Walther v. Secretary of Health & Human Services

69 Fed. Cl. 123, 2005 U.S. Claims LEXIS 387, 2005 WL 3597244
CourtUnited States Court of Federal Claims
DecidedDecember 8, 2005
DocketNo. 00-426V
StatusPublished
Cited by3 cases

This text of 69 Fed. Cl. 123 (Walther v. Secretary of Health & Human Services) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Walther v. Secretary of Health & Human Services, 69 Fed. Cl. 123, 2005 U.S. Claims LEXIS 387, 2005 WL 3597244 (uscfc 2005).

Opinion

OPINION

FIRESTONE, Judge.

This National Childhood Vaccine Injury .Act (‘'Vaccine Act” or “Act”), 42 U.S.C. §§ 300aa-10 to ~34 (2000), matter is before the court on the petitioner’s, Patricia Ann D. Walther (“petitioner”), Motion for Review of the July 29, 2005 decision by Special Master John F. Edwards. The special master denied relief on the grounds that the petitioner had failed to satisfy her burden of proof that a diphtheria-tetanus (“Td”) vaccination she received on July 31, 1997 caused her to develop a “post vaccinal encephalomyelitis,” in the form of acute disseminate encephalo-myelitis (“ADEM”). The petitioner argues that under the Federal Circuit’s recent ruling in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed.Cir.2005), the special master applied the wrong legal standard for causation. The petitioner asks the court to find that she satisfied her burden of proof and is entitled to relief.

ADEM is not an injury listed on the Vaccine Injury Table, 42 U.S.C. § 300aa-14(a), in connection with the Td vaccine. Thus, the petitioner was required to prove by a preponderance of the evidence that the Td vaccine, actually caused the petitioner’s alleged ADEM. 42 U.S.C. §§ 300aa-13(a)(l) and 300aa-ll(c)(l)(C)(ii)(I). Under the Federal Circuit’s recent ruling in Althen, 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 the vaccination and the injury.” 418 F.3d at 1278. Once the petitioner satisfies this burden, she is entitled to recover unless the government (“the respondent”) shows, also by a “preponderance of the evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Id. (quoting Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 547 (Fed.Cir.1994)) (alteration in the original). As discussed below, the court finds that Althen did not change the burden of proof for this petitioner and therefore it does not mandate reversal of the special master’s decision. The special master’s decision was not arbitrary or capricious and therefore it must be affirmed.

BACKGROUND

The undisputed facts show that the petitioner, a doctor of veterinary medicine, received several vaccinations while she was serving as a Captain in the United States Army during the summer of 1997. On July 31, 1997, the petitioner received a Td vaccination, as well as vaccinations for yellow fever, typhoid, and meningitis. A week later, she received a rabies vaccination. Of the five [125]*125vaccinations petitioner received in July and August 1997, only the Td vaccine is a “listed” vaccine under the Vaccine Injury Table, and thus it is the only vaccine subject to a claim under the Act.

At a hearing held by the special master, the petitioner and the respondent both presented opinion testimony as to (1) the causation of the petitioner’s ADEM by the Td vaccine, and (2) the diagnosis of ADEM.

In order to establish causation under the Act, the petitioner presented the opinion testimony of Vera Byers, M.D., Ph.D. Dr. Byers received her medical degree from the University of California at San Francisco. She is certified by the American Board of Internal Medicine. She completed a Fellowship in Clinical Immunology at the Department of Medicine, University of California at San Francisco. She is a Fellow of the American Academy of Allergy and a member of the American Association of Immunologists.

Dr. Byers testified that, accepting the diagnosis that the petitioner had ADEM, she believed to a medical certainty that the petitioner’s ADEM was caused by the Td vaccination that the petitioner received in July 1997. Tr. 57. She focused her opinion on the tetanus component of the vaccine, which Dr. Byers stated can cause destruction of nerve tissue, which could lead to ADEM. Tr. 57-59. Dr. Byers explained that the petitioner’s symptoms began seven days after the Td vaccination, which is within the four to seven day window expected for secondary responses to Td vaccinations. Tr. 63-64. Dr. Byers stated that the petitioner suffered from a secondary response because she had previously received a Td vaccination. Tr. 64. Dr. Byers testified that she did not believe that the rabies vaccine could have caused the ADEM because the rabies vaccine was administered only one day before the petitioner started to show symptoms. Tr. 65. Dr. Byers also testified that she did not believe that the yellow fever vaccine was the cause because the petitioner did not show any other signs of an adverse response to the yellow fever vaccine, which she said would have been expected. Tr. 68-69.

On cross-examination, the respondent focused on Dr. Byers’ report and in particular on the conclusions she had drawn from the various studies and case reports she had identified therein. On cross-examination, Dr. Byers could not recall whether a study she relied upon involved the Td vaccine or the DPT vaccine, which includes a vaccine for pertussis. Tr. 89. She was also unable to recall the specifics of other studies she relied upon. Tr. 88, 90, 100. In addition, Dr. Byers could not explain her reliance on the British National Childhood Encephalopathy Study (“NCES”), which she stated contained “a concise description of the lines of evidence indicating that [the] tetanus [vaccine has a] causal role in acute encephalitis.” Tr. 114. In response to questioning by the special master, Dr. Byers failed to explain how the study supported her opinion. She could not explain how the study’s focus on the DPT vaccine, which includes a vaccine for pertussis, supported her opinion. She also failed to explain how the study’s conclusion that most neurological injury occurred within 72 hours — and not within seven days as Dr. Byers’ testified — supported her opinion. Finally, she could not explain the study’s conclusion that the Td vaccine, as opposed to the DPT vaccine, did not show any statistically significant increase in acute neurological injury. Tr. 108-115. Decision at 5.

In response to other questions from the special master, Dr. Byers conceded that any vaccine “is capable of producing a demyeli-nating condition.” Tr. 116. She further conceded that the other vaccines the petitioner received concurrently with the Td vaccination “were candidates for the cause of’ the petitioner’s condition. Tr. 117, 122. Dr. Byers stated that she focused on the Td vaccine as the cause because of the greater number of case reports associating the tetanus vaccine with demyelinating disorders. Tr. 122.

In addition to providing testimony on causation, the petitioner presented testimony on the nature of her condition. The petitioner presented testimony from Marcel Kinsb-ourne, M.D., and Margaret Montana, M.D. Dr. Kinsbourne is certified by the American Board of Pediatrics.

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Related

Walther v. Secretary of Health and Human Services
485 F.3d 1146 (Federal Circuit, 2007)
Campbell v. Secretary of Health & Human Services
69 Fed. Cl. 775 (Federal Claims, 2006)

Cite This Page — Counsel Stack

Bluebook (online)
69 Fed. Cl. 123, 2005 U.S. Claims LEXIS 387, 2005 WL 3597244, Counsel Stack Legal Research, https://law.counselstack.com/opinion/walther-v-secretary-of-health-human-services-uscfc-2005.