Doe/11 ex rel. Estate of Child/Doe/11 v. Secretary of the Dept. of Health & Human Services

87 Fed. Cl. 1, 2009 WL 1315449
CourtUnited States Court of Federal Claims
DecidedMay 7, 2009
DocketNo. 99-212V
StatusPublished
Cited by11 cases

This text of 87 Fed. Cl. 1 (Doe/11 ex rel. Estate of Child/Doe/11 v. Secretary of the Dept. 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
Doe/11 ex rel. Estate of Child/Doe/11 v. Secretary of the Dept. of Health & Human Services, 87 Fed. Cl. 1, 2009 WL 1315449 (uscfc 2009).

Opinion

OPINION AND ORDER

WILLIAMS, Judge.

This matter comes before the Court on Petitioners’ Motion for Review of the Special Master’s Decision on Remand, which denied Petitioners’ claim that the Hepatitis B vaccine caused the death of their daughter, Monica.

In the original Decision on Entitlement, the Special Master ruled that Petitioners did not establish that the vaccine caused Monica’s death, and instead found that a “factor unrelated” to the Hepatitis B vaccination, Sudden Infant Death Syndrome (SIDS), which the Special Master characterized as asphyxiation, overlaying or wedging, caused her death. This Court vacated the original decision and remanded the petition, finding inter alia that the Special Master had improperly allocated and applied the burden of proof.

On remand, the Special Master found that Petitionei’s failed to establish a prima facie ease that the Hepatitis B vaccination caused Monica’s death and did not reach the issue of whether Defendant established that an unrelated factor caused her death. In the instant Motion for Review, Petitioners argue that the Special Master failed to follow this Court’s instructions on remand, issued arbitrary and capricious findings of fact on Monica’s brain weight, and erroneously considered evidence of SIDS as a factor unrelated in analyzing Petitioners’ prima facie case. Because Petitioners have not demonstrated that their asserted legal or factual errors warrant reversal or remand, this Court upholds the Special Master’s Decision on Remand.

Background 2

On December 21, 1994, Monica, a healthy infant of seven and one-half weeks of age, received her second Hepatitis B vaccination at approximately 2:00 p.m.3 The vaccination was administered in Monica’s thigh. After Monica’s appointment, the family went holiday shopping at a mall for several hours. Monica’s father carried her in a transportable car seat, and she slept during the entire shopping trip and did not cry or interact with [4]*4her parents. Monica’s mother tried to feed Monica a bottle on several occasions towards the end of the shopping trip, but Monica did not drink from the bottle. Monica’s parents did not take her temperature. The family returned home between approximately 5:00 and 5:30 p.m. that evening and took a nap. Monica’s father laid Monica on a futon next to him, face up and propped up on a pillow. He slept from approximately 5:30 until 6:00 p.m. beside Monica, and upon awakening, discovered that Monica, who was still propped up on a pillow face up, was “blue in the face” and not breathing.

Monica’s mother called paramedics at 6:49 p.m., and her father performed CPR until the paramedics arrived via ambulance at 6:54 p.m. The paramedics “found [Monica] supine on couch.” Pet’rs’ Ex. 4 at 2. The paramedics determined that Monica had no heartbeat, pulse, or respiration, and she did not respond to CPR. Id. The emergency room records listed Monica’s diagnosis as “cardiopulmonary arrest, unknown participant.” Pet’rs’ Ex. 5 at 6. The paramedics also noted that Monica’s “skin was warm, dry and extrem-itLies] were mottled and chest and abdfomen] was white ... and Lpatient’s] abdLomen] was distend[ed].” Pet’rs’ Ex. 4 at 1. Shortly after her arrival at the emergency room, Monica was diagnosed as having suffered cardiopulmonary arrest of an unknown cause, and she was pronounced dead at 8:00 p.m.

Forensic pathologist Robert M. Anthony M.D./Ph.D. performed an autopsy on Monica on December 22, 1994, the day after her death.4 Dr. Anthony recorded Monica’s weight as 12 pounds 12 ounces and her length as 25 inches. Dr. Anthony noted that Monica’s bladder and stomach were both empty and that her lungs revealed “moderate pulmonary congestion and edema.” Pet’rs’ Ex. 6 at 4-5.5 Dr. Anthony determined the condition of Monica’s brain to be “grossly unremarkable” with “no evidence of edema or herniation.” Id. at 5. The autopsy report did not indicate that any of Monica’s visceral organs, other than her lungs, showed the presence of edema. Id. at 3-5. Dr. Anthony recorded the cause of Monica’s death as SIDS.6

The Althen Factors

In Althen v. Secretary of Health & Human Services, 418 F.3d 1274, 1278 (Fed.Cir.2005), the Federal Circuit set forth a three-pronged test a petitioner must meet in order to establish causation under the Vaccine Act. Under Althen, a petitioner must prove by a preponderance of the evidence:

(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.

Althen, 418 F.3d at 1278.

The Special Master’s First Decision, Vaca-tur and Remand

In the original Decision on Entitlement, the Special Master ruled that Petitioners did [5]*5not establish that the vaccine caused Monica’s death, and instead found that a “factor unrelated” to the Hepatitis B vaccination, Sudden Infant Death Syndrome (SIDS)— which the Special Master characterized as asphyxiation, overlaying or wedging — caused her death.

The Court vacated the Special Master’s decision and remanded the matter, finding that the Special Master had misallocated the burden of proof and effectively required Petitioners to disprove that SIDS was the cause of death as part of their prima facie case. The Court further ruled that, to the extent the Special Master had concluded that an idiopathic condition either defeated Petitioners’ prima facie case of causation or constituted an unrelated factor that caused Monica’s death, the decision was contrary to the Vaccine Act’s definition of a “factor unrelated” as a cause that “does not include any idiopathic, unexplained, unknown, hypothetical or undocumentable cause, factor, injury, illness or condition_” 42 U.S.C. § 300aa-13(a)(2) (emphasis added). The Court instructed the Special Master to clarify what unrelated factor caused Monica’s death and to assess whether such factor was idiopathic.

The Court also held that the Special Master placed an overly onerous burden of proof on Petitioners under Althen’s prong one by requiring them to prove that the medical theory linking the Hepatitis B vaccine with edema and an adverse reaction known as “cytokine storm” was “more likely than not,” instead of establishing that the theory was medically plausible. Finally, the Court found that the Special Master had not considered the totality of the evidence in finding that Monica’s brain weight of 570 grams was within the normal range. The Court found that the Special Master did not address Petitioners’ evidence of normal brain weight and appeared to rely on a study whose subjects suffered moderate to severe edema as a marker of normal brain weight. The Court instructed the Special Master to reevaluate the totality of evidence on brain weight and reconsider her conclusion that Monica’s brain weight was within the normal range.

The Special Master’s Decision On Remand

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Bluebook (online)
87 Fed. Cl. 1, 2009 WL 1315449, Counsel Stack Legal Research, https://law.counselstack.com/opinion/doe11-ex-rel-estate-of-childdoe11-v-secretary-of-the-dept-of-health-uscfc-2009.