United States of Federal Claims

No. 90-3409 V

(Filed: November 3, 2000)

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ROBERT LEE TURNER and

SANDRA KAY TURNER, as Legal

Representatives on behalf of

ROBERT CLEVELAND TURNER,

Petitioners,

v.

SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES,

Respondent.

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42 U.S.C. 300aa-1 et seq. Vaccine Act; factors unrelated; causation.

Scott Richard Brann, Houston, TX, for petitioners.

Mark William Rogers, Washington, DC, for respondent.

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OPINION

 

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DAMICH, Judge.

Petitioners Robert Lee and Sandra Kay Turner, the parents and legal representatives of Robert Cleveland ("Bobby") Turner, have filed a petition for review of a decision dated May 30, 2000, by the Office of Special Masters denying compensation under the National Childhood Vaccine Injury Compensation Act of 1986, 42 U.S.C. 300aa-1 et seq. ("Vaccine Act"). The Special Master found that the Petitioners failed to prove that post-vaccinal symptoms other than seizures were neurologically significant for Petitioners to impeach the Respondent's evidence that tubular sclerosis ("TS") caused in fact the onset of Bobby Turner's seizures. The Petitioners claim that the Special Master, by requiring them to establish that Bobby's symptoms other than seizures were "neurologically significant," had imposed an evidentiary burden contrary to the Vaccine Act. The Petitioners also allege that the Special Master's findings of fact are not supported by the evidence. For the reasons set forth below, the Court DENIES the Petitioners' motion for review and AFFIRMS the decision of the Special Master.

Bobby Turner suffers from a genetic disease known as tubular sclerosis, ("TS"), that is pre-existent to his vaccination. According to the Respondent's expert, Dr. Robert Zimmerman, Bobby has thirteen cortical tubers. Bobby received his second DPT vaccination on November 21, 1978. Within the evening, Bobby had a fever which responded to symptomatic treatment though the parties dispute the magnitude and duration of the fever. Bobby cried and was irritable that evening, though he also fell asleep and was able to drink without difficulty. Bobby, however, also suffered from significant infantile spasms after the vaccine. The Petitioners claim that all of the symptoms, including the infantile spasms, occurred immediately after his second DPT vaccine.

 

The Petitioners filed a petition for compensation under the Vaccine Act on behalf of Bobby Turner. The original petition alleged that Bobby experienced the first onset of a residual seizure disorder within 3 days after his second DPT vaccination on November 21, 1978. The Petitioners also alleged that the DPT vaccination significantly aggravated his TS condition.

The Special Master who issued the decision in this case was also assigned to over 60 TS-related cases. In the early stages of this litigation, TS children who suffered "on-Table" seizures were entitled to a presumption of significant aggravation of their condition. Costa v. Sec'y H.H.S., 26 Cl. Ct. 866 (1992). On January 22, 1996, the Special Master issued a decision which held that because Bobby's seizures occurred within 3 days of his November 21, 1978 DPT vaccination, his seizures were "on-Table" and therefore presumed to be caused by the vaccine. Turner v. Sec'y H.H.S., No. 90-3489V, slip op. at 6 (Fed. Cl. Sp. Mstr. Jan 22, 1996) ("Decision at ____").

However, the Respondent presented new evidence to the Court in all pending TS cases, including Bobby's, concerning the relationship between the cortical tubers of TS patients and their seizures and mental retardation. The evidence suggested that DPT vaccines do not cause seizures in TS patients. The Special Master, therefore, delayed a final decision on entitlement to compensation so that the Respondent could present this evidence. Decision at 2.

On April 11, 1996, the Special Master issued an Omnibus Order consolidating all TS-related vaccine cases, including Turner, in order to conduct an expert hearing to determine whether the claimants' seizures and other conditions were due to TS, a "factor unrelated" to the DPT vaccine pursuant to 42 U.S.C. 300aa-13(a)(1)(B). The expert hearing was held from October 8-11, 1996, and June 3-4, 1997.

The Special Master issued a "TS Omnibus Decision" on September 15, 1997. The Special Master found that "TS is the overwhelming cause of seizures in a child afflicted with the disease, unless he develops a fever or some other well-recognized reaction to a vaccination." Barnes v. Sec'y H.H.S., 1997 WL 620115, at * 31 (Fed. Cl. Sp. Mstr. Sept. 15, 1997). Further, the Special Master states "the epidemiology that is available . . . supports the view that DPT does not initiate seizures in TS patients." Id. at 32. Consequently, the Special Master determined that,

[r]espondent has successfully rebutted petitioners' presumption of significant aggravation of pre-existing TS from DPT vaccine by proving that TS caused in fact both petitioners onset of seizures and current condition.

Id. at * 34. Hence, in all TS cases, the Special Master found that TS is presumed to have caused all cases of seizures. However, that presumption could be rebutted if ". . . he develops a fever or some other well-recognized reaction to a vaccination." Id. at * 31.

Subsequent to the Omnibus decision, the Special Master issued an order granting compensation to the Petitioner. Turner v. Sec'y H.H.S., No. 90-3409V, Order (Fed. Cl. Sp. Mstr. Sept. 27, 1997). Because that order was granted without the benefit of expert testimony, the Special Master ordered the production of medical reports to determine whether the symptoms had neurological significance.

Based on the expert testimony received, on August 18, 1998, the Special Master held that in order for Petitioners to rebut the presumption that TS caused the onset of Bobby's seizures, the Petitioners must show that post-vaccinal symptoms, other than seizures, must exist and be neurologically significant. (1) The Special Master found that Bobby's symptoms did not meet this standard. Bobby's fever was low and his crying and irritability were insufficiently prolonged to have any neurological significance. Turner v. Sec'y H.H.S., No. 90-3409V, 1998 U.S. Claims LEXIS 213, at * 8 (Fed. Cl. Sp. Mstr. August 18, 1998). Accordingly, the Special Master dismissed the petition. However, that decision was vacated on September 18, 1998, pending an appeal in Hanlon v. Sec'y H.H.S. On May 30, 2000, the day the Supreme Court denied certiorari in Hanlon, the Special Master reissued an opinion which reiterated the holding of her August 18, 1998 opinion. (2) The Special Master dismissed the petition with prejudice. The Petitioners filed a motion for review with the Court on June 21, 2000.

III. Statutory Framework of the Vaccine Act

The Vaccine Act provides a system for compensating individuals who claim to have been injured by certain vaccines. The Vaccine Act essentially shortcuts the burden of proving causation that the petitioner would normally face in standard tort litigation. Instead of proving causation, the Vaccine Act provides a burden-shifting device known as the "Vaccine Injury Table." 42 U.S.C. 300aa-14(a). If a case is "on-Table," then the Table provides a presumption that injuries were caused by the vaccine if the petitioner establishes that the onset or "significant aggravation" of predicate injuries occurred within a time period set by the Table. 42 U.S.C. 300aa-11(c)(1)(C)(i).

However, the respondent has the opportunity to rebut this presumption. If the respondent proves that the injuries sustained were due to "factors unrelated" to the vaccine, the petitioner cannot be compensated. 42 U.S.C. 300aa-13(a)(1)(B). (3) If the government claims that the injuries were due to a "factor unrelated," the petitioner can respond to the "factor unrelated" claim by stating that the alleged factor was not "principally responsible" for the injury suffered. Thus, the special master shall, in determining whether to award compensation to the petitioner, weigh the proffered evidence provided by both petitioner and respondent including all "relevant medical and scientific evidence contained in the record" as well as "any . . . diagnosis, conclusion, [or] medical judgment . . . regarding the nature, causation, and aggravation of the petitioner's illness . . . . 42 U.S.C. 300aa-13(b)(1).

IV. Standard of Review

The Court must uphold any findings of fact or conclusions of law of the Special Master unless the findings are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 42 U.S.C. 300aa-12(e)(2)(B). With respect to findings of fact, the Special Master has broad discretion to weigh expert evidence and make factual determinations. Bradley v. Sec'y H.H.S., 991 F.2d 1570, 1575 (Fed. Cir. 1986). "If the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate." Hines v. Sec'y H.H.S., 970 F.2d 863 (Fed. Cir. 1992).

The Petitioners claim that the Special Master improperly required them to establish that Bobby's symptoms of fever, crying, irritability, and so on had "neurological significance" apart from TS. (Pl.'s Mot. at 5.) The Petitioners note that the term "neurological significance" does not appear anywhere in the statute or the TS Omnibus Decision. Id. They further claim that having to prove that Bobby's symptoms were "neurologically significant" would defeat the statutory presumption of entitlement to compensation for "on-Table" DPT cases. Id. at 7. The Petitioners further contend that establishing the "neurological significance" of the symptoms would serve as an impossible burden on the Petitioners, and that the Respondent did not fully prove that Bobby's symptoms were "factors unrelated" to the vaccine. Id. at 7-8.

The Respondents argue that the Federal Circuit in Hanlon had already determined conclusively that TS is a factor unrelated in any case where the Table onset of symptoms constituted seizures only, and that the Special Master only had to determine whether the other symptoms were of such importance so as to warrant a departure from the findings of the Omnibus opinion. (Def's Resp. at 15). As to the allocation of evidentiary burdens, the Respondent characterizes the demonstration of "neurological significance" as "one final opportunity to rebut respondent's convincing proof that the child's TS is the cause of his condition." Id. at 16. The Respondent claims that this allocation of evidentiary burdens was fully approved by the Federal Circuit in Hanlon.

The Federal Circuit's decision in Hanlon does not explicitly mention or affirm any "one final opportunity to rebut" the respondent's evidence that TS causes DPT. However, the prior Court of Federal Claims decision in Hanlon does affirm an allocation of evidentiary burdens that is similar to the present case. Before the Court of Federal Claims, the petitioners argued that the Special Master held them to a causation-in-fact standard after they had satisfied their "on-Table" presumption. Hanlon v. Sec'y H.H.S., 40 Fed. Cl. 625, 631. Judge Turner answered this objection by stating that the "[r]espondent simply put on a strong rebuttal which itself "required" petitioners to do more than rest on their prima facie showing if they wished to prevail. We conclude that petitioners were not required to prove that DPT caused in fact [petitioner's] seizures in order to prove a Table injury." Id. The Respondent, therefore, infers that the affirmation by the Federal Circuit serves as an affirmation of the Special Master's evidentiary standard. Since the Federal Circuit did not squarely address that issue, such an inference is not necessarily true. The best inference that can be drawn from the Federal Circuit's decision in Hanlon is that providing the petitioner with "one final opportunity to rebut" the respondent's presumption that TS, not DPT, vaccines caused Bobby's symptoms is not necessarily inconsistent with the evidentiary burdens established by the Vaccine Act. Therefore Hanlon is not controlling in this case.

Nevertheless, requiring the Petitioners to demonstrate "neurological significance" to rebut the Respondent's proof that TS was the cause of Bobby's symptoms is neither unreasonable nor contrary to the Vaccine Act. The fact that the Special Master initially decided in favor of entitlement to compensation on January 22, 1996, and issued an order to that effect on September 27, 1997, demonstrates that the Petitioners had in fact already met their on-Table evidentiary presumption and that the Respondent had not yet, by a preponderance of the evidence, proved that Bobby's symptoms were caused by TS. The Special Master never imposed a burden on the Petitioners of proving causation-in-fact. Not until expert reports were taken on neurological impairment, did the Respondent prove that Bobby's post-vaccinal symptoms were caused by TS rather than the vaccine. (4) In no sense can it be said that the Court imposed an extra evidentiary burden not contemplated by the Vaccine Act. Instead, the Special Master gave the Petitioners an extra opportunity to rebut the Omnibus Decision that TS did not cause Bobby's fussiness, crying, and fever.

Likewise, the requirement to demonstrate "neurological significance" to rebut the respondent's presumption that TS caused Bobby's symptoms is not an impossible burden. It is understood that the term "significance" suggests that the evidence provided need not be conclusive, but only evidence that is not unimportant. This burden was not a difficult standard for the petitioners to meet. In fact, the petitioners did not meet this standard at all by failing to interpret Bobby's seizures. Final Decision at 8.

It is understandable that the Petitioners would be disappointed by their sudden reversal of fortune after the Special Master decided to reconsider her decision and to take expert testimony. Nevertheless, that decision was well within the scope of her discretion to consider "relevant medical and scientific evidence." 42 U.S.C. 300aa-12(a)(1). The Court has no reason to second-guess her in this regard.

The Petitioners argue that the Special Master erred by failing to follow her own prior rulings in TS related cases. (5) Specifically, the Petitioners seize on the following statement by the Special Master in the TS Omnibus Decision: "where a TS child receives DPT vaccine, and remains perfectly normal, in temperature, eating, sleeping, affect, and activity, but has a seizure within three days, TS, not DPT is the cause of that seizure." Barnes, 1997 WL 620115 at * 32. Because Bobby Turner displayed a majority of those symptoms, so the Petitioners argue, the Special Master was required to find that DPT, rather than TS, significantly aggravated Bobby's seizures. However, the Court cannot agree with such a simplistic "checklist" approach to determining whether Bobby's non-seizure symptoms were significantly aggravated by his vaccine. Such an analysis does not take into account the duration or magnitude of Bobby's non-seizure symptoms. Nor does such an approach even attempt to find a medical nexus between Bobby's symptoms and the vaccine. A medical judgment in which Bobby's various symptoms are analyzed qualitatively by experts, as the Special Master provided for, is reasonable.

The record clearly shows that the Special Master reviewed the evidence submitted by the experts. The Special Master clearly relied on the opinion of the Respondent's expert, Dr. Guggenheim, that

" . . . Bobby's infantile spasms were related to his underlying TS because he did not have an acute encephalopathy after his DPT vaccination . . . The fever that he had on the evening of the vaccination lasted only a few hours and responded to symptomatic treatment . . . Although Bobby cried and was fussy, irritable, and whiny, he fell asleep and was able to drink without difficulty. The seizures were his only neurologic abnormality."

Final Decision at * 1. In contrast, the Special Master found that the Petitioners' expert,

Dr. Kinsbourne, "failed to interpret Bobby's symptoms," and instead focused on "rearguments of the issues the undersigned had already decided in the TS Omnibus Decision." Final Decision at * 9-10. These findings by the Special Master are entitled

to deference. The Court holds that the Special Master made reasonable inferences in weighing the medical evidence on the record and, therefore, her inferences shall remain unmolested.

Therefore, the Court AFFIRMS the Special Master's decision dated May 30, 2000. The petition is dismissed with prejudice.

 

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EDWARD J. DAMICH

Judge

1. The Special Master's opinion states that ". . . post-vaccinal symptoms, other than seizures, must exist and be neurologically significant for petitioners to rebut the presumption that DPT caused the onset of Bobby's seizures." Turner v. Sec'y H.H.S., No. 90-3409V, 1998 U.S. Claims LEXIS 213, at * 8 (Fed. Cl. Sp. Mstr. August 18, 1998). Given the context of the decision, it is clear that the term "DPT" was a typographical error, and the Special Master meant "TS."

2. "[T]he Court finds that post-vaccinal symptoms, other than seizures, must exist and be neurologically significant for petitioners to impeach respondent's evidence that TS caused in fact the onset of Bobby's seizures. Bobby's symptoms did not have neurological signficance." Turner v. Sec'y H.H.S., No. 90-3409V, 2000 U.S. Claims LEXIS 113, at * 9 (Fed. Cl. Sp. Mstr. May 30, 2000) ("Final Decision").

3. The statute provides that "factors unrelated" may include those injuries such as "trauma . . . which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner's illness, disability, injury, condition, or death." 42 U.S.C. 300aa-13(a)(2)(B).

4. The Special Master in her final decision noted that the Petitioners' expert, Dr. Kinsborne completely failed to interpret Bobby's symptoms at all, but instead tried to re-litigate the Omnibus Decision that TS, not DPT, causes seizures, while in contrast the Respondent's experts clearly analyzed symptomatology. Final Decision at 8. Under such circumstances, the Respondent satisfied its prima facie case outright.

5. The Petitioners also re-argue factual issues that were before the Special Master in the Omnibus TS Decision and ultimately affirmed on appeal; namely, the ongoing relationship between TS and DPT vaccines and the merits of the position of experts who testified in that proceeding. (Pet.'s Mot. at 13-17). Such arguments are not properly before the Court and therefore will not be considered.

OFFICE OF SPECIAL MASTERS

No. 90-3409V

(Filed: May 30, 2000)

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ROBERT LEE TURNER and *
SANDRA KAY TURNER, as Legal *
Representatives on behalf of *
ROBERT CLEVELAND TURNER, *
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Petitioners, * TO BE PUBLISHED
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SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
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Respondent. *
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Scott R. Brann, Houston, TX, for petitioners.

Karen P. Hewitt, Washington, DC, for respondent.

DECISION

MILLMAN, Special Master.

On September 18, 1998, the undersigned issued an Order vacating its prior decision dated August 18, 1998, in order to suspend the case while other tuberous sclerosis (TS) cases went to the Federal Circuit (and ultimately the United States Supreme Court) on appeal. In the undersigned's initial opinion, the court had dismissed this case.

On May 30, 2000, the Supreme Court denied certiorari in Hanlon v. Secretary, HHS, No. 99-1223. Since the Federal Circuit has previously affirmed the undersigned's holdings in the TS cases, this case is dismissed. What follows is the material that the undersigned has previously described in the vacated decision of August 18, 1998.

History

On January 22, 1996, the undersigned issued a decision holding that Robert Cleveland Turner's seizures began in Table time of his DPT vaccination. (Robert Cleveland Turner is referred to as Bobby.) Since Bobby suffers from TS, this matter became part of the cases pending during the undersigned's Omnibus TS hearing dated October 8-11, 1996 and June 3-4, 1997. After the court's decision in the Omnibus case, dated September 15, 1997,(1) the undersigned determined what course to follow in this individual case. To determine liability in light of the findings after the Omnibus hearing, the court questioned the medical significance of Bobby's fever and crankiness in the context of his seizures.

To address the court's question, the parties submitted medical expert reports. Petitioners submitted a report from Dr. Marcel Kinsbourne, a pediatric neurologist. P. Ex. Q. Respondent submitted reports from Dr. Mary Anne Guggenheim (R. Exs. T, X), Dr. Steven H. Lamm (R. Ex. Y), and Dr. Martin H. Bellman (R. Ex. S). Petitioners' counsel requested that the court decide the matter on the record without a hearing.

EXPERT REPORTS

Respondent filed a report from Dr. Robert Zimmerman, a radiologist, as part of the Omnibus TS proceedings. R. Ex. Q. This report reflects that Bobby has a total of thirteen cortical tubers. Id. Dr. Zimmerman found four tubers in the right cerebral hemisphere of Bobby's brain, and nine tubers in the left cerebral hemisphere. Id.

On March 7, 1998, respondent filed the first of two reports from Dr. Guggenheim. R. Ex. T. In this report, Dr. Guggenheim opines that Bobby's infantile spasms were related to his underlying TS because he did not have an acute encephalopathy after his DPT vaccination. R. Ex. T, pp. 2-3. The fever that he had the evening of vaccination lasted for only a few hours and responded to symptomatic treatment. R. Ex. T, p. 2. Although Bobby cried and was fussy, irritable, and whiny, he fell asleep and was able to drink without difficulty. Id. The seizures were his only neurologic abnormality. Id.

Dr. Guggenheim further notes that infantile spasms, which usually begin between the ages of three and eight months, are the most common form of seizure in TS children.(2) Id. As they age, TS children who have infantile spasms develop a persistent seizure disorder of a different form as well as mental retardation. Id. Dr. Guggenheim traces Bobby's neurodevelopmental impairment solely to his TS. R. Ex. T, p. 3.

Based on both clinical experience and the medical literature, Dr. Guggenheim does not believe that fever causes infantile spasms. R. Ex. T, p. 2. In Dr. Guggenheim's opinion, infantile spasms do not occur as acute reactions to an acute injury. Id. Rather, these seizures present weeks after an injury occurs. Id. Dr. Guggenheim concludes that Bobby's tuber count places him at a high statistical risk for neurodevelopmental problems. R. Ex. T, p. 3.

Petitioners filed a report from Dr. Marcel Kinsbourne dated May 28, 1998. P. Ex. Q. Dr. Kinsbourne states that the majority of TS individuals do not develop seizures; however, those who do develop them generally have infantile spasms. P. Ex. Q, p. 1. Dr. Kinsbourne further notes that although TS individuals with high tuber counts are more likely to seize, a tuber count by itself cannot be considered a valid predictor of seizure onset because there is so much variability and exception in each case. Id. Citing the National Childhood Encephalopathy Study (hereinafter NCES), Dr. Kinsbourne states that DPT can precipitate infantile spasms in previously normal children.(3) P. Ex. Q.

Dr. Kinsbourne's report fails, however, to address whether Bobby's post-vaccination symptoms of fever, crankiness, and irritability had any neurological significance.

In reply to Dr. Kinsbourne's report, respondent filed a second report from Dr. Guggenheim dated July 27, 1998. R. Ex. X. In this report, Dr. Guggenheim notes that there are no specific references to support Dr. Kinsbourne's assertion that the majority of TS individuals do not develop seizures. R. Ex. X, p. 1. Rather, Dr. Guggenheim's experience reflects that most TS individuals do have seizures. Id. Citing a paper co-authored by Dr. John Osborne,(4) Dr. Guggenheim states that the majority of TS individuals will seize, with onset occurring in their first year of life. Id.

Dr. Guggenheim's report also addresses Dr. Kinsbourne's statement that a high tuber count is not associated with the occurrence of seizures. R. Ex. X, p. 1. Citing various studies, including a meta-analysis conducted for the Omnibus TS hearing, Dr. Guggenheim asserts that a high tuber count is associated with the severity of cerebral dysfunction in TS patients. Id.

Based on a 1983 paper co-authored by Dr. Bellman, Dr. Guggenheim further notes that DPT does not cause infantile spasms. R. Ex. X, p. 3. Dr. Guggenheim concludes her report by reiterating her prior opinion that TS caused Bobby's current neurological problems. Id.

Respondent submitted the expert report of Dr. Robert Lamm, an epidemiologist, in response to Dr. Kinsbourne's statistical arguments. R. Ex. Y. Citing two studies, Dr. Lamm concludes that a majority of TS patients do develop seizures.(5) R. Ex. Y, p. 1. Dr. Lamm further states that TS individuals with more than seven cortical tubers are sixteen times more likely to have seizures which are difficult to control. Id. A similar study found the risk of seizure to be nine times as likely. Id.

Disagreeing with Dr. Kinsbourne's statement that the age of seizure onset can predict the severity of one's condition, Dr. Lamm opines that it is the type of seizure, not the age, that is the significant predictable variable. Id.

Referring to the Bellman data, Dr. Lamm states that the NCES shows no association between DPT and onset of infantile spasms. R. Ex. Y, p. 2. There was no significant difference between onset of infantile spasms after either DT or DPT vaccine.(6) Id.

Dr. Lamm further notes that the failure of the NCES to detect all TS individuals occurred because the NCES was not searching for an underlying cause of neurological disorders. R. Ex. Y, pp. 2-3. Rather, the NCES sought a defined group of acute severe neurological disorders, including infantile spasms. Id. Dr. Lamm notes that various studies in the medical literature reflect that there is no association between DPT and TS or infantile spasms. R. Ex. Y, p. 3. He opines that this finding is strong evidence that TS is the cause of moderate to severe mental retardation and poorly controlled seizures in TS children. Id.

DISCUSSION

Significant Aggravation

The reports that respondent submitted address specifically the significance vel non of Bobby's symptomatology, i.e., whining, fever, and fussiness, during the onset of his infantile spasms. Dr. Guggenheim clearly interpreted these symptoms as non-neurologic when compared to the infantile spasms.

Based on this court's holding in the Omnibus TS Decision, the court finds that post-vaccinal symptoms, other than seizure, must exist and be neurologically significant for petitioners to impeach respondent's evidence that TS caused in fact the onset of Bobby's seizures. Bobby's symptoms did not have neurological significance. His fever was low, lasting for a brief period of time. His crying and irritability are of neither significant magnitude nor duration to be important neurologically.

The undersigned remains unconvinced by petitioners' evidence. Petitioners' medical expert, Dr. Kinsbourne, failed to interpret Bobby's symptoms. Rather, Dr. Kinsbourne attempted to impeach the evidence that TS children frequently seize, that a large cortical tuber count is a poor indicator of future normalcy, and that the NCES data and Bellman's interpretation thereof involving inter alia TS individuals and infantile spasms concluded that DPT had no relationship to the onset of infantile spasms. These issues were not what the court had asked the parties to address and were rearguments of the issues the undersigned had already decided in the TS Omnibus Decision. Drs. Guggenheim, Bellman, and Lamm, respondent's experts, not only clearly dealt with Bobby's symptomatology but also addressed Dr. Kinsbourne's undocumented assertions in their respective reports.

Petitioners have failed to impeach respondent's proof that TS, not DPT, was the cause of Bobby's seizures. The vaccination was purely coincidental. The court finds that DPT did not significantly aggravate Bobby's TS, and respondent has satisfied its burden of showing a known factor unrelated caused Bobby's onset of seizures and current condition.

CONCLUSION

This petition is dismissed with prejudice. In the absence of a motion for review filed pursuant to RCFC Appendix J, the

clerk of the court is directed to enter judgment in accordance herewith.

IT IS SO ORDERED.

_________________________ _________________________

DATE: Laura D. Millman

Special Master

1. Barnes et al. v. Secretary, HHS, 1997 WL 620115 (Fed. Cl. Spec. Mstr. Sept. 15, 1997).

2. Bobby was four and one-half months at the time of his second DPT.

3. Dr. Bellman, respondent's expert, co-authored the NCES. In a submission dated March 20, 1996, Dr. Bellman contradicts Dr. Kinsbourne's statement by explaining the classification method used in the NCES. R. Ex. S. He states that children with TS were classified in the previously abnormal category even if they were clinically normal prior to the onset of their seizures. Id. The previously abnormal category was used for children with neurological abnormality. Id.

4. Dr. Osborne was one of petitioners' expert witnesses at the Omnibus TS hearing.

5. In the first study, 78% of the TS individuals had seizures, while in the second study, 87% of the TS individuals developed seizures. R. Ex. Y, p. 1.

6. Dr. Lamm's report also corrects Dr. Kinsbourne's assumption about the categorization of TS individuals in the Bellman study. R. Ex. Y, p. 2.