• A Case for Randomized, Double-Blinded, Sham-Controlled Class III Medical Device Trials

      Wright, Megan (2016-07-06)
      In this paper, I evaluate the ethical implications of the FDA’s move to en-courage randomized, double-blinded, sham-controlled trials for Class III devices when such studies are possible. In Part I, I describe the placebo effect and how researchers control for it. In Part II, I describe the results of studies of medical procedures and devices that have used a sham control. In Part III, I de-scribe the ethical concerns surrounding the use of sham surgeries to study medical devices. In Part IV, I argue for the use of randomized, double-blinded, sham-controlled device trials, and propose an ethical framework for these studies.
    • A Circuit-Splitting Headache: The Hangover of the Supreme Court's Twenty-First Amendment Jurisprudence

      Schnabel, Timothy (2015-11-12)
      Bridenbaugh v. Freeman-Wilson, 227 F.3d 848 (7th Cir. 2000). Bainbridge v. Turner, 311 F.3d 1104 (11 th Cir. 2002). In recent years, many small wineries have taken advantage of the Internet as a sales tool, creating challenges to existing state laws that prohibit the direct shipment of alcohol to consumers. Were these businesses shipping nearly any other product, the constraints of the "dormant Commerce Clause" of the federal constitution would prevent states from regulating such transactions. The Twenty-first Amendment, however, grants the states unique powers when the object of regulation is alcoholic beverages. The extent to which this grant creates an exception to the dormant Commerce Clause, along with the manner in which that exception may be used, has been the subject of two recent cases in the Seventh and Eleventh Circuits. In Bridenbaugh v. Freeman- Wilson, the Seventh Circuit upheld an Indiana law prohibiting the direct shipment of alcohol to Indiana consumers by anyone in the business of selling alcohol in another state or country. Yet shortly thereafter in Bainbridge v. Turner, the Eleventh Circuit explicitly rejected the Seventh Circuit's approach and greatly limited the scope of Florida's regulatory powers under the Twenty-first Amendment. This circuit split has important implications for both oenophiles and federalists, and may occasion a Supreme Court decision that clearly shows the effect on national policy of that Court's changing composition.
    • A Comparison of Initial Recommendation Procedures: Judicial Selection Under Reagan and Carter

      Fowler, W. (2015-09-30)
      Reforming the judicial selection process has long stirred the interests of lawyers, politicians, bar associations, professors, and judges. Since the passage of the Omnibus Judgeship Act of 1978 and its creation of 152 new federal court positions, interest in reform has increased dramatically. Reforms in judicial selection have focused on the initial recommendation process. Thus, reformers have questioned the basis of senatorial power in judicial selection: the custom of senatorial courtesy that allows a senator of the President's party and of the nominee's home state to select candidates and to block unacceptable nominees for district and circuit court positions. These reforms have advocated the use of screening panels or "merit panels" in federal judicial selection.
    • A Conference at the Yale Law School March 25 and 26, 1988: Editor's Note

      2015-10-12
      The following pages contain selected remarks from the conference, The Fair Housing Act After Twenty Years, held at the Yale Law School on March 25 and 26, 1988.
    • A Contractual Solution to the Contraceptive Crisis

      Bernsteint, David (2015-10-15)
      Over the last decade or so, there has been an explosion in litigation involving claims that certain pharmaceutical products cause birth defects. This litigation has dealt a major blow to the contraceptive industry in general, and in particular to efforts to research and develop a new generation of safer and more effective contraceptives.
    • A Conversation with Justice Stevens

      Stevens, John; Greenhouse, Linda (2015-12-11)
      GREENHOUSE: Let me start out by quoting you, Justice Stevens. You've said many times that "learning on the job" was an important part of your long tenure. You were already an experienced federal judge by the time you got to the Court at the age of fifty-five, but things looked different by the end of your tenure than they had seemed at the beginning, so I wanted to give you a chance to reflect on some of what that learning consisted of. STEVENS: Well, the answer to that question would be rather long. But it's true: Every judge learns on the job. Every good judge learns on the job, that is. Your comment makes me think a little bit about the confirmation process, and when I went through the process, Ed Levi, who was the Attorney General, didn't give me any advice on how to answer questions, and neither did anyone else in the White House.
    • A Critical Look at the National Drug Control Strategy

      Skolnick, Jerome (2015-10-15)
      In September 1989, the Bush Administration published its drug control policy document, the National Drug Control Strategy, prepared under the direction of William J. Bennett, Director of the Office of National Drug Control Policy. As a study of the appropriate responses to the nation's drug problem, the Strategy is an important, well-reasoned, and engagingly written document. It acknowledges the importance of treatment and education strategies as responses to the American drug problem. While it does not deny the limitations of international and other law enforcement initiatives, the Strategy's primary message advocates an "unprecedented" expansion of police, prisons, prosecutors, courts, and interdiction -much more of the same, evidently on the theory that we have been losing the war on drugs because of a lack of resolve.
    • A Decade of Making Dreams into Reality: Lessons from the I Have A Dream Program

      Coons, Christopher; Petrick, Elizabeth (2015-10-16)
      Ten years ago, Eugene Lang startled a graduating class of East Harlem sixth-graders by promising to pay for their college educations. He had been advised by their principal that most of the students would drop out before completing high school; Lang hoped the tuition promise would motivate them to stay in school. But Lang soon discovered he needed to provide more than money to make the distant prospect of college a reality for his students, whom he called "Dreamers." To augment his promise, Lang rented a meeting space and hired Johnny Rivera, a young caseworker with a neighborhood social service organization, to coordinate support services for the Dreamers and their families. Over the next ten years, Lang and Rivera worked closely with the students, as mentors and motivators. Most importantly, they built caring, personal relationships with their Dreamers. The original inspiration of the scholarship promise, combined with a decade of guidance and support, produced striking results.
    • A Derivative Right to Education: How Standards- Based Education Reform Redefines the Individuals with Disabilities Education Act

      Dannenberg, Michael (2015-11-03)
      More than twenty years ago, the Individuals with Disabilities Education Act (IDEA) promised disabled children they would receive a "free appropriate public education" in regular classrooms with non-disabled children whenever possible-a minimally adequate education and access to an integrated school setting. The Supreme Court undermined the first half of that promise in 1982, interpreting an "appropriate" or minimally adequate education primarily as one that is reasonably calculated to confer "some educational benefit." It is a standard even the poorest classroom arguably meets.
    • A Dual Approach to Contract Remedies

      Knobler, Michael (2015-12-11)
      Numerous disagreements in contract law stem from the answer to a straightforward definitional question: What is a contract? Is it a mutual commitment to perform, or is it merely a promise to deliver the agreed-upon performance or pay damages, with each choice treated as equally acceptable? Is a contract about the right to obtain an agreed-upon good or service at a given time, or is it about the right to obtain an agreed-upon value at a given time?
    • A Federal Cause of Action Under Superfund: Case Management Considerations

      Freeman, Alison (2015-10-02)
      In 1978 the area of Love Canal, New York, became a focal point of media attention. The homes and schools of Love Canal, it was discovered, had been built on land contaminated by hazardous wastes and residents of the area were suffering from debilitating illnesses due to exposure to the wastes. Publicity of this specter of disease provoked widespread concern regarding the existence of other toxic waste disposal sites and the effects of hazardous wastes on health and the environment. The most significant legislative response to these concerns was the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or "Superfund").
    • A History of British Regional Policy in the 1970s

      Howarth, David (2015-10-02)
      There are many studies which purport to show whether the regional policy of a particular country at a particular time was or was not "efficient," or "effective" or even "rational." This study, however, is not concerned with technical economic analysis, which the writer prefers to leave to economists, but with a simpler, though perhaps less empowered question of politics: What exactly was British regional policy during the 1970s?
    • A Limited Defense of Clinical Placebo Deception

      Kolber, Adam (2015-12-01)
      Placebo treatments, like sugar pills and saline injections, are effective in treating pain and perhaps a host of other conditions. In fact, recent neuroimaging studies show that the pathways of placebo pain relief in the brain largely overlap the pathways of pain relief from drugs like morphine.1 Placebos are also cheaper and safer than corresponding active medications. To most effectively use placebos to diagnose and treat patients in clinical practice, however, doctors must deceive patients as to the placebo nature of the intervention. Such deception runs counter to a fifty-year trend in medical ethics and health law that emphasizes patient autonomy and requires doctors to disclose the nature of a proposed intervention in order to obtain patients' informed consent.
    • A Modern WPA: A Proposal to Empower Our People and Rebuild Our Country

      Boren, David (2015-10-20)
      The current welfare system defies common sense and good judgment. It manages to cheat both the taxpayers and those it is supposed to help. Taxpayers resent supporting an overly expensive, inefficient system with very few tangible benefits in return for what they pay. At the same time, poor Americans, who rely on the welfare system for support and hope, are becoming increasingly alienated from mainstream American society. Denied the self-esteem that comes from performing useful work, welfare beneficiaries are left with no hope and little motivation to achieve. Many commentators believe that idleness encouraged by the current welfare system contributes to increased crime rates, family disintegration, higher school dropout rates, and many other serious social problems.
    • A Paradox of Spontaneous Formation: The Evolution of Private Legal Systems

      Aviram, Amitai (2015-11-13)
      Scholarship on private legal systems (PLSs) explains the evolution of norms created and enforced by PLSs but rarely addresses the evolution of institutions that form PLSs. Such institutions are assumed to form spontaneously (unless suppressed by law) when law fails, neglects, or chooses not to direct behavior in a welfare-maximizing manner.
    • A Perspective on Federalism and Medical Malpractice

      Blumstein, James (2015-11-03)
      This Article develops an analytical framework by which to assess the appropriate federal role in medical malpractice. It identifies a set of non exhaustive criteria for federal involvement, including: (1) Is there a need for uniformity across states? (2) Are there overriding national interests? (3) Is there consensus on identification of the problem and on the range of potential solutions? (4) Are states actively considering or dealing with the issue? (5) Is there a special federal comparative advantage in addressing the issue? On the basis of these various criteria, I establish a continuum of potential federal involvement and suggest some particular areas appropriate for a constructive federal role.
    • A Political Process Argument for the Constitutionality of Student-Led, Student-Initiated Prayer

      Cronan, John (2015-11-06)
      Doe v. Santa Fe Independent School District, 168 F.3d 806 (5th Cir. 1999), cert. granted, 60 U.S.L.W. 3079 (U.S. Nov. 15, 1999) (No. 99-62). Justice William O. Douglas's words, written nearly 40 years ago, demonstrate the constitutional tightrope on which religion walks. From the inscription, "In God We Trust," on our currency to the words of the presidential oath, it is hard to dispute that religion permeates many aspects of American society. The critical inquiry, however, ponders whether religious exercise represents constitutionally protected free exercise or constitutionally condemned government endorsement. The Supreme Court has performed this inquiry with respect to religion's presence in a myriad of areas, including school graduation ceremonies, legislative sessions, tax status, tuition rebates, and city- sponsored displays. In Galveston, Texas, religion recently made its way into a new and unexpected locale, the high school football field.
    • A Progressive Creed: The Experimental Federalism of Justice Brandeis

      Steiner, E. (2015-09-30)
      As Alexander Bickel predicted in 1970, the doctrine of experimental federalism espoused by Justice Brandeis in New Slate Ice Co. v. Leibmann is exhibiting new vigor throughout the American legal community. Citations to this famous dissent are no longer confined to U.S. Supreme Court dissents, as they were during the Warren Court era. Instead, they have emerged in Burger Court majority opinions, as well as in concurrences and dissents. Further, Brandeisian localism has been brought to the attention of a growing number of lower federal and state appellate courts. Growing judicial interest has been mirrored by an increasing scholarly attention to "the still exciting idea . that states are laboratories for experimentation."
    • A Proposal for Democratically Financed Congressional Elections

      Jezer, Marty; Kehler, Randy; Senturia, Ben (2015-10-21)
      Ever since 1905, when President Theodore Roosevelt proposed to Congress that "[a]ll contributions by corporations to any political committee or for any political purpose should be forbidden by law," American political reformers have been proposing to break the bond between special-interest money and electoral politics by regulating the way candidates raise money to campaign for elective office. Since Teddy Roosevelt's call, Congress has passed no fewer than twelve different bills to reform the campaign finance system. The first of these bills, the Tillman Act of 1907, was a direct result of Roosevelt's effort. It sought to prohibit campaign contributions from corporations. In addition to offering no provisions for enforcement, the Act nullified the intent of its prohibition against corporate contributions by allowing individual contributions from corporate stockholders and executives.
    • A Review of Lani Guinier's The Tyranny of the Majority

      Marshall, Burke (2015-10-22)
      Lani Guinier, The Tyranny of the Majority: Fundamental Fairness in Representative Democracy. Free Press, 1994. Pp. 508, $24.95 Almost thirty years ago, after three insufficient runs at the problem in 1957, 1960, and 1964, the Congress of the United States overwhelmingly approved a comprehensive federal law designed to eradicate racial discrimination in voting. The Voting Rights Act of 1965 was radical, in federalism terms. It superseded basic state law in many respects, providing for direct federal supervision, indeed implementation, of the process of registration and voting in numerous localities, and required preclearance by the Justice Department, or a court, of changes in laws affecting voting rights in jurisdictions deemed by a statistical yardstick, without any other proof, to have engaged in racial discrimination in the process. The Act was directed in the first instance at voter registration, through control of which hundreds of thousands of African-Americans had been denied by state officials any entry at all into politics. It had an almost immediate impact, resulting in the registration of thousands for the 1966 and 1968 elections, particularly in the States of the Deep South. Over a period of time this surge in registration combined with other factors to cause a stunning increase in the election of black officials to local and federal offices, from a few hundred in 1965 to over 8,000 by 1994, including thirty-nine members of the House of Representatives.