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Daubert_rpt/prnt

Daubert:
The Most Influential Supreme Court
Ruling You’ve Never Heard Of

A Publication of the Project on Scientific Knowledge andPublic Policy, coordinated by the Tellus Institute Daubert:
The Most Influential Supreme Court
Ruling You’ve Never Heard Of

A Publication of the Project on Scientific Knowledge andPublic Policy, coordinated by the Tellus Institute THE PROJECT ON SCIENTIFIC KNOWLEDGE AND PUBLIC POLICY (SKAPP) isan initiative engaging eminent scholars and scientists to examine scientific evidenceand its application in the legal and regulatory arenas. The project encourages theunderstanding and use of the best available scientific evidence in policy decision-making. The planning committee and staff for SKAPP include academics andresearchers with backgrounds in philosophy, biochemistry, medicine, epidemiology,economics, and occupational and environmental health, several of whom have pre-viously served at high levels in government. Planning Committee
Eula Bingham, PhD, Professor of Environmental Health, University of Cincinnati Les Boden, PhD, Associate Chair and Professor of Environmental Health, Boston Richard Clapp, DSc, MPH, Professor of Environmental Health, Boston University Polly Hoppin, ScD, Senior Scientist, Tellus Institute.
Sheldon Krimsky, PhD, Professor of Urban and Environmental Policy and Planning, David Michaels, PhD, MPH, Research Professor of Environmental and Occupational Health, George Washington University School of Public Healthand Health Services.
David Ozonoff, MD, MPH, Professor of Environmental Health, Boston University Anthony Robbins, MD, MPA, Professor of Family and Community Medicine, Tufts Molly Jacobs, MPH, Research Associate, Tellus Institute. Celeste Monforton, Senior Research Associate, George Washington University School of Public Health and Health Services.
Daubert:
The Most Influential Supreme Court
Ruling You’ve Never Heard Of

TEN YEARS AGO, on June 28, 1993, the United States Supreme Court issued anopinion relating to how federal judges should decide whether to allow expert testi-mony into the courtroom. Prior to this, most federal and state court judges had beenrelying upon two standards to decide if expert testimony was admissible: relevance (ifthe testimony addressed a fact at issue in the case and if it would be helpful to thejury); and a 1923 ruling known as Frye, which held that the methods used by theexpert in forming his scientific conclusions must be generally accepted within theexpert community. Critics of Frye argued that it often excluded new but legitimatescience that had not yet gained a consensus within the scientific community.
Moreover they pointed out that science was not a “majority rules” endeavor. On theother hand, others argued that abandoning the Frye standard and relying merely onthe relevance standard allowed in too much science that was poorly designed or not reliable – what some chose to call “junk science.” The Supreme Court sought to clarify these standards in Daubert v. Merrell DowPharmaceuticals, Inc.1 by directing judges to act as “gatekeepers” in the courtroom. Itinstructed judges to examine the scientific method underlying expert evidence and toadmit only that evidence that was both “relevant and reliable.” Two later cases,General Electric v. Joiner and Kumho Tire Co. v. Carmichael, expanded upon this opin-ion.2 In Joiner, the Supreme Court ruled that appellate courts should not overturnthe admissibility decision of a trial court unless the trial court abused its discretion,an extremely difficult thing to show. Kumho clarified the Daubert ruling by findingthat it should be applied to all expert testimony, including testimony based on expe-rience, not merely that which relied upon science.
But what started as a well-intentioned attempt to ensure reliable and relevant evi-dentiary science has had troubling consequences. Over the past 10 years some judges,in our opinion, have routinely misinterpreted and broadened the reach of Daubert,which has become the latest and most effective tool used by tort defendants to pro-tect themselves from product liability and personal injury cases. Polluters and man-ufacturers of dangerous products are successfully using Daubert to keep juries fromhearing scientific or any other evidence against them.
In the aftermath of Daubert, not only are many legitimate scientists and their workbeing barred from the courtroom, but plaintiffs are being denied their day in court,unfairly in our view. Much of the evidence that forms the basis of a plaintiff ’s case, fromthe safety of drugs and consumer products to whether pollution has caused harm, isbased on science. In many cases, pre-trial “Daubert hearings” exclude so much of theevidence upon which plaintiffs intend to rely that a given case cannot proceed. D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F Moreover, this process is largely shielded from public view. The Daubert hearing doesnot happen at the trial, and most judicial decisions on admissibility are not pub-lished. And because of Joiner, they are nearly impossible to overturn.
The percentage of expert testimony by scientists that was excluded from the This rise in excluded testimony has led to an increase in successful motions for sum- mary judgment, since, without expert testimony, there is often little left with whichto proceed. The percentage of summary judgments granted post-Daubert more thandoubled. Over 90 percent of these judgments came down against plaintiffs.4 The expense of defending a Daubert challenge appears to be having a “chilling effect” upon plaintiffs, who don’t have the same resources as large corporationsand often cannot afford to defend against aggressive attacks on their experts.5 Scientists and physicians are likely to be increasingly reluctant to provide expert testimony in civil litigation cases because of the lengths to which defendants goto discredit them and their work. Emboldened by their success in the courtroom, powerful interests are now trying to extend the reach of Daubert-like evidentiary standards to the regulatory arena,where they may affect the federal government’s ability to understand and act toreduce risk from hazardous exposures.6,7 In contrast, because of the cost of mounting Daubert challenges, they are rarely brought in the criminal justice system, where life and liberty – rather than eco-nomic interests – are at stake.3 It is in this arena where the most meager ratherthan the most stringent scrutiny of scientific evidence is applied. The Daubert Definition of Good Science
When the Supreme Court issued its opinion in Daubert, it suggested four criteria fordetermining whether science was reliable and, therefore, admissible: 1) is the evidence based on a testable theory or technique; 2) has the theory or technique been peer reviewed; 3) in the case of a particular technique, does it have a known error rate and stan- dards controlling the techniques operation; and 4) is the underlying science generally accepted? The Court cautioned that the list should not be regarded by judges as “a definitivechecklist or test,” opening the door for judges to employ criteria of their own.
Two Supreme Court Justices voiced serious concerns about asking federal judges totake on the role of deciding what is good versus bad science, fearing that this was akinto asking judges to become “amateur scientists.” Notably, Chief Justice Rehnquist,joined by Justice Stevens, wrote in a dissenting opinion: “Questions arise simply fromreading this part of the Court’s opinion, and countless more questions will surelyarise when hundreds of district judges try to apply its teaching to particular offers ofexpert testimony.”1 It isn’t just federal district judges who interpret these teachings, however. ThoughDaubert was based on an interpretation of the Federal Rules of Evidence, and intend-ed for use by federal judges, roughly one-third of state courts (which routinely adoptFederal Rules of Evidence) have also adopted the Daubert criteria in determining theadmissibility of expert testimony. Some leading jurists, however, seem quite dismayed by the notion of judges attempt-ing to determine the validity of scientific evidence using the criteria established inDaubert. “…the Daubert opinion appears politically naïve about the ‘methods and pro-cedures’ of both science and evidentiary admissibility,” wrote Arizona SupremeCourt Chief Justice Stanley Feldman, in a case in which expert testimony hadbeen excluded in a lower court. “Multi-factored, ‘flexible’ tests of the sortannounced in Daubert are more likely to produce arbitrary results than they areto produce nuanced treatment of complex questions of admissibility.”8 One result of Daubert is a battle over where product liability and toxic tort cases aretried. Plaintiffs prefer those state courts that are friendlier to their experts.
Defendants on the other hand, try to remove these cases to federal court, where theyhave a better chance of having expert testimony excluded and winning summaryjudgment.
In some cases, plaintiffs have even tried suing the doctor who prescribed the drug orthe pharmacist who filled the prescription to keep the case in state court. Noted legalscholar and Brooklyn Law School Professor Margaret Berger explains that if one ofthe defendants lives in the same jurisdiction as the plaintiff, the action cannot beremoved to federal court. “Now, there is an effort by defendants to stop that [venue-based suits] by allegingfraud or collusion because the plaintiff never really intended to proceed against thedoctor or pharmacists,” said Berger. “Defendants are asking that the case should beremovable to federal court where it’s often much easier to get the plaintiff ’s expertsexcluded; because it’s in federal court that you are getting these opinions.”9 D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F Whose Definition of Science Is This?
In the two decades prior to Daubert, the number of product liability and so-called“toxic tort” cases had been rapidly increasing. Corporations that had manufacturedhazardous products, like asbestos, were losing in court and paying large sums ofmoney to people who died or were made sick by their products.
It was against this backdrop that Peter Huber and the ultra-Conservative ManhattanInstitute launched a highly successful public relations campaign aimed at discredit-ing the work of scientists who found evidence of adverse health effects caused byexposure to a range of toxic chemicals.10 Well-funded by corporate backers, Huber and the Manhattan Institute promoted thephrase “junk science.” The term “junk science” has no real meaning. In his widelypublicized and distributed book, Galileo’s Revenge, Huber offers only a broad-ranging“I know it when I see it” description of “junk science” rather than a definition: “Junk science is the mirror image of real science, with much of the same formbut none of the substance….It is a hodgepodge of biased data, spurious infer-ence, and logical legerdemain….It is a catalog of every conceivable kind oferror: data dredging, wishful thinking, truculent dogmatism, and, now andagain, outright fraud.”11 The term “junk science,” like pornography, seems to be in the eye of the beholder.
Simply stated, junk science usually seems to be science whose results or methods theuser of the phrase disagrees with. Predictably, researchers who are funded by thetobacco industry, (which also helped fund the “junk science” movement) are neverlabeled junk scientists by Huber and his colleagues.
In Galileo’s Revenge, Huber attacked the environmental and occupational sciences inparticular, leveling factually inaccurate charges against many scientific endeavors thatmight appear to threaten corporate interests. Following the publication of his bookin 1991, Huber gained unprecedented influence among judges and policymakers.
The widespread publicity elevated Huber to a position as one of the country’s lead-ing voices in the policy debate over tort reform. Galileo’s Revenge became so widely recognized it was frequently cited by lawyers, lob-byists, former Vice President Dan Quayle and – most crucially – Judge AlexKozinski, who used Huber’s definition of “good science” as “the main explication ofthe scientific method” when writing his opinion in Daubert for the U.S. Court ofAppeals for the Ninth Circuit, where the case was remanded by the U.S. SupremeCourt.12 That this book was quoted by Judge Kozinski when he wrote his opinion was a majorcoup for Huber and his backers. The Daubert opinion – and the way in which it is beinginterpreted – has provided a mechanism for Huber’s point of view to substantiallyimpact the entire civil litigation system.
When Judge Becomes Scientist…and Clinician…and Jury
One of the myths propagated by Daubert is that scientific methodologies and opin-ions are made up of universally-adopted standards that can be evaluated by judgesusing a simple checklist. Daubert encourages judges to separately evaluate the variouselements of scientific evidence, rather than proceeding as most scientists do, byassessing the totality of the evidence, giving greater or lesser importance to particularparts. Reputable scientists often reach different conclusions when analyzing the samedata and using the same methodologies. Perhaps in an attempt to find clarity wherenone may yet exist, some federal judges seem to be setting standards for “good sci-ence” that are higher (and often based on an erroneous understanding of the meth- ods) than those used by experts within the field – taking on precisely the role of“amateur scientist” as Chief Justice Rehnquist feared. Scientific evidence and opinion is especially crucial in toxic tort cases, when a plain-tiff relies on scientific experts to demonstrate causality. This burden on the plaintiffis considerable because very little is known about the toxicity of the 100,000 chem-icals or their derivatives that are registered for use in commerce. A study by theNational Research Council found that the most basic toxicity data on 75 percent ofthe nation’s 3,000 high-volume chemicals cannot be found in public records.13 Even when toxicity data is available, researchers rarely reach definitive conclusions thatproclaim: “exposure to toxic substance A will cause disease B.” What they do find is thata group of people, when exposed to a certain substance, are more or less likely to devel-op a particular disease or condition than those not exposed. Epidemiologists – scientistswho study the distribution and determinants of disease and injury – also examine thelength of time between an exposure and when a person first develops symptoms of the dis-ease; the intensity and duration of the exposure; and other factors, such as whether shehas been exposed to anything else that might have caused the disease, among other things.
“In the final analysis, assessment of evidence and causal inferences depend on accu-mulating all potentially relevant evidence and making a subjective judgment aboutthe strength of the evidence,” according to Dr. Jerome P. Kassirer, former editor-in-chief of the New England Journal of Medicine and Dr. Joe S. Cecil of the FederalJudicial Center. Drs. Kassirer and Cecil examined the impact of Daubert in a 2002article published in the Journal of the American Medical Association (JAMA). Theyfound that a number of courts require standards for expert testimony that exceedthose that physicians use in ordinary clinical decision-making.14 D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F Some judges, however, have dismissed cases because the plaintiff did not have evi-dence from epidemiological studies. The scientific community understands that formany toxic substances, epidemiological evidence does not exist and may never beavailable for particular chemicals. It is unethical for researchers to feed toxic sub-stances to people or force them to breathe hazardous chemicals to see what dose caus-es cancer. Instead, scientists rely on the results of “natural experiments” where expo-sures have already happened. Scientists rely on the data that is available, like a detec-tive gathering evidence. Scientists, like detectives, may never have all the evidence,but will offer an opinion based on the available information. Making “reasoned judgments” after “accumulating all potentially relevant evidence”is the role a jury ordinary plays. The “preponderance of the evidence” standard,which juries are directed to apply in civil cases, would have them do precisely that.
But oftentimes juries do not have the opportunity to make those judgments, becausejudges are excluding evidence via Daubert hearings – not based on its cumulativeimpact but based upon the strength or weakness of each individual piece of evidence “It is all being handled pretrial,” remarked Berger. “And the public trial before a jurydoesn’t occur.” That’s more than just a shame – it raises serious constitutional issues.
“I think the Seventh Amendment could be read as not just entitling a litigant to ajury verdict, but more broadly to a jury trial when experts in different disciplines dis-agree,” Berger explained. “Even if a plaintiff ’s verdict were ultimately set aside as not based on sufficient evi-dence of causation, a public trial means the plaintiff gets to tell his or her story andit also means that wrongdoing on the part of defendants can be exposed. Evenwhen causation cannot be proved, that does not necessarily mean that defendantsdid not act in a reprehensible manner in exposing the public to risk. For example,problems often develop with drugs long after they have been approved for market.
Jury trials could reveal whether corporations knowingly kept drugs or products onthe market after it became clear that problems existed. If such a case ends with aDaubert hearing, none of this will ever become public.”9 The Two-Fold Increase in Risk Standard & Statistical Significance
In the post-Daubert world, judges increasingly prevent juries from hearing any epi-demiological evidence related to causation. One reason for this is that some judgesrequire that an epidemiological study demonstrate a two-fold increase in risk of health effects from an exposure, plus statistical significance. In addition, it is wellestablished that the legal community equates epidemiologic measures such as a two-fold increase in disease with the legal threshold of “more probable than not.”15 “Insisting upon a study finding a two-fold increase in risk of disease related to expo-sure as a fixed standard of association inappropriately confuses a number of funda-mental epidemiologic principles,” said Dr. Barry Levy, a physician and epidemiolo-gist. Dr. Levy is an independent consultant in occupational and environmentalhealth and an Adjunct Professor of Family Medicine and Community Health at TuftsUniversity School of Medicine. He is also a past president of the American PublicHealth Association and senior co-editor of a leading textbook on occupationalhealth, now in its fourth edition. “There are many relatively weak associations thatare well accepted as being causal, such as the association between passive smokingand lung cancer,” he said.9 “For example, most studies of the relative risks of lung cancer among nonsmokingwomen as a result of their husbands being light smokers show a relative risk between 1.0 and 2.0 – elevated, but not doubled. This less than two-fold risk increase is wide-ly accepted as causal. But under the two-fold standard required by some judges, thisscientific finding would have been thrown out.” Consider the court’s misunderstanding of epidemiologic principles in the case ofChambers v. Exxon Corp., in which a contractor at an oil refinery in Baton Rouge wasexposed to benzene and who then developed chronic myelogenous leukemia (CML),a rare form of cancer. Dr. Peter Infante, former Director of the Office of Standards Review at the U.S.
Department of Labor’s Occupational Safety and Health Administration and an AdjunctProfessor of Environmental and Occupational Health at George Washington University,was to have testified as the author of a 1977 study that confirmed that benzene causedleukemia. He also would have testified regarding a 1995 analysis he published that founda four-fold increase in the risk of developing CML from exposure to benzene.16 But the judge excluded his testimony, relying upon a statistical significance standard,and issued a summary judgment in favor of the defendant. Dr. Infante said the judgenot only made a factual error – his analysis was the first to show a more than two-fold increase plus statistical significance – he asked for more than what most in thefield would have required for such a rare disease. “No one in the world will disagree that benzene causes leukemia,” Dr. Infante said. “But,to show it causes the less common types of leukemia is very difficult because studies ofblue collar workers don’t have enough statistical power to identify these excessive riskseven when they are present. Nonetheless, my 1995 analysis did just that.”9 D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F In the Chambers v Exxon case, it should not have been necessary to push the bar tosuch elevated heights, in any event, Dr. Infante said. “Because if you looked at thetotality of the scientific evidence, there were enough other facts to support the claim.
Furthermore, he was exposed to benzene and nothing else that was known to causeleukemia. How could it not have contributed to it?” Legal scholar Margaret Berger notes that some state courts, such as the New JerseySupreme Court, have rejected the two-fold relative risk as a threshold for the admis-sion of epidemiological evidence. Methodology
Because Daubert requires judges to examine scientific methodology, some judgesappear to have interpreted this to mean they can simply exclude all testimony thatrelies upon any methodology they are not comfortable with – even if the methodol- ogy is well-accepted by experts in the field.
In the case of Castellow v. Chevron USA, for example, the court rejected all of theplaintiff ’s experts because it did not believe in the methodologies used by one ofthem.17 In this case, Dr. Levy was to have testified regarding the strong associationbetween exposure to benzene and development of acute myelogenous leukemia(AML), as he had in a deposition. In his trial testimony, he would have stated thatbenzene has been shown to cause AML and that, specifically, the plaintiff ’s exposureto benzene more likely than not caused him to develop this disease.
Another expert, a senior industrial hygienist, testified in a deposition about the expo-sure assessment he prepared that used an exposure model to estimate the plaintiff ’sexposure to benzene. “The judge excluded both the industrial hygienist’s modeling testimony and my tes-timony, which was, in part, based on modeling, because the judge did not believe inmodeling as a methodology – even though modeling is an established practice amongresearchers and others in the field,” Levy said.9 Other federal judges have excluded testimony because they disapprove of certainkinds of evidence, such as case studies or clinical diagnoses. In Nelson v. AmericanHome Products Corp., a man who was prescribed the drug Cordarone to control ven-tricular arrhythmia following a heart attack began losing sight in one eye shortly afterhe began taking the drug. The plaintiff brought together six expert witnesses, includ-ing a professor of neuro-ophthalmology at the University of California San Franciscowho had diagnosed three similar cases of Cordarone-induced optic neuropathy.
Included in their testimony would have been evidence that following this gentleman’s injury, the manufacturer changed the package insert for the drug, noting that somepatients developed impaired vision after taking it.18 However, because most of the evidence the plaintiff would have presented was in theform of clinical evidence and case studies and not epidemiological studies, the judgeexcluded all of the evidence and granted summary judgment in favor of AmericanHome Products.
Case reports, the judge wrote, “do not demonstrate a causal link sufficient for admis-sion to a finder of fact in court,” are not subject to peer review and “do not advancetestable scientific analysis.” The last two of these three points are false. Yet this is thetype of evidence routinely used by clinicians, according to Drs. Kassirer and Cecil intheir 2002 JAMA article on inconsistencies in evidentiary standards. “In clinical med-icine, a biologically plausible relationship, physiological studies of a drug, animalstudies, or even a handful of case reports can be useful in individual cases in helpinga practitioner make judgments about cause and effect relationships.”14 Same Evidence, Different Standards
Respected scientists often reach different conclusions regarding the same data.
Unfortunately, when confronted with disagreement within the scientific communityregarding such evidence, some judges take it upon themselves to resolve these dis-putes or disallow all testimony, rather than allowing the jury to hear both sides.
Not unexpectedly, different judges have also reached different conclusions when pre-sented with the same evidence.
Several similar lawsuits brought in state and federal court against the manufacturerof Parlodel, a drug used to suppress lactation, support this point. Plaintiffs in thesecases alleged that Parlodel caused them to have strokes, seizures and heart attacks.
Sandoz Pharmaceuticals, the manufacturer of Parlodel, eventually revised its packageinsert to report case studies of postpartum hypertension, seizures and strokes. TheFDA continued to receive reports of adverse reactions to the drug and in 1994Sandoz agreed to the Food and Drug Administration’s proposal that it completelywithdraw the drug’s indication as a lactation suppressant.19 The plaintiffs in these suits against Sandoz presented case studies, animal studies,challenge-rechallenge data, toxicology studies and the opinions of medical profes-sionals, including testimony from a member of the FDA’s Fertility and MaternalHealth Drugs Advisory Committee who had reviewed the safety of Parlodel for thefederal government.
D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F In the majority of cases, judges excluded the expert testimony and granted summaryjudgment to Sandoz. In Hollander v. Sandoz Pharmaceuticals, Corp., for example, thejudge dismissed two entire classes of science – animal studies and case reports – asunreliable. The judge said the results of animal studies could not be extrapolated tohumans and gave no credibility to case studies because they “are not controlled stud-ies and do not eliminate confounding variables.”20 At least one judge thought a jury should hear the disputed facts regarding Parlodeland make up its own mind. In Globetti v. Sandoz Pharmaceuticals, the U.S. DistrictCourt for the Northern District of Alabama wrote a starkly contrasting opinion,based upon much of the same evidence. “It is not part of the trial judge’s gatekeeping role to determine whether the prof-fered opinion is scientifically correct or certain in the way one might think of thelaw of gravity [emphasis in original],” the court wrote. “…it is the fact-finder’srole (usually a jury) to determine whether the opinion is correct or worthy of credence. For the trial court to overreach in the gatekeeping function and deter-mine whether the opinion evidence is correct or worthy of credence is to usurpthe jury’s right to decide the facts of the case. All the trial judge is asked to decideis whether the proffered evidence is based on “good grounds” tied to the scien-tific method.”21 Chilling Effect
Defending a Daubert challenge can cost plaintiffs hundreds of thousands of dollars.
Even if the plaintiff prevails the jury award may barely cover those costs. This may beone of the reasons that, in the 10 years since Daubert, the number of tort trials hasbeen steadily decreasing.5 In a 2002 analysis by the RAND Institute for Civil Justice, researchers examined 399published and unpublished federal decisions over a 20-year period to determine theoverall impact of Daubert. They found that after an initial spike in the number ofchallenges to expert testimony, the incidence began to fall off dramatically, suggest-ing that plaintiffs increasingly decided not to bring actions that relied heavily uponscientific testimony unless that testimony met the Daubert standards. Plaintiffs may likely have been further discouraged from bringing claims by the risein summary judgments following Daubert. The RAND analysis found that, in theperiod immediately after the ruling, several trends occurred simultaneously: the proportion of evidence that was challenged rose; the proportion of challenges resulting in evidence being excluded rose; the frequency with which motions for summary judgment were brought (and The RAND analysis also found that judges were excluding challenged evidence if itfailed to meet even a single one of the Daubert criteria, despite the Supreme Court’scaution that they should not use these criteria as a “checklist.” These trends may have discouraged plaintiffs from bringing suits, and they clearlyencouraged defendants “to expand the scope of their challenges to the point wherethey increasingly challenged the entire basis of the case and thus more frequentlyrequested summary judgment,” the RAND authors wrote. The percentage of sum-mary judgments granted post-Daubert more than doubled, the RAND report found.
Nearly 90 percent of these judgments were granted in favor of defendants.4 “Daubert works effectively as another tool for terminating litigation without a trial orjury,” concluded Professor Berger, in her own analysis of the impact of Daubert, pre-sented at a conference on scientific evidence and public policy earlier this year.5 “In my mind, Daubert gives trial judges far more authority over civil cases thanthey ought to have,” said Arizona State Supreme Court Chief Justice StanleyFeldman, now retired after 20 years on the bench. “What I feared would hap-pen eventually, and what has happened, is that instead of having jury trials wenow have Daubert hearings before the judge. The judge, in effect, then deter-mines the outcome of the case by granting summary judgment. To my mind,this far exceeds any power that the Constitution gave judges over jury trials.”9 If Daubert has had a chilling effect upon plaintiffs, it has also discouraged the experts,many highly regarded in their fields, whose testimony is at risk of being discreditedby judges who disapprove of the methodology they used.
David Michaels, a Professor in the Department of Environmental and OccupationalHealth at the George Washington University School of Public Health and HealthServices and former Assistant Secretary of Energy for Environment, Safety andHealth at the U.S. Department of Energy, said the Daubert process may be keepingwell-regarded scientists out of an area where they could be providing a public service. “I’m concerned that scientists are hesitant to testify for fear of being drawninto a lengthy and unpleasant process where they have to defend their good names,”he said.9 Likewise, “some physicians now decline in frustration to participate in legal pro-ceedings,” Drs. Kassirer and Cecil write in their 2002 JAMA article.
D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F Another costly consequence for plaintiffs is that the presentation of evidence at aDaubert hearing allows the defendant ample time to prepare its own experts. Since mostdefendants in product liability or toxic tort cases have far more resources than the per-son bringing suit, they can easily hire experts to prepare studies that, at the very least,cast doubt upon the “guilt” of their product.
As Justice Feldman rightly pointed out in his 2000 opinion, “corporations and otherwealthy defendants…(are) the very parties most capable of manufacturing or pur-chasing questionable scientific opinions.”8 Your Money or Your Life: Where’s Daubert?
Daubert has not been widely applied in the criminal justice sciences, where prosecu-tors often rely on evidence of questionable validity (such as bite marks, blood splat-ter and shoe identification) – even though far more is at stake. Most defendants in criminal cases simply do not have the financial resources tolaunch Daubert challenges to the state’s expert witnesses, Berger points out. Nor canthey afford to bring in their own experts. Because challenges to expert testimony inthe criminal justice system are rare, exclusions are even rarer. “There have been someattempts but most criminals are indigent and get assigned counsel,” she said. “Theyhave neither resources nor time to investigate complex legal issues, and states withstrained budgets are often unwilling to fund defense experts.”9 Moreover, the courts tend not to sympathize with people accused of committingcrimes. Faulty science routinely goes unchallenged in the criminal courts accordingto Peter Neufeld, an attorney and co-founder of The Innocence Project at theBenjamin N. Cardozo School of Law. The Innocence Project represents hundreds ofinmates seeking post-conviction release through DNA testing. “Daubert has had lit-tle impact on protecting criminal defendants from wrongful convictions,” Neufeldlaments. Absent the context of potentially millions of dollars of corporate finances atstake, “in that kind of context, you’re not going to get that kind of rigorous investi-gation of the merits of the evidence, generally speaking,” he said.22 And that, said Professor Michaels, is where Daubert has turned our nation’s system ofjustice upon its head. “Given our societal commitment to convict only those who areguilty of a crime beyond a reasonable doubt, the quality of scientific evidence usedin criminal cases deserves far greater scrutiny than it currently receives,” he said. “Incontrast, it appears that inappropriate and inconsistent scrutiny of expert witness tes-timony is occurring in our system of civil justice. There is something very wrongabout this.”9 Taking Daubert Beyond the Courtroom
The influence of Daubert does not end at the doors of the courtroom. Empoweredby their success in the federal and some state courts, tort “reform” groups, well-financed by industry and insurance trade associations, have expanded their decades-long campaign against “junk science,” to include forays into the regulatory arena. Toward this end, the Annapolis Center – a think tank founded by a vice president ofthe National Association of Manufacturers and funded by several steel companies, oilrefiners, electric utilities and industry groups –convened a work group of scientists,doctors and lawyers – to develop “a primer for non-scientists who seek to understandepidemiologic studies” and how such evidence “can best be used by legal decision-makers.” The primer, titled, “Epidemiology in Decision-Making” published in 1999,calls for “the application of Daubert to judicial review of the science upon whichadministrative agencies rely.”7 Indeed, large corporations and their representatives have recently issued several Daubert-like challenges to the U.S. Environmental Protection Agency (EPA) underthe Data Quality Act. This Act, passed in 2000, provides interested parties with a for-mal administrative mechanism for challenging the quality of scientific informationused in Federal regulatory agency decision making.23,24 In one of the first petitions under the Data Quality Act, the Center for RegulatoryEffectiveness (CRE) – a lobbying group acting on behalf of corn growers and thechemical industry – challenged EPA’s right to draw conclusions about the potentialecological effects of the widely-used herbicide, atrazine. The CRE petition arguedthat EPA could not include peer-reviewed academic studies documenting endocrinedisruption effects in its assessment of risk from atrazine, because EPA had not yetestablished testing protocols to characterize endocrine effects. These studies showedthat developing frogs exposed to atrazine at levels below those currently allowed indrinking water and ambient water produced sexual deformities, including hermaph-roditism.25,26 The EPA has deferred its decision about what conclusions it will draw about theendocrine-disrupting potential of atrazine until after a meeting of the pesticideScientific Advisory Panel, scheduled for June 2003. But in a written response, EPAreassured CRE that the revised risk assessment would state that, “based on the exist-ing data uncertainties, the chemical should be subject to more definitive testing oncethe appropriate testing protocols have been established.” This comment raises thespecter of EPA ignoring credible peer-reviewed studies that show unexpectedly dra-matic effects because of industry pressure applied under the Data Quality Act.27 D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F Last year, the U.S. Chamber of Commerce went even further, proposing that theBush administration adopt an Executive Order “requiring all federal agencies to applythe Daubert standards in the administrative rulemaking process.” In a statement post-ed on its website, the Chamber calls for “the same standards of relevance and relia-bility that safeguard the rights of litigants in federal courts” to be applied to the sci-ence underlying federal regulations.6 Should an Executive Order be adopted, the Chamber statement assures, “we willwork with the administration and Congress to ensure that adequate enforcementprocedures are available to compel agency compliance with any Daubert-basedExecutive Order or legislation and will continue to track federal agency rulemakingto ensure compliance with existing laws requiring the use of high quality informationin the rulemaking process.”6 Clearly, some powerful interests are hoping to extend the reach of Daubert wellbeyond the civil justice system and deep into the policies and regulations that protect Where Will It End?
In his study of evidentiary standards in regulation and law, Professor SheldonKrimsky of Tufts University identifies a disparity between how regulatory agenciesand the courts assess risk of exposure to chemicals and other hazards.28 Regulatorybodies such as the EPA and the Occupational Safety and Health Administration,drawing on practices widely accepted in the scientific and medical communities, arecommitted to a weight-of-evidence approach in which the totality of the evidence isconsidered. In contrast, some courts are following selected interpretations of Daubertand are rejecting a weight-of-evidence approach, and instead are evaluating eachstrand of evidence in isolation. This approach by the courts will typically tilt thescales of justice in favor of polluters and product liability defendants. The Supreme Court may not have intended that the Daubert decision create animbalance in our nation’s system of justice. But, in our opinion, taken together, theCourt’s trilogy of decisions – Daubert, Joiner and Kumho – have done just that.
Daubert and Kumho hand judges extensive powers for deciding not only whethercomplex evidence should be allowed into the courtroom, but whether a case shouldmove forward at all when there are differences of opinion among experts. This is arole that the U.S. Constitution intended for juries. But plaintiffs who appeal theseevidentiary exclusions run head-on into Joiner, which makes it extremely difficult forappellate courts to overturn the trial court’s actions unless there is clear-cut abuse ofjudicial discretion, an extraordinarily high standard.
Chief Justice Rehnquist’s prediction in his cautionary dissent was prescient. Today,judges acting as “amateur scientists” are issuing legal declarations about the validityof work in fields well outside their area of expertise. On the tenth anniversary of Daubert, the scientific community needs to becomemuch more aware that an obscure procedural decision intended to provide clarity hasinstead given rise to a serious social imbalance. It has led to unreasonable legaldemands of scientific certainty when considering expert testimony that might other-wise demonstrate harm of individual plaintiffs by defendants, often wealthy andpowerful companies. At the same time, inappropriate or inaccurate interpretations ofscience are becoming embedded in legal precedent. Yet in contrast, Daubert has failedto demand from criminal prosecutors better science in the face of weak forensicmethods, resulting in the potential conviction of innocent people. And now, theapplication of Daubert and Daubert-like challenges threaten to paralyze the systemswe use to protect public health and the environment. D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F E N D N O T E S
1 Daubert v. Merrell Dow Pharmaceuticals, Inc., 113 S.Ct. 2786 (1993).
2 General Electric v. Joiner, 522 U.S. 136 (1997) and Kumho Tire Co. v. Carmichael, 526 3 Risinger DM. Navigating expert reliability: are criminal standards of certainty being left on the dock? Albany Law Review. 64: 99-152 (2000).
4 Dixon L, Gill B. Changes in the standards for admitting expert evidence in federal civil cases since the Daubert decision. RAND Institute for Civil Justice (2002).
5 Berger MA. What has a decade of Daubert wrought? The Coronado Conference on Scientific Evidence and Public Policy. San Diego, California (2003 March 13-14).
6 U.S. Chamber of Commerce. Scientific information in federal rulemaking [cited 2003 June 5]; Available from: URL: http://www.uschamber.com/government/issues/regulatory/sci-entific.html. 7 The Annapolis Center. Epidemiology in decision-making [cited 2003 June 5]; Available from: URL: http://www.annapoliscenter.org/Reports/epidemiology.pdf. 8 Logerquist v. McVey, 196 Ariz. 470, 1 P.3d 113, (2000).
9 Statements made during interviews conducted with SKAPP staff during the period May 10 Huber PW. Galileo's revenge. New York: Basic Books (1991).
11 Rampton S, Stauber J. Trust us, we're experts! New York: Penguin Putnam, Inc. (2001).
12 Chesebro KJ. Galileo’s retort: Peter Huber’s junk scholarship, The American University Law Review. 42 (1993 Summer).
13 Cranor CF, Eastmond DA. Scientific ignorance and reliable patterns of evidence in toxic tort causation: is there a need for liability reform, Law and Contemporary Problems. 64:5-48 (2001 Autumn).
14 Kassierer JP, Cecil JS. Inconsistency in evidentiary standards for medical testimony: dis- order in the courts, JAMA. 288:1382-1387 (2002 September 18).
15 Greenland S, Robins JM. Epidemiology, justice, and the probability of causation, Jurimetrics. 40: 321-340 (2000 Spring).
16 Infante PF. Benzene and leukemia: cell types, latency and amount of exposure associated with leukemia, Advances in Occupational Medicine and Rehabilitation. 1 (1995).
17 Castellow v. Chevron USA, 97 F. Supp. 2d 780 (2000).
18 Nelson v. American Home Products Corp., 92 F. Supp. 2d 954 (2000).
19 U.S. Food and Drug Administration. FDA moves to end use of bromocriptine for postpar- tum breast engorgement [news release]. (1994 August 17).
20 Hollander v. Sandoz Pharmaceuticals Corp., 289 F.3d 1193 (2002).
21 Globetti v. Sandoz Pharmaceuticals, Corp., 2001 U.S. Dist. LEXIS 2093 (2001). 22 Neufeld PJ. [Remarks] The Coronado Conference on Scientific Evidence and Public Policy. San Diego, California (2003 March 13-14).
23 Treasury and General Government Appropriations Act for Fiscal Year 2001, Pub.L. No. 24 Office of Management and Budget. Guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of information dissemination by federal agencies,Federal Register. 67: 8452-8460 (2002 February 22).
25 Hayes T, Collins A, Lee M, et al. Hermaphroditic, demasculinized frogs after exposure to the herbicide atrazine at low ecologically relevant doses, Proc Natl Acad Sci. 99:5478-5480 (2002 April 16).
26 Hayes T, Haston K, Mable T, et al. Atrazine-induced hermaphroditism at 0.1 ppb in american leopard frogs (rana pipiens): laboratory and field evidence, Environ HealthPersp. 111: 568-575 (2003 April).
27 U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances. EPA response to comments from Syngenta and its contractors, the TriazineNetwork, the Center for Regulatory Effectiveness, the American Water Works Association, etal. [Agency memorandum]. (2003 January 28).
28 Krimsky S. The ‘weight-of-scientific-evidence’ in policy and law, The Coronado Conference on Scientific Evidence and Public Policy. San Diego, California (2003 March13-14).
D A U B E R T : T H E M O S T I N F L U E N T I A L S U P R E M E C O U R T R U L I N G Y O U ’ V E N E V E R H E A R D O F Major support for the Project on Scientific Knowledge and Public Policy is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability Litigation, with additional support from the Alice Hamilton Fund and the Bauman Foundation. The Planning Committee would like to acknowledge Laura Williamson who provided editorial assistance for this report and Susie Hart-Walker for the cover illustration. The opinions expressed in this document are those of the members of the SKAPP Planning Committee, and do not necessarily represent those of the funders of the project. A Publication of the Project on Scientific Knowledge and Public Policy, coordinated by the Tellus Institute

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The following is a list of the most commonly prescribed drugs. It representsan abbreviated version of the drug list (formulary) that is at the core ofyour prescription-drug benefit plan. The list is not all-inclusive and doesnot guarantee coverage. In addition to using this list, you are encouragedto ask your doctor to prescribe generic drugs whenever appropriate. 2012 Express Scripts PLEAS

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Potentially Dangerous Drug Interactions Missed By Prescribers Research led by The University of Arizona College of Pharmacy has found that medication prescribers correctly identified fewer than half of drug pairs with potentially dangerous drug-drug interactions. These findings raise concern because of the high number of drugs Americans take: an average of 2.3 medications is prescribed duri

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