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olution. Cambridge University Press, Cambridge,
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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
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Keeley L H 1980 Experimental Determination of Stone Tool
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Knecht H (ed.) 1997 Projectile Technology. Plenum Press, New
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Leroi-Gourhan A 1993 Gesture and Speech (trans. of Le geste et
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Leroi-Gourhan A 1943 En
olution et Techniques, I: L’homme et la
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olution et Techniques, II: Milieu et
Technique. Albin Michel, Paris
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Peebles C S (eds.) Representations in Archaeology. Indiana
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J. Pelegrin
Litigation
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 com-
pleting 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 organiz-
ations (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) auth-
oritative 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 sys-
tems are common in many countries and trans-
nationally. 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. Formaliz-
ation 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 com-
munity-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 adjudi-
cator 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 inde-
pendence. 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.
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 contro-
versy 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 contro-
versy 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 Eng-
land 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
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 pro-
tection 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 in-
surance companies in the Netherlands have insti-
tutionalized 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 liti-
gation an unattractive option. In 1991 legislation was
passed permitting punitive damages in intentional
discrimination cases making redress through litigation
more feasible.
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 infor-
mation necessary for the adjudicator to reach a
decision, and establish decision-making rules (stand-
ards of proof, who makes the decision, etc.). Pro-
cedural rules also determine the availability of ag-
gregation 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

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 be-
tween 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 impli-
cations, 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: insti-
tutional fees, costs of representation, and expenses for
investigation, experts, etc. The fourth incentive is the
Litigation
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 pro-
cessing involved).
As with procedure generally, incentive structures
lend themselves to economic analyses. Extensive for-
mal 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, pro-
cedural 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. Un-
certainty creates risk, and the parties involving in
litigation differ significantly in their ability and will-
ingness 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 pro-
8991
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 combi-
nation 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 re-
sponsibility 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 Figure 1
many more adjudicators in civil law countries; the Litigation rates around the world. (Source:
perceived quality of judges making the initial decision Wollschlager C 1998 Exploring global landscapes of
is lower in civil law countries compared to common litigation rates. In: Brand J, Strempel D (eds.)
law countries where judges are relatively small in Soziologie des Rechts: Festschrift fur Erhard
number and are chosen selectively after years of legal Blankenburg zum 60. Geburtstag. Nomos, Baden-
practice. In civil law countries, it is relatively easy to Baden, Germany, pp. 587–88)
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 changing or is overstated. Fig. 1 shows estimated
because the parties can fight each other every step of litigation rates circa 1990; clearly there is substantial
the way. However, in civil law countries, appeals are variation among countries in the use of litigation, and
more common, making the economic advantage of the US, while at the higher end of the distribution,
one system over another unclear. In common law does not stand out as exceptional.
countries the emphasis in the civil justice process is on Many explanations for the variation have been
proof provided by the parties; in civil law systems the advanced. These include stage of economic devel-
emphasis is on logical reasoning by the judge. opment, 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
3.2 Cross-national Patterns in Litigiousness
avoid conflict, and hence litigation. An alternative
The United States has a reputation as particularly explanation is that events such as automobile accidents
litigious. This in part reflects the important role of law are dealt with in a way that avoids the need for
and courts in the United States from its beginning. litigation. A third explanation is that the Japanese elite
However, systematic evidence indicates that the sup- intentionally has restricted access to litigation as a
posed exceptionalism of the United States is either form of redress.

8992

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 develop-
ing such alternative baselines.
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 mech-
anism 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.
3.4 Nature of Litigants
The nature of litigants typically varies depending on
the type of case. Tort (injury) cases are dominated by
Litigation
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 ad-
vantage 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.
3.5 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 domi-
8993
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.
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 rela-
tively few exceptions, studies of litigation outcome
ignore these complications. A second problem is that,
particularly in common law countries, the final res-
olution of litigation is most often a private agreement
among the parties. Those cases resolved through
formal, final adjudication tend to be a small, non-
representative subset. Some scholars argue that the
cases resolved through trial are those where uncer-
tainty 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 nongovern-
mental 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 ex-
penses, 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 pro-
8994
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, plain-
tiffs 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 ques-
tions 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 pub-
lished decisions by federal trial judges, and dis-
tinguishes 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 (like-
lihood of success, who is bearing costs, the magnitude
of costs both absolutely and relative to stakes)
combined with risk preference are central to under-
standing 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 disagree-
ment about the likely outcome. It is less clear to what
degree the intervention of court officials can influence

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 Alterna-
tive Dispute Resolution (ADR); Procedure: Legal
Aspects; Rules in the Legal Process
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Oxford, UK
M. Kritzer
Copyright # 2001 Elsevier Science Ltd.
All rights reserved.
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
Litigation: Effects on Medical Research
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 de-
veloped 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 dis-
illusioned, and consequently have limited their inno-
vativeness 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 court-
imposed constraints on innovativeness or participants’
rights. Thus the competing accounts of the effects of
litigation on medical research are inconclusive. Never-
theless 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 re-
searcher and subject.
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 com-
pensation, 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
ISBN: 0-08-043076-7