Food and Drug Law Commons^™

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski

Faculty Scholarship

No abstract provided.

Newsroom: Logan Quoted In Bloomberg News On Opiod Litigation 08-16-2017, Jef Feeley, Jared S. Hopkins

Life of the Law School (1993- )

No abstract provided.

Obesity Prevention Policies At The Local Level: Tobacco's Lessons, Paul A. Diller

Maine Law Review

For at least a decade, commentators have speculated that obesity is the next tobacco, a public health scourge that might nonetheless offer a gold mine to ambitious plaintiffs’ lawyers. Successful lawsuits, as in the tobacco context, might spur the food industry to reform its practices so as to help reduce the alarmingly high national obesity rate. The obesity narrative, however, has not played out accordingly to the same script as tobacco. Relatively quick action by most state legislatures immunized the food industry to tort lawsuits seeking obesity-related damages, and the scant judicial opinions on the issue have skeptically assessed plaintiffs’ …

Value Hypocrisy And Policy Sincerity: A Food Law Case Study, Joshua Ulan Galperin

Elisabeth Haub School of Law Faculty Publications

t is tempting to say that in 2017 there is a unique problem of hypocrisy in politics, where words and behaviors are so often in opposition. In fact, hypocrisy is nothing new. A robust legal and psychological literature on the importance of procedural justice demonstrates a longstanding concern with developing more just governing processes. One of the important features of this scholarship is that it does not focus only on the consequences of policymaking, in which behaviors, but not words, are relevant. Instead, it respects the intrinsic importance of fair process, lending credence not only to votes but also to …

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.

Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi

Faculty Articles

No abstract provided.

The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan Jr.

Brooklyn Law Review

Foodborne illnesses sicken millions and kill thousands of Americans every year, leading many to conclude that our dysfunctional government food safety system, which still relies heavily on physical inspections of food and facilities, is incapable of protecting us. As a result, many now look to the private market for solutions to our food safety crisis. One private market approach, food safety liability insurance, is gaining popularity. This article examines the benefits and drawbacks to food safety liability insurance and raises doubts about its ability to improve food safety. The market for safe food is plagued by overwhelming information problems that …

The Medical Liability Exemption: A Path To Affordable Pharmaceuticals, Carrie E. Rosato

Florida State University Law Review

Patent monopolies are tolerated because we believe they promote progress that benefits society. What should be done when these monopolies actually increase human suffering? Drug prices in America are fifty to eighty percent higher than the rest of the world, meaning many cannot afford drugs that will improve or even save their lives. When striking a balance between the interests of the patent holder and that of the public, it is important to bear in mind that the rewards granted to patentees are secondary to the public benefit derived from their labors. The ideal solution would come from Congress creating …

Requiem For A Remedy: The Law And Economics Of Mutual Pharmaceutical V. Bartlett’S Over-Preemption, Robert C. Baker Iii

Maryland Law Review Online

No abstract provided.

Fda Approval Of Drugs And Devices: Preemption Of State Laws For “Parallel” Tort Claims, Marcia Boumil

Journal of Health Care Law and Policy

The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from claims of injury due to an alleged “design defect.” The Court previously ruled that FDA approval does not preempt state law claims based upon failure-to-warn, at least with respect to brand name products. In contrast, the Court previously ruled that the federal regulatory process leading to FDA approval of generic equivalents of brand drugs—and designation of the drug label—does preempt state law as …

Tort As Democracy: Lessons From The Food Wars, Melissa Mortazavi

Faculty Articles

This Article develops alternative emerging theories regarding the function of tort in American civil society. Often, scholars and policymakers evaluate the tort system in terms of compensation, loss allocation, and risk management. This focus overlooks an important modern function of tort; in the context of the modern administrative state, tort is a vital player in the democratic deliberative process. Tort suits bring forth new ideas, force fact-finding, and increase communication amongst public and private institutional actors to develop sound and legitimate law and policy. Perhaps nowhere is this more obvious today than with the current boom of food litigation. Lawsuits …

Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition, Neil M. Issar

Vanderbilt Journal of Entertainment & Technology Law

A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA's express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit …

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

Prosser's Bait-And-Switch: How Food Safety Was Sacrificed In The Battle For Tort's Empire, Denis W. Stearns

Nevada Law Journal

No abstract provided.

Making Liquor Immunity Worse: Nevada's Undue Protection Of Commercial Hosts Evicting Vulnerable And Dangerous Patrons, Jeffrey W. Stempel

Nevada Law Journal

No abstract provided.

Unequal Protection Under The Law: Why Fda Should Use Negotiated Rulemaking To Reform The Regulation Of Generic Drugs, Marie Boyd

Cardozo Law Review

The duty to ensure the safety of drug products, through adequate warnings or other means, should ultimately rest with the drug's manufacturer regardless of whether the drug is a generic drug or a brand-name drug. Recent U.S. Supreme Court holdings, however, suggest that while the manufacturer of a brand-name drug is always responsible for its label's content, this is not the case for generic drugs. In addition, by holding that failure-to-warn claims against generic drug manufacturers based on state law are preempted, the Court has removed the protections and compensation that state tort law can provide consumers of generic drugs …

Fair Or Foul? Major League Baseball's Use Of A Tortious Interference Lawsuit As A Means Of Investigation, Michael S. Beck

Cardozo Arts & Entertainment Law Journal

No abstract provided.

A Prescription Warning, Carlton Lee Harpst

Pepperdine Law Review

No abstract provided.

California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor

Pepperdine Law Review

The California Supreme Court, in the novel and unprecedented case of Sindell v. Abbott Laboratories, eliminated the plaintiffs burden of identification of a negligent party, and thus the causation requirement, in a multiple party tort action. In the course of this decision, the court adopted the "market share" theory of liability which dictated in Sindell that nonidentifiable defendant-manufacturers of the generic drug DES would be liable for the damages in proportion to their share of business in the market. The author thoroughly examines various theories of recovery, such as "alternative liability," "concert of action" and "enterprise liability," which the court …

Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler

Pepperdine Dispute Resolution Law Journal

The article presents information on the Vaccine Injury Compensation Program. It discusses the U.S. Federal circuit case Hazlehurst v. Sec'y of Health & Human Servs., in which lawsuit against the defendant was filed by the plaintiff who sought claims against the liability of product to recover damages for alleged injuries which his son had received from vaccines. It also provides information on the structural moral hazard of the program which devolves it into a litigious adjudicatory process.

No Duty To Warn Of Drug Interactions: A Dangerous Prescription, 46 J. Marshall L. Rev. 533 (2013), Ryanne Bush Dent

UIC Law Review

No abstract provided.

Check Please: Using Legal Liability To Inform Food Safety Regulation, Alexia Brunet Marks

Publications

Food safety is a hotly debated issue. While food nourishes, sustains, and enriches our lives, it can also kill us. At any given meal, our menu comes from a dozen different sources. Without proper incentives to encourage food safety, microbial pathogens can, and do enter the food source--so much so that according to the Centers for Disease Control and Prevention (CDC), each year roughly one in six Americans (or forty-eight million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. What is the optimal way to prevent unsafe foods from entering the marketplace?

Safety in the food …

Vaccines And The Law, Michael Sanzo Ph.D.

Pepperdine Law Review

The last twenty years have seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence under the National Childhood Vaccine Injury Act compensation program for injuries that might have been the result of vaccinations. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of causal certainty that would be required …

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

Disease-Branding And Drug-Mongering: Could Pharmaceutical Industry Promotional Practices Result In Tort Liability?, Jason S. Cetel

Student Works

No abstract provided.

Litigating Together: Social, Moral, And Legal Obligations, Elizabeth Chamblee Burch

Scholarly Works

In a post-Class Action Fairness Act world, the modern mass-tort class action is disappearing. Indeed, multi-district litigation and private aggregation through contracts with plaintiffs’ law firms are the new mass-tort frontier. But something’s amiss with this “nonclass aggregation.” These new procedures involve a fundamentally different dynamic than class actions: plaintiffs have names, faces, and something deeply personal at stake. Their claims are independently economically viable, which gives them autonomy expectations about being able to control the course of their litigation. Yet, they participate in a familiar, collective effort to establish the defendant’s liability. They litigate from both a personal and …

Voices From The Field: An Inter-Professional Approach To Managing Critical Information

Cardozo Law Review

No abstract provided.

The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness

Law Faculty Scholarly Articles

On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. In …

Two Masters, Carl E. Schneider

Articles

American government rests on the principle of distrust of government. Not only is power within the federal government checked and balanced. Power is divided between the federal government and the state governments. So what if a state law conflicts with a federal law? The Constitution says that the "Constitution, and the Laws of the United States ... shall be the supreme Law of the Land; ... any Thing in the ... Laws of any State to the Contrary notwithstanding." Sometimes the conflict between federal and state law is obvious and the Supremacy Clause is easily applied. But sometimes ...