O'Connell v. Shalala, 95-1355

Citation79 F.3d 170
Decision Date07 December 1995
Docket NumberNo. 95-1355,95-1355
PartiesFrancis O'CONNELL and Lisa O'Connell, as the Legal Representatives of their Minor Daughter, Kelliann O'Connell, and Dissatisfied Parents Together, a Virginia Non-Profit Corporation, Petitioners, v. Donna E. SHALALA, Secretary of the United States Department of Health and Human Services, Respondent. . Heard
CourtUnited States Courts of Appeals. United States Court of Appeals (1st Circuit)

Petition for Review of a Final Rule of the Secretary of Health and Human Services.

Curtis R. Webb, with whom Michael R. Hugo and Conway, Crowley & Hugo, P.C. were on brief, Twin Falls, ID, for petitioners.

Charles R. Gross, Attorney, Civil Division, United States Department of Justice, with whom Frank W. Hunger, Assistant Attorney General, Helene M. Goldberg, Director, Civil Division, Barbara C. Biddle, Attorney, Civil Division, David Benor and Deborah Harris, Office of the General Counsel, United States Department of Health and Human Services, were on brief, for respondent.

Before TORRUELLA, Chief Judge, ALDRICH, Senior Circuit Judge, and SELYA, Circuit Judge.

SELYA, Circuit Judge.

This is a petition for review and vacatur of a final rule promulgated by the Secretary of Health and Human Services (the Secretary) under the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 through 300aa-34 (1994). We have jurisdiction under 42 U.S.C. § 300aa-32. In the pages that follow, we explore the pertinent statutory framework, recount the proceedings to date, and then examine the petitioners' three-pronged challenge. When all is said and done, we deny the petition and leave the rule intact.

I. THE STATUTORY SCHEME

The administration of childhood vaccines, though critically important to public health, "is not always without risk." Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines, Institute of Medicine, Adverse Effects of Pertussis and Rubella Vaccines 1 (1991) (IOM Report). Since vaccines generally contain either dead bacteria or live but weakened viruses, it is not surprising that they are capable of causing serious adverse effects. See id. Despite the infrequency of such episodes, Congress feared that the long shadow of tort liability cast by vaccine-related injuries would drive up prices and eventually force vaccine suppliers out of the market. See H.R.Rep. No. 908, 99th Cong., 2d Sess. 1, 4, 6-7 (1986), reprinted in 1986 U.S.C.C.A.N. 6287, 6344, 6345, 6347-48. Congress also worried that the vagaries of litigation, coupled with the cost, might leave many deserving victims of vaccine-related injuries undercompensated. See id.

To protect the supply of vaccines while ensuring fair, timely compensation for victims, Congress departed from the traditional tort system and wrote the National Childhood Vaccine Injury Act (the Act), Pub.L. No. 99-660, tit. III, 100 Stat. 3755 (1986). Among other things, the Act established a special tribunal (the Vaccine Court), and moved vaccine-injury cases partly outside the customary tort framework. See Schafer v. American Cyanamid Co., 20 F.3d 1, 2 (1st Cir.1994) (explaining the mechanics of the Act). 1 In respect to cases brought before this tribunal, Congress eased the complainants' burdens both by dispensing with the requirement of proving negligence and by greatly simplifying the requisite proof of causation. See 42 U.S.C. §§ 300aa-11. Of course, there are tradeoffs; for example, Congress limited the damages that a victim could obtain for vaccine-related injuries. See id. § 300aa-15.

In aid of the neoteric regulatory regime, the Act provides, in tabular format, a listing of vaccines and a parallel listing of medical conditions commonly associated with the use of each vaccine. See id. § 300aa-14(a). These listings, known collectively as the Vaccine Injury Table (the Table), are accompanied by, and are to be read in light of, the Qualifications and Aids to Interpretation (QAI). The QAI is a separate subsection that provides definitions and explanations for the terms used in the Table. See id. § 300aa-14(b). To receive compensation for a vaccine-related injury, a recipient must simply petition the Vaccine Court and show that, within a prescribed time span, she suffered one or more of the disorders listed in the Table as associated with the particular vaccine that she received. Thus, the content of the Table (a sample of which is excerpted in the Appendix) is critical: it is only when a vaccinated child suffers a listed condition within applicable temporal parameters that compensation will be forthcoming without the time, expense, proof requirements, and uncertainty of full-blown litigation.

The Table is not intended to be static. Congress gave the Secretary express power to promulgate regulations adding to or subtracting from the tabular list of conditions, and changing the delineated time periods. See 42 U.S.C. § 300aa-14(c)(3). This is a rather odd approach because it authorizes the Secretary, in effect, to amend the statutorily enacted Table by way of administrative rulemaking. 2 This grant of power probably reflected a congressional consensus that the first iteration of the Table was not perfect. Driven by a sense of urgency to put something into place, the solons knowingly used incomplete data when forging the causal links between vaccines and associated medical conditions. Mindful of its haste, Congress directed the Secretary to have the Institute of Medicine (IOM)--an arm of the National Academy of Science--conduct an extensive review of all available information bearing on the relationship between vaccines and medical conditions, and thereafter to publish findings and revise the Table based on the IOM's study. See Vaccine Act § 312, 100 Stat. at 3779.

To assist the Secretary in updating the Table, Congress created the Advisory Commission on Childhood Vaccines (ACCV)--a body composed of a cross-section of health professionals, legal experts, interested citizens (including two who are parents of children victimized by vaccine-related injuries), and federal officials. See 42 U.S.C. § 300aa-19. Congress directed the Secretary to provide the ACCV with a copy of each contemplated regulation before formally proposing it, and then to await the expiration of a ninety-day comment period before moving forward. See id. § 300aa-14(d).

II. THE COURSE OF EVENTS

In 1991, the IOM completed its study and, on August 27, issued the IOM Report. Among the many conclusions contained in this tome the IOM found a causal relation between DPT (diphtheria-pertussis-tetanus) vaccine, on one hand, and acute encephalopathy and hypotonic, hyporesponse episodes (HHE), on the other hand. 3 See IOM Report at 118, 177. However, the IOM found insufficient evidence to indicate a causal relationship between DPT vaccine and residual seizure disorders (such as epilepsy). See id. at 118 n. 3. The project director gave the ACCV a full briefing on the IOM Report in September of 1991.

In anticipation of receiving the IOM Report, the Secretary formed a Public Health Service Task Force as a vehicle for revising the Table. She also enlisted yet another helpmate, the National Vaccine Advisory Committee (NVAC). Unlike the ACCV, which by statute counsels the Secretary in respect to the injury compensation program, see 42 U.S.C. § 300aa-19, the NVAC's statutory responsibility is to advise the director of the separate national program for developing and administering the public health aspects of immunization policy, see id. § 300aa-5. The Secretary transmitted the IOM Report to the Task Force, which then recommended a number of changes to the Table (including the removal of encephalopathy, HHE, and residual seizure disorders as associated medical conditions vis-a-vis DPT vaccination). 4 The NVAC concurred in these recommendations.

Despite the fact that the ACCV had not yet formally received the Task Force's or the NVAC's recommendations, it took up the substance of the proposed revisions at its December 1991 meeting. In lieu of the literal text of the suggested changes, the ACCV members received what has been referred to as a "matrix"--essentially, a table comparing a synthesis of Task Force and NVAC recommendations and summarizing the rationales advanced by those bodies. The ACCV discussed these recommendations at length and approved all but the one that suggested dropping encephalopathy from the Table. As a counter-proposal, the ACCV encouraged the Secretary to modify the QAI definition of encephalopathy in a way that would restrict its meaning to acute or chronic episodes of a type more likely to result in significant harm.

In due season, the Secretary published a Notice of Proposed Rulemaking (the Notice). See 57 Fed.Reg. 36,878 (proposed Aug. 14, 1992). The Notice included the required scientific findings and set forth regulations designed to revise the Table accordingly. These covered all the Task Force's recommendations save only for the dropping of encephalopathy. On that point the Secretary acquiesced in the ACCV's view and proposed a new definition of the condition similar in most respects to the definition discussed at the ACCV's December 1991 meeting. See id. at 36,880. A comment period and public hearing ensued.

In 1993, the results of a ten-year study of acute childhood neurologic illnesses became available. Recognizing the potential importance of the study, the Secretary stayed her hand and requested the IOM to review the newly compiled material. In March 1994 the IOM concluded that the "balance of the evidence is consistent with a causal relationship" between DPT vaccination and certain forms of chronic nervous system dysfunction suffered by children who experience an acute neurologic illness shortly after vaccination. Committee to Study New Research on Vaccines, Institute of Medicine, DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis 2-3 (1994). On March 24, 1994, the Secretary reopened the comment period for a...

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