures that represented the onset of her seizure condition, and that the major seizure after the third vaccine administration was a continuation of the pattern. Because he was erroneously analyzing each administration of the vaccine separately, the Special Master failed to appreciate the significance of the fourth vaccination a year later, and its remarkable support for the theory of causation set forth by Rachael’s experts. In misapprehending the significance of the fourth vaccination, the Special Master failed to appreciate a critical aspect of the case, and as a consequence his decision adverse to Rachael was arbitrary and capricious; for this reason as well, the Court of Federal Claims erred when it affirmed the Special Master’s decision.
The second extraordinary fact misapprehended by the Special Master is the significance of the incredibly extensive medical testing to which Rachael has been subjected. Most cases under the Vaccine Act involve babies and small children who recently received the vaccinations alleged to cause their injuries, and in some of the cases the vaccine recipient has died. Thus, the vaccine recipient has generally not been tested for more than a few possible alternative causes for his or her present condition.
In the present case, however, Rachael was 15 years old at the date of her petition (21 by the date of the hearing). As the record establishes in detail, in the course *1373of her life she has been subjected to virtually every known test for every known possible alternative cause for her condition. At the time of her first seizure, she was tested or examined for bacterial or viral infections, herpes/CMV, trauma, congenital abnormalities of the brain and abnormalities of the brain caused by birth trauma and hypoxia. Since then, she has been tested or examined for rubella, toxo-plasmosis, repeated amino acid testing (both urine and serum) for metabolic disturbances, serum hexosaminidase and B enzyme, arterio-venous malformations, hypoglycemia, chromosomal analysis with both Q- and G-banding, and degenerative diseases. Every one of these tests has been negative.
Throughout her life, she has been tested with all available medical technology— metabolic testing, genetics, X-ray technology, blood technology, endocrine technology — none of which have found any medical explanation for her condition other than the DPT vaccine. The power of this incredible breadth of testing is demonstrated by the fact that the Secretary’s own expert was utterly unable to postulate any plausible alternative cause; he was forced to fall back on identifying her condition as an “idiopathic [i.e., of undetermined origin] seizure disorder.”
The Special Master erred in failing to accord proper significance to the total lack of evidence of alternative causation, as demonstrated by the negative results from the extensive tests for alternative causes. While I recognize that the absence of alternative causation is not sufficient in itself to require compensation under the Vaccine Act, see Grant, 956 F.2d at 1149; Hodges, 9 F.3d at 960, such an absence is very strong evidence in support of a well developed theory of causation such as the one presented here, see Bunting, 931 F.2d at 872-73; see also Strother v. Secretary of Dep’t of Health & Human Servs., 21 Cl.Ct. 365, 375-76 (1990) (“[CJonclusive medical evidence eliminating all possible causes other than the vaccine could contribute to a finding of causation in fact.”).
In actual causation cases such as this one, the ultimate decision often turns on the outcome of the “battle of the experts,” and the present case is no exception. Both sides presented expert medical witnesses in support of their respective positions. The Special Master viewed Rachael’s witnesses as failing to provide “detailed credible testimony,” and “unpersuasive.” The Court of Federal Claims couched it in terms of determining the “credibility” of these competing witnesses. It is often said that, on appeal, evaluations of credibility are “virtually unreviewable.” See, e.g., Bradley, 991 F.2d at 1575. On closer examination, however, it becomes apparent that credibility is not really the issue in this case.
Rachael’s experts, about whose credentials there was no question, presented a highly plausible scenario, supported by medical evidence, explaining how she had a severe allergic reaction to the series of DPT vaccines. The Secretary’s witness, Dr. Snyder, never directly contradicted this theory, and in fact admitted that such a scenario was “possible.” See Special Master’s decision at 15. However, he maintained that it was not correct in the present case. His contention, however, is not supported by any evidence or reasoning. Dr. Snyder provides no alternative theory of causation, asserting only that it must be some “idiopathic [i.e., of unknown origin] seizure disorder” and that he could point to no other possible cause. Dr. Snyder’s testimony boils down to “I have no idea what caused Rachael’s seizure disorder, I just know it was not the DPT vaccination.” This level of testimony cannot form the basis for the Secretary’s denial of a claim under the Vaccine Act, in the face of the weight of the contrary evidence. Cf. 42 U.S.C. § 300aa-13(a)(2)(A) (“[T]he term ‘factors unrelated to the administration of the vaccine’ does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition” (referring to the Secretary’s burden of proof in refuting prima *1374facie table injuries).); Sumrall v. Secretary of Dept. of Health and Human Services, 23 Cl.Ct. 1, 8 (1991) (quoting the statute and dismissing testimony of expert that cause of seizure disorder was unknown as “not persuasive”).
The Special Master also erred in the burden he placed on Rachael’s expert medical witnesses. He rejected their testimony at least in part because they would not state unequivocally that the vaccine caused Rachael’s injuries. However, a significant part of the theory underlying the Vaccine Act is that it is difficult if not impossible to demonstrate conclusively that a particular injury was caused by a particular vaccine. Given the current state of scientific knowledge in the field, no responsible doctor can state unequivocally that a particular vaccine caused a particular injury (or, for that matter, that it did not cause such injury).
Indeed, any doctor who was willing to make such a statement would be immediately (and rightly) attacked as stating more than science can prove. Thus, the Special Master placed Rachael in an impossible position: either provide a witness who will state unequivocally that the vaccine caused the injury, in which case the witness will be rejected as not credible, and her case will fail; or provide a knowledgeable witness who will testify on the basis of best scientific understanding that the vaccine likely caused the injury, but is unwilling to say unequivocally that it was the cause, in which case the testimony will be insufficient to demonstrate actual causation, and her ease will fail. This interpretation of the law cannot be correct. Demonstrating actual causation does not require certainty; rather, it requires a plausible scientific explanation supported by a credible, reputable witness. See Grant, 956 F.2d at 1148. This is exactly what Rachael provided.
To add insult to injury, the Special Master criticized Rachael’s expert, stating “[the expert] called the DPT ‘instrumental in producing her seizure and neurological disorder’; this does not arise to the level of actual causation.” Special Master’s decision at 26. This conclusion is directly contrary to our holding in Shyface v. Secretary of Health & Human Servs., 165 F.3d 1344, 1353 (Fed.Cir.1999), in which we held that the vaccine need be only a “substantial factor” in bringing about injury, not necessarily the only or predominant factor.
Summary
Rachael has presented exactly the type of case required under Grant and our other precedents for a successful proof-of-causation case. She presented a medically-recognized theory of causation, a severe allergic response to the series of vaccinations. She presented two reputable expert witnesses who supported her theory. (The Special Master rejected the testimony of these witnesses solely because it did not fit his erroneous interpretation of the statute, requiring that the injury be linked to a particular administration of the vaccine.) Rachael presented voluminous evidence refuting all potential alternative causes for her injury. (The Secretary mustered little more than stubborn rejection, with no alternative explanation.) Thus, Rachael has met her burden of demonstrating actual causation, and the Special Master’s decision to the contrary is arbitrary, capricious, and not according to law. Proving a case that is not a table injury is fraught with difficulty for the petitioner, but if this case does not meet the standards of actual causation, it is hard to imagine a case that would.
The majority attempts to dismiss these realities by characterizing the dissent’s quarrel as “really with the special master’s evaluation of the evidence, which is a ‘matter[ ] within the purview of the fact finder.’ ” Maj. op. at 1364 (citation omitted). Indeed, my quarrel is with the special master’s evaluation of the evidence. He evaluated it using an incorrect analytical approach, repeatedly focusing on the individual vaccine administrations rather than the totality of the record before him; and neither he nor the majority persuasively *1375address, much less satisfactorily explain, the two extraordinary facts in this case set out above — the reaction to the booster shot in January of 1977, confirming the pattern of Rachael’s seizure responses over time, and the extraordinary record of medical testing to which Rachael has been subjected, eliminating all known alternative causes.
The majority tells us that the evaluation of evidence by a special master is “within the purview of the fact finder.” Id. That reflects the fundamental error in the majority’s approach to this case. Yes, determining who among conflicting live, witnesses is more credible is a determination that is rarely possible on a cold record, thus giving the trial official substantial freedom in making that determination; and yes, a fact-finder is entitled to substantial deference in resolving disputed questions of fact. But an appellate court is not a potted plant when the question is whether the trial official correctly evaluated the facts found, and whether he arrived at correct conclusions of fact and law based on the evidence. Indeed, Congress specifically provided for review by this court, under a proper standard of review, of precisely those questions. In many cases it is only disputed facts that are at issue, and our standard of review dictates that we withhold our hand; this is not one of them, and it does not do to try to make it one.
The Vaccine Act provides a “compensation program under which awards can be made to vaccine-injured persons quickly, easily, and with certainty and generosity,” despite the virtual impossibility of actually proving that a particular injury was the result of receiving the vaccine. See H.R.Rep. No. 99-908 (1986), reprinted in 1986 U.S.C.C.A.N. 6344. The primary vehicle for this compensation is the Vaccine Injury Table, which established an assumed scientific certainty by legal fiat. However, Congress recognized that not all injuries that can be deemed caused by vaccines would fit within the table. Rather than ignore this category of injury in favor of certainty, Congress chose to provide the injured with the option of demonstrating actual causation. If the interpretation, on the facts of this case, of what constitutes “actual causation,” expressed by the Special Master, accepted by the Court of Federal Claims, and affirmed by the majority here, is correct, the decision will have effectively nullified the clearly expressed Congressional purpose that underlies the Vaccine Act.
Accordingly, I would reverse the decision of the Court of Federal Claims, and remand with instructions for that court to vacate the decision of the Special Master. The case should be returned to the Special Master for reconsideration of the entire matter, examining all the facts in their proper context under the correct analytical framework, including proper analysis of the testimony of the medical experts. The correct analytical framework under the law includes using a sequential causation analysis, rather than an analysis that searches for a “smoking gun” causation event.
I respectfully dissent from the majority’s failure to do so.