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Abstract: Previous empirical studies have examined various aspects of medical malpractice damages caps, focusing primarily upon their overall effect in reducing insurance premium rates and plaintiffs' recoveries, and (to a lesser degree) upon other effects such as physicians' geographic choice of where to practice and the "anchoring" effect of caps that might inadvertently increase award amounts. This Article is the first to explore an unintended crossover effect that may be dampening the intended effects of caps. It posits that, where noneconomic damages are limited by caps, plaintiffs' attorneys will more vigorously pursue, and juries will award, larger economic damages, which are often unbounded. Implicit in such a crossover effect is the malleability of various components of medical malpractice damages, which often are considered categorically distinct, particularly in the tort reform context. This Article challenges this conventional wisdom. My original empirical analysis, using a comprehensive dataset of jury verdicts from 1992, 1996, and 2001, in counties located in twenty-two states, collected by the National Center for State Courts, concludes that the imposition of caps on noneconomic damages has no statistically significant effect on overall compensatory damages in medical malpractice jury verdicts or trial court judgments. This result is consistent with the crossover theory. Given the promulgation of noneconomic damages caps, the crossover effect may also partially explain the recently documented trend of rising economic (as opposed to noneconomic) damages in medical malpractice cases.
medical malpractice, damages, caps, tort reform
Abstract: In the preamble to its most recent (effective June 2006) prescription drug labeling rule, the Food and Drug Administration (FDA) made clear its belief that "FDA approval of labeling under the act . . . preempts conflicting or contrary State law." The latest rule (effective July 2007) handed down by the Consumer Product Safety Commission (CPSC) includes a sweeping preamble statement that the new federal standard preempts "inconsistent state standards and requirements, whether in the form of positive enactments or court created requirements." And, if the National Highway Traffic Safety Administration (NHTSA) has its way, its new safety standard for roofs on sport-utility vehicles will include language immunizing auto manufacturers from state tort lawsuits over defective roofs if their autos meet federal safety standards. Dubbed "silent tort reform," these preemption preambles may be only the tip of the iceberg, a harbinger of a future where federal agency regulations come armed with directives to displace competing or conflicting state regulations or common-law as a matter of course. With the issuance of these recent controversial preambles, federal agencies have thrust themselves into the preemption spotlight. In the "tale of three agencies" that follows, I place the recent aggressive stances adopted by the CPSC, the NHTSA, and the FDA in sharp relief against a historical backdrop of more mixed (and often muted), preemption positions. Next, setting the stakes of the agency preemption debate, I highlight a discernible trend both in the Supreme Court and lower courts in the direction of deference to agency preemption determinations. Given the momentum in this direction, I expose a potentially troublesome asymmetry: agencies are given fairly expansive discretion to interpret or declare the preemptive scope of the regulations they promulgate, but when it comes to inferring private rights of actions under those same regulations, their hands are tied by judicial tether. As Justice Scalia colorfully responded in the latter context: "Agencies may play the sorcerer's apprentice but not the sorcerer himself." Why can an agency play the role of the sorcerer in the context of preemption, but must remain a lowly apprentice with respect to implied rights of action? At the extreme, a disquieting scenario emerges, whereby aggressive regulatory preemption, combined with renewed vigor toward evisceration of federal private causes of action, could lead to a nearly complete substitution of public for private enforcement of the law. Even assuming the inexorable momentum towards federalization continues, as embodied most recently in agency preemption preambles, agencies and courts may have at their disposal means to harness this development in service of transparency, and, more ambitiously, a new era of accountability. Agencies might themselves foster federalism values by forcing Congress to confront the preemption question it has repeatedly dodged when it regulates products. Alternatively, agencies themselves might emerge as effective representatives of state interests, the situs for a rich, deliberative dialogue regarding the interplay of state law and federal regulatory schemes. Courts might condition deference to agency interpretations of the preemptive scope of regulations on compliance with various congressional and executive measures designed to increase the public participation of states, the legislature, and outside political groups: consultation mandates, "federalism impact statements," or even notice-and-comment periods required for all preemption statements. These information-forcing reforms would, at a bare minimum, shed light on what hitherto is an all-too-quiet, backdoor movement, in need of further scrutiny and debate.
preemption, preamble, federal agencies, tort reform, FDA, NHTSA, CPSC
Abstract: The Supreme Court's products liability preemption jurisprudence is a small but expanding area that traces its beginnings to the early 1990s with Cipollone v. Liggett Group, Inc., and continues, most recently, through the 2008 decision of Riegel v. Medtronic, Inc. At first glance, the United States Supreme Court's preemption jurisprudence in the realm of products liability cases is a nearly incoherent muddle. But a closer view actually reveals an unmistakable pattern: in every case, the Court, with only one exception, has adopted the position of the relevant federal agency as to whether the plaintiff's state law claims should be preempted by that agency's regulations. The Court is hardly forthright about its dependence upon agencies. My article proposes a new agency reference model to fill the doctrinal gap. The model serves two functions: a lens through which we might better understand what the Court has been doing, for the past fifteen years, in the product liability preemption cases that it has decided, and a prescriptive approach for the cases that it, and lower courts, will face down the road. The thorniest preemption cases arise where Congress has been silent as to the preemptive effect of its own legislation; where a statute that it has issued says nothing or else says contradictory things about the relationship of that law to state law claims. The tall interpretive task is left to courts and to agencies. The agency reference model is an effort to clarify the relationship between these two actors; a relationship that needs direction and parameters, not only to provide coherence and predictability to the law in this area, but, this article suggests, to guide courts to the optimal result in preemption cases. Under this model, courts should look to agencies to supply the data and analysis necessary to determine if preemption is appropriate; i.e., to determine when a uniform, national regulatory policy with respect to a certain product makes the most sense or, instead, whether such regulation is better left to the states, in which case a plaintiff's common law claim should be permitted to proceed. This model simply acknowledges and exploits the fact that agencies are best equipped to provide the information central to this determination (a fact that the Court apparently already recognizes). The role played by an agency might be significant in two respects. First, there is a degree of regulatory scrutiny employed by the agency in its review and approval of products. In addition, an agency often weighs in contemporaneously on factors that arguably determine the preemptive effect of its regulatory actions. Second, an agency may assume a distinct interpretive role as administrator of the congressional legislation, and has a variety of means at its disposal to express its position on preemption, from formal notice-and-comment rulemaking to less formal interpretive statements and preambles to litigation briefs. Finally, an agency may share its views before courts (including the Supreme Court) tasked with deciding preemption questions. The model acknowledges that there is good reason to be chary of agencies acting in their interpretive, as distinct from regulatory, capacity. Most of the arguments in favor of agencies' comparative expertise speak to the rigor of the product review and approval process. While it is certainly the case that an agency might manipulate its regulatory record at the time of its product review, that danger pales in comparison to the risk of an agency's post hoc rationalization of its actions in litigation briefs, or promulgation of interpretive rules and preambles. For this reason, the model incorporates various checks on agency preemptive power.
preemption, products liability, FDA, pharmaceuticals, tort, regulation
Abstract: How Juries Decide is a pathbreaking work of empirical scholarship based on experiments conducted with more than 8,000 jury-eligible citizens and more than 600 mock juries. Its basic premise - that cognitive flaws in human decisionmaking, especially those affecting the translation process by which moral judgments are transformed into dollar awards, lead to erratic and unprincipled punitive damages awards - has already had an important impact not only on scholarly literature but also on judicial decisionmaking in high profile suits. This Review offers a methodological, doctrinal, and institutional critique of this widely influential study, with particular emphasis on the discrepancies between the empirical data presented and the policy reforms advanced - which include, at the extreme, a call to banish the jury from punitive damages decisionmaking. The Review examines critically the authors' conclusions that jurors are intuitive retributionists and unable (or unwilling) to follow instructions based on the non-retributive optimal deterrence theory of punitive damages. More fundamentally, the Review challenges the authors' rigid separation between retributive-based punitive damages, which are linked to jurors' moral evaluations, from remedial-based compensatory damages (including pain and suffering), which are not. Although the authors fashion a seemingly narrowly tailored attack on jurors' assessments of punitive damages, in fact they raise fundamental questions about the civil jury system as a whole, questions that are in no relevant way confined to punitive damages. Conversely, to the extent that there is any non-retributive component to punitive damages, their attack upon the jury's ability to assess punitive damages might not be warranted across the board. What emerges is the distinct possibility that a system of non-retributive punitive damages might survive the authors' empirical challenges. Finally, How Juries Decide pays too little attention to institutional context and wholly overlooks potentially effective reforms within the existing jury system, such as those that take into account anchoring effects and regional differences among jurors - reforms that are clearly supported by their empirical findings.
Abstract: Two primary arguments are advanced for the contemporary functional importance of federalist constraints on centralized political power. The first is captured in Justice Brandeis's famous invocation of the states as the laboratories of democracy in which a single courageous State may blaze new paths by trying novel social and economic experiments. The second ties the smaller, decentralized scale of subnational units to a more robust democratic accountability, by which government is brought closer to the people, and democratic ideals are more fully realized. This Article is largely about circumstances in which these two arguments for federalism fail. The question that concerns us is what happens when one state's experimentation poses risks to the rest of the country, in the form of spillover effects that adversely affect citizens of other states. In such circumstances, not only may the benefits of heterogeneity fail, but also the citizens of other states are deprived the political means of compelling democratic accountability on economic actors shielded by other states' claims of sovereignty. In this Article, we will address the emergence of partial federalization of areas historically governed by state law. Our approach is to think of the battles over federalism as running across two dimensions. The more familiar is the question of which law controls, state or federal. But a second dimension is the battle over which forum should control, state or federal, and which is to be the catalyst for new legal norms. Focusing on the rise of federal preemption of state law, on the expansion of the federal forum through federal question subject matter jurisdiction or the newly minted Class Action Fairness Act, and on the constitutional override of matters formally assigned to state law, such as punitive damages, we hope to highlight and explain a quiet federalization of vital areas of law - one far less noticed than the heavily (and perhaps overly) publicized limitations on federal regulation of internal matters of state governance. Our main argument is that the Supreme Court has, in preemption and forum allocation cases, attempted to capture the considerable benefits that flow from national uniformity and to protect an increasingly unified national (and international) commercial market from the imposition of externalities by unfriendly state legislation. We hope to give a broader rendition of the legal response to market pressures toward predictability and uniformity than would emerge from a narrow focus on formal constitutional doctrine. We also aim to underscore aspects of horizontal federalism - namely policing relations between the States - that have tended to be obscured by the looming shadow of vertical federalism - namely, the balance of power, and division of labor, between federal and state sources of authority.
preemption, federalism, Class Action Fairness Act, punitive damages
Abstract: This Essay focuses on an illustration of "federalism in action" - namely, the divergent approaches of state and federal courts in deciding whether the Federal Food Drug and Cosmetic Act (FDCA), and accompanying regulations promulgated by the Food and Drug Administration (FDA), preempt state failure-to-warn claims brought against pharmaceutical companies. The Essay explores two salient factors that might affect state and federal courts' respective approaches to the FDA drug labeling preemption analysis: (1) the radical shift in the debate from regulatory compliance to preemption; and (2) the role and influence of the FDA. First, the recurrent debate - in the academy and the courts - regarding the interplay between federal regulations and state common law tort actions has, in less than a decade, radically shifted from regulatory compliance to federal preemption. If state courts have an institutional interest in preserving the autonomy of state common law from broad federal overrides, then presumably one should expect the same resistance to claims of outright preemption. Second, a myopic institutional focus on the courts alone misses the critical role and influence of federal agencies. Thus far largely overlooked is the extent to which federal agencies' role and influence may be a driving force behind the state-federal disparity in preemption determinations. In the realm of FDA prescription drug preemption, not only are federal courts more likely to defer to federal agencies, but - equally important in terms of explaining the decision-making process of courts - federal courts are more likely than state courts to solicit the views of the FDA and the FDA is more apt to intervene on its own in federal court cases. The Essay concludes with some thoughts regarding the federalism implications of state-federal court differences in approach to the preemption inquiry.
preemption, drug, pharmaceutical, federalism, tort, regulation
Abstract: My empirical study first replicates and then extends a prior preliminary empirical study of sexual harassment damages awards by Cass Sunstein and Judy Shih. It covers a comprehensive set of 232 cases in which plaintiffs won some positive amount of compensatory damages from state and federal, trial and appellate court decisions from 1982-2004 (published either in official Reporters or solely on Westlaw). Contrary to Sunstein and Shih's finding, my analysis of these data reveals a consistent, and statistically significant, positive relationship between punitive and compensatory damages (at least in cases where punitive damages are awarded). My new empirical study then employs dependent variables that, in my view, are more theoretically and statistically sound than those employed by Sunstein and Shih and others who have focused exclusively on the relationship between punitive and compensatory damages: total combined damages (i.e., all compensatory and punitive damages), and what I term outrage damages, or combined noneconomic compensatory and punitive damages. My empirical results, using these new dependent variables, essentially confirm Sunstein and Shih's conclusions regarding the irrelevance of variables pertaining to the nature and severity of harassment. What my study reveals as crucial predictive factors, by contrast, are factors pertaining to damages limitations. My study highlights that these factors - including the effect of the 1991 Civil Rights Act, and whether plaintiffs append state civil rights and tort claims to their Title VII claims - are critical to a fuller understanding of damages determinations in sexual harassment cases.
damages, Title VII, sexual harassment, empirical
Abstract: This Article offers a fresh perspective on the longstanding debate over the insurability of punitive damages. Prepared for a symposium on Calabresi's The Costs of Accidents: A Generation of Impact on Law and Scholarship, the Article takes as its starting point Calabresi's insight that the line separating insurable costs from noninsurable penalties should be grounded upon the distinction between accidental and intentional misconduct. The Article asks: Should punitive damages be insurable in a Calabresian world? In order to answer this question, the Article chronicles the insurability debate itself, from its origins in the 1960s up to the present. Close study of the divergent legislative, judicial, and insurance industry approaches reveals two competing insurance coverage dividing lines: one separates compensatory and punitive damages, relying heavily upon public policy considerations as set forth by legislatures and courts; the second forges a line between accidental and intentional conduct, resting primarily upon moral hazard economic principles followed by insurance companies. The Article argues that the traditional contours of the public-policy driven debate, which focuses on the nature of the damages - i.e., compensatory or punitive - should give way to the market-driven intentionality line, which focuses on the nature of the underlying conduct. A switch to the Calabresian/insurance industry line respects the changing and expanding multifaceted roles of punitive damages. Since the insurability debate arose in the 1960s in the context of drunken driving cases, punitive damages have entered the more complex realms of products liability, mass torts, employment discrimination, and other civil rights violations - disputes that implicate common law and statutory punitive damages serving a range of not only penal, but also remedial or compensatory purposes. Finally, the Article acknowledges the difficulties posed by the accidental-intentional line drawing, as exemplified in drunken driving cases, and identifies statutory multiple damages as a future challenge for the insurability debate.
insurance, punitive damages, Calabresi, tort reform
Abstract: Conventional wisdom suggests that punitive damages are growing out of control. To stop juries from awarding blockbuster punitive damages, a number of states have passed caps to set a ceiling on the amount of punitives. In principle, if plaintiffs' attorneys and/or juries wish to circumvent such caps, they could simply increase the amount of compensatory damages awarded. To investigate this possibility, we examine data from the Civil Justice Surveys performed by the National Center for State Courts and present evidence in both difference-in-difference and triple differences frameworks that punitive damage caps are associated with an increase in compensatory damage awards. These results suggest that caps alone are a poor way to constrain damage awards.
Tort Reform, Blockbuster Awards, Punitive Damages, Punitives, Juries, Litigation
Abstract: The fraud caveat is ubiquitous in key debates on the regulatory role of tort law: Even the most ardent supporters of either the state-based regulatory compliance defense to tort claims against product manufacturers, or the more powerful wholesale federal preemption of state tort law by administrative regulations, concede that fraud changes the equation. State legislatures that have adopted regulatory compliance provisions immunizing prescription drug manufacturers whose drugs were approved by the FDA from liability for damages (either entirely or just for punitive damages) have, without exception, included the fraud caveat. And courts interpreting these immunity statutes echo the caveat mantra. The fraud caveat remains an undertheorized but highly revealing and consequential aspect of regulatory preemption debates. In Warner-Lambert Co. v. Kent, the U.S. Supreme Court left for another day the resolution of the question whether Buckman preempts statutory fraud exceptions to drug manufacturer immunity statutes. The question raises a narrow doctrinal issue, but one that hits a raw federalism nerve, with correspondingly wide reverberations in products liability preemption jurisprudence. A satisfactory resolution of the doctrinal issue - relying upon the FDA to police fraud in the first instance, but enlisting private litigants on the remedial and enforcement end - provides the seeds of a more generalizable model of agency-court cooperation for the regulation of nationally regulated products, such as medical devices and pharmaceuticals. This institutional approach gives primacy to the agency to decide, in the first instance, the extent to which state law requirements would encroach upon its regulatory scheme, but reserves room for private litigant enforcement of federally determined standards.
fraud, immunity, regulatory compliance, preemption, FDA, drugs, pharmaceutical
Abstract: A number of states have passed caps on non-economic and punitive damage awards in civil cases. The conventional wisdom is that the passage of these caps is driven by "out-of-control" jury awards that need to be reigned in. However, it could be the case that voters harboring anti-litigation, pro-tort reform sentiments are more likely to support the passage of caps even in the absence of an upsurge in awards. To examine the effect of jury awards on the passage of caps, we estimate semi-parametric hazard models of cap passage using data from the Jury Verdict Research Reporter.
punitive damages, caps, damage caps, jury awards
Abstract: Riegel v. Medtronic, the Court's latest pro-preemption decision shielding manufacturers of certain FDA-approved medical devices from common law tort liability, can be fairly characterized as a narrow, textual interpretation of the preemption clause of a congressionally enacted statute. More typically in products statutes (governing motor vehicles, recreational boats, or consumer products, for example) Congress creates confusion by including both a preemption clause, which mandates displacement of competing or conflicting state law standards, and a savings clause, which purports not to upend existing state common law liability. Where statutory text is indeterminate, where are courts to look?
Drawing upon some suggestive gestures toward agency input in Riegel, this Essay applies what I have termed the "agency reference model" to the concrete setting of the regulation of pharmaceutical drugs and extends the model by specifying searching judicial review of evidence taken from the FDA's regulatory record to substantiate FDA findings of implied conflicts between state common law failure-to-warn claims and the federal regulation of the safety and efficacy of drugs.
On this account, what emerges as key to the preemption inquiry is setting the parameters for legitimate agency claims to authority both for its substantive determinations and for its interpretation of the governing statute. To whom much is given, much is required. Under the agency reference model, the FDA would be given an enhanced role, partnering so to speak with the courts in making preemption determinations; for this reason, courts must ensure that the actions and positions taken by the FDA merit deference. Redirecting the preemption inquiry in these directions would go a long way towards helping courts make implied conflict preemption decisions in products liability cases, where statutory text provides scant guidance.
FDA, preemption, Supreme Court, Riegel, Wyeth, products
Abstract: This Article takes as its starting point the "agency reference model" for judicial preemption decisions, adopting the foundational premise that courts should take advantage of what federal agencies, which are uniquely positioned to evaluate the impact of state regulation and common law liability upon federal regulatory schemes, have to offer. The Article's main focus is on the federalism dimension of the debate: Congress's and federal agencies' respective ability to serve as loci of meaningful debate with state governmental entities about the impact of federal regulatory schemes on state regulatory interests. Notwithstanding the dismal track record of federal agencies, which seems to be characterized by total neglect of states' regulatory interests, the Article sides with agencies over Congress and trains its focus on reform of the agency rulemaking process. Given that the 1999 Federalism Executive Order provides a blueprint for timely and meaningful consultation with the states, issuance of federalism impact statements, and robust interchanges during the notice-and-comment period, what is needed now is an effective enforcement mechanism. The Article advocates a variety of "agency-forcing" measures designed to enhance the ability of Congress, the executive, and especially the courts, to ensure that agencies abide by executive mandates and other reforms, and to provide a check on overt politicization or inaction on agencies' part. The Article introduces the concept of "indirect challenges" to agency rulemaking, arising outside of the Administrative Procedure Act's domain of direct challenges to agency action at a later juncture when a defendant asserts a preemption defense to state common law tort actions.
federal preemption, federalism, accountability, executive order 13132, Wyeth
Abstract: Written for The University of Pennsylvania Law Review's symposium, Fairness to Whom? Perspectives on the Class Action Fairness Act of 2005, this article evaluates the largely ignored settlement notice provision. The provision mandates that notice of every class action settlement within CAFA's purview must be provided to appropriate federal and state officials. The relevant federal official is the U.S. Attorney General. As for the states, the relevant official is the one who has primary regulatory or supervisory responsibility with respect to the defendant, or who licenses or otherwise authorizes the defendant to conduct business in the State, or, by default, the AG of any state in which any class member lives.
Some legal scholars have begun to ask whether CAFA's settlement notice provision will awaken a sleeping giant. The scant existing commentary is of two minds. This perhaps reflects the juxtaposition of the lofty goal of aggressive AG monitoring against the fact that the AGs lack a precise mandate for official review, let alone any additional resources for the endeavor.
At this early juncture, it is too soon to tell whether the CAFA settlement notice provision will have a significant impact on private settlements of class actions, let alone any wider impact in motivating state AGs to police more aggressively certain types of misconduct. To the extent that the provision does have a marked effect, it will most likely be due to the increased availability of information and to the facilitation of coordinated efforts on behalf of groups of state AGs. In order to assess the overall effect, it is necessary to delve beneath the layer of formal activity to probe the informal bargaining and negotiation taking place at the behest of state AGs.
The settlement notice provision also provides a window on an even grander topic: CAFA as regulatory policy. As if through a refracting lens, the view of CAFA is transformed by the angle from which it is viewed. The Article sets forth a series of progressively unfolding dyads in order to highlight the state/federal, ex ante/ex post, and public/private dimensions of regulatory policy implicated by CAFA. This triad of matrices proves a useful framework for evaluating the design of optimal regulatory policy - a large domain of which the CAFA settlement notice provision is but one small part.
CAFA, AG notice, settlement, class action, regulatory
Abstract: To date, the U.S. Supreme Court's focus has been on preemption of traditional tort claims impugning the safety of medical devices and drugs either through design defect or failure-to-warn claims. Even if the Court forecloses such tort claims, in whole or in part, most likely the nascent, but ever-expanding, realm of related consumer fraud claims arising from prescription drug advertising will emerge unscathed. The historical model for an end run around preemption of failure-to-warn claims is provided by the watershed case Cipollone v. Liggett Group, which forged a distinction between health and safety specific failure-to-warn claims - which were expressly preempted under the federal cigarette labeling statute - and general fraudulent misrepresentation claims - which were not preempted. Altria Group, Inc. v. Good, decided this Term breathes new life into efforts to structure state law fraud claims around federal preemption. The crux of the preemption debate centers on whether the decision-maker adjudges the FDA's regulation a floor (or minimal) or ceiling (or optimal) standard-the former permitting complementary state actions; the latter foreclosing them as meddlesome substitutes. The FDA's advertisement review process appears to provide a (rather weak) floor rather than an optimal regulatory standard. On the whole, the FDA does not appear to be engaged in an exercise of optimization, weighing the costs and benefits of the DTCA. For this reason, it would be rare for pursuit of the state law tort action to be characterized as a "redo" of what the FDA has already determined. And thus, consumer fraud claims arising from drug advertisements should withstand preemption challenges.
Abstract: Jury awards of classwide punitive damages provide windfalls to individual plaintiffs, particularly in products liability, fraud, civil rights, and employment discrimination cases. This suggests a new angle from which to approach the ongoing punitive damages debate. Under current law, classwide assessment of widespread public harms has proceeded under the rubric of retributive punishment and deterrence the traditional justifications for punitive damages bypassing class action procedural requirements and unjustly enriching the plaintiff. In the wake of the Supreme Court's admonition in State Farm that such a practice can violate due process by exposing defendants to the risk of multiple punitive damages awards for the same conduct, the Article proposes explicit recognition of a distinct category of compensatory societal damages for redress of third-party and societal harms. Up until now, this category has been quietly subsumed within punitive damages. But damages for specific harms to third parties and more diffuse harms to society are actually compensatory (as opposed to punitive) in nature, and should, once assessed, be distributed by legislatures, courts, and juries accordingly. Drawing upon heretofore unconnected trends in punitive damages and class action tort cases, and state-level legislative and judicial innovations with split-recovery schemes for distributing punitive awards, the Article explores various mechanisms for transforming punitive damages into societal damages, including the formation of an ex post class action at the remedial stage and the punitive-damages-only class at the liability stage. The theory of compensatory societal damages whether or not embraced by legislatures and courts reveals more clearly the tradeoffs in transforming the doctrine of punitive damages to achieve the compensatory and deterrence goals of the tort system.
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