SCIENCE, TECHNOLOGY, AND LAW

Law plays a growing critical role in the regulation of science and technology, including the ethical consequences of scientific research and new technologies. The relatively new field of law, science, and technology seeks to study systematically the diverse ways law interacts with science and technology. Law, science, and technology has been defined as "the discipline that deals with how our legal system can and must adjust to accommodate the problems created by the ever more urgent and ubiquitous impact of technology on society" (Wessel 1989, p. 260), and as seeking "to determine how the various processes of law—primarily judicial and legislative—respond to changes brought about by scientific advances" (Green 1990, p. 375).

Few law schools or legal scholars focused on the intersection of law with science and technology before the later part of the twentieth century. With advances in the computer, the Internet, biotechnology, genomics, telecommunications, and nanotechnology, technology has assumed an ever-increasing role in economic and daily life, and the law has struggled to keep pace. In the words of U.S. Supreme Court Justice Stephen Breyer, "[s]cientific issues [now] permeate the law" (Breyer 1998, p. 537). This has led to a proliferation in the study of law, science and technology interactions, including academic centers, textbooks (Sutton 2001, Areen et al. 1996), courses, specialized journals, conferences, and bar association sections (Merges 1988). There is also a growing awareness of the importance of scientific and technological developments by legal practitioners and scholars, with increased recognition among those outside the legal profession for the central importance of law in mediating the risks, benefits, and ethics of technology.

The field of law, science, and technology is premised on the belief that "[s]cience is a distinctive institution worthy of distinctive treatment by lawyers" (Goldberg 1986, p. 380). Despite increased awareness that science and technology present unique issues for the law, different formulations exist for examining law, science, and technology interactions. Here the field is divided into three primary strands. The first concerns the role of the law in managing the impacts of science and technology, including controlling the risks, promoting the benefits, and addressing ethical implications. The second concerns the institutions of law and science, examining how law affects the practice of scientific research, as well as the reciprocal relationship of how science and technology influence the law. The third involves a more generic inquiry into the problems and tensions that arise from the intersection of law with science and technology.

The Role of Law in Managing the Impacts of Science and Technology

Law plays a primary role in managing the impacts of science and technology. In the words of one prominent jurist, "[l]aw is the only tool that society has to tame and channel science and technology" (Markey 1984, p. 527). The impacts of science and technology that law seeks to manage can be subdivided into (a) risks, (b) benefits, and (c) ethical implications.

CONTROLLING RISKS OF NEW TECHNOLOGIES. New and existing technologies create many known and potential health, safety, environmental, and socioeconomic risks. Law is the principal societal institution for controlling these risks, through legislatures, regulators, and the judiciary (Jasanoff 1995). In developing such controls, the law relies on science to assess the relevant risks. Risk regulation thus involves two levels of science-law interactions: the role of law in regulating risks from science and technology; and the use of science by law to assess risk from new and existing technologies.

Legislation and regulation seek to address and reduce risks ex ante, before the risks are imposed. Most industrialized nations have comprehensive statutory and/or regulatory schemes in place to prospectively regulate potential risks from technologies such as pesticides, industrial chemicals, pharmaceuticals, natural resource extraction, genetically modified foods, and automobiles. Ex ante legislation and regulation by agencies statutorily empowered to do so presupposes the capability to adequately predict potential harms, a challenging undertaking for most risks. Indeed much of the complexity and controversy in ex ante risk regulation relates to uncertainties in the identification and quantification of potential risks. Nevertheless, given the preventive purpose of ex ante risk regulation, regulators are generally given considerable leeway in assessing risks, including the use of conservative (or plausible worst case) assumptions, requiring only substantial evidence and not necessarily the weight of evidence to support risk findings, and broad judicial deference to regulators' technical expertise.

One ongoing tension in ex ante regulation is the respective roles of legislators and regulators. The legislature in most jurisdictions has plenary power, and typically delegates to regulatory agencies the authority to regulate, subject to the substantive and procedural requirements included in the legislation. Regulatory agencies generally have greater technical expertise, available resources, and familiarity to address most risks associated with science and technology, and in that respect are the superior institution to make most risk regulatory decisions.

The legislature may take the lead when distrust between the legislature and regulatory agencies, or an issue itself, becomes so politically controversial that the greater legitimacy and accountability of the legislature is required (Goldberg 1987). A major concern is that legislation is usually more refractory to revision and updating than regulation, and thus inflexible statutory risk requirements can quickly become obsolete in areas of rapid technological change. An example is the so-called Delaney clause (1958) in the United States, which banned all food additives found to cause cancer in animals or humans based on a 1950s-vintage all or nothing view of carcinogenicity that had been scientifically outdated for many years before the law was finally repealed in 1996 (Merrill 1988).

Ex ante regulation of risks associated with science and technology thus presents some unique issues and tensions in institutional choice. Given the pace of technological change and the complexity of the subject, legislatures are likely to be at a greater disadvantage compared to regulatory agencies in determining risks associated with science and technology. By contrast the fundamental social, policy, and ethical issues raised by many new scientific and technological advances call for the greater accountability and plenary power elected legislatures offer.

The other major legal mechanism for regulating risks from science and technology is ex poste litigation and liability. Individuals injured by technologies may bring tort or product liability lawsuits seeking compensation, and science plays a critical role in providing proof of causation in such cases. Based on concern that such litigation was vulnerable to expert testimony of dubious scientific credibility, courts have focused on ensuring that scientific evidence presented to juries is sound. A leading development in this regard is the U.S. Supreme Court's 1993 decision in Daubert v. Merrell Dow Pharmaceuticals, Inc. that requires federal courts to perform a gatekeeping function to ensure that scientific evidence and testimony is reliable and relevant before it can be admitted. This opinion has resulted in judges being proactive and knowledgeable in screening prospective scientific testimony, and has generated an enormous body of scholarly commentary on how judges should evaluate scientific evidence (Black et al. 1994, Beecher-Monas 2000). It has also stimulated professional scientific organizations such as the American Association for the Advancement of Science (AAAS) to seek to educate judges about science and to provide lists of qualified experts.

Unlike ex ante regulation that evaluates whether a particular product, process, or technology may present risks, ex poste regulation is directed more specifically at whether the technology caused a specific type of injury in a particular individual or group of individuals. The scientific obstacles and uncertainties in demonstrating specific causation are even more complex than those faced in demonstrating general causation in the regulatory context. The judicial system uses presumptions, burdens of proof, and standards of proof in reaching decisions under conditions of uncertainty.

PROMOTING THE BENEFITS OF NEW TECHNOLOGIES. The law also plays a critical role in fostering innovation and promoting the development of new technologies through several legal mechanisms and doctrines. Perhaps the most important of these relates to intellectual property, by which the law gives inventors and creators a time-limited exclusive right to commercially exploit the output of their work. Intellectual property is protected through a number of legal forms, including patents, copyright, trademarks, and trade secrets. The underlying rationale for protecting intellectual property is to promote innovation, by giving researchers and authors economic incentives to create new inventions and works. Intellectual property protection is particularly important in high technology industries such as computer software and biotechnology where ideas and innovations rather than infrastructure and machinery are primary company assets.

New technologies present fundamental challenges to traditional intellectual property doctrines. For example, digital information may not be adequately protected by traditional copyright enforcement procedures, which require the copyright owner to bring a lawsuit alleging infringement. Because unlimited numbers of perfect digital copies can be made at almost zero marginal cost by simply uploading the material onto the Internet, legislatures and courts have extended greater copyright protections for digital data. This is exemplified by the notice and take-down provision of the U.S. Digital Millennium Copyright Act (1998) that compels Internet service providers (ISPs) to promptly remove information that copyright holders claim is infringing their copyright.

The rapid growth and use of peer-to-peer file exchange likewise challenges the capability of copyright law to protect copyrighted digital works, and has resulted in a renewed interest in using data protection technologies such as encryption instead of, or in addition to, the law to protect copyright. This trend, in turn, has created the need for legal restrictions on anti-circumvention measures that could be used for unauthorized bypassing of data protection technologies. However restrictions on anti-circumvention technologies have also been criticized for extending copyright beyond its traditional limits, including by undermining the fair use of digital data and unduly restricting scientific research (Samuelson 2001).

There are similar challenges in adapting patent law to genetic discoveries. Patenting genes has raised many scientific, legal, ethical, and practical complexities that established patent law is not equipped to address. For example, the traditional distinction between non-patentable products of nature and patentable human inventions and discoveries has been blurred by technology that permits the isolation of genes (often in a slightly different form) from living organisms. How should ethical and moral concerns about patenting genes and living organisms be considered in patent decisions, if at all? Should there be exceptions from patent enforcement for patented genes and organisms used for research or clinical applications? Might gene patents actually impede research and slow innovation, contrary to the very purpose of patenting, due to overlapping and stacked patent rights that make the administrative costs of licensing prohibitive (the so-called tragedy of the anticommons) (Heller & Eisenberg 1998)?

In addition to its efforts to protect intellectual property, the law encourages advances in technology through antitrust doctrine. Antitrust law promotes innovation by preventing companies from exercising monopoly power or colluding together to block new market entrants and innovations. Technology industries present unique antitrust issues. On the one hand, increased antitrust concerns and scrutiny may be warranted because of the potential for network effects to result in path dependency. Specifically the positive externalities of having other users with a compatible system may create an entry barrier to new competitors that can result in a de facto monopoly for the early industry leader, because users will be reluctant to adopt a new, better technology if it is not compatible with other users. The high initial costs of creating and introducing a new product combined with the low marginal cost of many knowledge-intensive industries heavily favors superior market power for the already-established player.

On the other hand, there are factors to suggest that antitrust issues might be of less concern in high technology industries. Rapid technological progress in high-technology sectors can result in rapid changes in market position, even for a market leader. For example, Word-Star was an early market leader in word processing software, but was quickly replaced by new market entrants with superior attributes. Given these conflicting factors, the role of antitrust law in regulating high technology industries and promoting technological innovation remains a major area of academic and policy debate (Hart 1998–1999, Liebowitz and Margolis 1996).

Antitrust actions brought in the United States and Europe against the Microsoft Corporation in the late 1990s and early 2000s illustrate these conflicting antitrust considerations. Government authorities claimed that Microsoft, by virtue of its Windows computer operating system, had a monopoly power with respect to other such operating systems that allowed Microsoft to suppress innovation in potentially competing products. Microsoft contended that it should be permitted to improve its products to include new functionalities (that is, a web browser), and that the antitrust enforcement actions were restraining such advances.

There are also other legal instruments for promoting innovation and advancing technology. Direct governmental funding of scientific research and development, as well as indirect subsidization through legal mechanisms such as research and development tax credits, are important stimulants. Technology-forcing regulations, such as motor vehicle emission standards, prompt technological progress in specific industries. Other standards that provide for uniformity of new technology formats, such as digital television, likewise are intended to facilitate technological development.

ADDRESSING ETHICAL IMPLICATIONS OF TECHNOLOGY. The law is the primary vehicle by which society seeks to resolve controversies raised by scientific research and new technologies. Whether the issue is surrogate motherhood, voluntary euthanasia, human cloning, genetic engineering, privacy in the workplace, online security, or any other technological advance with potential ethical consequences, society relies on legislatures and courts to develop and apply appropriate legal principles. The bioethicist Daniel Callahan has described this tendency to translate moral problems into legal problems as legalism, but he himself identifies a vacuum of societal institutions other than the law to resolve moral issues in a satisfactory manner (Callahan 1996). Indeed the failure to legally proscribe an activity carries an implicit message that the activity is morally acceptable.

In some cases, courts have restricted their own authority to consider the ethical aspects of controversial technological developments. For example, the U.S. Supreme Court held that living, engineered organisms such as the OncoMouse could be patented, and refused to address ethical arguments raised by such patenting, finding that those ethical objections were best addressed to the legislative arm of the government. Even when courts exclude ethical considerations, they often remain the primary motivation for litigation, which is then fought on surrogate legally-cognizable grounds.

Institutional Issues

The second major strand in the study of law-science interactions is the impact of science and technology on the practice of law, and the reciprocal effect of law on the practice of science.

EFFECTS OF SCIENCE AND TECHNOLOGY ON THE PRACTICE OF LAW. Scientific and technological advances have both substantive and procedural effects on the law. On the substantive side, new scientific evidence and techniques can change the way legal claims are resolved, including their outcomes. For example, forensic DNA evidence has fundamentally changed criminal law and paternity disputes by greatly improving the veracity of legal fact finding, while creating a plethora of new legal, ethical, and social issues (Imwinkelried and Kaye 2001). In criminal cases, forensic DNA has helped identify and convict guilty persons who might have otherwise escaped prosecution, and exonerated innocent persons accused or convicted. But this powerful forensic tool raises new issues, such as how and from whom DNA samples should be collected and stored, how genetic information may be used, and when convicted criminals should be permitted to reopen cases based on new DNA evidence.

Advances in technology are further revolutionizing the procedural aspects of law. The practice of law has historically been influenced by new technologies, including the printing press, telephone, photocopier, and fax (Loevinger 1985). In the early twenty-first century, digital evidence has improved the quality and availability of trial evidence, while raising concerns about tampering with digital photos and recordings. On-line databases, digital document repositories, electronic discovery, new graphics and presentation technologies, and digital courtrooms are changing the ways lawyers research, prepare, and present their arguments (Arkfeld 2001). On-line filing and availability of court records is increasing the convenience and availability of judicial proceedings, yet creating new privacy concerns.

EFFECTS OF LAW ON THE PRACTICE OF SCIENCE. According to Justice Breyer, "science depends on sound law—law that at a minimum supports science by offering the scientist breathing space, within which he or she may search freely for the truth on which all knowledge depends" (Breyer 1998, p. 537). Until recently, law rarely intruded into the inner sanctum of the space it created for science. Beginning in the 1980s, however, the law has steadily intruded into the practice of science. Investigations of claims of science misconduct have become more frequent and legalistic, as government investigators adopt adversarial and formal procedures approaching those used by criminal prosecutors. Individuals claiming to have been aggrieved by scientific misconduct or allegedly false claims of scientific misconduct frequently seek judicial remedies. Attorneys have even served non-party subpoenas on scientists who are doing research potentially relevant to a pending lawsuit, even if the subpoenaed scientists have no relationship to the litigation or any of the parties. This imposes a costly burden on scientists, and exposes them to intrusive searches and disclosures about their research activities.

Legislatures are also subjecting scientists to new legal requirements. Governmentally-funded researchers have long been subject to a number of requirements that are conditions of federal funding, such as requirements for human subject protection. But in 1998, the U.S. Congress passed the so-called Shelby Amendment that subjects researchers funded by the federal government to the Freedom of Information Act (FOIA), under which citizens can request and inspect all relevant documents not protected by limited exemptions. The Office of Management and Budget subsequently narrowed this legislation to federally-funded research directly relied upon in federal rulemaking, but even under such a constricted (and challengeable) interpretation, this legislation represented an unprecedented legal intrusion into the laboratory. In 2000 the U.S. Congress enacted the Data Quality Act, which imposes a series of substantive and procedural requirements on scientific evidence used by regulatory agencies. These developments indicate a trend of growing legal intrusion into the science, which was once perceived as a self-governing republic generally impervious to legal interventions (Goldberg 1994).

Tensions Between Law and Science

The third strand of law, science, and technology examines the tensions and conflicts that occur when law and science are juxtaposed in decision making. These tensions and conflicts generally flow from the fact that law and science have different objectives and procedures. One frequently mentioned difference is that the law focuses on process, whereas science is concerned with progress (Goldberg 1994). While both law and science are evidence-based systems for finding the truth (Kaye 1992a, Jasanoff 1995), the law is concerned with normative considerations such as fairness and justice, considerations generally outside the scientific framework. Given this difference, otherwise relevant evidence is inadmissible in law if its use or the way it was obtained is unfair, whereas the concept of excluding pertinent data is foreign to science (Loevinger 1992, Foster and Huber 1997). One U.S. federal judge described science as "mechanical, technical, value-free, and nonhumansitic," while law is "dialectical, idealistic, nontechnical, value-laden and humanistic" (Markey 1984, p. 527). Another difference is that "[c]onclusions in science are always probable and tentative," whereas "[c]onclusions in law are usually certain and dogmatic" (Loevinger 1985, p. 3). Given these and other contrasts, it is not surprising that tensions such as the following have developed.

TECHNICAL COMPETENCE. Most legal decision makers (for example legislators, judges, and juries) have very little scientific training and expertise, and yet are called upon to decide highly complex technological matters (Bazelon 1979, Faigman 1999). The result is that "amateurs end up deciding cases argued by experts" (Merges 1988, p. 324). There is therefore concern that legal decision makers will fail to reach scientifically credible decisions (Angell 1996) and will be improperly misled by junk science (Huber 1988).

The legal system has instituted a number of procedural and substantive innovations in an attempt to enhance the scientific merits and credibility of its decisions. One major change has been a systematic shift of decision-making authority from juries to judges, presumably because judges have greater capability and experience in distinguishing valid from invalid scientific testimony. Thus, as previously noted, judges in U.S. federal courts are required to perform a gatekeeping function to screen proposed scientific testimony for its reliability and relevance before it can be presented to a jury (Daubert v. Merrell Dow Pharmaceuticals, Inc. [1993]). Similarly, in patent infringement cases, the critical issue of interpreting the scope of a patent has been taken from juries and given to the trial judge pursuant to a 1996 U.S. Supreme Court decision.

Another innovation is the use of neutral or third party experts, appointed by the court rather than the contending parties to assist a judge or jury in understanding the scientific issues in a case. Some jurisdictions have also experimented with specialized courts better able to handle technological disputes, such as the digital court implemented by the State of Michigan. The increased use of pretrial conferences to narrow the scientific issues in dispute and the appointment of specially trained law clerks and special masters are other techniques courts employ to better handle complex scientific and technological cases (Breyer 1998).

In the legislative context, there is a growing recognition of the need for legislatures to have their own scientific and technological advisory bodies (Faigman 1999), with some pressures in the United States to replace the Office of Technology Assessment which was abolished in 1995. Most European governments and the European Union have established technology advisory bodies for their legislators.

LEGAL VS. SCIENTIFIC STANDARDS. Another area of dispute is whether the law should apply scientific standards and methods of proof, or apply its own standards to scientific evidence. An example is the concept of statistical significance, where the standard scientific convention is that a result will be considered statistically significant if the probability of the result being observed by chance alone is less than five percent (i.e., p < 0.05) (Foster and Huber 1997). Some legal experts argue that the law should apply a more lenient standard, specially in civil litigation where the standard of proof is the preponderance of the evidence (i.e., p > 0.5), because while science focuses primarily on preventing false positives, the law is equally if not more concerned about false negatives (Cranor 1995, Shrader-Frechette 1991). Other experts caution against equating the scientific standard of statistical significance with the legal standard of proof, because the two measures perform different functions and are like comparing apples and oranges (Kaye 1992b, Kaye 1987).

Judge Howard Markey, while sitting as Chief Judge of the U.S. Court of Appeals for the Federal Circuit, wrote that "[n]o court ... should base a decision solely on science if doing so would exclude the transcendental ethical values of the law" (Markey 1984, p. 525). He warned that "juriscience might displace jurisprudence" as a result of the tendency to "scientize the law" (Markey 1984, p. 525). In contrast, the U.S. Supreme Court's Daubert decision held that courts must ensure that scientific testimony have a "grounding in the methods and procedures of science," that is, be "derived by the scientific method" before it can admitted, which imports scientific standards of evidence into the law (Daubert v. Merrell Dow Pharmaceuticals, Inc. [1993], p. 590). Similarly Justice Breyer has argued "an increasingly important need for law to reflect sound science" (Breyer 1998, p. 538). Yet "some courts remain in the prescientific age" unless and until they "embrace the scientific culture of empirical testing" (Faigman 2002, p. 340).

TIMING OF DECISIONMAKING. Science and technology are progressing at increasing rates (Carlson 2003). A classic example of the rapid acceleration of technology is Moore's law, which predicts that the number of transistors on microchips will double every two years. The law is much slower to evolve, with case law advancing incrementally and gradually, and legislation advancing only sporadically. Statutes, in particular, can quickly become outdated as legislatures are limited, as a practical matter, to revisiting most issues every few years at best, and for some issues every few decades. Case law is also slow to adapt to advances in science and technology due to the binding effect of past precedents (stare decisis), something that does not impede science and technology. The result is that the law is often based on outdated scientific assumptions or fails to adapt to new technologies or scientific knowledge. Many experts argue that more flexible and adaptive legal regimes are needed to keep pace with advancing technological systems (Green 1990).

By contrast, there are situations where the law must address a question prematurely, before adequate scientific data are available (Faigman 1999). Science is in no rush to come to a final decision on any specific issue, and can afford to suspend judgment until all the evidence is in, even if that takes decades or centuries. Law does not always have the luxury of waiting (Goldberg 1994, Jasanoff 1995). When a defendant is charged with a crime, or a product manufacturer is sued for allegedly harming a citizen, the court must reach a final decision promptly without waiting for additional research to further clarify the issues. The bounded timeline of the law increases the risk of the legal system reaching decisions that may later be deemed scientifically invalid.

NEW TECHNOLOGIES VS. OLD LAWS. Another issue is whether new technologies require new laws or can be addressed by existing legal frameworks. One colorful articulation of this issue is the debate about whether there is any more need for the law of cyberspace than for the law of the horse (Easterbrook 1996, Lessig 1999). The analogy refers to the fact that there were no major legal doctrinal changes introduced to address the horse as it became a major part of commerce in earlier times, but rather existing doctrines were applied to the horse with only minor modifications. Thus there is a question about the need for new legal doctrines to address the Internet on issues such as privacy, copyright, pornography, and gambling. The passage of specialized laws such as the Digital Millennium Copyright Act and the Child Online Protection Act (1998) indicate a pattern of adopting new laws to address at least some cyberspace issues.

The same general issue arises in other technological contexts. One major debate in the regulation of genetically modified organisms is whether such products should be governed by existing environmental and food safety laws, or alternatively whether a new statutory regime created specifically for biotechnology products is required (Marchant 1988). Existing laws have generally been applied in the United States, while new enactments have been promulgated in Europe and other jurisdictions.

Another example is patent law, where to date existing patent rules have been applied to new technologies such as genes and other biomedical discoveries. Some commentators have argued that new laws, in particular new approaches that move away from the one-size-fits-all approach of current law, are needed to provide optimal patent protection for certain new and emerging technologies (Thurow 1997, Burk and Lemley 2002).

LEGAL INTERVENTION VS. MARKET FORCES. A final recurring issue is the respective roles of law and market in regulating new technologies. Specifically, under what circumstances is legal intervention (in the form of legislation or liability) appropriate, and when should the law pull back and leave the market to operate? Major disagreements on this fundamental issue exist. For example, there are conflicting views on whether government should restrict science funding to basic research, or also fund more applied research and development of new technologies.

This same basic tension between legal intervention and market forces underlay disagreements about whether Microsoft should have been subjected to antitrust enforcement because of its Windows operating system or whether market forces were adequate to prevent the company from unfairly exploiting its near monopoly. Another example is Internet privacy, where some commentators assert that technology and the market can provide adequate assurances of privacy, while others argue that a regulatory approach is needed. A third example is whether the government should set standards for technologies such as digital television and wireless communications, or leave it to the market to develop a de facto standard. These disputes rest on conflicting economic and political perspectives that are unlikely to be resolved in the foreseeable future.

Conclusion

The law interacts with science and technology in diverse ways. These interactions will proliferate in the future with advancing technologies that present novel risk, benefit, and ethical scenarios. The nascent legal field of law, science, and technology seeks to provide a systematic treatment of these actions, and will grow and evolve in parallel and apace with its subject matter.

GARY E. MARCHANT

SEE ALSO Aviation Regulatory Agencies;Building Codes;Communications Regulatory Agencies;Crime;Death Penalty;Environmental Regulatory Agencies;Expertise; Evidence;Food and Drug Agencies;Human Rights;Information Ethics;Intellectual Property;Internet;Justice;Just War;Misconduct in Science;Natural Law;Police;Regulation.

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