Food and Drug Law Commons^™

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 …

Note: A Painful Catch-22: Why Tort Liability For Inadequate Pain Management Will Make For Bad Medicine, James R. Blaufuss

William Mitchell Law Review

Part I of this note reviews current issues relating to pain treatment. Part II examines theoretical justifications of proposed tort liability for inadequate pain management. Part III examines how pain mismanagement does not fit within traditional notions of medical malpractice. Part IV studies the issues relating to a physician’s role as “gate-keeper” for opioids and suggests why tort liability could compromise this legislatively imposed role. Part V examines the issue of pain management in the context of end-of-life care. Part VI discusses current shifts in pain management philosophies and explains how these movements will effectuate the changes suggested by advocates …

Stemming The Tide Of Stem Cell Research: The Bush Compromise, 38 J. Marshall L. Rev. 1061 (2005), Patrick Walsh

UIC Law Review

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.

Public Use Or Experimental Use: Are Clinical Trials Susceptible To Another Attack Similar To That In Smithkline Beecham Corp. V. Apotex Corp., 39 J. Marshall L. Rev. 149 (2005), Nimalka Wickramasekera

UIC Law Review

No abstract provided.

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 …

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 …

Raich, Health Care, And The Commerce Clause, Alex Kreit, Aaron Marcus

William Mitchell Law Review

This article considers to what extent health care may be viewed as a traditional area of state concern in the context of the Supreme Court’s revival of federalism principles, in particular limits on Congress’ Commerce Clause power, and what effect Raich v. Ashcroft, heard by the Court in the fall 2004 term, might have on these issues. Addressing these questions will necessarily involve exploration of medical marijuana policy as well as the role of the “traditional state interest” principle within the Commerce Clause. However, the central focus of this article is not what impact Raich may have on the Commerce …

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 …

Breaking The Shield Of The Learned Intermediary Doctrine: Placing The Blame Where It Belongs, Sheryl Calabro

Cardozo Law Review

No abstract provided.

The Cocaine Vaccine, Dru Stevenson

ExpressO

The controversial new cocaine vaccine (TA-CD) has the potential to be an extremely effective treatment tool for recovering addicts, but it also presents opportunities for non-therapeutic uses, such as preventing cocaine use in the first place. It is foreseeable that the cocaine vaccine could become a condition of parole or probation, or receiving welfare payments, or for employment in certain occupations. Universal vaccination is also a possibility but less likely for political reasons. This article investigates each of these areas of potential use. Any setting where mandatory drug testing is currently in place could become a venue for the vaccination. …

Medical Marijuana And Personal Autonomy, 37 J. Marshall L. Rev. 1253 (2004), Andrew J. Boyd

UIC Law Review

No abstract provided.

How A Drug Becomes ‘Ethnic’: Law, Commerce, And The Production Of Racial Categories In Medicine, Jonathan Kahn

Faculty Scholarship

A drug called BiDil is poised to become the first drug ever approved by the Food and Drug Administration (FDA) to treat heart failure in African Americans - and only African Americans. This article explores the story of BiDil and considers some of its broader implications for the use of racial categories in law, medicine, and science. It argues that BiDil is an ethnic drug today as much, if not more because of the interventions of law and commerce as because of any biomedical considerations. The article is, first, a retrospective analysis of how law, commerce, science, and medicine interacted …

Ethnopharmacology, Patents And The Politics Of Plants' Genetic Resources, Remigius N. Nwabueze

Cardozo Journal of International and Comparative Law

The article critiques the exploitation of the South's biodiversity and genetic resources by the North, driven by self-interest and pharmaceutical needs, while highlighting the inequities perpetuated by international frameworks like TRIPS and the CBD. It argues that current legal systems, rooted in Western intellectual property principles, fail to protect indigenous knowledge and traditional practices adequately. The analysis proposes alternative approaches, such as compensation regimes and collective rights organizations, to address these disparities and ensure fair benefit-sharing.

Just What The Doctor Ordered: The Admissibility Of Differential Diagnosis In Pharmaceutical Product Litigation, Wendy Michelle Ertmer

Vanderbilt Law Review

In the decade since Daubert v. Merrell Dow Pharmaceuticals Inc., federal judges have exercised their role as gatekeepers of expert witness testimony to evaluate many different categories of scientific evidence. They have not done so without controversy, however. Because the element of causation in pharmaceutical product litigation is frequently dispositive, the application of Daubert to scientific evidence of causation has been particularly contentious. Plaintiffs in such cases must prove both general causation-that the product is capable of causing an injury of the type from which the plaintiff suffers-and specific causation-that the product was the actual cause of the plaintiffs injury. …

Curing Healthcare Providers' Failure To Administer Opioids In The Treatment Of Severe Pain, Rima J. Oken

Cardozo Law Review

No abstract provided.

Drug Designs Are Different, Aaron Twerski, J. A. Henderson

Faculty Scholarship

No abstract provided.

Self-Prescribing Medication: Regulating Prescription Drug Sales On The Internet, 20 J. Marshall J. Computer & Info. L. 57 (2001), Kristin Yoo

UIC John Marshall Journal of Information Technology & Privacy Law

"Online pharmacies, your friendly neighborhood drugstores." The Internet is not only a great telecommunication medium but also a low-cost and convenient commercial marketplace. It is no exception that online pharmacies flourished as a result, but the consequences of such development pose grave danger to the public and great challenges to regulations. The author discusses the benefits and risk of online pharmacies, the different types of online pharmacies, state governments' involvement in regulating online prescriptions and federal involvements. Despite both state and federal legislations and regulations, proliferation of online pharmacies, established inside and outside of the US, proves to be a …

Web Of Manipulation: The Learned Intermediary Doctrine And Direct-To-Consumer Advertising On The World Wide Web, 35 J. Marshall L. Rev. 97 (2001), April L. Foreman

UIC Law Review

No abstract provided.

Cigar Warnings: Proceed With Caution, 33 J. Marshall L. Rev. 521 (2000), Patricia A. Davidson

UIC Law Review

No abstract provided.

Rx For Liability: Advocating The Elimination Of The Pharmacist's No Duty To Warn Rule, 33 J. Marshall L. Rev. 425 (2000), Edward Casmere

UIC Law Review

No abstract provided.

Direct-To-Consumer Advertising Of Prescription Drugs: After A Decade Of Speculation, Courts Consider Another Exception To The Learned Intermediary Rule, Mae Joanne Rosok

Seattle University Law Review

This Comment will explore whether Washington courts should recognize direct-to-consumer advertising as an exception to the learned intermediary rule. With the ultimate goal of advocating the best protection for the consumer, the discussion will suggest that Washington courts should not create an exception. A review of other exceptions to the learned intermediary rule does not support abandoning the doctrine when a drug company advertises its product directly to consumers. Nevertheless, advertising does affect consumer purchases and does influence consumer choices, and drug companies should accept the responsibility to present balanced information. This responsibility should encompass more than meeting the minimum …

Dollywood Is Not Just A Theme Park In Tennessee Anymore: Unwarranted Prohibitory Human Cloning Legislation And Policy Guidelines For A Regulatory Approach To Cloning, 31 J. Marshall L. Rev. 1385 (1998), Paul Tully

UIC Law Review

No abstract provided.

In Memoriam: Ralph Seeley Obscured By Smoke: Medicinal Marijuana And The Need For Representation Reinforcement Review, Aryeh Y. Brown

Seattle University Law Review

This Comment contends that because of the continuing legislative inability to deal adequately with this issue the courts must apply strict judicial scrutiny by way of a representational reinforcement theory to cases concerning the medicinal use of marijuana. Failure to do so perpetuates the dysfunction of the judicial and legislative process. It additionally detracts from the legitimacy of that process by fostering cynicism and contempt toward the legislature that promulgates such oppressive laws and toward the judiciary that allows their enforcement.

Overdue Process: Why Denial Of Physician-Prescribed Marijuana To Terminally Ill Patients Violates The United States Constitution, Matthew Segal

Seattle University Law Review

This Comment will begin with a brief history of the medical use of marijuana in western culture and the United States. It will then examine the existing federal statutory scheme governing the use of marijuana and conclude with a look at current beliefs about the medical value of marijuana. Section III will analyze previous attempts to collaterally attack the scheduling of marijuana through the courts and show why those efforts have generally failed. Section IV will perform a substantive due process analysis of William Cohen's case and submit that Mr. Cohen has a fundamental right to consult with his physician …

The International Conference On Harmonization Of Pharmaceutical Regulations, The European Medicines Evaluation Agency, And The Fda: Who's Zooming Who?, Dan Kidd

Indiana Journal of Global Legal Studies

No abstract provided.

Hiv-Aids In The 1990s Aids Law Symposium: Legal, Ethical, And Policy Issues: Introduction, 27 J. Marshall L. Rev. 239 (1994), Michael L. Closen

UIC Law Review

No abstract provided.

Book Review: Aids In The World, 16 Hous. J. Int'l L. 709 (1994), Mark E. Wojcik

UIC Law Open Access Faculty Scholarship

No abstract provided.