Top Food and Drug Cases, 2017, & Cases to Watch, 2018

FDLI’s Top Food and Drug Cases is the companion volume to the popular panel at our Annual Conference.

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This is a distillation, by a selection of seasoned practitioners from leading law firms, universities, and public interest organizations, of the top legal and enforcement matters that we collectively reckoned to be among the most influential of 2017 and early 2018. But there is much more here than summaries of ten cases. The authors have situated each case in its legal or regulatory context, citing and discussing other recent and not-so-recent matters that contribute to the state of play. In addition, we have chapters discussing significant litigation and enforcement settlements and significant regulatory and enforcement actions of the past year. The authors also teamed up to nominate and discuss the currently ongoing cases that were expected to yield significant decisions and results in the months following our time of press.

Food and drug law might seem a narrow topic, but to my mind, the most impressive thing about this book is its breadth. It covers food, drugs, dietary supplements, medical devices, and tobacco products, and when appropriate, our team has not hesitated to discuss cases outside of the food and drug area that are important developments in areas of law that strongly impact practice the FDA product arena. Conversely, many of the legal issues described in this book have much more general applicability. Bristol Myers Squibb v. Superior Court of California deals with jurisdictional issues important to anyone litigating a class action, for example, and Eike v. Allergan has broad applicability in consumer deception cases. Core issues in FDA law continue to be aired in the courts; two significant examples in this volume are Sandoz v. Amgen’s interpretation of the Biologics Price Competition and Innovation Act and T.H. v. Novartis’ entry in the controversy over who, if anyone, is legally responsible for failure to warn for a generic drug when the original brand maker is no longer in a position to update the labeling.

August T. Horvath, Editor
Partner and Co-Chair of the Advertising & Marketing Law Practice Group, Foley Hoag LLP

Contents

Sandoz v. Amgen
Lynn C. Tyler, Barnes & Thornburg

The Supreme Court and the Federal Circuit hold that the innovator of a biologic cannot obtain injunctive relief to enforce a biosimilar applicant’s disclosure obligations under the Biologics Price Competition and Innovation Act.
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Bristol-Myers Squibb v. Superior Court of California
Mark E. Haddad and Naomi A. Igra, Sidley & Austin

The Supreme Court limits a state’s jurisdiction over a non-resident drug company in a product liability case to claims brought by plaintiffs who either resided in the state or incurred injury in the state.
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T.H. v. Novartis
Anand Agneshwar and Jocelyn Wiesner, Arnold & Porter

The Supreme Court of California finds that a brand-name manufacturer can be liable for failure to update a label even when the plaintiffs used a generic version of the product, years after the brand-name manufacturer last held rights to it.
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Eike v. Allergan
William M. Janssen, Charleston Law School

The Seventh and Third Circuits go separate ways on whether eye drop patients, alleging the medicine bottles dispense drops in sizes that are too large, have the constitutional right to sue pharmaceutical companies.
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In re Fosamax Product Liability Litigation
James M. Beck, Reed Smith

The Third Circuit rules that even FDA’s prior consideration of, and decision not to adopt, the safety warnings advocated by a plaintiff does not preempt the plaintiff’s suit under state law.
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U.S. ex rel Campie v. Gilead
Anne K. Walsh and Andrew J. Hull, Hyman, Phelps & McNamara

The Ninth Circuit finds that in a False Claims Act action predicated on Food, Drug & Cosmetic Act violations, FDA’s decision not to take the product off the market does not preclude the violation being material.
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LabMD v. FTC
Ginger Pigott and Richard Tabura, Greenberg Traurig

The Eleventh Circuit pondered whether the enforcement of reasonable data security practices falls within the FTC’s unfairness authority.
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FTC v. Quincy Bioscience
Megan Olsen, Council for Responsible Nutrition

In the Southern District of New York, a District Court finds that the FTC failed to meet its burden to show that the cognitive benefits of a dietary supplement were falsely advertised.
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Nicopure Labs v. FDA
Stacy L. Ehrlich and James William Woodlee, Kleinfeld Kaplan & Becker

The District Court for the District of Columbia rules that vaping products may be deemed subject to the Family Smoking Prevention and Tobacco Control Act even if they do not contain e-liquids or nicotine.
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Singleton v. Fifth Generation
August T. Horvath, Foley Hoag and Rebecca Kirk Fair, Analysis Group

The District Court for the Northern District of New York elaborates the standard for a damages model to pass muster under the Rule 23(b)(3) predominance standard in the post-Comcast world.
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Significant Settlements of 2017
Jacqueline J. Chan, Kleinfeld Kaplan & Becker
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Regulatory, Compliance and Enforcement Developments of 2017
Jonathan A. Havens, Saul Ewing Arnstein & Lehr
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Food and Drug Cases to Watch in 2018
The contributing authors
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