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Andreu v. Secretary of Health and Human Services

June 18, 2009


Appeal from the United States Court of Federal Claims in case 98-VV-817, Senior Judge James F. Merow.

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

Before NEWMAN, MAYER, and GAJARSA, Circuit Judges.

Enrique C. Andreu and Sonia C. Andreu ("the Andreus"), on behalf of their son, Enrique M. Andreu ("Enrique"), appeal the judgment of the United States Court of Federal Claims affirming a special master's decision denying their petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 ("Vaccine Act"). See Andreu v. Sec'y of Health & Human Servs., No. 98-817V (Fed. Cl. July 23, 2008) ("Court of Federal Claims Decision II"). Because we conclude that the special master's decision is inconsistent with Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005), and Capizzano v. Secretary of Health & Human Services, 440 F.3d 1317 (Fed. Cir. 2006), we reverse and remand.


Enrique was born on September 5, 1995; he was a full-term baby, born after an uneventful pregnancy. On October 31, 1995, when he was eight weeks old, Enrique was inoculated with the diphtheria, whole-cell pertussis and tetanus ("DPT") vaccine. Prior to this vaccination, Enrique was developing normally, although he had an ear infection and cold just prior to the time he was vaccinated.

Enrique cried a great deal throughout the evening of October 31, 1995. Jesus Gutierrez, Enrique's great-grandfather, testified that on the next day, November 1, 1995, Enrique's "left hand jumped for approximately one minute." Enrique's half-brother, Eric Andreu, also testified that he noticed Enrique's arm making shaking movements on November 2, and November 6, 1995. On the evening of November 10, 1995, Enrique's father observed Enrique's unusual arm movements. The next day, the Andreus took Enrique to his pediatrician, who also observed Enrique's arm movements. The pediatrician informed the Andreus that these movements were seizures, and arranged for Enrique to be taken to Miami Children's Hospital ("MCH"). At the hospital, Enrique's temperature was recorded at 99.4 degrees, and he was admitted for evaluation. See Andreu v. Sec'y of Health & Human Servs., No. 98-817V, 2007 U.S. Claims LEXIS 292, at *22 (Fed. Cl. Spec. Mstr. Aug. 29, 2007) ("Vaccine Court Decision I"). While at MCH, Enrique underwent a single-photon emission computed tomography ("SPECT") scan of his brain, which was "markedly abnormal," showing hyperfusion, or increased blood flow, in the right precentral gyrus area. Id. at *26. When a brain magnetic resonance imaging ("MRI") was performed two hours later, the results were normal. Id. Enrique was started on anti-seizure medication and released from the hospital on November 15, 1995.

On December 27, 1995, following his discharge from the hospital, Enrique was evaluated by Trevor Resnick, M.D., a pediatric neurologist. Resnick noted that Enrique continued to exhibit normal neurological development, but advised the Andreus that he should not receive further pertussis vaccinations. Id. at *27-28.

Enrique experienced another seizure in February 1996. He remained seizure-free until October 1996, when he was hospitalized with febrile seizures. Id. at *29. Over the next month, Enrique continued to have seizures, which began with jerking arm movements and then became generalized. Id. at *30.

By January 1998, Enrique's seizures had become "intractable and uncontrolled by medication." Court of Federal Claims Decision II, slip op. at 5. In July 1998, an interdisciplinary team determined that Enrique had an IQ of 63 and exhibited significant language and developmental delays. See Vaccine Court Decision I, 2007 U.S. Claims LEXIS 292, at *31.

The Andreus initiated their Vaccine Act claim on October 26, 1998, alleging that the DPT vaccine Enrique received on October 31, 1995, caused his seizure disorder. On December 4, 2001, the Andreus submitted a letter from Marcel Deray, M.D., Enrique's treating physician, who stated:

Enrique is a patient I have followed since 11/22/96. He has an encephalopathy and seizures. There has been no neurological cause found for his encephalopathy and no other explanation other than the DPT immunization given to him when he was an infant.

Enrique's case was assigned to Special Master Richard Abell, who held an onset hearing to determine the date of Enrique's first seizure. The special master found Gutierrez, Enrique's great-grandfather, to be "a man of great personal dignity and honor," and based upon his testimony, determined that Enrique's first seizure occurred on November 1, 1995, the day after he received the DPT vaccination. The case was subsequently transferred to Special Master Denise K. Vowell.

On November 28, 2005, the Andreus filed an expert report from Carlo Tornatore, M.D., a neurologist. Tornatore opined that the DPT vaccination that Enrique received on October 31, 1995, "resulted in an acute encephalopathy and seizures secondary to the direct toxicity of the components in the whole-cell pertussis vaccine." According to Tornatore, the DPT vaccine contains pertussis toxins and endotoxins, which can cross the brain-blood barrier, causing overstimulation of the nerves and supporting cells of the brain and provoking seizures. In support of his theory, Tornatore cited six articles showing that the pertussis toxin can be used to induce "excitotoxicity" in the brains of animals. In addition, Tornatore noted that persons infected with the pertussis virus can experience encephalopathy and seizures and that this "wild-type infection is actually in some ways reproduced by the vaccination."

In contrast, the government's expert, Joel Herskowitz, M.D., asserted that Enrique's seizure disorder was not caused by the DPT vaccine he received. Herskowitz emphasized that the medical "literature does not support the occurrence of afebrile focal seizures as a consequence of a DPT whole-cell immunization." In addition, although he acknowledged that Tornatore's theory of causation was biologically plausible, Vaccine Court Decision I, 2007 U.S. Claims LEXIS 292, at *69, he asserted that if there had been an assault to the brain from the pertussis toxin, he would "expect to see" neurological symptoms other than those Enrique experienced. For example, Herskowitz would expect that Enrique would have experienced generalized, as opposed to focal, seizures, and that he would have had a bulging fontanel and a change in personality and behavior in the period immediately following the vaccination. Upon questioning from Enrique's counsel, however, Herskowitz acknowledged that it was "reasonable" to assume that anything that can cause a "devastating" injury to the brain "can also cause a smaller amount of brain injury in a smaller area of the brain."

On August 29, 2007, the special master issued a decision denying Enrique compensation. On March 3, 2008, however, the Court of Federal Claims reversed. The court held that "Dr. Tornatore's expert report and testimony, standing alone, would meet the Capizzano requirements for recovery of compensation." Andreu v. Sec'y of Health & Human Servs., No. 98-817V, slip op. at 7 (Fed. Cl. Mar. 3, 2008) ("Court of Federal Claims Decision I"). The court also noted, however, that "[t]he question of a logical sequence of cause and effect showing that [Enrique's] vaccination was the reason for the injury is a matter of dispute between the expert opinion expressed by Dr. Tornatore and Dr. Herskowitz's testimony that Enrique's clinical picture does not match that to be expected from Dr. Tornatore's postulated series of events following administration of the whole-cell pertussis [vaccine] on October 31, 1995." Id. at 10. Accordingly, the court ordered the special master to reevaluate the evidence and, "to the extent possible," obtain the testimony of Enrique's treating physicians. Id. at 11. In the court's view, testimony from Enrique's treating physicians would be "most helpful" in establishing whether or not Enrique's seizure disorder was the result of the DPT vaccine he received. Id. at 12.

On remand, the special master issued a subpoena compelling Enrique's treating physicians, Deray and Resnick, to testify. Both doctors testified at a hearing held on April 28, 2008, in Miami, Florida. Resnick was asked by counsel for the government why he recommended that Enrique receive no further pertussis vaccinations. He responded that although he was "surmising," he thought he had made this recommendation because "there was a concern over the relationship with the immunization, and I felt it would be safer for him not to have the pertussis, because there was a concern about a reaction."

Resnick also testified that "[y]ou can see seizures within 24 hours of a vaccination, often in association with a fever, and that has been quite frequently reported epidemiologically." He asserted, however, that the pertussis vaccine could "provoke" a seizure in a child who was "[n]ot behaving normally" or "really irritable" even in the absence of a fever. He further noted that in some instances "temperature isn't measured," so that to conclude that a seizure provoked by the DPT vaccine must be related to a fever is "somewhat unfair."In addition, Resnick agreed that in Enrique's case no one knows whether the first seizure was febrile or afebrile.

Deray testified that it was "still [his] opinion . . . that there is no other explanation for Enrique's seizure disorder and encephalopathy other than the DPT vaccination."Deray explained that there were two reasons that he had concluded that there was a causal connection between the vaccination and Enrique's malady. First, although Deray could identify a cause for seizures in 70 to 75 percent of his patients, doctors, despite extensive testing, had "never found anything else" to explain Enrique's seizures. Second, since the seizures occurred soon after the vaccination, Enrique's "history would be consistent with [the] DPT immunization causing seizures."

In addition, Deray asserted that whether Enrique's initial seizures were febrile as opposed to afebrile would not influence his opinion that the DPT vaccine caused Enrique's seizure disorder. In response to a question from the special master asking whether there was anything in either the SPECT scan or the MRI suggesting that the DPT vaccine caused Enrique's seizures, Deray replied that whether or not the scans were normal "doesn't help us either way. . . . You can have a normal MRI for the rest of your life and have brain damage." On May 29, 2008, the special master issued a decision, again rejecting the Andreus' claim for compensation under the Vaccine Act. See Andreu v. Sec'y of Health & Human Servs., No. 98-817V (Fed. Cl. Spec. Mstr. May 29, 2008) ("Vaccine Court Decision II"). She concluded that the Andreus "failed to meet their burden to show a logical sequence of cause and effect" between Enrique's October 31, 1995, DPT vaccination and his seizure disorder, noting that "[w]hatever theoretical allure the [Andreus'] excitotoxin theory regarding the cause of seizures may have, the weight of the scientific and clinical evidence adduced here does not support pertussis toxin as the cause of Enrique's afebrile seizures." Id. at 7, 14.

On appeal, the Court of Federal Claims affirmed, concluding that the special master's decision to deny compensation was not arbitrary or capricious. Although the court noted that even the government's expert did not dispute the "biologic plausibility" of Tornatore's theory of causation, the court stated that "the clinical evidence of record concerning Enrique's seizures does not show the extent of initial injury sufficient to ...

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