Genomics and toxic torts: dismantling the risk-injury divide.

• Author: Grodsky, Jamie A.

INTRODUCTION I. THE DANCE OF LEGAL AND PHYSICAL INJURY A. The Latency Problem in Toxic Torts 1. Emergence of nontraditional tort theories 2. The asbestos controversy 3. Jurisprudence of ambivalence: Physical injury as a predicate to "risk-based" recovery 4. Requiring, injury to detect injury: The medical monitoring, paradox B. Genomics and Toxic Tort Law: Two Onrushing Freight Trains 1. Opening, the "black box": New intermediate biomarkers 2. Power, speed, and seale: Whole genome research 3. Emerging, fields: New molecular tapestries C. Implications: Challenging the Risk-Injury Divide II. EXPLORING THE RISK-INJURY DIVIDE A. "De Minimis Effects" or "Reversible Effects" Model B. "Significantly Enhanced Risk" or "Diseased State" Model C. Genomics and the Risk-Injury Divide 1. Genomics and "de minimis effects" 2. Genomics and the "diseased state" conception a. Objectivity and permanence b. Failure to repair c. "Early-stage disease" biomarkers D. Implications: The nebulous concept of physical injury III. TOWARD a NUANCED CONCEPTION OF INJURY AND REMEDY FOR THE GENOMIC AGE A. Reconsidering, Intermediate Remedies B. Physical Injury in the Context of Remedy: The Rainer Decision C. Medical Monitoring, in the Genomic Age: Recognizing, Risk or Redefining, Physical Injury? 1. Risk as legal injury: Returning to original conceptions of a nontraditional tort 2. Rethinking physical injury D. Future Convergence of Remedies E. Genomics and Toxic Tort Law: Unbridled Liability or Risks Without Remedies? CONCLUSION INTRODUCTION

Advances in molecular biology and genomics are poised to transform current conceptions of "risk" and "injury" in the law of toxic torts. (1) The legal system has yet to anticipate or plan for this emerging reality. This Article argues that if the law remains wedded to conventional notions of injury, it will ignore the fruits of a scientific revolution and thus may forego new remedial opportunities that could benefit both plaintiffs and defendants in the end.

An elemental principle of personal injury law is that plaintiffs must demonstrate "harm" in the form of physical injury prior to recovery. The modern world of synthetic chemicals and toxic torts has challenged this bedrock principle. Unlike traditional accidents involving broken bones or other immediate and obvious injuries, toxic exposure may breed diseases whose symptoms take years to manifest. These delayed effects can create intractable barriers for tort plaintiffs, potentially undermining the law's deterrent and corrective justice functions. Thus, toxic torts pose the novel question of whether plaintiffs exposed to toxic hazards and placed at significant risk of disease--yet perhaps not physically "injured"--should nonetheless be entitled to some form of legal remedy.

In recent years, several nontraditional claims have evolved to help toxic tort plaintiffs overcome traditional barriers to recovery, including claims for "mental distress," "enhanced risk," and "medical monitoring." Courts are now struggling with these developments, some of which serve important fairness and deterrence goals, yet arguably may divert resources from the truly impaired and unsettle established tort doctrine. Fueled partly by recent asbestos litigation, in which claims by the allegedly "unimpaired" have overwhelmed court dockets, the "latency problem" has emerged as one of the most critical issues in modern tort law. The genomic revolution promises to make this problem even more salient and controversial in the future. (2)

Remarkably, the debate over the tort system's role in responding to risks of toxic hazards all but overlooks emerging science. While commentators engage in abstract normative discussions of whether the law should remedy for latent "risk" versus concrete "injury," I argue that science may no longer support this conceptual dichotomy. New genomic technologies will strike at the core of the current risk-injury divide.

This is happening because foundational developments in molecular biology, fueled by the application of new genomic technologies since the 1990s, are enabling progressively fine-tuned observation of the effects of toxic substances on the body and the role of genetic makeup in modifying those toxic effects. The identification of new biological markers or "biomarkers" at the genetic and molecular levels has allowed scientists to characterize a number of previously undetectable, intermediate events between chemical exposure and environmentally induced disease. New high-speed, high-volume technologies, such as DNA "microarrays," are generating new kinds of biomarkers at an unprecedented rate and level of resolution. And as observational techniques evolve, scientists can test for suites of biological changes, providing more information than the genome alone can reveal. As a result, science may detect evidence that bodily integrity has been compromised long before classic clinical symptoms emerge.

Yet despite these developments, I argue that the law clings tenaciously to an older scientific model. Although the case law addressing subcellular damage is limited and has not yet addressed the fruits of "whole genome" research, most courts have treated such damage as benign, de minimis, or otherwise legally inconsequential. (3) Courts greatly prefer to draw bright lines between risk and injury, and continue to place the boundary at proof of classic medical symptoms or overt impairment. And indeed, this was fitting in an earlier era, when research tools were insufficient to identify many intermediate effects or to establish their relationship to ultimate disease--giving birth to the metaphor of disease emerging from an impenetrable "black box." (4) But these traditional legal presumptions about when "risk" translates to "injury" or disease may become less appropriate or desirable in the future.

Challenging this conventional framework, I draw upon the scientific literature to illustrate a growing "middle ground" between de minimis effects and classic medical symptoms. It follows that certain asymptomatic conditions, though perhaps not qualifying as fully developed (and hence fully compensable) "illness" or "disease," may nevertheless constitute risks or injuries that merit some form of legal recognition. New technologies lend support to my claim through their ability to identify damage to the body's repair functions. And so-called "early-stage" disease biomarkers may represent not only risk but the presence of disease itself. Thus, I argue, newly identifiable subclinical events may themselves represent substantially enhanced risk of disease or even a "diseased state."

Not only is the law failing to anticipate emerging science, but it may also be moving at cross purposes. For example, a growing number of jurisdictions require plaintiffs to show separately compensable physical injuries in the form of overt disease prior to recovering for medical monitoring. (5) Yet a defining feature of this cause of action, as it evolved to address the perils of toxic hazards, (6) is that exposed plaintiffs need not prove physical injury prior to recovery. This principle is grounded in pragmatism, as the very purpose of monitoring is to detect the onset of disease and allow for preventive medical intervention. Indeed, preventing disease progression at earlier stages may reduce treatment costs, limit future personal injury claims, and ultimately reduce health care costs for the nation. By forcing plaintiffs to attain late-stage injury, toxic tort law may actually discourage medical interventions that could benefit defendants and plaintiffs alike. Hence, recent legal developments not only undermine monitoring's preventive and deterrent functions, but run counter to a primary goal of twenty-first century medicine, which is to detect, prevent, and treat disease at the molecular level. (7)

Therefore, I conclude that the judiciary's retreat from medical monitoring may be coming at precisely the time when increased attention to this remedy is necessary. As research opens up new possibilities for ever-earlier medical intervention, society will need to consider whether a legal system whose remedies depend on unclear and perhaps outmoded notions of "physical injury" reflects sound science or appropriate legal policy. Limited relief for monitoring, where plaintiffs can prove the necessary elements, may appropriately balance deterrence and legal restraint in an age of accelerating scientific change.

Part I of this Article provides a snapshot of the remarkably unsettled legal landscape that the molecular-genomic revolution is soon to confront. Illustrating judicial ambivalence toward nontraditional tort theories, I highlight the growing role of a "physical injury" requirement in claims based presumptively on exposure and risk. In particular, I note the irony of requiring separately compensable injuries as predicates to medical monitoring recovery. And while a frequent justification for the injury requirement is to create a principled standard for separating valid from speculative claims, there is no consistency in the courts as to how to define physical injury. This Part also introduces elements of the new science most relevant to the future of toxic tort law. In brief, I suggest that as new molecular biomarkers blur the boundaries between risk and injury, health and disease, the oft-stated presumption that tort law provides remedies for injury but not for risk may prove to be a distinction without a difference. The concept of physical injury, already a tenuous standard for assigning legal rights and remedies, will become even more opaque as science observes the mechanisms of toxicity at the subcellular level. Courts will need to rethink just where in the exposure-disease continuum remediable injury or harm has occurred.

Part II situates future scientific discoveries in the existing doctrinal landscape, examining case law dealing with subcellular damage and other...