University of Pennsylvania - Biostatistics

More Than Just Spelling: How Differences in International Labor Laws Create Barriers to Expansion of the American National Sports Leagues into Europe

Anna E. Larson — Thu, 01 Sep 2011 10:31:49 PDT

For decades now, all four of the U.S. National Sporting Leagues have been discussing a potential international expansion into Europe. Exhibition games have been scheduled abroad to increase interest. Plans have been created to decrease the number of times teams would have to travel between continents to play. Provisions regarding international expansion have even been entered into several of the leagues’ Collective Bargaining Agreements (CBA). However, one large roadblock remains: international labor laws. As recent events in the NFL have shown us, the nature of a country’s labor law can have a monumental effect on how bargaining progresses. Without the player association’s threat of an antitrust suit bargaining may have progressed quite differently. Labor negotiations in the United States are regulated by a compromise known as the nonstatutory labor exemption whereby the courts will uphold provisions of a CBA, so long as it (1) primarily affects the parties of the CBA, (2) is a mandatory subject of collective bargaining, and (3) is a result of good faith, arms length, bargaining. This compromise allows the national leagues to impose restrictions necessary to their survival, which otherwise might run afoul of antitrust laws. However, European countries do not have as broad a labor exemption as the United States, which then begs the question: whose labor law prevails? This Comment will first look at the jurisprudence stemming from those national leagues containing Canadian teams, and attempts to extrapolate from there the effect European teams would have on the bargaining process. It will then examine other international leagues, such as the Union of European Leagues for Basketball, to suggest a way of organizing a European expansion.

Criminalizing the Denial of Honest Services After Skilling

Elizabeth R. Sheyn — Sun, 02 Jan 2011 18:05:05 PST

The United States Supreme Court’s recent decision in Skilling v. United States is only the latest in a series of blows that the Court has dealt to the intangible rights theory of mail fraud (also known as honest services fraud). In Skilling, the Court considered the constitutionality of the so-called honest services statute, which criminalizes “scheme[s] or artifice[s][designed] to deprive another of the intangible right of honest services,” and narrowed its scope considerably. The Court limited the application of the statute to schemes to defraud involving bribes or kickbacks. Most significantly, the Court rejected the notion that the statute applies to “undisclosed self-dealing by a public official or private employee—i.e., the taking of official action by the employee that furthers his own undisclosed financial interests while purporting to act in the interests of those to whom he owes a fiduciary duty.” The Skilling Court called on Congress to “speak more clearly” if it desired the statute “to go further.”

To address criminal conduct that would no longer be penalized following the Court’s drastic narrowing of the honest services statute, this Article provides recommendations concerning what the new honest services statute, which Congress would enact to replace the current, eviscerated statute, should look like. The considerations advanced in the Article aim to ensure that the new statute avoids potential federalism concerns, as well as the charges of vagueness that plagued the previous iterations of the honest services statute. Additionally, they provide a means of punishing truly criminal conduct that would otherwise fall outside the scope of the honest services statute (as it currently stands), the mail and wire fraud statutes, and 18 U.S.C. § 666.

The Niqab in the Courtroom: Protecting Free Exercise of Religion in a Post-Smith World

Adam A. Schwartzbaum — Tue, 12 Oct 2010 16:57:41 PDT

The niqab has become enmeshed in heated political controversy all across the world. In the United States, the situation of Ginnah Muhammad exemplifies the complex legal issues arising from conflicts between individuals whose religious beliefs compel this practice and the secular state. Muhammad, an African-American Muslim woman, was ejected from a Michigan small claims court for refusing to remove her veil while testifying. This Comment explores the constitutionality of this action, and a subsequent amendment to the Michigan Rules of Evidence passed in response to her case giving judges the power to “exercise reasonable control over parties and witnesses."

Inevitably, neutral, generally applicable laws will sometimes conflict with individuals’ religious practices. In Employment Division v. Smith, the Supreme Court concluded that in most of these situations, the secular goals of the state override the religious objections of the individual so long as the government can advance a rational basis for its legislation. Smith itself acknowledges that in certain limited circumstances, however, even neutral, generally applicable laws are subject to strict scrutiny. This Comment explores the idea that a ban on the niqab in the courtroom is one such case. It analyzes the division amongst the Courts of Appeals regarding "hybrid-rights" and argues that Muhammad’s case exemplifies precisely how the doctrine should work in practice, because such a rule violates a Muslim woman’s Free Exercise rights and her corresponding right of access to the courts. It then reviews the interests advanced by the state as compelling reasons for the ban, and presents legal and empirical evidence suggesting that these are not sufficiently compelling and narrowly tailored enough to overcome strict scrutiny. By showing why even individuals at the outer edges of the law still have a strong claim for a religious exemption, this Comment makes jurisprudential space for the vast majority of religious adherents to enjoy fair and equal treatment within the halls of American justice.

No Role for Apology: Remedial Work and the Problem of Medical Injury

Steven E. Raper MD — Thu, 22 Jul 2010 08:04:52 PDT

The past decade has produced ample evidence that patients are injured by medical care. A landmark document “To Err is Human” articulated a way to protect patients based on analysis of health care organizations according to complex systems and principles of human performance rather than “blame and shame”. To understand how to prevent injury, full – but protected – disclosure is required as well as institutional will to change. The literature is full of success stories all of which are based on frank and honest reporting of adverse events. Central to such reporting and analysis is the ability to discuss such events in the correct forum.

In this Article, I argue that physicians should not apologize to patients who sustain medical adverse events. There are three main problems with the use of apologies. First, medical injuries usually occur at the “sharp end” of complex systems where more than one latent failure has also happened. The idea of one individual apologizing to another for a medical injury sustained as the result of medical care is therefore contrived and insincere. Second, apologies - as opposed to other forms of remedial work – have a chilling effect on medical injury reporting and operates against the important social goal of increasing patient safety and third, legislatures attempting to enact common law and statutes - to make apologies inadmissible in litigation - vary widely among the states and render any attempted protections illusory.

The main alternative approach to improving patient safety is that of deterrence and corrective justice as sought in medical malpractice litigation. With its selectivity, long time line, and individual client-focused approach, malpractice litigation cannot be expected to impact patient safety in any meaningful way. Only patients with severe to catastrophic injury can get their cases tried, leaving the vast majority of those sustaining medical injuries without compensation.

The last section of this article discusses three main alternatives to ongoing legislative attempts to protect apology. First, state and federal evidentiary rules such as FRE 803(6) should be changed to strengthen protections for documents generated to improve patient safety. Second, legislative efforts such as the Patient Safety and Quality Improvement Act (PSQIA) of 2005 should be expanded into the states and directed at strengthening protection of peer review and institutional processes which are designed to get at the root cause of injuries as they happen, and to prevent similar injuries in the future. Third, physicians should be taught to disclose relevant details of injuries sustained by patients with accounts, an alternative type of remedial work which allows a focus on the injury but without the requirement of admitting regret, remorse, or responsibility.

Regulatory Approval of Follow-On Biologics: Takings Implications of Twelve Years of Market Exclusivity and Future Conflict in Determinations of Bioequivalence

Aileen M. McGill — Mon, 14 Jun 2010 08:34:37 PDT

Congressional interest in the availability of low-cost pharmaceuticals has focused on the increasingly important class of drugs known as “biologics.” Biologics are protein-based pharmaceuticals derived from living matter or manufactured in living cells, which are more complex than the chemically synthesized molecules found in most pharmaceutical products. While there are many scientific differences between small-molecule pharmaceuticals and biologics, one of the most significant is the inability to reproduce them in generic form, creating a legislative division between generic entry for standard pharmaceuticals governed by the Hatch-Waxman Act and a similar approval process for “follow-on biologics” (FOBs).

With the passage of the healthcare reform bill in March, 2010, Congress has finally given the FDA authority and guidance for the approval of FOBs. This article discusses two key provisions in this bill that differ from the Hatch-Waxman Act and the problems that are likely to arise from these terms. First, the statute implements twelve years of market exclusivity for pioneer products, a lengthy term that reflects the position advocated by the biotechnology industry after an ongoing debate with consumer advocacy groups and the FTC who advocated a substantially shorter term. This prolonged market exclusivity reflects the need to protect the substantial investments in R&D required to produce biological products. By adopting a lengthy market exclusivity term, however, Congress may have foreclosed future opportunities to shorten this term even if biological research advances lower the time and expense required for biological R&D because reducing market exclusivity would likely be an unconstitutional taking of pharmaceutical companies’ interest in exclusive marketing rights under the Fifth Amendment.

Second, this bill implements notice-and-comment procedures for individual case determinations of bioequivalence. This provision reflects legitimate scientific concerns that have thwarted a regulatory approval pathway for FOBs until this time: unlike small-molecule pharmaceuticals which carry a presumption of bioequivalence, biologics that are appear to be similar by methods that separate and measure proteins may in fact not have equivalent biologic actions due to structural alterations such as protein folding or changes in charge. The solicitation of public comment for product-specific testing requirements, however, raises some interesting questions under the Administrative Procedure Act and may lead to significant conflict between the FDA and FOB entrants due to the high costs of biosimilarity testing.

The Humanization of the Corporate Entity: Changing Views of Corporate Criminal Liability in the Wake of Citizens United

Elizabeth R. Sheyn — Mon, 07 Jun 2010 16:15:25 PDT

Although the recent United States Supreme Court decision in Citizens United v. Federal Election Commission clearly controls the First Amendment rights of corporations, the effect of Citizens United on corporate criminal liability is less obvious, though equally (if not more) significant. The Court’s view that corporations are equal to human beings, at least under the First Amendment’s Free Speech Clause, when combined with the traditional understanding that corporations are considered “persons” under the United States Constitution, likely impacts the way that corporations’ alleged misdeeds are investigated by the government and the manner in which the government subsequently deals with corporate misconduct, specifically through deferred prosecution agreements and non-prosecution agreements.

In particular, certain provisions that are typically included in deferred and non-prosecution agreements may have to be altered or eliminated from use altogether in the wake of Citizens United. Another result prompted by Citizens United could be the implementation of judicial oversight over deferred and non-prosecution agreements, which would include the submission of all such agreements to federal courts for approval and the provision of an opportunity for a corporation to be heard if the government makes a unilateral claim of breach. Undoubtedly, these changes would greatly alter the landscape of corporate criminal liability in the United States.

Compulsory Licensing of Patented Pharmaceuticals: Why a WTO Administrative Body Should Determine What Constitues a Public Health Crisis under the Doha Declaration

Aileen M. McGill — Fri, 26 Mar 2010 20:18:48 PDT

In response to concerns that patent protection for pharmaceuticals negatively affected world health, the WTO issued the Doha Declaration in 2001, allowing member nations to issue compulsory licenses for patented pharmaceuticals during a public health crisis. The terms of this Declaration allow countries to determine what constitutes a public health crisis, what terms are appropriate for compulsory licenses, and what medications they should be entitled to produce.

This article argues that the Doha Declaration has not served countries most in need of inexpensive medications: least developed countries with high rates of HIV/AIDS. The terms of the Doha Declaration are too broad, allowing countries to issue compulsory licenses for medications that do not treat life-threatening illnesses, such as Viagra and Plavix. Many countries have seem a dramatic drop in Foreign Direct Investment (FDI) as a result of extensive compulsory licensing of patented pharmaceuticals, making least developed countries hesitant to invoke the terms of the Doha Declaration for fear of similar losses in FDI. To safeguard the interests of countries facing severe health crises, the WTO should establish an administrative body to determine when a country may issue compulsory licenses of patented pharmaceuticals.

This article has been chosen by the American Intellectual Property Law Association as the winner of the 2009 Robert C. Watson Award.

How China Succeeded in Protecting Olympic Trademarks and Why this Success Will Not Generate Immediate Improvements in Intellectual Property Protection in China

Aileen M. McGill — Thu, 04 Feb 2010 08:48:53 PST

After centuries of stagnant growth and international isolation, China has emerged as the fastest-growing economy in the world and one of the most important parties in international trade. This staggering growth and influx of foreign goods has led to rampant counterfeiting of brand-name goods in a society with little cultural basis for individual intellectual property rights.

When Beijing was awarded the 2008 summer Olympics in 2001, the Chinese government moved quickly to prepare for this beloved international event, rallying this massive country for, what many considered to be their grand emergence onto the world stage. One of the reforms enacted in preparation for the Olympics was an administrative body dedicated to the protection of Olympic trademarks in conjunction with educational campaigns emphasizing the importance of Olympic symbols. China succeeded in protecting Olympic symbols from extensive counterfeiting. However, due to the cultural support for the Olympics and the importance of the Games to the Chinese people, overall, it is unlikely that China will translate this success into immediate improved protection of all commercial trademarks.

Although immediate improvements in intellectual property protection in China are unlikely, the Chinese government can apply the administrative structure for the enforcement of Olympic trademarks to limit counterfeiting and piracy nationwide. The growth of China’s economy has led to greater domestic franchising and an enormous urban consumer base that relies on trademarks to ensure product quality. Using the IPR enforcement structure of the Beijing Olympic Committee may bridge the gap between a culture that has traditionally been at odds with individual intellectual property rights and the need for improved intellectual property in China.

Defining “Sexual Abuse of a Minor” in Immigration Law: Finding a Place for Uniformity, Fairness and Feminism

Kate S. Barth — Wed, 30 Sep 2009 07:00:18 PDT

This article examines the circuit split over the proper definition of the term "sexual abuse of a minor" in the Immigration and Nationality Act, using considerations of fairness, uniform application of the law, and feminist perceptions of the purpose of statutory rape laws to help guide analysis. The Board of Immigration Appeals, the Second, Third, Fifth, Seventh, and Eleventh Circuits have tied the term "sexual abuse of a minor" to the definition given in 18 U.S.C § 3509(a)(8). The Ninth Circuit, on the other hand, recently decided that the term should more properly be tied to the definition given in 18 U.S.C.A. §§ 2242-2246. In addition, the First Circuit has refused to tie "sexual abuse of a minor" to a federal definition and has instead indicated that any state conviction for statutory rape constitutes an aggravated felony as intended by the INA. The differences between these possible definitions are striking. Because an alien who is concluded to have been convicted of "sexual abuse of a minor" is deportable as an aggravated felon, the breadth of the definition chosen by the courts has far-reaching consequences on the lives of the aliens it impacts. This article argues that rather than looking to § 3509(a)(8) or fully relying on a state conviction, courts should compare the state statute of conviction with the narrower definition of "sexual abuse of a minor" encoded in substantive federal criminal law at §§ 2242-2246 because this definition is construed in favor of the alien, results in a more uniform application of the law and aligns more closely with feminist perceptions of what a statutory rape law should accomplish.