VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_03-vv-00087
Package ID: USCOURTS-cofc-1_03-vv-00087
Petitioner: Mario Arturo Rodriguez
Filed: 2005-08-08
Decided: 2005-08-08
Vaccine: MMR
Vaccination date: 2000-01-25
Condition: transverse myelitis/quadriparesis
Outcome: unclear
Award amount USD: 

AI-assisted case summary:
Mario Arturo Rodriguez, an infant, received the measles-mumps-rubella (MMR) vaccination on January 25, 2000. Eleven days later, he manifested transverse myelitis (TM) with quadriparesis. Transverse myelitis is not an injury listed on the Vaccine Injury Table, so petitioner had to prove by a preponderance of the evidence that the MMR vaccination caused Mario's TM. The court reviewed the Chief Special Master's opinion, which denied relief, concluding that petitioner had failed to satisfy her burden of proof. The court, citing the Federal Circuit's ruling in Althen v. Secretary of Health and Human Services, reversed the denial and remanded the case for a compensation determination. The court found that petitioner satisfied her burden of proof under the Althen standard, which requires showing (1) a medical theory causally connecting the vaccination and the injury, (2) a logical sequence of cause and effect showing the vaccination was the reason for the injury, and (3) a proximate temporal relationship between vaccination and injury. The Chief Special Master found persuasive support from the Institute of Medicine, and prior special master decisions in Huston and Harris for the proposition that the MMR vaccine can cause TM, satisfying the first prong. For the second and third prongs, the Chief Special Master found that Mario's TM onset occurred eleven days after vaccination, within the medically acceptable one-to-four-week window, and that the TM was monophasic, a form associated with vaccine triggering. Respondent's expert offered no alternative explanation other than coincidence. The Chief Special Master also found that no better explanation for the TM existed in the record. Despite these findings, the Chief Special Master denied relief, requiring "direct evidence" linking the MMR to Mario's central nervous system, specifically the absence of an organism-specific antibody index (OSAI) test. The court held that this requirement for an OSAI test was an impermissible elevation of the burden of proof, preventing the use of circumstantial evidence and negating the system created by Congress. The court concluded that, without this erroneous OSAI requirement, the Chief Special Master's other findings were sufficient to establish entitlement. Petitioner's expert, Dr. Marcel Kinsbourne, testified to a reasonable medical certainty that the MMR caused Mario's TM. The court denied petitioner's motion for oral argument and respondent's motion to strike as moot.

Theory of causation field:
Petitioner alleged that the MMR vaccine administered on January 25, 2000, caused transverse myelitis (TM) with quadriparesis in her infant son, Mario Arturo Rodriguez, who manifested symptoms eleven days later. TM is not a Vaccine Injury Table injury, requiring proof of causation in fact under the Althen standard. Petitioner's expert, Dr. Marcel Kinsbourne, testified to a reasonable medical certainty that the MMR caused Mario's TM. Medical literature from the Institute of Medicine and prior special master decisions (Huston, Harris) supported the theory that MMR can cause TM. The Chief Special Master found this medical theory persuasive (Althen Prong 1). The eleven-day onset and monophasic nature of Mario's TM were found to satisfy the proximate temporal relationship and logical sequence of cause and effect prongs (Althen Prongs 2 & 3). Respondent's expert offered no alternative explanation. However, the Chief Special Master denied compensation, requiring "direct evidence" via an organism-specific antibody index (OSAI) test, which was not performed. The Court of Federal Claims reversed, holding that the OSAI requirement was an impermissible elevation of the burden of proof. Stripping out this erroneous requirement, the court found the Chief Special Master's other findings sufficient to establish entitlement. The case was remanded for a compensation determination. Petitioner was represented by counsel, and respondent was represented by counsel. The decision was issued by Senior Judge Merow on August 8, 2005.

Public staged source text:

================================================================================
DOCUMENT 1: USCOURTS-cofc-1_03-vv-00087-cl6654090
Date issued/filed: 2005-08-08
Pages: 1
Docket text: lead-opinion
--------------------------------------------------------------------------------
OPINION

MEROW, Senior Judge.
This National Childhood Vaccine Injury Act matter is before the court on Petitioner’s Motion for Review of the Opinion, filed May 13, 2005, in this case by the chief special master. The opinion in question denied relief concluding that petitioner had failed to satisfy her burden of proof that the measles-mumps-rubella (“MMR”) vaccination administered to her son, Mario Arturo Rodriguez (“Mario”) on January 25, 2000, caused the transverse myelitis/quadriparesis (“TM”) he manifested shortly thereafter.

Upon review of the record evidence together with the briefs of the parties and the recent ruling in Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274 (2005) it is concluded that petitioner satisfied her burden of proof and is entitled to relief.

TM is not an injury listed on the Vaccine Injury Table. 42 U.S.C. § 300aa-14(a). Therefore petitioner must prove by a preponderance of the evidence that the MMR vaccination caused Mario’s TM. 42 U.S.C. § 300aa-13(a)(1), — 11(c)(1)(C)(ii)(I). That is, as ruled in Althen at 1278, the petitioner’s

... burden is to show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. If Althen satisfies this burden, she is ‘entitled to recover unless the [government] shows, also by a preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine.’ *410Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 547 (Fed.Cir.1994) (alteration in original) (citation omitted).
With respect to the first “medical theory” element the expert testimony in this matter differed, but the chief special master determined (Chief Special Master Opinion “CSMO” p. 15) that,

Dr. Sladky’s [respondent’s expert] arguments aside, there is a wealth of persuasive support from IOM [Institute of Medicine of the National Academy of Sciences] Huston [Huston v. Secretary of HHS, 39 Fed.Cl. 632 (1997)] and Harris [Harris v. Secretary of HHS, No. 93-333 V, 2001 WL 530644] for the proposition that the MMR vaccine can cause TM. Accordingly, it is so found here.
The record evidence supports this finding.

As for the second “logical sequence” element and the third “proximate temporal relationship” element the record evidence together with findings by the chief special master demonstrate that the requisite burden of proof has been satisfied. The chief special master, in reliance on Harris, supra, determined that the petitioner was required to demonstrate that the onset of Mario’s TM occurred between one and four weeks after vaccination and that the TM was monophasic in course as contrasted with “bi” or “multiphasic” TM, where there is a relapse and remission of the illness. The onset of Mario’s TM occurred eleven days after vaccination, and the experts agreed that the TM was monophasic. CSMO, p. 16.

The chief special master also determined that the petitioner has the burden of demonstrating that no better explanation for the TM exists. Id. In Pafford v. Secy. of the Dep’t of Health and Human Servs., 64 Fed.Cl. 19, 35 (2005) it is concluded that this requirement does not mean “that the petitioner must discount every potential cause that exists within the entire realm of possibility, or ‘prove that an infinite number of potential causes were not at work causing the injuries suffered,’ Wagner v. Secretary of HHS, 37 Fed.Cl. 134, 139 (1997), but rather the petitioner must confront the range of potential causes that are evidenced in the record.” In the instant case respondent’s expert offered no alternative explanation for the cause of Mario’s TM other than coincidence. CSMO, p. 17. The chief special master found at p. 18 of his opinion, that, “A review of the record and the experts’ testimony shows that ‘no better explanation for the TM exists’ in the context of Pafford’s legal guidance.”1

Accordingly, with the findings discussed above, it is concluded that petitioner satisfied the required burden of proof as set forth in Althen. The record proof establishes a medical theory causally connecting the MMR vaccination with Mario’s TM. A logical sequence of cause and effect has been established showing, by a preponderance of the evidence, that the vaccination was the reason for Mario’s TM. Proximate temporal relationship between vaccination and injury is established. Respondent has not submitted any evidence that Mario’s TM was caused by factors unrelated to the vaccine. Petitioner is thus entitled to relief under the Vaccine Act.

Notwithstanding, the chief special master denied relief on the basis that “there is no direct evidence linking Mario’s TM to the MMR vaccination” CSMO, p. 19. The absence of an organism-specific antibody index (“OSAI”) test which, had one been timely conducted, could have provided direct evidence of vaccine linkage to the central nervous system and therefore verified the cause for Mario’s TM, is the basis for the determination that the burden of proof was not satisfied. Id.

*411However, similar to the special master’s added requirement for medical literature which was rejected in Althen at 1280, the added requirement for an OSAI test to provide “direct” evidence also “prevents the use of circumstantial evidence envisioned by the preponderance standard and negates the system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants.” Id. Deleting the erroneously added OSAI “direct evidence” requirement, the chief special master’s findings are otherwise sufficient to establish petitioner’s entitlement to recovery under the applicable burden of proof standard.

For the reasons discussed above, it is ORDERED:

(1) The determination of the chief special master that petitioner is not entitled to compensation under the Vaccine Act is REVERSED and the matter is REMANDED for a compensation determination;

(2) Petitioner’s Motion for Leave for Oral Argument, filed July 18, 2005, and Respondent’s Motion to Strike, filed July 22, 2005 are DENIED as moot.

. The chief special master, at pp. 16-17, 19ofhis opinion, does question the level of certainty expressed by petitioner's expert, Dr. Marcel Kinsbourne, with respect to MMR causation of Mario’s TM. However a review of the somewhat confusing transcript exchange (Kinsboume Tr. 51) shows his testimony was that he was reasonably certain to a level of medical certainty "... that the MMR did do it.” Dr. Kinsbourne’s testimony together with his expert report (Petitioner’s Exh. 18) fully satisfies the requirement for medical opinion supporting the MMR vaccination as the relevant cause for Mario's TM. 42 U.S.C. § 300aa-13(a)(1); Althen at 1280. As the chief special master found (slip op. pp. 17-18) with respect to MMR vaccination causation for Mario’s TM "no better explanation for the TM exists.” See Knudsen v. Sec’y of Health and Human Servs., supra at pp. 548-49.