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Full-Text Articles in Law
Regulating New Tech: Problems, Pathways, And People, Cary Coglianese
Regulating New Tech: Problems, Pathways, And People, Cary Coglianese
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New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
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Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …
Rediscovering Capture: Antitrust Federalism And The North Carolina Dental Case, Herbert J. Hovenkamp
Rediscovering Capture: Antitrust Federalism And The North Carolina Dental Case, Herbert J. Hovenkamp
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This brief essay analyzes the Supreme Court's 2015 decision in the North Carolina Dental case, assessing its implications for federalism. The decision promises to re-open old divisions that had once made the antitrust "state action" doctrine a controversial lightning rod for debate about state economic sovereignty.
One provocative issue that neither the majority nor the dissenters considered is indicated by the fact that nearly all the cartel customers in the Dental case were located within the state. By contrast, the cartel in Parker v. Brown, which the dissent held up as the correct exemplar of the doctrine, benefited California growers …
Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin
Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin
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As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …
Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro
Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro
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The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.
As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to …
Anticompetitive Patent Settlements And The Supreme Court's Actavis Decision, Herbert J. Hovenkamp
Anticompetitive Patent Settlements And The Supreme Court's Actavis Decision, Herbert J. Hovenkamp
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In FTC v. Actavis the Supreme Court held that settlement of a patent infringement suit in which the patentee of a branded pharmaceutical drug pays a generic infringer to stay out of the market may be illegal under the antitrust laws. Justice Breyer's majority opinion was surprisingly broad, in two critical senses. First, he spoke with a generality that reached far beyond the pharmaceutical generic drug disputes that have provoked numerous pay-for-delay settlements.
Second was the aggressive approach that the Court chose. The obvious alternatives were the rule that prevailed in most Circuits, that any settlement is immune from antitrust …
Regulators As Market-Makers: Accountable Care Organizations And Competition Policy, Thomas L. Greaney
Regulators As Market-Makers: Accountable Care Organizations And Competition Policy, Thomas L. Greaney
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Of the many elements animating structural change under health reform, Accountable Care Organizations (ACOs) have drawn the greatest attention. The ACO strategy entails regulatory interventions that at once aim to reshape the health care delivery system, improve outcomes, promote adoption of evidence based medicine and supportive technology, and create a platform for controlling costs under payment system reform. Ambitious aims to be sure. Implementation, however, has proved a wrenching process. This article looks at the intersection of markets and regulation under the Affordable Care Act. Specifically, it analyzes regulatory interventions under the MSSP designed to foster commercial market competition. Assessing …
Reverse Settlements As Patent Invalidity Signals, Gregory Dolin
Reverse Settlements As Patent Invalidity Signals, Gregory Dolin
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Over the last decade a new type of settlements, commonly referred to as “reversed payment settlements” or simply “reverse settlements,” emerged in litigation over patents covering pharmaceutical products. What differentiates these new settlements from their traditional counterparts is that whereas traditionally, the alleged trespasser on someone else's rights pays the rights-holder to settle the litigation, in these new settlements it is the rights holder that pays the alleged trespasser. These settlements are a direct consequence of the various incentives provided by the Hatch-Waxman Act - an Act designed to increase competition between brand name and generic manufactures of pharmaceutical products. …
Accountable Care Organizations: A New New Thing With Some Old Problems, Thomas L. Greaney
Accountable Care Organizations: A New New Thing With Some Old Problems, Thomas L. Greaney
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When pressed for evidence that the proposed health reform legislation will control costs, proponents invariably cite the numerous pilot programs and other innovations in Medicare payment policy contained in the bill. At first blush, the ACO model seems well designed to foster competition among providers. Not unlike health maintenance organizations and other integrated delivery forms, ACOs assume responsibility for coordinating care and thus have strong incentives to provide cost effective care and to do so in a manner that is transparent and hospitable to comparative shoppers. But at the same time, the path of ACO development could prove profoundly anti-competitive. …
Competition Policy And Organizational Fragmentation In Health Care, Thomas L. Greaney
Competition Policy And Organizational Fragmentation In Health Care, Thomas L. Greaney
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A central challenge for all health care reform proposals currently being discussed is finding the means to effectively channel market forces given many deeply embedded features of our system and the peculiar economics of health care delivery and financing. This essay traces the path of competition law in health care and explains its chicken-and-egg relationship with provider organizational arrangements. It explores a central puzzle for future health care policy: why have market forces failed to counteract organizational fragmentation? Answering this question requires an understanding of why competition policy is inexorably linked to the organizational structures of health care providers and …
Thirty Years Of Solicitude: Antitrust Law And Physician Cartels, Thomas L. Greaney
Thirty Years Of Solicitude: Antitrust Law And Physician Cartels, Thomas L. Greaney
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Over the last thirty years the Federal Trade Commission and the Department of Justice have challenged dozens of physician cartels, networks, and other arrangements that they alleged constituted price fixing or other restraints of trade under the antitrust laws. In addition, the antitrust agencies have issued numerous advisory opinions, published detailed statements of enforcement policy, and made dozens of public statements on the issue of physician collaboration. The puzzle explored in this essay is why the government's deployment of unparalleled enforcement resources has not curtailed physician attempts to engage in collective bargaining and other attempts to restrain price competition. It …
Antitrust & Hospital Mergers: Does The Nonprofit Form Affect Competitive Substance?, Thomas L. Greaney
Antitrust & Hospital Mergers: Does The Nonprofit Form Affect Competitive Substance?, Thomas L. Greaney
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Following a string of government losses in cases challenging hospital mergers in federal court, the Federal Trade Commission and the Department of Justice issued their report on competition in health care seeking to set the record straight on a number of issues that underlie the judiciary's resolution of these cases. One such issue is the import of nonprofit status for applying antitrust law. This essay describes antitrust's role in addressing the consolidation in the hospital sector and the subtle influence that the social function of the nonprofit hospital has had in merger litigation. Noting that the political and social context …
The Residency Match: Competitive Restraints In An Imperfect World, Kristin Madison
The Residency Match: Competitive Restraints In An Imperfect World, Kristin Madison
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Several years ago physicians filed a lawsuit alleging that “the match,” the more than fifty-year-old system by which medical students and other applicants are assigned to medical residency programs, violates Section 1 of the Sherman Act. Last year, without hearings or substantive debate on the issue, Congress found that the match was “highly efficient” and “pro-competitive” and granted a retroactive antitrust exemption for its operation. These seemingly incompatible views invite further analysis of the merits of the residency match from the perspective of public policy. This article considers the arguments of match advocates and critics, evaluating both theoretical models and …
Mission, Margin, And Trust In The Nonprofit Health Care Enterprise, Thomas L. Greaney, Kathleen Boozang
Mission, Margin, And Trust In The Nonprofit Health Care Enterprise, Thomas L. Greaney, Kathleen Boozang
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The law governing charitable corporations remains neglected and thoroughly muddled. Still unsettled are central issues regarding the accountability of directors and management, legal standards governing organic changes by nonprofit institutions, and mechanisms to ensure fidelity to the organization's charitable mission. For nonprofit corporations in the health care sector, which represent a large proportion of all health services supplied nationwide, particularly charity care, these shortcomings have had serious repercussions. The central issue addressed in this Article is how fidelity to the mission of the charitable health care corporation should be monitored. It advances the normative perspective that the law should maximize …
Chicago's Procrustean Bed: Applying Antitrust Law In Health Care, Thomas L. Greaney
Chicago's Procrustean Bed: Applying Antitrust Law In Health Care, Thomas L. Greaney
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Antitrust enforcement in health care has undergone considerable buffeting in recent years with government agencies losing a string of important cases in federal court and support for vigorous enforcement waning among some policymakers. Critics of doctrinal development in antitrust law have begun to question whether the underlying economic relationships are accurately reflected in the law of antitrust as applied in health care. This article advances the positive claim that antitrust doctrine often suppresses pertinent features of the health care marketplace and urges courts and enforcers to pause before applying precedent and evidentiary rules of thumb that do not fit the …
Night Landings On An Aircraft Carrier: Hospital Mergers And Antitrust Law, Thomas L. Greaney
Night Landings On An Aircraft Carrier: Hospital Mergers And Antitrust Law, Thomas L. Greaney
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Abstract: Analysis of the competitive effects of hospital mergers requires antitrust tribunals to make exceedingly fine-tuned appraisals of complex economic relationships. The law requires fact finding in a number of complex areas, e.g., defining product and geographic markets, predicting the possibility of that firms will engage in coordinated behavior; and assessing efficiencies flowing from the merger. Further complicating the process is the fact that these decisions require judgments regarding what the future may hold in an industry undergoing revolutionary change. Like pilots landing at night aboard an aircraft carrier, courts are aiming for a target that is small, shifting and …
Regulating For Efficiency In Health Care Through The Antitrust Laws, Thomas L. Greaney
Regulating For Efficiency In Health Care Through The Antitrust Laws, Thomas L. Greaney
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The need to evaluate the competitive consequences of cooperation among rivals has long posed a dilemma for antitrust enforcement. Collaboration can reduce rivalry, raise prices and otherwise reduce consumer welfare; at the same time cooperation among rivals carries the promise of creating cost savings, correcting market failures and producing other benefits. In many cases antitrust doctrine requires a balancing of the positive and negative effects of coordination. In health care, federal antitrust enforcement agencies have increasingly turned to regulatory tools including policy statements, advisory opinions, speeches and regulatory decrees settling cases to strike this balance. However, the agencies have paid …
Managed Competition, Integrated Delivery Systems And Antitrust, Thomas L. Greaney
Managed Competition, Integrated Delivery Systems And Antitrust, Thomas L. Greaney
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A central question confronting proponents of managed competition during the health reform debate in 1994 was whether competitive networks or integrated delivery systems would emerge. Under reformers’ vision, controlling costs depended on the emergence of a sufficient number of efficient and viable integrated delivery systems. Conversely, if one or a few integrated networks dominate the market for physician or hospital services, rivalry on the main issues of health care cost control would likely dissipate. This article argues that vigilant and sensible antitrust enforcement was also a prerequisite for the success of the managed competition model. Despite the considerable emphasis on …
Quality Of Care And Market Failure Defenses In Antitrust Health Care Litigation, Thomas L. Greaney
Quality Of Care And Market Failure Defenses In Antitrust Health Care Litigation, Thomas L. Greaney
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This article considers quality-based justifications for antitrust challenges to collaboration among health care professionals. It first examines doctrinal developments resisting such justifications and, with a skeptical eye, analyzes attempts to interject quality of care and worthy motive defenses into antitrust appraisals of horizontal restraints of trade. Next the article assesses the economic basis and the risks and benefits of a market failure defense that would allow some quality-enhancing restraints of trade to escape antitrust challenge. Its principle recommendation is that courts recognize a narrow, market failure defense subject to several limiting principles to cabin its reach. The article concludes by …