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The war against junk science: the use of expert panels in complex medical-legal scientific litigation
Biomaterials 19 (1998) 1425 — 1432
The war against junk science: the use of expert panels in complex medical-legal scientific litigation Joseph M. Price*, Ellen S. Rosenberg1 Faegre and Benson LLP, 90 South Seventh Street, 2200 Norwest Center, Minneapolis, MN 55402-3901, USA
Abstract In the legal context, junk science is defined as evidence that is outside of mainstream scientific or medical views. Junk science does not have indicia of reliability and is not generally accepted. Despite the lack of scientific reliability, US courts, expert witnesses and juries are increasingly reliant on junk science in making causation decisions in complex medical liability cases. Courts have accepted junk science even where reliable scientific evidence is available. The United States silicone gel breast implant litigation is a prime example of this phenomenon. The issue of whether silicone breast implants are associated with disease has been a controversial subject for scientists and physicians, an emotional issue for women who have breast implants, and a lucrative business for the lawyers and expert witnesses who are the proponents of junk science. Junk science has provided to juries a quick and convenient explanation for claimed diseases or syndromes which have required years for reliable scientists to conclude are not related to breast implants. The breast implant litigation highlights the often dramatic difference between decisions based upon junk science and decisions grounded in scientific method, fact and reality. Recently, judges involved in the breast implant litigation have become concerned about the use of junk science in light of the growing body of legitimate scientific evidence that breast implants do not cause disease. Several judges have been motivated to take the unique and novel approach of convening scientific panels of independent experts to study the scientific issues and make findings to the court. Through the use of independent scientific experts, several judges have meaningfully assessed the evidence that the litigants present and have prevented or strictly limited the use of junk science in the courtroom. Using this procedure, other judges are weighing the evidence for future cases. This paper will briefly explore the background of mass tort medical products litigation and the development of junk science. The paper will then focus on the history of the breast implant litigation and the steps that the courts have already taken to combat junk science, including the use of scientific panels. ( 1998 Elsevier Science Ltd. All rights reserved
2 the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags behind science; it does not lead it [1].
1. Introduction A matter of continuing concern to biomedical manufacturers and material suppliers is the ongoing, ever escalating issue of products liability litigation. One need only examine the proliferation of injury lawsuits involving products such as the Norplant contraceptive, penile pros*Corresponding author. Tel.: 612336-3000; fax: 613336-3026; e-mail: [email protected] 1The authors represent various medical manufacturers in biomedical mass tort litigation. The opinions expressed here are their own and not necessarily their clients’. 0142-9612/98/$19.00 ( 1998 Elsevier Science Ltd. All rights reserved. PII S 0 1 4 2 - 9 6 1 2 ( 9 8 ) 0 0 0 5 2 - 0
thesis, silicone breast implants, latex gloves, or pedicle screws, to name a few, to understand the threat presented by a seemingly unchecked legal system. Compounding the problem is the increasing impact of ‘junk science’ which materially affects the outcome of the lay jury decision-making process. This concept is premised on the acceptance of courts and juries of expert witnesses and ‘scientific’ studies at the fringe of, or even beyond, the outer perimeters of mainstream scientific or medical views. Reliance on such questionable scientific witnesses and testimony has resulted in runaway jury verdicts and consequently the loss to society of otherwise useful products as wide ranging as the anti-nausea drug
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Bendectin, silicone gel breast implants and biomaterials such as Teflon. Only recently have a few courts begun to reject otherwise unreliable and unsound scientific witnesses and data by the use of, and reliance on, scientific experts independent of the litigation process. These witnesses are called upon to give neutral, unbiased and scientifically sound analysis of otherwise questionable medical or scientific propositions. The purpose of this paper will be to explore the evolution of medical products liability, the rise of ‘junk science’ and the recent attempts to restore balance to a system that, to the objective observer, seems to be distorted in favor of unsound medical and scientific propositions.
2. Biomedical product and materials litigation and the advent and proliferation of ‘junk science’ Society today is faced with a flood of mass-tort products liability litigation involving pharmaceuticals, medical devices and biomaterials. This litigation constitutes a clear and present threat to manufacturers and suppliers of products that are generally thought to have significant social utility. This crisis threatens not only the existence of those manufacturers and providers, but also the ability of society to obtain otherwise useful and beneficial products which are demanded for the purposes of sustaining, prolonging and enhancing our quality of life. In the development of drugs and medical devices, manufacturers must incorporate the assumption that a product could possibly cause harm to some future user. It is incumbent upon the manufacturer to estimate the magnitude of the problem and to predict the likelihood of its occurrence. Consistent with that analysis is contemplation of the possibility of products liability litigation. Factors which may impact upon products liability exposure and potential litigation include [2]. 1. the risk of causing injury from known or unknown side effects, 2. loss of public confidence because of adverse publicity from lawsuits either won or lost, 3. cost from litigation even if the case is not meritorious including indirect costs such as disruption of business and the direct costs such as litigation and settlement expense. 4. delayed liability exposure from side effects which may not occur for five, ten or twenty years after manufacture and sale. 5. the potential for mass tort product liability litigation. 6. government investigations. 7. inability to rely upon governmental agencies as protection against liability. 8. cost and unavailability of product liability insurance and self insurance.
9. the political climate and tort reform. 10. the uncertainty of having highly technical and complex scientific issues evaluated by a judge and jury untrained in science and medicine. It is this last issue which has given rise to much of the present day mass tort litigation and put ‘junk science’ into the limelight. The concept of ‘junk science’ in products liability litigation is premised on the reliance by courts and juries on expert witnesses and studies which are outside the mainstream of scientific or medical evidence. Evidence is presented to lay juries by so called ‘experts’ who render opinions that are: 1. at the limits of scientific detectability or beyond, 2. of marginal statistical significance, 3. proposing hypothesis disregarding established theory, 4. embracing untested mechanisms for the effect reported on, and 5. without testing to see if the hypothesis is in any way false. 2.1. Plaintiffs+ lawyers escalate mass tort litigation Any understanding of the threat presented to biomedical manufacturers by ‘junk science’ requires an understanding of mass tort litigation and the approach used by successful plaintiffs’ lawyers. Their ultimate objective is to achieve huge damage recoveries under the implied or actual threat of driving a company, or an entire industry, into bankruptcy or insolvency. Mass torts such as the Dalkon Shield litigation, silicone gel breast implants and Norplant usually start out as individual cases against the biomedical manufacturer. Because the products involved, i.e. drugs and medical devices, are used by large numbers of people, and are rarely, if ever, risk free, once a perceived problem or defect is noted, litigation grows exponentially. As more claims are made, more plaintiffs’ lawyers join in the assault on the manufacturer, suppliers or both, and the result is an ever-escalating number of lawsuits. The cost and expense of defending thousands of lawsuits, as well as the potential exposure of jury verdicts often forces companies to settle unmeritorious litigation to avoid the drain on finances and resources: The dynamics of a mass tort demand that companies try to settle litigation—regardless of the merits—if they want to continue in business. The volume of lawsuits, their oppressive weight, is what brings companies to their knees. This is no exaggeration; just ask any major asbestos defendant, almost every one of which has been vaporized by litigation [3]. When one combines the crush of numbers of claims with the contingent fees generated to the lawyers, the incentives become understandable, yet unacceptable. Plaintiffs’ lawyers use the media and lawyer advertising to amass high numbers of cases which amount to economic blackmail. Because of the expense of defending
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multiple cases in multiple jurisdictions, a cost that sometimes may rise to $1 million per trial, defendants cannot afford to win every case brought against them. Plaintiffs’ lawyers hope that this type of pressure will force mass settlements. Through media hype and lawyer advertising, plaintiffs’ attorneys scare thousands of susceptible and often vulnerable claimants into filing lawsuits. The plaintiffs’ bar hires public relations firms to target reporters who will give them favorable press. The media is often merely a tool of an extremely well organized plaintiff’s bar: ‘Unfortunately, a number of journalists and medical organizations have not presented a balanced and informed view on the safety of silicone implants during the past year. This type of press has created an undue amount of unnecessary anxiety in many women, which in turn has provoked litigious behavior and inappropriate demands for explant surgery’ [4]. 2.2. Litigation results in loss of biomaterials In 1993 the Health Industries Manufacturers Association (HIMA) commissioned Aronoff Associates to do a study of the biomaterials market and the impact, in part, of catastrophic lawsuits. They found a pervasive fear of exposure to costly, possibly catastrophic lawsuits among those who manufactured or supplied raw materials to be used in medical devices [5]. Aronoff Associates revisited the issue for HIMA in 1997 with a subsequent report entitled ‘Biomaterials Materials Availability: A Vital Health Care Industry Hangs in the Balance’ [6]. Aronoff discovered that of the material supplier companies surveyed, 25% (down from 42% in 1993) were currently supplying or willing to consider supplying implant manufacturers. The remaining 75% were not willing to supply the medical manufacturer market. With respect to this decision, the risk of legal liability was a key factor for 100% of the suppliers while the market size was a key factor for only 60% of the suppliers and humanitarian concerns were a factor for 10% to 25% of the suppliers. For example, the impact of the Temporo-Mandibular Joint (TMJ) litigation on Dupont had a huge impact on other materials providers. Aronoff estimated that the cost of Dupont’s defense of hundreds of cases throughout the country cost $8 million per year [6, pp. 6, 7]. Aronoff commented: Because it requires only small volumes of materials that are used in perceived high liability risk applications, the medical implant industry has become a pariah to suppliers. Indeed, the policies of some supplier companies have become so restrictive that they have prohibited use of their materials for any implant device ‘regardless of the intended duration of implantation’ 2 [6, p. 9]. This has resulted in the disappearance of small companies and start up companies resulting in a restructur-
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ing of the biomaterials industry. The development of new and improved life saving, life enhancing implants has stagnated. Additionally, the report foresees a narrowing of the choices for doctors over the next five years in providing the best treatment for patients because implant products will disappear from the market [6, pp. 9, 10]. 2.3. Junk science experts perpetuate unfounded science Essential to the creation of a mass tort is the development of a small group of so-called ‘experts’ who will espouse ‘fringe’ theories sufficient to convince lay judges and juries to award large verdicts. ‘Junk science’ has tremendous negative societal ramifications and costs. In the drug arena, the anti-nausea pregnancy drug Bendectin swiftly fell to the onslaught of mass tort litigation. The Norplant contraceptive is currently under similar siege. Biomaterials such as Teflon, latex and silicone have been under continuous attack as have end products like Temporo-Mandibular Joint (TMJ) replacements and silicone gel breast implants. As early as 1986, the United States Attorney General’s Tort Policy Working Group expressed concern about the increasing reliance of judges and juries upon expert witnesses and studies ‘on the fringe or even well beyond the outer perimeters of mainstream scientific or medical views’ [7]. It was reported that ‘[t]he use of such invalid scientific evidence (commonly referred to as ‘junk science’) has resulted in findings of causation which simply cannot be justified or understood from the standpoint of the current state of credible scientific and medical knowledge’ [7]. Mass tort litigation and ‘junk science’ would not occur without highly paid expert witnesses who present fringe theories of liability in return for large financial rewards. Usually these theories have no solid scientific basis. Many such experts receive anywhere from $500 to $1000 per hour or more for their time testifying to unfounded scientific theories. Some have teamed up with plaintiffs’ attorneys to actively recruit potential claimants for litigation [8]. Others have their own financial interest in the litigation, having started laboratories and developed ‘scientific tests’ to test for illness or disease allegedly caused by the product [8]. ‘Junk science’ should be barred from the courtroom for a number of reasons, including: 1. The premise that juries can separate good science from bad science and are not persuaded by specious scientific arguments is incorrect when highly technical scientific issues are pitted against a sympathetic and often badly injured plaintiff. 2. Introduction of unreliable scientific evidence increases the chance that a jury will arrive at an unjust verdict because the evidence is inherently prejudicial due to the ‘aura of infallibility’ which encourages jurors to accept it without critical scrutiny.
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3. Introduction of unreliable scientific evidence also undermines the integrity of the fact-finding process because jurors do not have a sufficient understanding of the scientific principles underlying the competing theories presented to them to adequately evaluate and distinguish between those theories. 4. Jurors who come to a case lacking an understanding of the scientific method and who are not sufficiently instructed regarding it at trial are ill-equipped to arrive at a just verdict. Left to decide between two equally incomprehensible scientific theories, jurors are likely to simply disregard both and decide the case based on other factors such as empathy towards one of the parties rather than on the scientific merits [9].
3. Judicial standards for scientific evidence Whether it involved Bendectin, silicone breast implants, Norplant, latex gloves, penile prosthesis, TMJ devices or pedicle screws, most of the mass tort litigation has been generated, in large part, by ‘junk science’ propounded by a small group of expert ‘true believers’ (who had a huge financial stake in litigation). In most instances, these ‘experts’ had some scientific or medical degree or background but did not apply a valid scientific method to their analysis. Traditionally, courts have permitted such ‘experts’ to testify. The general approach of courts was that even these outlandish opinions should be presented to a jury to be tested by cross-examination by the other side. The analysis went to the weight not the admissibility of the testimony. This meant that the courts would not preclude the scientific evidence but would leave it up to lay jurors to decide how much emphasis they would give it. As one commentator has noted: [s]cientific evidence impresses lay jurors. They tend to assume it is more accurate and objective than lay testimony. A juror who thinks of scientific evidence visualizes instruments capable of amazingly precise measurement, of findings arrived at by dispassionate scientific tests. In short, in the mind of the typical lay juror, a scientific witness has a special aurora of credibility [10]. The problem with allowing jurors to evaluate complex scientific evidence is that most will not have sufficient scientific knowledge based on their life’s experience to be able to adequately analyze competing theories. ‘[M]ost people, which includes those who compose juries, do appreciate science but do not know how it is done nor how it works’ [11]. The difficulty of delegating scientific decisions to lay jurors was illustrated in an editorial by Dr. Marsha Angell in the New England Journal of Medicine: 2 scientific conclusions cannot be based on argument and opinion. There must be data. Yet, in the court-
room, acceptance of expert testimony on scientific questions usually turns on the ‘credibility’ of the witness, not the validity of the evidence on which the witness’s opinion is based [12]. Legal evidentiary standards, based on codified rules of evidence and case law, have governed the admissibility of expert testimony propounded to lay juries. For many years, the evidentiary standard was held to be some form of the rule enunciated in the case of Frye v. The United States, 293 F. 1013 (DC Cir. 1923). That case involved a type of lie detector test which measured systolic blood pressure in an attempt to determine whether the witness was telling the truth. The DC Circuit Court of Appeals, in rejecting the offered testimony, articulated a ‘general acceptance’ test for expert testimony which was founded on novel scientific concepts. The court held that ‘The thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs’. Frye v. United States at p. 1014. This rule seemingly prescribed a higher standard for admissibility of scientific evidence than for other types of evidence to prevent presentation of unsound scientific or medical theories to lay juries. For seventy years after Frye was decided, vigorous debate ensued over the admissibility standards of scientific evidence. Supporters of Frye applauded the result requiring general acceptance in the scientific community as a means of insuring that lay juries would not be overly impressed by theories that they lacked the appropriate capacity to evaluate. Critics, primarily plaintiffs’ advocates, and some legal scholars criticized Frye as being overly restrictive on the grounds that it would exclude otherwise reliable scientific evidence because it was ‘novel.’ Frye was also criticized because of difficulty in determining what exactly was the ‘particular field’ to which the offered evidence belonged, as well as whether it was in fact generally accepted. Some courts relied on the concept of peer review publication as a determination for general acceptance. Since 1975, when the codified Federal Rules of Evidence were adopted, a number of courts have rejected the Frye test. This set the stage for re-analysis of the issue by the United States Supreme Court in the case of Daubert v. Merrill Dow Pharmaceutical, Inc., 113 S. Ct. 2786 (1993). Daubert involved on appeal to the United States Supreme Court of the validity of scientific evidence introduced in connection with a Bendectin case. The Supreme Court found the Frye test to be replaced by Federal Rule of Evidence Rule 702 which states that ‘[i]f scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.’ The Supreme Court then ruled that the Federal Rules of
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Evidence, with their ‘liberal thrust’ was at odds with the ‘rigid general acceptance requirement’ of Frye [13]. Daubert required trial judges to become ‘gatekeepers’ and to perform a gatekeeping function to ‘insure that any and all scientific testimony or evidence admitted is not only relevant but reliable [13, p. 2795]. Judges were required to do a preliminary assessment of the reasoning or methodology underlying proposed testimony to determine whether it was valid and could properly be applied to the facts at issue [13, p. 2796]. Scientific evidence should only be admitted if it was founded on ‘scientific knowledge’ implying ‘a grounding in the methods and procedures of science’ and connoting more than just ‘subjective belief or unsupported speculation’ [13, p. 2795]. The Supreme Court found it particularly important to determine whether the evidence could be or had been actually tested [13, p. 2796], whether the theory or technique had been subject to peer review and publication, what the known or potential risk of error was and whether the conclusion had been generally accepted in the scientific community [13, p. 2797]. Thus, the Court essentially adopted standard scientific methodology and applied it to the legal arena. Predictably, reactions to the Daubert decision were mixed. Some felt that the test was too vague to apply. Federal judges protested that they were ill-equipped to fulfill the Daubert mandated role of scientific gatekeeper since many of them were no more scientifically adept than lay jurors. Some judges continued to just apply general acceptance criteria. Some used the standards of testability, peer review, error rate and general acceptance and others applied their own standards to the issue of scientific admissibility. Application of the Daubert standard is still evolving today and is likely to spawn additional court decisions and, probably, further confusion.
4. Scientific panels Recently several courageous and forward thinking courts concluded that their role as gatekeeper was one which required the assistance of more qualified participants. This conclusion arose out of the experience of the silicone breast implant litigation. Silicone has long been recognized as a safe, and efficacious implantable biomaterial with a history dating back almost 50 years in the biomedical arena. It was used in heart valves, pacemakers, shunts and orthopedic devices. Silicone gel breast implants were first marketed in the early 1960s and have well over 30 years of history, attesting to their safe use. Litigation replaced the scientific method as the arbiter of sound scientific and medical policy in 1982 when a series of anecdotal reports first appeared hypothesizing a possible link between silicone and various traditional autoimmune diseases and, later on, atypical
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connective-tissue disease. These reports were uncontrolled, involved very small populations and could not rule out other potential causes of these autoimmune diseases and symptoms, all of which occur in the female population (without breast implants) at large. The scientific way to determine whether silicone gel breast implants are associated with disease is by sound, well-reasoned epidemiologic studies. Such epidemiologic studies have gone on for the past ten years and do not support a causal relationship between silicone gel breast implants and autoimmune disease. In fact, virtually all of the epidemiologic data available today concludes that silicone gel breast implants do not cause autoimmune disease [14—18]. Today, there are more than 20 such studies. Despite the lack of valid scientific substantiation, plaintiffs and their lawyers in the 1980s and early 1990s regularly prevailed in convincing lay juries to award huge verdicts (some as high as $25 million) to women who claimed that their autoimmune disease was caused by their silicone gel breast implants. More recently, manufacturers have won most of the lawsuits litigated against them on the issue of silicone induced autoimmune disease. Even these verdicts, however, came at enormous expense to the manufacturers. There are thousands of lawsuits pending against the silicone manufacturers. The litigation has driven Dow Corning Corporation, the largest of the silicone breast implant manufacturers as well as another manufacturer, Bioplasty, into bankruptcy. Breast implant material suppliers have been sued as well. The transactional costs of defending against plaintiffs’ unsupported and unscientific claims has threatened the existence of an entire industry. The cost of defending these cases became so exorbitant that the manufacturers entered into a proposed ‘global’ settlement to attempt to resolve the litigation. The factors that mitigated in favor of this proposed global settlement had nothing to do with fault or liability on the part of manufacturers but was generated by the take over of American courtrooms by ‘junk science’ orchestrated by the plaintiffs’ personal injury bar. In connection with the breast implant litigation, the plaintiffs’ personal injury lawyers created a cottage industry for a small number of generally unqualified ‘expert’ witnesses some of whom have been paid over $1 million to testify about dangers of silicone and breast implants. The combination of ‘junk science experts’, the plaintiffs’ bar, and mass media hysteria have been largely responsible for the crisis concerning silicone gel breast implants and which has now spread to the Norplant contraceptive, penile prosthesis and other medical products. These developments prompted several judges to exercise their gatekeeper function under Daubert. The Federal Judicial Center, in 1994, in its Reference Manual on Scientific Evidence [19] devotes an entire section to a discussion of the use of court-appointed
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experts in complex litigation noting that these experts are increasingly used to educate judges on the fundamental scientific concepts on which the parties’ experts differ and to offer assessments of the methodologies on which those experts base their opinions. The manual offers advice as to when special masters should be appointed to sift through scientific evidence or manage pretrial issues involving expert testimony. Federal judges have two additional tools available to them. Under Rule 104 of the Federal Rules of Evidence ‘[p]reliminary questions concerning the qualifications of a person to be a witness, the existence of a privilege, or the admissibility of evidence shall be determined by the court 2 .’ Additionally under Rule 706 of the Federal Rules of Evidence, the ‘court may on its own motion or on the motion of any party enter an order to show cause why expert witnesses should not be appointed, and may request the parties submit nominations. The court may appoint any expert witness agreed upon by the parties and may appoint expert witnesses of its own selection 2 .’ These two tools give federal judges the power to appoint independent expert witnesses or panels to either assist them in arriving at decisions relating to the admissibility of proffered ‘junk science’ or to act as independent expert witnesses to weight the issues and testify, not at the calling of any party, but as a witness of the court. The process which resulted in independent experts analyzing the scientific evidence being offered in silicone gel breast implants started in April 1996 when US District Judge Jack Weinstein [20] appointed several experts from various academic backgrounds to serve as a selection panel to locate scientific experts for appointment to a panel that would consider the general principles for establishing cause and effect in the silicone breast implant litigation [21]. Judge Weinstein asked the selection panel to particularly focus on claims relating to ‘immune system dysfunction in connective-tissue and rheumatic disease’. He chose a law professor and two scientists, one of whom was also a lawyer, to select the scientific expert panel [22]. Judge Weinstein was joined by US District Judge Harold Baer and State Supreme Court Justice Joan Lobis in authorizing the selection panel to select preeminent scientific experts to analyze the causation issues. This approach was authorized pursuant to Rule 706 of the Federal Rules of Civil Procedure. At about the same time at Judge Weinstein was organizing his panel, US District Court Judge Robert Jones of the US District Court in Portland, Oregon, concluded that he too would appoint a panel of expert witnesses to evaluate silicone gel breast implant testimony. He embarked upon the selection of an expert panel to be comprised of an epidemiologist, rheumatologist, immunologist and polymer chemist to evaluate the plaintiff’s proffered expert witness testimony [23].
The existence of competing scientific expert panels caused concern in some circles because of the risk of conflicting or confusing outcomes. Because of this potential for conflict and confusion, US District Court Chief Judge Sam Pointer of Birmingham, Alabama, the judge to whom all of the federal silicone gel breast implant cases were assigned for pretrial handling by the Judicial Panel on Multi-District Litigation, appointed, as part of the multi-district litigation proceedings, a Rule 706 Panel consisting of four experts in the area of rheumatology, epidemiology, immunology and toxicology. The purpose of Judge Pointer’s panel was to determine the extent to which ‘existing studies, research, and reported observations provide a reliable and reasonable scientific basis for one to conclude that silicone gel breast implants cause or exacerbate’ 2 any one of a number of conditions outlined for the panel [24]. As a result of Judge Pointer’s appointment of a national scientific panel under Rule 706, Judge Jones determined to proceed with his hearings on the admissibility of plaintiffs’ scientific evidence and to convert his scientists from a Rule 706 panel of potentially testifying experts to a Rule 104 panel of technical advisors who would assist him in the examination and analysis of the testimony proffered by the plaintiffs. With expert assistance, Judge Jones would then rule on the soundness of plaintiffs’ science. Judge Jack Weinstein, along with Judges Baer and Lobis, deferred to Judge Pointer concerning the appointment of an expert panel under Rule 706 (in fact Judge Pointer conscripted Judge Weinstein’s selection panel to help choose his own Rule 706 experts) and went forward with court hearings on the validity of the science pursuant to the Supreme Court’s mandate relating to the gatekeeper function under the Daubert decision. Judge Jones and his technical advisors held lengthy hearings and reviewed hours of testimony presented by the plaintiffs and their ‘junk science’ experts as well as experts called by the defendant manufacturers. The technical advisors and Judge Jones were also provided with vast quantities of scientific literature, studies, journal articles, data and other materials as well as argument by the respective parties as to the scientific implications of the evidence. At the end of the process the technical advisors wrote lengthy opinions which were given to Judge Jones to enable him to better understand the issues and to reach conclusions concerning the reliability of the plaintiffs’ offered evidence on the causation issues. After all the material was submitted, Judge Jones provided his technical advisors with a series of specific questions which they were to address as part of their reports. Those specific questions involved the following: 1. Is the expert’s opinion supported by generally accepted scientific reasoning and methodology? 2. Is the expert’s opinion based upon scientifically reliable data?
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3. If epidemiological studies have not been done or are inconclusive, what other data can justify, to a reasonable medical probability, a conclusion concerning the cause of the syndrome or disease at issue? 4. Do the methodology and data support the expert’s conclusion? 5. Does the scientific data relied upon by the expert apply to the syndrome or disease at issue in these cases? [25]. Based on the information received from the technical advisers and Judge Jones’ analyses of Daubert he reached the conclusion that: Because ACTD [atypical connective-tissue disease] is at best an untested hypothesis, there is no scientific basis for any expert testimony as to its causes and presence in plaintiffs. Therefore, defendants’ motions [to exclude the testimony of plaintiffs’ experts] are granted as regards any expert testimony relating to the existence and causation of any atypical siliconecaused, autoimmune disorder [25, p. 1402]. Judge Jones analysis of plaintiffs’ experts led him to the opinion that their testimony was inherently unreliable. His ability to reach these conclusions was largely enhanced by the input from his scientific advisors panel which discredited plaintiffs ‘junk science’ experts ‘well traveled opinions’. Accordingly, he struck all of plaintiffs causation experts. Judge Jack Weinstein, in New York, concluded that he would not impanel his own separate Rule 706 experts, or use technical advisers, but he conducted hearing on his own to examine the testimony of expert witnesses offered by plaintiffs in the New York litigation. He was also given the information provided to Judge Jones in Oregon and had the Oregon experts’ reports available to him. After lengthy hearings from plaintiffs’ and defendants’ experts, Judge Weinstein issued an opinion which mirrored Judge Jones’ conclusions: It was the position of plaintiffs’ experts, controverted by those of defendants, that a new undifferentiated atypical disease associated with exposure to silicone was caused by silicone gel implants. The hundreds of symptoms associated with this undifferentiated disease, the lack of any acceptable agreed upon definition, the inadequacy of any satisfactory supporting epidemiological or animal studies, the lack of a scientifically acceptable showing of medical plausibility, and the questionable nature of the clinical conclusions of treating doctors, all point to a failure of proof in making a prima facie case that silicone implants cause any of the syndromes claimed except for local disease [26]. Judge Weinstein struck all of the plaintiffs’ expert witnesses on the issue of causation and bifurcated the issue of systemic disease from the issue of ‘local’ injury. He agreed to hear cases involving claims such as rupture, silicone gel migration, capsular contracture, etc. but suspended all of plaintiffs’ claims relating to systemic disease
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pending resolution of the scientific issue by Judge Pointer’s 706 Panel in Birmingham, Alabama. Judge Pointer, using Judge Weinstein’s selection panel, appointed a preeminent group of scientists including a rheumatologist, epidemiologist, immunologist and toxicologist to review the vast scientific literature relating to silicone gel breast implants and disease. That panel has been pouring over volumes of data and analyzing all of the scientific literature in preparation for its ultimate analysis of the issues. As of the writing of this article, hearings are set for Birmingham, Alabama, on 23—25 July 1997 at which time the parties will present scientific evidence and experts for the panel to examine. Plaintiffs will attempt to convince Judge Pointer’s panel of an outcome different from the results reached by Judge Jones and his technical advisers and Judge Weinstein. The science, however, has not improved for the plaintiffs and the 706 Panel will review and analyze essentially the same evidence that led to Judge Jones and Weinstein’s opinions [27].*
5. Conclusion Dr. Marcia Angell summed the junk science situation up best in her recently published book Science On Trial: ‘2 This indifference to the need for evidence is a common threat in the many medical alarms that are sounded periodically in this country; the breast implant story simply illustrates it writ large. Whether or not breast implants are dangerous is not a question to be left with public opinion, corporate self interest and legal machinations. We ought to want to know the truth (or as near as we can come to it). But finding it requires careful scientific research and unbiased interpretation of the results. There are no shortcuts. Only by relying on scientific evidence can we hope to curb the greed, fear and self indulgence that too often govern such disputes. That is the lesson of the breast implant story [28]. The story of junk science is a sad one with a tremendous cost to society. Silicone breast implants are no
*Presented with the same evidence and another of the plaintiffs’ ‘junk scientists’ a Texas US District Court Judge had this to say: What Dr. Espinosa is arguing is that if a patient has the plaintiff ’s symptoms, anomalous blood chemistry, and breast implants, then she has implant-caused Sjo¨rgren’s syndrome. If she has the plaintiff ’s symptoms, anomalous blood chemistry and no breast implants, then she has non-implant Sjo¨gren’s syndrome. What sort of disease she has depends solely, in Dr. Espinosa’s opinion, as to whether or not she had breast implants. This is a bit like saying that if a person has a scratchy throat, runny nose and a nasty cough, that person has a cold; if on the other hand, that person has a scratchy throat, runny nose, nasty cough and wears a watch, they have a watch-induced cold. Obviously, this sort of reasoning is extremely suspect, which is why other courts have rejected it as well.
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longer generally available. Other silicone products for medical use are being litigated off the market. Norplant, penile prosthesis, testicular implants and other plastic surgery implants are no longer available or only available at enormous legal and social cost. Companies the size of Dow Corning Corporation have been driven into bankruptcy. Suppliers are refusing to sell biomaterials to manufacturers and as a result societally useful medical products are not available or are becoming extinct. Hundreds of millions of dollars are being spent on litigation and scarce research money is going to research junk science theories. This money could be better spent on the real issues that science and medicine face. Sadly, patients are being unnecessarily frightened and are not getting the proper medical treatment. This may be the greatest tragedy of the long and tragic history of the silicone breast implant litigation and junk science. Perhaps the scientific panel sitting in Birmingham, Alabama, will once and for all lay to rest the issues of the relationship between connective-tissue disease and silicone. More importantly, however, it may set a precedent for other judges in other courts to follow in complex scientific litigation. In difficult scientific areas such as those faced in the breast implant litigation, the Norplant litigation, latex gloves, penile prosthesis and others, reliance upon paid experts, many of them who make their living testifying in court, is not in accord with scientific method. Perhaps the use of independent court appointed neutral scientists to analyze these issues will enhance our abilities to analyze and evaluate complex scientific issues in a more dispassionate and less adversarial way influenced by the lawyers, the media and the profit motive. For once and for all we may be able to junk ‘junk science’ and return to a more rational approach to scientific problem solving under the scientific method.
References [1] Rosen v. Ciba-Geigy Corp., 78 F.3d 316 (7 Cir. 1996). [2] Institute of Medicine. In: Harrison P, Rosenfield A, editors. Contraceptive research and development. Washington DC. National Academy Press, 1996:303. [3] Nocera J. ‘Fatal litigation’. Fortune Magazine, Oct. 30, 1995. [4] The Council on Scientific Affairs of the American Medical Association. Silicone gel breast implants. JAMA 1993;2602:6. [5] Aronoff Associates, Market Study: Biomaterials Supply for Permanent Medical Implants (1994) (Health Industries Manufacturers Association).
[6] http://www.himanet.com. [7] 1986 Att’y Gen. Tort Policy Working Group Rep., The Causes, Extent and Policy Implications of the Current Crisis in Insurance Availability and Affordability 62. [8] Kolata G, Will the lawyers kill off Norplant? N.Y. Times 1995;3:1. [9] Price J, Kelly G. Junk science in the courtroom: causes, effects and controls 19 Hamline Law Review 1996;3:396—8. [10] Imwinkelreid J. Evidence law and tactics for the proponents of scientific evidence. In: Immwinelried J, editor. Scientific and expert evidence. 1981:33—7 (2nd ed., NYC: Practising Law Inst., 1981). [11] Furst A. The Frye rule is out; is junk science in? J Am Coll Toxic (1995);14(1):61, 65. [12] Angell M. Do breast implants cause systemic disease? Science in the courtroom. New Eng J Med 1994;330:1748, 1748. [13] Daubert S. Ct. 113:2794. [14] Gabriel SE et al. Risk of connective tissue diseases and other disorders after breast implantation. New Eng J Med 1994; 330:1697, 1701—2. [15] Hennekens et al. ‘Self-reported breast implants and connectivetissue disease in female health professionals. JAMA 1996;275:616. [16] Hochberg M et al. Frequency of augmentation mammoplasty in patients with systemic sclerosis: data from the John Hopkins University of Maryland Scleroderma Center. J Clin Epidemiology 1994;48:565, 567. [17] Sanchez-Guerrera J et al. Silicone breast implants and the risk of connective-tissue diseases and symptoms. New Eng J Med 1995;332:1666, 1669. [18] Schottenfeld D et al. The design of a population-based casecontrol study of systemic sclerosis (Scleroderma): commentary on the University of Michigan study. J Clin Epidemiology 1994;48:583—4. [19] Federal Judicial Center Reference Manual on Scientific Evidence 1—5, 1994. [20] Weinstein JB. Rule 702 of the Federal Rules of Evidence is sound; it should not be amended. F.E.D. 1991;138:631, 632. Expert evidence can be both powerful and quite misleading because of the difficulty in evaluating it. [21] In re silicone gel breast implant products liability litigation. U.S. District Courts for the Eastern and Southern Districts of New York (96 BI-1) (E.D. N.Y.) and 91 CV 1996 et al. (S.D. N.Y.). [22] Marshall E. New York Courts seek ‘neutral’ experts. Science 1996;272:189. [23] Sanders J, Kaye D. Expert advice on silicone implant: Hall v. Baxter Healthcare Corp. 37 Jurimetrics 113, 1997;31:113. [24] In re silicone gel breast implant product liability litigation (MDL-926 No. CV92-P-1000-S (N.D. Ala. Oct. 31, 1996) Order No. 31E). [25] Hall v. Baxter Health Care Corporation. 947 F. Supp. 1387:1393—4. [26] In re breast implant cases (Amended Preliminary Memorandum October 23, 1996) (N.D. Ala.). [27] Kelly v. Baxter 957 F. Supp. 873 (W.D. Tex. 1997). [28] Angell M, Science on Trial. W. W. Norton & Company, 1996:209.
The war against junk science: the use of expert panels in complex medical-legal scientific litigation Joseph M. Price*, Ellen S. Rosenberg1 Faegre and Benson LLP, 90 South Seventh Street, 2200 Norwest Center, Minneapolis, MN 55402-3901, USA
Abstract In the legal context, junk science is defined as evidence that is outside of mainstream scientific or medical views. Junk science does not have indicia of reliability and is not generally accepted. Despite the lack of scientific reliability, US courts, expert witnesses and juries are increasingly reliant on junk science in making causation decisions in complex medical liability cases. Courts have accepted junk science even where reliable scientific evidence is available. The United States silicone gel breast implant litigation is a prime example of this phenomenon. The issue of whether silicone breast implants are associated with disease has been a controversial subject for scientists and physicians, an emotional issue for women who have breast implants, and a lucrative business for the lawyers and expert witnesses who are the proponents of junk science. Junk science has provided to juries a quick and convenient explanation for claimed diseases or syndromes which have required years for reliable scientists to conclude are not related to breast implants. The breast implant litigation highlights the often dramatic difference between decisions based upon junk science and decisions grounded in scientific method, fact and reality. Recently, judges involved in the breast implant litigation have become concerned about the use of junk science in light of the growing body of legitimate scientific evidence that breast implants do not cause disease. Several judges have been motivated to take the unique and novel approach of convening scientific panels of independent experts to study the scientific issues and make findings to the court. Through the use of independent scientific experts, several judges have meaningfully assessed the evidence that the litigants present and have prevented or strictly limited the use of junk science in the courtroom. Using this procedure, other judges are weighing the evidence for future cases. This paper will briefly explore the background of mass tort medical products litigation and the development of junk science. The paper will then focus on the history of the breast implant litigation and the steps that the courts have already taken to combat junk science, including the use of scientific panels. ( 1998 Elsevier Science Ltd. All rights reserved
2 the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags behind science; it does not lead it [1].
1. Introduction A matter of continuing concern to biomedical manufacturers and material suppliers is the ongoing, ever escalating issue of products liability litigation. One need only examine the proliferation of injury lawsuits involving products such as the Norplant contraceptive, penile pros*Corresponding author. Tel.: 612336-3000; fax: 613336-3026; e-mail: [email protected] 1The authors represent various medical manufacturers in biomedical mass tort litigation. The opinions expressed here are their own and not necessarily their clients’. 0142-9612/98/$19.00 ( 1998 Elsevier Science Ltd. All rights reserved. PII S 0 1 4 2 - 9 6 1 2 ( 9 8 ) 0 0 0 5 2 - 0
thesis, silicone breast implants, latex gloves, or pedicle screws, to name a few, to understand the threat presented by a seemingly unchecked legal system. Compounding the problem is the increasing impact of ‘junk science’ which materially affects the outcome of the lay jury decision-making process. This concept is premised on the acceptance of courts and juries of expert witnesses and ‘scientific’ studies at the fringe of, or even beyond, the outer perimeters of mainstream scientific or medical views. Reliance on such questionable scientific witnesses and testimony has resulted in runaway jury verdicts and consequently the loss to society of otherwise useful products as wide ranging as the anti-nausea drug
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Bendectin, silicone gel breast implants and biomaterials such as Teflon. Only recently have a few courts begun to reject otherwise unreliable and unsound scientific witnesses and data by the use of, and reliance on, scientific experts independent of the litigation process. These witnesses are called upon to give neutral, unbiased and scientifically sound analysis of otherwise questionable medical or scientific propositions. The purpose of this paper will be to explore the evolution of medical products liability, the rise of ‘junk science’ and the recent attempts to restore balance to a system that, to the objective observer, seems to be distorted in favor of unsound medical and scientific propositions.
2. Biomedical product and materials litigation and the advent and proliferation of ‘junk science’ Society today is faced with a flood of mass-tort products liability litigation involving pharmaceuticals, medical devices and biomaterials. This litigation constitutes a clear and present threat to manufacturers and suppliers of products that are generally thought to have significant social utility. This crisis threatens not only the existence of those manufacturers and providers, but also the ability of society to obtain otherwise useful and beneficial products which are demanded for the purposes of sustaining, prolonging and enhancing our quality of life. In the development of drugs and medical devices, manufacturers must incorporate the assumption that a product could possibly cause harm to some future user. It is incumbent upon the manufacturer to estimate the magnitude of the problem and to predict the likelihood of its occurrence. Consistent with that analysis is contemplation of the possibility of products liability litigation. Factors which may impact upon products liability exposure and potential litigation include [2]. 1. the risk of causing injury from known or unknown side effects, 2. loss of public confidence because of adverse publicity from lawsuits either won or lost, 3. cost from litigation even if the case is not meritorious including indirect costs such as disruption of business and the direct costs such as litigation and settlement expense. 4. delayed liability exposure from side effects which may not occur for five, ten or twenty years after manufacture and sale. 5. the potential for mass tort product liability litigation. 6. government investigations. 7. inability to rely upon governmental agencies as protection against liability. 8. cost and unavailability of product liability insurance and self insurance.
9. the political climate and tort reform. 10. the uncertainty of having highly technical and complex scientific issues evaluated by a judge and jury untrained in science and medicine. It is this last issue which has given rise to much of the present day mass tort litigation and put ‘junk science’ into the limelight. The concept of ‘junk science’ in products liability litigation is premised on the reliance by courts and juries on expert witnesses and studies which are outside the mainstream of scientific or medical evidence. Evidence is presented to lay juries by so called ‘experts’ who render opinions that are: 1. at the limits of scientific detectability or beyond, 2. of marginal statistical significance, 3. proposing hypothesis disregarding established theory, 4. embracing untested mechanisms for the effect reported on, and 5. without testing to see if the hypothesis is in any way false. 2.1. Plaintiffs+ lawyers escalate mass tort litigation Any understanding of the threat presented to biomedical manufacturers by ‘junk science’ requires an understanding of mass tort litigation and the approach used by successful plaintiffs’ lawyers. Their ultimate objective is to achieve huge damage recoveries under the implied or actual threat of driving a company, or an entire industry, into bankruptcy or insolvency. Mass torts such as the Dalkon Shield litigation, silicone gel breast implants and Norplant usually start out as individual cases against the biomedical manufacturer. Because the products involved, i.e. drugs and medical devices, are used by large numbers of people, and are rarely, if ever, risk free, once a perceived problem or defect is noted, litigation grows exponentially. As more claims are made, more plaintiffs’ lawyers join in the assault on the manufacturer, suppliers or both, and the result is an ever-escalating number of lawsuits. The cost and expense of defending thousands of lawsuits, as well as the potential exposure of jury verdicts often forces companies to settle unmeritorious litigation to avoid the drain on finances and resources: The dynamics of a mass tort demand that companies try to settle litigation—regardless of the merits—if they want to continue in business. The volume of lawsuits, their oppressive weight, is what brings companies to their knees. This is no exaggeration; just ask any major asbestos defendant, almost every one of which has been vaporized by litigation [3]. When one combines the crush of numbers of claims with the contingent fees generated to the lawyers, the incentives become understandable, yet unacceptable. Plaintiffs’ lawyers use the media and lawyer advertising to amass high numbers of cases which amount to economic blackmail. Because of the expense of defending
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multiple cases in multiple jurisdictions, a cost that sometimes may rise to $1 million per trial, defendants cannot afford to win every case brought against them. Plaintiffs’ lawyers hope that this type of pressure will force mass settlements. Through media hype and lawyer advertising, plaintiffs’ attorneys scare thousands of susceptible and often vulnerable claimants into filing lawsuits. The plaintiffs’ bar hires public relations firms to target reporters who will give them favorable press. The media is often merely a tool of an extremely well organized plaintiff’s bar: ‘Unfortunately, a number of journalists and medical organizations have not presented a balanced and informed view on the safety of silicone implants during the past year. This type of press has created an undue amount of unnecessary anxiety in many women, which in turn has provoked litigious behavior and inappropriate demands for explant surgery’ [4]. 2.2. Litigation results in loss of biomaterials In 1993 the Health Industries Manufacturers Association (HIMA) commissioned Aronoff Associates to do a study of the biomaterials market and the impact, in part, of catastrophic lawsuits. They found a pervasive fear of exposure to costly, possibly catastrophic lawsuits among those who manufactured or supplied raw materials to be used in medical devices [5]. Aronoff Associates revisited the issue for HIMA in 1997 with a subsequent report entitled ‘Biomaterials Materials Availability: A Vital Health Care Industry Hangs in the Balance’ [6]. Aronoff discovered that of the material supplier companies surveyed, 25% (down from 42% in 1993) were currently supplying or willing to consider supplying implant manufacturers. The remaining 75% were not willing to supply the medical manufacturer market. With respect to this decision, the risk of legal liability was a key factor for 100% of the suppliers while the market size was a key factor for only 60% of the suppliers and humanitarian concerns were a factor for 10% to 25% of the suppliers. For example, the impact of the Temporo-Mandibular Joint (TMJ) litigation on Dupont had a huge impact on other materials providers. Aronoff estimated that the cost of Dupont’s defense of hundreds of cases throughout the country cost $8 million per year [6, pp. 6, 7]. Aronoff commented: Because it requires only small volumes of materials that are used in perceived high liability risk applications, the medical implant industry has become a pariah to suppliers. Indeed, the policies of some supplier companies have become so restrictive that they have prohibited use of their materials for any implant device ‘regardless of the intended duration of implantation’ 2 [6, p. 9]. This has resulted in the disappearance of small companies and start up companies resulting in a restructur-
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ing of the biomaterials industry. The development of new and improved life saving, life enhancing implants has stagnated. Additionally, the report foresees a narrowing of the choices for doctors over the next five years in providing the best treatment for patients because implant products will disappear from the market [6, pp. 9, 10]. 2.3. Junk science experts perpetuate unfounded science Essential to the creation of a mass tort is the development of a small group of so-called ‘experts’ who will espouse ‘fringe’ theories sufficient to convince lay judges and juries to award large verdicts. ‘Junk science’ has tremendous negative societal ramifications and costs. In the drug arena, the anti-nausea pregnancy drug Bendectin swiftly fell to the onslaught of mass tort litigation. The Norplant contraceptive is currently under similar siege. Biomaterials such as Teflon, latex and silicone have been under continuous attack as have end products like Temporo-Mandibular Joint (TMJ) replacements and silicone gel breast implants. As early as 1986, the United States Attorney General’s Tort Policy Working Group expressed concern about the increasing reliance of judges and juries upon expert witnesses and studies ‘on the fringe or even well beyond the outer perimeters of mainstream scientific or medical views’ [7]. It was reported that ‘[t]he use of such invalid scientific evidence (commonly referred to as ‘junk science’) has resulted in findings of causation which simply cannot be justified or understood from the standpoint of the current state of credible scientific and medical knowledge’ [7]. Mass tort litigation and ‘junk science’ would not occur without highly paid expert witnesses who present fringe theories of liability in return for large financial rewards. Usually these theories have no solid scientific basis. Many such experts receive anywhere from $500 to $1000 per hour or more for their time testifying to unfounded scientific theories. Some have teamed up with plaintiffs’ attorneys to actively recruit potential claimants for litigation [8]. Others have their own financial interest in the litigation, having started laboratories and developed ‘scientific tests’ to test for illness or disease allegedly caused by the product [8]. ‘Junk science’ should be barred from the courtroom for a number of reasons, including: 1. The premise that juries can separate good science from bad science and are not persuaded by specious scientific arguments is incorrect when highly technical scientific issues are pitted against a sympathetic and often badly injured plaintiff. 2. Introduction of unreliable scientific evidence increases the chance that a jury will arrive at an unjust verdict because the evidence is inherently prejudicial due to the ‘aura of infallibility’ which encourages jurors to accept it without critical scrutiny.
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3. Introduction of unreliable scientific evidence also undermines the integrity of the fact-finding process because jurors do not have a sufficient understanding of the scientific principles underlying the competing theories presented to them to adequately evaluate and distinguish between those theories. 4. Jurors who come to a case lacking an understanding of the scientific method and who are not sufficiently instructed regarding it at trial are ill-equipped to arrive at a just verdict. Left to decide between two equally incomprehensible scientific theories, jurors are likely to simply disregard both and decide the case based on other factors such as empathy towards one of the parties rather than on the scientific merits [9].
3. Judicial standards for scientific evidence Whether it involved Bendectin, silicone breast implants, Norplant, latex gloves, penile prosthesis, TMJ devices or pedicle screws, most of the mass tort litigation has been generated, in large part, by ‘junk science’ propounded by a small group of expert ‘true believers’ (who had a huge financial stake in litigation). In most instances, these ‘experts’ had some scientific or medical degree or background but did not apply a valid scientific method to their analysis. Traditionally, courts have permitted such ‘experts’ to testify. The general approach of courts was that even these outlandish opinions should be presented to a jury to be tested by cross-examination by the other side. The analysis went to the weight not the admissibility of the testimony. This meant that the courts would not preclude the scientific evidence but would leave it up to lay jurors to decide how much emphasis they would give it. As one commentator has noted: [s]cientific evidence impresses lay jurors. They tend to assume it is more accurate and objective than lay testimony. A juror who thinks of scientific evidence visualizes instruments capable of amazingly precise measurement, of findings arrived at by dispassionate scientific tests. In short, in the mind of the typical lay juror, a scientific witness has a special aurora of credibility [10]. The problem with allowing jurors to evaluate complex scientific evidence is that most will not have sufficient scientific knowledge based on their life’s experience to be able to adequately analyze competing theories. ‘[M]ost people, which includes those who compose juries, do appreciate science but do not know how it is done nor how it works’ [11]. The difficulty of delegating scientific decisions to lay jurors was illustrated in an editorial by Dr. Marsha Angell in the New England Journal of Medicine: 2 scientific conclusions cannot be based on argument and opinion. There must be data. Yet, in the court-
room, acceptance of expert testimony on scientific questions usually turns on the ‘credibility’ of the witness, not the validity of the evidence on which the witness’s opinion is based [12]. Legal evidentiary standards, based on codified rules of evidence and case law, have governed the admissibility of expert testimony propounded to lay juries. For many years, the evidentiary standard was held to be some form of the rule enunciated in the case of Frye v. The United States, 293 F. 1013 (DC Cir. 1923). That case involved a type of lie detector test which measured systolic blood pressure in an attempt to determine whether the witness was telling the truth. The DC Circuit Court of Appeals, in rejecting the offered testimony, articulated a ‘general acceptance’ test for expert testimony which was founded on novel scientific concepts. The court held that ‘The thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs’. Frye v. United States at p. 1014. This rule seemingly prescribed a higher standard for admissibility of scientific evidence than for other types of evidence to prevent presentation of unsound scientific or medical theories to lay juries. For seventy years after Frye was decided, vigorous debate ensued over the admissibility standards of scientific evidence. Supporters of Frye applauded the result requiring general acceptance in the scientific community as a means of insuring that lay juries would not be overly impressed by theories that they lacked the appropriate capacity to evaluate. Critics, primarily plaintiffs’ advocates, and some legal scholars criticized Frye as being overly restrictive on the grounds that it would exclude otherwise reliable scientific evidence because it was ‘novel.’ Frye was also criticized because of difficulty in determining what exactly was the ‘particular field’ to which the offered evidence belonged, as well as whether it was in fact generally accepted. Some courts relied on the concept of peer review publication as a determination for general acceptance. Since 1975, when the codified Federal Rules of Evidence were adopted, a number of courts have rejected the Frye test. This set the stage for re-analysis of the issue by the United States Supreme Court in the case of Daubert v. Merrill Dow Pharmaceutical, Inc., 113 S. Ct. 2786 (1993). Daubert involved on appeal to the United States Supreme Court of the validity of scientific evidence introduced in connection with a Bendectin case. The Supreme Court found the Frye test to be replaced by Federal Rule of Evidence Rule 702 which states that ‘[i]f scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.’ The Supreme Court then ruled that the Federal Rules of
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Evidence, with their ‘liberal thrust’ was at odds with the ‘rigid general acceptance requirement’ of Frye [13]. Daubert required trial judges to become ‘gatekeepers’ and to perform a gatekeeping function to ‘insure that any and all scientific testimony or evidence admitted is not only relevant but reliable [13, p. 2795]. Judges were required to do a preliminary assessment of the reasoning or methodology underlying proposed testimony to determine whether it was valid and could properly be applied to the facts at issue [13, p. 2796]. Scientific evidence should only be admitted if it was founded on ‘scientific knowledge’ implying ‘a grounding in the methods and procedures of science’ and connoting more than just ‘subjective belief or unsupported speculation’ [13, p. 2795]. The Supreme Court found it particularly important to determine whether the evidence could be or had been actually tested [13, p. 2796], whether the theory or technique had been subject to peer review and publication, what the known or potential risk of error was and whether the conclusion had been generally accepted in the scientific community [13, p. 2797]. Thus, the Court essentially adopted standard scientific methodology and applied it to the legal arena. Predictably, reactions to the Daubert decision were mixed. Some felt that the test was too vague to apply. Federal judges protested that they were ill-equipped to fulfill the Daubert mandated role of scientific gatekeeper since many of them were no more scientifically adept than lay jurors. Some judges continued to just apply general acceptance criteria. Some used the standards of testability, peer review, error rate and general acceptance and others applied their own standards to the issue of scientific admissibility. Application of the Daubert standard is still evolving today and is likely to spawn additional court decisions and, probably, further confusion.
4. Scientific panels Recently several courageous and forward thinking courts concluded that their role as gatekeeper was one which required the assistance of more qualified participants. This conclusion arose out of the experience of the silicone breast implant litigation. Silicone has long been recognized as a safe, and efficacious implantable biomaterial with a history dating back almost 50 years in the biomedical arena. It was used in heart valves, pacemakers, shunts and orthopedic devices. Silicone gel breast implants were first marketed in the early 1960s and have well over 30 years of history, attesting to their safe use. Litigation replaced the scientific method as the arbiter of sound scientific and medical policy in 1982 when a series of anecdotal reports first appeared hypothesizing a possible link between silicone and various traditional autoimmune diseases and, later on, atypical
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connective-tissue disease. These reports were uncontrolled, involved very small populations and could not rule out other potential causes of these autoimmune diseases and symptoms, all of which occur in the female population (without breast implants) at large. The scientific way to determine whether silicone gel breast implants are associated with disease is by sound, well-reasoned epidemiologic studies. Such epidemiologic studies have gone on for the past ten years and do not support a causal relationship between silicone gel breast implants and autoimmune disease. In fact, virtually all of the epidemiologic data available today concludes that silicone gel breast implants do not cause autoimmune disease [14—18]. Today, there are more than 20 such studies. Despite the lack of valid scientific substantiation, plaintiffs and their lawyers in the 1980s and early 1990s regularly prevailed in convincing lay juries to award huge verdicts (some as high as $25 million) to women who claimed that their autoimmune disease was caused by their silicone gel breast implants. More recently, manufacturers have won most of the lawsuits litigated against them on the issue of silicone induced autoimmune disease. Even these verdicts, however, came at enormous expense to the manufacturers. There are thousands of lawsuits pending against the silicone manufacturers. The litigation has driven Dow Corning Corporation, the largest of the silicone breast implant manufacturers as well as another manufacturer, Bioplasty, into bankruptcy. Breast implant material suppliers have been sued as well. The transactional costs of defending against plaintiffs’ unsupported and unscientific claims has threatened the existence of an entire industry. The cost of defending these cases became so exorbitant that the manufacturers entered into a proposed ‘global’ settlement to attempt to resolve the litigation. The factors that mitigated in favor of this proposed global settlement had nothing to do with fault or liability on the part of manufacturers but was generated by the take over of American courtrooms by ‘junk science’ orchestrated by the plaintiffs’ personal injury bar. In connection with the breast implant litigation, the plaintiffs’ personal injury lawyers created a cottage industry for a small number of generally unqualified ‘expert’ witnesses some of whom have been paid over $1 million to testify about dangers of silicone and breast implants. The combination of ‘junk science experts’, the plaintiffs’ bar, and mass media hysteria have been largely responsible for the crisis concerning silicone gel breast implants and which has now spread to the Norplant contraceptive, penile prosthesis and other medical products. These developments prompted several judges to exercise their gatekeeper function under Daubert. The Federal Judicial Center, in 1994, in its Reference Manual on Scientific Evidence [19] devotes an entire section to a discussion of the use of court-appointed
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experts in complex litigation noting that these experts are increasingly used to educate judges on the fundamental scientific concepts on which the parties’ experts differ and to offer assessments of the methodologies on which those experts base their opinions. The manual offers advice as to when special masters should be appointed to sift through scientific evidence or manage pretrial issues involving expert testimony. Federal judges have two additional tools available to them. Under Rule 104 of the Federal Rules of Evidence ‘[p]reliminary questions concerning the qualifications of a person to be a witness, the existence of a privilege, or the admissibility of evidence shall be determined by the court 2 .’ Additionally under Rule 706 of the Federal Rules of Evidence, the ‘court may on its own motion or on the motion of any party enter an order to show cause why expert witnesses should not be appointed, and may request the parties submit nominations. The court may appoint any expert witness agreed upon by the parties and may appoint expert witnesses of its own selection 2 .’ These two tools give federal judges the power to appoint independent expert witnesses or panels to either assist them in arriving at decisions relating to the admissibility of proffered ‘junk science’ or to act as independent expert witnesses to weight the issues and testify, not at the calling of any party, but as a witness of the court. The process which resulted in independent experts analyzing the scientific evidence being offered in silicone gel breast implants started in April 1996 when US District Judge Jack Weinstein [20] appointed several experts from various academic backgrounds to serve as a selection panel to locate scientific experts for appointment to a panel that would consider the general principles for establishing cause and effect in the silicone breast implant litigation [21]. Judge Weinstein asked the selection panel to particularly focus on claims relating to ‘immune system dysfunction in connective-tissue and rheumatic disease’. He chose a law professor and two scientists, one of whom was also a lawyer, to select the scientific expert panel [22]. Judge Weinstein was joined by US District Judge Harold Baer and State Supreme Court Justice Joan Lobis in authorizing the selection panel to select preeminent scientific experts to analyze the causation issues. This approach was authorized pursuant to Rule 706 of the Federal Rules of Civil Procedure. At about the same time at Judge Weinstein was organizing his panel, US District Court Judge Robert Jones of the US District Court in Portland, Oregon, concluded that he too would appoint a panel of expert witnesses to evaluate silicone gel breast implant testimony. He embarked upon the selection of an expert panel to be comprised of an epidemiologist, rheumatologist, immunologist and polymer chemist to evaluate the plaintiff’s proffered expert witness testimony [23].
The existence of competing scientific expert panels caused concern in some circles because of the risk of conflicting or confusing outcomes. Because of this potential for conflict and confusion, US District Court Chief Judge Sam Pointer of Birmingham, Alabama, the judge to whom all of the federal silicone gel breast implant cases were assigned for pretrial handling by the Judicial Panel on Multi-District Litigation, appointed, as part of the multi-district litigation proceedings, a Rule 706 Panel consisting of four experts in the area of rheumatology, epidemiology, immunology and toxicology. The purpose of Judge Pointer’s panel was to determine the extent to which ‘existing studies, research, and reported observations provide a reliable and reasonable scientific basis for one to conclude that silicone gel breast implants cause or exacerbate’ 2 any one of a number of conditions outlined for the panel [24]. As a result of Judge Pointer’s appointment of a national scientific panel under Rule 706, Judge Jones determined to proceed with his hearings on the admissibility of plaintiffs’ scientific evidence and to convert his scientists from a Rule 706 panel of potentially testifying experts to a Rule 104 panel of technical advisors who would assist him in the examination and analysis of the testimony proffered by the plaintiffs. With expert assistance, Judge Jones would then rule on the soundness of plaintiffs’ science. Judge Jack Weinstein, along with Judges Baer and Lobis, deferred to Judge Pointer concerning the appointment of an expert panel under Rule 706 (in fact Judge Pointer conscripted Judge Weinstein’s selection panel to help choose his own Rule 706 experts) and went forward with court hearings on the validity of the science pursuant to the Supreme Court’s mandate relating to the gatekeeper function under the Daubert decision. Judge Jones and his technical advisors held lengthy hearings and reviewed hours of testimony presented by the plaintiffs and their ‘junk science’ experts as well as experts called by the defendant manufacturers. The technical advisors and Judge Jones were also provided with vast quantities of scientific literature, studies, journal articles, data and other materials as well as argument by the respective parties as to the scientific implications of the evidence. At the end of the process the technical advisors wrote lengthy opinions which were given to Judge Jones to enable him to better understand the issues and to reach conclusions concerning the reliability of the plaintiffs’ offered evidence on the causation issues. After all the material was submitted, Judge Jones provided his technical advisors with a series of specific questions which they were to address as part of their reports. Those specific questions involved the following: 1. Is the expert’s opinion supported by generally accepted scientific reasoning and methodology? 2. Is the expert’s opinion based upon scientifically reliable data?
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3. If epidemiological studies have not been done or are inconclusive, what other data can justify, to a reasonable medical probability, a conclusion concerning the cause of the syndrome or disease at issue? 4. Do the methodology and data support the expert’s conclusion? 5. Does the scientific data relied upon by the expert apply to the syndrome or disease at issue in these cases? [25]. Based on the information received from the technical advisers and Judge Jones’ analyses of Daubert he reached the conclusion that: Because ACTD [atypical connective-tissue disease] is at best an untested hypothesis, there is no scientific basis for any expert testimony as to its causes and presence in plaintiffs. Therefore, defendants’ motions [to exclude the testimony of plaintiffs’ experts] are granted as regards any expert testimony relating to the existence and causation of any atypical siliconecaused, autoimmune disorder [25, p. 1402]. Judge Jones analysis of plaintiffs’ experts led him to the opinion that their testimony was inherently unreliable. His ability to reach these conclusions was largely enhanced by the input from his scientific advisors panel which discredited plaintiffs ‘junk science’ experts ‘well traveled opinions’. Accordingly, he struck all of plaintiffs causation experts. Judge Jack Weinstein, in New York, concluded that he would not impanel his own separate Rule 706 experts, or use technical advisers, but he conducted hearing on his own to examine the testimony of expert witnesses offered by plaintiffs in the New York litigation. He was also given the information provided to Judge Jones in Oregon and had the Oregon experts’ reports available to him. After lengthy hearings from plaintiffs’ and defendants’ experts, Judge Weinstein issued an opinion which mirrored Judge Jones’ conclusions: It was the position of plaintiffs’ experts, controverted by those of defendants, that a new undifferentiated atypical disease associated with exposure to silicone was caused by silicone gel implants. The hundreds of symptoms associated with this undifferentiated disease, the lack of any acceptable agreed upon definition, the inadequacy of any satisfactory supporting epidemiological or animal studies, the lack of a scientifically acceptable showing of medical plausibility, and the questionable nature of the clinical conclusions of treating doctors, all point to a failure of proof in making a prima facie case that silicone implants cause any of the syndromes claimed except for local disease [26]. Judge Weinstein struck all of the plaintiffs’ expert witnesses on the issue of causation and bifurcated the issue of systemic disease from the issue of ‘local’ injury. He agreed to hear cases involving claims such as rupture, silicone gel migration, capsular contracture, etc. but suspended all of plaintiffs’ claims relating to systemic disease
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pending resolution of the scientific issue by Judge Pointer’s 706 Panel in Birmingham, Alabama. Judge Pointer, using Judge Weinstein’s selection panel, appointed a preeminent group of scientists including a rheumatologist, epidemiologist, immunologist and toxicologist to review the vast scientific literature relating to silicone gel breast implants and disease. That panel has been pouring over volumes of data and analyzing all of the scientific literature in preparation for its ultimate analysis of the issues. As of the writing of this article, hearings are set for Birmingham, Alabama, on 23—25 July 1997 at which time the parties will present scientific evidence and experts for the panel to examine. Plaintiffs will attempt to convince Judge Pointer’s panel of an outcome different from the results reached by Judge Jones and his technical advisers and Judge Weinstein. The science, however, has not improved for the plaintiffs and the 706 Panel will review and analyze essentially the same evidence that led to Judge Jones and Weinstein’s opinions [27].*
5. Conclusion Dr. Marcia Angell summed the junk science situation up best in her recently published book Science On Trial: ‘2 This indifference to the need for evidence is a common threat in the many medical alarms that are sounded periodically in this country; the breast implant story simply illustrates it writ large. Whether or not breast implants are dangerous is not a question to be left with public opinion, corporate self interest and legal machinations. We ought to want to know the truth (or as near as we can come to it). But finding it requires careful scientific research and unbiased interpretation of the results. There are no shortcuts. Only by relying on scientific evidence can we hope to curb the greed, fear and self indulgence that too often govern such disputes. That is the lesson of the breast implant story [28]. The story of junk science is a sad one with a tremendous cost to society. Silicone breast implants are no
*Presented with the same evidence and another of the plaintiffs’ ‘junk scientists’ a Texas US District Court Judge had this to say: What Dr. Espinosa is arguing is that if a patient has the plaintiff ’s symptoms, anomalous blood chemistry, and breast implants, then she has implant-caused Sjo¨rgren’s syndrome. If she has the plaintiff ’s symptoms, anomalous blood chemistry and no breast implants, then she has non-implant Sjo¨gren’s syndrome. What sort of disease she has depends solely, in Dr. Espinosa’s opinion, as to whether or not she had breast implants. This is a bit like saying that if a person has a scratchy throat, runny nose and a nasty cough, that person has a cold; if on the other hand, that person has a scratchy throat, runny nose, nasty cough and wears a watch, they have a watch-induced cold. Obviously, this sort of reasoning is extremely suspect, which is why other courts have rejected it as well.
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longer generally available. Other silicone products for medical use are being litigated off the market. Norplant, penile prosthesis, testicular implants and other plastic surgery implants are no longer available or only available at enormous legal and social cost. Companies the size of Dow Corning Corporation have been driven into bankruptcy. Suppliers are refusing to sell biomaterials to manufacturers and as a result societally useful medical products are not available or are becoming extinct. Hundreds of millions of dollars are being spent on litigation and scarce research money is going to research junk science theories. This money could be better spent on the real issues that science and medicine face. Sadly, patients are being unnecessarily frightened and are not getting the proper medical treatment. This may be the greatest tragedy of the long and tragic history of the silicone breast implant litigation and junk science. Perhaps the scientific panel sitting in Birmingham, Alabama, will once and for all lay to rest the issues of the relationship between connective-tissue disease and silicone. More importantly, however, it may set a precedent for other judges in other courts to follow in complex scientific litigation. In difficult scientific areas such as those faced in the breast implant litigation, the Norplant litigation, latex gloves, penile prosthesis and others, reliance upon paid experts, many of them who make their living testifying in court, is not in accord with scientific method. Perhaps the use of independent court appointed neutral scientists to analyze these issues will enhance our abilities to analyze and evaluate complex scientific issues in a more dispassionate and less adversarial way influenced by the lawyers, the media and the profit motive. For once and for all we may be able to junk ‘junk science’ and return to a more rational approach to scientific problem solving under the scientific method.
References [1] Rosen v. Ciba-Geigy Corp., 78 F.3d 316 (7 Cir. 1996). [2] Institute of Medicine. In: Harrison P, Rosenfield A, editors. Contraceptive research and development. Washington DC. National Academy Press, 1996:303. [3] Nocera J. ‘Fatal litigation’. Fortune Magazine, Oct. 30, 1995. [4] The Council on Scientific Affairs of the American Medical Association. Silicone gel breast implants. JAMA 1993;2602:6. [5] Aronoff Associates, Market Study: Biomaterials Supply for Permanent Medical Implants (1994) (Health Industries Manufacturers Association).
[6] http://www.himanet.com. [7] 1986 Att’y Gen. Tort Policy Working Group Rep., The Causes, Extent and Policy Implications of the Current Crisis in Insurance Availability and Affordability 62. [8] Kolata G, Will the lawyers kill off Norplant? N.Y. Times 1995;3:1. [9] Price J, Kelly G. Junk science in the courtroom: causes, effects and controls 19 Hamline Law Review 1996;3:396—8. [10] Imwinkelreid J. Evidence law and tactics for the proponents of scientific evidence. In: Immwinelried J, editor. Scientific and expert evidence. 1981:33—7 (2nd ed., NYC: Practising Law Inst., 1981). [11] Furst A. The Frye rule is out; is junk science in? J Am Coll Toxic (1995);14(1):61, 65. [12] Angell M. Do breast implants cause systemic disease? Science in the courtroom. New Eng J Med 1994;330:1748, 1748. [13] Daubert S. Ct. 113:2794. [14] Gabriel SE et al. Risk of connective tissue diseases and other disorders after breast implantation. New Eng J Med 1994; 330:1697, 1701—2. [15] Hennekens et al. ‘Self-reported breast implants and connectivetissue disease in female health professionals. JAMA 1996;275:616. [16] Hochberg M et al. Frequency of augmentation mammoplasty in patients with systemic sclerosis: data from the John Hopkins University of Maryland Scleroderma Center. J Clin Epidemiology 1994;48:565, 567. [17] Sanchez-Guerrera J et al. Silicone breast implants and the risk of connective-tissue diseases and symptoms. New Eng J Med 1995;332:1666, 1669. [18] Schottenfeld D et al. The design of a population-based casecontrol study of systemic sclerosis (Scleroderma): commentary on the University of Michigan study. J Clin Epidemiology 1994;48:583—4. [19] Federal Judicial Center Reference Manual on Scientific Evidence 1—5, 1994. [20] Weinstein JB. Rule 702 of the Federal Rules of Evidence is sound; it should not be amended. F.E.D. 1991;138:631, 632. Expert evidence can be both powerful and quite misleading because of the difficulty in evaluating it. [21] In re silicone gel breast implant products liability litigation. U.S. District Courts for the Eastern and Southern Districts of New York (96 BI-1) (E.D. N.Y.) and 91 CV 1996 et al. (S.D. N.Y.). [22] Marshall E. New York Courts seek ‘neutral’ experts. Science 1996;272:189. [23] Sanders J, Kaye D. Expert advice on silicone implant: Hall v. Baxter Healthcare Corp. 37 Jurimetrics 113, 1997;31:113. [24] In re silicone gel breast implant product liability litigation (MDL-926 No. CV92-P-1000-S (N.D. Ala. Oct. 31, 1996) Order No. 31E). [25] Hall v. Baxter Health Care Corporation. 947 F. Supp. 1387:1393—4. [26] In re breast implant cases (Amended Preliminary Memorandum October 23, 1996) (N.D. Ala.). [27] Kelly v. Baxter 957 F. Supp. 873 (W.D. Tex. 1997). [28] Angell M, Science on Trial. W. W. Norton & Company, 1996:209.