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The Tobacco Deposition and Trial Testimony Archive (DATTA) project: origins, aims, and methods.

Research on previously secret tobacco industry documents has grown substantially during the past decade, since these documents first became available as the result of private and governmental litigation and investigations by the US Congress and the US Food and Drug Administration. Complementary research on tobacco litigation testimony is now being conducted through the Tobacco Deposition and Trial Testimony Archive (DATTA) project. We obtained transcripts of depositions and trial testimony, deposition and trial exhibits, expert reports, and other litigation documents from law firms, court reporter firms, individual lawyers and witnesses, tobacco company websites, and other sources. As of 3 March 2006, the publicly available collection of DATTA (http://tobaccodocuments.org/datta) contained 4850 transcripts of depositions and trial testimony, including a total of about 820,000 transcript pages. Transcripts covered testimony from 1957 to 2005 (85% were for testimony from 1990 to 2005) given by more than 1500 witnesses in a total of 232 lawsuits. Twelve research teams were established to study the transcripts, with each team covering a particular topic (for example, the health consequences of tobacco use, addiction and pharmacology, tobacco advertising and promotion, tobacco-product design and manufacture, economic impact of tobacco use, youth initiation of tobacco use, and public understanding of the risks of tobacco use and exposure to second-hand smoke). The teams used qualitative research methods to analyse the documents, and their initial findings are published throughout this journal supplement.

Archives↗

Medicolegal affairs. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

ISSUES: Increasing litigation over alleged false negative cervical cytologic (CC) smears threatens the viability of this test for cervical cancer detection. The problem appears to be largely American but is beginning to appear in some other countries. In the vast majority of cases there is either a settlement or jury verdict for the plaintiff based largely on the testimony of expert witnesses. Cases are judged on an individual basis without significant consideration of the general performance of the CC smear in laboratories operating in compliance with a wide array of laboratory regulations and with documented and comprehensive quality control practices in place. It is acknowledged that there are problem laboratories and cytology practitioners. There is an emerging issue of automated preparation and screening devices and issues of informed patient consent. CONSENSUS POSITION: Cytology professionals have done an extraordinary and commendable job of educating the public about the benefits of the CC smear. We have been less successful and conscientious about explaining and defining the limitations of the CC test. There is a need for public and professional education as to the benefits and limitations of the CC smear for cervical cancer detection. The process suggested is to work with women's groups, public health agencies, government agencies, and state and national legislatures and to coordinate professional committees working on liability issues. Contextual information could be included with the CC smear report to indicate that a negative report confers a low probability of developing cervical cancer. It is suggested that appropriate language and a menu of statements be developed. Increased efforts should be directed to physician education with respect to informed consent concerning the benefits and limitations of CC smear testing and the application of new technology to improve smear accuracy. The process should include development of appropriate statements on the use of alternative technology. The profession should develop "process guidelines" for review of CC smears in the context of possible litigation, including standardized methods for blind slide review of smears that reduce or eliminate context and outcome bias. It is suggested that review panels be anonymous, that the process be standardized and that there be limitations on liability for participating organizations. Professional cytopathology and pathology societies should formulate acceptable guidelines for expert witnesses. The standards should be applicable to both defendant and plaintiff experts. All materials to the extent practical, including consultant opinions, should be available for peer review. Professional cytopathology and pathology societies should monitor expert testimony for objectivity and scientific accuracy. ONGOING ISSUES: For the near future, litigation will continue to focus on false negative CC smears on a case-by-case basis. Laboratories and individuals can reduce the risk of malpractice liability by directing their attention to proactive quality control and quality assurance methods. In the final analysis, consumer education about the benefits and limitations of the test is key to limiting malpractice claims. To stem the tide of continued medicolegal challenges to the integrity of cytology practice, the cytology community has now focused its efforts on developing and utilizing standards that convey to patients, attorneys and cytologists the contemporary status of and reasonable expectations for the practice of cytology. Guidelines such as those for uniform reporting terminology and clinical management of cervical abnormalities form the basis of cytology practice standards on which legal standards of practice can be based. Consensus conference reports, clinical management trials and scientifically valid studies of false negative rates that analyze the type, frequency and cause of missed cases represent sounder methods of establishing defensible

Cell Biology↗

Overview: the right to treatment--comments on the law and its impact.

The constitutional right to treatment has now become an accepted premise of litigation in the United States. It lacks only the imprimatur of the Supreme Court. The author presents a brief description of the history of right to treatment cases and comments on the problems and possibilities the law holds for psychiatry. He warns that psychiatric institutions must be aware of the costs and benefits of such litigation and must obtain skilled legal counsel to advise them of their rights and obligations. He calls on psychiatry as a profession to participate in right to treatment litigation and to attempt to shape legal standards so that future generations of psychiatrists can provide appropriate care to patients.

Costs and Cost Analysis↗

The treatment program at Searcy Hospital before and after Wyatt.

Long before the Wyatt litigation began, staff at Searcy Hospital were aware of and concerned about changes that needed to be made in order to improve the quality of care at the institution; adequate funding was not available to make the changes. However, the staff did initiate some change. They moved into the same buildings with patients to increase contact and used a team approach to treatment. They organized discharge planning teams and tried to interest families in caring for patients at home. During an 11-month period before the Wyatt litigation began, the patient census decreased by about 21%. It was the Wyatt litigation that provided the legal impetus for the implementation of changes that resulted in enhanced treatment programs, a decrease in patient population, and an increase in staff.

Alabama↗

Malingering and mild brain injury: how low is too low.

The purpose of this study was to investigate potential validity markers for 4 commonly used neuropsychological tests. Participants were divided into 5 groups: moderate/severe brain injury (n = 27), mild brain injury--nonlitigating (n = 35), normal controls (n = 30), mild brain injury--litigating (n = 49), and malingering "actors" (n = 20). Participants completed a flexible neuropsychological battery that included the 4 tests of interest (Judgment of Line Orientation, Token Test, Dichotic Listening, and 20-item forced choice). Results demonstrated cutoff levels on all 4 tests below which people with mild brain injury would not be expected to fall. The fact that some litigants, but no nonlitigants, fell below these cutoff levels suggests these tests and their cutoff levels may be used appropriately as internal validity markers. There was 100% specificity and 95% sensitivity found when all 4 tests were used together (1-test criteria) to separate litigants, nonlitigants, and actors. It is suggested that further examination of these tests and other neuropsychological tests, be completed so that, eventually, all neuropsychological tests will have internal validity markers.

Adult↗

Policing Medicaid and Medicare managed care: the role of courts and administrative agencies.

The much-publicized 2000 case of Frew v. Gilbert, in which a federal judge castigated the State of Texas for deficiencies in its Medicaid program, brought renewed attention to the issue of regulating the quality of care in Medicaid and Medicare HMOs. Frew and other recent cases highlight both the promise and the pitfalls of relying on courts to correct deficiencies in public managed care programs. This article argues that while litigation over inadequacies in Medicare and Medicaid managed care can serve an important signaling function in alerting agencies and legislatures about the need for reform, the role of the courts in policing public managed care is circumscribed by several constraints. Barriers to class action litigation and differences in the institutional capacities of courts and administrative agencies mean that litigation is best viewed as a supplement, not an alternative, to a renewed commitment to strong quality monitoring on the part of Centers for Medicare and Medicaid Services and state Medicaid agencies.

Centers for Medicare and Medicaid Services, U.S.↗

Lesbian and gay rights as a free speech issue: a review of relevant caselaw.

The legal struggles waged by lesbian and gay male litigants almost invariably involve issues of freedom of expression, broadly construed. To illustrate this point, a wide array of caselaw is examined--ranging from classic "access to a forum" controversies to those concerning symbolic conduct and freedom of association (including marriage and child custody law), employment discrimination, and proscriptions against deviant sexual conduct. In each category, claims to a right of freedom of expression are manifested. Cautionary notes are offered concerning those cases in which gay litigants try to protect their rights by inhibiting the speech of others. A brief concluding section assesses the long-term and short-term efficacy of raising First Amendment arguments (as opposed to privacy or equal protection arguments) in lesbian/gay male litigation.

Adult↗

Disclosure of medical injury to patients: an improbable risk management strategy.

Pressure mounts on physicians and hospitals to disclose adverse outcomes of care to patients. Although such transparency diverges from traditional risk management strategy, recent commentary has suggested that disclosure will actually reduce providers' liability exposure. We tested this theory by modeling the litigation consequences of disclosure. We found that forecasts of reduced litigation volume or cost do not withstand close scrutiny. A policy question more pressing than whether moving toward routine disclosure will expand litigation is the question of how large such an expansion might be.

Compensation and Redress↗

'Lumping it': the hidden denominator of the medical malpractice crisis.

In a recent article, Miller has reminded us that medical malpractice litigation is not simply an economic problem which inhibits medical practice and increases health care costs. She argues that it has three broader "societal objectives": reparation, emotional vindication, and deterrence. Viewed in the broader perspective of social values, the Maine data suggest that our current approach to medical malpractice does not perform well. Significant numbers of respondents believe that they have been neither vindicated nor compensated for their own or their relatives' illness, injury, or death; and that they have not had the opportunity to protect others from harm. As Miller suggests in her review of British alternatives to medical malpractice litigation, there may be more efficient and effective means of reparation. There may also be more direct and less costly means to deter incompetent practitioners and vindicate those who are harmed. We shall never discover these alternatives if we view the medical malpractice "crisis" as a simple or straightforward problem of costs of premiums, costs of settlements, and costs of judgments; numerators. Medical malpractice litigation is the expression of deep and highly complicated problems, which cannot be solved or even significantly alleviated by false solutions motivated only by concerns of costs and cost containment. They can be addressed only by careful, thoughtful, and comprehensive analysis.

Adult↗

Silicone breast implants: epidemiological evidence of sequelae.

Skeptics may certainly find fault with the third study (the only one to report a significant finding) or with all or any of the statistics described. But few could argue, after examining these studies, that the relative risk for a known and well-defined connective tissue disease is likely greater than 2. Another possibility has been raised, one that calls to mind other difficult-to-study syndromes linked to exposures. In a study addressing Gulf War syndrome, signs and symptoms were often mentioned that proved difficult to describe systematically and therefore difficult to study. What if a suspected silicone exposure syndrome were so mild and transient that it did not warrant a physician visit (as in the Mayo Clinic study). receive a diagnosis (as in the Nurses' Health Study), or require admission to a hospital (as in the Danish and Swedish studies)? And if such a disorder were, in fact, mild and transient, should it merit the concern that has been shown and the compensation that has been awarded in the silicone implant litigation cases to date? We suggest that neither a well-described disorder with a relative risk of less than 2 nor a transient and mild disorder seems compatible with the number of litigants over silicone implants and the apparent seriousness of their complaints. Some 400,000 women joined in one class action suit for damages, and 170,000 joined in another. Even if there had been 2 million implants undertaken in the United States over the 3 decades in which implant surgery has been practiced (and some estimates put the number closer to 1 million), there is no conceivable way in which a relative risk of 2 or 3 (or even 4) for each of the rare syndromes reported could explain so many exposed women being affected. At most, 2200 out of 2 million unexposed women would be expected to have had any one of the listed forms of connective tissue disorders, most of which are very rare. Doubling the risk among the exposed population yields 4400, and increasing the risk 20-fold produces 44,000. At this rate, there is no way in which 400,000 litigants could all be affected. Extensions of the already-completed studies are ongoing, at least 1 of which is government funded; apparently it is thought in the United States (though not in the United Kingdom or elsewhere) that there is still room for reasonable doubt as to the supposed causal relationships. But if epidemiology is invoked in the interest of public health to prevent the many uses of silicone, the weight of the evidence abstracted here supports the inference that silicone breast implants have not been proved guilty of causing connective tissue disorders.

Autoimmune Diseases↗

Notable minimum value of relative risk recognized by Japanese epidemiologists and rule of proof in civil trial: questionnaire survey.

Members of The Japanese Society of Cancer Epidemiology were questioned about relative risk in cancer epidemiology. The notable minimum value of relative risk recognized by the epidemiologists distributed from 1.1 to 5.0, and the mean and the standard deviation of the notable minimum value were 1.92 and 0.760. In civil litigation of United States a plaintiff must prove one's case by a "preponderance of evidence," which means that a causal relationship between risk factors and a health disturbance to a plaintiff is proved when relative risk is 2.0 or more. The mean value 1.92 of the notable minimum value of relative risk nearly corresponded to the relative risk 2.0, which indicates that opinion of Japanese epidemiologists did not disagree with the rule of the proof in civil litigation of United States. It is mentioned that the standard of the proof should be "high probability" based on "a high level of conviction in the judge's own mind" in Japanese civil trials, and that the "high probability" means that relative risk is 5.0 or more if we dare to quantify the vagueness. This value corresponded to the maximum value of the notable minimum relative risk in the questionnaire to the Japanese epidemiologists. In civil litigation of Japan, the standard of the proof based on epidemiological results may be more conservative than the opinion of Japanese epidemiologists.

Causality↗

Response bias in self-reported history of plaintiffs compared with nonlitigating patients.

Response bias refers to systematic error in the data produced by patients or research subjects, e.g., due to erroneous recall or reporting. In forensic settings, response bias appears to be associated with the nature of the proceedings. The present study tested whether patients in litigation exhibit different response patterns than nonlitigating patients when asked about their preinjury problems. 34 litigants and 80 nonlitigants rated various areas of cognitive and emotional functioning as problematic in the past and currently. The primary finding was that plaintiffs reported pre-injury functioning superior to that of controls. These findings suggest the need for caution in inferences that litigants are either reliable or deceitful because response biases may affect self-reports in a misleading fashion.

Activities of Daily Living↗

Status of medical liability claims in Saudi Arabia.

BACKGROUND: With the evolution of healthcare services in Saudi Arabia, there has been an increase in the number of medical practice litigations. The author analyzed the medical malpractice litigation that was referred to the National Medico-Legal Committee (MLC) in order to evaluate the magnitude and underlying factors of the problem in Saudi Arabia. METHODS: A retrospective analysis of the official records of Medico-Legal malpractice claims over the period 1420H-1424H (1999-2003) was performed. The incidence among different medical specialties, location, and final resolution of each claim were identified. RESULTS: Data analysis revealed an increasing trend in the total number of claims over the study period, with a sharp increase in the transition between 1422H and 1423H (2001-2002). The distribution of claims over different medical specialties showed that obstetrical practice took the lead with 27%, followed by general surgery and subspecialties, represented by 17% each, internal medicine 13%, while pediatrics contributed 10% of claims; the fewest claims were in dentistry with 2.5%. The majority of claims were referred to Ministry of Health and private sectors medical facilities. Most claims were from the Riyadh region over the period between 1420H to 1422H (1999-2001), while thereafter, during 1423 and 1424H (2002 and 2003), the Holy Capital had the highest number of claims referred to the MLC. CONCLUSION: Adherence to standards of medical practice is by far the best approach to avoid or reduce the incidence of litigation.

Humans↗

Projections of Australian obstetricians ceasing practice and the reasons.

OBJECTIVES: To assess the intentions of Australia's specialist obstetricians to cease practice and their reasons for abandoning this specialty. DESIGN: A structured questionnaire posted to Fellows of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), issued 11 July 2001 with a return date of 31 July 2001 (in practice, responses were accepted up to 31 August 2001). PARTICIPANTS: Australian specialists holding a Fellowship of the RANZCOG. MAIN OUTCOME MEASURES: Demographic data (eg, age, sex); type and location of practice; past, current and intended future obstetric practice; reasons for stopping practice; cost of indemnity premiums; experience of litigation and its influence on practice; and experience in giving medicolegal opinion. RESULTS: The response rate was 74% (829/1116), with 826 responses fulfilling our selection criteria. The median number of years since admission as a Fellow was 17 (range, 1-47 years), and 19% (158/817) of respondents were women (9 people did not specify their sex). Of the 826 respondents, 596 (72%) were currently practising obstetrics, 548 (66%) intended to still be practising after one year, 365 (44%) intended to be practising after five years, and 196 (24%) intended to be practising after 10 years. The median indemnity premium in 2001-02 was $35,515 (range, nil to $156,000) for practising obstetricians. The main reasons given for ceasing obstetrics were intention to specialise in gynaecology, fear of litigation, high indemnity costs, family disruption, and long working hours. About two-thirds of respondents (557/818) had experienced the threat of litigation, and almost all (768/803) desired some type of "no-fault" indemnity scheme. Thirty-three of the 314 respondents who had given medicolegal opinions accounted for 71% of the total number of opinions. Many of these were non-practising obstetricians who were not accredited RANZCOG expert witnesses. CONCLUSION: There will soon be a shortage of experienced practising obstetricians in Australia.

Adult↗

Alternative dispute resolution: methods to address workplace conflict in health services organizations.

As healthcare organizations become increasingly complex, healthcare administrators and human resource managers face the cost and challenges of employment-related disputes. Litigation and legal costs associated with employment disputes are escalating at a significant rate. Additionally, litigation procedures are drawn out and damage the employer-employee relationship. Alternative dispute resolution (ADR) programs such as mediation and arbitration alleviate the burden of litigation and preserve positive employment relationships between the organization and its employees. A proposed ADR program is presented is a guideline for health services organizations considering the adoption of such programs.

Civil Rights↗

Decreeing organizational change: judicial supervision of public institutions.

In the last fifteen years or so, courts have issued a small but significant number of decrees requiring that governmental bodies reorganize themselves so that their behavior will comport with certain legal standards. Such decrees, addressed to school systems, prison and mental hospital officials, welfare administrators, and public housing authorities, insert trial courts in the ongoing business of public administration. In this article, Professor Horowitz traces the origins, characteristics, and consequences of organizational change decrees. He finds their roots in an unusually fluid and indeterminate system of procedural forms and legal rules, a system hospitable to the impact of changing ideas about the performance of bureaucracy and the role of courts. He explores the problematic character of organizational change litigation, underscoring the ways in which organizational behaviour is fraught with a variety of informal relationships beyond the contemplation of the courts. In Professor Horowitz 's judgment, efforts to augment the capacity of courts to cope more effectively with organizational change litigation may redound to the disadvantage of the judicial process by emphasizing the new managerial role of the courts at the expense of their traditional moral function. He concludes by suggesting that capricious budgetary ramifications, unintended consequences, and the impact of unconventional enforcement practices on the courts themselves be included among the elements of a full evaluation of organizational change litigation.

Government↗

Medical-legal concerns of providing high risk neonatal care in an HMO.

Prepaid health plans have particular vulnerability to perinatal malpractice litigation because of the presumed influence of cost containment systems on medical decision making. Risk management responsibility by HMOs, individual physicians, and hospitals may limit malpractice litigation. Common areas of perinatal malpractice suits include cases involving perinatal asphyxia, prematurity, failure to diagnose, and iatrogenic injuries. Defensive strategies to deter litigation in brain-damaged infants include the use of standard forms, good documentation, the appropriate use of Apgar scoring and cord blood gases, and full evaluation of low Apgar score babies in the neonatal period. Conscientious physicians and HMOs should be able to avoid malpractice suits by understanding the legal system and developing good communication and documentation skills.

Cost Control↗

From tobacco to health care and beyond--a critique of lawsuits targeting unpopular industries.

The 1998 settlement between state Medicaid agencies and the five major tobacco companies heralded a new form of litigation in which individual or government plaintiffs allied with private class action attorneys use economic, political and moral leverage to extract huge settlements from entire industries. Beginning with several class action suits filed in late 1999 against managed care companies by aggrieved HMO enrollees, and continuing with government suits against the paint and handgun industries, this new form of litigation has become a powerful vehicle for plaintiffs to punish unpopular--but entirely legal--industries. In this Note, the author demonstrates that the popular appeal of these suits conceals legal theories of recovery that probably could not survive courtroom scrutiny. The author argues that the thin legal merits of these class action claims are often tolerated by courts, who urge settlement in order to clear their dockets, and by the industries, who regard settlement merely as a cost of doing business. The author concludes that the tobacco litigation and its progeny encourage citizens and the executive branches of government to seek restitution and fundamental social change in the courts after losing in the legislative arena, thus forcing the judiciary branches into the unwise and improper role of policymaker.

Delivery of Health Care↗