Food and Drug Law Commons^™

California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor

Pepperdine Law Review

The California Supreme Court, in the novel and unprecedented case of Sindell v. Abbott Laboratories, eliminated the plaintiffs burden of identification of a negligent party, and thus the causation requirement, in a multiple party tort action. In the course of this decision, the court adopted the "market share" theory of liability which dictated in Sindell that nonidentifiable defendant-manufacturers of the generic drug DES would be liable for the damages in proportion to their share of business in the market. The author thoroughly examines various theories of recovery, such as "alternative liability," "concert of action" and "enterprise liability," which the court …

Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler

Pepperdine Dispute Resolution Law Journal

The article presents information on the Vaccine Injury Compensation Program. It discusses the U.S. Federal circuit case Hazlehurst v. Sec'y of Health & Human Servs., in which lawsuit against the defendant was filed by the plaintiff who sought claims against the liability of product to recover damages for alleged injuries which his son had received from vaccines. It also provides information on the structural moral hazard of the program which devolves it into a litigious adjudicatory process.

Mandatory Drug Testing Of College Athletes: Are Athletes Being Denied Their Constitutional Rights? , Allison Rose

Pepperdine Law Review

No abstract provided.

Public-Private Regime Interactions In Global Food Safety Governance, Ching-Fu Lin

Transnational Business Governance Interactions Working Papers

In response to an apparent decline in global food safety, numerous public and private regulatory initiatives have emerged to restore public confidence. This trend has been particularly marked by the growing influence of private regulators such as multinational food companies, supermarket chains and non-governmental organizations (NGOs), who employ private standards, certification protocols, third-party auditing, and transnational contracting practices. This paper explores how the structure and processes of private food safety governance interact with traditional public governance regimes, focusing on Global Good Agricultural Practices (GlobalGAP) as a primary example of the former. Due to the inefficiency and ineffectiveness of public regulation …

Implications Of The Supreme Court's Decision In Pliva, Inc. V. Mensing: Why Generic And Brand-Name Pharmaceuticals Must Be Treated Equally Under The Federal Food, Drug, And Cosmetic Act

Marquette Elder's Advisor

No abstract provided.

Christopher V. Smithkline Beecham Corporation: An Unsurprising Loss For Pharmaceutical Sales Representatives And An Erosion Of Power For Administrative Agencies, Anna Johnston

Proxy

No abstract provided.

Rights And Roles: Alaska Natives And Ocean And Coastal Subsistence Resources, Jordan Diamond, Greta Swanson, Kathryn Mengerink

Florida A & M University Law Review

This article explores the strengths and weaknesses of the two pillars of the framework for managing marine subsistence resources in Alaska: the pillar that protects Alaska Native rights to marine subsistence resources, and the pillar that protects the resources themselves. It focuses on how well the pillars support subsistence practices and Alaska Native leadership in the management framework. Part I summarizes the management challenge posed by the effects rapid climate change is causing in the Arctic, including impacts to the marine subsistence resources upon which Alaska Natives depend. Part II explores the laws and doctrines related to Alaska Native subsistence …

The Unconstitutional Prosecution Of Controlled Substance Metabolites Under Utah Code § 41-6a-517, Joshua C. Snow

Utah OnLaw: The Utah Law Review Online Supplement

This Article achieves three main goals. First, it explains and explores Utah’s per se metabolite laws against the backdrop of the national landscape of metabolite laws. Second, this Article provides a concise explanation regarding the science of drug metabolites. Finally, this Article presents two constitutional challenges to Utah Code section 41-6a-517. The first challenge argues that the statute creates an impermissible status offense in violation of the Eighth Amendment to the U.S. Constitution. The second challenge argues that the statute violates Utah’s Uniform Operation of Laws Clause found in the Utah Constitution. This Article concludes by asking Utah state courts …

Chapter 415: Big Help For Small Businesses, Matthew Read

McGeorge Law Review

No abstract provided.

Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork

Michigan Telecommunications & Technology Law Review

Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …

State Medical Marijuana Implementation And Federal Policy, Karen O'Keefe

Journal of Health Care Law and Policy

No abstract provided.

No Duty To Warn Of Drug Interactions: A Dangerous Prescription, 46 J. Marshall L. Rev. 533 (2013), Ryanne Bush Dent

UIC Law Review

No abstract provided.

Do You Know What's On Your Plate?: The Importance Of Regulating The Processes Of Food Production, Martha Dragich

Faculty Publications

This article argues that the current regulatory approach-focusing on the supposed equivalence of new foods to traditional ones-is unduly narrow, particularly given the characteristics of the modem food system. To achieve the broad objectives of the FDCA in the context of the industrialized, highly processed, and global food supply of the twenty-first century requires adopting a broader understanding of consumer protection needs with respect to food. The FDCA itself is written in very broad terms and provides much of the authority needed today. The FDA's enforcement capacity, however, already is severely strained.52 Moreover, the scientific basis for some process- oriented …

Pharmageddon: A Statutory Solution To Curb Ohio's Prescription Abuse Problem, Ed Woodworth

Journal of Law and Health

Prescription abuse in Ohio continues to be a serious and complex issue that should be addressed. Accordingly, Part II of this Note examines the background of prescription drug abuse generally. It identifies the dangers of prescription drug abuse, the cost drug abuse places on society, some reasons for prescription drug abuse, sources of prescription drugs, and discusses the current state and federal laws regarding prescription drug abuse and prescription reporting. Part III discusses the positive and negative aspects of H.B. 93 and Medical Rule 4731-11-11 and then offers proposals to more effectively prevent prescription drug abuse. Part IV discusses various …

Finding A Cure: Incentivizing Partnerships Between Disease Advocacy Groups And Academic Commercial Researchers , Anne M. Readel

Journal of Law and Health

Collaborations between for-profit drug companies and not-for-profit disease advocacy groups have risen in recent years in an effort to find cures for orphan diseases. These unique and beneficial collaborations are a result of disease advocacy groups assuming a more active role in drug development through the use of “venture philanthropy,” which employs concepts and techniques from venture capitalism and applies them to achieving philanthropic goals. While these collaborations have found remarkable success, such as the discovery of the first known cure for cystic fibrosis in 2012, venture philanthropy for drug discovery presents numerous legal and social challenges. This Article examines …

Is Sugar The New Tobacco? How To Regulate Toxic Foods, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

This article explores the health risks associated with added sugar. It then examines how, if at all, sugar should be regulated, by considering tobacco regulation as a possible model. Part I identifies the health risks of sugar consumption. Part II examines the reasons why sugar is added to so much of our food supply. Part III provides an overview of tobacco regulation, including educational initiatives, warning labels, advertising restrictions, age limitations, and taxes. Finally, Part IV provides a framework for sugar regulation, suggesting that most of the foregoing laws designed to discourage tobacco use should, with the exception of age …

Investing In Cannabis: Inconsistent Government Regulation And Constraints On Capital, Adrian A. Ohmer

Michigan Business & Entrepreneurial Law Review

This note’s focus is on the future of investing in the growing legalized cannabis industry. In Part II, it will provide a brief history of federal and state regulation of cannabis. Part III will discuss the current role of the federal government in regulating the cannabis industry. Part IV will explore the current avenues of access to capital for the cannabis industry. Lastly, Part V will provide suggestions for the federal government and state governments to reduce investment risk that exists in the cannabis industry.

Frameworks For Amending Reservoir Water Management, Ethan Mower, Leandro E. Miranda

Publications

Managing water storage and withdrawals in many reservoirs requires establishing seasonal targets for water levels (i.e., rule curves) that are influenced by regional precipitation and diverse water demands. Rule curves are established as an attempt to balance various water needs such as flood control, irrigation, and environmental benefits such as fish and wildlife management. The processes and challenges associated with amending rule curves to balance multiuse needs are complicated and mostly unfamiliar to non-US Army Corps of Engineers (USACE) natural resource managers and to the public. To inform natural resource managers and the public we describe the policies and process …

Winter 2013 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Faculty Publications

The past several decades have seen the creation of transformative new technologies that are being used to design innovative consumer product ingredients never seen before in nature. Examples include the use of nanotechnology and genetic modification, and, right around the corner, cloning and lab grown meat. These innovative technologies are harbingers of more pioneering consumer product ingredients to come. The remarkable pace of the development of ground-breaking new technologies means that the population is being steadily exposed to novel ingredients with unknown health risks.

Optimally, the Food & Drug Administration ("FDA") should be regulating these innovative, novel ingredients in consumer …