The Little “Black” Pill: Dressing Unlikely Murderers For Defense Success, 48 J. Marshall L. Rev. 933 (2015),
2015
UIC School of Law
The Little “Black” Pill: Dressing Unlikely Murderers For Defense Success, 48 J. Marshall L. Rev. 933 (2015), Cassandra Wich
UIC Law Review
No abstract provided.
Doping In Cycling: Incentivizing The Reporting Of Uci Anti-Doping Rules Violations Through Organizational Oversight And Accountability, 49 J. Marshall L. Rev. 625 (2015),
2015
UIC School of Law
Doping In Cycling: Incentivizing The Reporting Of Uci Anti-Doping Rules Violations Through Organizational Oversight And Accountability, 49 J. Marshall L. Rev. 625 (2015), Tom Laser
UIC Law Review
No abstract provided.
Legal Preparedness And Ebola Vaccines,
2015
University of Missouri School of Law
Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan
Faculty Publications
On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other …
Sharing The Burden Of Ebola Vaccine Related Adverse Events,
2015
University of Missouri School of Law
Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan
Faculty Publications
Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are multiple options available to …
Fda Approval Of Drugs And Devices: Preemption Of State Laws For “Parallel” Tort Claims,
2015
University of Maryland Francis King Carey School of Law
Fda Approval Of Drugs And Devices: Preemption Of State Laws For “Parallel” Tort Claims, Marcia Boumil
Journal of Health Care Law and Policy
The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from claims of injury due to an alleged “design defect.” The Court previously ruled that FDA approval does not preempt state law claims based upon failure-to-warn, at least with respect to brand name products. In contrast, the Court previously ruled that the federal regulatory process leading to FDA approval of generic equivalents of brand drugs—and designation of the drug label—does preempt state law as …
New York City Rules! Regulatory Models For Environmental And Public Health,
2015
Elisabeth Haub School of Law at Pace University
New York City Rules! Regulatory Models For Environmental And Public Health, Jason J. Czarnezki
Elisabeth Haub School of Law Faculty Publications
Scholars have become increasingly interested in facilitating improvement in environmental and public health at the local level. Over the last few years, former New York City Mayor Michael Bloomberg and the New York City Council have proposed and adopted numerous environmental and public health initiatives, providing a useful case study for analyzing the development and success (or failure) of various regulatory tools, and offering larger lessons about regulation that can be extrapolated to other substantive areas. This Article, first, seeks to categorize and evaluate these “New York Rules,” creating a new taxonomy to understand different types of regulation. These “New …
Regulating Farming: Balancing Food Safety And Environmental Protection In A Cooperative Governance Regime,
2015
Elisabeth Haub School of Law at Pace University
Regulating Farming: Balancing Food Safety And Environmental Protection In A Cooperative Governance Regime, Margot J. Pollans
Elisabeth Haub School of Law Faculty Publications
After providing a brief overview of regulation in each area, Part I of this Article identifies three types of discordance between produce safety and environmental protection on farms. First, because of limited resources, farmers will have to choose between implementing food safety practices and implementing environmental practices. Second, indirect trade-offs between the two regulatory goals result in damaging collateral consequences for the environment. Food safety regulation may exacerbate a range of existing environmental harms. Third, there is at least one direct clash that may make compliance with food safety law incompatible with participation in certain environmental programs. Part I also …
Michigan Craft Beer Legislation,
2015
University of Michigan Law School
Michigan Craft Beer Legislation, Kincaid C. Brown
Law Librarian Scholarship
Michigan is currently in the midst of a craft beer boom. The Michigan Brewers Guild’s member list includes more than 150 breweries and brewpubs brewing craft beer. Michigan’s craft beer industry is boosting the state’s economy. According to an analysis by the Brewers Association customized by the Michigan Brewers Guild, the craft beer industry is directly responsible for more than 5,000 Michigan jobs and contributes more than $277 million to the state’s economy and more than $144 million in wages.
Regulating The Underground: Secret Supper Clubs, Pop-Up Restaurants And The Role O F Law,
2015
University of Maine School of Law
Regulating The Underground: Secret Supper Clubs, Pop-Up Restaurants And The Role O F Law, Sarah B. Schindler
Faculty Publications
Instagram pictures of elegantly plated dinners, long farmstyle tables, and well-to-do people laughing in what looks like a loft apartment are followed by commenters asking, “Where is this?” This is the world of underground dining. Aspiring and established chefs invite strangers into their homes (or their friends’ stores after hours, or the empty warehouse at the edge of town, or the nearest farm) for a night of food and revelry in exchange for cash. Although decidedly antiestablishment, these secret suppers and pop-up restaurants are popular—there are websites to help people locate them, and many respected publications have penned stories about …
Sprung From Night Into The Sun: An Examination Of Colorado's Marijuana Regulatory Framework Since Legalization,
2015
Hoban & Feola, LLC
Sprung From Night Into The Sun: An Examination Of Colorado's Marijuana Regulatory Framework Since Legalization, Robert T. Hoban, Raushanah A. Patterson
Kentucky Journal of Equine, Agriculture, & Natural Resources Law
No abstract provided.
The Lanham Act's Wonderful Complement To The Fdca: Pom Wonderful V.Coca-Cola Enhances Protection Against Misleading Labeling Through Integrated Regulation,
2015
Loyola University Chicago, School of Law
The Lanham Act's Wonderful Complement To The Fdca: Pom Wonderful V.Coca-Cola Enhances Protection Against Misleading Labeling Through Integrated Regulation, Jennifer Thurswell Radis
Loyola University Chicago Law Journal
POM Wonderful sued Coca-Cola under the Lanham Act claiming that it suffered losses due to the misleading label on Coca-Cola’s Minute Maid brand’s Pomegranate Blueberry juice blend. Reversing the Ninth Circuit’s decision in June 2014, the Supreme Court found that POM’s claim was not precluded even though the label was regulated by the FDCA. In fact, the Court acknowledged the complementary nature of private enforcement with FDA regulation, as it did in Wyeth v. Levine in 2009. This Article submits that POM exemplifies the Court’s willingness to strengthen the Lanham Act’s protections against misleading labeling, as it did the same …
From Silicon Valley To The Kitchen Table: Innovative Online Agriculture & Food Start-Ups And The Law,
2015
University of Kentucky
From Silicon Valley To The Kitchen Table: Innovative Online Agriculture & Food Start-Ups And The Law, Matthew A. Forcum
Kentucky Journal of Equine, Agriculture, & Natural Resources Law
No abstract provided.
A Practitioner's Guide To Defending "Natural" Food Labeling Litigation,
2015
Foscolo & Handel PLLC
A Practitioner's Guide To Defending "Natural" Food Labeling Litigation, Lauren E. Handel
Kentucky Journal of Equine, Agriculture, & Natural Resources Law
No abstract provided.
Mad Cow Disease: Is There An App For That?,
2015
University of Kentucky
Mad Cow Disease: Is There An App For That?, Sara Gonzalez-Rothi Kronenthal
Kentucky Journal of Equine, Agriculture, & Natural Resources Law
No abstract provided.
The Aged Distilled Spirits Competitiveness Act: Increasing Kentucky's Economic Output While Leveling The Playing Field For Kentucky Distilleries,
2015
University of Kentucky
The Aged Distilled Spirits Competitiveness Act: Increasing Kentucky's Economic Output While Leveling The Playing Field For Kentucky Distilleries, Drake Staples
Kentucky Journal of Equine, Agriculture, & Natural Resources Law
No abstract provided.
Taking "The War On Drugs" To The Fields: The Importance Of Agriculture In Reforming International Law On The Illegal Drug Market,
2015
University of Kentucky
Taking "The War On Drugs" To The Fields: The Importance Of Agriculture In Reforming International Law On The Illegal Drug Market, Terra Rivera
Kentucky Journal of Equine, Agriculture, & Natural Resources Law
No abstract provided.
Independent Drug Testing To Ensure Drug Safety And Efficacy,
2015
University of Maryland Francis King Carey School of Law
Independent Drug Testing To Ensure Drug Safety And Efficacy, Marc A. Rodwin
Journal of Health Care Law and Policy
This Article explores a proposal that would preclude biased drug testing by removing all drug sponsor influence on the design and conduct of clinical trials for new drug applications (“NDAs”), a reform that would address the root of institutional corruption. Recently advocated by leading scholars, the idea has a long history, yet was neglected for over half a century due to pharmaceutical industry opposition.
The Codex Alimentarius Commission, Corporate Influence, And International Trade: A Perspective On Fda's Global Role,
2015
University of Missouri School of Law
The Codex Alimentarius Commission, Corporate Influence, And International Trade: A Perspective On Fda's Global Role, Sam F. Halabi
Faculty Publications
Section 305 of the FDA Food Safety Modernization Act specifically calls for FDA to develop recommendations on whether and how to harmonize requirements under the Codex Alimentarius Commission (“Codex”), an international organization charged with developing food standards, guidelines, codes of practice and “other recommendations to ensure fair practices in food trade and protect[ion of] the health of consumers.” FDA’s International Food Safety Capacity-Building Plan is largely supportive and deferential to Codex, concluding that “the use of Codex standards helps assure a safe global food supply.” To be sure, Codex’s stated mission and policies should create and facilitate adoption of universal …
Toward Coherent Federal Oversight Of Medicine,
2015
Georgia State University College of Law
Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler
Faculty Publications By Year
The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …
Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition,
2015
Vanderbilt University Law School
Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition, Neil M. Issar
Vanderbilt Journal of Entertainment & Technology Law
A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA's express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit …
