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Abstract:
This Article challenges the conventional wisdom that special rules of informed consent should apply in the experimental context. To a greater or lesser extent, all medical interventions have an investigational quality to them. In many cases, of course, patients are subjects in medical research in only the mildest sense, and few if any concerns arise about injury and exploitation. On the other hand, patients increasingly choose to enroll in formal clinical trials, and they benefit from a number of special protections including but not limited to comprehensive informed consent requirements. An intermediate category, which is sometimes referred to as clinical innovation and is largely unregulated by both federal agencies and the courts, deserves more careful attention. If, in fact, no clear line of demarcation exists between standard and experimental treatments, then the all-or-nothing approach of federal regulatory agencies becomes difficult to justify. Conversely, because all medical interventions lie along a spectrum of scientific uncertainty, one can question the largely undifferentiated rules applied by the courts when they resolve medical malpractice litigation.

Abstract:
This paper catalogues several types of missteps made in loss-of-a-chance cases. Whether a court has decided to endorse or to reject proportional recoveries for the loss of less-than-even odds of a favorable outcome, more careful consideration of the mathematical and other concepts involved in such cases should promote greater clarity in the analysis. Unfortunately, a number of judges, lawyers, and commentators have made errors in dealing with loss-of-a-chance claims, including mistakes related to comparisons across stages of a disease, flawed assumptions about background mortality rates, and faulty calculations related to changes in the chance of survival. This paper recommends that courts adopt an attributable risk equation when resolving these cases.

Abstract:
Biotechnology has ushered in both profound and mundane innovations, and it has presented accompanying challenges for a variety of legal institutions, but the academic literature on this subject is littered with superficial and overly alarmist work. Among other things, this Article selects for an extended critique a pair of recently published papers as emblematic of the sorry state of legal analysis concerning the ways in which we regulate the fruits of the biotech revolution.

Abstract:
The opportunity for increased precision in pharmaceutical therapy will represent one of the important legacies of the Human Genome Project. Medical researchers have long suspected that genetic differences account for some of the significant variability seen in patient response to drugs, but now they hope that the identification of single nucleotide polymorphisms will allow physicians to customize pharmaceutical interventions. This Article describes these scientific developments as a prelude to asking whether legal institutions will manage to catch up to or, instead, hinder such advances. Pharmacogenomics will lead to fundamental changes in how drugs are discovered, tested, manufactured, labeled, and marketed. Federal regulators, the courts, and other policy makers will face challenges in accommodating these changes, and, in turn, their responses may have important impacts on the maturation and diffusion of this technology.

Abstract:
This essay anticipates that courts may encounter an increasing number of educational malpractice claims against medical schools when patients suffer injuries at the hands of recent graduates. Such lawsuits will pose difficult questions, and they fall at the intersection of two divergent litigation trends - namely, a greater willingness to impose duties on health care institutions (and also to extend tort duties to third party beneficiaries in various contexts), but a longstanding unease with claims of educational malpractice. It is difficult to predict which of these tendencies will predominate when courts resolve future (m)ed-mal claims. Such lawsuits may well falter after a thorough analysis of the evidence and competing policy arguments, but judges should carefully articulate their reasons for declining to recognize these sorts of cases rather than simply parroting the weak rationales used to reject tort claims asserted by public high school students who graduate with inadequate basic skills. The characteristics of medical education - and the foreseeable consequences of doing a poor job of training future health care professionals - demand a closer evaluation of the possible benefits and burdens of holding medical schools accountable for failing in their mission.

Abstract:
This Article suggests that the time has come to reconsider the safety and effectiveness of fertility drugs in order to combat some of the continuing problems arising from the aggressive use of assisted reproductive technologies, especially the hazards associated with multifetal pregnancies. After critically assessing the arguments made by some commentators about the power of malpractice law to curb any abuses by fertility clinics and specialists, the Article concludes that the Food and Drug Administration should consider restricting or withdrawing pharmaceutical products used to induce ovulation. Although such a drastic move would not prevent the continued use of in vitro
fertilization and other advanced fertility treatments (over which the agency probably has limited jurisdiction in any event), it would dramatically reduce the frequency of multifetal pregnancies, and it should not run afoul of constitutional protections of procreative liberty.

Abstract:
Authors and publishers of "How To" manuals, cookbooks, textbooks, and field guides sometimes include hazardous misinformation that readers foreseeably may rely upon to their detriment. With the growth in consumer demand for these nonfiction titles, coupled with increased short-cuts taken by publishers, we can expect more tort litigation involving such books in the future. In the limited number of cases decided to date, however, courts have treated books as special, unlike other mass-produced commercial goods, often citing policies derived from constitutional protections against governmental interference with free speech. This Article suggests that these decisions incorrectly distinguish books from other consumer goods routinely made subject to strict products liability and also overstate the First Amendment rationales for immunizing authors and publishers from the threat of tort claims. Existing products liability doctrines can fully accommodate any special problems that would arise from treating authors and publishers in the same way as manufacturers and distributors of other types of consumer goods.

Abstract:
Authors and publishers of "How To" manuals, cookbooks, textbooks, and field guides sometimes include hazardous misinformation that readers foreseeably may rely upon to their detriment. With the growth in consumer demand for these nonfiction titles, coupled with increased short-cuts taken by publishers, we can expect more tort litigation involving such books in the future. In the limited number of cases decided to date, however, courts have treated books as special, unlike other mass-produced commercial goods, often citing policies derived from constitutional protections against governmental interference with free speech. This Article suggests that these decisions incorrectly distinguish books from other consumer goods routinely made subject to strict products liability and also overstate the First Amendment rationales for immunizing authors and publishers from the threat of tort claims. Existing products liability doctrines can fully accommodate any special problems that would arise from treating authors and publishers in the same way as manufacturers and distributors of other types of consumer goods.

Abstract:
This paper attempts to offer a comprehensive evaluation of the various facets of the Products Liability Restatement that relate to medical technologies, and it does so from a perspective rooted in the regulatory as opposed to the doctrinal challenges posed by these products. The special provisions applicable to prescription drugs and devices have provoked a great deal of scholarly commentary, and the few courts to consider the issue have uncritically relied upon the published critiques. I find little merit in most of these negative assessments, though I point out some flaws in section 6 of new Restatement that seemingly no one else has identified. Part II addresses production defects, focusing on the heated debate over what standards to use in deciding whether a prescription drug suffers from a defective design. Part III considers defects related to the information that accompanies prescription drugs, especially those advertised directly to consumers. Finally, Part IV touches on some of the peculiar issues raised by investigational products, generic drugs, prescription medical devices, and the duties of non-manufacturing sellers.

Abstract:
This paper is part of a forthcoming symposium that focuses on human embryonic stem cell research, and it responds to the lead paper by Ann Kiessling that urges the use of a more precise scientific definition of the term embryo to include only fertilized ova after implantation in the uterus, which would exclude the conceptus in vitro as well as the products of parthenogenesis and somatic cell nuclear transfer. Although agreeing with her about the desirability of promoting stem cell research, this paper quibbles with Kiessling's account of inconsistencies in definitions of the term embryo found in dictionaries, state statutes, judicial opinions, and advisory panel reports, and it emphasizes the extent to which the question turns on political rather than scientific factors. The paper explains that the federal government uses a definition directly at odds with the one Kiessling recommends, and it criticizes the extent to which the Bush administration has further politicized the issue, but the paper ultimately challenges the premise that semantic games can help to circumvent this debate.

Abstract:
In searching for more efficient mechanisms to issue regulations, federal agencies have begun to utilize a novel technique called "direct final rulemaking," which entails the issuance of a final rule deemed to be non-controversial coupled with a delayed effective date and a commitment to withdraw this rule should anyone file a significant adverse comment within a short period of time. This article reviews recent experience with the use of this procedure and suggests that direct final rules may be vulnerable to judicial invalidation on both procedural and substantive grounds. Contrary to the claims of proponents, neither the "good cause" exception to notice-and-comment rulemaking requirements, nor an agency's substantial compliance with those requirements, would authorize this short-cut. Moreover, the truncated internal and external reviews of the merits of a direct final rule will complicate a court's effort to assess any substantive challenge, and, no matter how unlikely they might be as a practical matter, such challenges will not falter on waiver or failure to exhaust grounds.

Abstract:
In searching for more efficient mechanisms to issue regulations, federal agencies have begun to utilize a novel technique called "direct final rulemaking," which entails the issuance of a final rule deemed to be non-controversial coupled with a delayed effective date and a commitment to withdraw this rule should anyone file a significant adverse comment within a short period of time. This article reviews recent experience with the use of this procedure and suggests that direct final rules may be vulnerable to judicial invalidation on both procedural and substantive grounds. Contrary to the claims of proponents, neither the "good cause" exception to notice-and-comment rulemaking requirements, nor an agency's substantial compliance with those requirements, would authorize this short-cut. Moreover, the truncated internal and external reviews of the merits of a direct final rule will complicate a court's effort to assess any substantive challenge, and, no matter how unlikely they might be as a practical matter, such challenges will not falter on waiver or failure to exhaust grounds.

Abstract:
This paper suggests that, notwithstanding oft-repeated complaints that Congress has stripped it of such power, the Food and Drug Administration (FDA) still has mechanisms for identifying and managing some of the most serious risks presented by dietary supplements, if only it would focus on those that are pharmacologically active and potentially efficacious.

Abstract:
This Article considers, in turn, the roles played by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) in regulating a range of pain management technologies, especially narcotic analgesics. Although implemented by two quite dissimilar agencies, the former preoccupied with medical and scientific questions while the latter focuses on law enforcement matters, these two regulatory regimes operate in tandem and overlap in potentially important ways. The Article contrasts the behavior of these agencies and suggests that Congress might want to reconsider this unstable division of regulatory authority. Finally, the tools currently available to both agencies may be too blunt for sensibly addressing the conflict that often arises between the needs of patients and efforts to prevent irresponsible use, as in the controversy currently surrounding OxyContin.

Abstract:
This paper responds to a new article by Carl Coleman that critiques the risk assessment process applied to biomedical research by institutional review boards (IRBs). Coleman's central argument that IRBs exercise delegated governmental authority and should strive to emulate appellate decision making suffers from several flaws: it exaggerates the centrality of these boards in existing systems of human subject protection, it incorrectly adopts a court-centered view of the processes used by other regulatory institutions, and it fails to appreciate some of the countervailing advantages of an underproceduralized decision making model. Human research subject protection efforts suffer from many shortcomings, but it would be a mistake to pursue solutions that recast boards as miniature appellate courts in an effort to promote consistency and transparency when an inquisitorial model akin to mechanisms of peer review better describes the activities of IRBs.

Abstract:
The U.S. Food and Drug Administration has imposed increasingly restrictive conditions on access to pharmaceutical products such as isotretinoin (Accutance) and thalidomide that carry a serious risk of birth defects. This Article focuses on the requirement that female patients agree to use two forms of contraception, drawing parallels to suggestions that similar conditions apply to certain persons on welfare or probation, and posing hypothetical variations of the FDA's access restriction. If anyone ever challenged this aspect of the agency's risk management strategy, a court would have to decide whether the policy (1) grew out of state action (complicated by the fact that the FDA did not technically mandate it and could not sanction patients who failed to comply); (2) affected the exercise of a fundamental right (e.g., procreative liberty (declining contraception), free exercise/speech); (3) inappropriately conditioned access to a benefit on the waiver of one of these rights; and (4) failed strict scrutiny (in light of the argument made in other contexts that, even though the government may seek to minimize the risk of in utero exposure to teratogens, it lacks a compelling interest in preventing the birth of a child so exposed).

Abstract:
For a variety of reasons, vaccines and other critical pharmaceutical products have become increasingly scarce in the last few years, and persistent shortages involving dozens of essential drugs may imperil the public health. Pressures emanating from regulatory agencies, the courts, and insurers have conspired to make some lines of the pharmaceutical business less than attractive. Although concerns about unpredictable tort liability received most of the blame in the past, two other factors may help to account for the latest round of drug shortages: stringent federal control of manufacturing facilities and aggressive cost-containment efforts that further erode profit margins. Whatever the cause, scarce supplies necessitate efforts at rationing that pose their own difficulties for health care providers. Policymakers could avoid putting physicians to such tough choices among patients by focusing on ways to ensure the production of adequate quantities of these highly cost-effective medical technologies. Some commentators have called for greater public sector involvement, but this Article concludes that, in addition to bolstering its emergency stockpiles, the federal government instead needs to take steps designed to encourage private manufacturers to continue supplying critical pharmaceuticals. To this end, it should adopt more flexible regulations governing manufacturing facilities, provide companies with greater protection from the vagaries of tort liability, and avoid pursuing excessive cost-control strategies. Otherwise, patients may continue to lose access to important therapeutic products.

Abstract:
Recent initiatives by the federal government to prevent the medical use of marijuana, to prevent the use of certain controlled substances for physician-assisted suicide, and to prohibit partial-birth abortions all have at least one thing in common: critics have objected to each of these actions as inconsistent with principles of federalism. This paper critically evaluates the claim that the federal government has no business intruding on the prerogative of the states to regulate the practice of medicine. Although the last decade has witnessed what some have called a federalism revival, the national government retains power over health care professionals. It has exercised such authority only rarely in the past, content to leave issues concerning the quality of medical care to state supervision and professional self-regulation. Whatever one thinks about the controversial recent exceptions to this pattern of non-interference, this paper explains that nothing in the Constitution would foreclose the possibility of greater federal involvement, and it suggests a few matters over which such regulation might have genuine merit as a matter of policy.

Abstract:
Pain and suffering long ago became synonymous with noneconomic damages, but it makes no sense to treat nonphysical harms as invariably noneconomic, at least not nowadays. Physical and mental injuries have both pecuniary and nonpecuniary consequences, but doctrine continues to reflect long-discredited notions about the nature of emotional harms. In addition, judicial hostility to psychiatric mitigation emerged at a time when available treatment options were decidedly primitive. As interventions have become safer and more effective, and as the social stigma associated with their use has largely dissipated, courts should revisit the issue. Applying the doctrine of avoidable consequences in cases of emotional injury should result in a recharacterization of some pain-and-suffering damages as medical expenses, whether or not the plaintiff chooses to make such use of an award in the future, and it might help to confine what remains under the banner of noneconomic damages.

Abstract:
Over the course of a century of struggling to protect the public health with its limited statutory powers and often inadequate resources, the U.S. Food and Drug Administration (FDA) has institutionalized a practice of cavalierly ignoring legal constraints. This essay explains that the FDA has disregarded legislative directives in at least three different senses: failing to adhere to procedures specified by Congress; deploying expressly delegated powers in order to achieve ends beyond those envisioned in the legislation; and branching out to reach matters that arguably exceed its jurisdiction. At times, the agency's creativity has received belated endorsement from Congress or the courts, though, on other occasions, members of these branches have condemned it for showing excessive initiative. Separately, the FDA also has shown a marked indifference to constitutional limits on its range of actions.

Abstract:
This paper analyzes the drive to switch more pharmaceutical products to nonprescription status. First, it describes the mechanisms and criteria used by the U.S. Food and Drug Administration to distinguish between prescription and over-the-counter (OTC) drugs. Next, it views the distinction through the lens of tort law, suggesting a number of reasons why an Rx-to-OTC switch might increase a seller's exposure to liability. Finally, it unpacks the oft-repeated point that an involuntary switch would be unprecedented, which connotes both procedural and substantive objections (arising under both statute and the Constitution), focusing in particular on the possibility of pressing a regulatory takings claim.

Abstract:
This paper focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. A growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation of "product stewardship" or "informed choice"). This paper explains the serious flaws in such proposals, but it also suggests one novel basis for imposing liability (distribution restrictions) that might make some sense. Genuine product stewardship, at least if understood as an effort to make the most of a scarce resource, strikes me as far more defensible than the approaches suggested by other commentators.

Abstract:
In the last decade, "evidence-based medicine" (EBM) has become all the rage. Just as the Supreme Court instructed the federal judiciary to take a more critical approach to the assessment of expert testimony, proponents of EBM call on health care professionals to apply the best available evidence when making treatment decisions. Instead of relying on what they may remember from medical school or have learned from their personal experiences (or from drug company sales-persons), EBM insists that physicians consult the biomedical literature for the latest clinical research findings. The fact that the medical profession views such an idea as novel offers a startling picture of traditional ("opinion-based") medical practice, one quite different from that imagined by courts and regulatory agencies when they blithely assume that physicians can effectively assimilate tremendous quantities of complex information. EBM may, however, embody some naive assumptions about the character of the available scientific evidence, failing to appreciate shortcomings such as the extent to which conflicts of interest have affected the biomedical literature. Nevertheless, the debate surrounding evidence-based medicine offers important insights for various decisionmakers when they address health care quality issues. In turn, legal institutions may help to facilitate EBM by addressing conflicts of interest in biomedical research and by encouraging physicians to rely on rigorous research rather than largely anecdotal information when treating their patients.

Abstract:
Jury nullification occurs when jurors intentionally disregard the law in returning a verdict. The phenomenon has attracted a great deal of scholarly attention, though almost exclusively in connection with criminal trials. Indeed, some commentators have taken the position that civil juries cannot nullify. In contrast to verdicts of acquittal, trial and appellate judges do have the power to intercede in civil cases, but in practice they may find it difficult to discern and correct instances of intentional jury departures from their instructions. Although it is hard to document cases of civil jury nullification, it is also not clear how often criminal juries engage in acts of nullification. The lack of evidence confirming the descriptive claim has not, however, discouraged scholars from evaluating the merits of criminal jury nullification.

This Article canvasses the extensive debate over criminal jury nullification as a prelude to considering the possible arguments for and against its counterpart in civil litigation. Although a number of commentators have praised certain aspects of jury departures from the law in the latter context, the case in favor of civil jury nullification is much weaker than it is in the criminal arena. Concerns about protecting citizens against oppressive government action do not arise in lawsuits between private parties. Beneficiaries of nullification may applaud the jury's function in softening the application of seemingly harsh rules, but their adversaries will voice legitimate complaints that nullification sacrifices their due process rights. In addition, when a jury chooses to disregard laws adopted by legislatures or courts, it undemocratically usurps the lawmaking function lodged in those institutions. Thus, courts should more readily embrace tools such as special verdicts and bifurcation of trials in order to minimize the risks that civil juries will deviate from their instructions.

Abstract:
This essay addresses the controversy over the abortifacient drug mifepristone (RU-486). First, it traces the history of the U.S. Food and Drug Administration's review and comments on a number of peculiar aspects of the approval process. For instance, the FDA applied special rules normally reserved for the evaluation of life-saving drugs, it imposed unusual restrictions on the distribution of the drug, and it promised to keep the identity of the manufacturer secret. These and other features of the agency's review of mifepristone were truly unprecedented. Second, this essay evaluates several scenarios concerning the future of the drug. Critics of the FDA's decision have suggested that the new administration, Congress, or individual states could take steps to either revoke the approval or impose significant restrictions on the drug's distribution, though each of these strategies would present difficult statutory and constitutional questions.

Abstract:
In recent years, lawmakers have become interested in scientific peer review, hoping that scrutiny by independent experts might improve the quality of agency decisionmaking. Proponents of regulatory reform should not, however, oversell the utility of independent peer review of technical judgments made by agencies. Notwithstanding its centrality as a quality control mechanism for the scientific community, peer review does not provide a bromide for what some observers think ails our government (i.e., overzealous bureaucrats issuing health and safety rules based on a misunderstanding or conscious disregard of the best available data). Involving outside scientists in the process undoubtedly will promote greater care and reflection, and these peer reviewers may help steer agencies clear of embarrassing and costly mistakes, but ultimately the independent experts cannot and should not displace the broader deliberative process about hard policy questions that science cannot answer. The New Deal faith in expertise continues to have strong appeal, especially as contrasted with the pluralist vision of agencies simply brokering compromises between competing interest groups. So long as independent peer review does not become a substitute
for public participation or judicial review, it may provide a
forum for genuine deliberation that can facilitate subsequent
steps in the administrative process and help to better focus
other forms of external scrutiny of agency decisionmaking.

Abstract:
Commentators have suggested at least three competing metaphors to describe statutes that delegate authority to administrative agencies, likening these "enabling" acts to corporate charters, constitutions, or sources of common law norms. These differing conceptions of regulatory legislation reflect distinctive visions about the distribution of power among the three branches of government. Understanding organic acts as corporate charters would hold agency officials to the precise terms of the authority granted to them by their legislative principal, and reviewing courts would invalidate actions taken beyond such expressly delegated power as ultra vires. The constitutional metaphor, at least if read against the backdrop of a tradition of flexible interpretation of the U.S. Constitution, would more readily recognize implied agency powers to pursue the ends that underlie the enabling statute, but the judiciary would continue to define and police these looser boundaries, invalidating actions that exceed implied agency powers. Finally, the common law metaphor recently promoted by Professor Cass Sunstein would free regulatory officials even from the constraints of a flexibly interpreted constitutive document by viewing the organic act as granting agencies a general subject matter jurisdiction and accompanying power to generate common law principles derived initially from, but not constrained by, the enabling statute. This Article identifies flaws in the latter conception, especially insofar as it condones bureaucratic tendencies toward the expansion of power. It also rejects the affiliated suggestion that courts should extend "Chevron" deference to agency interpretations of ambiguities in their enabling statutes when these interpretations concern the very scope of the agency's jurisdiction. Although the constitutional metaphor may still provide a plausible account of early statutes that represented open-ended delegations of authority to administrative agencies, this Article argues that the more restrictive charter metaphor provides the default position that best accommodates separation-of-powers and federalism values expressed in existing doctrines concerning the delegation of legislative power, restrictions on congressional attempts to prohibit judicial review of agency action, and constraints on the power of the courts to generate federal common law.

Abstract:
This Article juxtaposes the recent debates about statutory interpretation and the judicial uses of legislative histories with the relative quiescence over methods for interpreting agency regulations. The latter subject merits more attention than it has received given the relatively greater prevalence and practical import of legislative rules issued by administrative agencies as compared with statutory commands from the legislature. Unlike attempts to understand the legislature's original intent, whether by focusing solely on statutory text or considering extrinsic aids found in various pre-enactment explanatory materials, courts routinely defer to agencies' post-promulgation interpretations of the meaning of their regulations. This grants executive officials unnecessary license for creative reinterpretations of a legislative rule, inviting them to sidestep notice-and-comment rulemaking requirements.

The tradition of deference to agency interpretations of ambiguous regulations emerged at a time when courts and litigants had little information that might shed light on original agency intent, but, during the last thirty years, the quantity and accessibility of pre-promulgation materials have exploded. In particular, agencies must issue detailed preambles and regulatory analyses to accompany final rules, and, at earlier stages of the rulemaking process, they may generate various proposals, advisory committee recommendations, and interagency memoranda that document some of the choices made by regulatory officials. More importantly, these materials pose less of a risk of manipulation than do legislative histories because agencies have a statutory obligation to explain new rules to the public and Congress, and, in the event of a direct challenge, they must defend the validity of their handiwork in the courts.

If judges focus on agency preambles and the rest of the administrative record compiled during rulemaking when resolving pre-enforcement and other direct challenges to the validity of a regulation, then these same materials should provide the best evidence of the agency's original intent when questions about the meaning of such rules later emerge in a variety of contexts. This Article concludes that courts should embrace such valuable interpretive materials rather than rushing to defer to the "dynamic" interpretation that an incumbent administration finds most expedient. The various weaknesses that textualists have identified with intentionalism as a method of statutory construction need not trouble a court when it must interpret an unclear agency rule.

Abstract:
This essay, which is part of a symposium about the government standards defense for FDA-regulated products, generally argues in favor of the recognition of a rule that would make compliance with agency regulations conclusive evidence of non-defectiveness. Although they are not formally obligated to adopt such rules as particularizing the standard of care in tort litigation (at least absent federal preemption), judges should take them far more seriously than they do at present. As the decision-makers empowered by the citizenry to set safety standards, legislatures and regulatory agencies select levels of product risk that they deem appropriate, based on scientific, economic, and political considerations. But when the courts treat these standards as presumptively sub-optimal, they arrogate such important societal decisions for themselves. As a result, often unsophisticated jurors in different parts of the country will make their own judgments about appropriate prescription drug and medical device labeling and design, thereby second-guessing the far more expert, politically accountable, and uniform determinations made by the FDA in the course of promulgating a rule. When their arguments fail to move agency officials, consumer activists should not get to keep waging what they regard as the good fight in the more congenial arena of tort litigation, addressing their evidence to often receptive panels of jurors who are accountable to no one for decisions that have undoubted regulatory effects. If federal safety requirements appropriately set the standard of care (through a negligence per se instruction) when that helps plaintiffs (notwithstanding fears of regulatory obsolescence or ambiguity that are emphasized by opponents of the government standards defense), then compliance with those very same safety requirements should satisfy the standard of care in products liability cases even though that happens to help defendants.

Abstract:
This essay focuses on one narrow aspect of the recent controversy surrounding the line item veto that has gone largely unnoticed to date--namely, the similarity between the President's exercise of that authority and the widely accepted power of the judiciary to sever unconstitutional provisions from previously enacted federal legislation. Courts routinely sever invalidated provisions from statutes even without an express delegation of authority to do so. In effect, the judiciary has asserted a limited line item veto power over legislation. Naturally, the two techniques of postenactment statutory "editing" without formally amending the legislation have different origins and applications, but they also share striking commonalities that cast serious doubt on the majority's Presentment Clause analysis in Clinton v. City of New York, 118 S. Ct. 2091, 2108 (1998).

Abstract:
Disease definitions and clinical judgments routinely affect coverage and reimbursement decisions by health insurers, the licensing determinations of regulatory agencies charged with reviewing new therapeutic technologies, evidentiary and substantive rulings by the judiciary in personal injury lawsuits and criminal trials, eligibility decisions in disability programs, and the resolution of claims before workers' compensation tribunals. This reliance on the definition and identification of disease by the medical profession fails to appreciate the extent to which our conceptions of illness are socially constructed rather than based on value-neutral scientific data and the application of technical expertise. Just as social forces shape medical practice, legal institutions have influenced nosology and diagnosis, but the nature and consequences of their effects on the definition and identification of disease have gone largely unnoticed. By virtue of their often uncritical reliance on clinical judgments, agencies and courts have to some extent distorted and even corrupted medical practice, interfering with the primarily therapeutic purposes underlying diagnostic decisionmaking by asking physicians, psychiatrists, and clinical researchers to provide answers to difficult legal and political questions. To the extent that medical professionals make diagnostic judgments to serve non-therapeutic purposes, they may work against promoting the best interests of their patients and society.

Abstract:
This article evaluates an important but rarely discussed type of informal agency activity denominated "arm-twisting," defined as the use of threats by an administrative agency to impose a sanction or withhold a benefit in hopes of encouraging voluntary compliance with a request that the agency could not impose directly on a regulated entity. The article first describes the variety of arm-twisting techniques available to federal regulators, in contexts ranging from licensing and government contracting to product recalls and settlements of enforcement actions. In each of these settings, agencies enjoy significant leverage overregulated entities, allowing federal officials to extract nominally voluntary concessions. Agencies may threaten to deny licenses, refuse to enter into procurement agreements, disseminate adverse publicity, or impose other sanctions against uncooperative parties, and, in at least some cases, such threats allow agencies to pursue extrastatutory goals, seemingly incontravention of the limits on their delegated authority. The article then draws comparisons to arm-twisting in other contexts, including land use exactions and criminal plea bargaining. Finally, after considering the unconstitutional conditions doctrine as well as judicial constraints on plea bargaining and administrative consent decrees, the article suggests a series of possible substantive and procedural safeguards aimed at minimizing the risk of overreaching by federal regulatory officials. Because the problem often is not amenable to judicial control, greater agency self-restraint and congressional oversight may offer the only realistic prospects for curbing improper uses of administrative arm-twisting.