The progression of science can be thought of as the movement towards an idea or principle within an expert community qualified to assess it. Tycho Brahe, arguably the greatest 16th-century astronomer, believed and argued to his contemporaries that the sun revolved around a stationary earth. 1Victor E. Thoren & John Robert Christianson, The Lord of Uraniborg: A Biography of Tycho Brahe 241-42, 287 (1990). The astrological community eventually rejected the theory in favor of heliocentrism, that conclusion filtered down to the public and is now accepted as general truth.
Contrast this to science in litigation, where, at the end of the day it is not the astrological community but the lay public that has watched the heavens revolve around it deciding scientific truth. Tycho Brahe no doubt would have had more luck with that jury than he did with one of his peers. The judicial gate-keeping standard established by the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals sought to resolve this tension between science and legal evidence by requiring judges to scrutinize the scientific basis of expert testimony. 2509 U.S. 579, 590 (1993) (developing a non-exhaustive, four-factor reliability test for expert testimony which will be discussed in detail below). Daubert’s judicial scrutiny of expert testimony seeks to shield juries from “experts” who would essentially argue that the earth no longer revolves around the sun. 3See id.; see also Peter W. Huber, Galileo’s Revenge: Junk Science in the Courtroom 1-2 (1993). The Daubert case itself largely ended the infamous Benedictine litigation in 1993. 4See Joseph Sanders, Bendectin on Trial: A Study of Mass Tort Litigation 157-58 (1998) (outlining the evolution and eventual unraveling of the Bendectin litigation).
In February 2009, Daubert’s judicial-scrutiny standard was used to strike what could be a fatal blow to the conceptually similar litigation theory that vaccines cause autism. 5Special Master Finds No Link Between Childhood Vaccines, Autism, 24 Toxics L. Rep. (BNA) No. 8, at 234 (Feb. 19, 2009). Three Special Masters of the United States Court of Federal Claims ruled (in separate decisions) that petitioners’ experts failed to demonstrate two alternate causation theories: (1) that the MMR vaccine alone causes autism, and (2) that the combination of the MMR vaccine with thimerosal (a mercury-based vaccine preservative) causes autism. 6Cedillo v. Sec’y of HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. 2009); Hazelhurst v. Sec’y of HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. 2009); Snyder v. Sec’y of HHS, No. 01-162V, 2009 WL 332044 (Fed. Cl. 2009). One Special Master stated that the experts presented by the government “were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts concerning most of the key points.” 7Cedillo, 2009 WL 331968, at *1. Therefore, the theory that vaccines cause autism appears to be headed for its legal end. 8“[A third] general causation theory—that thimerosal containing vaccines alone can cause autism” is in the post-hearing briefing stage and should conclude in the summer of 2009. Review of Expert Proof Finds No Link Between Childhood Vaccines and Autism, 9 Expert Evidence Rep. (BNA) No. 3, at 96 (Feb. 23, 2009). The Special Masters have already expressed doubt regarding this theory as well. One year later, the scientific community has followed suit. The Lancet, the British medical journal that first published Dr. Andrew Wakefield’s 1998 scientific paper that served as a central pillar for the idea that vaccination could increase children’s risk of developing autism, formally retracted Dr. Wakefield’s paper following the January 28, 2010, decision by the United Kingdom’s General Medical Council finding that Dr. Wakefield was guilty of “dishonest,” “irresponsible,” and “misleading” conduct in the substantive descriptions in that paper and in failing to disclose conflicts of interest. 9General Medical Council, Fitness to Practise Panel Hearing 28 January 2010, Dr. Andrew Jeremy Wakefield, et al., pp. 44-52 (herein after “Wakefield GMC”) available at http://www.scribd.com/doc/25983372/FACTS-WWSM-280110-Final-Complete-Corrected; Dan Childs and Lauren Cox, “Lancet Retracts Controversial Autism Paper: Retraction of 1998 Wakefield Study May Not Sway Those Who Fear Vaccine-Autism Link,” ABC News Medical Unit (Feb. 3, 2010), available at: http://abcnews.go.com/Health/AutismNews/lancet-retracts-controversial-autism-paper/story?id=9730805&page=1.
The post-moratorium on the vaccine-autism litigation gives a good account of Daubert’s gatekeepers. That litigation had all the making of another Bendectin disaster: a large plaintiff pool vulnerable to the causal assertion being made; committed media-savvy experts willing to misstate their findings in the literature in support of the assertion; sensational media coverage of the causal claim; and the potential to do real harm to public health. However, thanks to the judicial-scrutiny standard established by Daubert, the vaccine-autism litigation is ending with less financial pain and much less legal criticism than its Bendectin counterpart. This Article compares and contrasts these two groups of tort litigation and explores the evolution of Daubert from the Bendectin cases in the 1970s and 80s to the recent rulings on the vaccine-autism litigation and what the difference tells of the future of judicial scrutiny.
Keeping Junk Science Away From Juries
Tort law has seen its share of scientific theories that have the appearance of legitimacy but are eventually exposed as being nothing more than junk science. 10Huber, supra note 5, at 1 (discussing examples of tort theories based on junk science, such as: spermicide in contraceptives causing birth defects, whooping cough vaccine causing permanent brain damage and death, and swine flu vaccine causing serum sickness). Junk science “is the mirror image of real science, with much of the same form but none of the same substance.” 11Id. at 2. Junk science may also be defined as being “conducted to support litigation rather than to advance medical and scientific understanding.” Snyder, No. 01-162V, 2009 WL 332044, at *147. The introduction of judicial gate-keeping in Daubert established “a standard of evidentiary reliability,” allowing judges to reject an expert’s theory of causation if the theory does not have a solid and reliable scientific basis. 12Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 590 (1993). Daubert arose in part as a remedy to the Bendectin saga, which is told below.
A. Bendectin Litigation
Bendectin litigation has been called the epitome of tort pathology, “the single most criticized piece of large-scale litigation of all time.” 13Gary Edmond, Whigs in Court: Historical Problems with Expert Evidence, 14 Yale J.L. & Human. 123, 160 (2002) (noting that “almost all scholarly accounts describe the Bendectin litigation as an extreme example of legal pathology,” and those that have studied it largely agree that “Bendectin is the Taj Mahal of horror stories about the tort system”). See generally James M. Sabovich, Petition Without Prejudice: Against the Fraud Exception to Noerr-Pennington Immunity from the Toxic Tort Perspective, 17 Penn. St. Envtl. L. Rev. 28-32 (2008) (outlining the rise and fall of the Bendectin litigation). It seemed to start legitimately with a mother who genuinely believes that Bendectin caused her son’s birth defect and a world renowned teratologist supporting the claim. But by its end it was clear the judicial system and public had been hoodwinked—at a high cost to both.
Betty Mekdeci’s 14Michael D. Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation 97 (Univ. of Pa. Press 1996). son was born in 1975 with limb and other birth defects, and she was consumed with discovering the cause. She settled on Bendectin by process of elimination. She had taken three drugs during the relevant period in pregnancy. 15See Green, supra note 14, at 99. Of them Bendectin had been alleged 16See generally Another Birth Drug Suspect, Sydney Morning Herald, Apr. 19, 1972. to cause birth defects by Dr. William McBride, the “father of teratology” who uncovered the link between thalidomide and reduced limb birth defects. 17See McBride v. Merrell Dow & Pharm., Inc., 800 F.2d 1208, 1211 (D.C. Cir. 1986) (describing Dr. McBride as a world-renowned expert on birth defects as a result of discovering the dangers of Thalimodine). Ms. Mekdeci convinced famed personal injury attorney Melvin Belli to bring a toxic tort suit for her. The litigation was an isolated incident until October of 1979 when the National Enquirer published a story it received from Mr. Belli backing the causal allegation with Dr. McBride’s prestige. 18Id.; David E. Bernstein, The Breast Implant Fiasco, 87 Cal. L. Rev. 457, 460 (1999); New Thalidomide-Type Scandal—Experts Reveal … Common Drug Causing Deformed Babies, Nat’l Enquirer, Oct. 9, 1979, at 20.
Cases proliferated throughout the 1980s, but as the litigation grew it became apparent the causal theory undermining the litigation was false and that Dr. McBride, who “occupied a central place in the Bendectin debate” as a frequent plaintiffs’ expert, 19Dr. McBride served widely as a causation expert for Bendectin plaintiffs, until investigations of his altering results to obtain research findings against Bendectin undercut his credibility. See Joseph Sanders, From Science to Evidence: The Testimony on Causation in the Bendectin Cases, 46 Stan. L. Rev. 1, 34 (1993); Norman Swan, The Man Who Stopped Thalidomide Accused of Fraud, Sydney Morning Herald, Dec. 14, 1987, at 1. had “falsified the experimental data to imply that teratogenicity had occurred when it had not” 20See Frank Wells, Fraud and Misconduct in Medical Research, 43 Brit. J. Clinical Pharmacology 3, 3-7 (1997) (“[Dr. McBride] then went on to indict Debendox (known in Australia as Bendectin) as a drug which had the same teratogenic effects as thalidomide, but without any evidence to support the indictment. In fact, he falsified the experimental data to imply that teratogenicity had occurred when it had not because his blind belief in the dangers of Debendox was so great that he consciously changed the data `in the long term interest of humanity.’ ”). so as to link the active ingredient in Bendectin to limb birth defects. 21See Margaret Scheikowski, Thalidomide Doctor Back After Fraud, The Daily Telegraph (Sydney, Australia), Nov. 10, 1998, at 3 (reporting that in 1993, Dr. McBride was “struck off the medical register for falsifying research data in the Debendox [(Bendectin)] case,” had his application rejected in 1996, then was readmitted after he “apologized, admitted the deliberate fraud and said his continued attempts to self justify the paper had been wrong”). Because of his pre-existing prestige and his status as one of only two plaintiffs’ Bendectin experts to have published on this issue, 22See Robert L. Brent, Bendectin: Review of the Medical Literature of a Comprehensively Studied Human Nonteratogen and the Most Prevalent Tortogen-Litigen, 9 Reprod. Toxicology 337, 344 (1995). The only other plaintiff expert to publish concerning Bendectin was Dr. Newman, whose work was limited to in vitro (test tube) studies. See id. Dr. McBride’s professional demise was highly significant to the rise and fall of Bendectin litigation.
There remained a small cadre of plaintiffs’ experts willing to indict Bendectin at trial even though the theory had been overwhelmingly rejected by the scientific community. The legal system had no uniform solution to them: sometimes their testimony was admitted but the verdict reversed for want of “substantial evidence,” 23Richardson v. Richardson-Merrell, Inc. 649 F. Supp. 799 (D.D.C. 1986); Merrell Dow Pharms. v. Havner, 953 S.W.2d 706, 709 (Tex. 1997); Blum v. Merrell Dow Pharms., Inc. 564 Pa. 3, 5 (Pa. 2000). others times the Frye general acceptance standard was used to exclude them, 24Daubert v. Merrell Dow Pharmaceuticals, 951 F.2d 1128, 1130 (9th Cir. 1991) vacated 509 U.S. 904 (1993). while still other courts employed a pre-Daubert reliability analysis. 25Ealy v. Richardson-Merrell, Inc., 897 F.2d 1159, 1163 (D.C. Cir. 1990).
B. Daubert and the Judicial Reckoning for Bendectin
The significance of the Supreme Court’s opinion to Bendectin is not so much that it ended the litigation. The Bendectin litigation was already dying by the time the issue reached the Supreme Court in 1993. Federal and state case reporters were brimming with published opinions rejecting the proposition that Bendectin caused birth defects, and many plaintiffs’ experts found themselves called out by name in those opinions. Rather it is that the opinion affirmatively charged federal judges, and trial judges in states that follow Rule 702 of the Federal Rules of Evidence, with an affirmative obligation to keep junk science from the jury. In essence, the Supreme Court set forth a uniform analytical structure to deal with the next wave of toxic tort claims.
On remand from the Supreme Court, Judge Kozinski, after preliminarily lamenting the “Brave New World” in which federal judges were to take on the “heady task” of “resolv[ing] disputes among respected, well-credentialed scientists about matters squarely within their expertise,” 26Daubert v. Merrell Dow Pharmaceuticals, 43 F.3d 1311, 1316 (9th Cir. Cal. 1995) applied the newly created Daubert gate-keeping factors to plaintiffs’ causation experts. 27See Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1322 (1995); see also Sanders, supra note 6, at 158. The Daubert decision set out two prongs: reliability of the opinion and fit of the testimony to the case, 28Daubert v. Merrell Dow Pharmaceuticals, 43 F.3d 1311, 1315 (9th Cir. Cal. 1995) and the Ninth Circuit’s application set precedents for each. For the first prong, the Court focused predominantly on whether the Bendectin-causes-birth-defects theory had been subjected to peer review and publication and whether the experts’ opinions were developed expressly for purposes of litigation. 29Id. at 1317. Analyzing whether expert testimony was prepared for the express purpose of litigation was not directly considered a reliability factor by the Supreme Court in Daubert but has been used by other courts (including the Supreme Court) in determining the reliability of expert testimony. See Snyder, No. 01-162V, 2009 WL 332044, at *139 (citing Exxon Shipping Co. v. Baker, 128 S. Ct. 2605, 2626 n.17 (2008)). A decade of prior litigation had decided those issues against plaintiffs. 30Daubert, 43 F.3d at 1318 (citing Huber, supra note 5, at 209 (suggesting that “the ultimate test of [a scientific expert’s] integrity is her readiness to publish and be damned”)). “Bendectin litigation has been pending … for over a decade, yet the only review the plaintiffs’ experts’ work has received has been by judges and juries … . None of the plaintiffs’ experts has published his work on Bendectin in a scientific journal or solicited formal review by his colleagues.” The Ninth Circuit also demonstrated that the Bendectin experts prepared their testimony for the sole purpose of litigation, saying, “We … find that none of the experts based his testimony on preexisting or independent research.” 31Id. at 1317. Judge Kozinski further explained that none of the experts “claims to have studied the effect of Bendectin on limb reduction defects before being hired to testify in this or related cases.” 32Id. Therefore, the Ninth Circuit held that the Bendectin experts’ testimony was inadmissible as a matter of law under the reliability prong of Daubert. 33See id. at 1319.
Equally important was the Ninth Circuit’s “fit” analysis. The weaker, tentative opinion that some small increase in risk is possible naturally needs less support to be reliable than a full-force causation opinion. A Daubert gate-keeper would be more of a doorman if a plaintiff could present tentative but plausible causal testimony to the jury and expect the jury to infer the difference between that testimony and plaintiffs’ burden of proof. The Ninth Circuit thus held that plaintiffs’ experts were required to demonstrate not merely that Bendectin increased the likelihood of injury, but that Bendectin more likely than not caused their injuries. 34Id. This “more likely than not” standard also is used by the Special Masters in the vaccine-autism cases. See, e.g., Cedillo v. Sec’y of HHS, No. 98-916V, 2009 WL 331968, at *2, (Fed. Cl. 2009) (citing Althen v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005)). The Bendectin experts could only testify to a possibility of Bendectin causing birth defects, not a probability. Therefore, plaintiffs’ expert testimony was rendered inadmissible under the second prong of Daubert as well.
Bendectin’s Revenge: Daubert and Vaccine-Autism Litigation
It is difficult to study the Bendectin litigation at any length and not be troubled by it. The legal system eventually reached the correct result after a decade of litigation, 35W. Kip Viscusi, Corporate Risk Analysis: A Reckless Act?, 52 Stan. L. Rev. 547, 584 (2000). but at a high societal cost. In sense the Bendectin litigation was an inhumane act of the legal system against the general population: thousands of mothers were tricked into believing their act of taking a morning sickness pill had permanently disfigured their children. Many times more women now suffer pregnancy related nausea, which can be quite serious, 36Green, supra note 14, at 336. without a medical solution. They do so because Bendectin was the only prescription drug ever approved by the FDA to treat that condition 37See P. Mazzota et al., Attitudes, Management and Consequences of Nausea and Vomiting of Pregnancy in the United States and Canada, 70 Int’l. J. Gynecology & Obstetrics 359, 360 (2000). and the manufacturer made the rational business decision to withdraw it once litigation began.
Its 21st century successor, the vaccine-autism litigation, had the capacity to do much, much worse. If the judicial system had indulged the vaccine-autism plaintiffs with the platform and perceived legitimacy it lent the Bendectin litigants, it is entirely possible a significant portion of the population would have chosen not to vaccinate their children.
A. Origins of the Vaccine-Autism Theory
The current vaccine–autism litigation traces its lineage to a February 1998 a peer-reviewed article in the highly respected medical journal Lancet. In this paper, a British doctor named Andrew Wakefield, along with twelve of his colleagues, alleged a link between the MMR vaccine and autism based on the twelve recipients of that vaccine developing autism shortly after being vaccinated. 38Andrew J. Wakefield et al., Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis, and Pervasive Developmental Disorder in Children, 351 Lancet No. 9103, at 637-41 (Feb. 28, 1998). The study was conducted with a total of twelve patients—eleven boys and one girl between the ages of two and nine. Dr. Wakefield’s paper “triggered a public health crisis”—parents wondered if, while trying to protect their children’s health through vaccinations, they were actually making their children more susceptible to autism. 39See Brian Deer, Hidden Records Show MMR Truth, Sunday Times, Feb. 8, 2009, available at http://www.timesonline.co.uk/tol/life_and_style/health/article5683643.ece.
Beginning in 1999, researchers in the United States and Britain theorized that the mercury-based vaccine preservative thimerosal might also be contributing to the cause of autism. 40Cedillo, No. 98-916V, 2009 WL 331968, at *8. Throughout the last decade, Wakefield was a prominent figure in vaccine-autism research and litigation, participating in several studies both in Britain and the United States. 41Id. at *54-56, 79-80, 88. With researchers alleging a link between vaccines and autism, thousands of families prepared to bring lawsuits to recover for their children’s alleged vaccine-related injuries.
As with Bendectin, the causal assertion received widespread media attention, including notable celebrity endorsements from such stars as Jim Carrey and Jenny McCarthy. 42See e.g., Larry King Live, Jenny McCarthy and Jim Carrey Discuss Autism; Medical Experts Weigh In (April 3, 2009) available at http://transcripts.cnn.com/TRANSCRIPTS/0904/03/lkl.01.html. Both presidential candidates in the 2008 election professed belief in the theory. 43Gordon Shemin, Mercury Rising: The Ominbus Autism Proceeding and What Families Should Know Before Rushing Out of Vaccine Court, 58 Am. U.L. Rev. 459, 480 (2008).
That the Wakefield paper was as flawed as, if not more than, the Bendectin research became abundantly clear when the Lancet issued a full retraction of the Wakefield paper from the published record following the January 28, 2010 judgment against Dr. Wakefield by the United Kingdom’s General Medical Council’s Fitness to Practice Panel. 44Wakefield GMC, 45 (“the Panel notes that the project reported in the Lancet paper was established with the purpose to investigate a postulated new syndrome and yet the Lancet paper did not describe this fact at all … .”);. The Panel found Dr. Wakefield guilty of acting unethically during his research on the purported vaccine-autism connection. 45Ibid. Specifically, the Panel found that Dr. Wakefield was not truthful about the manner in which the twelve participants were chosen for the study. He claimed they were referred to his department through normal channels for gastrointestinal problems, 46WakeField GMC, 45, 47. and was found to have implied he “had played no active part” in the selection process. 47Ibid. In truth the “patients” were subjects in an undisclosed litigation related research project Dr. Wakefield was conducting on “a postulated new syndrome” from vaccines. 48Ibid. In fact, nearly half of the children were part of a lawsuit looking into the effects of the MMR vaccine and some of the children did not have stomach ailments at all. 49Ibid.; Childs and Cox, “Lancet Retracts Controversial Autism Paper: Retraction of 1998 Wakefield Study May Not Sway Those Who Fear Vaccine-Autism Link,” ABC News Medical Unit (Feb. 3, 2010), supra, available at: http://abcnews.go.com/Health/AutismNews/lancet-retracts-controversial-autism-paper/story?id=9730805&page=1. The difference between the two is the difference between discovery and staging because discovering that twelve children with autism recently received vaccinations is meaningless when the children were selected because of those criteria. The Panel further found that Dr. Wakefield failed to disclose that he was paid by the plaintiffs’ attorneys pursuing the MMR vaccine litigation and that he had a patent pending for a new MMR vaccine when he submitted his paper. 50Ibid.
While the Wakefield paper has been resoundingly debunked, its long-term effects on public health, and the legal system, cannot be denied. When the public learned of Wakefield’s paper, worried parents started skipping their children’s vaccines, and the percentage of children who were not vaccinated in the United States rose from 0.77 percent in 1997 to 2.1 percent in 2000. 51Michael J. Smith, MD, Susan S. Ellenberg, PhD, Louis M. Bell, MD, David M. Rubin, MD, MSCE, Media Coverage of the Measles-Mumps-Rubella Vaccine and Autism Controversy and Its Relationship to MMR Immunization Rates in the United States, Pediatrics, Vol. 121 No. 4 (April 1, 2008), pp. e836-e843, available at: http://pediatrics.aappublications.org/cgi/ content/full/121/4/e836?maxtoshow=&HITS=10&hits=10&RESULT FORMAT=1&author1=Smith%2C+Michael&andorexacttitle =and&andorexacttitleabs=and&andorexactfulltext=and& searchid=1&FIRSTINDEX=0&sortspec=relevance&fdate= 1/1/2000&tdate=1/31/2010& resourcetype=HWCIT. A similar rise in children not being vaccinated occurred in Britain. 52Ibid. The United States and Great Britain have both seen a resurgence in diseases previously thought to be eradicated by vaccine. Measles made a reappearance in both countries with outbreaks in 2008. 53National Center for Immunization and Respiratory Diseases, “Update: Measles Outbreak Continues in U.S.” (Oct. 20, 2008), available at: http://www.cdc.gov/Features/MeaslesUpdate/. According to the U.S. Centers for Disease Control and Prevention, “[f]rom January through July 2008, CDC received reports of 131 measles cases from 15 states and the District of Columbia—the highest year-to-date number since 1996. More than 90% of those infected had not been vaccinated, or their vaccination status was unknown. Many of these individuals were children whose parents chose not to have them vaccinated. Fifteen of the patients, including four infants, were hospitalized.” 54Ibid.
Scientists fear that families will continue to reject vaccinations as a result of the Wakefield paper, even in light of its complete retraction and Wakefield’s conduct. Thanks in large part to the Daubert procedures put in place as a result of the Bendectin litigation, the autism-vaccine litigation has received a much shorter shelf life in the courts than the erroneous link will in the minds of the public at large.
B. Autism-Vaccine Litigation and the Omnibus Autism Proceeding
The Vaccine Act was adopted in response to a health scare that the diphtheria-pertussis-tentanus vaccine, commonly called DPT, caused neurological damage. By 1986 suits so alleging had “become common,” 55Arnold Reitz, Federal Compensation for Vaccination Induced Injuries, 13 B.C. Envtl. Aff. L. Rev. 169, 188 (1986). as had sizable settlements and verdicts. This prompted manufacturers to cease making the vaccine, thus threatening the national supply of the DPT vaccine and creating the impetus for the Vaccine Act. 56Catherine M. Polizzi, A Proposal for a Federal AIDS Immunization Policy, 9 J.L. & Health 1, 3 (1994); Peggy J. Naile, Tort Liability for DPT Vaccine Injury and the Preemption Doctrine, 22 Ind. L. Rev. 655, 682 (1989)
Under the Vaccine Act, 5742 U.S.C. §§300aa-1 to -34 (2008). The Vaccine Act creates a no-fault compensation scheme for vaccine-related injuries. Doe v. Bayer Corp., 367 F. Supp. 2d 904, 908 (N.D.N.C. 2005). The compensation scheme allows injured parties to file a petition for compensation against the U.S. Government, rather than the vaccine manufacturer. Id. To recover, petitioners must first prove causation before a Special Master—once causation is demonstrated, the Special Master awards damages. Id. at 909 (citing 42 U.S.C. §300aa-10(a) (2008)). plaintiffs claiming vaccine-related injuries are required to first bring their claims in the federal Vaccine Court—“No civil action may be filed in state or federal court until the Vaccine Court has issued a judgment on the matter … .” 58Bayer, 367 F. Supp. at 909. Consequently, claims against manufacturers of the components of vaccines, namely thimerosal, proceed in the civil federal and state court system 59See e.g., Holder v. Abbott Labs., Inc., 444 F.3d 383, 389-390 (5th Cir. 2006) (holding that the Vaccine Act does not bar claims against Thimerosal manufacturers). while those against vaccine manufacturers have taken place before the Federal Claims Court. Most of those filed against vaccine manufacturers – numbering nearly 5,000 – were heard in the Vaccine Court. 60Id.
In both forums, Daubert has effectively denied plaintiffs what the lack of it gave in the Bendectin litigation: favorable verdicts that beget more cases and impart credibility. The civil cases seem to be fairing poorly; those reported have almost uniformly held expert opinions that vaccines cause autism to be unreliable and speculative under Daubert or its state corollaries. 61Doe v. Ortho-Clinical Diagnostics, Inc., 440 F. Supp. 2d 465, 475 (M.D.N.C. 2006); See Redfoot v. B.F. Ascher & Co., No. 05-2045PJH, 2007 WL 1593239, at 10 (N.D. Cal. June 1, 2007); Blackwell v. Wyeth, 971 A.2d 268 (Md. 2009) (affirming exclusion of expert under the Frye general acceptance test); Easter v. Aventis Pasteur, Inc., 358 F. Supp. 2d 574, 579 (E.D. Tex. 2005) (“the record will not permit the court to admit Dr. Bradstreet’s opinion on specific causation because of the concession that the plaintiffs cannot prove that [plaintiff’s] autism was caused by thimerosal.”).
Claims proceeding under the Vaccine Act have been similarly discredited in a closely followed Omnibus proceeding. Because those cases deal with a common factual issue, and because scientific data, with the sole exception of the Wakefield paper, has so far failed to find a causal connection between vaccines and autism, the Vaccine Court adopted a special process to facilitate discovery for petitioners through the Omnibus Autism Proceeding. 62Hazelhurst v. Sec’y of HHS, No. 03-654V, 2009 WL 332306 *1-2 (Fed. Cl. 2009); see also Bayer, 367 F. Supp. at 909-10. The Omnibus Autism Proceeding was instituted by the Vaccine Court to conduct a single discovery proceeding for the thousands of anticipated vaccine-autism claims. Bayer, 367 F. Supp. at 909. During the discovery period, petitioners received over 215,000 documents from the FDA, the CDC, and the Agency for Toxic Substances Disease Registry. See Hazelhurst, No. 03-654V, 2009 WL 332306, at *2. Following the approximately four year discovery period, the Vaccine Court decided to hear three independent test cases for each of petitioners’ theories of causation. 63As discussed above, petitioners originally planned to present three theories of causation (which would result in nine test cases), but the Office of Special Masters decided that petitioners’ theories could be adequately argued and decided using two groups of three test cases. See supra note 55 and accompanying text. It is important to note that even when an omnibus proceeding is utilized, each individual case will be resolved individually—however, in deciding other cases involving the same theory of general causation, judges will closely refer to the decisions on causation found in the test cases. Cedillo, No. 98-916V, 2009 WL 331968, at *12. The three recent test cases by the Court of Federal Claims determined whether the MMR vaccine alone causes autism and whether the combination of the MMR vaccine with the mercury-based preservative thimerosal causes autism. 64Three other test cases for a second general causation theory have been engaged in an “extensive post-hearing briefing process, which will conclude in the late spring of 2009.” Id. at *11 n.16. Three separate decisions will then be issued by three separate Special Masters on that theory as well. Id.
After thoroughly reviewing the mountains of evidence presented in the three test cases, 65In the Cedillo case alone, the two parties filed 23 expert reports, 658 medical journal articles or medical text excerpts, had a three-week evidentiary hearing where the parties presented 17 witnesses (16 of them experts). Id. at *10. The parties also filed extensive post-hearing briefs in all three cases. Id. at *11 all three Special Masters rejected petitioners’ theories of causation, ruling that petitioners’ experts failed Daubert’s reliability prong. 66See, e.g., Snyder v. Sec’y of HHS, No. 01-162V, 2009 WL 332044, at *194 (Fed. Cl. 2009) (“It is clear that petitioners’ theory is not generally accepted.”). In rejecting petitioners’ vaccine-autism causation theory, all three Special Masters applied the Daubert reliability factors to petitioners’ experts and found them lacking. 67Cedillo, No. 98-916V, 2009 WL 331968, at *3; Hazelhurst, No. 03-654V, 2009 WL 332306, at *15-16; Snyder, No. 01-162V, 2009 WL 332044, at *138-39. These cases also refer to a Vaccine Act decision by the Federal Circuit which uses the “causation-in-fact” standard—a standard very similar to the Daubert standard. Cedillo, No. 98-916V, 2009 WL 331968, at *77 (citing Althen v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005)). Dr. Wakefield was a central figure among petitioners’ experts. 68Along with his influential study published in 1998 referred to above, Dr. Wakefield co-authored vaccine-autism articles with two of petitioners’ experts (Drs. Bradstreet and Kawashima), and Wakefield’s now-retracted 1998 article greatly influenced the findings of three other petitioner experts (Drs. Kinsbourne, Corbier and Krigsman). Cedillo, No. 98-916V, 2009 WL 331968, at *54-56, 79-80, 103. All three courts, especially the Cedillo court, went to great lengths in demonstrating Wakefield’s lack of both credibility and scientific reliability under Daubert. In Michelle Cedillo’s test case, 69See supra notes 56-63 and accompanying text. Special Master Hastings explained that since Wakefield’s 1998 article, several studies by a number of different research groups “found no evidence that the MMR vaccination is associated with autism.” 70Id. at *86. Special Master Hastings also pointed out that ten of Wakefield’s twelve co-authors on the 1998 article retracted the causation interpretation (that the MMR vaccine causes autism) of the article. 71See id. at *88; see also Simon H. Murch et al., Retraction of an Interpretation, 363 Lancet No. 9411, at 750 (Mar. 6, 2004). Furthermore, a week before the three test-case rulings were issued, the London-based Sunday Times reported that Dr. Wakefield “misreported results in his research [in the 1998 article], creating the appearance of a possible link with autism.” 72Brian Deer, MMR Doctor Andrew Wakefield Fixed Data on Autism, Sunday Times, Feb. 8, 2009, available at http://www.timesonline.co.uk/tol/life_and_style/health/article5683671.ece. Two years before the 1998 article was published, Wakefield was hired by a law firm representing autism victims—eventually receiving 435,643 pounds for his work, plus additional funding to support his research. 73See Deer, supra note 65. Wakefield’s work was described as a “deception” and a “scientific fraud.” 74Cedillo, No. 98-916V, 2009 WL 331968, at *110-11. The causation theories presented by experts who relied upon Wakefield’s work were rejected as lacking a scientifically reliable basis under Daubert. 75See, e.g., id. at *81 (rejecting Dr. Corbier as an expert under Daubert’s peer-review/publication factor because “Dr. Corbier has not published, in any peer-reviewed journal, any articles relevant to autism or to the causation issues concerning which he opined.”); Snyder v. Sec’y of HHS, No. 01-162V, 2009 WL 332044, at *139 (Fed. Cl. 2009) (rejecting Dr. Kinsbourne’s theory of causation because he “has conducted no research on autism, has not actively treated patients for more than 17 years, has published only a few speculative and theoretical articles on autism … .”); Snyder, No. 01-162V, 2009 WL 332044, at *194 (“It is clear that petitioners’ theory is not generally accepted.”). The remaining experts for the petitioners were similarly rejected under Daubert, the Special Masters finding their causation theories “weak, contradictory, and unpersuasive.” 76Snyder, No. 01-162V, 2009 WL 332044, at *147. There were three separate proceedings at the U.S. Court of Federal Claims, all of which were rightly affirmed on appeal. 77Hazlehurst ex rel. Hazlehurst v. Secretary, Dept. of Health & Human Services, 2009 WL 2371336, 6 (Fed. Cl.) (Fed. Cl., 2009); Cedillo v. Secretary, Dept. of Health & Human Services, __ Fed. Cl. __ (Aug. 6, 2009) (“the Court finds that Petitioners’ arguments linking Michelle Cedillo’s injuries to thimerosal and the MMR vaccine are without merit.”).
C. Bendectin v. Vaccine-Autism Theory
Setting aside the unique forum of the Claims Court, the vaccine litigation is, in terms of tort dynamics, practically indistinguishable from the Bendectin litigation. It, like Bendectin, involved a terrifying claim of harm to infants and children that received widespread and favorable media and political attention. As with Bendectin, there was a massive pool of potential plaintiffs all with potentially sizable personal injury claims. Both litigations feature an initiating protagonist that have now been found to have not been truthful in their original work.
The institutionalization and refinement of judicial scrutiny that has taken place in the years separating the two litigations, however, has allowed the legal system to treat the claims quite differently. The pre-Daubert system of the 1980s and early 1990s lent an aura of legitimacy to the unfounded Bendectin claims. The widely reported verdicts it produced, even when quietly reversed years later, gave credibility to the proposition that Bendectin caused birth defects without ever demanding the bona-fides the scientific community would itself require before so espousing. Doing so had and continues to have real world consequences. One sees in the Bendectin litigation that a substance that is both effective and widely needed will always make a tempting toxic tort target because so many people are exposed to it. Bendectin was an attractive litogen because 30 million women took it, and the reason 30 million women took it is because it worked to alleviate morning sickness. 78James M. Sabovich, Petition Without Prejudice: Against the Fraud Exception to Noerr-Pennington Immunity from the Toxic Tort Perspective, 17 Penn. St. Envtl. L. Rev. 28-32 (2008) So when litigation drove it from the market, society lost, and continues to be without, something valuable in the aggregate (increased productivity, decreased hospitalization for nausea, etc.) and valuable in terms of pure quality of life. Up to eighty percent of pregnant women suffer from nausea 79Jeffrey Quinland & Ashley Hill, Nausea and Vomiting of Pregnancy, 68 Am. Fam. Physician 121 (2003), available at http://www.aafp.org/afp/20030701/121.html. and no doubt one-hundred percent of those women would rather they did not.
The same principles apply to vaccines. Virtually everyone is “exposed” to vaccines and for good reason: vaccines prevent diseases that would otherwise kill or maim a great many people. The smallpox vaccination alone is estimated to save three million lives per year globally. 80R. Levine and the What Works Working Group, with M. Kinder, Millions Saved: Proven Successes in Global Health (Washington: Center for Global Development, 2004). More and more, it seems probable that one of the other great predators of humans, cancer, may be susceptible in some of its forms to vaccines, too. 81National Cancer Institute, FactSheet: Cancer Vaccines (3/17/2009) at http://www.cancer.gov/cancertopics/factsheet/Therapy/cancer-vaccines. Judicially discouraging vaccination, then, has serious implications. Before Dr. Wakefield’s 1998 study, 56 cases of measles were reported in Britain. 82See Deer, supra note 65. Ten years later, measles had returned to “endemic” levels in Britain—reporting 1,348 measles cases in 2008. 83Id. (“With less than 95% of the population vaccinated, Britain has lost its herd immunity against [measles].”). In 2006, a thirteen-year-old boy became the first person in the UK to die from measles in fourteen years. See Brian Deer, How the MMR Scare Led to the Return of Measles, Sunday Times, Feb. 8, 2009, available at http://www.timesonline.co.uk/tol/life_and_style/health/article5683687.ece. With parents still questioning whether vaccines cause autism despite so much evidence to the contrary, illnesses that have virtually disappeared in first-world countries continue to make a resurgence.
Possibly recognizing the past toxic tort debacles of the Bendectin litigation and the breast-implant litigation, 84See Sabovich, supra note 14, at 32-34; see also Doe v. Bayer Corp., 367 F. Supp. 2d 904, 908 (N.D.N.C. 2005) (explaining that the compensation scheme for vaccine-related injuries was designed to “ease the burden on both injured parties and vaccine manufacturers” in toxic tort suits by reducing attorneys fees, courts fees and insurance fees). The compensation scheme itself shows a realization that trying each individual toxic tort case, or even a class of cases has exorbitantly high costs with potentially no returns for the alleged victims. Bayer, 367 F. Supp. at 908. the Court of Federal Claims decided to conduct an orderly and extensive discovery process followed by three thorough test-case hearings on petitioners’ causation theories. Although the Special Masters’ findings did not immediately bring all vaccine-autism litigation to an end, 85After the Vaccine Court has made its rulings, individual plaintiffs can choose to reject the Special Masters’ decisions and file their cases in civil jurisdictions throughout the country. Bayer, 367 F. Supp. at 909. However, civil courts will very likely look to the very thorough decisions made in the Court of Federal Claims as a guide to their decisions. See, e.g., Redfoot v. B.F. Ascher & Co., 2007 U.S. Dist. LEXIS 40002 (N.D. Cal. 2007) (referring to past Court of Federal Claims decisions, the court excluded plaintiffs’ sole causation witness who would testify that thimerosal in nasal spray caused a boy’s autism). the rulings represented Daubert’s successful impact in preventing junk science from being improperly used to show causation—a fact that has now been affirmed by the Lancet’s retraction of the 1998 Wakefield paper that started this glut of false vaccine litigation in the first place. The Bendectin litigation resulted in forty-nine published and unpublished appellate decisions—all cases eventually being decided for defendants. 86See Sanders, supra note 6, at 156-58. These cases represent only a fraction of an enormous waste of time and money for all parties involved in the Bendectin litigation. The vaccine-autism litigation, however, appears to be headed toward a different, much less wasteful legal result. The judges who will hear each of the over 5,000 vaccine-autism claims still pending in the federal Vaccine Court now have a clear guide for deciding causation, 87See Cedillo v. Sec’y of HHS, No. 98-916V, 2009 WL 331968, at *12 (Fed. Cl. 2009). and the defendants and Vaccine Court now have even stronger proof that there is no causal link. If plaintiffs decide to reject the Vaccine Court’s rulings on causation and take their claims to other jurisdictions, civil courts throughout the United States also have a clear and very thorough guide to follow when deciding vaccine-autism causation. 88See supra note 90 and accompanying text.
Conclusion
With the retraction of the article that started the vaccine litigation and the Vaccine Court’s rejection of its causal premise, the vaccine litigation appears to be ending. That ending brings occasion to reflect on the institutionalized judicial scrutiny meant to treat the “legal pathology” exposed by the vaccine litigation’s predecessor, the Bendectin litigation. 89Gary Edmond, Whigs in Court: Historical Problems With Expert Evidence, 14 Yale J.L. & Human 123, 160 (2002). All things considered, what Judge Kozinski called the “Brave New World” of judicial scrutiny is better than the old one and the “heady task” is worth doing.
