NewYorkUniversity
LawReview

Notes

2018

An Adverse Reaction: FDA Regulation of Generic Drug Labeleing

Mitchell Russell Stern

Thanks to a streamlined approval process under the 1984 Hatch-Waxman Act, generic drugs have largely helped make prescription medications in the United States more affordable by providing an essentially identical product at a lower price. While generics may appear to be a perfect substitute for brand-name pharmaceuticals, consumers injured by prescription drugs may encounter an unexpected difference: because federal regulations severely restrict the ability of generic manufacturers to unilaterally update their warning labels, the Supreme Court has held that many products liability claims against generic manufacturers are pre-empted. At the same time, the Court has held that identical claims against brand name manufacturers remain viable. In response, the Federal Food and Drug Administration (FDA) has recently proposed a rule that would purportedly “fix” this asymmetry by allowing generic manufacturers to make labeling changes without prior FDA approval, even if it results in a brand-name drug and its generic “equivalent” bearing different warning labels.

This Note argues that the FDA’s response, while well intentioned, loses the forest for the trees by overvaluing compensation for injured consumers at the expense of low-cost generic drugs and accurate, consistent information for consumers. Instead, both the Agency and consumers injured by generic drugs should focus on discrepancies that already exist—that violate FDA regulations—between generic and brand name labels. Such cases not only present an information problem that should be corrected, but they may also provide a viable avenue for litigating products liability claims. While there is currently a circuit split on the issue, this Note explains why these failure-to-update claims should not be preempted. Moreover, given that such differences may occur in a majority of generic drug labels, these claims offer the possibility of recovery for a significant number of consumers.

Resegregation and Nonparty Preclusion

Steven D. Marcus

A discriminatory school district is sued, placed under court supervision, remedies the discrimination, and is released from court supervision. What next? There is a growing, and worrisome, trend towards the resegregation of schools following their release from supervision. While the problems of resegregation have recently drawn attention among social scientists and journalists, the procedural hurdles to litigating a claim of resegregation remain largely unexamined. Indeed, certain procedural hurdles could greatly impede litigation to challenge resegregation. This Note examines the defense of preclusion in the resegregation context, and concludes that in two categories of cases—pre-1966 class actions, and post-1966 “implied” class actions—school districts cannot rely on preclusion to defeat an action challenging resegregation. The first category, pre-1966 class actions, were filed before the 1966 Amendments to Rule 23, which provide greater procedural protections to ensure adequate representation. The second category, implied class actions, were filed after the 1966 amendments, never formally certified as class actions, but informally treated as such by courts. Because many pre-1966 class actions and post-1966 implied class actions do not provide the procedural protections to satisfy the constitutional requirement for adequate representation, judgments releasing school districts from court supervision cannot properly bind future plaintiffs challenging resegregation.

Reconciling Rational-Basis Review

Raphael Holoszyc-Pimentel

When Does Rational Basis Bite?

Traditionally, rational-basis scrutiny is extremely deferential and rarely invalidates legislation under the Equal Protection Clause. However, a small number of Supreme Court cases, while purporting to apply rational-basis review, have held laws unconstitutional under a higher standard often termed “rational basis with bite.” This Note analyzes every rational-basis-with-bite case from the 1971 through 2014 Terms and nine factors that appear to recur throughout these cases. This Note argues that rational basis with bite is most strongly correlated with laws that classify on the basis of an immutable characteristic or burden a significant right. These two factors are particularly likely to be present in rational-basis-with-bite cases, which can be explained on both doctrinal and prudential grounds. This conclusion upends the conventional wisdom that animus is the critical factor in rational basis with bite and reveals that other routes to rational basis with bite exist. Finally, this Note observes that applying at least rational basis with bite to discrimination against gay, lesbian, bisexual, and transgender individuals is consistent with the pattern of cases implicating immutability and significant rights.

Good for the Gander, Good for the Goose

Gabriel Ascher

Extending the Affordable Care Act Under Equal Protection Law to Cover Male Sterilization

The Affordable Care Act requires coverage for female but not male sterilization, a disparity that this Note refers to as the Sterilization Gap. Although female sterilization is more dangerous, more expensive, and less effective than male sterilization, the Sterilization Gap incentivizes women to be sterilized rather than men. This Note argues that sterilization coverage should be extended to men. Because courts are empowered to extend underinclusive laws—like that which creates the Sterilization Gap—if they find them unconstitutional, litigation may be the best method of extending coverage. This Note presents a comprehensive argument for why the Sterilization Gap is unconstitutional and coverage should be extended. First, it argues that the Sterilization Gap is a facial sex classification because both sexes can be sterilized, even though the procedure is sex specific. Next, it argues that the classification violates constitutional equal protection law, because it is not based on a biological difference and does not remedy discrimination against women. Then, it argues that the classification was created either through impermissible oversight or gender stereotypes, and that it will perpetuate the stereotype that contraception is a woman’s responsibility, to the detriment of both sexes. Finally, it concludes by asserting that had Congress known that the Sterilization Gap was unconstitutional, it would likely have chosen to extend coverage to men rather than nullify the law, because extension would further its goals while causing comparatively little disruption to the statutory scheme.

First Amendment Limitations on Police Surveillance

Matthew A. Wasserman

The Case of the Muslim Surveillance Program

This Note focuses on a single example of targeted domestic surveillance: the “Muslim Surveillance Program” of the New York City Police Department. In considering the constitutionality of the program, this Note attempts to articulate a general legal framework for regulating police surveillance targeting religious and political minorities. Part I discusses the Muslim Surveillance Program and its chilling effects on speech and association. Part II covers questions of standing, concluding that at least some plaintiffs have standing to challenge this program and similar programs of targeted surveillance. Finally, Part III assesses the legality of the program, arguing that while this surveillance is unregulated by the Fourth Amendment, it is subject to First Amendment challenge. The Note argues that a “First Amendment criminal procedure” could fill the gaps in Fourth Amendment coverage by providing for the protection of expressive behavior that is likely chilled by targeted police surveillance. Using the First Amendment to regulate domestic surveillance would require an extension of current case law, but would be a vindication of the central First Amendment value of protecting minority viewpoints, as well as the fundamental principles underlying Fourth Amendment jurisprudence, such as the right to privacy.

Why Shouldn’t We Protect Internal Whistleblowers?

Andrew Walker

Exploring Justifications for the Asadi Decision

What kind of whistleblowing should the Dodd-Frank Act protect? In Asadi v. G.E. Energy (USA), L.L.C., the Fifth Circuit held that Dodd-Frank’s antiretaliation provisions extend only to whistleblowers who report information externally, an interpretation of the statute that leaves “internal whistleblowers” unprotected. At first glance, such a ruling, by minimizing protection for whistleblowers, appears likely to result in negative consequences. This Note argues, however, that the Fifth Circuit put forward a rule that not only rests upon a legitimate interpretation of the Dodd-Frank Act but that also may have positive real world consequences. Such consequences, this Note argues, include better channeling of information to the SEC, incentivizing a stronger “tone at the top” within corporations, and minimizing opportunities for corporations to mask wrongdoing.

Failed Snitches and Sentencing Stitches

Shana Knizhnik

Substantial Assistance and the Cooperator’s Dilemma

The “substantial assistance” provisions of the U.S. Sentencing Guidelines dominate the practice of modern federal criminal law. This primary mechanism by which criminal defendants who provide valuable information to federal prosecutors are compensated for their cooperation—namely, in the form of a sentence either below the calculated Guidelines sentencing range or, more significantly, below any mandatory minimum—has created a system where defendants are incentivized to incriminate themselves and as many others as possible, all without any guarantee that their cooperation will actually result in a lesser sentence. This Note explores the operation of this provision; the consequent “cooperator’s dilemma” it creates for defendants considering cooperation; and the unreliable, unfair, and unethical results it generates. It offers a novel incremental solution: an intermediate departure provision called “good faith cooperation,” whereby defendants who have attempted to cooperate but do not obtain substantial assistance motions can move to receive sentences below guidelines ranges and mandatory minimums on the basis of their attempted assistance. This provision provides a politically feasible option for legislators and commissioners that addresses multiple concerns regarding the current system without entirely upending the practice of federal criminal law as it exists.

Support with a Catch

Mikayla K. Consalvo

New York’s Persons in Need of Supervision and Parental Rights

When parents find they can no longer control their children—they are skipping school, staying out past curfew, and even getting in trouble with the police—what can they do? That answer depends, of course, on what types of resources are available to them. For unprivileged parents in New York State, the answer is often Persons in Need of Supervision (PINS). Intended to be a tool for parents in these situations that avoids exposing children to the criminal justice system, enlistment in PINS has become a “risky resource” to parents. In exchange for the support of county diversion programs offered by PINS, parents relinquish the control they have over their children’s lives. This is not required to happen through affirmative and fully informed waivers of their control, even though parents’ rights are afforded constitutional protection. Instead, parents are assumed to implicitly waive their right to raise their children by filing a request for PINS services. This Note argues that this system is out of line with Supreme Court precedent defining and outlining parents’ substantive due process rights and has serious consequences for children and their families. To remedy these constitutional and policy-based issues, this Note proposes that New York cease treating PINS petitions as implicit waivers of parental control. Though certainly not a complete fix for all concerns that arise from the PINS system, this solution would at least partially correct the imbalance between parents and the state under the PINS regime.

Routine Emergencies

Adrienne Lee Benson

Judicial Review, Liability Rules, and the Habeas Corpus Act of 1863

A national security emergency justifying the elimination of full judicial review and remedies for executive action is often analyzed as an exceptional, distinctive challenge to the rule of law. However, the possibility of irreparable harm frequently supports bypassing judicial procedures in more pedestrian peacetime law, such as an exigent-circumstances exception to the Fourth Amendment’s warrant requirement or a preliminary injunction to avoid irreparable harm before a trial on the merits. While the scale may be different in national security crises, the problem is the same: how to maintain the rule of law when the traditional procedures and remedial doctrines of a reviewing institution may be ill-suited for avoiding irreparable harm in the time required for judicial review.

This Note uses the immunity provisions of the Habeas Corpus Act of 1863—in which Congress explicitly eliminated legal remedies during the greatest national crisis of American history—to illuminate the broader principles behind the availability of judicial remedies in exigent circumstances. In “routine” exigencies, such as a request for a preliminary injunction or exceptions to the warrant requirement, a shortcut around full procedure for the determination of rights and duties is permitted subject to the availability of judicial review after the intervention, and, often, compensation. The immunity provisions of the Habeas Corpus Act of 1863 cut off both of these remedial functions. Such immunities defeat the compensation purpose of remedies unnecessarily; as remedies in “routine” emergency interventions demonstrate, the compensation and judicial review functions need not always result in deterrence of executive action in a crisis. Immunity provisions such as those in the Act also hinder the development of the law and increase uncertainty for future actors and their possible future victims, even outside emergency situations. This Note argues that the best approach to judicial review in national security crises is not to eliminate remedies entirely, as the Habeas Corpus Act attempted to do, but to “code-switch” from a regime of property rules to a regime of liability rules in order to preserve victim compensation and the rule of law.

Pennoyer’s Ghost

Kevin D. Benish

Consent, Registration Statutes, and General Jurisdiction After Daimler AG v. Bauman

This Note evaluates general personal jurisdiction based on a “consent-by-registration” theory, arguing that this old basis of jurisdiction is unconstitutional after Daimler AG v. Bauman. Daimler overturned nearly seventy years of law on general jurisdiction, and in doing so provoked the return to a basis of jurisdiction dating back to Pennoyer v. Neff, with plaintiffs arguing that foreign corporations “consent” to general jurisdiction when they register to do business in states outside their place of incorporation or principal place of business. But Pennoyer is dead. Thus, the question is whether Pennoyer‘s ghost provides a constitutional basis for general jurisdiction, even after Daimler‘s severe limitations of it.