Law Commons^™

From Harm To Robustness: A Principled Approach To Vice Regulation, Jim Leitzel

ExpressO

John Stuart Mill’s harm principle maintains that adult behavior cannot justifiably be subject to social coercion unless the behavior involves harm or a significant risk of harm to non-consenting others. The absence of harms to others, however, is one of the distinguishing features of many manifestations of “vices” such as the consumption of alcohol, nicotine, recreational drugs, prostitution, pornography, and gambling. It is with respect to vice policy, then, that the harm principle tends to be most constraining, and some current vice controls, such as prohibitions on drug possession and prostitution, violate Mill’s precept. In the vice arena, we seem …

Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

This Article will first examine why it is that plaintiffs have been unable to prove causation under the Daubert guidelines in toxic tort litigation. Second, it will look at the two existing models for informed choice litigation medical malpractice and products liability-and demonstrate why neither of these models gives toxic tort plaintiffs a fair opportunity to recover for the deprivation of patient autonomy against drug manufacturers who have breached their duty to warn of known or knowable risks. Finally, this Article will explore the elements of a causation-free informed choice cause of action. It will suggest the appropriate standard for …

Deadly Discounts: How Reimportation Jeopardizes The Safety Of The U.S. Pharmaceutical Drug Supply Under The Federal Trade Commission Amendment, Nicole C. Bates

ExpressO

The amendment to a Federal Trade Commission (FTC) reauthorization bill, previously introduced as Senate Bill 334 (S.334) Pharmaceutical Market Access and Drug Safety Act of 2005 allows for the reimportation of prescription drugs into the United States from approximately 25 countries, including Canada via Internet pharmacies. There are no guarantees that the internet websites advertising as Canadian pharmacies are legitimate. The shipping of pharmaceutical drugs occurs through importation, which refers to drugs produced abroad then later shipped to the U.S., or re-importation, a term applied when drugs are produced in the U.S. and exported for sale to foreign countries and …

Blame Canada (And The Rest Of The World): The Twenty-Year War On Imported Prescription Drugs, Daniel L. Pollock

ExpressO

Rising budget deficits and sticker shock over the new Medicare drug benefit have put the issue of prescription drug costs back into the spotlight. The growth in the cost of prescription drugs continues to represent a staggering burden for taxpayer-funded health care programs, even while costs of non-drug health care services have slowed or even decreased. Among the many proposals for cutting prescription drug costs, drug importation is unique. Although bipartisan support for drug importation has existed in Congress for over five years, the federal government continues to maintain that a system of safe and effective drug importation is impossible. …

Project Bioshield, More Than Meets The Eye: A Critique Of The U.S.’S Proposed Silver Bullet For Responding To Bio-Terrorism, Jodi A. Phillipo

ExpressO

No abstract provided.

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

“Racially-Tailored” Medicine Unraveled, Sharona Hoffman

ExpressO

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus, is the first treatment of its kind. The drug likely portends a future of growing interest in “race-based” medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that “race” has no biological meaning, and consequently, “racially-tailored” medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on “racial-profiling” in medicine. It analyzes the risks and dangers of this approach, including medical …

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

George Mason University School of Law Working Papers Series

This paper is a critique of Margaret Berger and Aaron Twerski, “Uncertainty and Informed Choice: Unmasking Daubert”, forthcoming the Michigan Law Review. Berger and Twerski propose that courts recognize a cause of action that would allow plaintiffs who claim injury from pharmaceutical products, but who do not have sufficient evidence to prove causation, to recover damages for deprivation of informed choice. Berger and Twerski claim inspiration from the litigation over allegations that the morning sickness drug Bendectin caused birth defects. Considering the criteria Berger and Twerski suggest for their proposed cause of action in the context of Bendectin, it appears …

Liability For Direct Advertising Of Drugs To Consumers: An Idea Whose Time Has Not Come, Aaron Twerski

Faculty Scholarship

No abstract provided.

A Government Of Limited Powers, Carl E. Schneider

Articles

Roscoe C. Filburn owned a small farm in Ohio where he raised poultry, dairy cows, and a modest acreage of winter wheat. Some wheat he fed his animals, some he sold, and some he kept for his family's daily bread. The Agricultural Adjustment Act of 1938 limited the wheat Mr. Filburn could grow without incurring penalties, but his 1941 crop exceeded those limits. Mr. Filburn sued. He said Claude Wickard, the Secretary of Agriculture, could not enforce the AAI's limits because Congress lacked authority to regulate wheat grown for one's own use. He reasoned: In our federal system, the states …

The Effects Of Price Regulation On Pharmaceutical R&D And Innovation, Heather M. O'Neill, Lena Clarissa Crain

Business and Economics Faculty Publications

As rising health care expenditures focus government attention on slowing the growth, the pharmaceutical industry comes under increasing pressure to curb prices of ethical drugs. Pharmaceutical price regulations have been implemented in many countries to control pharmaceutical expenditures. Yet, creating innovative drugs requires enormous R&D costs, which in turn require adequate expected economic returns. Since price controls reduce profits and expected returns, as countries invoke stricter price regulations, firms will either move their R&D process into less regulated markets or move out of innovative R&D. This paper assesses the impact of drug price regulations in Japan compared to market-priced drugs …

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …

Adequate Drug Warnings In The Face Of Uncertain Causality: The Learned Intermediary Doctrine And The Need For Clarity, Michael Imbroscio, Gabriel Bell

West Virginia Law Review

No abstract provided.

Protecting Protected Speech: First Amendment Taxonomy And The Food And Drug Administration's Regulation Of "Enduring Materials", Daniel J. Gilman

Faculty Scholarship

Numerous comments have called upon the Food and Drug Administration (FDA) to exercise restraint in its treatment of the dissemination of “enduring materials” (e.g., textbooks, journal articles, etc.) that address off-label uses of drug or biological products. This article considers the constitutional protections that apply to enduring materials as examples of commercial speech, and questions whether such materials—even though distributed by manufacturers—might be viewed more properly as scientific speech. Four conclusions will be set forth: 1) enduring materials regarding off-label uses deserve at least as much protection as the Constitution affords commercial speech; 2) there are good reasons to think …

Debacle In Dixie: A Story Of Six Rivers, Three States, Two Compacts And One Well-Paved Path, George William Sherk

Publications

No abstract provided.

Delawate River Basin Compact, Jeffrey Featherstone

Publications

No abstract provided.

The Impact And Limits Of The Constitutional Deregulation Of Health Claims On Foods And Supplements: From Dementia To Nuts To Chocolate To Saw Palmetto, Margaret Gilhooley

Mercer Law Review

The Food and Drug Administration ("FDA") recently issued an enforcement policy identifying the types of health claims in the disclaimers that are constitutionally permitted on foods and dietary supplements. In 1990 Congress required that before a company could make a health claim on a food product, the FDA must approve the claim as based on significant scientific agreement. While the 1990 law gave the FDA discretion to establish a lesser standard for nutritional supplements than for food products, the FDA chose to apply the same standard. Thus, claims on nutritional supplements had to be supported by significant scientific agreement. Supplement …

Strictly Speaking About Ephedra: A Baseball Tragedy Helping To Define The Dynamic Between Warning Defect And Design Defect, Michael Kane

Jeffrey S. Moorad Sports Law Journal

No abstract provided.

The Roles Of Precaution And Political Accountability In The Regulation Of Polybrominated Diphenyl Ethers, Danielle Brim

Vanderbilt Journal of Transnational Law

The differing approaches used in the United States and the European Union to regulate toxic chemicals have been highlighted by debates about a group of chemicals called polybrominated diphenyl ethers, or PBDEs. PBDEs act as flame-retardants and are added to consumer products to increase their safety. Questions about the continued use of PBDEs have been raised, however, because of concerns that PBDEs may be dangerous to human health and the environment. The European Union has decided to ban two types of PBDEs, while the United States has not issued similar restrictions. In this Note, the Author argues that neither decision …

Minnesota: Leading The Way On Canadian Prescription Medicine Importation, Kevin Goodno, Karen Janisch

William Mitchell Law Review

In the United States, about $160 billion is spent on prescription medicines each year, with Minnesotans spending about $3 billion. The costs of prescription medicines receive so much attention in large part because, although prescription medicine costs constitute only 10.5% of total health care spending, they account for 23% of the total out-of-pocket costs that people incur when purchasing health care. Minnesota has been a leader in controlling prescription medicine costs. It has aggressively used purchasing pools when possible, and encouraged the use of lower cost, generic prescription medicines when appropriate. Even with these efforts to control costs, prescription medicines …

Aetna V. Davila/Cigna V. Calad: A Missed Opportunity, Leonard A. Nelson

William Mitchell Law Review

On June 21, 2004, the United States Supreme Court decided the health law “case of the year” in the two consolidated cases of Aetna Health, Inc. v. Davila and CIGNA HealthCare of Texas, Inc. v. Calad. The Court held that section 502(a) of the Employee Retirement Income Security Act of 1974 (ERISA) “completely preempt[s]” and thus invalidates the tort liability provisions of the Texas Health Care Liability Act (THCLA). The case could potentially affect the rights of millions of Americans in a matter of vital concern—whether they will receive the health insurance coverage promised them if they become unable to …

Note: Capping Noneconomic Damages In Medical Malpractice Suits Is Not The Panacea Of The “Medical Liability Crisis”, Melissa C. Gregory

William Mitchell Law Review

This note explores the history behind the rising costs of medical malpractice insurance rates and the responsive state legislative proposals to limit noneconomic damages. The current state of health care liability and the recent federal proposals that include caps on noneconomic damages are then discussed. This note analyzes the reasons why the federal government should not cap noneconomic damages, primarily because: (1) states are better able to regulate health care, (2) noneconomic damages are not the determinate cause of rising medical malpractice insurance rates, and (3) caps infringe on equal protection guarantees by limiting compensation of medical malpractice victims. This …

The End Of Azt Patent: A New Beginning Or Too Little Too Late?, Lindsay Frank

Public Interest Law Reporter

No abstract provided.

Free Trade And Illegal Drugs: Will Nafta Transform The United States Into The Netherlands?, Taylor W. French

Vanderbilt Journal of Transnational Law

In the postwar era, the United States typically has taken an approach to dealing with illegal drugs different from Europe. Americans have favored prohibitionist measures to combat drug use, while Europeans have gradually relaxed many of their illicit substance laws. Recently, however, there has been a growing movement within the United States to decriminalize and legalize marijuana. Numerous states have already reformed their laws to allow doctors to prescribe marijuana to patients. Moreover, many states are dramatically decriminalizing personal use of cannabis.

A review of postwar Europe's experience with drugs provides a useful paradigm to explain the U.S.'s shifting attitude. …

Access To Justice And The Right To Adequate Food: Implementing Millennium Development Goal One, Marc J. Cohen, Mary Ashby Brown

Sustainable Development Law & Policy

No abstract provided.

World News, Blase Kornacki, Abby Okrent, Jennifer Rohleder, Mauro Zinner

Sustainable Development Law & Policy

No abstract provided.

Water Privatization And Obstacles To Achieving Millennium Development Goal Seven's Targets For Sustainable Drinking Water, Maria Vanko

Sustainable Development Law & Policy

No abstract provided.

Patients Beware: Preemption Of Common Law Claims Under The Medical Device Amendments, 39 J. Marshall L. Rev. 75 (2005), Michael P. Dinatale

UIC Law Review

No abstract provided.

"Racially-Tailored" Medicine Unraveled, Sharona Hoffman

American University Law Review

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus is the first treatment of its kind. The drug likely portends a future of growing interest in "race-based" medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that "race" has no biological meaning, and consequently, "racially-tailored" medicine is both puzzling and troubling. This Article explores the reasons for the new focus on "racial-profiling" in medicine. It analyzes the risks and dangers of this approach, including medical …

Off-Label Use And The Medical Negligence Standard Under Minnesota Law, Cynthia A. Moyer

William Mitchell Law Review

Who decides whether a drug can be used off-label and under what circumstances? If a physician decides to prescribe a drug off-label, what legal issues, if any, should the physician be aware of? With the increased practice of prescribing drugs for off-label use, coupled with a somewhat dated and incomplete medical negligence standard in Minnesota, the intersection of the off-label use doctrine with Minnesota’s medical negligence standard is ripe for review. This article examines the off-label use doctrine and the medical negligence standard under Minnesota law. First, the article examines what the phrase “off-label use” means. Next, the article explores …