Day 1 - Monday, January 25, 2016

A Comprehensive Guide on Health Claims Substantiation: How to Meet Applicable FDA and FTC Standards to Avoid Attacks on Health-Related Claims

Jeffrey B. Margulies
Norton Rose Fulbright LLP

Rebecca Cross
BraunHagey & Borden LLP (San Francisco, CA)

At this interactive pre-summit working group, you will gain a thorough understanding of health claim substantiation. Come and learn what you need to know avoid making risky health claims that can subject you to consumer fraud litigation. Submit your questions beforehand to [email protected] or bring your questions to the session as ample time will be left for Q&A.

  • Complying with 21 U.S.C. 343 (r)(3)(B)(i) – “significant scientific agreement among experts” for health claims
  • Addressing health red flags before making health-related statements, nutrient content, and “structure-function” claims
  • What standards FDA and FTC use when reviewing scientific studies, data, and other evidence supporting various types of claims
  • Understanding how the FDA and FTC do (and do not) work together during the claim substantiation process
  • Assessing the importance of POM and Bayer in terms of their collective impact on claim substantiation standards and their trickle-down effect on advertising and labeling of dietary supplements
  • Appreciating the freedom of speech protections afforded to the supplements industry by POM
  • Exploring the FTC’s continuing push for two Randomized Clinical Trials (RTCs) to substantiate supplement claims despite the POM ruling (FTC witness testimony, implied claims)

​1:30pm — 5:00pm (Registration begins at 1:00pm)

Day 2 - Tuesday, January 26, 2016

Registration Begins and Continental Breakfast
Co-Chairs’ Opening Remarks — Summit Roadmap

David T. Biderman
Perkins Coie LLP (San Francisco, CA)

Ani Gulati
Chief Litigation Counsel
General Mills

State of the Food Court — Update on 9th Circuit Trends that May Affect Your Litigation Strategy

Steven Steinborn
Hogan Lovells LLP

Jeffrey B. Margulies
Norton Rose Fulbright LLP

Using recent “Food Court” cases as a guide for the discussion, session leaders will go through the ins and outs of claims-based litigation at the 9th Circuit. Expert leaders will take you through each case and present critical points for you to consider when developing your litigation strategy and points to drive home to your business leaders and marketing departments.

  • Reid v. Johnson & Johnson – “natural” claims for food labeling
  • Astiana v. The Hain Celestial Group – “No Trans Fat” or “Trans Fat-Free” claims
  • Kumar v. Salov North America Corp. – olive oil deceptively labeled as “Imported from Italy”
  • Cabral v. Supple LLC – misrepresentations of health benefit of nutritional beverage

Dissecting the Class Certification Requirement of Commonality — What Guidance Can You Glean from the Tyson Foods, Inc. v. Bouaphakeo Supreme Court Case?

Angela Agrusa
Liner LLP

Rick Shackelford
Greenberg Traurig LLP (Los Angeles, CA)

  • Can differences among individual class members be ignored, and a class certified, when plaintiffs use statistical techniques that presume that all class members are identical?
  • Can a class be certified that contains hundreds of members who were not injured and have no legal right to damages?
  • What impact could the Supreme Court’s decision in Tyson have on the standards for obtaining class certification in the future?
  • How may the Tyson decision affect plaintiffs’ leverage to settle if they cannot meet the commonality requirement class certification?

Morning Coffee Break
Class Action Moot Court — Debating Why the Issue of Ascertainaiblity is So Important in Defending Your Case

Richard Fama
Cozen (New York, NY)

David T. Biderman
Perkins Coie LLP (San Francisco, CA)

Set up as a moot court, you will witness some of plaintiffs’ most persuasive arguments for, and the most strategic ways defendants attack ascertainability in the class certification phase of food-related consumer class actions. Gain crucial insights from seasoned food litigation veterans at this unique session that will take you through a number of scenarios based on real-life cases:

  • 3rd Circuit – Carrera v. Bayer: should classes whose membership cannot be determined flunk the ascertainability requirement and therefore not be certified
  • 9th Circuit – Jones v. Conagra: should the ascertainability requirement be either eliminated from the class certification analysis or substantially relaxed in order to clear the runway for consumer class actions
  • POM Wonderful – is it possible to reliably determine who purchased Defendant’s products or when they did so

In-House Roundtable: How Counsel at Food Companies Manage Consumer Fraud Cases from Start to Finish

Nicole Bearce
Associate General Counsel – Litigation
Unilever United States, Inc.

Faith Greenfield
Vice President – Legal
Campbell Soup Company

Justin Mervis
Vice President and General Counsel

Panel Moderator

Amy Norris
Chief Legal Counsel
Clif Bar & Company

  • What happens right after the company is served or case is filed?
  • How does in-house litigation counsel select which law firm to engage?
  • What litigation costs, legal fees, and budget discussions happen internally and with outside counsel?
  • Discussing the strengths and weakness of plaintiff ’s case, and strategy on how to defend against asserted claims
  • Understanding the internal discussions between in-house counsel and management on whether to settle or take the case to trial

FDA Keynote Address:FDA Enforcement and Labeling Updates

Lynn Szybist (Invited)
Food and Drug Administration (College Park, MD)

Networking Luncheon
Attacking Plaintiff’s Damages Model — Understanding Damages Theories Used in Consumer Fraud Class Actions

Anthony Anscombe
Sedgewick LLP (Chicago, IL)

  • Understand how plaintiffs present the Full Refund and Price Premium models
  • What is the “Benefit of the Bargain?” model and how is it differentiated from the price premium model?
  • Considering plaintiff ’s use of regression models and when they tend to be rejected by courts
    • Hedonic regressions analysis, Conjoint analysis
  • Discussing the risks of plaintiff ’s use of the Survey Damages model
  • In what context does plaintiff usually assert the Disgorgement of Profits model?
  • Statutory Damages – determining the statutory penalty or minimum amount of damages that can be awarded under state consumer protection statutes

Settlement Best Practices — Strategies on When, Why, and How to Settle a Claim

David S. Almeida
Sheppard Mullin

Ronald Levine
Partner, Co-Chair, Litigation Department Chair, Best Practices Committee
Herrick, Feinstein LLP

In this interactive session, expert panelists will outline negotiation strategies on how to best settle your food fraud case. Negotiating the best financial resolution for your client is premised upon many different factors. This session will give attendees the unique vision from senior practitioners into how these cases are settled, and what to look out for.

  • Under what circumstances should you settle a case – factors to consider
  • How these factors change when considering an individual versus class settlement
  • How to value and settle a case – a step by step approach
  • Insurance considerations for these types of claims – how much coverage is enough?

Networking Break
Beech-Nut and its Backlash — The Battle Over Prop 65’s Fundamentals

James M. Schurz
Morrison Foerster

Sarah Esmaili
Arnold & Porter LLP

  • Practical learnings from the trial of Environmental Law Foundation v. Beech-Nut
  • Beech-Nut’s holdings on averaging and “naturally occurring”
  • The Mateel v. OEHHA effort to invalidate the lead safe harbor
  • The Center for Environmental Health petition to OEHHA revise the lead safe harbor
  • OEHHA’s proposals on the lead safe harbor, averaging over time, averaging across lots, naturally occurring, and geometric vs. arithmetic mean
  • Update on OEHHA’s proposed revisions to safe harbor warnings
  • Recent developments in Prop 65 litigation, chemical listings, and safe harbors
  • Prospects for Prop 65 reform

What’s Coming Next — PHOs, Beyond “Natural”, and the New Mislabeling Claim Trends

Jo E. Osborn
Vice President & Assistant General Counsel
TreeHouse Foods Inc. (Oak Brook, IL)

Clausen Ely
Senior Counsel
Covington & Burling LLP

  • Discussing claims of “simple, pure, wholesome”
  • What are the implications of FDA’s determination that PHOs are not GRAS (generally recognized as safe)
  • New mislabeling claims: “craft,” “artisanal,” “handmade”
  • Kind Bars – “evaporated cane juice”
  • Update on GMO state labeling laws

Town Hall Wrap Up Session — Are Food Cases the New Tobacco Litigation?

Some consumer groups and class action plaintiffs are likening food and beverage companies to the tobacco companies of old by saying that manufacturers are making foods and beverages with “addictive” ingredients like high fructose corn syrup, salt, and fat. In this interactive town hall, you will have the opportunity to hear the opinions of your peers and voice your thoughts on this controversial topic.

  • Understanding the addiction hypothesis: Salt, sugar (high fructose corn syrup), fat
  • How are these ingredients in food being compared to nicotine in tobacco?
  • How is the defense of self-control now weakened by this food addiction hypothesis?
  • Under what theory will these new claims be brought (mislabeling, personal injury)

Summit Concludes