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July 2005, Vol 95, No. S1 | American Journal of Public Health S59-S65
© 2005 American Public Health Association
DOI: 10.2105/AJPH.2004.044701


PUBLIC HEALTH MATTERS

What Has a Decade of Daubert Wrought?

Margaret A. Berger, JD

The author is with Brooklyn Law School, Brooklyn, NY.

Correspondence: Requests for reprints should be sent to Margaret A. Berger, JD, Brooklyn Law School, 250 Joralemon Street, Room 911, Brooklyn, NY 11201 (e-mail: margaret.berger{at}brooklaw.edu).


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There have been changes within the judicial system that may be attributable to opinions on the admissibility of expert testimony that began with the Supreme Court’s 1993 decision in Daubert v Merrell Dow Pharmaceuticals, Inc. After surveying Daubert and subsequent related Supreme Court opinions, I examine a number of questions.

Do the factors courts apply post-Daubert in ruling on the admissibility of expert testimony make scientific sense? Has Daubert had an impact on the willingness of scientists to become expert witnesses? What do we know about Daubert’s impact on improving science in the court room? What has been Daubert’s effect on access to the courts? Does Daubert further public policy objectives of protecting the public against harm?


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Ten years ago, the U.S. Supreme Court decided Daubert v Merrell Dow Pharmaceuticals, Inc,1 the first in a trilogy of cases about the admissibility of expert testimony. [The other two cases are General Electric Co v Joiner, 522 US 136 (1997) and Kumho Tire Co v Carmichael, 526 US 137 (1999).] To understand the significance of this case, which some deem one of the more important decisions of the twentieth century,2 we must first appreciate the central role of expert witnesses in civil litigation. As the modern world becomes increasingly complex, more and more issues in legal disputes cannot be resolved without recourse to specialized knowledge. The necessary input is supplied through the testimony of expert witnesses. Plaintiffs bear the burden of proving their claims are more probable than not; they cannot succeed when expertise is required to support their claims unless they are allowed to introduce expert testimony. By setting out new rules for when an expert may testify, Daubert has therefore had an enormous effect on the outcome of legal controversies.

Before we look at Daubert and the other Supreme Court’s opinions in more detail, I’d like to speculate for a moment on what led the Supreme Court to plunge into the realm of expert proof. After all, the Supreme Court reviews only about 80 cases in a given year. Furthermore, many of the cases it does hear involve constitutional issues, the interpretation of federal statutes, or the review of administrative decisions, which are the kinds of cases that lie at the heart of Supreme Court jurisprudence. That the Supreme Court issued three opinions on expert testimony in civil cases over a 6-year period obviously suggests a great deal of interest in this topic. In addition, the Supreme Court decided a fourth case, Weisgram v Marley Co, 528 US 440 (2000), which has an indirect effect on expert testimony that is discussed infra at notes 29–30.

We can, of course, only conjecture about the impetus for the Court’s foray into this area of the law. Certainly, the growing dependence on technology and science in our society meant that more issues turning on expert testimony were entering the courtroom. For example, the explosive growth of computers required parties to present complex forms of data and statistical studies needing expert elucidation. In addition, the revolutionary advent of forensic DNA technology, which was first introduced in an American courtroom just a few years before Daubert, undoubtedly drew the Supreme Court’s attention to how science and law interact. In addition, numerous prestigious groups, including the Federal Courts Study Commission established by Congress, the Judicial Conference, and the Carnegie Commission on Science, Law and Technology, had begun actively calling for a reexamination of how courts handle complex scientific and technological issues.

Demands for tort reform may also have played a part in the Court’s willingness to accept the Daubert case for review. There had been an enormous increase in product liability cases and toxic tort litigation in the previous 15 years or so. Asbestos litigation was already threatening bankruptcies and unmanageable court congestion. By the time the Supreme Court undertook to hear Daubert, plaintiffs’ experts were being castigated with some frequency as the villains whose testimony, supposedly based on "junk science,"3 was responsible for huge unjustified verdicts in product liability and toxic tort actions. The phrase in quotes, coined in a book published in 1991, quickly became a shorthand expression for referring to perceived problems with expert witnesses.

Given this climate, it is probably not surprising that Daubert was a toxic tort case, as was General Electric v Joinersecond case in the trilogy. Toxic tort cases are a subspecies of product liability litigation in which the plaintiffs claim that their adverse health effects were caused by exposure to the defendant’s product. The third case in the trilogy, Kumho Tire Co v Carmichael, though not a toxic tort case, was a product liability case. The crucial issue in all these cases was causation. To prevail, plaintiffs in each case, through the offer of expert testimony, had to discharge their burden of proving that the defendant’s product had caused the plaintiffs’ injuries. Because plaintiffs’ expert testimony was excluded, plaintiffs lost.

Daubert was one of a series of cases in which plaintiffs claimed that their serious birth defects stemmed from their mothers having taken a drug called Bendectin, an anti–morning sickness drug that had been taken by over 20 million women. As a result of the litigation, the defendant took the drug off the market, although it never lost its Food and Drug Administration approval and continued to be available in Canada. In support of its contentions, plaintiffs relied on in vitro and in vivo studies, pharmacological studies of the chemical structure of Bendectin, and their experts’ reanalyses of previously published epidemiological studies. The lower courts hearing Daubert relied on the so-called Frye or "general acceptance" test to hold that the plaintiffs’ expert testimony on causation was inadmissible and that, consequently, plaintiffs "could not satisfy their burden of proving causation at trial."4

The Frye test, which gets its name from Frye v United States, a 1923 federal case involving the admissibility of polygraph evidence,5 was then used by some federal courts, primarily in criminal cases, and is still in use in some of our most populous states, such as California, Illinois, and New York. Frye conditions the admissibility of expert testimony about a novel scientific principle on there being a consensus, or "general acceptance," of the underlying theory in the relevant field. The Frye test has been criticized on numerous grounds, for example, that it fails to explain how to determine what is the relevant field, that it counts the noses of experts rather than looking at the validity of their opinions, and that it leads to self-validating experts who claim that their particular subspecialty is the relevant field.

In Daubert, the Supreme Court first found that the Frye test was superseded when the Federal Rules of Evidence, which govern evidentiary questions in federal court, were enacted in 1975 and failed to mention Frye. Second, the Court set out a new two-pronged test for the admissibility of scientific evidence, whose object was to ensure that expert testimony "is not only relevant, but reliable."5 Justice Blackmun, who wrote the majority opinion for the Court, explained that in order to satisfy reliability, the expert must have derived his or her conclusion by the scientific method; he noted the following factors, which, though not definitive, operate as markers of the scientific method: hypothesis testing, peer review and publication, known or potential rates of error, and the existence of standards controlling the technique’s operation. General acceptance of the methodology in the relevant discipline, although no longer dispositive, was mentioned as a factor also to be considered. The second prong—relevancy—meant that the expert’s theory had to fit the facts of the case. Even if the expert’s theory was completely scientific, it had no application if it dealt with a matter that was not at issue. The Court explained its concept of fit by citing the Third Circuit’s opinion in United States v Downing, 753 F2d 1224,1242 (3d Cir 1985). In Downing, the defendant had sought to introduce expert testimony about the unreliability of eyewitness testimony. The court held that such evidence was admissible if it "fit" the facts of the case. On remand, the district court excluded the expert’s testimony about problems with cross-racial identification because there had been no cross-racial identifications.

Perhaps of paramount importance, the Daubert opinion recast the role of the trial court. Trial judges had always had the power to exclude inappropriate expert testimony, but some preferred to leave this task to the jury, particularly when the expert proof related to complex scientific principles with which the judge was not very familiar or comfortable. But the Court now told trial judges that they were "gatekeepers" who were obliged to screen scientific expert testimony for relevancy and reliability before it could be admitted.

The Supreme Court did not apply its new test for the admissibility of expert testimony in the Daubert case. Instead, it reversed the decision and remanded the case to the lower court. The day after the Supreme Court decided Daubert, the Wall Street Journal stated that plaintiffs had won because the Ninth Circuit had been reversed for using the wrong test 6; the New York Times, which better understood the implications of the opinion, predicted that defendants were the true victors.7 On remand, the Ninth Circuit again excluded the evidence and granted summary judgment for the defendant because the plaintiffs were unable to prove causation.8 (Rule 56 of the Federal Rules of Civil Procedure provides that a court may grant summary judgment and dismiss a case before trial when there is no genuine issue as to any material fact. When plaintiffs cannot prove a material fact such as causation because their experts have been excluded, there is no longer a disputed issue for the jury to resolve.)

Of course, Daubert was read by lawyers as well as judges. Defense counsel quickly began making motions—soon known as "Daubert motions"—prior to trial asking the court to exclude the plaintiffs’ expert. One such case, in which the trial court granted the defendant’s motion and then dismissed the action, was brought by a 37-year-old plaintiff named Joiner against General Electric. Joiner, who was a heavy smoker with a family history of lung cancer, claimed that exposure to poly-chlorinated biphenyls (PCBs) and their derivatives had promoted the development of his small-cell lung cancer. The appellate court reversed because it found that a very stringent standard of review had to be used when the exclusion of evidence was outcome determinative, that is, when the refusal to permit the plaintiff’s expert to testify would result in dismissal of the case. The Supreme Court, however, held unanimously in Joiner, that regardless of whether the trial court admits or excludes evidence, the appellate court must use an abuse of discretion standard in reviewing a trial court’s evidentiary ruling. This standard means that the reviewing court may not look at the ruling de novo and decide how it would have ruled under the circumstances; instead, it must defer to the rulings of the trial court unless they are manifestly erroneous.

Accordingly, in Joiner, the Supreme Court examined the record to determine whether the district court had abused its discretion when it excluded the plaintiff’s expert testimony. The Court found that the trial court had not erred when it concluded that the plaintiff’s experts had not explained "how and why" they could extrapolate proof of causation from animal studies conducted under circumstances that differed from the conditions surrounding the plaintiff’s exposure. The studies involved infant mice injected with massive doses of PCBs; the plaintiff was exposed as an adult through physical contact with fluids containing far lower concentrations of PCBs, and the mice and the plaintiff developed different forms of cancer.

The Court further found that the trial court had not abused its discretion when it rejected the plaintiff’s epidemiological evidence. According to the district court, the authors of one study had refused to conclude that PCBs were the cause of a somewhat higher than expected rate of lung cancer at an Italian plant; the results of another study were not statistically significant; a third study did not mention PCBs; and the workers in a fourth study considered by the trial judge had been exposed to numerous other possible carcinogens. Consequently, the Supreme Court found that the trial court could properly conclude that "the studies upon which the experts relied were not sufficient, whether individually or in combination, to support their conclusions that Joiner’s exposure to PCBs contributed to his cancer."9

The third Supreme Court case, Kumho, dealt with the admissibility of engineering testimony offered to prove that the blowout of a tire on the plaintiff’s minivan was caused by a defect that brought about an accident in which one passenger was killed and others suffered serious injuries. The plaintiff’s expert intended to testify, as he had during a deposition, that on the basis of a visual inspection he could tell that the tire had not been abused and therefore must have been defective. When the defendant made a Daubert motion, the trial court originally excluded the expert on the ground that the four Daubert factors—testability, peer review or publication, known error rates and standards, and general acceptance—had not been satisfied. On reconsideration, the trial judge conceded that he had erred in treating the factors as mandatory rather than illustrative indicators of reliability, but he nevertheless again excluded the plaintiff’s expert and granted summary judgment.

The intermediate appellate court reversed on the ground that Daubert applied only to testimony that relies on the application of scientific theories or principles and not to testimony based on the expert’s "skill- or experience-based observation."9 It was the split in the courts about Daubert ’s applicability to nonscientific evidence that was the Supreme Court’s stated reason for reviewing the Kumho case.

All the justices, in an opinion by Justice Breyer, agreed that the trial court’s gatekeeping obligation to screen expert testimony before it may be admitted extends to all expert testimony. The Court noted that the governing rule of evidence "makes no relevant distinction between ‘scientific’ knowledge and ‘technical’ or ‘other specialized’ knowledge" and "applies its reliability standard to all . . . matters within its scope."10 The Court stressed that the gatekeeping role requires the trial court to "make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field."

But the Court declined to articulate a rigid classification system for different fields of expertise. The Court refused to find "a schematism that segregates expertise by type while mapping certain kinds of questions to certain kinds of experts. Life and the legal cases that it generates are too complex to warrant so definitive a match." The Court explained that the Daubert factors are not always relevant even when the expert relies on scientific evidence. The Court emphasized that "Too much depends on the particular circumstances of the particular case at issue." Quoting from the brief for the United States as Amicus Curiae, the Court explained that admissibility will depend "on the nature of the issue, the expert’s particular expertise, and the subject of his testimony."

Although nothing in the Kumho opinion is inconsistent with Daubert, the Court’s opinion does seem to set out a more flexible test. Instead of stressing factors that, although not definitive, are nevertheless suggested as guides for determining reliability, Justice Breyer in Kumho stressed the need to look at reliability in the context of the particular case and the testimony being offered. Courts, however, are citing and relying on Daubert more frequently than Kumho. (A Westlaw search on June 28, 2004, found 2708 citations in judicial opinions to Daubert since Kumho was decided and only 1454 citations to Kumho.)


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Having examined what the Supreme Court said in these three opinions, I now turn to the trilogy’s effects, first in toxic tort cases, and then on litigation in general. (This is not to suggest that Daubert is not having an impact in numerous other fields. Engineers, economists, psychologists, and numerous other types of experts are also being excluded.) Clearly, Daubert is viewed as extremely important. There are now Daubert databases that collect judicial opinions that already number in the thousands, at least one looseleaf service that deals exclusively with expert witness testimony, countless symposiums and continuing legal education programs, and a vast law review literature. Even in jurisdictions that purportedly follow the Frye "general acceptance" test, judges are citing and analyzing Daubert and its progeny, and many states have adopted Daubert.

Impact on Toxic Tort Litigation
If we look at toxic tort cases, we see that numerous problems arise when courts seek to determine, as commanded by Daubert, whether the expert’s conclusions were reached through the scientific method. Some commentators have expressed doubt about the ability of courts to understand scientific principles and have suggested that some judges simply use the Daubert factors as a checklist without understanding how they relate to reliability.11 Some support for these critiques was furnished by a recent survey of 400 state court judges that concluded that the participating judges had little understanding of the key concept of hypothesis testing or of the significance of error rates, although they did considerably better with the other two Daubert criteria of peer review and general acceptance.12 However, critics have also questioned the appropriateness of the Daubert factors as guides to reliability. A recent issue of the Journal of the American Medical Association raises serious doubt about the efficacy of peer review in assuring the reliability of scientific publications.13 As peer review appears to be a criterion that judges understand, it may be that they are relying too heavily on a problematic marker of good science.

In most instances, plaintiffs seeking to establish causation in a toxic tort case do not suffer from a "signature disease" that is uniquely associated with exposure to the defendant’s product. Instead, they have experienced adverse health consequences that also affect those who have not been exposed to the substance in question and have no explanation for how the exposure caused their disease. (In some instances, plaintiffs have a causal explanation, as in the Dalkon Shield cases in which plaintiffs claimed that the string on the shield wicked bacteria into the wearer’s uterus.) As in Joiner, plaintiffs will typically rely on a combination of epidemiology and animals studies to prove causation. Courts have expressed a preference for the epidemiologic study because it relates to human effects. But such studies may not be available when the plaintiff needs to institute an action in order to avoid having the suit barred by the statute of limitations. Or it may be impossible to do an epidemiologic study because the product has been taken off the market or because the condition from which the plaintiff suffers is so rare. In addition, such studies are expensive and time-consuming and subject to confounders and biases.14 Nevertheless, some courts have suggested that plaintiffs cannot win in the absence of a positive epidemiological study, even when the defendant has far more available information and resources to undertake such a study, and even though the scientific community looks to other forms of proof in assessing causation, especially animal studies. Some courts appear to find all animals studies irrelevant because of the need to extrapolate to humans and because, to see an effect, the doses to which the animals are subjected must be many times higher than those administered to humans. See, for example, Wade-Greaux v Whitehall Labs, Inc, 874 FSupp 1441,1480 (DVI 1994), in which the court stated: "The notion that one can accurately extrapolate from animal data to human to prove causation without supportive epidemiologic studies is scientifically invalid because it is inconsistent with several universally accepted and tested scientific principles. The principle of species specificity has been tested and demonstrates that different species can react differently to the same agent." Compare Joint Discussion of Science, Technology, and Law Panel and American Law Institute, Restatement of Torts, January 21, 2003: "There are an extraordinarily few number of places in the literature where anyone has ever even asked the question, if it happens in mice, does it happen in people? Is an animal model, an animal [study] that is done in a mouse or a rat, how is that comparable to humans?" (Statement of Douglas Weed.)

The standard of proof. Courts also fail to recognize that in reporting the results of their studies, epidemiologists use a far more stringent standard than the preponderance of the evidence standard that applies in civil litigation. See, for example, Joint Discussion of Science, Technology, and Law Panel and American Law Institute, Restatement of Torts, January 21, 2003: [Epidemiologists experience] "inarticulateness in expressing the levels of uncertainty below classical levels of surety"; epidemiologists are not familiar using language "to express and navigate this very, very difficult, sort of intermediate territory, which is exactly the territory where many of these suits are occurring as evidence is accumulating, as you say, you have very little epidemiologic evidence.") (Statement of Steven Goodman.) Because the scientific objective is to obtain the most knowledge possible, the system deliberately chooses to err on the side of wrongly rejecting the hypothesis being tested—drug A causes disease X—rather than erroneously finding that it was proven.15 But the fact that a hypothesis was not proven does not mean that it was disproved. If a study fails to achieve a 0.05 level of statistical significance—a convention often used to ensure the stringent scientific standard of proof—that does not mean it has no probative value. To a scientist, it simply means that more research may be in order. Some courts, however, read Daubert to mean that expert testimony that does not meet this scientific standard is inadmissible, even though a plaintiff in a civil case only has the burden of proving its case by a preponderance of the evidence. That is, the plaintiff’s burden is to convince the trier of fact on the basis of all the evidence that was admitted that it is more probable than not that defendant did what was alleged in the complaint. These courts condition admitting an expert’s testimony on there being evidence sufficient from a scientific standpoint to prove the hypothesis being tested, which is a standard of proof that far exceeds that applicable to civil litigation.

Another problem confronting plaintiffs in toxic tort cases is that courts often do what the district court in Joiner did. It examined and rejected separately each study on which the plaintiff’s expert relied rather than looking jointly at all the scientific studies on which the plaintiff’s experts based their opinions. The Supreme Court in Joiner seemed to approve this practice because it found that the trial court did not abuse its discretion in finding the studies insufficient, "whether individually or in combination." But scientists, including epidemiologists, typically state that they would look at the totality of the evidence before reaching a conclusion.

Parlodel cases. The different approaches courts take on the admissibility of expert proof in toxic tort cases is exemplified by the inconsistent results in the line of cases involving Parlodel. Parlodel is a drug that was approved in 1980 to suppress lactation in women who did not wish to nurse. In a number of instances, women taking the drug suffered strokes or heart attacks within a few days of commencing the medication. Reports of these incidents led the FDA to conclude that Parlodel should not be used to prevent lactation. These occurrences also resulted in law suits in both federal and state courts. The results have been mixed. Some courts have permitted plaintiffs’ experts to testify [see, for example, Globetti v Sandoz Pharmaceuticals Corp, 111 FSupp2d 1174 (ND Ala 2000)]; but others have excluded the experts and granted summary judgment [see, for example, Siharath v Sandoz Pharmaceuticals Corp, 131 FSupp2d 1347 (ND Ga 2001), aff’d, Rider v Sandoz Pharmaceuticals Corp, 295 F3d 1194 (11th Cir 2002)]. The plaintiffs offered an explanatory theory of the causal process—that the drug, like other ergot alkaloids, can cause vasoconstriction and hypertension, which in turn can cause seizures and strokes. They also relied on animal studies, adverse reaction reports, opinions by clinicians and, probably most importantly, the results of a number of de-challenge/re-challenge experiments in which women given Parlodel developed relevant symptoms that ceased when the drug was discontinued and recommenced when the drug was reinstituted. The little epidemiological evidence available was inconclusive.

The courts that excluded plaintiffs’ experts in the Parlodel litigation simply found that this evidence did not suffice to prove causation. They termed the adverse reaction reports anecdotal and were unimpressed with the testimony proffered by clinicians. One court stated that "with regard to general causation, the relevant scientific field is epidemiology or toxicology and not clinical medicine." [See Siharath v Sandoz Pharmaceuticals (2001).] And yet the Supreme Court in Kumho proposed as a test "that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Although it is true that in many cases, a clinician would not be concerned with what caused a patient’s disease, because treatment would in no way be affected by the answer to that question, a clinician may have to make a judgment about the safety of a drug like Parlodel in deciding whether to keep prescribing it to his or her patients. A clinician called as an expert witness who looks at all the available evidence in reaching a decision about Parlodel’s ability to cause strokes and heart attacks therefore seems to fulfill the dictates of Kumho. The role of clinicians in proving causation is, however, a question about which there is a good deal of controversy.16

Does Daubert promote deterrence? Markedly absent from this debate is a consideration of whether a stringent scientific standard of causation furthers the deterrence objective of tort law and provides the public with adequate protection at a time when we are constantly being exposed to new unstudied substances and do not yet fully understand the mechanisms that cause disease. It is, of course, true that the plaintiff bears the burden of proof, but defendants are the ones creating the risk. However, even the regulatory administrative agencies, whose mandate is to deal with risk rather than causation, are beginning to feel the impact of Daubert.17

I suggested a number of years ago, pre-Enron, that stock options—now such a key component of executive compensation—create disincentives for corporate behavior aimed at preventing injury.18 Corporate executives do not wish to publicize adverse reports about their products for fear that stock prices will tumble. News that a corporation is undertaking additional research about an item already on the market may be viewed as a sign of trouble. Furthermore, as the results of any studies would be subject to discovery if litigation occurred, it may be too dangerous to ask questions to which no one knows the answer. For corporations to take an ostrich-like approach is quite rational given our present system. A note from a corporate official was introduced in a lawsuit claiming that the corporation deliberately avoided studying potential links between its product and a rare muscle disorder; the note stated that "if the FDA asks for bad news, we have to give, but if we don’t have it, then we can’t give it to them."19

The difficulty plaintiffs face in proving causation may make the corporation’s risk of liability seem quite minimal when it first learns of adverse reactions and, besides, even if plaintiffs ultimately succeed in proving causation, any corporate loss that results is likely to occur on the watch of future management. The executives who were present when problems first surfaced will probably long since have cashed out. This time lag perhaps explains why corporate officials may take a short-range view that is absolutely detrimental to a corporation’s long-term objectives. Perhaps the clearest example of this phenomenon is the terrible but well-documented story of an AIDs-infected blood-clotting factor for hemophiliacs that Cutter Biological nevertheless kept selling overseas even though the product eventually killed its customers.20

(Although the manufacturer of the blood factor knew by October 1984 that heat treatment kills the AIDS virus, which it knew could be transmitted through blood products, it continued to ship the unheated product, which had become unmarketable in the United States, until the summer of 1985, because it needed to use up its inventory of unheated stock.)

Information about other pharmaceuticals that are the subject of toxic tort litigation further supports the hypothesis that corporations may fail to acknowledge problems with their products. The Second Circuit Court’s opinion in Desiano v Warner-Lambert Co21 discusses Rezulin, an anti-diabetes drug that was approved by the FDA in January 1997 and was withdrawn from the U.S. market in March 2000 after the FDA concluded that Rezulin usage "poses an unacceptable risk to patients."22 The defendant had apparently continued to advertise its drug as safe, with "Side Effects Comparable to Placebo," even after it became aware of fatalities in persons taking the drug and of reports linking severe liver damage with Rezulin usage.23

It is, of course, impossible to know whether the corporation’s decision to promote the drug despite its knowledge of adverse reactions was in any way affected by the difficulty users of Rezulin would encounter in proving causation if they sued for their alleged injuries. Possibly, the future outcome and impact of the Desiano case may shed some light on this question. Desiano is a consumer fraud class action suit, not a toxic tort case, that was brought by health insurers who allege that the cost of Rezulin, which was three times greater than that of other diabetes drugs, was far higher than it would have been had the defendant disclosed information relevant to the safety of the product. Plaintiffs allege that they spent $1.4 billion purchasing Rezulin. The appellate court reviewing Desiano reversed the district judge who had dismissed the complaint for failing to state a claim. In doing so, the appellate court noted that plaintiffs would not have to prove that Rezulin actually caused injuries. If plaintiffs ultimately succeed in this law suit or obtain a favorable settlement (keeping in mind that they seek damages in the neighborhood of one third of $1.4 billion), it will be interesting to see whether a fraud claim not requiring proof of injury to users will induce pharmaceutical companies to divulge more information about potential problems with their products than they have provided under a regime in which liability requires proof of causation.

Daubert in Criminal Cases
Contrary to the very strict scrutiny some federal courts apply when plaintiffs’ experts seek to testify, it should be noted that they seem to require considerably less with regard to prosecution experts in criminal cases. This is so even though in criminal proceedings, the prosecution must meet a much higher standard of proof. The prosecution must prove its case beyond a reasonable doubt rather than by a preponderance of the evidence. Nevertheless, although courts often exclude plaintiffs’ experts in toxic tort cases, courts virtually always permit a prosecution expert to testify after a Daubert challenge. Much of the expert proof in criminal cases consists of forensic identification testimony; it would seem far easier to test whether a given technique can in fact match two tangible samples and to determine the frequency of such a match than to decide whether a substance can cause a particular disease. Clearly, however, except for a few cases excluding or limiting testimony about handwriting analysis,24 the courts are not applying Daubert stringently in the criminal context. The paramount example is fingerprint evidence that has never been validated. Although no one doubts that full sets of fingerprints can be matched, the fingerprint found at a crime scene is often a partial, latent, contaminated print. How much of a print is needed for a match under these circumstances has not been determined. Although a number of Daubert challenges have been made by defense counsel, they have to date been uniformly rejected. A federal judge who initially limited fingerprint experts to explaining similarities but barred them from expressing an opinion about identity changed his mind. Compare United States v Llara Plaza, 179 FSupp2d 492 (ED Pa 2002) with United States v Llara Plaza, 188 FSupp2d 549 (ED Pa 2002). Both cases acknowledge the lack of research into the validity of matching fingerprints; examiners have only been tested for proficiency.25 When it comes to expert testimony issues in criminal cases, the courts seem very conscious of the need to protect society against dangerous persons.

Impact on Litigation in General
What conclusions can be drawn about the general effects Daubert has had on civil litigation? It needs to be noted that serious research on the effects of Daubert has just begun and that it is difficult to do. Although cases in which judges exclude the plaintiffs’ experts and grant summary judgment can generally be found because the trial court must write an opinion explaining its reasoning if it is to avoid reversal for an "abuse of discretion," many cases in which plaintiffs win a Daubert hearing undoubtedly settle without being counted and disappear from sight, or they go to trial and verdict without an opinion being written. The high visibility of decisions that exclude plaintiffs’ experts and grant summary judgment may make the law appear more settled than it actually is.

Recent studies. Nevertheless, recent studies by the Federal Judicial Center26 and the RAND Institute27 have concluded that judges are much more likely since Daubert to scrutinize expert testimony before trial and then to limit or exclude expert testimony. As I stated at the outset, the exclusion of expert testimony affects plaintiffs far more than defendants because plaintiffs may then not be able to meet their burden on proof. Furthermore, there is little point in plaintiffs going to the expense of Daubert motions to exclude defendant’s experts until they know if their case will proceed. So if more experts are now being excluded, then Daubert has undoubtedly shifted the balance between plaintiffs and defendants and made it more difficult for plaintiffs to litigate successfully. Certainly, plaintiffs’ counsel believe that this has happened. When given a choice of whether to proceed in federal or state court, many plaintiffs now choose to bring suit in state court, where they think they will have a better chance of presenting their case to a jury.

Has the trilogy led to better expert proof? That, after all, was the rationale for the Supreme Court’s opinions. Nobody at this point has the data to support such a conclusion, because no one has as yet systematically compared proffered expert testimony that is excluded with that which is admitted. The RAND Institute of Civil Justice has expressed an interest in doing such work in the future, but whether this is a viable project remains to be seen, given the thousands of pages of exhibits that often accompany a Daubert motion and the disagreements among experts in different disciplines.

Impact on potential experts. Ironically, however, the trilogy may be making reputable scientists even more leery of participating in the legal system. That a judge, who possibly has some incorrect or unsophisticated views about science, has the power to exclude the scientist as an expert witness and make some cutting remarks in print while doing so, may be enough to convince some scientists that they do not wish to be involved with the legal system. And they may also for similar reasons decline to undertake research related to litigation. On the remand of Daubert, Judge Kozinski of the Ninth Circuit added as a factor for courts to consider in assessing reliability whether the expert’s research was conducted expressly for the purpose of testifying and suggested that unless science is conducted independently of litigation, it is not likely to amount to "good science."28 But often the need for research does not become apparent until litigation begins. Judge Kozinski’s assessment puts another potential obstacle in plaintiffs’ path by perhaps driving out of the courtroom good scientists who do not want to be castigated as hired guns.

Daubert’s impact on transaction costs. The RAND study also concluded that the rate of exclusion of expert testimony has begun to drop and suggested that this may be due to better testimony being offered or to counsel not pursuing cases in which Daubert standards cannot be met. But there is an alternative explanation. Plaintiffs may be warding off Daubert exclusions by offering more expert testimony than they used to and, accordingly, are litigating only those cases in which the potential award is large enough to cover these additional expenses for experts. (The expense is more than just the experts’ fees. For attorneys paid on a contingent fee basis, as attorneys in tort cases invariably are, Daubert undoubtedly forces them to spend much more time for which they cannot bill in preparing their experts. To explain to a court the meaning of statistical significance, for example, requires understanding this concept and preparing an expert to explain the standard of proof on which his or her opinion is based.) The Supreme Court’s 2000 opinion in Weisgram v Marley,29 which is sometimes referred to as the Supreme Court’s fourth case on expert testimony, helps force plaintiffs into this choice. In Weisgram, the trial court admitted the plaintiffs’ experts. Despite the abuse of discretion standard, the appellate court found that the experts should have been excluded, reversed, and entered judgment for defendant. (In Kumho, the Court had once again endorsed the abuse of discretion standard of review, which requires deference to a trial court that admits expert testimony. However, Justices O’Connor and Thomas joined Justice Scalia in a brief concurring opinion to warn that the abuse of discretion standard "is not discretion to abandon the gatekeeping function" or "to perform the function inadequately." It is not clear whether appellate courts will find an abuse of discretion more often when the trial court admits the plaintiff’s expert proof than when it excludes it.) The plaintiffs argued that they were entitled to a new trial at which they could produce other experts. The Supreme Court did not review the exclusion of the plaintiffs’ experts by the appellate court; it dealt only with plaintiffs’ claim to a new trial, which it rejected. "Since Daubert, moreover, parties relying on expert evidence have had notice of the exacting standards of reliability such evidence must meet. . . . It is implausible to suggest, post-Daubert, that parties will initially present less than their best expert evidence in the expectation of a second chance should their first try fail."30 (Of course, in contingent fee cases, plaintiffs’ lawyers who felt confident that the trial court would allow the plaintiffs’ experts to testify might simply have been trying to save money that would come out of their pockets if the lawsuit was unsuccessful; this is a gamble they can no longer afford to take.)

Although hiring battalions of experts has improved plaintiffs’ success rates and has produced larger awards, clients with smaller claims may be unable to find representation. It is expensive to proffer more experts at trial than the trial court requires in the hope of warding off a reversal on appeal. (It should be noted that it is not only Daubert that has made expert proof more costly. Amendments to the Federal Rules of Civil Procedure that became effective in 1993, the year Daubert was decided, with the same objective of improving expert testimony, require testifying experts to prepare written reports about their opinions, after which they may be deposed. All of this, as well as complying with Daubert and appearing at a Daubert hearing, means that the contingent fee lawyer must spend far more time, which is not billable, on expert testimony than before.)

One lawyer quoted in the New York Times explained, "I can no longer afford to spend $300,000 trying a case that is only worth $500,000, and that’s ridiculous."31 The number of product liability cases filed in federal court has dropped precipitously. Daubert may be stifling access to the courts at the same time it is fueling demands for tort reform by escalating awards.

The RAND report concluded, "Challenges to expert testimony increasingly resulted in summary judgment after Daubert," although it also noted that "the increase may reflect broader trends in litigation practices that have little to do with Daubert." Certainly, the number of civil trials had been steadily decreasing even before the Supreme Court’s opinions on expert testimony, in part because the Supreme Court in another trilogy of opinions had made it easier for defendants to obtain summary judgment.32 Daubert works effectively as another tool for terminating litigation without a trial or jury.


    Acknowledgments
 
This paper was supported, in part, by the Project on Scientific Knowledge and Public Policy.


    Footnotes
 
Peer Reviewed

Accepted for publication July 27, 2004.


    References
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 ABSTRACT
 THE SUPREME COURT TRILOGY...
 THE IMPACT OF THE...
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24. See, for example, United States v Saelee, 162 FSupp2d 1097 (D Alaska 2001); United States v Fuji, 152 FSupp2d 939 (ND Ill 2000). Contra: United States v Prime, 220 FSupp2d 1203 (WD Wash 2002).

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29. Weisgram v Marley, 528 US 440 (2000).

30. Weisgram v Marley, 528 US 440, 455 (2000).

31. Winter G. Jury awards soar as lawsuits decline on defective goods. New York Times. January 30, 2001:A1.

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