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Safety and Effectiveness: The FDAâs Approach to Risk in Prescription MedicationPhilip Gentry, Anne Elissa 11 April 2016 (has links)
The Food and Drug Administration (FDA) regulates the risks associated with pharmaceutical products; however, some drug uses are not directly regulated, and appropriate usage is left to the physicianâs discretion. These risks can often be ambiguous or uncertain. In this dissertation, I study how consumers respond to ambiguity in pharmaceutical risk. I also examine two areas where risk is either not directly regulated or is perceived to be insufficiently regulatedâI study whether patients, physicians, and third-party payers are sensitive to these risks or whether further regulation would be preferable. This dissertation begins by using an incentivized experiment to empirically estimate participantsâ reactions to ambiguity in risks that a drug is unsafe or ineffective in the presence of framing effects. The experiment finds that attitudes toward ambiguity are sensitive to risk type and framing effects. The dissertation then concentrates on two areas where risk is not directly regulated: The second chapter studies narrow therapeutic index drugs, drugs for which the generic approval process has been suspected to be inadequate in ensuring therapeutic equivalence. It finds evidence of a price penalty for the extra risk associated with NTI drugs. The third chapter studies off-label usesâthe prescription of a drug for an unapproved useâand examines whether inappropriate off-label uses are relinquished even in the absence of direct FDA regulation. It finds evidence that relinquishment of off-label uses can be spurred by False Claims Act suits. The dissertation provides insight into areas in which parties seem sensitive to risk absent regulation and those in which further regulation may be necessary.
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An Empirical Examination of Consumer Litigation FundingXiao, Jean Y. 30 March 2017 (has links)
This dissertation is the first work to empirically examine a growing type of credit for cash-constrained tort plaintiffs called consumer litigation funding (âCLFâ), which takes the form of a nonrecourse loan. A plaintiff obtains a cash advance in exchange for repaying that advance and any interest or fees out of the lawsuit proceeds that remain after the attorney and other higher-priority creditors are paid. The plaintiff pays either these remaining case proceeds or the total owed to the financierâwhichever amount is lower. The plaintiff pays the financier nothing if he loses his lawsuit. Chapter I investigates the effect of access to CLF on medical malpractice claim payment, claim duration, and the filing rate. Chapter II explores the effect of access to CLF on consumer welfare, measured by Chapter 7 and 13 bankruptcy filings. Chapter III examines whether the strength of the relationship between the financier and the funded plaintiffâs law firm is positively or negatively associated with the financierâs gross return and interest rate. Further, Chapter III presents the first look at descriptive statistics of a CLF financierâs administrative data.
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Evaluating the Impact of Monitoring and Enforcement in the Clean Air ActLim, Jinghui 26 July 2013 (has links)
Although Congress passed the Clean Air Act in 1963 to promote public health and welfare, there has been relatively little research into the effectiveness of its monitoring and enforcement.
This dissertation investigates the impact of monitoring and enforcement on emissions and air quality and examines escalating penalties for repeat violations of environmental regulations.
Chapter I shows that penalties decrease emissions of criteria pollutantscommonly found air pollutants that harm human health and welfare. Previous studies have not examined the impact of monitoring and enforcement on emission of these important pollutants. Using a dataset of nitrogen oxides emissions in California, Chapter I shows that penalties reduce emissions. Facilities that were assessed a penalty in the previous year reduce emissions by 5.60 tons on average, a 7.7% reduction in mean facility emissions. Interestingly, inspections have no significant impact, likely because inspection rates in California are consistently high.
Chapter II shows that penalties improve air quality. Previous studies have found that nonattainment of federal air quality standards, which implies more stringent regulations, improves air quality. No research has directly examined the impact of monitoring and enforcement on air quality. Focusing on California, Chapter II finds that increasing penalties at facilities around an air quality monitor improves air quality. Increasing penalties assessed from the 25th to the 75th percentile of the penalty distribution reduces ambient ozone concentrations by 0.348 parts per billion, a 0.4% reduction in mean ambient ozone concentrations.
Chapter III performs empirical analysis of repeat violations in California and finds limited evidence of escalating penalties. Results show that most facilities are compliant; 71.3% were compliant in at least eight out of the nine years studied. There is no evidence that penalties escalate, and facilities that were in violation for longer periods of time were assessed smaller penalties, on average, per year of violation. This is likely because repeat violations are less severe and do not merit large penalties. Therefore, even though penalties do not escalate, persistent violators might not be the worst actors as their violations are less serious.
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Obesity in the Labor Market: Implications for the Legal SystemShinall, Jennifer Hope Bennett 19 April 2012 (has links)
This dissertation examines the impact of obesity on the labor market from a legal point of view. Previous scholars have documented a discrepancy between the wages of the obese and the non-obese that is particularly large for women. Chapter I aims to explain this wage discrepancy by presenting evidence on sorting by occupational characteristics. The results in Chapter I demonstrate that the heaviest female workers sort into occupations requiring physical activity and out of occupations requiring communication. These results are consistent with the existence of discrimination against obese workers. Chapter II shifts focus to the existing legal remedies that currently prohibit discrimination against the obese in the labor market. Although multiple protective laws exist on the Federal, state, and city levels, only two of these laws have improved employment outcomes for the obese. Chapter II argues that strong enforcement mechanisms in these two jurisdictions, Madison, Wisconsin and Urbana, Illinois, are responsible for the success of their laws. Chapter III builds on Chapter II by proposing a new Federal law to protect the obese in the labor market. Because Chapter II points out serious flaws in the current Federal enforcement process, however, Chapter III also recommends changes to the Federal agency in charge of administering anti-discrimination laws. Chapter III argues that both a new Federal law and administrative changes to the Federal enforcement process are necessary to improve employment outcomes of the obese.
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Occupational Licensing and Legal Liability: The Effect of Regulation and Litigation on Nurse Practitioners, Physician Assistants, and the Healthcare SystemMcMichael, Benjamin Jacob 02 April 2015 (has links)
As millions of new patients enter the healthcare system in the wake of the Affordable Care Act, the greater use of nurse practitioners (NPs) and physician assistants (PAs) represents an important option for increasing the availability and decreasing the cost of healthcare. However, state occupational licensing laws restrict the capacity of NPs and PAs to provide healthcare in many states, and the threat of malpractice liability may adversely impact the practices of these professionals. In this dissertation, I first explore the political determinants of licensing laws and find that political contributions by physician and hospital interest groups play a salient role in the adoption of less restrictive licensing laws. I next consider the effect of licensing laws and tort reforms on the location decisions of NPs and PAs and find that both sets of laws affect where NPs and PAs decide to supply healthcare. Finally, I find that while broader licensing laws have an ambiguous effect on healthcare quality, they generally increase the use of preventative cancer screenings. Some tort reforms, on the other hand, reduce these screenings.
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Judicial and Agency Enforcement of Nondiscrimination LawsDruhan Bullock, Virginia Blair 06 April 2015 (has links)
Each branch of the federal government has a role in enforcing the federal nondiscrimination statutes. Congress creates and amends the statutes; the federal courts apply the law when parties file lawsuits under the statutes; and the Equal Employment Opportunity Commission (EEOC), a federal agency, administers and investigates each charge filed under the statutes and litigates cases of importance. This dissertation empirically analyzes the roles of the federal courts and the EEOC. In Chapter 1, I provide empirical evidence that supports the Supreme Courts vicariously liability standard for supervisor harassment, but not the lower courts expansion of an affirmative defense to liability when a victim does not report: employees who are harassed by their supervisor and those who report the harassment are statistically significantly more likely to experience an adverse action following the harassment as compared to those harassed by their coworker and those who do not report. In Chapter 2, I then addresses the concern over the number of frivolous charges filed with the EEOC and federal courts, as expressed by the Supreme Court in University of Texas Southwestern Medical Center v. Nassar. This chapter empirically shows for the first time that federal court decisions can increase or decrease the presence of frivolous charges filed with the EEOC depending on the nature of the case (liberal or strict). I conclude with Chapter 3 and provide empirical evidence that suggests that higher rates of race charges filed with the EEOC in and industry and in a state have a positive effect on black male wages in that industry and state.
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Toward More Effective Endangered Species RegulationByl, Jacob Peter 08 April 2015 (has links)
The Endangered Species Act is a strong environmental law that gives federal agencies authority to conserve imperiled species by regulating private and public parties. In this dissertation, I use data on timber harvests near endangered woodpeckers in North Carolina to estimate that landowners are 25% more likely to harvest mature pine trees if there are woodpeckers nearby. A safe-harbor program appears to have a modest effect on slowing the destruction of habitat. I next use a computer-based experiment to confirm that the safe-harbor program is an improvement for both landowners and endangered species over the status quo of strict regulation. A policy with strong financial incentives is most effective at encouraging landowner cooperation, but weak financial incentives are surprisingly ineffective. Finally, I explore the role of cost-benefit analysis of critical habitat designation under the Endangered Species Act. The current agency methodology leads to estimates of low costs and zero benefits of critical habitat. I argue that agencies should use a broader concept of costs and benefits because it is a better reading of the Act and can lead to more effective regulations.
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Economic and Empirical Analysis of Contractual Dispute ResolutionMiller, Samuel Mark 08 April 2015 (has links)
This dissertation uses Python-based programming to retrieve and analyze a sample of approximately 400,000 material contracts that companies filed with the Securities and Exchange Commission between 2001 and 2013, focusing on the dispute resolution mechanisms specified therein. The first chapter considers the effectiveness of two state-level efforts to attract dispute resolution business, examining how specialized business courts and the Revised Uniform Arbitration Act affected arbitration and choice-of-forum clause use in these material contracts. The second chapter examines whether and how companies and executives customized their arbitration clauses in response to Internal Revenue Code Section 409A, which increased both the likelihood and the complexity of potential disputes between these parties. The third chapter considers how companies and executives responded when the Supreme Court overturned the Ninth Circuits anomalous refusal to enforce employment-related arbitration clauses. Each chapter finds that contracting parties adjusted their dispute resolution provisions in response to the policy change(s) at issue suggesting that for the sophisticated parties in my dataset, these provisions receive careful thought and are not mere boilerplate.
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Shale Development: Risks, Responses, and RegulationCecot, Caroline 26 April 2014 (has links)
Advances in horizontal drilling and high-volume hydraulic fracturing have allowed operators to profit from oil and gas extracted from the extensive shale formations found in the United States. The resulting boom in shale development has exposed many areas, including heavily populated and environmentally sensitive areas, to the common as well as to the uncertain risks associated with drilling activities. This dissertation empirically analyzes responses to perceived risks of shale development as revealed through property transactions in a Pennsylvania county and through legislative decisions by New York towns. In general, I find that perceived risks to water feature prominently in both contexts. In Chapter I, I find that an additional nearby horizontal well increases property values on average, but that this positive effect is diminished for properties that rely on private wells for drinking water. Chapter II then considers when towns adopt a ban on shale development. In particular, I find that greater reliance on private water wells is associated with a higher probability of adopting a ban. Finally, in Chapter III, I discuss how governments could use regulations, tort liability, and insurance mandates to better manage risks to water, thereby possibly preventing property-value losses and outright bans.
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Property rights and market institutions: The case of Russian property reformVelev, Ivan Mitev. January 2002 (has links)
Thesis (PH.D.) -- Syracuse University, 2002. / "Publication number AAT 3046864"
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