Volume 61 Issue 3
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Table of Contents
> Obesity, Food Marketing and Consumer Litigation: Threat or Opportunity?by Sarah Taylor Roller, Of Counsel in the law firm of Covington & Burling LLP, Washington, D.C. She specializes in Food and Drug Law, Consumer Law, and Public Health Law and Policy
and
Theodore Voorhees, Jr., Partner in the law firm of Covington & Burling LLP, Washington, D.C. and is Chair of the firm’s Product Liability and Toxic Tort Practice Group
and
Ashley K. Lunkenheimer, litigation Associate in the law firm of Covington & Burling LLP, Washington, D.C.
> Not the Next Tobacco: Defense to Obesity Claims
by Joseph P. McMenamin, M.D., J.D., Partner in the law firm of McGuireWoods LLP, Richmond, VA
and
Andrea D. Tiglio, Ph.D., J.D., Associate in the law firm of McGuireWoods LLP, McLean, VA
> Defending an Emerging Threat: Consumer Fraud Class Action Suits in Pharmaceutical
and Medical Device Products-Based Litigation
by Joseph J. Leghorn, Partner in the law firm of Nixon Peabody LLP, Boston, MA. He represents manufacturers of pharmaceutical and medical devices, both based in Nixon Peabody’s Boston office
and
J. Christopher Allen, Jr., Associate in the law firm of Nixon Peabody LLP, Boston, MA. He represents manufacturers of pharmaceutical and medical devices, both based in Nixon Peabody’s Boston office
and
Tavares Brewington, Associate in the law firm of Nixon Peabody LLP, Boston, MA. He represents manufacturers of pharmaceutical and medical devices, both based in Nixon Peabody’s Boston office
> A Bitter Pill For Plaintiffs: Obstacles to Market Theories of Causation in Prescription Drug
Consumer Fraud Cases
by James D. Arden, Partner with the law firm of Sidley Austin LLP, New York, NY
and
Peter C. Brensilver, Associate in the law firm of Sidley Austin LLP, New York, NY
> Consumer Litigation and FDA-Regulated Products: The Unique State of California
by Trenton H. Norris, Partner in the law firm of Bingham McCutchen LLP, San Francisco, CA
> The Class Action Fairness Act of 2005: Changing the Class
by Ashish R. Talati, Associate at Amin Law, Chicago, IL where he practices Food and Drug law
> The Canadian Perspective: Trends in Drug and Medical Device Class Actions in Canada
by Litigation Associate at Blake, Cassels & Graydon LLP in Toronto
> Pros and Cons of Off-Label Promotion Investigations and Prosecutions
by Michael K. Loucks
Obesity, Food Marketing and Consumer Litigation: Threat or Opportunity?
Authors: Sarah Taylor Roller, Theodore Voorhees, Jr. & Ashley K. Lunkenheimer
61 FOOD AND DRUG LAW JOURNAL 419-444 (2006).
The prevalence of overweight and obesity in the United States has increased substantially during the past four decades, and the chronic disease burden linked to unhealthy weight is costing Americans an estimated $69 to $117 billion per year. Reversing obesity trends is a leading public health priority, and presents challenging policy issues concerning how best to establish healthy dietary and lifestyle practices.
Significant debate has emerged concerning the role that food marketing practices and related public policies may play in fostering healthy dietary practices. Empirical evidence evaluating historical food marketing practices and public policies, including the Nutrition Labeling and Education Act of 1990 (NLEA), shows that rigid government regulation inhibits food companies from undertaking health-promoting marketing initiatives.
This article examines the arguments made by some groups advocating consumer lawsuits against food companies as a purported strategy for advancing public health, and discusses the counter-productive results of many such lawsuits, including the chilling effects litigation can have on responsible and effective healthy food marketing practices. Regulatory policies that promote food industry self-regulation and encourage the industry's use of healthy food marketing practices in ways that are effective in motivating healthy consumer behavior appear to be the better course.
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Not the Next Tobacco: Defenses to Obesity Claims
Authors: Joseph P. McMenamin, & Andrea D. Tiglio
61 FOOD AND DRUG LAW JOURNAL 445-518 (2006).
The extraordinary success of the plaintiffs’ bar in extracting immense damages from the tobacco industry, the prevalence and severity of tobacco-related and obesity-related health problems in the United States, and superficial similarities between the consumption of tobacco and of food may all tend to prompt plaintiffs’ lawyers to attempt to draw analogies between litigation against tobacco companies and litigation against food companies.
This article considers similarities and differences between these forms of litigation, and concludes that similarities are more apparent than real. Eating is essential for survival; tobacco consumption jeopardizes survival. Food consumption is but one factor in obesity risk among many; tobacco consumption is often the predominant and sometimes the only risk factor for the harms it causes. Nicotine, delivered most commonly through tobacco products, is a classically addicting compound. Food, made up of many compounds, is not, nor can eating be properly understood as an addiction. Suing farmers or food companies for overweight or obesity will do more harm than good. On balance, litigation against food companies to compensate those who elect to overeat should be discouraged.
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Defending an Emerging Threat: Consumer Fraud Class Action Suits in Pharmaceutical and Medical Device Products-Based Litigation
Authors: Joseph J. Leghorn, J. Christopher Allen, Jr. & Tavares Brewington
61 FOOD AND DRUG LAW JOURNAL 519-538 (2006).
Over the last few years, pharmaceutical and medical manufacturers have seen the rise of lawsuits based not on traditional theories of personal injury, but rather on violations of nebulous standards of conduct espoused by consumer protection statutes. Together with the rise of direct-to-consumer advertising, manufacturers see claims of false or deceptive trade practices whenever a label change is made or a study purportedly showing adverse consequences is published.
The lower standards for proof of causation and the possibility of class certification make these actions an attractive alternative to traditional products liability claims. Often these actions expressly eschew claims for personal injury, limiting the claims to economic damages based on the price of the product.
This article explores recent developments in consumer protection claims and defenses to them. While there is not any panacea to deal with these actions against manufacturer, this article reviews the various arguments and techniques to manage and defeat these claims in an effective and efficient manner.
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A Bitter Pill For Plaintiffs: Obstacles to Market Theories of Causation
in Prescription Drug Consumer Fraud Cases
Authors: James D. Arden & Peter C. Brensilver
61 FOOD AND DRUG LAW JOURNAL 539-546 (2006).
Direct-to-consumer advertising of prescription drugs has been challenged in a number of consumer fraud actions against drug makers. State consumer protection statutes generally require proof of a causal nexus between the alleged misrepresentation and plaintiff’s injury.
In recent years, some plaintiffs have sought to shift the focus in these actions from whether the plaintiff or the plaintiff’s physician received alleged misstatements to whether the “market” received and absorbed alleged misrepresentations. After reviewing the underpinnings of the traditional “fraud-on-the-market” theory as developed in the securities litigation context, this article examines whether the theory is appropriate for the market for pharmaceuticals. That these unique products are highly regulated and unavailable to the public except by a health care professional’s prescription weighs against application of a “market” theory. These distinct characteristics likewise undermine efforts to broadly allege causation based on circumstantial evidence. Accordingly, the prescription drug market should be resistant to the fraud-on-the-market theory and analogous market-based theories of causation.
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Consumer Litigation and FDA-Regulated Products: The Unique State of California
Author: Trenton H. Norris
61 FOOD AND DRUG LAW JOURNAL 547-558 (2006).
California’s expansive consumer protection laws are the basis for substantial litigation involving FDA-regulated products affecting all major stakeholders in the food and drug industry. For manufacturers, distributors, and retailers, these suits can become an expensive nuisance and threaten important product lines. For consumer advocates, they can effectuate change in FDA-regulated products outside the usual regulatory process. And, for the FDA, these suits present a challenge to its primary role in regulating foods, dietary supplements, drugs, medical devices and cosmetics.
This article describes the four major laws used by consumer advocates and plaintiffs lawyers to challenge makers and sellers of FDA-regulated products: Proposition 65, the Unfair Competition Law, the False Advertising Law and the Consumers Legal Remedies Act. It summarizes their key elements and reviews recent efforts to set limits on their coverage.
The article also examines the interplay between FDA regulation and the California consumer protection laws, noting the legal and policy hazards―for businesses, consumers and FDA―of this thicket of state laws enforced primarily by private plaintiffs.
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The Class Action Fairness Act of 2005: Changing the Class Action Landscape Circuit by Circuit
Author: Ashish R. Talati
61 FOOD AND DRUG LAW JOURNAL 561-568 (2006).
The pharmaceutical industry lobbied Congress for years to pass a tort reform measure. Its prayers were answered with the Class Action Fairness Act of 2005 (CAFA). Since the passage of CAFA, class action practitioners have had more than 18 months to understand and comprehend its ramification. CAFA undoubtedly has made fundamental changes to the class action landscape. Gradually its impact is becoming clear through various court decisions. However, since CAFA is only in its second year, it will take a few more years before plaintiffs and defendants fine-tune their strategies. This article reviews some of the prominent court decisions interpreting CAFA.
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The Canadian Perspective: Trends in Drug and Medical Device Class Actions in Canada
Author: Waleska Vernon
61 FOOD AND DRUG LAW JOURNAL 569-576 (2006).
Pharmaceutical and medical device litigation has risen dramatically in the last 20 years in Canada, due mainly to the increased access to the courts afforded to plaintiffs.
This article discusses whether one of the primary goals of class actions—behavior modification—has been achieved. The regulatory standards to which pharmaceutical manufacturers are held in Canada are increasingly strict, and there is no direct evidence that class actions, in fact, cause pharmaceutical defendants to change their behavior. Given the disconnect between the goals of class actions and their actual impact on pharmaceutical manufacturers, the article concludes that the regulation of pharmaceutical manufacturers should be left to Health Canada, the governmental body created for just this purpose.
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Pros and Cons of Off-Label Promotion Investigations and Prosecutions
Author: Michael K. Loucks
61 FOOD AND DRUG LAW JOURNAL 577-584 (2006).
This article is the prepared text of remarks delivered as the keynote speech at the 49th Annual Conference of the Food and Drug Law Institute, April 7, 2006. The speech asserted that the “core victims” of the “crimes of off-label promotion” include those companies that have invested the time and money to gain the benefit of the regulatory barrier to entry to the marketplace: the company who has a lawful right to active promote a product for a particular use.
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