Terran v. Secretary of Health Human Serv.

• Decision Date: 27 October 1999
• Citation: 195 F.3d 1302
• Parties: (Fed. Cir. 1999) MICHELE Y. TERRAN, as legal representative of Julie F. Terran, a minor, Petitioner-Appellant, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee. 98-5161 DECIDED:
• Court: U.S. Court of Appeals — Federal Circuit

Page 1302

195 F.3d 1302 (Fed. Cir. 1999)

MICHELE Y. TERRAN, as legal representative of Julie F. Terran, a minor, Petitioner-Appellant, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.

98-5161

United States Court of Appeals for the Federal Circuit

DECIDED: October 27, 1999

Appealed from: United States Court of Federal Claims Judge Moody R. Tidwell

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[Copyrighted Material Omitted]

Andrew W. Dodd, of Torrance, California, argued for petitioner-appellant.

Claudia G. Gangi, Trial Attorney, Torts Branch, Civil Division, Department of Justice, of Washington, DC, argued for respondent-appellee. With her on the brief were Helene M. Goldberg, Director and John Lodge Euler, Deputy Director.

Before PLAGER, LOURIE, and CLEVENGER, Circuit Judges.

Opinion for the court filed by Circuit Judge CLEVENGER. Dissenting opinion filed by Circuit Judge PLAGER.

CLEVENGER, Circuit Judge.

Michele Terran appeals from the judgment by the United States Court of Federal Claims sustaining the Special Master's decision to deny compensation to Julie F. Terran under the National Child Vaccine Injury Act of 1986 (the "Vaccine Act" or "Act"). See Terran v. Secretary of Health & Human Servs., No. 95-451V (Fed. Cl. July 10, 1998). Terran argues that the Vaccine Injury Table applied by the Special Master to her claim is invalid because the statutory scheme pursuant to which it was created is unconstitutional, and also that the Court of Federal Claims erred both legally and factually in sustaining the Special Master's ruling. We hold, however, that the Vaccine Act does not violate separation of powers principles, and that the Court of Federal Claims committed no reversible error. We therefore affirm.

I

This appeal raises three issues: (i) whether the Court of Federal Claims has jurisdiction to adjudicate constitutional challenges to the validity of the current Vaccine Injury Table, which was promulgated by the Secretary pursuant to 42 U.S.C. § 300aa-14(c) and which became effective on March 10, 1995 (the "1995 Table"); (ii) whether the section of the Vaccine Act that authorizes the Secretary to create the 1995 Table, see 42 U.S.C. § 300aa-14(c) (1994), violates separation of powers principles found in the Constitution; and (iii) whether the Court of Federal Claims erred in sustaining the Special Master's decision to deny Julie compensation under the Vaccine Act.

A

The relevant facts are not in dispute. Julie Terran was born on February 10, 1992, in Phoenix, Arizona, and was discharged in good health from the hospital the next day. Julie received her first diphtheria-pertussis-tetanus ("DPT") vaccination when she was two months old, and her second DPT vaccination when she was three and one-half months old. On August 10, 1992, when Julie was six months old, she received her third DPT vaccination. Julie received her fourth DPT vaccination on September 22, 1993. All of the vaccinations were given by Dr. Gary Berebitsky, Julie's pediatrician, at her well-baby care checkup examinations. The first three DPT vaccines utilized whole cell pertussis bacteria, whereas the fourth was an acellular DPT vaccine. Julie's third vaccination, which occurred on August 10, 1992, is the basis for this dispute.

On August 11, 1992, the day after her third DPT vaccination, Julie experienced a seizure lasting approximately seven seconds which caused one of her arms to become stiff. The next day, August 12, Julie suffered four afebrile seizures, each lasting roughly one minute in length. Immediately after the seizures, Julie was rushed by ambulance to Phoenix Children's Hospital, where she was admitted. On August 13, in the presence of hospital personnel, Julie suffered another seizure lasting approximately five and one-half minutes. Hospital personnel then administered the anti-convulsant drug Phenobarbital to Julie. In the seven days following Julie's third DPT vaccination, she experienced a total of approximately twelve minutes of seizure activity. On September 12, roughly one month after the vaccination in question, Julie suffered a seizure lasting 50 minutes even though she was on Phenobarbital at the time. Julie's seizures continue to this day.

On September 13, 1993, Dr. Berebitsky noted that Julie was "well appearing" and "neurologically intact." However, in November 1993, he noted a problem with Julie's neurological condition, indicating that she scored a borderline passing grade on the Denver Developmental Screening Test. Julie is currently mentally retarded.

Julie also had a meningocele lump removed from her skull as a young child. Prior to her third DPT vaccination, Julie's doctors conducted several tests to determine whether she suffered any permanent brain damage as a result of the lump. These tests concluded that she had no brain abnormalities. An MRI scan conducted on May 18, 1992, showed that Julie had normal brain structure, and a test showed that there was no cancer in the removed lump. A certified pediatric neurosurgeon conducted a follow-up on Julie's surgery and found her neurological condition to be unremarkable except for moderate strabismus. Two MRI's conducted after Julie's third vaccination showed that she had no structural pathology in her brain. In connection with Terran's claim for compensation under the Vaccine Act, the Government requested that Julie undergo two separate genetic workups, both of which showed normal results.

B

Childhood vaccinations, though an important part of the public health program, are not without risk. Because vaccines often contain either killed bacteria or live but weakened viruses, they can cause serious adverse effects. See O'Connell v. Shalala, 79 F.3d 170, 172 (1st Cir. 1996) (citing Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines, Institute of Medicine, Adverse Effects of Pertussis and Rubella Vaccines 1 (1991)). Despite the relatively rare occurrence of such problems, Congress became concerned that tort liability and related costs might drive up the prices of vaccines and discourage vaccine manufacturers from staying in this market, and that normal tort litigation might leave many sufferers of vaccine-caused injuries uncompensated. See H. R. Rep. No. 99-908, at 1, 4, 6-7 (1986), reprinted in 1986 U.S.C.C.A.N. 6287, 6344, 6345, 6347-48; see also O'Connell, 79 F.3d at 172-73.

Accordingly, in 1986, Congress passed the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 1986 U.S.C.C.A.N. (100 Stat.) 3755 (codified as amended at 42 U.S.C. §§ 300aa-1 to -34 (1994)), which established a program administered by the Secretary of Health and Human Services ("Secretary") to increase the safety and availability of vaccines. See 42 U.S.C. § 300aa-1 (1994). As part of this program, Congress established a Vaccine Injury Compensation Program through which claimants could petition to receive compensation for vaccine-related injuries or death. See id. § 300aa-10(a). To receive compensation, a claimant must petition the Court of Federal Claims and demonstrate by a preponderance of the evidence either that (i) the vaccinated child suffered an injury listed on a table, or a complication or "sequela" thereof; or (ii) that the vaccine caused or significantly aggravated the child's injury or condition. See id. §§ 300aa-11, -13 to -14; 42 C.F.R. § 100.3 (1996). Thus, the Vaccine Act provides two possible ways for a claimant to receive compensation: first, by showing that she suffered a "table injury," or second, by proving causation in fact.¹ The Vaccine Act establishes an Office of Special Masters within the United States Court of Federal Claims to decide petitions for compensation, provides for review of a Special Master's decision by the Court of Federal Claims, and allows appeal of the Court of Federal Claims's rulings to this court. See 42 U.S.C. § 300aa-12 (1994).

To aid the Vaccine Program's goal of providing efficient compensation for vaccine injuries, Congress provided, in the form of a table, a list of vaccines, a parallel list of adverse medical conditions commonly associated with the use of each vaccine, and, for certain medical conditions, a time period in which the first symptoms should become apparent following vaccination. See id. § 300aa-14(a). These listings comprise the initial Vaccine Injury Table (the "Initial Table"), and are to be read in conjunction with a separate subsection, the "Qualifications and aids to interpretation" (the "QAIs"), that provides explanations and definitions for terms used in the Initial Table. Id. § 300aa-14(b). To demonstrate a table injury, a claimant must prove that within the prescribed time period following a vaccination, she suffered one of the disorders set forth on the Vaccine Injury Table corresponding to the vaccine administered. If she cannot make this showing, she must instead prove causation in fact. For example, with respect to a DPT vaccine, the Initial Table grants recovery if the claimant suffers, inter alia, a first symptom of, or a first manifestation of onset of, "residual seizure disorder" or "encephalopathy" within three days of receiving the vaccine. See id. The QAIs define "encephalopathy" to mean "any significant acquired abnormality of, or injury to, or impairment of function of the brain," and set forth certain symptoms or manifestations of an encephalopathy. Id. § 300aa-14(b)(3)(A).

Congress included the Initial Table in the Vaccine Act legislation, rather than delegating the creation of the first injury table to the Secretary, because it was concerned that the administrative process would significantly delay the implementation of the Vaccine Compensation Program. See Vaccine Injury Compensation: Hearings on H.R. 5810 Before the Subcomm. on Health and the Env't of the House Comm. on Energy and Commerce, 98th Cong. 210-11 (1984) (letter from Martin H. Smith, Vice President, American Academy of Pediatrics to Representative Henry A. Waxman). Congress intended...