Martin H. Redish

Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection

When the Food and Drug Administration (FDA) authorizes the marketing of a new drug or medical device, the license reflects the FDA’s review of data and information relating to uses specified by the manufacturer and set forth in agency-approved labeling. Authorized products are often used “off-label,” i.e., for purposes other than those for which they are labeled. However, such uses are legal. Indeed, “off-label” use can be standard medical practice. Despite this undisputed fact, in most instances the FDA prohibits manufacturers from promoting such off-label uses, even to members of the medical profession. In short, the FDA prohibits the speech, even though the activity promoted is perfectly legal and the speech is neither false nor misleading. In this article, we seek to accomplish two goals: (1) to explore the political and administrative dynamics underlying the evolution of the FDA’s policy towards off-label promotion, and (2) to test that policy by reference to both controlling commercial speech jurisprudence and the underlying values of the First Amendment’s guarantee of free expression. We conclude that the FDA’s prohibition of off-label promotion is the product of a complex set of political factors. We further conclude that not only is the FDA’s policy towards manufacturers’ promotion of off-label use unambiguously inconsistent with well established Supreme Court doctrine on commercial speech, it also contravenes core precepts of democratic theory that provide the normative foundation for the constitutional protection of free expression.

Electronic Discovery and the Litigation Matrix

The impact of the technological revolution on the operation of the discovery system in the federal courts has been dramatic. The enormous increase in storage capacity and communication that the use of computers in the corporate world has brought about has correspondingly increased both the burdens and stakes of the discovery process. This Article considers the extent to which these dramatic practical changes have created a need to develop a legal framework especially for the discovery of electronically stored information. Because the burdens of electronic discovery are likely to be substantially more severe than those involved in traditional discovery, the drafters of the Federal Rules of Civil Procedure or the courts should adopt a conditional cost-shifting model solely for use in the electronic discovery context. Ultimately, the model must be informed by the deep structural values underlying the litigation system. Copyright

The adversary First Amendment : free expression and the foundations of American democracy

The Adversary First Amendment presents a unique and controversial rethinking of modern American democratic theory and free speech. Most free speech scholars understand the First Amendment as a vehicle for or protection of democracy itself, relying upon cooperative or collectivist theories of democracy. Martin Redish reconsiders free speech in the context of adversary democracy, arguing that individuals should have the opportunity to affect the outcomes of collective decision-making according to their own values and interests. Adversary democracy recognises the inevitability of conflict within a democratic society, as well as the need for regulation of that conflict to prevent the onset of tyranny. In doing so, it embraces pluralism, diversity, and the individual growth and development deriving from the promotion of individual interests. Drawing on previous free speech scholarship and case studies of controversial speech, Redish advances a theory of free expression grounded in democratic notions of self-promotion and controlled adversary conflict, making a strong case for its application across such areas as commercial speech, campaign spending, and anonymous speech.

Private Contingent Fee Lawyers and Public Power: Constitutional and Political Implications

A dangerous trend has developed in the litigation of state civil damage claims brought against private individuals and entities: the state’s use of private contingent fee lawyers, who are compensated based on a percentage of the amount recovered. As is the case when contingent fee lawyers represent private clients, if the state loses the litigation the lawyers recover nothing. While such an arrangement arguably has much to recommend it in the case of purely private litigation, when employed by the state it threatens core precepts of American political and constitutional theory. Because, unlike private litigants, the state wields potentially dominating power over private society, those exercising the state’s legal power are obligated by democratic and constitutional principles, as well as the dictates of legal ethics, to assess and pursue the public interest without direct concern for personal or private gain. When private contingent fee attorneys are vested with authority to vindicate the interests of the state through litigation, with their compensation determined solely on the basis of the ultimate amount of damages recovered, society is presented with an ominous mixture of public power and private motivation, effectively leaving us with the worst of all possible worlds. Fundamental ethical principles, as well as constitutional dictates limiting state power, are threatened by such an arrangement.

Response: Good Behavior, Judicial Independence, and the Foundations of American Constitutionalism

The so-called Good Behavior Clause of Article III could well be the most mysterious provision in the United States Constitution—and that, of course, is really saying something. While constitutional text was on occasion chosen for the very purpose of avoiding the resolution of, rather than resolving, disputes, and while ambiguity permeates many of the most famed and controversial provisions, rarely are a provision’s purpose, scope, and methodology so totally nonexistent to the naked eye.