The Federalist Society

Colloquium: Junk Science, the Courts, and the Regulatory State (part I)

Environmental Law & Property Rights Practice Group Newsletter - Volume 1, Issue 3, Fall 1997

December 1, 1997

Jeffrey Bossert Clark

The Federalist Society's three E.L. Wiegand Practice Groups in Administrative Law & Regulation, Environmental Law & Property Rights, and Litigation held a colloquium entitled "Junk Science, the Courts, and the Regulatory State" on July 10, 1997 at the University Club in Washington, D.C. The five participants in the morning session of the colloquium focused on the interplay between risk regulation in administrative agencies and risk regulation through the tort system, while the two participants in the afternoon session examined the question of who should decide scientific questions in the toxic-tort context -- judges, juries, or expert panels. Peter Huber, one of the pioneers of the attack on the use of "junk science" in the courtroom and a partner in the law firm of Kellogg, Huber, as well as a Senior Fellow of the Manhattan Institute, delivered a luncheon address exploring the meaning of the evidentiary tests for true "science" announced by the Supreme Court in its landmark case, Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).

Panelists in both sessions, including a representative of the plaintiffs' bar, seemed to agree that "junk science" was to some degree a problem. In fact, Peter Huber went so far as to claim that the battle to establish the need to eradicate "junk science" from the courts had been won in Daubert and that the principal task now remaining undone was to work out how to apply Daubert properly. Most panelists, however, coalesced around the idea that much more needed to be done to solve the vexing problems posed by "junk science." Edward Warren, a partner in the law firm of Kirkland & Ellis and a participant in the morning session, captured this view when he noted that Daubert seemed a second-best solution to a recurring legal and policy problem demanding bolder action. Panelists diverged on exactly how the regime of legal rules governing the use of science in the courtroom and in the halls of administrative agencies should be improved, although a number of potentially constructive solutions were advanced. These potential solutions ranged from toughening judicial review of agency decisionmaking by cross-applying Daubert in the administrative context, to reforming the rules in other problematic areas of the law such as class actions, punitive damages, and discovery, to taking the scientific fact-finding powers away from juries almost entirely by instructing juries in scientific facts as they are now instructed in the law.

The four-hour colloquium was brisk, intellectually rigorous, and even when there were disagreements, conducted in an atmosphere of collegiality. As a colleague sitting near me throughout the colloquium remarked, the "junk science" program was conducted on too high a plane and was far too much fun to warrant continuing-legal-education (CLE) credit. But it should come as no surprise to Federalist Society members that its programs are of a consistently high quality and are much more provocative than standard bar fare.

What follows is Part I of a two-part series of articles.

The morning session began with a panel entitled "Junk Science: The Interplay Between Risk Regulation and the Torts System." Panelists included: Arthur Bryant, Executive Director, Trial Lawyers for Public Justice; Dr. George Ehrlich, University of Pennsylvania Medical School; Alan Raul, Sidley & Austin, Chairman of the E.L. Wiegand Practice Group in Environmental Law & Property Rights; Edward Warren, Kirkland & Ellis, Chairman of the E.L. Wiegand Practice Group in Administrative Law & Regulation; James Gauch, as moderator, Jones, Day, Reavis & Pogue, Vice Chairman of Programs for the E.L. Wiegand Practice Group in Administrative Law & Regulation.

James Gauch introduced the morning's panelists and noted that it was his intention to place the spotlight on neglected topics -- should courts exercise the same gatekeeping function over the uses of science by administrative agencies that they now serve over science in the courtroom, and is science consumed by agencies in the same way it is consumed by the courts? Gauch began by introducing Edward Warren and commending to the audience Warren's article bearing on these questions -- Judge Leventhal's Revenge: The Courts as "Gatekeepers" of "Good Science" After Daubert, 1994 Pub. Int. L. Rev. 93 (1994) (arguing that Daubert was similar to former D.C. Circuit Judge Harold Leventhal's "hard-look" brand of judicial review of technical and scientific agency decisionmaking). Gauch then noted that Dr. George Ehrlich has been an advisor to the FDA and consultant to the manufacturers of breast implants. Gauch said Alan Raul planned to focus on relevant lessons from tobacco-related regulation. Lastly, Gauch introduced Arthur Bryant as a champion of the plaintiffs' bar who would do his best to rebut what other panelists would say.

Alan Raul, partner at Sidley & Austin and Chairman of the practice group in Environmental Law & Property Rights, made the first presentation. Holding up his pocket computer, Raul joked that it was only a matter of time before he became a member of a class action involving radio emissions or carpal-tunnel syndrome. Throughout his presentation, Raul peppered his analysis with examples drawn from his experience with the regulatory treatment of and science surrounding so-called "environmental tobacco smoke" (ETS) or "second-hand smoke." Raul's thesis was that Daubert should be applied "actively and aggressively" by federal judges reviewing the scientific underpinnings of agency action. Acknowledging the "[anti-]democratic risk" of his approach, Raul cautioned that he was not advocating the substitution by judges of their own preferences for those of Congress or for the preferences of agencies legitimately delegated lawmaking authority. What he was advocating and what deeply troubled him was the tendency he perceived for agencies to make rules and other decisions based on various assumptions, default principles, and "fudge factors" that often remain undisclosed to the regulated public. According to Raul, federal judges should follow the example of Daubert in the tort context by excising such unexamined and unscientific regulatory assumptions with the scalpel of searching judicial review.

Raul recommended that the audience read Wendy E. Wagner's article, The Science Charade in Toxic Risk Regulation, 95 Colum. L. Rev. 1613 (1995). Though it approached the issues posed by regulatory science from a liberal perspective, Raul argued that the article's observation that agencies were deliberately obfuscating their modus operandi by calling it "science" rather than naked "policymaking" was correct and should be taken to heart. Raul apparently parts company with Wagner's follow-up argument that agencies shouldn't have to pretend and thus should be allowed to make policy openly. In Raul's view, the problem in the regulatory context in most cases isn't "junk science," it's "junk policy." The science is fine; it's what the agency does with the science that's invalid. In the ETS context, for example, perfectly valid epidemiologic studies establish that ETS increases the risk of certain diseases by a factor of 1.19. According to Raul, however, epidemiologists are in general agreement that such a factor would have to exceed at least 2 and possibly 3 before there was any cause for alarm, yet ETS studies far below that threshold are currently being cited by regulators to justify administrative action.

In Raul's view, agencies regulating on the basis of unarticulated assumptions become essentially a "farm team" for the plaintiffs' bar. Whenever an agency takes action or does a study suggesting that a product or service causes harm and there is a "deep pocket" anywhere in the vicinity, litigation is inevitable. For support, Raul ticked off the examples of Love Canal, the "junk science" behind banning asbestos in building materials, the baselessness of breast-implant litigation, and the dioxin scare. To his recommended reading list Raul added a publication by the American Council on Science and Health, Facts vs. Fears, which reviews the twenty greatest modern health scares perpetrated in our country.

To solve the problems he identified, Raul advocated using the Daubert-like approach to judicial review of regulation described above, an approach that Raul believes Judge Leventhal would have applauded. Unfortunately, Raul noted that the only court to address this question explicitly, the Seventh Circuit, has rejected a similar argument. See Sierra Club v. Marita, 46 F.3d 606, 621-22 (7th Cir. 1995) ("While such a proposal might assure better documentation of an agency's scientific decisions, we think that forcing an agency to make such a showing as a general rule is intrusive, undeferential, and not required.").

The next to speak was Dr. George Ehrlich from the University of Pennsylvania Medical School. Dr. Ehrlich explained that he was a man of "strong opinions," as reflected in his television appearances concerning breast-implant litigation and science. He noted that it is inevitable that as a new medical product or service becomes more widely used in society, the segment of the population using the new product or service will begin to show some incidence of the rare diseases that manifest themselves in the population at large. Breast implants are only one example of this phenomenon. Dr. Ehrlich suggested that the recent uproar over the weight-loss drug fen-phen was another.

Given this rather obvious statistical fact, Dr. Ehrlich posed the question of how it is that widespread claims of rare diseases being caused by medical products or services are taken seriously in the courts and by doctors, even though the science supporting such claims is flimsy or nonexistent. He believes the answer lies in "Bergson's fallacy." Dr. Ehrlich explained that Bergson was a statistician at the Mayo Clinic who was often being asked by his doctor colleagues how it could be that they were seeing more and more patients with rare diseases unless the incidence of such diseases was truly increasing. The answer, Bergson explained, was that the doctors at the Mayo Clinic were super-specialists. Patients with rare diseases were concentrated at the Mayo Clinic because of its world-renowned reputation. (Psychologists Kahneman and Tversky have labeled the phenomenon also identified by Bergson the "availability heuristic" -- people tend to generalize inappropriately from what is common or rare in their own experience (including media reports) to conclusions about what is common or rare in the world as a whole. See Amos Tversky & Daniel Kahneman, Availability: A Heuristic for Judging Frequency and Probability, in Daniel Kahneman, et al., eds., Judgment under Uncertainty: Heuristics and Biases 166 (Cambridge 1982).) As an example, Dr. Ehrlich pointed out that many doctors practicing on the West Coast of Florida became convinced that breast implants were causing various health problems because they were seeing a lot of women with breast implants who had such problems. Of course, those doctors had fallen into Bergson's fallacy by failing to consider that breast implants were especially common in that part of the country and that women conscious of their appearances enough to obtain implants were more likely to search out doctors for any health problems they were experiencing.

Further elaborating on the example of breast implants, Dr. Ehrlich explained that the mine run of epidemiologic studies demonstrate consistently that breast implants do not cause diseases such as scleroderma or rheumatoid arthritis. (Dr. Ehrlich is a rheumatologist.) Thus, breast-implant plaintiffs have resorted to arguing that they suffer from what Dr. Ehrlich called "fake" illnesses, such as "atypical connective-tissue disease." The problem with these diseases is that they are non-falsifiable because they rely on subjective expressions of pain -- that is why the list of symptoms for these kinds of "diseases" is at 150 and growing. In the same category Dr. Ehrlich put other so-called diseases such as "fibromyalgia," "chemical sensitivity syndrome," and "repetitive-strain syndrome."

In contrast to Raul's observation that regulatory action tends to spur litigation, Dr. Ehrlich seemed more concerned that agency mandates have expanded because of action by an aggressive plaintiffs' bar. He described how the Food and Drug Administration's (FDA's) powers to regulate have expanded from the power to ensure safety to include powers to ensure efficacy. In Dr. Ehrlich's view, these new powers give regulators the ability to impose the impossible burden on manufacturers to prove scientifically that their products are absolutely safe.

Dr. Ehrlich also argued that the proliferation of spurious science is not entirely the fault of plaintiffs themselves. Dr. Ehrlich lays blame at the feet of both plaintiffs' attorneys and doctors. Many of the plaintiffs in breast-implant cases are proceeding in good faith, according to Dr. Ehrlich -- it's simply that their doctors and lawyers have convinced them that inside their breasts wait ticking time bombs and therefore that they should sue now before the inevitable illnesses arrive.

Moderator James Gauch next introduced Edward Warren, a partner at Kirkland & Ellis and Chairman of the Administrative Law & Regulation practice group. Borrowing the thesis of an obscure article written at the turn of the century in the Albany Medical Journal, Warren argued that Daubert was a second-best solution to a very old legal problem. Turns out that the article was written by none other than the famed jurist Learned Hand and reprinted shortly thereafter in the Harvard Law Review. See Historical and Practical Considerations Regarding Expert Testimony, 15 Harv. L. Rev. 40 (1902). In Warren's view, Judge Hand's analysis of the problems posed by expert scientific testimony were "prescient" and so fresh they "could have been written yesterday."

In his article, Judge Hand analyzed a long line of common-law decisions to make the point that it was an anomaly in Anglo-Saxon jurisprudence for witnesses to be allowed to testify to opinions. The liberal treatment of experts in this regard was thus an exception to that general rule. Judge Hand thought that this exception was totally unwarranted. The usual trope advanced to justify this exception even in Judge Hand's day was that juries were incapable of applying scientific learning to pure facts to draw valid inferences because such learning was outside their experience or maybe beyond their ken. But Judge Hand emphasized that this same problem also clearly counseled against allowing juries to weigh the opinions of conflicting experts at all. The solution to the problem of jury incompetence in this area, according to Judge Hand, was to treat scientific knowledge in the same way courts are accustomed to treating something else universally acknowledged to be beyond the jury's powers -- the law. Thus, juries should be instructed about scientific conclusions as if they were law. In Judge Hand's schema, either judges or expert panels of neutral scientists would be tasked with crafting the "science instructions" in a particular case. Warren subscribes fully to Judge Hand's view as the "first-best" approach that is correct as a matter of logic and law.

Turning from the ideal world to the existing one dominated by Daubert's schema, Warren noted that the lower federal courts have by and large applied Daubert faithfully. The most glaring exception to that trend has been the Eleventh Circuit's decision in Joiner v. General Elec. Co., 78 F.3d 524 (11th Cir. 1996) (Barkett, J.), cert. granted, 117 S. Ct. 1243 (1997), a case in which the plaintiff alleged that his lung cancer was caused by PCBs and the court reasoned, despite a careful district court opinion to the contrary below, that two mouse studies and the mere credentials of the plaintiff's experts were enough to allow the case to go to a jury. The Supreme Court has granted certiorari in Joiner, and in Warren's view, the Court did not take that step with an eye to affirm. Therefore, Warren expects that Daubert will be strengthened in some way or confirmed in the Court's next term. Alternatively, the Court could choose to use the case as a vehicle to explore the powers of the courts of appeals to reverse evidentiary rulings excluding experts, but at the very least that approach would leave Daubert intact.

Expanding on the analysis he advanced in his piece in the Public Interest Law Review, Warren next explored the differences between how science is used by agencies and how science is used by courts. By contrast to Raul, Warren thinks that agencies should be given a wider latitude in their use of science than courts. This is because it is the task of agencies to regulate in a forward-looking, prophylactic manner, while courts are tasked with deciding individual cases under the backward-looking standard of whether a plaintiff can show that his particular injury was more likely than not caused by a defendant's actions. Warren then expressed his view that Judge Alex Kozinski properly emphasized the point on remand in Daubert that the "more likely than not" standard is a "pretty tough test." See Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311 (9th Cir.), cert. denied, 116 S. Ct. 189 (1995). Because agencies use science in a different way than courts, Warren concluded by arguing that courts should not defer to agencies whenever agencies decide that the risks warrant taking administrative action. On the other hand, if an agency, with the broader scope of action entrusted to it, decides not to regulate, then courts should in most cases defer to the expert agency's determination and thus block lawsuits running contrary to such an agency's effective determination that a product or service is safe.

The last panelist to make a presentation in the morning was Arthur Bryant, Executive Director of Trial Lawyers for Public Justice. Bryant joked that he felt like the man invited to a barbecue only to find out that he was the main course. Bryant predicted that the audience would be shocked by his exclamation: "Ich bin ein Federalist." Bryant chastised other panel members for advocating an expanded role for federal judges and agencies to control "junk science" as anti-Federalist and argued that because of the more liberal treatment trial lawyers champion for expert testimony in the law they are actually more in line with Federalist principles than the Federalist Society.

The theme of Bryant's presentation was that there were no easy answers -- each case had to be decided on its facts and each agency possessed unique problems and capabilities that needed to be considered. Bryant also argued that the problem of "junk science" cuts both ways -- that corporate defendants often deploy "junk science" in order to ward off valid claims. He pointed to a Title IX case that he recently litigated against Brown University in which Brown attempted to cut its female gymnastics and volleyball programs costing about $60,000 annually. Brown paid $100,000, however, to commission a study designed to show that men are generally more interested in participating in college-sports programs than women. In Bryant's view, that study was a prime example of "junk science." Continuing with his "complexity" theme, Bryant asked whether defendant tobacco manufacturers would agree with him that Daubert bars them from presenting an expert to testify before a jury that smoking does not cause lung cancer, despite the current scientific consensus to the contrary.

According to Bryant, there are two reasons why plaintiffs are commonly perceived as being more set back by Daubert than defendants: (1) plaintiffs have the burden of proof, and if all scientific evidence is excluded when scientific evidence is in fact necessary to establish liability, then plaintiffs obviously lose; and (2) Peter Huber successfully framed the issue this way in his book, Galileo's Revenge: Junk Science in the Courtroom (Basic Books 1991). Likening Huber's method to the Spanish Inquisition (proving only what it set out to prove), Bryant accused Huber of ironically providing no scientific basis for the claims he made in that book. For Bryant, Huber has claimed the commanding heights on this issue only because of a vigorous public-relations campaign to promote the book conducted by the Manhattan Institute.

Pushing his oversimplification thesis, Bryant argued that "eggshell" plaintiffs deserve protection by our tort system, and that some breast implants cause some diseases, but not others. He explained his point that not all agencies are created equal by pointing to the example of the FDA, which lacks subpoena powers and thus was apprised of some of the evidence available to buttress claims of breast-implant risk only by plaintiffs' lawyers, sometimes in violation of judicial protective orders. In Bryant's view, truth isn't absolutely knowable and unchangeable and thus, while cases must be decided at a specific point in time, courts should never crystallize the prevailing view of mainstream science in the law. To support this claim he relied on the Supreme Court's rejection of the asbestos class-action settlement in Amchem Prods., Inc. v. Windsor, No. 96-270, 1997 WL 345149 (June 25, 1997), where a district court was reversed for binding future asbestos claimants to the settlement, despite the possibility that their claims might be different from those of current plaintiffs and that the ability of future plaintiffs to prove their claims might similarly be different in light of subsequent advances in science. Bryant also noted that many of the proposals for reform advanced by other panelists relied on giving a freer rein to judges, though in some cases the judiciary inspires less confidence than juries. Summing up, Bryant cautioned everyone to "be more skeptical" of attacks on "junk science" because "science is about as an efficient search for truth as the legal system is an efficient search for justice."

When initial morning presentations concluded, Gauch gave each of the panelists a chance to react to their fellow panelists' arguments. Raul began by turning around Bryant's point about public relations. He argued that in reality the so-called public interest groups have been far more effective in playing the public-relations game than those of Peter Huber's persuasion. He pointed out that a single person can place a call to the Larry King Live cable-television program claiming that his wife died of brain cancer because she frequently used a cellular telephone and soon there is a national panic. Raul did give credit to agencies here in rejecting calls to regulate cellular telephones on the ground their use causes physical harm, however. On the whole, though, Raul thought that Bryant had been quite reasonable, noting that both sides in the debate are sometimes prone to oversimplification. In reality, subtle questions, not easy questions, are involved in this issue.

Dr. Ehrlich agreed with Bryant's point that courts should never freeze current scientific views into the law, quoting Captain Cook's quip that "There are no black swans until you encounter your first one." He disagreed with Bryant's point that there are two sides to science, however. He argued that there is always only one side that is currently supportable and, thus, the other side must be presumed to engage in speculation. Case reports and the like can provide useful signals that the current orthodoxy should be changed, but case studies alone cannot be the basis for doing so. He referenced the principles of bacteriology that maintain that even epidemiologic evidence not be taken as conclusive until medical science has established the causal links in a chain operating at the cellular level.

Returning to the subject of breast implants, Dr. Ehrlich pointed out that the types of silicone used in such implants are safe and inert. In fact, silicone is used to coat needles and to make artificial limbs, in pacemakers, in devices like Norplant, and even in anti-flatulence drugs and in breakfast cereals. The only silicone ever shown to cause health problems according to Dr. Ehrlich is a type of silicone that Japanese prostitutes injected into their breasts in the aftermath of WWII.

Responding to criticisms on federalism grounds of his recommendations for reforming the problems associated with "junk science," especially to his arguments that courts should defer to agencies that decide not to regulate, Warren indicated that he was not at that point arguing for the preemption of state lawsuits, merely that a flexible principle of deference should be voluntarily recognized and applied. Warren also stated his opinion that "junk science" is the symptom of a much larger problem and not the cause. In this vein he argued that there is too much dual regulation between the federal agencies and the tort system and thus that Congress should explicitly preempt more tort law. (The implementation of Judge Hand's solution would also require legislative action.) He applauded the Supreme Court's recent ruling in Metro-North Commuter R.R. Co. v. Buckley, No. 96-320, 1997 WL 338550, (June 23, 1997) (rejecting a fear-of-cancer tort under the Federal Employers' Liability Act (FELA)). Like Bryant, Warren also referred to the Supreme Court's rejection of the asbestos class action in Windsor, but as an example of the rampant abuse of the rules of civil procedure by plaintiffs. Finally, Warren decried unbelievable punitive-damage awards and the rise of a "discovery tort" used by the plaintiffs' bar to shift the focus from the reality of cases of dubious scientific merit to alleged misconduct by products-liability defendants, who are often crushed by oppressive discovery requests in multiple fora.

Bryant responded to his critics by noting that there was little disagreement with his "oversimplification" thesis. He then recounted how the first breast implant case settled for a sizable sum in exchange for a sealing of the record, suggesting that "there must have been something there." Dr. Ehrlich couldn't help but exclaim that it's often cheaper for defendants to settle than to litigate. Bryant then moved to a different subject, agreeing with Warren's claim that science is and should be used in different ways in the regulatory and judicial contexts. In Bryant's words, "the agencies work wholesale, while the courts work retail." He took issue, however, with Dr. Ehrlich's point that there is only one side to science. Bryant said the scientists he talks to tell him that there is plenty of room for disagreement on many scientific questions. Finally, Bryant attacked Warren's claim that courts should defer to agencies when they decide not to regulate. He suggested that embedded within any such argument is an ideological assumption that the agencies always do their best to assert that a potentially regulable product or service causes harm. He did not dispute that deference was appropriate in some cases, but argued that plaintiffs should be able to present evidence to a jury that an agency decision not to regulate was caused by a lack of information or by political concerns.

The first question from the audience was put to Raul and focused on whether institutional pressures creating a "flight from science and reason" turned too many scientists into cowards. Raul acknowledged that it is dangerous for a scientist to be caught outside the mainstream -- that even scientists can fall prey to "political correctness" because they fear losing the right to compete on a level playing field for future grants. Raul was considerably more sanguine than the questioner that good science could win out, however, because the light of full disclosure is a powerful medicine. He pointed to the example of the Congressional Research Service's unmasking of the fact that EPA reduced the standards for statistical significance when reviewing the studies on ETS.

Warren primarily fielded a question arguing that it was ironic for Federalists to be advocating giving judges more power in order to solve the problem of "junk science." Warren responded that, as Judge Hand had recognized, allowing expert witnesses to testify to opinions is a rule at war with our legal tradition. Therefore, any qualms Federalists have with fixing the problems of "junk science" by strengthening the role of the judiciary operates from an incorrect legal baseline. The best solution to the problem of "junk science" is for courts to impanel expert advisory panels in Warren's view. (As additional support for Warren's argument that Judge Hand's solution is not radical, consider the fact that Lord Mansfield, to cite the practice of only one eminent common-law judge, convened expert juries to address complex questions arising under the commercial law. See 1 James Oldham, The Mansfield Manuscripts and the Growth of English Law in the Eighteenth Century 93-99 (1992)). Warren also agreed with Raul that while there is a price to be paid for speaking out against "junk science" we should be optimistic that scientists generally have enough courage to do so. In particular, Warren argued that reputable scientists would participate in the expert panels he recommended be utilized because this move would free them from the taint associated with being labeled "hired guns."

*Jeffrey Bossert Clark is an associate at the law firm of Kirkland & Ellis.

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--Colloquium: Junk Science, the Courts, and the Regulatory State (part II)


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