Law Commons^™

Heart Pills Are Red, Viagra Is Blue… When Does Pill Color Become Functional? An Analysis Of Utilitarian And Aesthetic Functionality And Their Unintended Side Effects In The Pharmaceutical Industry, Signe H. Naeve

Signe H. Naeve

Abstract: As consumers we often associate pill color and shape with particular medications. Should that trade dress be protected beyond the expiration of the patent? Legal scholars have recognized some of the tensions and inconsistencies in court opinions when it comes to trade dress protection for pill shape and color. This article focuses on the specific tensions between requiring secondary meaning and non-functionality, as well as the potential of “genericide” when generic pharmaceuticals enter the market. Ultimately this article makes some novel recommendations to assess functionality at the time of FDA approval for the pharmaceutical and to have the FDA …

Water Rx: The Problem Of Pharmaceuticals In Our Nation's Waters, Melanie Leitman

Melanie Leitman

No abstract provided.

Memory And Punishment, Orlando Carter Snead

O. Carter Snead

This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish is inextricably intertwined with how a crime is remembered — by the offender, by the sentencing authority, …

Information Defects In The Age Of Information: When More Is Less, Edward C. Combs Jr.

Edward C Combs Jr.

Warning labels from product manufacturers serve both as a shield to the consumer from physical injury and as a safeguard to the manufacturer from civil liability. A question then arises whether these two distinct interests, that of the manufacturer and of the consumer, are equally protected by our current products liability jurisprudence. Another way to approach this question is by asking when is a product deemed “safe”? Is it determined by an assessment of the totality of injuries associated with its use or do we arrive at the premise that a product is “safe” when a court finds no liability …

Food Sovereignty Is A Gendered Issue, Margaret Ellinger-Locke

Margaret Ellinger-Locke

No abstract provided.

Putting The Gene Back In The Bottle: Why California Needs Stronger Protection Of Genetic Privacy In The Wake Of Affordable Dna Testing, Farid Zakaria

Farid Zakaria

In recent years, many “direct-to-consumer” genetic testing companies have started offering a DNA analysis service to the public. Based on the analysis of the DNA contained in saliva, these companies are able to inform the customer about his or her likelihood of having certain traits and of developing a number of diseases. Given the sensitive nature of this kind of information, this paper considers whether it is sufficiently protected under the current legal and regulatory framework. Specifically, the paper studies whether current federal, state, and common law that protects medical and private information also guarantees the privacy of genetic information. …

“Supplementing” The Dshea: Congress Must Invest The Fda With Greater Regulatory Authority Over Nutraceutical Manufacturers By Amending The Dietary Supplement Health And Education Act. 98 Cal. L. Rev. 493., Rahi Azizi

Rahi Azizi

ABSTRACT This paper addresses serious deficiencies in the Dietary Supplement Health and Education Act, or "DSHEA." In it, I argue that the DSHEA (a federal statute passed by Congress in 1994, superseding the Food Drug and Cosmetics Act as the applicable law governing the sale of nutraceutical products) gives impermissible latitude to manufacturers of dietary supplements by allowing them to sell products without establishing whether they are safe or effective. The DSHEA also allows manufacturers to employ unsubstantiated and misleading labeling claims in marketing their products. I assert that the DSHEA promotes deceptive labeling practices. I also suggest that the …

Cheaters Shouldn't Prosper And Consumers Shouldn't Suffer: The Need For Governmental Enforcement Against Economic Adulteration Of 100% Pomegranate Juice And Other Imported Food Products, Michael T. Roberts

Michael T. Roberts Esq.

ABSTRACT

This article examines the failure of government agencies, including the U.S. Food and Drug Administration, to enforce against the adulteration of economically adulterated imported food product. The problem of economic adulteration has emerged in the modern global food system as a serious threat to the health of consumers, the economic livelihoods of honest purveyors of food, and the integrity of national food regulatory systems. These consequences were recently evidenced by the China melamine scandal that sickened and killed both infants and pets.

This article addresses the problem of a lack of enforcement against economic adulteration through the prism of …

Military Technologies, Nanotechnology And Law: Using Nano-Science Fiction As An Analytical Tool, Victoria Sutton

Victoria Sutton

Michael Crichton’s novel, Prey, a science fiction, cautionary tale about nanotechnologies and their development for military use, is useful in analyzing our regulatory framework for nanotechnologies.

Improving The Safety Of Central Nervous System Stimulants, Anne Kulli

Anne Kulli

No abstract provided.

An Educational Approach To School Food: Using Nutrition Standards To Promote Healthy Dietary Habits, Timothy D. Lytton

Timothy D. Lytton

This article proposes a novel approach to school food reform that promotes healthy dietary habits. Daily aggregate nutrition standardization (DANS) assigns each student an individualized standard to monitor the nutritional quality of all food provided to that student in school at any time of the day, including meals and snacks, whether from the cafeteria, vending machines, bake sales, or in class. DANS would enable schools to track all foods purchased by or served to a student each day and to compare the nutritional content of those foods to a nutrition standard appropriate for that student. Cafeteria registers and vending machines …

The Supreme Court's Assault On Litigation: Why (And How) It Could Be Good For Health Law, Abigail R. Moncrieff

Abigail R. Moncrieff

In recent years, the Supreme Court has narrowed or eliminated private rights of action in many legal regimes, much to the chagrin of the legal academy. That trend, although certainly not limited to health law, has had a significant impact on the field; the Court’s decisions have eliminated the private enforcement mechanism for at least three important healthcare regimes: Medicaid, employer-sponsored insurance, and medical devices. In a similar trend outside the courts, state legislatures have capped noneconomic and punitive damages for medical malpractice litigation, weakening the tort system’s deterrent capacity in those states. This Article points out that the trend …

An Educational Approach To School Food: Using Nutrition Standards To Promote Healthy Dietary Habits, Timothy D. Lytton

Timothy D. Lytton

This article proposes a novel approach to school food reform that promotes healthy dietary habits. Daily aggregate nutrition standardization (DANS) assigns each student an individualized standard to monitor the nutritional quality of all food provided to that student in school at any time of the day, including meals and snacks, whether from the cafeteria, vending machines, bake sales, or in class. DANS would enable schools to track all foods purchased by or served to a student each day and to compare the nutritional content of those foods to a nutrition standard appropriate for that student. Cafeteria registers and vending machines …

Improving The Fda Approval Process, Anup Malani

Anup Malani

The FDA employs an average-patient standard when reviewing drugs: it approves a drug only if is safe and effective for the average patient in a clinical trial. It is common, however, for patients to respond differently to a drug. Therefore, the average-patient standard can reject a drug that benefits certain patient subgroups (false negative) and even approval a drug that harms other patient subgroups (false positives). These errors increase the cost of drug development – and thus health care – by wasting research on unproductive or unapproved drugs. The reason why the FDA sticks with an average patient standard is …

A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Should Employees Have To Choose Between Enduring Pain And Keeping Their Jobs?, Reka Bala

Reka Bala

For patients in constant pain, medical marijuana is often the only substance that offers complete relief. Yet these individuals and their employers are still at risk of job-related concerns as cannabis legislation consistently neglects employment issues. In a controversial 2008 decision, Ross v. RagingWire Telecommunications, Inc. forced California cannabis patients to cruelly decide between alleviating pain and staying employed. This Note argues that Ross contradicts legislative intent and violates state and federal law, all of which call for broader rights to medical marijuana users. It also recommends changing California law or designing a judicial remedy to better protect patients from …

Should Employees Have To Choose Between Enduring Pain And Keeping Their Jobs?, Reka Bala

Reka Bala

For patients in constant pain, medical marijuana is often the only substance that offers complete relief. Yet these individuals and their employers are still at risk of job-related concerns as cannabis legislation consistently neglects employment issues. In a controversial 2008 decision, Ross v. RagingWire Telecommunications, Inc. forced California cannabis patients to cruelly decide between alleviating pain and staying employed. This Note argues that Ross contradicts legislative intent and violates state and federal law, all of which call for broader rights to medical marijuana users. It also recommends changing California law or designing a judicial remedy to better protect patients from …

Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman

Christopher M Holman

Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB …

An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin

Margarita Rubin

ABSTRACT Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical …

An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin

Margarita Rubin

ABSTRACT Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical …

If I Eat This Will It Kill Me? An Analysis Of China's New Food Safety Law And Other Protections To Regulate Food Produced In China, Marisa Anne Pagnattaro, Ellen Peirce

marisa pagnattaro

Reports about defective and dangerous food and drugs manufactured in China are a regular occurrence. The growing complexity these supply chains present legal liability and risks to the suppliers, manufacturers, retailers and, ultimately, to consumers. Part I of this paper describes two examples, milk and heparin, illustrating the problems with food and drug safety; Part II analyzes China’s developing regulations, focusing on the comprehensive new Food Safety Law, effective on June 1, 2009. Part III details the U.S. regulatory framework and recent steps taken by the U.S. government to monitor food safety in China. Part IV contrasts the European Union …

Harder, Better, Faster Stronger: Regulating Illicit Adderall Use Among Law Students And Law Schools, Jennifer Schiffner

Jennifer Schiffner

The widespread illicit use of Adderall as a performance enhancer raises significant challenges for law schools and for law students entering the legal profession. Adderall, a stimulant-based performance enhancer prescribed for those with juvenile and adult attention deficit (ADD) and attention-deficit hyperactivity disorder (ADHD), increases a person’s ability to concentrate by stimulating the production of dopamine and norepinephrine in the brain. Taken without a prescription for ADD or ADHD, Adderall over-stimulates the brain allowing for super-enhanced focus with a simple pill. For law students, the allure of this Controlled Substances Act Schedule II drug is simple: efficiency. However, despite easing …

All I Need Is A Miracle And A Constitutional Right To Access It: The Rights Of The Terminally Ill Reconsidered, Amy M. Dudash

Amy M. Dudash

In Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, Abigail Alliance sought to enjoin the FDA from preventing the sale of investigational drugs to terminally ill patients. The Alliance argued that terminally ill patients have a constitutional right to access investigational drugs under the Due Process Clause of Fifth Amendment. In order to determine if a right to non-FDA approved drugs existed under the Due Process Clause, the court applied the test laid out in Washington v. Glucksberg. An en banc panel of the D.C. Circuit Court of Appeals held that terminally ill patients did not have …

Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley

Margaret Gilhooley

1/11/10

PREPUBLICATION VERSION

DRUG SAFETY AND COMMERCIAL SPEECH:

TELEVISION ADVERTISEMENTS AND REPRINTS ON OFF-LABEL USES

By Margaret Gilhooley©

ABSTRACT

This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a …

An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin

Margarita Rubin

ABSTRACT Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical …

Improving The Safety Of Central Nervous System Stimulants, Anne Kulli

Anne Kulli

Anonymity removed in this document.

The “California Effect” & The Future Of American Food: How California’S Growing Crackdown On Food & Agriculture Harms The State & The Nation, Baylen J. Linnekin

Baylen J. Linnekin

For several decades, California has served as the epicenter of the American food scene. California produces one-third of the nation’s food, is home to one in eight American consumers, and boasts a staggering 90,000 restaurants. California is also where eating trends are born, and where fast food, organic food, and Napa Valley wines became durable icons of American culinary culture.

The state’s place atop the national food chain, though, is in jeopardy. In recent years, California legislators have pursued regulations that negatively impact many important agricultural and culinary trends. State and local governments have banned or severely regulated a veritable …

Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman

Christopher M Holman

Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB …

These Statements Have Not Been Approved By The Fda: Improving The Post-Approval Regulation Of Prescription Drugs, Christopher R. Page

Christopher R. Page

The American public’s confidence in the FDA is waning in the midst of increased reporting of inefficiencies in the agency. The missteps by the FDA in the post-approval regulation of prescription drugs are magnified by the pervasive use of prescription drugs in the market. This article identifies these missteps. It also chronicles the response of the state attorneys general to this void in regulation, from the famous class action suit against the tobacco industry to the Oxycontin litigation to the recent Vioxx settlement.

This response to the public’s lack of confidence is accomplished through lawsuits against pharmaceutical companies under state …

Regression By Progression Unleveling The Classroom Playing Field Through Cosmetic Neurology, Helia Garrido Hull

Faculty Scholarship

No abstract provided.