Andreu Ex Rel. Andreu v. Secretary of Health and Human Services

569 F.3d 1367, 2009 U.S. App. LEXIS 13048, 2009 WL 1688231
CourtCourt of Appeals for the Federal Circuit
DecidedJune 18, 2009
Docket2008-5184
StatusPublished
Cited by1,162 cases

This text of 569 F.3d 1367 (Andreu Ex Rel. Andreu v. Secretary of Health and Human Services) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Andreu Ex Rel. Andreu v. Secretary of Health and Human Services, 569 F.3d 1367, 2009 U.S. App. LEXIS 13048, 2009 WL 1688231 (Fed. Cir. 2009).

Opinion

MAYER, Circuit Judge.

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-l to -34 (“Vaccine Act”). See Andreu v. Sec’y of Health & Human Servs., No. 98-817V, 2008 WL 4725455 (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.

BACKGROUND

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 *1371 was “markedly abnormal,” showing hyper-fusion, 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 An-dreus 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, 2008 WL 4725455, 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, 2007 WL 2706157.

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 Torna-tore, 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 expei'ience 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 *1372 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, 2007 WL 2706157, 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, Her-skowitz 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.

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569 F.3d 1367, 2009 U.S. App. LEXIS 13048, 2009 WL 1688231, Counsel Stack Legal Research, https://law.counselstack.com/opinion/andreu-ex-rel-andreu-v-secretary-of-health-and-human-services-cafc-2009.