Defending FDA-Regulated Consumer Products Class Actions

Co-Chairs’ Opening Remarks

David Biderman
Partner
Firmwide Chair, Consumer Products & Services Litigation
Perkins Coie LLP

Lori Leskin
Partner
Co-Chair, Consumer Products Practice Group
Arnold & Porter Kaye Scholer LLP

The food, cosmetics and dietary supplements industries remain a consistent target of putative class action litigation, with plaintiffs’ counsel continuing to scrutinize the labels of FDA-regulated consumer products for potential lawsuits. In this opening session, our esteemed co-chairs will set the stage for the conference with a high-level “state of the industry” and a statistical analysis of the last year’s case filings.

Cross-Industry Class Action Roundup: Examining the Latest Class Action Trends in Food, Cosmetics and Dietary Supplements

Sabrina Mizrachi
VP, Litigation & Global Product Regulatory
Estée Lauder Companies

Christine McInerney
Head of Litigation
Nestle Health Science

Amanda Weinberger
Senior Counsel
Sara Lee Frozen Bakery

Mark Brian Levine
Associate General Counsel
Reckitt Benckiser

Ani Gulati
Chief Litigation Counsel
General Mills

Moderator:

David Biderman
Partner
Firmwide Chair, Consumer Products & Services Litigation
Perkins Coie LLP

In our morning roundup, leading in-house counsel from the food, cosmetic, and dietary supplements industries will provide an analysis of the latest class action activity targeting their respective industries. Topics of discussion will include:

• The latest advertising and labeling practices which are triggering class action claims
• Healthy
• Natural
• Sustainable
• Health claims vs. structure function
• Key lessons and takeaways from the latest class litigations
• Insights on where the next class action hot spots may occur
• Supplements and illegal drug claims, Li et al v. Amazon (N.D. Cal. 2023)
• Predicting when you may be a class action target

Exploring How New Legislation and Agency Guidance Will Impact Future Class Action Litigation Involving FDA Consumer Products

Megan Olsen
Senior Vice President & General Counsel
Council for Responsible Nutrition

Joseph Conklin
SVP & Global Deputy General Counsel
Coty Inc.

Joseph Aquilina
Sr. Director, Associate General Counsel
Consumer Brands Association

• Assessing the impact of new cosmetic regulatory reform: how will the Modernization of Cosmetics Regulation Act of 2022 (MOCRA) impact the industry and future litigation?
• Examining the FTC’s recent revisions to dietary supplement advertising guidelines: how does this expand or reinforce FTC’s authority and what are the potential implications on future claims?
• Exploring the potential impact of FDA’s new proposed rule updating the criteria for making “healthy” claims on food labels
• Understanding how potential FTC updates to the Green Guides for the Use of Environmental Claims may impact future claims across the food, cosmetic and supplements industry

Morning Coffee Break

A Cross-Circuit Analysis of Recent Class Certification Developments in Food, Cosmetics and Supplements Class Actions

Lori Leskin
Partner
Co-Chair, Consumer Products Practice Group
Arnold & Porter Kaye Scholer LLP

Thomas Sullivan
Partner
Shook Hardy & Bacon LLP

Sylvia Simson
Shareholder
Greenberg Traurig LLP

• Assessing the latest class certification rulings and trends across key circuits relating to food, cosmetics and supplements
• What plaintiff strategies are winning the day in certifying classes in FDA-regulated consumer product cases?
• Identifying defense challenges to class certification that are seeing the most success in these industries

To Respond or Not Respond? What to Do After You Receive the Demand Letter

Matthew Orr
Partner
Amin Talati Wasserman LLP

Class actions lawsuits affecting food cosmetics, and supplements usually begin with a demand letter. This session will provide a look at recent demand letter trends affecting these industries and strategies to employ for when one arrives on your desk.

• Examining demand letter trends in these FDA-Consumer industries
• Recent labeling and marketing triggers
• State consumer protection law violations
• Developing internal protocols to address demand letters
• Evaluating the class action probability from the letter
• What can we glean about the potential of the case from the law firm/attorney who sent the letter?
• Understanding when and how to enlist outside counsel
• Weighing the risk of responding vs. not responding while being mindful of the response deadline
• Identifying who else may have received the same demand letter and how this should factor into your decision
• Understanding how to make the “fish or cut bait” decision
• Which actions are worth fighting and which should be settled right away?
• Grasping what types of cases settle, which don’t, and how much should be paid
• Identifying claims that never win, e.g., FDC&A defeat

Networking Luncheon

Contamination Class Actions

Contaminant Class Actions: What Every Defense Attorney for an FDA-Regulated Consumer Industry Needs to Know About PFAS, Heavy Metals, and Titanium Dioxide

Dale Giali
Partner
King & Spalding LLP

Aliza R. Karetnick
Partner
Ballard Spahr LLP

Contaminants such as PFAS – forever chemicals, heavy metals, and other trace substances are spawning a new breed of highly aggressive class action litigation. They are affecting almost every industry but are of particular concern to the FDA-regulated consumer goods sector. What’s more, the plaintiffs’ bar has begun bringing putative class actions alleging that the presence of Titanium Dioxide makes consumer products unsafe. This panel will examine recent contaminant class actions affecting these industries and provide insights on what to do if your company is hit with one of these lawsuits. This panel will examine:

PFAS, Heavy Metals & Other Trace Chemicals

• Understanding the legal nuances of contaminant litigations – How are these lawsuits different from other class action claims?
• What theories are plaintiffs relying on in these claims, and what defense strategies are proving to withstand the latest plaintiff challenges?
• Examining how product testing/sourcing and recorded regulatory approval can yield additional strategies for class-action defense of PFAS and other related trace chemical lawsuits

Spotlight on Titanium Dioxide: The Latest Target in FDA-Regulated Consumer Product Class-Action Lawsuits

• Examining the rising trend of Titanium Dioxide class actions being brought across the food, cosmetic and supplements industry
• Common themes, allegations and takeaways
• How companies and their counsel should be reviewing product formulations and label claims to mitigate litigation risks associated with the presence of TiO₂

Afternoon Break

Understanding How Prop 65 Activity is Influencing Class Actions Against FDA-Regulated Consumer Product Companies

Amy Lally
Partner
Sidley Austin LLP

Rohit Sabnis
Partner
Keller & Heckman

• Examining the latest trends in Prop 65 activity that the food, cosmetic and dietary supplements industries should be paying attention to
• Understanding how the Prop 65 acrylamide ruling may have ended class actions against food companies in this category
• Examining the new dark chocolate class actions and their similarity to Prop 65 actions

Tactical Tools for Class Action Prevention: How Proper Claims Substantiation and Sound Labeling Practices Are Sometimes Your Best Offense

Abby Meyer
Partner
Sheppard, Mullin, Richter & Hampton LLP

John W.M. Claud
Counsel
Hyman, Phelps & McNamara, P.C.

• Examining claims language, advertising methods and other actions a company can take to reduce the risk of a class action
• Understanding how proper and compliant labeling can defeat a class
• FDC&A compliance
• Being proactive in substantiating marketing and labeling claims with competent and reliable scientific evidence

Conference Adjourns

Co-Chairs’ Welcome Back and Recap of Day 1

Understanding How Consumer Protection Groups, and the Plaintiff’s Bar Are Working in Tandem to Police Claims, Labeling, and Other Marketing Practices Leading to Class Actions

Thomas A. Evans
Partner
Alston & Bird

Amy Mudge
Partner and Chair Advertising, Marketing and Digital Media Team
Baker & Hostetler LLP

Claudia Lewis
Partner
Venable

• How is the plaintiff’s bar targeting labeling practices governed by the FDCA and other statutes that do not include a private right of action?
• Understanding the role that consumer protection groups (and third parties that hold themselves out as consumer protection organizations) play in policing claims and labeling practices that springboard into class actions
• Assessing the DC Consumer Protection Procedures Act and precedent allowing third-party consumer protection groups the right to sue for allegedly false or misleading claims
• How can companies defend against third-party lawsuits and reduce the risk of these lawsuits?
• Understanding how industry can work with regulators and consumer protection groups to ensure proper claims and self-police thereby avoiding class actions
• Examining the plaintiff’s bar’s recent attempts to police claims and labeling like government regulators through recent class action activity

Addressing the Role of Flawed Science in Driving Mass Litigation in the Food, Cosmetic and Supplements Industries

Risa Drexler
Associate General Counsel – Global Litigation
Nutrition North America, Unilever

Chris Liwski
Head of Legal North America and Global Head of Litigation
Sanofi Consumer Healthcare

Patrick Oot
Partner
Shook, Hardy & Bacon LLP

Julie L. Tersigni
Senior Counsel, Products Liability
Kenvue

Testing labs have recently filed citizen petitions with the FDA in attempts to provide support for economic loss class actions and personal injury mass tort litigation in the consumer products space. This panel will address the rising role of independent laboratories spawning FDA consumer product class actions, and examine topics including:

• What types of products are they targeting for independent testing?
• What should consumer product companies be doing to stay out of their spotlight?
• Crafting successful challenges to the legitimacy of the independent testing of these groups and the science behind their studies
• How to educate the court about the junk science that FRE 702 is designed to protect against

Morning Coffee Break

Crafting Successful Jurisdiction, Standing and Preemption Arguments at the Motion to Dismiss Stage

Kristine Argentine
Partner
Seyfarth Shaw LLP

Jonah Knobler
Partner
Patterson Belknap Webb & Tyler LLP

• Identifying primary jurisdiction and standing arguments which may be effective in eliminating or narrowing a class at the motion to dismiss stage
• Understanding the primary jurisdiction challenges which are most prevalent in FDA-regulated consumer product class actions, as well as how to manage and overcome them
• Navigating standing in the aftermath of TransUnion LLC v. Ramirez: incorporating takeaways from the latest court rulings into your class action litigation practices and strategies

A New Look at Preemption: Recent Developments Impacting How Food, Cosmetic and Supplement Defendants May Rely on this Defense in Future Class Actions

Jessica Davidson
Partner
Skadden, Arps, Slate, Meagher & Flom LLP

• Examining the impact of MoCRA on future class action preemption defenses, particularly with regard to PFAS
• Assessing how FDA’s recent guidance (e.g. guidance for determining and declaring the protein grams in a serving) has helped to provide preemption defenses to false advertising in the food, cosmetic, as supplement space
• Analyzing recent case law developments impacting express and implied preemption and how this may be useful to FDA-regulated consumer goods companies
• Truss v. Bayer Healthcare Pharmaceuticals Inc.
• Nexus Pharmaceuticals Inc. v. Central Admixture Pharmacy

Networking Luncheon

Combatting New and Creative Plaintiff’s Bar Tactics in FDA Consumer Product Class Actions

Jason Meltzer
Partner
Gibson, Dunn & Crutcher LLP

Jason Stiehl
Partner
Crowell & Moring LLP

• Examining creative plaintiffs’ bar tactics being used in these types of class actions as well as winning defense strategies to combat them
• Identifying new types of causes of actions being brought: what do current trends in class claims predict about potential future class action activity?
• Exploring examples where plaintiff’s counsel has been successful in defeating preemption defenses
• In light of new developments in preemption, predicting how plaintiff’s bar tactics may change going forward

Advanced Settlement Strategies for FDA-Regulated Consumer Product Class Actions

Kimberly Bousquet
Counsel
Davis Wright Tremaine LLP

Hih Song Kim
Executive Vice President, General Counsel and Corporate
BlueTriton Brands

• Identifying common challenges arising in FDA consumer product class settlements as well as key strategies for tackling those challenges
• Comparing class settlement trends by jurisdiction
• Identifying favorable jurisdictions to settle in, as well as jurisdictions to avoid settlement in
• Proven defense strategies for drafting settlement agreements, structuring the settlement benefit and noticing the class
• Best practices for dealing with more than one judge when a class action is filed in multiple jurisdictions
• Working with a settlement administrator to ensure the settlement is implemented with efficiency and accuracy
• Understanding how to make the decision of whether to settle or go to trial
• Structuring your settlement agreement so you don’t leave yourself exposed to future lawsuits

Afternoon Break

LAB

Learn, Apply, and Benchmark: Interactive FDA Consumer Product Class Action Defense Exercise

Trenton Norris
Partner
Hogan Lovells

Lori Leskin
Partner
Co-Chair, Consumer Products Practice Group
Arnold & Porter Kaye Scholer LLP

This hands-on session will test your litigation savvy through a series of complex, hypothetical scenarios which may arise in an FDA-regulated consumer product class action. Using audience polling, you will discover how your approach to mounting and tackling a class action defense compares to your peers. Benefit from a practical discussion of the polling results and walk away with winning strategies for all phases of a class action litigation, including:

• Designing thorough internal class action preparedness protocols
• Forging pre-suit defense strategies
• Establishing document hold and retention policies
• Pre-suit demand letter protocols
• Considerations for budgeting and forecasting of litigation costs
• Building joint litigation agreements
• Class formation challenges
• Discovery challenges
• Knowing when going to trial is the right thing to do
• Understanding when settlement is your best option

Conference Ends