Law Commons^™

The World Trade Organization Dispute Over Genetically Modified Organisms: The Precautionary Principle Meets International Trade Law, David A. Wirth

David A. Wirth

“Precaution” is increasingly accepted as a basis for governmental policy in the areas of public health and environment on both the domestic and international levels. A precautionary perspective counsels action to avert danger or threats in situations of scientific uncertainty or incomplete information. Precautionary approaches find expression in internationally harmonized formulations as non-binding exhortations, binding treaties, and meta-level principles. Precaution is a particular challenge to free trade agreements, whose purpose is to eliminate unjustified barriers to trade. In that context, precaution as a justification for a challenged governmental measure may appear to be nothing more than a pretext for protectionism. …

The Unbearable Whiteness Of Milk: Food Oppression And The Usda, Andrea Freeman

UC Irvine Law Review

No abstract provided.

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Maryland Law Review Online

No abstract provided.

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Faculty Scholarship

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Breathe Deeply: The Tort Of Smokers' Battery, Irene Scharf

Irene Scharf

This Article explores the long and faltering history of attempts to impose liability on tobacco product manufactures. Part II traces the manufacturers' historical and current actions of targeting youth through both promotions and deceptive advertising. Part III argues in favor of an expanded cause of action against the manufacturers for the intentional tort of battery. Part IV discusses the prospect of awards of punitive damages in these cases, and the Epilogue summarizes other advantages of the battery cause of action.

Brand Name Or Generic? A Case Note On Caraco Pharmaceutical Laboratories V. Novo Nordisck , Michael Vincent Ruocco

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

The 1988 U.N. Convention Against Illicit Traffic In Narcotic Drugs And Psychotropic Substances - A Ten Year Perspective: Is International Cooperation Merely Illusory?, Jimmy Gurule

Jimmy Gurule

On the ten-year anniversary of the adoption of the 1988 U.N. Drug Convention, this Article analyzes whether signatory- parties have complied with the duties and obligations imposed thereunder, and, in particular, whether the Convention has enhanced international cooperation in narcotics enforcement. Part I of this Article examines the legal obligations and duties imposed under the 1988 U.N. Drug Convention, with special emphasis on the provisions aimed at criminalizing money laundering and at forfeiture of illicit drug proceeds and instrumentalities of narcotics trafficking. Additionally, Part I examines the requirement that parties afford one another the "widest measure of mutual legal assistance …

The Grapes Of Wrath: Encouraging Fruitful Collaborations Between Local Governments And Farm Wineries In The Commonwealth, Philip Carter Strother, Andrew E. Tarney

University of Richmond Law Review

No abstract provided.

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Joe M Stell Ombudsman Program - Taos Settlement Technical Work, Peggy Barroll

Publications

No abstract provided.

Seeing Through The Murky Vial: Does The Fda Have The Authority To Stop Compounding Pharmacies From Pirate Manufacturing?, Michael Snow

Vanderbilt Law Review

In late 2012 and early 2013, tainted steroid shots from the New England Compounding Center ("NECC") caused fifty-five deaths and 745 cases of fungal meningitis in twenty states.' On October 1, 2012, the Food and Drug Administration ("FDA") inspected NECC and found vials of steroids filled with enough floating contamination to be visible to the human eye. These NECC steroid shots were distributed primarily to treat back pain, but the patients who received them were injected with foreign matter containing the deadly fungi Exserohilum rostratum or Aspergillus fumigatus. The earliest reported death from fungal meningitis caused by NECC was seventy-eight-year-old …

Eating Invaders: Managing Biological Invasions With Fork And Knife?, Joshua Ulan Galperin, Sara Kuebbing

Elisabeth Haub School of Law Faculty Publications

As the public, academy, government, and private sector all turn increased attention to food systems, new ideas constantly emerge for healthy, sustainable, and just innovations in growing, marketing, and eating food. “Invasivory” — eating invasive species — is one such idea. Biological invasions occur when humans transport an organism from its ecosystem of origin into a new ecosystem and that organism adapts to its new location, spreading widely from the site of introduction. Invasive species can cause significant ecological, economic, and public health damage. Crops, homes, and native species are all at risk. “Invasivores,” as the proponents of invasivory are …

"Rfra Exemptions From The Contraception Mandate: An Unconstitutional Accommodation Of Religion", Frederick Mark Gedicks, Rebecca G. Van Tassell

Frederick Mark Gedicks

Litigation surrounding use of the Religious Freedom Restoration Act to exempt employers from the Affordable Care Act’s “contraception mandate” is moving steadily towards eventual resolution in the U.S. Supreme Court. Both opponents and supporters of the mandate, however, have overlooked Establishment Clause limits on such exemptions. The fiery religious-liberty rhetoric surrounding the mandate has obscured that RFRA is a “permissive” rather than “mandatory” accommodation of religion—that is, a voluntary government concession to religious belief and practice that is not required by the Free Exercise Clause. Permissive accommodations must satisfy Establishment Clause constraints, notably the requirement that the accommodation not impose …

Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.

Lisa C. Blanton BS., MJ.

The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.^[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status^[2] and granting accelerated “fast-track” approval time-frames.^[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA …

Farm To Institution, Harvard Law School Food Law And Policy Clinic, Harvard Law School Mississippi Delta Project

Delta Directions: Publications

In a state with rich agricultural resources and a long farming tradition, why are Mississippi’s institutions serving fruits and vegetables mostly shipped from other states and countries? Connecting Mississippi growers with institutions within the state offers a promising way to increase fruit and vegetable consumption while improving the economic viability of local farms. This step-by-step guide aims to help growers in Mississippi start to sell locally grown foods to be served in meals at institutions around the state, such as hospitals, schools, prisons, and state and local government agencies.

Groundwater Challenges In Spain: Lessons From The Western Mancha Aquifer, Pedro Martinez-Santos

Publications

No abstract provided.

Conflicting Federal And State Medical Marijuana Policies: A Threat To Cooperative Federalism, Todd Grabarsky

West Virginia Law Review

The legal status of medical marijuana in the United States is something of a paradox. On one hand, the federal government has placed a ban on the drug with no exceptions. On the other hand, forty percent of states have legal- ized its cultivation, distribution, and consumption for medical purposes. As such, medical marijuana activity is at the same time proscribed (by the federal government) and encouraged (by state governments through their systems of regulation and taxation). This Article seeks to shed light on this unprecedented, nebulous zone of legality in which an activity is both legal and illegal, what …

Pharmaceutical Efficacy: The Illusory Legal Standard , Jonathan J. Darrow

Washington and Lee Law Review

The very long and expensive process of new drug research and development might suggest to observers that the efficacy standard for drugs is elevated and substantial, but this is not the case. Under the U.S. Federal Food, Drug, and Co smetic Act, new drug approval merely requires that there be “substantial evidence that the drug will have the effect it purports or is represented to have.” While the evidence of effectiveness must therefore be substantial, the efficacy attested to by that evidence need not surpass any particular threshold (other than zero), thus allowing drugs with de minimis efficacy to be …

After Caronia: First Amendment Concerns In Off-Label Promotion, Stephanie Greene

Stephanie Greene

After Caronia: First Amendment Concerns in Off-Label Promotion by Stephanie M. Greene* Abstract The government has successfully prosecuted pharmaceutical companies for off-label promotion of drugs, maintaining that such promotion impermissibly undermines the FDA’s pre-market approval process and jeopardizes the public health. In several recent cases, however, pharmaceutical companies have alleged that regulations prohibiting such promotion are unconstitutional because off-label promotion is protected under the First Amendment. Two recent Supreme Court cases contain language that gives broad protection to advertising and marketing in the pharmaceutical field. This paper questions the reach of these cases as applied to the practice of off-label …

A Decade’S Quest For Safer Drugs: Congressional Committee Green Lights Regulation Of Drug Supply Chains And Compounding Manufacturers, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died …

Bioethics And Law In The United States: A Legal Process Perspective, Charles Baron

Charles H. Baron

An analytical exposition of the law regarding a patient's "right to die" as it has developed in the United States over the last 30 years provides an exemplar overview of the variety of legal mechanisms that American legal institutions can and do bring to bear to deal with the challenges posed by new developments in medicine and the biosciences. Opposing "pro-life" and "pro-choice" ideological and political forces have been channeled through the federal and state legislative, judicial, and executive branches, where the various legal actors have developed legal principles that so far provide patients with a right to refuse any …

The Dialogue Between Biomedicine And Law In An “Intraamerican Transnational Perspective”, Charles Baron

Charles H. Baron

No abstract provided.

Blood Transfusions, Jehovah’S Witnesses, And The American Patients’ Rights Movement, Charles H. Baron

Charles H. Baron

The litigation to protect Jehovah’s Witnesses from unwanted blood transfusions, which their theology considers a violation of the biblical prohibition against drinking blood, has produced important changes in both the right to refuse treatment and in the preferred treatment methods of all patients. This article traces the evolution of the rights of competent medical patients in the United States to refuse medical treatment. It also discusses the impact this litigation has had on the medical community’s realization that blood transfusions were neither as safe nor as medically necessary as medical culture posited.

Competency And Common Law: Why And How Decision-Making Capacity Criteria Should Be Drawn From The Capacity-Determination Process, Charles Baron

Charles H. Baron

Determining competence to request physician-assisted suicide should be no more difficult than determining competence to refuse life-prolonging treatment. In both cases, criteria and procedures should be developed out of the process of actually making capacity determinations; they should not be promulgated a priori. Because patient demeanor plays a critical role in capacity determinations, it should be made part of the record of such determinations through greater use of video- and audiotapes.

Hastening Death: The Seven Deadly Sins Of The Status Quo, Charles Baron

Charles H. Baron

The seven deadly sins of the status quo -- inhumanity, paternalism, Utilitarianism, hypocrisy, lawlessness, injustice, and the deadly risk of error and abuse -- are seven arguments against maintaining the artificial bright-line distinction between the prohibition against assisted suicide and the allowance of patients’ right to refuse life-prolonging treatment. This article calls on courts and legislatures to follow the successful example of the Oregon Death with Dignity statute.

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

Visual Gut Punch: Persuasion, Emotion, And The Constitutional Meaning Of Graphic Disclosure, Ellen P. Goodman

ellen p. goodman

The ability of government to “nudge” with information mandates, or merely to inform consumers of risks, is circumscribed by First Amendment interests that have been poorly articulated in the relevant law and commentary. New graphic cigarette warning labels supplied courts with the first opportunity to assess the informational interests attending novel forms of product disclosures. The D.C. Circuit enjoined them as unconstitutional, compelled by a narrative that the graphic labels converted government from objective informer to ideological persuader, shouting its warning to manipulate consumer decisions. This interpretation will leave little room for graphic disclosure and is already being used to …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …