Gibson K R, Ingold T (eds.) 1993 Tools, Language and Cognition in Human E olution. Cambridge University Press, Cambridge, UK Inizan M-L, Reduron-Ballinger M, Roche H, Tixier J 1999 Technology and Terminology of Knapped Stone (PreT histoire de la pierre tailleT e, 5). CREP, Nanterre, France Johnson L L 1978 A history of flintknapping experimentation: 1838–1976. Current Anthropology 19(2): 337–72 Keeley L H 1980 Experimental Determination of Stone Tool Uses. University of Chicago Press, Chicago Knecht H (ed.) 1997 Projectile Technology. Plenum Press, New York Leroi-Gourhan A 1993 Gesture and Speech (trans. of Le geste et la parole, 1964, Albin Michel, Paris). MIT Press, Cambridge, MA n Leroi-Gourhan A 1943 E olution et Techniques, I: L’homme et la Z Matiere. Albin Michel, Paris n Leroi-Gourhan A 1945 E olution et Techniques, II: Milieu et Technique. Albin Michel, Paris Mellars P (ed.) 1990 The Emergence of Modern Humans: An Archaeological Perspecti e. Cornell University Press, Ithaca, NY Odell G (ed.) 1996 Stone Tools: Theoretical Insights into Human Prehistory (Interdisciplinary Contributions to Archaeology series). Plenum Press, New York ' Perles C 1992 In search of lithic strategies: A cognitive approach to prehistoric chipped stone assemblages. In: Gardin J-C, Peebles C S (eds.) Representations in Archaeology. Indiana University Press, Bloomington, IN, pp. 223–47 Renfrew C (ed.) 1973 The Explanation of Cultural Change: Models in Prehistory. University of Pittsburgh Press, Pittsburgh, PA Renfrew C, Zubrow E B W (eds.) 1994 The Ancient Mind: Elements of Cogniti e Archaeology. Cambridge University Press, Cambridge, UK Roche H 1980 Premiers outils tailleT s d’Afrique. Socie! te! d’Ethnographie, Paris Semenov S A 1964 Prehistoric Technology. Cory and MacKey, London Sieveking G de G, Newcomer M H (eds.) 1987 The human uses of flint and chert (Proceedings of the Fourth International Flint Symposium held at Brighton Polytechnic 10–15 April 1983). Cambridge University Press, Cambridge, UK Sinclair A, Schlanger N (eds.) 1990 Technology in the humanities. Archaeological Re iew 9(1) Torrence R (ed.) 1989 Time, Energy and Stone Tools (New Directions in Archaeology series). Cambridge University Press, Cambridge

J. Pelegrin

1. Definition
Litigation is a highly structured process of dispute resolution that invokes the power of the state, or a contractually agreed to private decision maker, to provide a means to authoritatively adjudicate a dispute between two or more parties. In many countries in a large proportion of disputes or cases involving liti-

gation, the parties reach resolutions without completing the full litigation process, either by voluntary settlement, abandonment by one party, or some intermediate authoritative decision that short circuits the full process. Unless there is some legal requirement that the adjudication process be invoked, there is typically an even larger set of disputes that never enter into the formal litigation process but which are resolved with the knowledge that the process could be invoked. Most cases of litigation involve disputes among private parties, either individuals or organizations (businesses, corporations, etc.). Some cases involve the government as a party to the dispute, and, especially in federal systems, the parties on both sides of a case can be governmental entities. Adjudication involves three key elements: (a) authoritative resolution of a dispute, (b) by a neutral third party, and (c) through the application of pre-existing norms or rules. While the courts customarily are associated with adjudication, there is nothing that limits adjudicatory dispute resolution to courts or other governmental bodies; private adjudication systems are common in many countries and transnationally. Also, while the pre-existing norms or rules most often associated with adjudication comprise what is normally called ‘law,’ there is nothing that precludes adjudication relying upon any agreed upon set of norms or rules, including those derived from custom or religious texts. Litigation is a particular form of adjudication that is based on a set of formalized procedures. Formalization is a matter of degree. There are forms of adjudicate dispute resolution that dispense with most aspects of formalized process; examples include small claims courts, qadi courts, or other kinds of community-based courts. On the formality continuum, there is no bright line separating what is appropriately labeled litigation and what is not. When a governmental entity serves as the adjudicator and oversees the litigation process, it is most often a court. In some governmental systems, the courts are formally independent of the other branches of government, while in other systems the courts are more integrated into the executive. Even in systems where the courts are independent of the executive, there are often specialized adjudicatory forums within the executive, possessing varying degrees of independence. What is labeled a ‘court’ in one system, may be labeled a ‘tribunal’ or a ‘commission’ in another. For example, in Germany, there is a system of ‘labor courts’ to handle litigation involving many types of disputes arising from the workplace; in Britain some of the cases that would go to labor courts in Germany go to ‘Industrial Tribunals’ and in the United States the forum is called a Labor Relations or Employment Relations ‘Commission’ or Workers’ Compensation Board. Even within a single country, one finds entities labeled as ‘courts’ (the US Tax Court) or as something else (‘Tax Appeals Commission’) where both are 8989

Litigation involved in similar adjudicatory activities. Thus, while the ‘court’ label is usually linked to litigation, that need not be the case. For a dispute-resolution process to be a form of litigation it only requires that the method of resolution be adjudication as defined above and that there is a formalized, structured process governing the forum’s activities. Litigation involves a wide range of issues, and the cases range from the most routine, mundane disputes, to mega-disputes involving large numbers of people or huge sums of money, or both. Because of this range, generalizations are difficult, and it is best to think in terms of multiple worlds of litigation reflecting differing scales of activities and issues. important. In England, consumers may bring claims for defective goods, but they may also turn to authorities to enforce criminal laws vis-a-vis the duties of sellers of consumer goods (i.e., consumer protection can be dealt with under criminal as well as through civil litigation). Despite substantial social and cultural similarities, litigation over torts arising from auto accidents is lower in the Netherlands than in neighboring areas of Germany in part because insurance companies in the Netherlands have institutionalized mechanisms for resolving claims without litigation. The remedies available also have a great deal to do with whether or not litigation is invoked. In the United States, mass disasters such as fires, airplane crashes, and the like typically result in litigation because American law provides substantial remedies to the victims of such events. In contrast where remedies are severely limited, litigation is less likely. For example, in 1987, an English cross-channel ferry capsized due to crew negligence resulting in almost 200 deaths; English law strictly limited damages, and the ferry company and its insurers quickly resolved the victims’ claims. A second example of the impact of available remedies involves persons in the United States claiming job discrimination on some basis other than race. Until the early 1990s civil rights laws limited remedies to lost wages and\or reinstatement; this typically made litigation an unattractive option. In 1991 legislation was passed permitting punitive damages in intentional discrimination cases making redress through litigation more feasible.

2. Theoretical Issues in Understanding Litigation
The highly structured nature of litigation derives form a combination of rights, procedures, and incentives. Each of these elements influences who uses litigation, when they choose to use it, and the specific nature of the litigation process.

2.1 Rights Rights refer first of all to who is granted access to the mechanism of litigation. In the United States and Canada there are complex rules governing who has ‘standing’ to bring an action in (federal) court, and under what circumstances they may bring that action; under the US Constitution, the jurisdiction of federal courts is limited to ‘cases and controversies,’ and only those who are in fact affected by the case or controversy may bring an action. In other countries (e.g., Israel or Germany) many kinds of actions can be brought by persons who have only a tangential connection to harm or the issue in dispute. In still other countries litigation is used regularly as a means of obtaining advisory opinions from judicial bodies, and there need not be any immediate case or controversy in the American sense. The legal rules and norms within a country or jurisdiction control the kinds of substantive issues subject to litigation. For example, in England tenants often have what amount to a property interest in their tenancy; this can lead to costly disputes and litigation over whether or not a property owner can obtain the use of property held under such a tenancy. In the United States there are very detailed protections afforded certain categories of employees, and there is significant litigation over those protections; in England there are many fewer specific protections, but a more general limitation on an employer’s ability to discharge employees without just cause. In addition to whether or not there are issues that are subject to litigation, the question of whether there are avenues of redress other than litigation is extremely 8990

2.2 Procedures A set of rules of procedure govern litigation, whether in a court, an administrative tribunal, or a private setting. These rules determine the form by which litigants initiate claims, provide for mechanisms to inform and establish jurisdiction of defendants\ respondents, set procedures for gathering the information necessary for the adjudicator to reach a decision, and establish decision-making rules (standards of proof, who makes the decision, etc.). Procedural rules also determine the availability of aggregation procedures (e.g., class actions), who bears the burdens of the cost of litigation (i.e., fee shifting), and who actually serves as the adjudicator of issues of fact and issues of law (professional judges, lay juries, some mixed form). Specific rules may be set by the forum, by the parties, or by some combination of the two, depending upon the structure of the forum. While there are many variations in specific rules, there are two very broad approaches to litigation which are associated with the two dominant legal traditions: common law systems and civil law systems. The former is built on a model of party adversity, with the adjudicator playing an umpirial role; the parties

Litigation and their agents primarily control the flow and process of litigation, with the adjudicator receiving what is offered and forming a decision based on what the parties present. The latter is built on a model variously described as ‘inquisitorial’ or ‘investigatory,’ where the primary responsibility for determining and requesting information lies with the adjudicator. Under the common law system, the formal adjudication tends to be concentrated around an event called a trial when the two sides bring in their evidence and witnesses for presentation to the adjudicator. Under the civil law system, the formal proceedings are more episodic with the adjudicator determining what additional evidence he or she would like to see based on what transpires at a particular session. A second major difference between the two traditions is the relative balance placed on oral vs. written processes, with common law procedures involving a heavier oral component while civil law countries emphasizing written materials. Developments in recent years have moved the two systems closer together, with more effort in civil systems to reduce the episodic nature of adjudication procedures and reduce the burden or producing written materials, while common law systems have moved toward increased reliance on written materials. The specific rules create a vehicle for analyses of litigation by social scientists. These analyses may be process-based, building on the flow of litigation; one approach models litigation as a series of stages and transitions, with litigation progressing from the initial harm through the initiation of a dispute into the formal litigation process culminating in a trail and possibly and appeal. Other analyses rely on tools such as game theory and economic modeling. These latter analyses provide predictions of relative advantages and disadvantages created by the rules, and provide models of how the parties and their agents should behave under assumptions of economic rationality and uncertainty. 2.3 Incenti es Litigation frequently has significant financial implications, in terms of the costs of litigation and\or the resulting remedies. The result is a set of incentives which serve to structure the decision-making of the parties and their agents. The first incentive is the likelihood of success, both in terms of ‘winning’ and in terms of obtaining the desired redress; those who must bear the cost of litigation are sensitive to whether or not the litigation will succeed. The second incentive is the size of potential remedies, which is a function of the severity of the alleged harm, the law or rules governing the awarding of remedies, and possibly the nature of the adjudicator of the remedy: professional, lay, single, or group, expert, or nonexpert. The third incentive is the costs associated with litigation: institutional fees, costs of representation, and expenses for investigation, experts, etc. The fourth incentive is the nature of the payment system for legal representation: pri ate payment based on effort, payment contingent on success either on a percentage\commission or some other basis, or third party payment such as legal aid, legal insurance, or some other type of group assistance; closely related to payment system is whether or not there is a system of partial or full fee shifting (‘loser pays’), and how the level of attorneys’s fees is set (relation to size of case, outcome, amount of processing involved). As with procedure generally, incentive structures lend themselves to economic analyses. Extensive formal analyses have been made of rules governing cost allocation and their expected impacts on decisions to litigate, decisions to go to trial or to settle, the likelihood of frivolous litigation, and the role of attorneys. In addition, to theoretical analyses, procedural rules and the resulting incentives have been the subject of extensive empirical analyses, most heavily in the United States, but also in England. 2.4 The Role of Uncertainty One of the central features of litigation is uncertainty, and the decisions of actors in the litigation system must be made in light of this uncertainty. Both the degree and source of uncertainty vary depending on rules, the substance of the case, and the general structure of the system. Key elements of uncertainty include: which side will the adjudicator favor, the size or nature of the remedy that the adjudicator will award, the length of time the litigation process will take, and the costs that will be incurred. Part of the uncertainty reflects the strategic nature of all conflict, and part of it reflects the introduction of a third party neutral decision-maker, combined with formalized procedures for influencing that decision-maker. Uncertainty creates risk, and the parties involving in litigation differ significantly in their ability and willingness to bear the burdens created by risk.

3. Empirical Results Concerning Litigation
The most extensive empirical research on litigation has been carried out in the United States, although there are also bodies of empirical litigation focusing on litigation from other common law countries, many European civil law countries, and countries from other regions of the world (Japan, India, the Phillippines, etc.). 3.1 The Likelihood that Disputants will Turn to Litigation Research from a variety of countries consistently has shown that relatively small proportions of most disputes eventually invoke formal litigation pro8991

Litigation cedures. The exceptions involve certain types of cases which by law require formal court action (e.g., dissolution of marriage in many countries), but those types of cases frequently involve only pro forma court action. Particularly in common law countries, the image of the filtering process has often been cast as a ‘Disputing Pyramid,’ with ‘injuries’ lying at the base of the pyramid, and final adjudicatory resolution at the top. The base of the pyramid is broad and the upper areas are narrow; most of the variation whether by type of dispute or country, tends to come in the middle regions of the pyramid, reflecting a combination of incentive structures and alternative avenues of redress. The initiation of litigation presupposes that an injury is perceived, that responsibility for the injury is externalized, and that a grievant (or an agent of the grievant) seeks redress. Most research in common law countries shows substantial attrition from potential claims to act claims, often reflecting that injured parties are never aware that they have suffered an injury, do not attribute to someone else the responsibility for the injury, or do not initiate a claim because of a belief that redress is not practical or it is not needed given alternative sources of compensation. As suggested above, even if litigation is initiated, most cases end before final adjudication. Settlements occur in what has been dubbed the ‘shadow of the law’ and they reflect anticipations of what judges or juries will decide. In civil law countries, the adjudicator plays a more central role and multilevel review is a more integral and usual part of the process. As a result, there are many more adjudicators in civil law countries; the perceived quality of judges making the initial decision is lower in civil law countries compared to common law countries where judges are relatively small in number and are chosen selectively after years of legal practice. In civil law countries, it is relatively easy to get an initial court decision because the judge controls the process; in common law countries, obtaining an initial court decision is more difficult and costly because the parties can fight each other every step of the way. However, in civil law countries, appeals are more common, making the economic advantage of one system over another unclear. In common law countries the emphasis in the civil justice process is on proof provided by the parties; in civil law systems the emphasis is on logical reasoning by the judge.

Figure 1 Litigation rates around the world. (Source: Wollschlager C 1998 Exploring global landscapes of litigation rates. In: Brand J, Strempel D (eds.) Soziologie des Rechts: Festschrift fur Erhard Blankenburg zum 60. Geburtstag. Nomos, BadenBaden, Germany, pp. 587–88)

3.2 Cross-national Patterns in Litigiousness The United States has a reputation as particularly litigious. This in part reflects the important role of law and courts in the United States from its beginning. However, systematic evidence indicates that the supposed exceptionalism of the United States is either 8992

changing or is overstated. Fig. 1 shows estimated litigation rates circa 1990; clearly there is substantial variation among countries in the use of litigation, and the US, while at the higher end of the distribution, does not stand out as exceptional. Many explanations for the variation have been advanced. These include stage of economic development, institutional structures, national cultures, alternative remedy systems, and incentive structures. For example, Japan frequently is cited as a country with a very low litigation rate. One explanation for this is that within Japanese culture there is an imperative to avoid conflict, and hence litigation. An alternative explanation is that events such as automobile accidents are dealt with in a way that avoids the need for litigation. A third explanation is that the Japanese elite intentionally has restricted access to litigation as a form of redress.

Litigation One general problem with comparing litigiousness is the baseline that should be used. Almost all studies rely on per capita litigation rates. However, litigation arises out of very specific types of events the number of which is not simply a function of population. For example, product liability litigation arises from events involving products that are purchased; a country with a higher rate of material consumption may have a higher per capita rate of product liability litigation simply because the transactions that might give rise to such litigation are more common. The problem of using baselines other than simple population is almost never addressed because of the difficulties of developing such alternative baselines. individuals as plaintiffs while contract cases more often involve businesses as plaintiffs. Defendants in tort cases are often nominally individuals, but most individual defendants are insured and the insurance company becomes the effective defendant. In contract cases defendants are distributed among individuals and organizations, with variations depending on the exact nature of the issue at stake. Litigants are not created equal. Litigation typically requires resources and expertise, and analysts have argued that this advantages the wealthy. Galanter (1974) distinguished between ‘one shot’ and ‘repeat players’ in litigation, arguing that the repeat players should be expected to win more often than ‘one shotters.’ While some of the advantages of repeat players reflect resources, other advantages reflect the ability of the repeat player to take a long-run view of litigation. The result is that repeat players are more able to ‘play the odds’ (i.e., they can act as risk neutral participants), and more able to ‘play for rules’ (i.e., try to establish precedents that will work to their advantage over the long run). The importance of the one shot versus repeat player distinction for understanding how litigants behave is further enhanced by dividing the repeat player into the ‘government player’ which may have even fewer economic constraints than other repeat players, and the ‘routine player’ for whom litigation is genuinely a part of doing business (e.g., the liability insurance company) and who cares little about the outcome of individual cases as long as it is able to comfortably predict the likelihood of winning and losing. Yet another type of ‘repeat player’ is the political interest group which uses litigation for explicitly political purposes. While this is most often discussed in the American context, it is by no means unique to the United States; particularly as politics becomes more judicialized, these types of litigants are becoming both more common and more important. Developments such as the increasing role of the European Court of Justice reflect and encourage these changes. Notably, while there has been an increase in ‘interest group litigation,’ the evidence is inconsistent on whether interest group involvement increases the likelihood of success or whether when successful in court interest groups achieve their ultimate goals.

3.3 The Role that Litigants and their Agents (Lawyers) Play Decisions to initiate litigation typically are made by litigants in consultation with their legal advisors. Two elements dominate the decision to litigate. The first is the need to finance the litigation. The second is the likelihood of success, both in terms of whether the desired decision can be obtained, and whether the decision will be enforceable. Research throughout much of the twentieth century has shown consistently that a key element in obtaining redress in tort cases is the availability of a source of payment, either a wealthy defendant or insurance coverage. Where the potential litigant must directly finance the litigation, the decision to initiate litigation will lie almost entirely with the potential litigant. Lawyers may seek to dissuade potential litigants from pursuing the claim, citing the financial, time, and emotional costs as well as the uncertainty inherent in the process. Where the cost, or at least the risk, of the litigation is to be borne by some other actor, these actors will typically be more involved in the decision to proceed. For example, in the United States where much litigation is funded by the lawyers through the mechanism of a contingency fee, the lawyers’ decisions whether or not to accept cases are crucial, and lawyers turn down at least as many cases as they accept. When some third party will cover the litigation expense, such as an insurance company (through litigation expense insurance) or legal aid or a trade union, the third party will need either make the decision whether or not to proceed or require that it be allowed to review and veto any decision to proceed. These decisions are determined by a combination of likelihood of success and the amount at stake.

3.5 Litigation Process Research on the process of litigation is generally nation specific because the process is so closely tied to the rules governing that process. Some of the research focuses on the handling of specific types of cases, such as injury cases or divorce cases. Much of this research focuses on the role of the lawyer in the litigation process, and how lawyers relate to their clients; there is disagreement over the degree to which lawyers domi8993

3.4 Nature of Litigants The nature of litigants typically varies depending on the type of case. Tort (injury) cases are dominated by

Litigation nate in the decision making process. Other studies focus on specific aspects of litigation, such as the impact of specific rules, the role the judge plays in questions other than adjudication, or problems in aggregating claims. There is no theoretical framework or argument tying together this disparate research which is heavily concentrated in the United States. portion of verdicts or decisions involving modest amounts of money, but with a distribution showing an extreme tail (i.e., a small number of very large verdicts). While over the broad range of cases, plaintiffs win about half the time and defendants win about half the time, the studies also show a range of plaintiff success depending on the nature of the case reflecting in part whether the uncertainty is over liability or the amount of damages. Research looking at decisions of American trial judges vis-a-vis questions such as liability and damages is much less common; what research there is shows that judges are more likely to find for the plaintiff although the typical judge’s award is about 20 percent less than the typical jury’s. A danger in all of these comparisons between decisions by judges and decisions by juries is that the cases decided by judges and juries are probably not comparable because litigants themselves choose between the two types of trials. Another line of research in the US focuses on the substantive decisions of judges in civil cases. This research typically relies upon the examination published decisions by federal trial judges, and distinguishes between decisions described as ‘liberal’ or ‘conservative’ (using contemporary American notions of this continuum). The core results of the research demonstrate that there are measurable differences in outcomes depending on whether judges are identified with the Republican or Democratic parties based on either their own affiliation prior to appointment or the affiliation of the President who appointed them. One recognized problem with this research is that published decisions differ from the full population of decisions made by federal district judges in civil cases, and results differ when unpublished decisions are included in the analysis, reducing or eliminating the relationship between decisions and partisanship. While substantial attention has focused on formal adjudication by judges and juries, less attention has been directed at the outcomes of cases resolved short of adjudication. Part of the reason for this is that determining outcomes is more difficult because they are not part of the public records. A number of empirical studies have focused on the settlement process, both in the United States and elsewhere, generally showing that economic considerations (likelihood of success, who is bearing costs, the magnitude of costs both absolutely and relative to stakes) combined with risk preference are central to understanding settlement. Simply put, cases will tend to settle when the plaintiffs net expected gain (recovery discounted by probability of success minus expected costs) is less than or equal to the defendants expected loss (pay out discounted by probability of plaintiff success plus costs). When stakes are relatively small, this is almost always true, and it is frequently true for larger cases even when there is substantial disagreement about the likely outcome. It is less clear to what degree the intervention of court officials can influence

3.6 Winning and Losing in Litigation A natural issue in the study of litigation concerns the outcome: who wins and who loses, and why? The definition of winning and losing is problematic: should outcomes be measured in absolute terms or relative terms? If a plaintiff (the initiator of litigation) obtains some redress from the court, has the plaintiff ‘won’? What if that very same result could have been achieved without litigation, and what the plaintiff sought was something more which it failed to achieve? What if the only reason it could have achieved that lesser result was that the option of litigation existed? With relatively few exceptions, studies of litigation outcome ignore these complications. A second problem is that, particularly in common law countries, the final resolution of litigation is most often a private agreement among the parties. Those cases resolved through formal, final adjudication tend to be a small, nonrepresentative subset. Some scholars argue that the cases resolved through trial are those where uncertainty is high or there are strongly conflicting views of the likely outcome. Others argue that some types of parties avoid adjudicatory outcomes intentionally when the result will produce unfavorable results, and concentrate their adjudicatory efforts on cases that will produce favourable precedential outcomes. Many studies have looked at the relative success of different types of litigants, and while the majority of studies have found that repeat players are more successful than one shot players, the patterns reveal major complications. First, the largest gaps tend to come not between repeat players and one-shot players but between government litigants and nongovernmental litigants. Second, few researchers ask the question of whether one shotters are better off with or without litigation as a means of dispute resolution, that is, litigation must be assessed not just internally but externally vis-a-vis its alternatives. For example, are persons injured through medical negligence better off with litigation as the means of redress, or relying upon the goodwill of medical providers, or with a system of insurance that provides for medical expenses, loss of wages, etc.? In the United States there has been substantial research on the outcomes of civil trials, particularly those trials decided by juries. Some of these studies focus on civil cases generally, while others focus on single areas such as medical malpractice or products liability. Typically, these studies show a large pro8994

Litigation: Effects on Medical Research the settlement process, in no small part because such a large proportion of cases settle regardless. See also: Courts and Adjudication; Judges; Lawyers; Legal Insurance; Legal Process and Social Science: United States; Mediation, Arbitration, and Alternative Dispute Resolution (ADR); Procedure: Legal Aspects; Rules in the Legal Process There is a common view that litigation better suits the strategies of powerful, well-resourced parties, and hence has a tendency to determine justice according to their interests. These issues are not addressed in detail in this article as they are not peculiar to the research relationship. This article examines, from a sociolegal perspective, the content of court decisions about medical research and the way that judges have developed legal rules that govern, and hence shape, the experience of research. It considers the claims that judges’ decisions have led to legal defensiveness in research and participants’ unwillingness to volunteer. A significant point to note is that there is no clarity about the effect that litigation has had on medical research. On the one hand it is claimed that while court decisions have been aimed at justice, the law in practice has led medical researchers to be anxious and disillusioned, and consequently have limited their innovativeness and medical progress. On the other hand it is claimed that research subjects are concerned about the strength of their legal rights and this makes them reluctant to participate in medical research. There is little empirical data to support either the view that the quality of medical research has diminished, nor whether the effect is due to direct or indirect courtimposed constraints on innovativeness or participants’ rights. Thus the competing accounts of the effects of litigation on medical research are inconclusive. Nevertheless it is informative to consider the main areas of law that are reported as being structural evidence for litigation’s impact on the relationship between researcher and subject.

Blankenburg E 1998 Patterns of legal culture: The Netherlands compared to neighboring Germany. American Journal of Comparati e Law 46: 1–41 Daniels S, Martin J 1995 Ci il Juries and the Politics of Reform. Northwestern University Press, Evantson, IL Galanter M 1974 Why the ‘Haves’ come out ahead: Speculations on the limits of legal change. Law & Society Re iew 9: 95–160 Genn H 1987 Hard Bargaining: Out of Court Settlement in Personal Injury Actions. Oxford University Press, Oxford, UK Kritzer H M 1990 The Justice Broker: Lawyers and Ordinary Litigation. Oxford University Press, New York Mnookin R H, Kornhauser L 1979 Bargaining in the shadow of the law: The case of divorce. Yale Law Journal 88: 950–97 Priest G L, Klein B 1984 The selection of disputes for litigation. Journal of Legal Studies 13: 1–55 Shavell S 1982 Suit, settlement, and trial: A theoretical analysis under alternative methods for the allocation of legal costs. Journal of Legal Studies 11: 55–81 Tanase T 1990 The management of disputes—automobile accident compensation in Japan. Law & Society Re iew 24: 651–91 Zuckerman A A S (ed.) 1999 Ci il Justice in Crisis: Comparati e Perspecti es of Ci il Procedure. Oxford University Press, Oxford, UK

M. Kritzer Copyright # 2001 Elsevier Science Ltd. All rights reserved.

1. Compensation for Harm Caused by Medical Research
Medical research inevitably results in some injuries and harm to research subjects irrespective of the care and caution taken. It is a natural consequence of the search for new knowledge. Some researchers have insurance cover, and funding bodies occasionally have a policy of offering limited payment for injuries that were caused by the research, but this is far from universal. However, to receive large sums of compensation, research participants have needed to litigate in the courts. The compensation cases are usually based on product liability laws, the law of negligence, or insurance contracts. To win their case, the injured person has to prove as a bare minimum that their injury was ‘caused’ by the medical research and not due to any alternative causal agent like environmental pollutants or underlying disease. ‘Causation’ has a technical meaning in the law. Suffice to say that it can be difficult to prove legal causation because the typical side effects complained of can be caused by many things and, in therapeutic research, patients are ill to begin with. 8995

Litigation: Effects on Medical Research
Litigation, broadly defined, is the process where two parties attempt to settle a dispute by court action. The general objective is to obtain a judicial decision about which party’s claim is legally stronger. This article considers how litigation has affected medical research. It highlights the concerns of researchers and research subjects about court decisions regarding their rights and liabilities, and how this may have affected their approach to research. The main regions in focus are the USA, Europe, and the Commonwealth countries. One general area of concern is the nature of dispute resolution in the courts. The ability of parties to argue fairly in an atmosphere that is competitive, stressful, and expensive and the efficacy of legal norms about justice and truth have been widely discussed in critical legal studies literature as well as in media reports.

International Encyclopedia of the Social & Behavioral Sciences

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