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3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom 2016 University of San Diego

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Evan R. Youngstrom

Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must ...


Congress Puts The Usda’S Cool Enforcement On Ice, Golden Gate University School of Law 2016 Golden Gate University School of Law

Congress Puts The Usda’S Cool Enforcement On Ice, Golden Gate University School Of Law

GGU Law Review Blog

It is more important that Americans have safer food than to know if their steak is “single‑origin”. Especially in the wake of major E. coli outbreaks at mega chains like Chipotle, food safety in the United States should take priority over pseudo‑protectionist policymaking and food transparency.


A Potential Liability Scenario For "Non-Gmo" Labeling, David Wallace 2016 Herbert Smith Freehills New York LLP

A Potential Liability Scenario For "Non-Gmo" Labeling, David Wallace

David L Wallace

In this legal briefing, disputes partner David Wallace discusses a liability scenario that voluntary "non-GMO" labeling claims have the potential to spawn in the United States, which does not (yet) have a mandatory labeling regime, and best practices for mitigating that risk.


(Mis)Perceptions Of Law In Consumer Markets, Oren Bar-Gill, Kevin E. Davis 2016 Harvard Law School

(Mis)Perceptions Of Law In Consumer Markets, Oren Bar-Gill, Kevin E. Davis

New York University Law and Economics Working Papers

There are good reasons to believe that consumers’ behavior is sometimes influenced by systematic misperceptions of legal norms that govern product quality. Consumers might misperceive specific rules, such as those found in food safety regulations, as well as more general standards, such as the unconscionability doctrine or limitations on waivers of default substantive or procedural rights. When demand is affected by systematic misperceptions of legal norms, lawmakers may be able to maximize welfare by deviating from the legal standard that would be optimal in the absence of misperception. We use a formal model to characterize these optimal deviations under different ...


Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price II., Arti K. Rai 2016 University of Michigan Law School

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and ...


A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort 2016 O'Melveny & Meyers LLP

A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort

Articles

Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed ...


Underbanked: Cooperative Banking As A Potential Solution To The Marijuana-Banking Problem, Patrick A. Tighe 2016 University of Michigan Law School

Underbanked: Cooperative Banking As A Potential Solution To The Marijuana-Banking Problem, Patrick A. Tighe

Michigan Law Review

Numerous states have recently legalized recreational marijuana, which has created a burgeoning marijuana industry needing and demanding access to a variety of banking and financial services. Due, however, to the interplay between the federal criminalization of marijuana and federal anti-money laundering laws, U.S. financial institutions cannot handle legally the proceeds from marijuana activity. As a result, most financial institutions are unwilling to flout federal anti-money laundering laws, and so too few marijuana-related businesses can access banking services. This Note argues that the most viable policy option for resolving this “underbanking” problem is a financial cooperative approach such as a ...


Immortal Invasive Initiatives? The Need For A Genetic "Right To Be Forgotten", Thomas Hale-Kupiec 2016 University of Minnesota Law School

Immortal Invasive Initiatives? The Need For A Genetic "Right To Be Forgotten", Thomas Hale-Kupiec

Minnesota Journal of Law, Science & Technology

No abstract provided.


The Effects Of Allergies And Anaphylaxis On The Body And Mind: A Survey Of Opinions And Knowledge On These Disorders, Kathryn E. O'Brien 2016 Augustana College, Rock Island Illinois

The Effects Of Allergies And Anaphylaxis On The Body And Mind: A Survey Of Opinions And Knowledge On These Disorders, Kathryn E. O'Brien

Honors Program: Student Scholarship & Creative Works

Despite common knowledge, allergies and anaphylaxis are considered disabilities. As such, these disorders affect the daily lives of those who have them, including one's mental health. In this paper, all the nuances of allergies and anaphylaxis will be discussed as the etiology and scientific aspects of allergies, anaphylaxis, and hypersensitivity are distinguished from one another. Furthermore, the findings are reported from two surveys; an assessment of how well educated and prepared teachers are for students with allergies and whether other students with food allergies have had similar experiences to the author's and those described in research by other ...


Maryland's Medical Marijuana Law: Transactional And Ethical Perspectives For Real Estate Practitioners, Nicole M. Lacoste Folks, Lawrence F. Haislip, Matthew L. Kimball 2016 The Law Office of Nicole M. Folks

Maryland's Medical Marijuana Law: Transactional And Ethical Perspectives For Real Estate Practitioners, Nicole M. Lacoste Folks, Lawrence F. Haislip, Matthew L. Kimball

University of Baltimore Journal of Land and Development

The congruence between Federal and state laws relating to marijuana, 2 which has existed for generations, is unraveling. In recent years a number of states have reduced or eliminated criminal penalties for the possession or use of small amounts of marijuana;3 twentythree states have established a state law exception for medical marijuana; 4 and Colorado, Washington, Alaska and Oregon now authorize the retail and personal growth, sale and possession of marijuana as a matter of state law.5 Maryland has lately joined the list of states purporting to create exceptions or safe harbors for those wishing to engage in ...


Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher 2016 Indiana University Robert H. McKinney School of Law

Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher

Washington University Journal of Law & Policy

This article focuses on the unique nature of prohibited disclosures within the health care field. Specifically, this article details the relationship between restrictions on off-label drug use advertising and constitutionally protected free speech. Orentlicher explores the conflict between regulation of off-label drug use through direct prohibition versus regulation through indirect advertising restrictions. Ultimately, Orentlicher argues that pharmaceutical companies should not be able to invoke first amendment arguments against off-label advertising restrictions due to the potential for harm to the consumer.


A Natural Food Fight: The Battle Between The “Natural” Label And Gmos, Colleen Gray 2016 Washington University School of Law

A Natural Food Fight: The Battle Between The “Natural” Label And Gmos, Colleen Gray

Washington University Journal of Law & Policy

This note addresses the complex nature of food labeling in the United States, specifically in relation to the rise of “natural” products. Gray analyzes the history of food labeling, focusing on the use of the term “natural” in relation to products containing genetically modified organisms (GMOs). Gray then argues that due to a lack of regulation by the FDA on what the term “natural” means, consumers have a right to know that the “natural” product they are consuming may contain GMOs.


“Right To Try” Legislation And Its Implications For The Fda Drug Approval Process, Emily Hogan 2016 Washington University School of Law

“Right To Try” Legislation And Its Implications For The Fda Drug Approval Process, Emily Hogan

Washington University Journal of Law & Policy

This note analyzes the regulation of experimental drugs by the FDA within the context of “right-to-try” laws. Hogan explores the FDA’s drug approval process, highlighting the specific options for terminally ill patients to fast-track their access to potentially life-saving drugs. Hogan then turns to state “right-to-try” laws, addressing them in relation to federal preemption, pharmaceutical companies, and actual assistance to terminally ill patients. Hogan recommends a relaxation of the FDA’s drug approval process, specifically streamlining the “expanded access” program to give terminally ill patients access to experimental drugs.


Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States, 15 J. Marshall Rev. Intell. Prop. L. 228 (2016), Daria Kim 2016 John Marshall Law School

Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States, 15 J. Marshall Rev. Intell. Prop. L. 228 (2016), Daria Kim

The John Marshall Review of Intellectual Property Law

The article addresses specifics of trade secret protection under international investment law. As a particular example, it analyzes protection of pharmaceutical regulatory data against the background of the growing public policy campaign for broader access to clinical trial data and the recent unprecedented practice of the European Medicines Agency of disclosing clinical dossiers submitted for drug marketing approval. Given the significant role of foreign direct investment in the global pharmaceutical industry and substantial, exponentially increasing costs incurred by drug originator companies in conducting clinical trials, the prospect of investor-state dispute over data disclosure does not appear purely hypothetical. The question ...


The Art Of Food Placement: Will The U.S. Follow Germany's Lead In Copyrighting Artistic Food Placement?, 15 J. Marshall Rev. Intell. Prop. L. 565 (2016), Julianna Walo 2016 John Marshall Law School

The Art Of Food Placement: Will The U.S. Follow Germany's Lead In Copyrighting Artistic Food Placement?, 15 J. Marshall Rev. Intell. Prop. L. 565 (2016), Julianna Walo

The John Marshall Review of Intellectual Property Law

Recently, German courts created groundbreaking precedent allowing copyright protection for the artistic placement of food on a plate. The rulings allow chefs to prohibit people from taking pictures of the copyrighted food placement. While Germany’s moral-based legal system allows for such copyright protections, this comment compares the U.S. legal system to that of Germany and examines if and how such copyright protection could extend to food placement in the U.S.


Nafta Largely Responsible For The Obesity Epidemic In Mexico, Alana D. Siegel 2016 Washington University in St. Louis

Nafta Largely Responsible For The Obesity Epidemic In Mexico, Alana D. Siegel

Washington University Journal of Law & Policy

This note examines the link between the obesity epidemic in Mexico and NAFTA. Siegel argues that NAFTA’s leniency towards Foreign Direct Investments as well as its limitations on governmental regulation has impeded Mexico’s ability to address detrimental public health concerns, directly contributing to their obesity epidemic. Siegel then attempts to reconcile the desire for free trade with public health regulation by proposing changes to NAFTA’s language in order to create the flexibility necessary to directly address public health concerns.


Introducing Marijuana Law Into The Legal Writing Curriculum, Howard Bromberg, Mark K. Osbeck 2016 University of Michigan Law School

Introducing Marijuana Law Into The Legal Writing Curriculum, Howard Bromberg, Mark K. Osbeck

Articles

Interest in marijuana law continues to grow, due in large part to the complicated and rapidly evolving landscape of marijuana laws in the United States. Nearly every day, newspapers report on new or proposed legislation and the legal controversies that have arisen with regard to this evolving landscape. There are now several marijuana-law blogs on the Internet, Congress is considering sweeping legislation that would essentially grant significant deference to the individual states, and public opinion continues to move in favor of increased legalization. For the last two years, Newsweek magazine has published special editions devoted exclusively to marijuana law and ...


Lessons From Washington And Colorado: The Potential Financial Gains Of Recreational Marijuana To Canada, Nachshon Goltz, Ekaterina Bogdanov 2016 Osgoode Hall Law School of York University

Lessons From Washington And Colorado: The Potential Financial Gains Of Recreational Marijuana To Canada, Nachshon Goltz, Ekaterina Bogdanov

Osgoode Legal Studies Research Paper Series

While Colorado and Washington are among the jurisdictions spearheading the global trend towards legalization of recreational Cannabis (marijuana), Canada lags behind in the regulatory process - but not in Cannabis consumption. An empirical study conducted in downtown Toronto, as well as studies done by Statistics Canada, reveal that Cannabis use is widespread among Canadians, which indicates that the current regulatory regime is not effective as a deterrent.

This paper details the results of the above-mentioned empirical study, reviews the regulatory framework of recreational Cannabis use in Colorado, Washington and Canada, and uses taxation data from Colorado to estimate the potential financial ...


Gras-Fed Americans: Sick Of Lax Regulation Of Food Additives, Martha Dragich 2016 University of Missouri School of Law

Gras-Fed Americans: Sick Of Lax Regulation Of Food Additives, Martha Dragich

Faculty Publications

Americans are “GRAS-fed” because of a “loophole” in the strict regime Congress provided for the regulation of food additives. Additives - and food products containing them - are exempt from this strict regime if they are accorded GRAS (Generally Recognized as Safe) status. The guidelines Congress provided for achieving that status by scientific evidence of safety are no longer observed. Most additives are determined by the producer alone to be GRAS. At the same time, Americans’ consumption of highly processed foods continues to rise, giving rise to long-term health problems that are increasingly tied to diet. The average American’s diet includes ...


Comment: Maryland State Bank: The Responsible Solution For Fostering The Growth Of Maryland's Medical Cannabis Program, David Bronfein 2016 University of Baltimore School of Law

Comment: Maryland State Bank: The Responsible Solution For Fostering The Growth Of Maryland's Medical Cannabis Program, David Bronfein

University of Baltimore Law Forum

In 2013, Maryland passed its initial medical cannabis law.1 Although seemingly a success in the medical cannabis reform movement, the law only allowed for “academic medical centers” to participate in the program.2 In essence, an academic medical center could dispense medical cannabis to patients who met the criteria for participation in their research program.3 The success of this type of program structure was a concern for medical cannabis advocates,4 and the concerns were validated when no academic medical centers decided to participate.5 As a result of this lackluster program, the General Assembly responded by passing ...


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