Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Doe v. Secretary of Health and Human Services

April 13, 2010


Petition for review of the United States Court of Federal Claims in 99-VV-212, Judge Mary Ellen Coster Williams.

The opinion of the court was delivered by: Prost, Circuit Judge.

Published opinion

Before BRYSON, GAJARSA, and PROST, Circuit Judges.

This is a Vaccine Act*fn1 case. We must decide whether the claimants, John and Jane Doe (collectively "Doe"), met their burden of proving that their daughter Monica's death was caused by a hepatitis B vaccination. See 42 U.S.C. § 300aa-11. It is an off-Table case because Monica's injury is not listed in the Vaccine Act Injury Table. See 42 U.S.C. § 300aa-14; 42 C.F.R. § 100.3(a). Accordingly, the burden was on Doe to prove that Monica's death was actually caused by the vaccine. 42 U.S.C. § 300aa-11(c); see Walther v. Sec'y of Health & Human Servs., 485 F.3d 1146, 1149 (Fed. Cir. 2007).

Under the test for causation set out in Althen v. Secretary of Health and Human Services, 418 F.3d 1274 (Fed. Cir. 2005), a claimant must prove three things: (1) a medical theory causally connecting the vaccination to 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 the vaccination and the injury. Id. at 1278. In this case, the special master denied compensation, concluding that Doe failed to prove prongs two and three of the Althen test by a preponderance of evidence. In a careful, well-reasoned opinion, the U.S. Court of Federal Claims upheld the special master's decision. Doe ex. rel Estate of Child Doe v. Sec'y of Health & Human Servs., 87 Fed. Cl. 1 (2009) ("Doe IV"). We now affirm.

Our review primarily focuses on the special master's factual findings, which were subsequently adopted by the Court of Federal Claims. Under the Vaccine Act, the question is whether these findings were arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. 42 U.S.C. § 300aa-12(e)(2)(B). In addition, we must decide whether the special master committed legal error by considering evidence of a possible alternative cause, Sudden Infant Death Syndrome ("SIDS"), in deciding whether Doe established a prima facie case.

We reach the same conclusion as the Court of Federal Claims. The special master's factual findings regarding the significance of the decedent's length, weight of her brain and other organs, and pre-death behavior were not arbitrary or capricious, particularly in light of the credibility findings made as to the parties' respective experts.

Further, under this court's decisions in de Bazan v. Secretary of Health and Human Services, 539 F.3d 1347 (Fed. Cir. 2008), and Pafford v. Secretary of Health and Human Services, 451 F.3d 1352, 1359 (Fed. Cir. 2006), the special master did not commit legal error in considering evidence of SIDS, an allegedly alternative cause. Nothing in the Vaccine Act prohibits the government from presenting evidence that the petitioner's injury was due to "factors unrelated" to the vaccine (here, SIDS). Under 42 U.S.C. § 300aa-13(a) and de Bazan, the special master could consider such evidence in deciding whether Doe established a prima facie case; the Vaccine Act only prohibits the government from rebutting an established prima facie case with an idiopathic condition like SIDS. 42 U.S.C. § 300aa-13(a)(2)(A).


Monica Doe was born in October 1994. On the day she was born, she received her first hepatitis B vaccination. Monica was discharged from the hospital the next day.

At approximately 2 p.m. on December 21, 1994, Monica received her second vaccination for hepatitis B. At the time, Monica was seven and a half weeks old and weighed eleven pounds. The vaccine was administered to Monica's thigh. After the doctor's appointment, the family went shopping. During the shopping trip, Monica was carried in an infant car seat by her father. Her father testified that Monica slept the entire time, without evidencing a fever, abnormal jerking, or crying. Her mother testified that Monica was awake during the shopping trip and unusually quiet, since Monica "usually" cried. To the extent their accounts conflicted, the special master credited the father's testimony that Monica was asleep, because the father was the one carrying Monica.

Around 5 p.m., the family returned home. Monica's mother and two brothers lay down for a nap in the bedroom, while Monica and her father remained in the living room. Monica's father lay down on the couch to watch the news, positioning Monica next to him, propped face up on a pillow. Monica's father testified that he fell asleep on the couch between 5:30 and 6 p.m. When he awoke approximately thirty minutes later, Monica was "blue in the face." Awakened by calls from her husband, Monica's mother observed Monica lying face up on the pillow, with a "bluish" complexion. Monica was not breathing when her parents called 911 at 6:49 p.m. The ambulance arrived about five minutes later, by which time Monica's father had begun CPR.

The emergency medical technician ("EMT") who responded to the 911 call observed Monica face up on the couch, receiving CPR from a fire department emergency responder. The EMT found Monica had no heartbeat and was not breathing, though her skin was warm and dry. He observed that Monica's extremities were "mottled and chest and abdomen were white," while her abdomen was "distended." At the emergency room, a physician diagnosed Monica as having suffered cardiopulmonary arrest, cause unknown. Monica was pronounced dead at 8 p.m., approximately six hours after she received her hepatitis B vaccination.

A forensic pathologist named Dr. Robert Anthony performed an autopsy the following day. His report notes a "moderate amount of fixed purple livor mortis over the posterior aspects of the body surfaces." Monica's stomach and bladder were empty. Her lungs, however, exhibited "moderate pulmonary congestion and edema," and her heart had "rare epicardial petechiae." Significantly, Dr. Anthony opined that Monica's brain was "grossly unremarkable," with "no evidence of edema or herniation" and "clear, glistening and intact" meninges. The report lists a brain weight of 570 grams and SIDS as the cause of death. At the time he performed the autopsy, Dr. Anthony did not know the circumstances surrounding Monica's death.

Monica's parents (collectively, "Doe") subsequently filed a claim under the Vaccine Act on behalf of Monica's estate. The claim alleges that Monica died as a result of receiving a hepatitis B vaccination on December 21, 1994. The special master assigned to the case held an evidentiary hearing. Among the evidence presented at the hearing was expert testimony by Dr. John Shane and Dr. Alan Levin for Doe, and expert testimony by Dr. Enid Gilbert-Barness and Dr. Christine McCusker for the government.

Dr. Shane, accepted as an expert in pathology generally, though not pediatric pathology, opined that Monica died from acute encephalopathy caused by the hepatitis B vaccine. In support of this theory, Dr. Shane cited Monica's brain weight, which he testified was "abnormally" high for a child of that age and thus evidence of cerebral edema. Doe's other expert, Dr. Levin, similarly opined that Monica's death was caused by the hepatitis B vaccine. Accepted as an expert in immunology, Dr. Levin testified that the vaccine led to ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.