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Terran v. Secretary of Health and Human Services

October 27, 1999

MICHELE Y. TERRAN, AS LEGAL REPRESENTATIVE OF JULIE F. TERRAN, A MINOR, PETITIONER-APPELLANT,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES, RESPONDENT-APPELLEE.



Before Plager, Lourie, and Clevenger, Circuit Judges.

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

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

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

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. *fn1 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 the Secretary to revise and update the Initial Table with more accurate information that would become available as a result of the research on vaccine injuries mandated by the Vaccine Act. See National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99- 660, § 312, 1986 U.S.C.C.A.N. (100 Stat.) 3755, 3779-81 (requiring the Secretary to make findings on the accuracy of the Initial Table with respect to, inter alia, pertussis vaccines and to propose regulations to modify the Initial Table accordingly); H.R. Rep. No. 99-908, at 18, reprinted in 1986 U.S.C.C.A.N. 6344, 6359. Thus, the Vaccine Act gives the Secretary the express power to promulgate regulations that modify the Table by adding to, or deleting from, the list of compensable disorders and by revising the time periods contained in the Table. See 42 U.S.C. § 300aa-14(c)(3) (1994). The Vaccine Act requires the Secretary to make such modifications pursuant to notice and comment rulemaking, and to provide at least 180 days for public comment and an opportunity for a public hearing. See id. § 300aa-14(c)(1). In addition, the Act provides that if the Initial Table is modified, the original QAIs cease to apply unless the modified Table expressly states that they remain valid. See id. § 300aa-14(c)(4). In February 1995, the Secretary promulgated regulations creating the current Vaccine Injury Table (the "1995 Table") and associated new QAIs, which became effective on March 10, 1995. See 42 C.F.R. § 100.3 (1996). As relevant to this case, the 1995 Table and associated QAIs deleted residual seizure disorder ("RSD") from the list of compensable table injuries related to DPT vaccine and significantly narrowed the definition of "encephalopathy." The 1995 Table and the modified QAIs apply to all petitions filed on or after their effective date of March 10, 1995. See 42 U.S.C. § 300aa-14(c)(4) (1994).

C.

Terran filed a petition for compensation with the Court of Federal Claims on July 12, 1995. The petition alleged that Julie's third DPT vaccination, administered on August 10, 1992, caused Julie to suffer both RSD and encephalopathy. Because the 1995 Table does not list RSD as a compensable injury associated with DPT vaccine, the Special Master concluded that Terran must establish causation in fact to prevail on this count. With respect to encephalopathy, Terran conceded that Julie's disorder did not meet the definition of an encephalopathy as set forth in the revised QAIs, and the Special Master accordingly concluded that Terran could prevail only if she demonstrated causation in fact for this illness as well. See Terran v. Secretary of Health & Human Servs., No. 95-451V, slip op. at 8-9 (Fed. Cl. (Special Master) Jan. 23, 1998). After examining the medical records and testimony, the Special Master determined that Terran failed to establish a prima facie case of causation in fact for either of Julie's conditions and denied compensation. See id. at 18.

Terran sought review of the Special Master's findings in the Court of Federal Claims. In her motion for review, Terran first alleged that the Vaccine Act is unconstitutional insofar as it authorizes the Secretary to modify the statutorily-enacted Initial Table found at 42 U.S.C. § 300aa-14(a) via administrative rulemaking. Second, Terran argued that even if the 1995 Table was valid, the Special Master erred in applying it to Julie's case and that he improperly rejected her theory of causation in fact under Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579 (1993). The Court of Federal Claims held that it was without jurisdiction to consider Terran's constitutional challenge, and sustained the Special Master's decision in all respects. See Terran, No. 95-451V, slip op. at 5, 10. Terran then petitioned for review to this court. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(3) and 42 U.S.C. § 300aa-12(f).

II.

We consider first the Court of Federal Claims's ruling that it does not have jurisdiction to consider appellant's constitutional challenge to the Vaccine Act. We review questions involving the jurisdiction of the Court of Federal Claims de novo. See Widdoss v. Secretary of Health & Human Servs., 989 F.2d 1170, 1174 (Fed. Cir. 1993). Determining the jurisdiction of the Court of Federal Claims necessarily involves statutory interpretation, which we likewise review de novo. See Munn v. Secretary of Health & Human Servs., 970 F.2d 863, 870 (Fed. Cir. 1993); Neher v. Secretary of Health & Human Servs., 984 F.2d 1195, 1197-98 (Fed. Cir. 1993).

A.

The Court of Federal Claims found that it lacked jurisdiction on two grounds. Reciting the well-known fact that it only has jurisdiction to hear claims against the Government for money damages, the court ruled that Terran's argument that the Vaccine Act violated the Presentment Clause of the Constitution, see U.S. Const. art. I, § 7, cl. 2, was not based on a "money mandating provision" of the Constitution, thereby depriving it of jurisdiction. See Terran v. Secretary of Health & Human Servs., No. 95-451V, slip op. at 5 (Fed. Cl. July 10, 1998) (citing Carruth v. United States, 627 F.2d 1068, 1081 (Ct. Cl. 1980)).

It is well understood that the Court of Federal Claims, like all federal courts, is a court of limited jurisdiction. Its jurisdiction is defined by the Tucker Act, which gives that court authority to

render judgment upon any claim against the United States founded either upon the Constitution, or any Act of Congress or any regulation of an executive department, or upon any express or implied contract with the United States, or for liquidated or unliquidated damages in cases not sounding in tort.

28 U.S.C. § 1491(a)(1) (1994). The Supreme Court has interpreted this language to mean that a plaintiff who seeks redress in the Court of Federal Claims must present a claim for "actual, presently due money damages from the United States." United States v. King, 395 U.S. 1, 3 (1969); see also United States v. Testan, 424 U.S. 392, 400 (1976). Although the Tucker Act provides jurisdiction for damage suits against the United States Government, it is equally clear that the Tucker Act does not itself create a cause of action against the Government. Rather, a plaintiff seeking recovery against the Government in the Court of Federal Claims must point to a money-mandating constitutional provision, statute, regulation, or contract with the United States affording it a right to money damages. See United States v. Mitchell, 463 U.S. 206, 216-17 (1983); Loveladies Harbor, Inc. v. United States, 27 F.3d 1545, 1554 (Fed. Cir. 1994) (en banc); United States v. Connolly, 716 F.2d 882, 885 (Fed. Cir. 1983) (en banc).

We think that the Court of Federal Claims misconstrued the scope of its jurisdiction. The Presentment Clause of the Constitution states that before becoming law, a legislative act must be approved by both houses of Congress and must be presented to the President of the United States for approval. See U.S. Const. art. I, § 7, cl. 2. We agree that this constitutional provision neither explicitly nor implicitly obligates the federal Government to pay damages, and accordingly is not by itself actionable in the Court of Federal Claims. Cf. Connolly, 716 F.2d at 887 (holding that the First Amendment does not by itself give rise to a cause of action for damages); Carruth v. United States, 627 F.2d 1068, 1081 (Ct. Cl. 1980) (holding that claims based on the Fifth Amendment's Due Process and Equal Protection clauses do not give rise to jurisdiction under the Tucker Act); Walton v. United States, 213 Ct. Cl. 755, 757 (1977). When determining jurisdiction, however, we must look to the true nature of the underlying action. See Katz v. Cisneros, 16 F.3d 1204, 1207 (Fed. Cir. 1994); Livingston v. Derwinski, 959 F.2d 224, 225 (Fed. Cir. 1992). Here, Terran's claim for relief is based on the Vaccine Act and is a claim for money--that is, compensation under the Act. Therefore, the Vaccine Act is the "Act of Congress" which forms the basis of Terran's claim, and there is little dispute that such a claim is one for presently due money damages. Indeed, we note that the Vaccine Act itself gives jurisdiction to the Court of Federal Claims to determine whether Terran is entitled to compensation, independent of the Tucker Act. See 42 U.S.C. § 300aa-12(a) (1994).

Because jurisdiction is proper, the Court of Federal Claims had the power to address Terran's argument based on the Constitution. See Beck v. Secretary, 924 F.2d 1029, 1036 (Fed. Cir. 1991) ("It is, however, reasonable to infer that the [Vaccine] Act must confer on the Claims Court that power which is necessary to adjudicate the controversy before it."); compare Connolly, 716 F.2d at 887 (holding that the Court of Claims did not have jurisdiction over plaintiff's First Amendment claim of improper removal) with Jackson v. United States, 428 F.2d 844, 846 (Ct. Cl. 1970) (holding that the Court of Claims did have jurisdiction over plaintiff's statutory claim for back pay, including arguments based on the First Amendment). We are therefore ...


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