Top Food and Drug Cases, 2018, & Cases to Watch, 2019

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

Welcome to the 2019 volume of the Food and Drug Law Institute’s annual roundup of the most important and interesting legal controversies affecting the food and drug industries. As in past years, we gathered a team of knowledgeable and experienced practitioners from public interest groups and the private sector, each of whom nominated and described a chosen case for the volume. In addition, Jacqueline Chan returns with her summary of significant settlements in 2018, and Jonathan Havens describes important regulatory and enforcement developments from the past year. For the final chorus, much of the team came together to describe seven cases worth watching in what remains of 2019. We might see some of those “cases to watch” as significant cases in next year’s volume.

Preemption of state statutory and tort claims against products covered by the Food, Drug & Cosmetic Act is a perennial hot topic in our sector. This year, Ginger Pigott and Rich Tabura discuss Conklin v. Medtronic, a case that concerns the scope of a device maker’s duty to warn. Two of our 2019 cases to watch also concern preemption issues.

Class action cases raise unique issues that transcend the food and drug sectors, but food and drugs are such hotbeds of litigation nowadays that many of the most influential cases arise from this industry. In 2018, as Anand Agneshwar and Jocelyn Wiesner describe, the First Circuit Court of Appeals addressed the issue of class certification under Rule 23 when not all class members have been injured in In re Asacol Antitrust Litigation. And Rebecca Kirk Fair and Rene Befurt tell us about developments in the related area of plaintiffs’ efforts to model class-wide damages, necessary to establish predominance under Rule 23, through their explication of the Hilsley v. Ocean Spray Cranberries decision.

We also cover cases where government regulatory agencies are parties. Stacy Erlich and James Woodslee tell us about the Cigar Association of America v. FDA case, in which the tobacco industry challenges the agency’s implementation of the Family Smoking Prevention and Tobacco Control Act of 2009. In the dietary supplement sector, Megan Olsen reports on Amarin Pharma v. ITC, concerning a challenge by a seldom-heard-from regulatory agency on allegdly deceptive ingredient claims. Lynn Tyler describes a constitutional challenge to a 2017 Maryland law seeking to prevent price gouging in generic drugs, styled Association for Accessible Medicines v. Frosh. Anne Walsh and Rachael Hunt report on Eagle Pharms., Inc. v. Azar, seeking to require the FDA to grant marketing exclusivity to a drug under the Orphan Drug Act.

James Beck provides a window on the tactics being deployed in consolidated multidistrict product liability litigation in his review of In Re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation. And, Bill Janssen outlines developments in the thorny issue of innovator liability for consumers claiming injury from generic versions of their branded drugs, discussing McNair v. Johnson & Johnson.

All told, it has been another important and fascinating year in the development of legal issues in the food and drug industry. On behalf of FDLI, I thank this stellar team of authors for their generosity and insight in sharing with us these reports of 2018’s top food and drug cases.

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

August T. Horvath is a partner and co-chair of the Advertising & Marketing Law Practice Group at Foley Hoag LLP. He litigates, counsels, and defends regulatory actions in false advertising and deceptive practices matters for clients in the food and drug as well as other industries. August is co-Editor of the Advertising and Marketing Law Blog,


Association for Accessible Medicines v. Frosh
Lynn C. Tyler, Barnes & Thornburg LLP

In re Asacol Antitrust Litigation
Anand Agneshwar and Jocelyn Wiesner, Arnold & Porter LLP

McNair V. Johnson & Johnson
William M. Janssen, Charleston School of Law

In re DePuy Orthopaedics, Inc., Pinnacle Product Liability Litigation
James M. Beck, Reed Smith LLP

Eagle Pharms., Inc. v. Azar
Anne K. Walsh and Rachael E. Hunt, Hyman, Phelps & McNamara, PC

Conklin v. Medtronic, Inc.
Ginger Pigott and Richard Tabura, Greenberg Traurig LLP

Amarin Pharma, Inc. v. ITC
Megan Olsen, Council for Responsible Nutrition                 

Cigar Association of America et al. v. FDA et al.
Stacy L. Ehrlich and James William Woodlee, Kleinfeld, Kaplan & Becker LLP                      

Hilsley v. Ocean Spray Cranberries, Inc.
Rebecca Kirk Fair and Rene Befurt, Analysis Group, Inc.

Significant Settlements of 2018
Jacqueline J. Chan, Kleinfeld Kaplan & Becker LLP

FDA Opens Tobacco Rulemaking Dockets, Approves First Cannabis-Derived Drug and Reacts to the Legalization of Hemp, and Announces Plans to Significantly Change Medical Device Programs
Jonathan A. Havens, Saul Ewing Arnstein & Lehr LLP

Food and Drug Cases to Watch in 2019
The contributing authors