Doe/17 v. Secretary of Health & Human Services

84 Fed. Cl. 691, 2008 U.S. Claims LEXIS 402
CourtUnited States Court of Federal Claims
DecidedDecember 16, 2008
StatusPublished
Cited by45 cases

This text of 84 Fed. Cl. 691 (Doe/17 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.

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Doe/17 v. Secretary of Health & Human Services, 84 Fed. Cl. 691, 2008 U.S. Claims LEXIS 402 (uscfc 2008).

Opinion

OPINION AND ORDER

BUSH, Judge.

Before the court is petitioner Jane Doe/ 17’s motion to review the Chief Special Master’s May 30, 2008 decision, 2008 WL 2541188 (Opin.) denying her request for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-l to -34 (2000) (the Act). In her Vaccine Act petition (Pet.) filed March 31, 2004, Jane Doe/17 alleged that a varicella vaccine administered to her at age forty-seven “significantly aggravated] a pre-existing condition.”2 Pet. at 1. [694]*694The Chief Special Master denied relief to Jane Doe/17, finding that she had not “established by a preponderance of the evidence that the varicella vaccinations petitioner received on March 7, 2001 and June 4, 2001, more likely than not significantly aggravated a pre-existing condition.” Opin. at 18, 2008 WL 2541188 at *13. For the reasons stated below, the court upholds the Chief Special Master’s decision.

BACKGROUND

I. Factual Disputes Summary

Jane Doe/17 participated in a clinical research trial (the study) as a healthy control when she was forty-seven years old. There are many disputes of fact as to petitioner’s health both before and after she received varicella vaccinations through the study in 2001. The court begins by addressing the most significant of these disputes, briefly presenting petitioner’s relevant allegations of fact and the Chief Special Master’s findings of fact.

The first dispute is whether Jane Doe/17 suffered from an immune deficiency before getting the varicella vaccinations. The particular immune deficiency alleged by petitioner is Common Variable Immunodeficiency (CVID). Pet’s 3d Sub. at 1.3 This disorder is “characterized by low levels of serum immunoglobulins (antibodies) and increased susceptibility to infections.” Pet.’s 4th Sub. at 12. CVID is the pre-existing condition alleged by petitioner to have been aggravated by her varicella vaccinations. The Chief Special Master found that petitioner had not shown by a preponderance of the evidence that she had CVID prior to receiving the vaccinations. Opin. at 13, 2008 WL 2541188 at *8.

Another factual dispute concerns Jane Doe/17’s history of irritable bowel syndrome (IBS).3 4 According to petitioner, she had one bout of severe IBS in 1978, which responded to treatment and was resolved no later than 1979. Pet. at 2. Jane Doe/17 alleges that diarrhea symptoms reappeared approximately two weeks after she received her second varicella vaccination on June 4, 2001, beginning with severe flu-like symptoms, evolving into chronic mild diarrhea, then worsening into severe diarrhea. Id. The Chief Special Master found, instead, that Jane Doe/17 suffered from chronic IBS prior to receiving the varicella vaccinations. Opin. at 15-16, 2008 WL 2541188 at *10.

There is also a dispute as to whether petitioner, or other members of her family, had severe immune responses to vaccinations in their medical histories. Jane Doe/17 alleges that two of her immediate family members experienced anaphylactic reactions to either smallpox or tetanus immunizations.5 Pet.’s 3d Sub. at 5. Petitioner also alleges that she fell ill with pneumonia each time she received oral polio vaccine, in 1960 and in 1962. Id. at 4-5. In addition, Jane Doe/17 claims to have had serum sickness after receiving a rabies antitoxin in 1967.6 Id. at 4. The Chief Special Master noted that these allegations were not supported by any direct, contemporaneous proof, such as medical records discussing severe reactions to vaccinations. Opin. at 14, 2008 WL 2541188 at *9. Therefore, the Chief Special Master, negatively assessing the credibility of petitioner, found no basis for concluding that Jane Doe/17’s family had a history of autoimmune problems.

[695]*695Finally, a dispute exists as to whether Jane Doe/17 reported adverse gastrointestinal reactions to the study staff within weeks after receiving the two varicella vaccinations, one on March 7, 2001 and the other on June 4, 2001. Petitioner alleges that she had “severe flu like symptoms 2 weeks post [second] injection, ... includ[ing] severe nausea, vomiting and diarrhea.” Pet. at 2. Petitioner also alleges that she “continued to experience worsening diarrhea, nausea, abdominal pain and retching through the summer and fall of 2001.” Id. Jane Doe/17 testified that she reported these symptoms to study staff. Hearing Transcript (Tr.) at 23, 66.

The most nearly contemporaneous documentation of petitioner’s post-vaccination gastrointestinal symptoms is not in records from the study, but in a treating gastroenter-ologist’s letter written March 11, 2002, noting that petitioner had reported on March 8, 2002 that her chronic IBS had been worsening for the “past eight months,” or from July 2001 to March 2002. Pet. Ex. at 94. The principal investigator conducting the study logged an adverse event report in 2003 which stated that Jane Doe/17 reported her chrome diarrhea symptoms to study staff in 2003. See Pet’s 2d Sub. at 4 (report of chronic diarrhea and collagenous colitis diagnosis recorded in June 2003); see also id. at 11 (report of collagenous bowel disorder and anti-diarrheal medications use recorded March 20, 2003).7 The contemporaneous records from 2001 maintained by the vaccine study are silent as to petitioner’s alleged gastrointestinal symptoms, although other complaints from Jane Doe/17 are documented. Id. at 5, 8. The Chief Special Master, again negatively assessing the credibility of petitioner and relying more on the study records, was not persuaded that Jane Doe/17 had reported diarrhea symptoms to the study staff in the weeks immediately following her second inoculation.

II. Overview of Procedural History and Certain Relevant Facts

Jane Doe/ 17 filed her petition for compensation under the Act on March 31, 2004, originally proceeding pro se. Accompanying her petition were one hundred pages of supporting medical records and other documents. One of these documents, the consent form for the study, describes the procedures for collecting health information from study participants after they received vaccinations:

Study personnel will talk to you by telephone from the clinic every week for three weeks after each dose of vaccine. You will be asked about any symptoms you may have experienced between visits to the clinic. In addition to these phone calls, for 42 days (6 weeks) after each injection you will record any symptoms you may have in a diary given to you at the clinic.
Six weeks after each dose of vaccine, you will come to the clinic. You will be expected to return your diary at these visits, answer questions about side effects to the vaccine, and have a physical exam performed.
You will go to the clinic for a total of 8 visits during the study. These visits will be scheduled weeks 0 (when you receive the initial dose of vaccine), 6,12,18, 24, 52 and months 24 and 36. At each visit you will have a physical exam, and blood tests____

Pet. Ex. at 5.

Petitioner also attached correspondence from various treating physicians to her petition. Three letters from Dr. Victor M.

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84 Fed. Cl. 691, 2008 U.S. Claims LEXIS 402, Counsel Stack Legal Research, https://law.counselstack.com/opinion/doe17-v-secretary-of-health-human-services-uscfc-2008.