NewYorkUniversity
LawReview

Notes

2018

Excessive Pricing of Off-Patent Pharmaceuticals: Hatch It or Ratchet?

Jennifer L. Graber

There is growing concern over the pharmaceutical industry’s ability to set and raise drug prices as it sees fit. The price of a drug that has not been protected by a patent for decades can suddenly increase—or “ratchet”—as much as 10,000%. This Note identifies the problem of ratcheting drug prices and considers whether these abrupt changes in drug prices derive from a longstanding problem inherent in the United States’ pharmaceutical regulatory regime. It then considers the most commonly suggested mechanism for countering high drug prices—stimulating competition in the pharmaceutical market—but ultimately concludes that focusing solely on increasing competition constructs an overly simplistic view of ratcheting drug prices. In order to find an effective solution to unexpected increases in drug prices, this Note evaluates a small subset of pharmaceuticals that have recently undergone a sudden price increase and separates the ratcheting events into two categories: (1) those that occur as a result of natural deviations in the market, and (2) those that occur due to business tactics that take advantage of vulnerabilities in the drug market. It concludes that under this categorization, antitrust law may provide an effective solution specifically directed at ratcheting events of the second category— those driven by anticompetitive behavior.

Enough of this Manure: Why the EPA Needs to Define the Agricultural Stormwater Exemption to Limit the “Runoff” from the ALT Court

Emily Kenyon

This Note challenges the Alt court’s restriction of the EPA’s authority to regulate Concentrated Animal Feeding Operations (CAFOs) and proposes that the EPA conduct a new rulemaking to address this issue. CAFOs pollute our nation’s waterways with contaminated manure, damaging our environment and injuring public health. Recognizing their potential to pollute, Congress included CAFOs within the statutory definition of a point source in the Clean Water Act in 1972. Fifteen years later, Congress amended the statute and exempted agricultural stormwater from the definition of a point source. Controversy surrounded the application of the agricultural stormwater exemption to CAFOs until 2003, when the EPA specified that the exemption only applied to precipitation-based discharges from the land application area of a CAFO when manure had been applied pursuant to prudent agricultural practices. Unfortunately, in Alt v. EPA, industry capitalized on the ambiguity in the Clean Water Act and secured a district court ruling expanding the agricultural stormwater exemption to include discharges outside the land application area, allowing CAFOs to further pollute our waterways. After providing the relevant history of CAFO regulation, this Note critiques the Alt decision—concluding that the court misinterpreted the agricultural stormwater exemption. Finally, it argues that the EPA should initiate a rulemaking and comprehensively define the agricultural stormwater exemption to prevent further environmental degradation and harm to human health.

Disproportionate Impact: An Impetus to Raise the Standard of Proof at Sentencing

Anthony LoMonaco

It is well-known that in a criminal trial, the prosecution must prove culpability beyond a reasonable doubt. But during the subsequent sentencing phase, the standard of proof is much lower: a preponderance of the evidence. This relatively low standard can lead to a problem known as “disproportionate impact.” Disproportionate impact occurs when evidence of additional criminal activity is introduced during the sentencing phase and becomes more determinative of the defendant’s punishment than the actual crime of conviction. Such evidence can subject criminal defendants to significantly more punishment without the safeguards available at a criminal trial, and it may include uncharged and acquitted crimes. In response to this issue, some circuit courts fashioned an exception to the preponderance rule, raising the standard of proof to the clear and convincing standard to protect the due process rights of criminal defendants. However, use of this exception was curtailed in all circuits but the Ninth when the Supreme Court rendered the Sentencing Guidelines advisory in 2005. This Note analyzes the lopsided circuit split surrounding the disproportionate impact exception and challenges the notion that the exception is no longer necessary because the Guidelines have become advisory.

The Response of Copyright to the Enforcement Strain of Inexpensive Copying Technology

Jayashri Srikantiah

Advances in reprographic technology have spawned inexpensive photocopiers, videotape recorders (VTRs), modems, computers, networks, and tape recorders capable of making high-quality copies. These inexpensive devices have improved the dissemination of information to all of society’s members. Unfortunately, however, the cheap pricing and wide availability of such devices have also caused a drastic increase in the unauthorized reproduction of copyrighted works.

Hopwood v. Texas: A Backward Look at Affirmative Action in Education

Laura C. Scanlan

In 1992 the University of Texas Law School (Law School) rejected the applications of Cheryl Hopwood, Douglas Carvell, Kenneth Elliott, and David Rogers. These four applicants, who are white, subsequently filed suit against the State of Texas and the University of Texas, alleging that both the State and the Law School discriminated against them by using an affirmative action admissions process that placed black and Mexican American applicants in a separate admissions pool and consequently accepted members of those groups over nonminority students who had comparable grades and test scores. The plaintiffs argued that any use of race in the admissions process unconstitutionally infringed on their Fourteenth Amendment right to equal protection.

This Estoppel Has Got to Stop: Judicial Estoppel and the Americans with Disabilities Act

Anne E. Beaumont

There are more than forty million people with disabilities in the United States. It has been said that the best definition of what it means to be a person with a disability in America is to be unemployed. The Americans with Disabilities Act (ADA) was enacted in 1990 to implement a federal policy of greater inclusion of people with disabilities in all facets of the nation’s life–including employment. The employment provisions of the Americans with Disabilities Act have the potential to ameliorate the staggering unemployment rate of people with disabilities by protecting them against discrimination on the basis of disability as they enter and advance in American workplaces.

Taking Sides: The Burden of Proof Switch in Dolan v. City of Tigard

Marshall S. Sprung

In June 1994, the United States Supreme Court handed down a decision which, for all its real or imagined inventiveness, followed tradition in at least one important respect. Dolan v. City of Tigard, the eagerly awaited addition to the Rehnquist Court’s already controversial takings jurisprudence, said a mouthful about the constitutional status of the Takings Clause and the shape of the regulatory takings doctrine. Along the way, and almost matter-of-factly, the Court announced a shift in the burden of proof to the government. However, while it devoted a great deal of effort to its discussion of constitutional issues and state takings cases, the Dolan Court chose to make this burden shift without extended comment and confined its remarks to the space of a short footnote and a few lines of text. That a burden of proof shift occurred so quietly, yet coincided with considerable advancement in the substantive law, represents a familiar judicial tactic.

Preventing Undue Terminations: A Critical Evaluation of the Length-of-Time-out-of-Custody Ground for Termination of Parental Rights

Jennifer Ayres Hand

The American legal system views the relationship between parent and child as sacrosanct, only to be severed through a knowing, voluntary relinquishment by the parent or through a formal court proceeding known as a termination of parental rights (TPR). Termination of parental rights fundamentally affects the relationship between parent and child. For the parent, termination means the irretrievable loss of “the companionship, care, custody, and management of his or her children.”‘ For the child, termination raises the specter of total loss of the parent as well as loss of “‘the right of support… ; the right to inherit; and all other rights inherent in the legal parent-child relationship, not just for [a limited] period…, but forever.”‘

Seeking a Superior Institutional Liability Standard Under Title IX for Teacher-Student Sexual Harassment

Neera Rellan Stacy

Once a court finds that a teacher has sexually harassed a student, it must decide whether the school should bear liability for the teacher’s harassment. While most agree that the teacher should be held liable for his actions, many courts disagree as to the liability of the institution that employs the teacher. When should a school district be held accountable for a teacher’s misconduct? Title IX of the Education Amendments of 1971 “[u]nquestionably … place[s] on [educational institutions] the duty not to discriminate on the basis of sex.” Sex-based discrimination resulting from sexually harassing conduct by a teacher may manifest itself in various forms: For example, a teacher may make sexual comments, leer, or inappropriately touch a student; he may make offensive sexual advances toward a student; he may solicit or coerce sexual acts from a student by promising to grade the student highly if the student complies or by threatening to fail the student if she does not; and he may rape a student. Although Title IX allows a student to bring a claim against a school for such abusive misconduct by a teacher, no definitive legal standard for assessing liability currently exists. In addition, the standards that are applied today by most courts are inadequate: They fail to provide schools with sufficient incentives to create effective preventive and monitoring measures against harassment, and they fail to provide students who have been sexually harassed with appropriate relief under Title IX. A superior standard is needed.