ACI's Advanced Forum on Defending FDA-Regulated Consumer Products Class Actions - S

Esteemed Co-Chairs:

David Biderman Partner

ACI’s Advanced Forum on

Defending FDA-Regulated Consumer Products Class Actions

The Latest Class Action Prevention, Preparedness and Litigation Strategies for the Food, Cosmetics, and Dietary Supplement Industries

Gain Insights from Key Industry Stakeholders:

Firmwide Chair, Consumer Products & Services Litigation Perkins Coie LLP

Lori Leskin Partner

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

Conference Highlights Include:

y Think Tank on How MoCRA and the New FTC Health Products Compliance Guidance May Affect Class Action Activity

y Focus Session on the Connection Between Consumer Groups, Independent Labs and the Plaintiff’s Bar

y Cross-Circuit Analysis of Recent Class Certification Developments

y Navigating the Nuances of PFAS and Titanium Dioxide Class Actions

Christine McInerney Head of Litigation Nestle Health Science

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

Amanda Weinberger Senior Counsel Sara Lee Frozen Bakery

Mark Brian Levine Associate General Counsel

Reckitt Benckiser

Joseph Conklin

SVP & Global Deputy General Counsel Coty Inc.

Urmi Patel

Senior Principal Legal Counsel Whole Foods Market

y Strategy Session on How Sound Claims Substantiation and Labeling Practices Are the Best Offense

y Working Group on New Preemption Arguments in light of MoCRA and other FDA developments

y Pre-Litigation Playbook: What to Do After Receiving a Demand Letter

y Navigating Common Class-Action Settlement Challenges Across the Food, Cosmetics and Supplements Industries

ASSOCIATE SPONSOR

PREMIUM EXHIBITOR

The plaintiffs’ bar is becoming increasingly aggressive in targeting food, cosmetic, and dietary supplement companies in class action lawsuits. Many of these lawsuits range from the ridiculous to the absurd and are taking up too much time and money to defend.

The time to stop this madness is now. To help defense counsel address this never-ending barrage of class action filings, American Conference Institute (ACI) is pleased to introduce our Advanced Forum on Defending FDA-Regulated Consumer Products Class Actions

Join us this Spring for two days of comprehensive strategy sessions which will equip you with the tactical tools needed to avoid, combat and defend against the latest class action lawsuits.

We look forward to seeing you in New York City for what is sure to be one of the most valuable gatherings of the year!

Meet Our Faculty

ESTEEMED CO-CHAIRS

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

DISTINGUISHED SPEAKERS

Kristine Argentine Partner

Seyfarth Shaw LLP

Kimberly Bousquet Counsel

Davis Wright Tremaine LLP

Joseph Conklin SVP & Global Deputy General Counsel Coty Inc.

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

Thomas A. Evans Partner Alston & Bird

Stefanie Fogel Partner Global Co-Chair, Consumer Goods DLA Piper

Dale Giali Partner King & Spalding LLP

Aliza R. Karetnick Partner Ballard Spahr LLP

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

Jonah Knobler Partner

Patterson Belknap Webb & Tyler LLP

Amy Lally Partner

Sidley Austin LLP

Mark Brian Levine Associate General Counsel Reckitt Benckiser

Christine McInerney Head of Litigation Nestle Health Science

Jason Meltzer Partner Gibson, Dunn & Crutcher LLP

Abby Meyer Partner

Sheppard, Mullin, Richter & Hampton LLP

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

REGISTER NOW

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

Megan Olsen Senior Vice President & General Counsel

Council for Responsible Nutrition

Matthew Orr Partner

Amin Talati Wasserman LLP

Urmi Patel Senior Principal Legal Counsel Whole Foods Market

Jason Stiehl Partner Crowell & Moring LLP

Thomas Sullivan Partner Shook Hardy & Bacon LLP

Amanda Weinberger Senior Counsel

Sara Lee Frozen Bakery

Co-Chairs’ Opening Remarks

Microphone-alt 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

9:00

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

Microphone-alt

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

Urmi Patel, Senior Principal Legal Counsel, Whole Foods Market

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

10:15

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

Microphone-alt Megan Olsen, Senior Vice President & General Counsel, Council for Responsible Nutrition

Joseph Conklin, SVP & Global Deputy General Counsel, Coty Inc.

• Assessing how the Modernization of Cosmetics Regulation Act of 2022 (MOCRA) will impact class actions against the cosmetics and personal care industries

• Examining how the FTC’s recent revisions to the Health Products Compliance Guidance may trigger new class action activity against the food and dietary supplement industries

• Exploring how the FDA’s new proposed rule on Food Labeling will impact class action activity involving making “healthy” claims on food labels

• Understanding how potential updates to the FTC Green Guides may impact future claims across the food, cosmetic and supplements industry

11:00 Morning Coffee Break

11:30

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

Microphone-alt Lori Leskin, Partner, Arnold & Porter Kaye Scholer LLP

Thomas J. Sullivan, Partner, Shook, Hardy & Bacon 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

Microphone-alt Stefanie Fogel, Partner, Global Co-Chair, Consumer Goods, DLA Piper

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

» Reasonable consumer standard

• 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

1:00 Networking Luncheon

Contamination Class Actions

2:00

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

Microphone-alt 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

3:30

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

Microphone-alt 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

4:15

How Proper Claims Substantiation and Sound Labeling Practices Can Be Your Best Offense

Microphone-alt Abby Meyer, Partner, Sheppard, Mullin, Richter & Hampton LLP

Matthew Orr, Partner, Amin Talati Wasserman LLP

• 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

5:00 Conference Adjourns

Upcoming Events

March 28–29, 2023 | New York

April 18–19, 2023 | Chicago

MEDIA PARTNERS:

June 28–29, 2023 | New York

8:45

Co-Chairs’ Welcome Back and Recap of Day 1

9:00

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

Microphone-alt Thomas A. Evans, Partner, Alston & Bird

Amy Mudge, Partner and Co-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

9:45

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

Microphone-alt 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

10:30

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

Microphone-alt 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 recent FDA guidances (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

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

Microphone-alt 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?

• Tracking government and consumer protection group enforcement activity which the plaintiff’s bar might try to piggy-back on

• 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

Microphone-alt 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

• 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

1:00 Conference Ends

Post-Conference Workshop

Tuesday, May 2, 2023

2:00–5:00

For In-Person Attendees only.

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

This hands-on workshop will test your litigation savvy through a series of complex, hypothetical scenarios which may arise in an FDA-regulated consumer product class action. Discover how your approach to mounting and tackling a class action defense compares to your peers. Benefit from a practical discussion 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

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