What to do with Daubert: how to bring standards of reliable scientific evidence to the national vaccine injury compensation program.

• Author: Boxler, Brandon L.

TABLE OF CONTENTS INTRODUCTION I. THE LEGAL SYSTEM'S INTERACTION WITH NATIONAL IMMUNIZATION POLICIES A. Benefits and Risks of Vaccination B. Good Law Is Rooted in Good Science Co Junk Science and the Risk to Public Health II. A DELICATE MEDICOLEGAL BALANCE: THE NATIONAL CHILDHOOD VACCINE INJURY ACT OF 1986 A. Unfettered Litigation and a Public Health Emergency B. The Vaccine Act's Basic Statutory Scheme C. Rules of Discovery, Evidence, and Procedure in the Vaccine Program III. DEFICIENT EVIDENTIARY STANDARDS: THE PROBLEM AND ITS JURISPRUDENTIAL CONSEQUENCES A. The "Overwhelming Discretion" of Special Masters B. Why Have No Uniform Standards Emerged? C. Inconsistent and Unpredictable Case Law D. A Unique Need for Evidentiary Guidance IV. DAUBERT'S TREATMENT IN VACCINE ACT LITIGATION A. The Supreme Court's Focus on Reliable Science B. Daubert Without the Federal Rules of Evidence? C. Federal Circuit Inconsistency D. What About Althen? E. A Final Example V. APPLYING DAUBERTTO THE VACCINE PROGRAM A. Special Master Expertise B. Using Daubert To Buttress Congressional Goals 1. A Move Toward Traditional Civil Litigation? 2. An Example of Inefficiency C. Daubert Without Judicial Gatekeeping CONCLUSION INTRODUCTION

Whether a vaccine caused a person's injuries is a complex biological question. Yet every day, litigants ask judges and jurors who lack scientific sophistication to answer this and other difficult medical questions. (1) And as scientific knowledge advances, the number of science-based disputes reaching our country's courtrooms is exploding. (2)

Legal institutions must adapt to this dynamic medicolegal nexus by developing standards and procedures that enable courts to utilize the benefits of novel scientific truths while simultaneously avoiding the perils of junk science. (3) The legal system's response to scientific advancement, however, should not come at the expense of its own institutional goals of efficiently resolving conflicts and achieving justice. (4) Although "[s]cientific issues permeate the law," (5) they should not swallow the legal decision-making process altogether. In other words, "we must build legal foundations that are sound in science, as well as in law." (6)

Striking the appropriate medicolegal balance is not easy, but it is important especially when litigants ask courts to resolve disputes involving alleged vaccine injuries. (7) If the legal system decides without a sufficient medical basis that a vaccine can or did cause a certain injury, it not only increases the divide between science and law, (8) it also risks decreasing the public's trust in vaccines and potentially destabilizing one of the most important public health institutions of the modern world. (9)

This Note explores the interaction among science, law, and justice within the context of our country's immunization policies. It argues that courts should protect the stability and integrity of our national immunization program by refusing to declare that a vaccine harmed someone without basing that finding on reliable science. Special masters (10) presiding over proceedings brought under the National Childhood Vaccine Injury Act of 1986 (Vaccine Act or Act) (11) should thus have clear, uniform standards by which to scrutinize the complex medical evidence presented in their cases. In particular, special masters should have the power to weigh and exclude evidence and testimony pursuant to the standards set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc. (12) And they should have that power even though the Federal Rules of Evidence do not govern litigation brought under the Act. (13)

Part I of this Note outlines the importance of maintaining an appropriate balance between law and science within the context of our national immunization policies and legal institutions. It also highlights the public's increased attention to vaccine injuries and discusses how misinformation about vaccine safety can create adverse public health consequences. Part II briefly reviews the legal procedures and evidentiary requirements for receiving compensation under the Vaccine Act. Part III details why the Vaccine Act and the Federal Circuit case law fail to provide sufficient guidance regarding the type and amount of scientific evidence plaintiffs must provide to receive compensation under the Act, and it explains how this void negatively affects the accuracy, consistency, and fairness of judicial decision making. Part IV then discusses how Vaccine Act jurisprudence has applied Daubert, details why the case law fails to provide a sufficient analytical framework for scrutinizing evidence, and highlights the special masters' continued need for uniform evidentiary standards. Finally, Part V argues that Daubert's analytical framework should be binding precedent in all Vaccine Act litigation in order to maintain the Act's congressional purpose and ensure that decisions linking vaccines to injury are firmly rooted in reliable science.

1. THE LEGAL SYSTEM'S INTERACTION WITH NATIONAL IMMUNIZATION POLICIES

   1. Benefits and Risks of Vaccination

      Vaccines are one of the greatest medical achievements in human history. (14) In the 1950s, measles infected more than 500,000 children per year in the United States. (15) The disease caused a range of respiratory and neurological complications that resulted in more than 48,000 hospitalizations and 450 deaths every year in the United States alone. (16) But after a measles vaccine was licensed in 1963, (17) the disease's morbidity plummeted: in 1998, measles infected fewer than 100 people. (18)

      Vaccines have similarly reduced the morbidity of other diseases, including rubella, mumps, tetanus, diphtheria, and pertussis--each of which used to harm thousands of children every year. (19) Widespread vaccination against these diseases (20) reduced their morbidities by over 95 percent. (21) Perhaps the most notable vaccine accomplishment was the eradication of smallpox in the United States in 1977--a disease that caused an average of 1528 deaths per year from 1900 to 1904. (22) Put simply, vaccines prevent disease and save lives. (23)

      Yet no vaccine is perfect. (24) Many immunizations contain live or attenuated viruses (25) and a range of chemical ingredients that trigger adverse reactions in some members of the population. (26) Indeed, the Vaccine Act contains a 'Vaccine Injury Table" that lists several postimmunization injuries that are presumptively causally related to vaccines. (27) Plaintiffs earn this presumption of causation if they prove onset of an injury listed in the Table within a specified time period. (28) Once Vaccine Act plaintiffs establish that they suffered an "on-Table" injury, "the burden shifts to the [government] to prove that a factor unrelated to the vaccination actually caused the illness, disability, injury, or condition." (29)

      Despite their potential harmful effects, vaccines continue to be "one of the most spectacularly effective public health initiatives [the] country has ever undertaken." (30) For that reason, all fifty states have passed compulsory vaccination laws. (31) Governments recognize that the substantial benefits of widespread immunization and disease prevention outweigh the risk of injury that vaccines pose to some subpopulations. (32) Indeed, in upholding the constitutionality of these laws, the U.S. Supreme Court acknowledged that some children and adults "might not be fit subjects of vaccination," (33) and that it may be "impossible ... to determine with absolute certainty whether a particular person could be safely vaccinated." (34) But according to the unanimous Court, these risks do not "strip the legislative department of its function to care for the public health and the public safety when endangered by epidemics of disease." (35)

   2. Good Law Is Rooted in Good Science

      National immunization policies, therefore, must balance the benefits of disease prevention with the risks of sporadic, idiosyncratic adverse reactions. (36) In many ways, this policy balance is a social compact: individuals assume a "tiny risk of harm for the greater good"; (37) in return, the government ensures that those harmed by vaccines receive a fair and just legal process to compensate their injuries. (38) Accordingly, law and medicine cannot be analyzed in isolation--at least not when viewed within the context of vaccine policy. Their relationship is symbiotic: medical decisions impact legal institutions (39) and legal institutions impact medical decisions. (40)

      Because of this relationship, courts deciding whether a particular vaccine caused an injury must root their decisions in reliable scientific evidence. Otherwise, the legal system risks unduly influencing public health based on junk science. Justice Breyer has made a similar observation:

      The importance of scientific accuracy ... reach[es] well beyond the case itself. A decision wrongly denying compensation in a toxic substance case, for example, can deprive not only the plaintiff, say a worker, of warranted compensation, but can discourage other, similarly situated workers from even trying to obtain compensation and encourage the continued use of a dangerous substance. On the other hand, a decision wrongly granting compensation, while of immediate benefit to the plaintiff worker, can ... improperly force abandonment of the substance. This, if the decision is wrong, will improperly deprive the public of what can be far more important benefits--say those surrounding a drug that cures many while subjecting to less serious risk a few. (41) This risk of inaccurate decision making applies to any legal dispute involving toxic substances or pharmaceutical products. But Justice Breyer's insights apply to an even greater extent in cases where the outcome can have a considerable effect on one of the most important public health institutions of the modern world: vaccines.

   3. Junk Science and the Risk to Public Health

      Any legal decision involving an...