The Expressive Cost of Corporate Immunity
Gregory M. Gilchrist
Volume 64, Issue 1, 1-57
Is it possible to justify imposing criminal liability on corporations? Two basic aspects of criminal law have no application to corporations: Corporations cannot be jailed and they cannot form mental states. Moreover, there is reason to think that much of the deterrent effect generated by corporate criminal liability could be generated more efficiently by civil liability. Still, the demand for criminal prosecution of corporations remains high. This Article seeks to understand why we have corporate criminal liability, and it concludes that expressivism is necessary to justify the practice. Expressivism justifies punishment by reference to the benefits of a statement of moral condemnation. With regard to corporations, however, the power of expressivism is strongest in the absence of liability. While there may be some expressive benefit to holding corporations criminally liable, the expressive cost of excluding corporations from criminal law altogether is the real driving force in justifying corporate criminal liability: Immunity presents a materially harmful expression. This expressive cost of immunity justifies holding corporations criminally liable. Of course, just because it is possible to justify corporate criminal liability by reference to the expressive cost of immunity, it does not necessarily follow that the current practice of prosecuting corporations serves this end well. There are reasons to think it does not, but the relationship between expressivism and corporate criminal liability suggests a fruitful path toward reimagining how and when corporations ought to be subject to criminal liability. The path to reform will be the subject of a subsequent article; this Article lays the theoretical groundwork for reform.
Understanding and Incentivizing Biosimilars
Jason Kanter and Robin Feldman
Volume 64, Issue 1, 57-83
Congress recently passed the Biosimilars Act in an attempt to replicate the success that generic small molecule drugs have enjoyed under the Hatch-Waxman Act. The Biosimilars Act provides a pathway for biosimilars to achieve quicker and less expensive FDA approval than what is required for a new biopharmaceutical. There is, however, greater uncertainty and cost associated with achieving the coveted biosimilarity status. This reflects the complex production methods of biopharmaceuticals, along with the many factors that can alter the structure and function of such drugs.
This Article analyzes the Biosimilars Act and the draft guidances recently released by the FDA. The Article identifies areas of uncertainty and other aspects of the current regime that create disincentives for the development of biosimilars, as well as suggesting improvements. If we are serious about reducing the price of biological drugs and encouraging the creation of biosimilars, we will need to develop a more effective pathway for approval. This is no easy task. The greater risks associated with the production of biosimilars should prompt a fair degree of caution in establishing the pathway for approval. Balancing consumer safety with appropriate market incentives is a delicate mission. Nevertheless, under the current regime, we risk the possibility that companies will focus on developing so-called biodifferents and biobetters (new drugs designed to mimic an existing biological drug), completely forgoing the opportunity to develop biosimilars.
The loser, of course, is the consumer. It is doubtful that biobetters and biosimilars will have the same price-lowering effects as generics. These drugs will be patented, creating full exclusivity in the market, and prices will remain high in the biological drug space. It would be unfortunate if the tremendous energy and creativity invested in designing and implementing the Biosimilars Act were to have very little effect in the long run.
Going Rogue: Stop the Beach Renourishment as an Object of Morbid Fascination
Mary Doyle and Stephen J. Schnably
Volume 64, Issue 1, 83-140
Scholarly response to the Supreme Court’s decision in Stop the Beach Renourishment, Inc. v. Florida Department of Environmental Protection has focused on the plurality’s strong advocacy of a judicial takings doctrine. We take a different tack. While the concept of judicial takings is worthy of serious attention, it is wrong to treat the plurality opinion as an ordinary object of analysis. It is, instead, the emanation of a Court going rogue.
Three basic symptoms of the pathology stand out. First, sleight of hand: The plurality opinion purports to be about an institutional issue—can a state court commit a taking?—while slipping in a major rewrite of takings law that would undermine the Court’s recent, unanimous effort to clarify it. Second, feigned obliviousness: The plurality opinion conveniently overlooks the Court’s federalism jurisprudence even as it would expand the federal courts’ power over state law. Third, knowing artlessness: Despite being written as a virtuoso performance—identifying a case the Florida Supreme Court “overlooked”—the plurality’s treatment of state law betrays surprising naïveté as to how state law is made, though, as it turns out, this seeming naïveté serves the purpose of shifting power within states from legislatures to courts.
While the history and tone of Justice Scalia’s close attention to beach access issues makes pique a surprisingly strong candidate for why the plurality went rogue, the more worrying explanation is the willingness of the Court’s more conservative members to expand their own power into new areas of state law without the slightest sign of support from the political branches. There is a danger that conservative attacks on courts over decisions on controversial social issues will distract from a more basic problem: If the Court’s enforcement of federalism rests on what Justice O’Connor called Congress’s “underdeveloped capacity for self-restraint,” we suggest that commentary should focus on the Court’s own similarly underdeveloped capacity.
Wrong About the Right: How Courts Undermine the Fair Cross-Section Guarantee by Confusing It with Equal Protection
Nina W. Chernoff
Volume 64, Issue 1, 141-200
This Article exposes a surprising doctrinal distortion that has unfolded since the Supreme Court first established the Sixth Amendment standard for the right to a jury selected from a fair cross-section of the community. A significant number of courts are erroneously applying the test for a violation of the Fourteenth Amendment’s equal protection guarantee to Sixth Amendment claims. As a result, criminal defendants are being deprived of the unique Sixth Amendment fair cross-section right, which encompasses more than just protection from discrimination.
Under the Sixth Amendment, a defendant need not allege that any state actor discriminated in the jury selection process. Instead, a defendant can establish a prima facie violation by showing that the underrepresentation of a distinctive group in the jury pool is inherent in the selection process, whether by accident or design. The equal protection clause, in contrast, demands evidence of discriminatory intent.
This Article reveals that at least ten federal circuits and nineteen states have erroneously denied defendants’ Sixth Amendment claims for failure to satisfy the Fourteenth Amendment’s discrimination requirement. This Article also uses an original survey of federal and state cases to explore the potential scope of the problem. In over one-third of the relevant cases, courts denied defendants’ fair cross-section claims for failing to meet equal protection standards.
In contrast to scholarship arguing that the underpinnings of the fair cross-section standard need to be revisited, this Article asserts that the key to enforcing the cross-section guarantee is not to change the standard, but to apply it consistently with the Sixth Amendment and Supreme Court doctrine.
Diversity May Be Justified
Volume 64, Issue 1, 201-256
What about diversity as a rationale for affirmative action is compelling enough to justify the hurts it inflicts on individuals? Judges, legislators, public opinion, and implementers of diversity programs in education and the workforce have defended their initiatives either with vague, anodyne, ill-founded paeans or, more often, with silence about what the rationale achieves. They have offered no justification of diversity.
From the premise that any state action that generates (or even risks) harm must be supported with reason, this Article undertakes the task of justification. What makes diversity unique among the rationales for affirmative action, this Article argues, is its power simultaneously to achieve two social goods—the repair of subordination and the strengthening of pluralism—that rest on independent and mutually constitutive jurisprudential bases.
Note – The Right to Be Forgotten
Robert Kirk Walker
Volume 64, Issue 1, 257-286
Information posted to the Internet is never truly forgotten. While permanently available data offers significant social benefits, it also carries substantial risks to a data subject if personal information is used out of context or in ways that are harmful to the subject’s reputation. The potential for harm is especially dire when personal information is disclosed without a subject’s consent. In response to these risks, European policymakers have proposed legislation recognizing a “right to be forgotten.” This right would provide persons in European Union countries with a legal mechanism to compel the removal of their personal data from online databases.
However, only a limited form of the right to be forgotten—a right to delete data that a user has personally submitted—would be compatible with U.S. constitutional law. By itself, this limited right is insufficient to address the myriad privacy issues raised by networked technologies, but it is nevertheless an essential component of a properly balanced regulatory portfolio—as existing privacy tort law is inadequate in this context. As such, this Note argues that Congress should recognize this limited right through adoption of a default contract rule where an implied covenant to delete user-submitted data upon request is read into website terms of service contracts.