Cedillo v. Sec'y Of Health And Human Serv.

• Citation: 617 F.3d 1328
• Decision Date: 27 August 2010
• Docket Number: No. 2010-5004.,2010-5004.
• Parties: Theresa CEDILLO and Michael Cedillo, (as Parents and Natural Guardians of), Michelle Cedillo, Petitioners-Appellants,v.SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

617 F.3d 1328

Theresa CEDILLO and Michael Cedillo, (as Parents and Natural Guardians of), Michelle Cedillo, Petitioners-Appellants,v.SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.

No. 2010-5004.

United States Court of Appeals,

Federal Circuit.

Aug. 27, 2010.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

Ronald C. Homer, Conway, Homer & Chin-Caplan, P.C. of Boston, MA, argued for petitioners-appellants.

Lynn E. Ricciardella, Trial Attorney, Torts Branch, Civil Division, United States

Department of Justice, of Washington, DC, argued for respondent-appellee. With her on the brief were Tony West, Assistant Attorney General, Timothy P. Garren, Director, and Gabrielle M. Fielding, Assistant Director.

Mary Holland, Attorney-at-Law, of New York, NY, for amicus curiae Elizabeth Birt Center for Autism Law and Advocacy, et al.

Before NEWMAN, LINN, and Dyk, Circuit Judges.

DYK, Circuit Judge.

This case is one of approximately five thousand cases that have been filed under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (“Vaccine Act”) in the Court of Federal Claims claiming a link between childhood vaccines and autism. The Special Masters created the Omnibus Autism Proceeding (“OAP”) to determine the relationship, if any, between vaccines and autistic spectrum disorders.

Petitioners Theresa and Michael Cedillo seek compensation on behalf of their daughter, Michelle Cedillo (“Michelle”). Their case is a part of the OAP proceeding. The Cedillos alleged that the measles-mumps-rubella (“MMR”) vaccine together with thimerosal-containing vaccines (“TCVs”) caused Michelle to suffer from various medical conditions, including autism. A Special Master denied the Cedillos' petition, and the Court of Federal Claims affirmed. Cedillo v. Sec'y of Health & Human Servs., 89 Fed.Cl. 158 (2009) (“ Final Decision ”). We affirm.

Background

I

Michelle Cedillo was born on August 30, 1994. The pregnancy and birth were uncomplicated. Michelle's pediatric visits during her first sixteen months were unremarkable. During her first fifteen months of life, she received routine childhood vaccinations, some of which contained a mercury-based preservative called thimerosal. On December 20, 1995, at fifteen months of age, she received an MMR vaccination. She next saw her pediatrician on January 6, 1996. The record of the visit shows that one week after her MMR vaccination, Michelle had a fever and rash. Although the initial fever improved, she experienced another fever on January 5, 1996, accompanied by coughing, gagging, and vomiting. By the morning of January 6, 1996, Michelle's temperature was 105.7 degrees. Her temperature at the pediatrician's office was 100.3 degrees, and she had a “purulent postnasal drip.” Cedillo v. Sec'y of Health & Human Servs., No. 98-916V, 2009 WL 331968, *5 (Fed.Cl. Feb. 12, 2009) (“ Initial Decision ”). The pediatrician diagnosed “sinusitis vs. flu,” and prescribed antibiotics. Id. Michelle next saw her pediatrician on March 15, 1996, for an eighteen-month well-child visit. No significant health concerns were recorded, and Michelle was noted to “stool [ ] well.” Id. Her doctor also noted that Michelle was “talking less since ill in Jan.” Id. A pediatric visit on April 24, 1997, noted “developmental delay suspected,” and subsequent medical records confirmed that Michelle's development was indeed very abnormal. Id. In July 1997, Michelle was diagnosed with “severe Autism” as well as “profound Mental Retardation.” Id.

In addition to Michelle's autism and severe mental retardation, Michelle has suffered from other medical problems. She has experienced chronic constipation and diarrhea. She has also suffered from possible gastroesophageal reflux disease, erosive esophagitis, and fecal impaction. At times, Michelle has also displayed symptoms of arthritis and pancreatitis and has experienced seizures.

II

Petitioners filed for compensation under the Vaccine Act on December 9, 1998. To obtain compensation for a vaccine-related injury or death, a petitioner must file a petition in the United States Court of Federal Claims and must show, by a preponderance of the evidence, that he or she received a vaccine listed on the Vaccine Injury Table and suffered a corresponding listed injury, in which case causation is presumed (“Table injury”), or that a listed vaccine in fact caused or significantly aggravated any injury (“non-Table injury”). See 42 U.S.C. § 300aa-11(a), -11(c), -12(a), -12(b), -13(a). Petitioners' theory of the case here is “causation-in-fact” (a non-Table injury claim), meaning that petitioners were required to prove causation. Once a petitioner establishes a prima facie case, the government then bears the burden of establishing alternative causation by a preponderance of the evidence. Walther v. Sec'y of Health & Human Servs., 485 F.3d 1146, 1151 (Fed.Cir.2007).

The question at the heart of this proceeding is whether Michelle Cedillo's admitted autism has been shown to have been caused by certain childhood vaccines. Petitioners claim that the ethyl mercury in thimerosal in various childhood vaccines damaged Michelle's immune system, and that due to her immune deficiency, she was unable to clear from her body the measles virus contained in the MMR vaccine. As a result, the vaccine-strain measles virus persisted and replicated in Michelle's body, causing her to suffer inflammatory bowel disease. Finally, the Cedillos “contend that the measles virus ultimately entered her brain, causing inflammation and autism.” Final Decision, 89 Fed.Cl. at 163.

At the Cedillos' request, Michelle's case was consolidated into the OAP. In December of 2005, counsel representing the petitioners in the OAP, known as the Petitioners' Steering Commit tee (“PSC”), proposed a “test case” approach to present general causation evidence and then designated Michelle Cedillo's case as a lead claim to be tried in June 2007. Hazlehurst v. Secretary of Health & Human Services., No. 03-654V, and Snyder v. Secretary of Health & Human Services, No. 01-162V, were also designated as test cases. Special Master Hastings presided over the Cedillo case and two other Special Masters were assigned to the Hazlehurst and Snyder cases. Though the general causation evidence from the three cases was considered by the Special Masters in each of the cases, each individual case was considered individually on its own merits by a single Special Master.¹

A three-week evidentiary hearing in this case was held in June of 2007, in which both general causation evidence and evidence specific to the Cedillo case was presented. Petitioners presented testimony on general causation from six expert witnesses. Central to petitioners' theory of causation was testing done by Unigenetics Ltd. Laboratory in Dublin, Ireland (“Unigenetics”) that reported successful use of the polymerase chain reaction technique (“PCR”) to identify and amplify measles virus genetic material from the blood and intestinal tissue of autistic children who had received the MMR vaccine, including Michelle Cedillo. The Unigenetics research formed the basis for a 2002 article (“the Uhlmann article”). The Unigenetics laboratory, which is no longer in business, was a for-profit, non-accredited institution that was established to support United Kingdom (“UK”) civil litigation against vaccine manufacturers in which it was alleged that the MMR vaccine caused autism. The Unigenetics testing on Michelle Cedillo was performed in 2002. Due to Michelle's gastrointestinal problems, she had undergone multiple endoscopies. Following one such procedure, in 2002, a tissue sample was taken from her intestine and a measles virus detection test was performed on the biopsied tissue by Unigenetics. The March 15, 2002, report of that test stated that “measles virus was detected” in the tissue. Initial Decision, 2009 WL 331968, *4.

Petitioners' expert witnesses, Drs. Hepner and Kennedy, testified that Unigenetics had reliably detected persistent vaccine-strain measles in the bodies of children with autism and gastrointestinal dysfunction, including Michelle Cedillo. Drs. Kennedy and Hepner also offered opinions supporting petitioners' vaccine-strain measles/causation theory. Petitioners' expert Dr. Kinsbourne testified that vaccine-strain measles virus persisted in Michelle's body, damaged her brain, and thereby caused her autism. Petitioners also relied on testimony from Dr. Corbier from the Hazlehurst case to support their causation claim. Dr. Corbier testified in Hazlehurst that the MMR vaccine can play a role in causing autism, either by itself or in conjunction with thimerosal-containing vaccines, in persons with a genetic susceptibility to autism. Petitioners' expert Dr. Byers testified that Michelle has a weakened immune system due to thimerosal from vaccines, and petitioners' expert Dr. Aposhian testified that “thimerosal-containing vaccines can harm infant immune systems.” Initial Decision, 2009 WL 331968, *11. Petitioners' expert Dr. Krigsman testified as to an autism-gastrointestinal dysfunction link and opined that the MMR vaccine can cause chronic gastrointestinal dysfunction. He testified in particular that Michelle's gastrointestinal symptoms and ultimately, her autism, were caused by persistent measles virus from the MMR vaccine. Petitioners' theory of causation depended on the Unigenetics finding that the measles virus was present in Michelle Cedillo's body.

In response to petitioners' evidence concerning the Unigenetics testing, the government offered evidence that the Unigenetics testing was unreliable and that therefore, Unigenetics can not be said to have found evidence of persisting measles virus in the intestinal tissue of any of the children studied, including Michelle Cedillo. In particular, in order to establish the unreliability of the Unigenetics testing, the government offered expert testimony and...