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Deribeaux v. Secretary of Health and Human Services

United States Court of Appeals, Federal Circuit

June 7, 2013

MADISON DERIBEAUX, a minor, by her parents and natural guardians, GUS DERIBEAUX, AND KIMBERLY BURSHIEM, Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.

Appeal from the United States Court of Federal Claims in No. 05-VV-306, Judge George W. Miller.

Clifford J. Shoemaker, Shoemaker, Gentry & Knickelbein, of Vienna, Virginia, argued for petitioners-appellants.

Glenn A. MacLeod, Senior Trial Counsel, Torts Branch, Civil Division, United States Department of Justice, of Washington, DC, argued for respondent-appellee. With him on the brief were Stuart F. Delery, Principal Deputy Assistant Attorney General, Rupa Bhattacharyya, Director, Vincent J. Matanoski, Deputy Director, and Gabrielle M. Fielding, Assistant Director.

Before Lourie, Clevenger, and Reyna, Circuit Judges.

Lourie, Circuit Judge.

Petitioners Gus Deribeaux and Kimberly Burshiem, on behalf of their daughter, Madison Deribeaux ("Deribeaux"), appeal from the judgment of the United States Court of Federal Claims affirming a special master's decision denying their claim for compensation under the National Vaccine Injury Compensation Program for injuries allegedly caused by the Diphtheria-Tetanus-acellular Pertussis ("DTaP") vaccine. Deribeaux ex rel. Deribeaux v. Sec'y of Health & Human Servs., 105 Fed.Cl. 583 (2012). Because the special master did not apply an incorrect legal standard and because her evaluation of the case was not arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law, we affirm.

Background

Deribeaux was born on August 19, 2001, and received the DTaP vaccination on March 28, 2002. The next day, she was taken to the emergency room having suffered from a prolonged seizure. She continued to seize, and her temperature was later recorded as 103.6 degrees Fahrenheit; but all other tests were reported normal and she did not suffer any additional seizures during several subsequent days that she remained at the hospital. Deribeaux, 105 Fed.Cl. at 585. Deribeaux continued to experience seizures throughout the following year, however, and she was again admitted to the hospital in April 2003 with recurrent convulsive episodes. Her discharge note from that instance stated that she had a seizure disorder that began two days after the DTaP vaccination, with subse- quent admission and treatment for atypical Kawasaki disease (a rare, immune-mediated vasculitis); Deribeaux continued to experience seizures through 2005. Id. at 585–86.

In December 2005, genetic testing revealed that Deribeaux had a DNA sequence variation in her SCN1A gene, which was reportedly not inherited and arose spontaneously. Id. at 586. SCN1A mutations have been associated with several epilepsy syndromes, including Severe Myoclonic Epilepsy of Infancy ("SMEI"), also known as Dravet's Syndrome. Following genetic testing, Deribeaux's treating physicians consistently noted the diagnosis of SMEI and SCN1A mutation in association with her chronic seizures and developmental delays. Id.

This case was brought under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 ("Vaccine Act"), as amended, which created the National Vaccine Injury Compensation Program through which claimants can petition the Court of Federal Claims to receive compensation for vaccine-related injuries or death. On March 11, 2005, before Deribeaux's genetic mutation was discovered, a petition was filed alleging that the administration of the DTaP vaccine was a substantial cause of her seizure disorder and developmental delay. Pursuant to 42 U.S.C. § 300aa-12(d), a hearing was held before a special master on September 20, 2007.

At that hearing, Deribeaux presented expert testimony that she had a reaction to the vaccine as a result of her poor immune system, which triggered her initial seizure and subsequent condition. Deribeaux, 105 Fed.Cl. at 587. In contrast, the Secretary presented expert testimony that Deribeaux's condition could be explained completely by Kawasaki disease or by enterovirus, that there was no evidence that her initial seizure resulted in brain damage, and that DTaP vaccination can cause febrile seizures but not chronic seizure disorders in children. Id. None of the medical records of treating physicians who diagnosed Deribeaux with SMEI were filed into the record prior to the initial entitlement hearing and no evidence concerning Deribeaux's genetic mutation or her diagnosis of SMEI was presented. The special master concluded that Deribeaux had established causation and was entitled to compensation, and therefore directed the parties to begin the damages phase of the proceeding. Id.

During the damages phase, Deribeaux produced new medical records, including documentation of her genetic mutation and diagnosis of SMEI, which her treating physicians had noted was the cause of her neurological disorder. Id. In light of that new evidence, the Secretary moved to set aside the special master's decision and to reopen the issue of entitlement. The case was then transferred to a second special master, who determined that the evidence presented at the hearing conducted by the earlier special master was sufficient to set forth Deribeaux's prima facie case and therefore to shift the burden of proof to the Secretary to establish alternative causation. Id.

A limited supplemental hearing was held on June 28, 2011, focused on whether the Secretary could rebut Deribeaux's prima facie case by showing that her disorder was caused by her SCN1A gene mutation, a factor unrelated to vaccination, pursuant to 42 U.S.C. § 300aa-13(a)(1)(A)–(B). The Secretary acknowledged that a vaccine-induced fever likely triggered Deribeaux's first febrile seizure because individuals with SMEI are prone to suffer seizures in the context of any temperature elevation, and presented additional expert testimony showing that the sole cause of Deribeaux's neurological disorders was her genetic mutation and that the vaccination neither caused nor aggravated her condition. Deribeaux, 105 Fed.Cl. at 587. The Secretary's position was thus that the course of Deribeaux's disorder was not altered by her initial seizure and that the disabilities caused by her genetic mutation would have been the same with or without the vaccine-induced seizure. Deribeaux contended that, notwithstanding her genetic mutation and diagnosis of SMEI, it was the DTaP vaccination that caused her condition by triggering an immune deficiency that led to additional disorders, including the atypical Kawasaki disease, and further neurological damage.

After considering the record as a whole, the special master determined that the Secretary had carried the burden of demonstrating alternative causation by establishing that an unrelated factor, namely, genetic mutation, caused Deribeaux's seizures and other neurological disorders, and concluded that SMEI provided a complete, alternative explanation for Deribeaux's condition. Id. at 588. Accordingly, the special master set aside the previous entitlement ...


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