PERS PE C T IV E when vaccine injury claims go to court When Vaccine Injury Claims Go to Court Alexandra M. Stewart, J.D. I n February 2009, the National Vaccine Injury Compensation Program (VICP) released decisions for the first three test cases heard under the program’s Omnibus Autism Proceeding. In each of the cases — Cedillo v. Secretary of Health and Human Services, Hazlehurst v. Secretary of Health and Human Services, and Snyder v. Secretary of Health and Human Services — the petitioners alleged that a child’s autism spectrum disorder was caused by the combination of the measles– mumps–rubella (MMR) vaccine and thimerosal-containing vaccines. The decisions will have a substantial effect on vaccine policy and practice in the United States and will influence the analysis of more than 5300 similar, pending claims. Before the VICP was established, state courts proved to be ill equipped to resolve vaccine-injury cases adequately or to establish and apply predictable standards of liability for vaccine manufacturers. As a result, several manufacturers withdrew from the market, creating shortages, decreasing access to immunizations, and threatening immunization rates. The VICP was enacted because Congress understood that disruption of the vaccine supply would cause far greater harm to people than injuries caused by vaccines. The program ensures that all persons who sustain injuries from vaccines are adequately compensated. By eliminating the threat of litigation for vaccine manufacturers, the program has helped stabilize vaccine supply and prices, increase immunization rates, and maintain vaccine research and development. As an alternative to the traditional civil tort system, the VICP provides a more accessible, less adversarial process for ensuring timely compensation. People who believe that they have suffered a serious injury as a result of a vaccination must bring their claim to the VICP before approaching state courts. Special masters serve as judges and hear cases in the Court of Federal Claims. Petitioners are charged a filing fee, currently $250, which may be waived at the discretion of the special master assigned to the case. Petitioners are not required to obtain legal counsel; however, the special master may award reasonable attorney’s fees regardless of the outcome of the claim. These financial arrangements ensure that families who would not otherwise be able to file suit or retain counsel can have their cases heard. On the basis of the “preponderance of the evidence” standard, petitioners qualify for compensation either by showing that an injury meets the criteria outlined in the program’s Vaccine Injury Table or by presenting evidence, as in other tort litigation, that the vaccine in fact caused the injury. The injury table identifies known adverse events that may occur after vaccination and the period after vaccination during which they must manifest for cause to be established. For example, adverse effects of the MMR vaccine include anaphylaxis or anaphylactic shock (within 0 to 4 hours), encephalopathy (5 to 15 days), and any acute complication or sequela of these conditions (for which a time interval is not applicable). The evidence must show that it is “more probable than not” that a vaccination caused the injury. The range of proof that a special master may consider is not governed by the discovery or evidentiary rules applicable in federal district court, so petitioners may introduce a broader array of documentation to substantiate their arguments, including expert medical opinion, circumstantial evidence, and widely accepted, albeit unproven, scientific theories. The three petitioners claimed that their children had injuries not included in the Vaccine Injury Table and argued that their gastrointestinal symptoms and autism were caused by the combination of the MMR vaccine and thimerosal-containing vaccines. Special Masters George Hastings, Denise Vowell, and Patricia Campbell-Smith found that the petitioners were relying on unproven theories, supported by insufficiently rigorous testing and studies; their expert witnesses lacked adequate credentials and were unpersuasive when compared with the government’s witnesses; the cause of autism is unknown, and current credible theories point to causation unrelated to vaccines; and no sound epidemiologic study has identified any association between MMR vaccine and autism. In Snyder, Vowell concluded: “Sadly, the petitioners in this litigation have been the victims of bad science, conducted to support litigation rather than to advance medical and scientific understanding of autism spectrum disorder.”1 In Cedillo, Hastings concluded that the petitioners failed to demonstrate that it is more prob- 2498 n engl j med 360;24 nejm.org june 11, 2009 Downloaded from www.nejm.org on December 25, 2009 . Copyright © 2009 Massachusetts Medical Society. All rights reserved. PE R S PE C T IV E When Vaccine Injury Claims Go to Court able than not that either type of vaccine can be a substantial cause of autism and concluded as well that “it is extremely unlikely that any of [the] disorders were in any way causally connected to [the] MMR vaccination, or any other vaccination.”2 Furthermore, the physicians who advised the Cedillo family “have been very wrong.”2 Thus, awards from the VICP will not be forthcoming. All the petitioners have disagreed with the decisions and have filed appeals. Their cases will remain under federal jurisdiction, and the Court of Federal Claims will conduct the first review (see flowchart). This court could uphold and sustain the special masters’ decisions, remand the petitions back to the special masters for further action, or set aside the findings of fact and conclusions of law, but only if they are “found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” If the findings and conclusions are set aside, new findings of fact and conclusions of law will be issued. Then, either party may request an additional review from the Court of Appeals for the Federal Circuit. If that court does not award compensation, the petitioners may appeal to the Supreme Court. The petitioners may withdraw their case after 420 days without a judgment and file a civil action. Alternatively, at any point after the special masters’ decisions, petitioners can discontinue the appeals, permit the case to go to judgment, reject the judgment, and then file a traditional civil action in state court against the vaccine provider or manufacturer. However, two types of claims are barred in state courts: those based on injuries resulting from un- Suspected vaccine injury occurs Petitioners must file a claim with the Federal Vaccine Injury Compensation Program (VICP) VICP, Court of Federal Claims, reviews the evidence Petitioners must show that the injury satisfies the criteria in the Vaccine Injury Table or present evidence to show that it is “more probable than not” that the vaccine caused the injury If claim is not decided within 420 days, petitioners may withdraw case and file a civil action in state court Special master decides that vaccine caused injury Special master decides that vaccine did not cause injury Petitioners are offered compensation. If compensation is accepted, no further legal action is required. Petitioners reject judgment and file claim in state court All findings from the federal decisions are inadmissible; all evidence must satisfy the preponderance standard Petitioners appeal to U.S. Court of Federal Claims Decision may be sustained or returned to special master for further action, or findings and conclusions may be set aside and new ones issued Either party may demand further review from the Court of Appeals for the Federal Circuit Decision may be sustained or overturned Either party may demand further review from the Supreme Court Decision may be sustained or overturned Procedure for Seeking Compensation for an Alleged Vaccine Injury. 2nd avoidable side effects, when theof 1 from the federal decisions would REG F FIGURE 1 3rd vaccine was properly prepared and be inadmissible, and the evidence CASE Revised 4-C Line the packaging included proper di- presented wouldSIZE to satisfy have EMail ARTIST: ts H/T H/T 2 standard. rections and warnings, and those the preponderancecol Enon Combo based on the manufacturer’s AUTHOR, PLEASE NOTE: failThus, vaccine manufacturers Figure has been redrawn and type has been reset. ure to warn the injured party di- and providers should not anticiPlease check carefully. rectly about the potential dangers pate the return of the pre-VICP from the vaccination. During any legal environment, characterized JOB: 36024 ISSUE: 06-11-09 state proceedings, all findings by an onslaught of civil claims ICM AUTHOR: Stewart RETAKE 1st n engl j med 360;24 nejm.org june 11, 2009 2499 Downloaded from www.nejm.org on December 25, 2009 . Copyright © 2009 Massachusetts Medical Society. All rights reserved. PERS PE C T IV E when vaccine injury claims go to court throughout the country. The program’s four levels of federal review provide a powerful shield against large numbers of cases reaching state courts. In any cases that do reach state courts, it is highly unlikely that plaintiffs will succeed without additional scientific advancements to support their claims. Because state courts must deliver judgments based on credible evidence that satisfies traditional legal standards, claims relying on evidence similar to that presented under the Omnibus Autism Proceeding will have difficulty surviving judicial scrutiny. The government is committed to ensuring that the vaccine supply is as safe as the current state of scientific knowledge allows. This commitment includes oversight of all aspects of vaccine development, manufacturing, and administration and promotion of activities that ensure that adverse events are infrequent. As part of this obligation, the VICP has perhaps the saddest duty — determining which persons have truly been harmed by vaccines. Consequently, the program has adjudicated more than 7000 cases since its inception, yet only 2284 claims have been deemed legally eligible for awards, totaling $1.8 billion. As Camp- bell-Smith noted in Hazlehurst, the special master’s charge “does not permit decision making on the basis of sentiment but rather requires a careful legal analysis of the evidence.”3 No potential conflict of interest relevant to this article was reported. Ms. Stewart is an assistant research professor at the Department of Health Policy, School of Public Health and Health Services, the George Washington University Medical Center, Washington, DC. 1. Snyder v. Secretary of Health and Human Services, Case No. 01-162V. 2. Cedillo v. Secretary of Health and Human Services, Case No. 98-916V. 3. Hazlehurst v. Secretary of Health and Human Services, Case No. 03-654V. Copyright © 2009 Massachusetts Medical Society. Litigation, Regulation, and Education — Protecting the Public’s Health through Childhood Immunization Ross D. Silverman, J.D., M.P.H. ecently, three special masters of the U.S. Court of Federal Claims issued carefully reasoned, strongly worded opinions rejecting claims that medical and scientific evidence could demonstrate causal links between thimerosal-containing vaccines or measles–mumps–rubella (MMR) vaccination and the development of chronic health conditions such as autism, immune dysfunction, and gastrointestinal dysfunction. The three cases were test cases drawn from more than 5000 similar claims filed under the National Vaccine Injury Compensation Program (VICP), which was established in 1988 in response to concerns that injury lawsuits against vaccine manufacturers and administrators were threatening the nation’s childhood-vaccine supply. Because the injuries claimed in these cases were not listed in the VICP’s Vaccine Injury Table, in order to receive compensation un2500 R der the program, the families had to demonstrate through medical or scientific evidence that it is more likely than not that vaccination played a significant role in causing such injuries. In VICP-related proceedings, the court has broad authority to seek out and consider information that might help it resolve questions about injury causation. Toward this end, the special masters informed their decisions by reviewing an extraordinary amount of scientific and medical evidence, including the testimony of 28 medical experts, 50 expert reports, and more than 5000 pages of proceedings transcripts and briefs that included more than 900 scientific articles. The concern the special masters felt for the families who must cope with the daily challenges of caring for children with devastating chronic illnesses of as yet unknown origin is evident n engl j med 360;24 nejm.org june 11, 2009 throughout the more than 600 pages of legal decisions. Furthermore, the special masters were convinced that the parents had filed their claims in good faith. However, they were far less sympathetic toward both the evidence proffered by the claimants and the physicians who testified and offered research in support of the claims. According to Special Master George Hastings, writing in Cedillo v. Sec’y of HHS, “This case . . . is not a close case. The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories. . . . Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment” (emphasis in the original).1 Absent significant and dramatic new scientific findings, future litigation attempting to tie autism to vaccination is likely to meet a similar fate. However, many challenges for the Downloaded from www.nejm.org on December 25, 2009 . Copyright © 2009 Massachusetts Medical Society. All rights reserved.