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The measure describes the additional risk in those exposed. In fact, the potential for litigation and the related need for risk management have figured prominently in the tactics of the tobacco industry since the early s. The Miles now known as the Price case class action litigation in the State of Illinois was based in a claim of fraud around the beneficial health implications of labeling and marketing cigarettes with the "light" designation. In inferring that smoking causes disease, the implication is that smoking is a cause of disease generally; the causal conclusion does not exclude the possibility that risk may be different in subsets of the population based on the presence of other exposures, e. Repeatedly, in the state cases and in class action cases, e. The relevant epidemiological and other evidence has recently been reviewed by the U. The use of scientific evidence in tobacco litigation. The impact of advertising and promotion, particularly on children has been one point of contention. It stated that "[i]n view of the continuing and mounting evidence from many sources, it is the judgment of the Committee that cigarette smoking contributes substantially to mortality from certain specific diseases and to the overall death rate. Surgeon General, for example, added cancers of the stomach and the cervix and acute myeloid leukemia to the smoking-caused malignancies 4 table III. Additional issues in litigation to date that have involved use of scientific evidence include the costs of diseases caused by smoking and of the smoking-related reduction of health in general, the impact of advertising, and the consequences of production characteristics, such as machine-measured yield of tar and nicotine. Liggett Group , Rose Cipollone and her husband, Antonio Cipollone, brought a products liability suit against several tobacco companies after Rose Cipollone was diagnosed with lung cancer.{/INSERTKEYS}{/PARAGRAPH} For example, the relative risk for lung cancer in current smokers in the United States is presently about 20, so that AR E for current smokers is 0. However, plaintiffs' attorneys added the new theories of failure to warn and strict liability to their suits. {PARAGRAPH}{INSERTKEYS}I Public Health Advocacy Institute. Therefore, despite the defense's tactics, such as focusing on the plaintiff's conduct and his or her alleged freedom of choice in smoking, the plaintiff could have a "partial victory" with an award based on the defendant's percentage of fault. Similarly, in the litigation brought by the U. The continuing litigation in the United States remains a threat to the industry, in spite of the mixed outcomes of recent cases. Motions, trial transcripts, and submitted evidence, among other things, are also provided. These documents further empowered the tobacco control movement and strengthened the basis for legal action. The general approach to cost estimation involved application of the concept of attributable risk, but for estimation of the costs as the outcome of concern rather than the burden of illness. Department of Justice against the tobacco industry, one of the main elements in the claim of racketeering and fraudulent and corrupt business practices was related to deceptive marketing of cigarettes with reduced yields, as assessed by a machine. The report evaluated the entirety of the evidence in an objective and comprehensive fashion using pre-specified criteria for causal inference, often referred to as the Surgeon General's criteria or guidelines table II. Nonetheless, there is now substantial experience showing that litigation can be used successfully against the tobacco industry and to advance public health. The process of litigation against the tobacco industry is inherently adversarial and those scientists who agree to serve as experts in cases against the industry should anticipate a potentially combative process on a playing field quite distinct from that in which scientific matters are typically debated. Individual plaintiffs bringing suits under theories of negligence, deceit, and breach of warranty characterized the first wave of litigation against the tobacco industry. In the litigation brought by the various states in the United States, it was necessary to estimate the health costs of smoking to the Medicaid systems of the states so that a scientifically justified claim could be made. Lowe, a Saint Louis factory worker, filed a products liability suit against the tobacco industry. Often, the defense would attempt to put the plaintiff on trial, investigating into every detail of the plaintiff's past. Litigation by flight attendants and the states led to substantial settlements and some beneficial consequences for tobacco control. Key words: Litigation; tobacco; control; industry; legal. Philip Morris developed a complete collection of materials related to the trial entitled "Trial-in-a-Box. As the base of evidence regarding health effects has evolved and new legal strategies have emerged, successive waves of litigation have occurred. In both individual and class cases, causation of disease by cigarette smoking has been a foundation for the litigation; similarly, in the cases brought by the individual states against the tobacco industry, the fact that smoking causes disease has been the basis for estimating and requesting recovery of the costs to the states for participants in their Medicaid programs. Any rebuttal placed experts for the tobacco industry in the position of arguing against the Surgeon General, the World Health Organization, and other incontestable sources. This resource is hosted for free by the Tobacco Products Liability Project in an effort to disseminate evidence to the legal community that has proved successful in previous trials. This approach is inherent, for example, in the estimation system and related programs developed by the U. Since the mids, the evidence on passive smoking and health has been similarly reviewed with causal conclusions related to both children and adults table IV. The many failures by the first and second waves were followed by some notable successes in the third. American Tobacco Co. The approach involved use of the NMES data to estimate the health costs associated with smoking, both for specific diseases caused by smoking and for those excess episodes of health care utilization that were a consequence of the diminished health of smokers in general. The key measure estimated is the smoking attributable fraction, that is, the percentage of expenditures for particular diseases attributable to smoking. Experts have been called on to opine on whether industry activities increased the number of youths starting and then continuing to smoke. There is now years of experience in the United States litigating against the tobacco industry. The plaintiff's knowledge about the hazards of smoking was not an issue during the first wave, because the dangers of smoking were then not common knowledge at the time the plaintiff started and continued to smoke. Zeger et al. For instance, the legal team for the plaintiff in Boeken v. In litigation to date in the United States, the epidemiologic evidence has been used in addressing issues other than causation, including the consequences of modifications made to cigarettes that have led to reduced yield of tar, nicotine, and carbon monoxide, as assessed with standard protocols that use smoking machines. In the last decade, tobacco litigation has transformed tobacco control, providing another strategy in the tobacco control armentarium for limiting the tobacco industry's activities and providing redress to persons injured by use of tobacco products. The estimates of the smoking attributable fraction were then applied to calculate the smoking attributable expenditures. As more cases against the tobacco companies were filed, plaintiffs' attorneys and the health movements began to organize and pool resources. In , Reader's Digest ran an article entitled "Cancer by the Carton" which described the emerging evidence linking cigarette smoking to lung cancer. In , the first Surgeon General's Report reached the conclusion that smoking caused several diseases, including lung cancer in men. The typical first wave case consisted of an individual plaintiff and his or her attorney; the attorney usually had very limited resources and worked on a contingency fee, funding the costs of the litigation for a percentage of any awards. The Plaintiff, Lowe, was a factory worker in Missouri whose right lung was removed due to cancer; the defendants in the case were four cigarette companies who produced the cigarette brands Lowe smoked and the store where he bought his cigarettes. In these cases, the proposition needing to be supported is that smoking caused disease in this particular individual to "a reasonable degree of medical certainty. Asimismo, los pleitos con asistentes de vuelos y con los estados condujeron al establecimiento substancial de algunos beneficios para controlar el consumo de tabaco. This paper provides an overview of litigation as a strategy for tobacco control. The defendant tobacco companies, with their substantial resources, would take lengthy depositions and file a snowstorm of motions. Scientific evidence has played a key role in litigation against the tobacco industry; the range of issues that has been addressed is broad, although particular cases may relate to a specific scientific matter table I. National Cancer Institute, 14 and the U. The data were analyzed with econometric approaches to develop attributable risk models for application to the Medicaid participants. During the first wave of litigation, the tobacco industry's success was largely due to the plaintiffs' struggle to prove causation because of the lack of adequate medical evidence showing that cigarette smoking caused cancer and other diseases. It describes the experience in the United States, the most extensive of any developed country, and also key cases in other countries. Remarkably, since the report, smoking has been causally linked to an increasingly lengthy list of disease and other adverse consequences. Cipollone v. In using epidemiologic measures of association to estimate probability of causation, the parameter of attributable risk in the exposed AR E is often used, either explicitly or implicitly. This measure is calculated as:. Of necessity, the application of this type of model involves assumptions and the technical aspects of the estimation procedure are inevitably questioned by defense experts. While there may be some general lessons from the examples that we describe, the underlying principles and litigation strategies should be considered in other legal contexts with great care. The report of the U. Additionally, because the plaintiff could not afford the costs of starting a new trial, the plaintiff as a practical matter could not move for a mistrial based on the misconduct of the defendant's attorneys. The approaches that have been followed in these countries are particular to the laws of these countries and past litigation experience. Lowe sued for breach of warranty, stating that he had "'accepted the defendants' public assurances that their cigarettes were free from harmful substances. In the Federal Cigarette Labeling and Advertising Act was established to require all cigarette packages and advertising to contain a warning label. More detailed information on the approaches used to estimate health costs has been published. The general approach for these reviews reflects that employed in the landmark report of the US Surgeon General, one of the first to conclude that smoking is a cause of lung cancer. The history of the tobacco industry and its activities in relation to the emergence of the evidence on diseases caused by smoking has also been addressed in the courtroom. One of the most powerful consequences of the recent litigation has been the forced release of the industry's internal documents that are in depositories in Minneapolis, Minnesota and in Guildford, England and with the exception of the British American Tobacco documents, largely available in electronic data bases accessible on line. The second wave began in the 's because of the change in public attitude that spawned the United State's anti-smoking movement. Estos documentos fomentaron el movimiento del control del tabaco y consolidaron la base para su demanda legal. This dampened the defense's strategy of focusing on the plaintiff's actions, because it allowed in certain jurisdictions for fault to be apportioned between the plaintiff-smoker and the defendant-tobacco company. The evidence causally linking active and passive smoking has proved fundamental, showing that smokers are injured by their use of tobacco and that smoking causes disease. During the second wave, after the connection between smoking and disease had been established in the public's eye, the tobacco industry still attempted to shift the focus of the cases onto the plaintiff rather than the company or the product. The extension of the causal conclusions and underlying epidemiological evidence to specific individuals is inherent to litigation involving individual cases. Elsewhere, one of the authors of this paper JMS has described his experience as an expert in the Minnesota litigation. Palabras clave: litigio; tabaco; control; industria; legal. Rubin, who has testified for the tobacco companies, details some of these concerns in an essay published in Other issues in tobacco litigation have involved health research evidence and have led to the engagement of scientists as experts. In litigation to date, these causal conclusions have been used for two purposes: to infer that smoking damaged the health and caused disease in a group of smokers, e. The tobacco companies also uniformly devised a successful litigation strategy: never settle the case and exhaust the plaintiff with extensive procedural acrobatics. Surgeon General; 4 the reports are consistent in concluding that there is little evidence for reduced disease risk associated with using these products, in comparison with higher yield cigarettes. Eventually both the plaintiff and the plaintiff's attorney would be financially and emotionally bankrupted by the protracted litigation. This new knowledge started the first wave of tobacco litigation in when Ira C. Inference about causation in particular groups defined for litigation purposes is a readily justified extension of a causal conclusion. With regard to tobacco smoking, and cigarette smoking specifically, the evidence has been periodically subjected to systematic review by expert panels for the purpose of causal inference. Nonetheless, smoking is certain to be contributing to the causation of individuals with such diseases but for any particular individual we lack tools to calculate a specific probability to a high degree of certainty and generally use the average probability of causation for persons with the smoking profile of the individual of concern as the best estimate. Baltimore, USA. One of the most significant consequences of state litigation was access to the industry's documents, gained through the Minnesota settlement.