26th Annual Conference on Drug & Medical Device Litigation - DS

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26th Annual Conference on

DRUG&MEDICAL DEVICE L I T I G AT I O N

The Life Sciences Industry’s Premier Products Liability Conference

December 7–8, 2021 Marriott Marquis | New York, NY

EARN CLE CREDITS

Conference Chair

Lisa Dunkin

Assistant General Counsel, Litigation Zimmer Biomet

Benefit from the Insights of Esteemed In-House Counsel

Michele Suggs Adeleye Vice President and AGC Pfizer

Cindy Aribisala

Senior Counsel Gilead Sciences, Inc.

Elizabeth Balakhani

Assistant General Counsel GSK

Zane Riester

Senior Counsel Johnson & Johnson

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Eric Santoro

Senior Counsel, Global Litigation AstraZeneca

Jason Steinhart

Associate Vice President Associate General Counsel, North American Litigation Sanofi

DRUG&MEDICAL DEVICE L I T I G AT I O N

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Main Day Cocktail Sponsor:

Get set for...

Lead Sponsor + Luncheon Sponsor:

400+

Attendees

15+

Revamped Panel Discussions

60+

Speakers,

Including over Two Dozen Faculty Members from Industry and The Judiciary

2

Days of Networking

Welcome Cocktail Sponsor:

Lanyard Sponsor:

What’s NEW for 2021

Supporting Sponsors:

Hybrid Virtual/In-Person Trial Practice Toolkit Leading trial attorneys will explore post-pandemic trial practice, new and evolving client and court expectations, and strategies for conducting litigation in a hybrid virtual/in-person world.

FDA Think Tank Former FDA Chief Counsels will examine the latest FDA initiatives influencing the products liability sphere.

New MDL Focus Sessions

Associate Sponsors:

Leading defense counsel will engage in in-depth discussions on combatting plaintiff tactics that transform MDLs into the behemoth litigations we see today as well as navigating the remand process from transfer to trial.

CELEBRATING 120 YEARS

Spotlight on Opioid and NDMA Litigations Two all-star panels will explore takeaways from the NDMA and opioid litigations and explain how this is significant for future product liability trial practice in the life sciences.

Post-COVID-19 Jury Data Unveiled Leading jury consultants will share data on how the COVID-19 pandemic is actually impacting juror mindsets, perceptions, and verdicts.

Roadmap for Post-Albrecht Preemption Top drug and device product liability litigators will analyze and discuss recent rulings to create a future roadmap for obtaining Albrecht preemption.

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Premium Exhibitor:

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Exhibitor:

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ACI Drug and Med Advisory Board American Conference Institute’s Drug and Medical Device Litigation Advisory board is comprised of a prestigious selection of all-in-house counsel advisers, including General Counsel, Senior Litigation Counsel and Chief Legal Strategists from leading pharmaceutical and medical device companies. This ‘inner circle’ counsels ACI on the impact of litigation trends and emerging topics and helps facilitate ACI’s mission to provide industry-leading content and a world-renowned speaker faculty.

Patricia A. Barbieri SVP, General Counsel and Secretary Daiichi Sankyo, Inc. (Parsippany, NY)

Mary-Alice Barrett Associate General Counsel Genentech (Little Falls, NJ)

Debra L. Burns Senior Counsel Litigation/Investigations GE Healthcare (Wauwatosa, WI)

Christopher M. Guth Senior Assistant General Counsel Bayer (Pittsburgh, PA)

Donald LeGower Assistant General Counsel – Litigation and Government Investigations Bristol-Myers Squibb (Lawrenceville, NJ)

Malini Moorthy Vice President and Chief Deputy General Counsel Medtronic (Minneapolis, MN)

Richard W. Silbert V.P., Chief Legal Strategist Purdue Pharma L.P. (Stamford, CT)

Brennan Torregrossa Senior Vice President, Head of Global Litigation GSK (Philadelphia, PA)

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Distinguished Faculty Benefit from the Insights of Our Distinguished Chair:

Spotlight Speaker:

Lisa Dunkin Assistant General Counsel, Litigation Zimmer Biomet (Fort Wayne, IN)

Robert Charrow Shareholder Greenberg Traurig LLP Former General Counsel, U.S. Department of Health & Human Services (HHS) (Washington, DC)

Learn from Renowned Jurists:

Honorable Karen K. Caldwell

Honorable Nancy J. Rosenstengel

Honorable Eduardo C. Robreno

Honorable William F. Highberger

Chief Judge U.S. District Court, E.D. Kentucky Chair Judicial Panel on Multidistrict Litigation (JPML) (Lexington, KY)

Chief Judge U.S. District Court, S.D. Illinois (East St. Louis, IL)

Senior Judge U.S. District Court, E.D. Pennsylvania (Philadelphia, PA)

Superior Court Judge Los Angeles County Superior Court (Los Angeles, CA)

IN-HOUSE COUNSEL Michele Suggs Adeleye Vice President and AGC, Chief Counsel Digital Pfizer (New York, NY)

Adam Bassing Head of Global Litigation UCB, Inc. (Smyrna, GA)

Cindy Aribisala Senior Counsel Gilead Sciences, Inc. (Foster City, CA)

Lisa Dunkin Assistant General Counsel, Litigation Zimmer Biomet (Fort Wayne, IN)

Elizabeth Balakhani Assistant General Counsel GSK (Philadelphia, PA)

Christopher M. Guth Senior Assistant General Counsel Bayer (Pittsburgh, PA)

Mary-Alice Barrett Associate General Counsel Genentech (Little Falls, NJ)

Max Heerman Senior Legal Counsel, Litigation Medtronic (Washington, DC)

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Adrienne M. Hollander Assistant General Counsel American Regent Inc., a Daiichi Sankyo Group Company (Shirley, NY) Rachelle L. Laroche Assistant General Counsel – Trademarks Johnson & Johnson (Union City, NJ) Donald LeGower Assistant General Counsel – Litigation and Government Investigations Bristol-Myers Squibb (Lawrenceville, NJ) Sarah Padgitt Associate General Counsel Baxter (Chicago, IL)

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DRUG&MEDICAL DEVICE L I T I G AT I O N

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Sponsors

Zane Riester Senior Counsel Johnson & Johnson (New Brunswick, NJ) Eric Santoro Senior Counsel, Global Litigation AstraZeneca (Philadelphia, PA) Jason Steinhart Associate Vice President Associate General Counsel, North American Litigation Sanofi (Bridgewater, NJ) Brennan Torregrossa Senior Vice President, Head of Global Litigation GSK (Philadelphia, PA)

Advisory Board

Faculty

Marcella Ducca Co-Chair, Atlanta Products Liability Litigation Group Greenberg Traurig LLP (Atlanta, GA) Sandra A. Edwards Co-Chair, Product Liability & Mass Torts Practice Winston & Strawn LLP (San Francisco, CA) Ilana H. Eisenstein Partner DLA Piper (Philadelphia, PA) Sean P. Fahey Partner | Leader, Health Sciences Litigation Practice Group Troutman Pepper (Philadelphia, PA)

Justin Witzmann Senior Litigation Counsel Nuvasive (San Diego, CA)

Aileen Fair Senior Corporate Counsel, Litigation & Government Investigations Bristol Myers Squibb (Princeton, NJ)

LAW FIRM ATTORNEYS

Wendy West Feinstein Partner Morgan, Lewis & Bockius LLP (Pittsburgh, PA)

Stacy Amin Partner Co-Chair, FDA Regulatory & Compliance Practice Morrison & Foerster LLP Former Chief Counsel, Food and Drug Administration, 2018-2021 (Washington, DC)

John Galvin Partner Thompson Coburn LLP (St. Louis, MO)

Andrew T. (Andy) Bayman Partner King & Spalding LLP (Atlanta, GA)

Caycee D. Hampton Attorney at Law Carlton Fields (Tampa, FL)

James M. Beck Senior Life Sciences Policy Analyst Reed Smith LLP (Philadelphia, PA)

Andrew Kaplan Partner Crowell & Moring (Washington, DC)

Erin Bosman Partner, Co-Chair of Class Actions and Mass Torts Practice Group Morrison & Foerster LLP (San Diego, CA)

Kristin M. Kaplan Of Counsel Shook Hardy & Bacon LLP (Kansas City, MO)

Kim Bueno Attorney Butler Snow LLP (Austin, TX) Eva Canaan Partner King & Spalding LLP (New York, NY) Lori Cohen Law Firm Vice Chair Co-Chair, Global Litigation Practice Greenberg Traurig LLP (Atlanta, GA) Paul J. (PJ) Cosgrove Partner | Co-Group Leader, Product Liability Ulmer & Berne LLP (Cincinnati, OH) D’Lesli M. Davis Partner Norton Rose Fulbright US LLP (Dallas, TX)

Schedule of Events

John P. Lavelle, Jr. Partner Morgan, Lewis & Bockius LLP (Philadelphia, PA) John Lewis, Jr. Partner Shook Hardy & Bacon LLP (Houston, TX) Christina Marinakis, J.D., Psy.D. Shareholder/Director – Jury Research Litigation Insights (Los Angeles, CA) Douglas Moore Partner Irwin Fritchie Urquhart & Moore (New Orleans, LA) Mitch Morinec Shareholder Segal McCambridge Singer & Mahoney (Chicago, IL)

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Tariq M. Naeem Partner Tucker Ellis LLP (Cleveland, OH) Julie Park Partner Morrison Foerster LLP (San Diego, CA) Maithilee K. Pathak, PhD JD Partner R&D Strategic Solutions (Cumming GA) Andrea Roberts Pierson Partner Faegre Drinker Biddle & Reath LLP (Indianapolis, IN) Lyn Pruitt Partner DLA Piper (Dallas, TX) Kristen L. Richer Partner Barnes & Thornburg LLP (Los Angeles, CA) Susan Sharko Partner Faegre Drinker Biddle & Reath LLP (Florham Park, NJ) Rachel Sherman Partner Patterson Belknap Webb & Tyler LLP. (New York, NY) Erik Snapp Partner Dechert LLP (Chicago, IL) David N. Sneed Partner Covington & Burling LLP (Washington, DC) Danielle Gentin Stock Counsel Dechert LLP (New York, NY) Emily Ullman Partner Covington & Burling LLP (Washington, DC) Rachel Weil Partner Reed Smith LLP (Philadelphia, PA) Meredith Thornburgh White Partner Barnes & Thornburg LLP (Indianapolis, IN) Rebecca K. Wood Partner Global Life Sciences Leadership Council Sidley Austin LLP Former Chief Counsel, Food and Drug Administration (FDA) (Washington, DC)

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SCHEDULE OF EVENTS MAIN CONFERENCE DAY 1 | DECEMBER 7 y Drug and Medical Device 2021 Year in Review y Navigating the New Hybrid World of Virtual/In-Person Trial Practice y FDA Think Tank: Examining the Latest FDA Developments and Initiatives Influencing the Products Liability Sphere SPOTLIGHT ON MDLs » Combatting Plaintiff Tactics That Are Transforming MDLs Into the Machines We See Today

» Keys to Effectively Defending MDLs and Navigating the Remand Process from Transfer to Trial

y Creating a Roadmap for Post-Albrecht Preemption Using Takeaways from This Year’s Most Significant Rulings BREAKOUT SESSIONS » Daubert Revisited: Examining Recent Proposed Amendments to Rule 702 and What They Could Mean for the Future of Drug and Device Litigation » Incorporating Key Points from the Recent NDMA Litigations Into Your Future Trial Practice

» Lessons Learned from Recent Developments in This Year’s Opioid Trials » Analyzing Risks and Theories of Potential Liability Associated with New Technologies, Digital Health and Artificial Intelligence

y Cocktail Party Hosted by:

MAIN CONFERENCE DAY 2 | DECEMBER 8 y Addressing the Recent Rise of OTC Product Liability Litigation y Spotlight Speaker: Robert Charrow, Shareholder, Greenberg Traurig LLP, Former General Counsel, U.S. Department of Health and Human Services (HHS) y Judicial Insights on Drug and Medical Device Products Liability Litigation and How Courts Are Adjusting to the Lingering Effects of the Pandemic y Assessing How the COVID-19 Pandemic is Impacting Juror Mindsets, Perceptions, and Verdicts: What is the Data Showing? y Diversity, Equity & Inclusion Town Hall y Interactive Ethics Lab

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MAIN CONFERENCE DAY 1

Tuesday, December 7, 2021 7:15 | Breakfast and Registration

9:30

8:15

Chair’s Welcome Remarks Lisa Dunkin Assistant General Counsel, Litigation Zimmer Biomet (Fort Wayne, IN) 8:30

Drug and Medical Device 2021 Year in Review: How the Most Significant Product Liability Decisions of the Last Year are Impacting Your Clients and Cases Brennan Torregrossa Senior Vice President, Head of Global Litigation GSK (Philadelphia, PA) Eric Santoro Senior Counsel, Global Litigation AstraZeneca (Philadelphia, PA) Donald LeGower Assistant General Counsel – Litigation and Government Investigations Bristol-Myers Squibb (Lawrenceville, NJ)

Mary-Alice Barrett Associate General Counsel Genentech (Little Falls, NJ) Sarah Padgitt Associate General Counsel Baxter (Chicago, IL) Moderator: Lori Cohen Law Firm Vice Chair Co-Chair, Global Litigation Practice Greenberg Traurig, LLP (Atlanta, GA)

Navigating the New Hybrid World of Virtual/InPerson Trial Practice: Managing Shifting Client and Court Expectations and Implementing Strategies for Successful Outcomes Jason Steinhart Associate Vice President Associate General Counsel, North American Litigation Sanofi (Bridgewater, NJ) Justin Witzmann Senior Litigation Counsel Nuvasive (San Diego, CA) Meredith Thornburgh White Partner Barnes & Thornburg LLP (Indianapolis, IN) Kim Bueno Attorney Butler Snow LLP (Austin, TX) Moderator: Erin Bosman Partner, Co-Chair of Class Actions and Mass Torts Practice Group Morrison & Foerster LLP (San Diego, CA) • Examining what post-pandemic trial practice will look like in the mass torts arena • What aspects of trial practice will clients prefer to be done live/in-person vs. virtually?

Our opening panel of esteemed in-house counsel will kick off this year’s event by engaging in an interactive discussion of the most important case law developments of the past year, their real-life impact on drug and medical device litigation practice, and their implications and influence on future decisions, trends and strategies in this arena.

• How have in-house counsel expectations of their law firm counsel shifted amidst the recent transition to virtual trial practice, and how may their expectations continue to shift moving forward?

Points of discussion will include:

• Understanding when it is advantageous to request that something be in-person

• A survey of the year’s most significant and influential court decisions involving drug and medical device claims • Pending decisions that may have the most foreseeable future impact • How practitioners can update their practice and litigation strategies in response to the latest developments

• Are courts continuing to adopt virtual/zoom models for conferences, hearings and depositions?

• How will these changing trends impact how law firm counsel manage things for their clients going forward?

• Assessing the implications of continued aspects of virtual trial practice » How might having virtual aspects of jury trials impact the subpoena power of witnesses?

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FDA Think Tank: Examining the Latest FDA Initiatives Influencing the Products Liability Sphere Stacy Amin Partner Co-Chair, FDA Regulatory & Compliance Practice Morrison & Foerster LLP Former Chief Counsel, Food and Drug Administration, 2018-2021 (Washington, DC) Rebecca K. Wood Partner Global Life Sciences Leadership Council Sidley Austin LLP Former Chief Counsel, Food and Drug Administration, 2017-2018 (Washington, DC) Kristin M. Kaplan Of Counsel Shook Hardy & Bacon LLP (Kansas City, MO) Moderator: Julie Park Partner Morrison Foerster LLP (San Diego, CA) • Examining FDA guidance related to controls on NDMA in Zantac and other drugs • Exploring what future FDA approval processes and timelines will look like moving forward » Should the industry expect to see accelerated approvals for new drugs outside of those intended to treat COVID-19? (E.g. recent accelerated approval of Alzheimer’s drug Aduhelm) • Understanding the path forward for companies that received EUAs during the pandemic: what happens once the public health emergency is over?

How will EUAs need to be converted to traditional approvals?

• How will the events of the last two years impact the FDA in the next coming year and priorities and initiatives moving forward?

• What implications may recent developments have on future product liability litigation?

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SPOTLIGHT ON MDLs

10:30 | Morning Coffee Break 11:00

Schedule of Events

1:00

Taking Down the Rising Behemoth: Combatting Plaintiff Tactics That Are Transforming MDLs Into the Machines We See Today Lisa Dunkin Assistant General Counsel, Litigation Zimmer Biomet (Fort Wayne, IN) Sean P. Fahey Partner | Leader, Health Sciences Litigation Practice Group Troutman Pepper (Philadelphia, PA)

Andrew Kaplan Partner Crowell & Moring (Washington, DC) John Galvin Partner Thompson Coburn LLP (St. Louis, MO) Moderator:

Susan Sharko Partner Faegre Drinker Biddle & Reath LLP (Florham Park, NJ)

Douglas Moore Partner Irwin Fritchie Urquhart & Moore (New Orleans, LA)

Plaintiff Advertising • Developing concrete strategies to neutralize the effects of increasingly aggressive plaintiffs’ advertising - What are some of the specific things companies can do? Have there been any successful strategies thus far?

• Limiting plaintiff advertising: taking an aggressive stance against false or misleading messages to the public

Third-Party Litigation Funding • Mitigating challenges created by Third-Party Litigation Funding (TPLF) in the mass tort arena • Proactive measures that companies can take to push back on the effects of TPLF • Recent state law strides towards requiring disclosure of TPLF agreements in civil lawsuits

Initial Census Forms • Examining how the data and analytics from initial census forms are being used to weed out meritless claims • How have the use of these forms been playing out in recent prominent MDLs? • How is the data in these forms impacting judicial decisions and future proceedings?

12:00

Networking Luncheon Sponsored by:

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• Assessing the pros and cons of these census registries, and how they may impact MDLs moving forward

Social Media • Using social media and online investigation tools to identify and control meritless claims early on

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2:30

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Keys to Effectively Defending MDLs and Navigating the Remand Process from Transfer to Trial

Creating a Roadmap for Post-Albrecht Preemption Using Takeaways from This Year’s Most Significant Rulings

Zane Riester Senior Counsel Johnson & Johnson (New Brunswick, NJ) Cindy Aribisala Senior Counsel Gilead Sciences, Inc. (Foster City, CA) Andrea Roberts Pierson Partner Faegre Drinker Biddle & Reath LLP (Indianapolis, IN) D’Lesli M. Davis Partner Norton Rose Fulbright US LLP (Dallas, TX) Moderator: Marcella Ducca Co-Chair, Atlanta Products Liability Litigation Group Greenberg Traurig LLP (Atlanta, GA)

Mitch Morinec Shareholder Segal McCambridge Singer & Mahoney (Chicago, IL) Ilana H. Eisenstein Partner DLA Piper (Philadelphia, PA) James M. Beck Senior Life Sciences Policy Analyst Reed Smith LLP (Philadelphia, PA) Moderator: Emily Ullman Partner Covington & Burling LLP (Washington, DC) • Analyzing key implications and takeaways of recent, significant post-Albrecht preemption rulings in the Zofran, Pradaxa, Incretin and Gadolinium litigations

• Understanding the discrete challenges that MDLs present

» In re Zofran Products Liability Litigation (D. Mass. June 1, 2021)

• Implementing effective strategies for managing discovery, scheduling, case management, pre-trial motions, and bellwether considerations unique to consolidated proceedings

» Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc. (Conn. Super.

March 13, 2020)

• Developing tactics for approaching negotiations with plaintiffs’ counsel throughout the MDL process • Understanding how defendants (manufacturers, distributors, retailers, etc.) can all play in the MDL sandbox without causing problems for each other » How to make sure pretrial orders are negotiated so that everyone’s interests are considered » How to coordinate arguments in briefings so as not to undercut one another

» In re Incretin-Based Therapies Products Liability Litigation (S.D. Cal.) » Gremo v. Bayer Corp. (D.N.J. Jun. 29, 2020) • Understanding the key challenges that are being ironed out by the courts post-Albrecht • Applying lessons learned from recent rulings to create a future roadmap for obtaining Albrecht preemption • Examining new theories that the plaintiffs’ bar is using to get around preemption and keep generic drug companies in litigation – and creative defense tactics to combat these new plaintiff theories

• How to navigate the remand process from transfer to trial » Ensuring that the remand court’s docket is complete: practical considerations for how to designate material that will go to the remand court » Assessing whether there is any outstanding discovery that needs to be completed, and strategies for managing additional discovery in the remand court » Analyzing whether to file dispositive or evidentiary motions » Preparing the final pretrial order 3:45 | Afternoon Refreshment Break

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AFTERNOON BREAKOUT SESSIONS 4:45

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Daubert Revisited: Examining Recent Proposed Amendments to Rule 702 and What They Could Mean for the Future of Drug and Device Litigation Christopher M. Guth Senior Assistant General Counsel Bayer (Pittsburgh, PA) Rachel Weil Partner Reed Smith LLP (Philadelphia, PA)

B

John P. Lavelle, Jr. Partner Morgan, Lewis & Bockius LLP (Philadelphia, PA)

Erik Snapp Partner Dechert LLP (Chicago, IL) Eva Canaan Partner King & Spalding LLP (New York, NY)

• Taking a look at what changes to the Daubert test may be coming down the pike • What are the specifics of the possible new rule changes being considered by the Federal Rules Committee?

• What is the current status of these amendments? Where are they in the process?

• What would this reform mean for future litigation?

Incorporating Key Points from the Recent NDMA Litigations Into Your Future Trial Practice (Zantac, Valsartan and Metformin)

Paul J. (PJ) Cosgrove Partner | Co-Group Leader, Product Liability Ulmer & Berne LLP (Cincinnati, OH) Join this panel as they take a deep dive into the latest developments in the burning NDMA litigations, and how practitioners can incorporate takeaways from these litigations into their future trial practices. Our panelists will compare and contrast the unique elements of the Zantac, Valsartan and Metformin litigations, and will provide insights on each of their: • • • •

Distinctive litigation challenges Significant and impactful macro issues Notable judicial rulings Lessons learned

5:30

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Lessons Learned from Recent Developments in This Year’s Opioid Trials Wendy West Feinstein Partner Morgan, Lewis & Bockius LLP (Pittsburgh, PA) Tariq M. Naeem Partner Tucker Ellis LLP (Cleveland, OH)

Danielle Gentin Stock Counsel Dechert LLP (New York, NY)

• A comprehensive overview of the latest developments in this year’s opioid trials going forward in California, West Virginia, Oklahoma, Ohio, Washington, and New York • Examining notable verdicts, settlements, judicial rulings, and key takeaways from the various trials • Assessing nuances and unique elements of the opioid MDL • Examining new theories of tort liability being advanced and how these expansions of traditional confines of tort law may impact other areas of products liability litigation • What are we learning from these trials that will be useful to practitioners going forward?

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Analyzing Risks and Theories of Potential Liability Associated with New Technologies, Digital Health, and Artificial Intelligence Michele Suggs Adeleye Vice President and AGC, Chief Counsel Digital Pfizer (New York, NY) Max Heerman Senior Legal Counsel, Litigation Medtronic (Washington, DC)

David N. Sneed Partner Covington & Burling LLP (Washington, DC)

• Analyzing the latest developments in digital health technologies and Artificial Intelligence currently being utilized in the medical and healthcare sectors • How are these new technologies being utilized in drug development, disease diagnosis processes, marketing strategies and beyond?

• Examining the risks of new mistakes and liability risks associated with these new technologies, including cyber security challenges • Ensuring proper protection to all relevant legally protected interests, and preparing to minimize future liabilities associated with new technologies

6:15

Conference Adjourns

Cocktail Party Hosted by:

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MAIN CONFERENCE DAY 2

Wednesday, December 8, 2021 7:45 | Continental Breakfast

10:00

Spotlight Speaker

8:30

Robert Charrow Shareholder Greenberg Traurig LLP Former General Counsel, U.S. Department of Health and Human Services (HHS)

Opening Remarks and Recap of Day 1 8:45

An Industry Under Attack: Addressing the Recent Rise of OTC Product Liability Litigation Elizabeth Balakhani Assistant General Counsel GSK (Philadelphia, PA) Sandra A. Edwards Co-Chair, Product Liability & Mass Torts Practice Winston & Strawn LLP (San Francisco, CA) Caycee D. Hampton Attorney at Law Carlton Fields (Tampa, FL) Kristen L. Richer Partner Barnes & Thornburg LLP (Los Angeles, CA) • Examining the recent spike in OTC product liability litigation, increased scrutiny of chemical additives, and the role of consumer advocacy groups in targeting pharma and over-the-counter products • Assessing recent OTC product litigation (Bayer Roundup, One A Day Gummy Vitamins, sunscreen class actions): what lessons can be taken from these litigations that may apply to litigation in the Rx pharma space?

• Addressing the recent trend of consumer advocacy groups performing their own testing on various OTC products that are spawning product recalls and litigations? » Understanding the role of these consumer advocacy groups and their coordination with the plaintiffs’ bar » Exploring recent challenges to the legitimacy of their testing and the science behind their studies (e.g. recent retraction of Valisure study that led to the Zantac recalls) • Taking a look at the recent withdrawal of titanium oxide from the safe food additive list: what will happen if this additive (used as a coating or filler on many tablets) is deemed unsafe for pharmaceutical products?

9:45 | Morning Coffee Break

10:30

A View from the Bench – 2021 Edition: Judicial Insights on Drug and Medical Device Products Liability Litigation and How Courts Are Adjusting to the Lingering Effects of the Pandemic Honorable Karen K. Caldwell Chief Judge – U.S. District Court, E.D. Kentucky Chair – Judicial Panel on Multidistrict Litigation (JPML) (Lexington, KY) Honorable Nancy J. Rosenstengel Chief Judge U.S. District Court, S.D. Illinois (East St. Louis, IL) Honorable Eduardo C. Robreno Senior Judge U.S. District Court, E.D. Pennsylvania (Philadelphia, PA) Honorable William F. Highberger Superior Court Judge Los Angeles County Superior Court (Los Angeles, CA) Moderator: Andrew T. (Andy) Bayman Partner King & Spalding LLP (Atlanta, GA) Hear from a panel of esteemed judges on topics including: • What continuing effects of the pandemic are being seen on their dockets, court functions and the JPML in general?

• What to expect in their courtrooms going forward as far as facets of trial practice being virtual vs. live?

• What arguments have they found most effective and persuasive when presiding over a drug or medical device products liability case?

• What works and doesn’t work in their courtroom with regard to jury instructions, voir dire and opening/closing statements?

• Examples they have seen of poor witness selection, inability to connect with a jury, and good vs. bad lawyering

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11:45

1:30

Assessing How the COVID-19 Pandemic is Impacting Juror Mindsets, Perceptions, and Verdicts: What is the Data Showing?

Diversity, Equity & Inclusion Town Hall: A Candid Discussion About Drivers of Successful DE&I Initiatives—What’s Working, What’s Not, and How We Can Do Better

Christina Marinakis, J.D., Psy.D. Shareholder/Director – Jury Research Litigation Insights (Los Angeles, CA)

Adrienne M. Hollander Assistant General Counsel American Regent Inc., a Daiichi Sankyo Group Company (Shirley, NY)

Maithilee K. Pathak, PhD JD Partner R&D Strategic Solutions (Cumming GA)

Rachelle L. Laroche Assistant General Counsel – Trademarks Johnson & Johnson (Union City, NJ)

Lyn Pruitt Partner DLA Piper (Dallas, TX) • Will post- COVID good will towards pharmaceutical and medical device companies actually play out at trial?

John Lewis, Jr. Partner Shook Hardy & Bacon LLP (Houston, TX)

• Are we seeing discrepancies between juror attitudes towards drug companies vs. device companies?

Let your voice be heard in this unique “open floor” session, designed to give attendees an opportunity to grab the microphone and add to the dialogue on successful DEI initiatives. Topics of discussion will include:

• How to relate juror reluctance to sit on a jury during the pandemic to how their perspectives would be while actually sitting on the jury?

• Implementing policies and practices that will truly effect change and promote a diverse workplace

• Are we seeing any correlation between vaccine hesitancy and juror perceptions of drug companies?

• Understanding what specific evidence of diversity in-house legal departments are seeking from outside counsel when vetting and choosing law firms to represent them

• Analyzing data about people l who are hesitant to get vaccinated and whether they tend to have a worse view of pharma companies? What can we glean from including the question “have you been vaccinated?” on a juror questionnaire?

• Best practices for evaluating a firm’s efforts in promoting diversity • How can companies manage and capitalize on generational diversity in the workplace?

• Shifting From Diversity and Inclusion to Diversity, Equity, and Inclusion – what does equity in the workplace look like?

12:30 | Networking Luncheon

2:30

Interactive Ethics Lab Adam Bassing Head of Global Litigation UCB, Inc. (Smyrna, GA) Aileen Fair Senior Corporate Counsel, Litigation & Government Investigations Bristol Myers Squibb (Princeton, NJ) Rachel Sherman Partner Patterson Belknap Webb & Tyler LLP. (New York, NY)

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Test your ethics skills with a series of anonymous polling questions on sensitive, complex hypothetical scenarios. Discover how your approach to tackling ethical dilemmas in drug and medical device litigation compares to your peers, and benefit from a practical discussion of the polling results and important takeaways for your practice.

3:30 | Conference Concludes

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DRUG&MEDICAL DEVICE L I T I G AT I O N

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VENUE INFORMATION Hotel: New York Marriott Marquis Address: 1535 Broadway, New York, NY 10036 Reservations: 212-398-1900 American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ACI’s Drug & Medical Device Litigation”.

Please note that the guest room block cut-off date is November 22, 2021. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

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Accreditation will be sought in those jurisdictions requested by the registrants which have continuing CREDITS education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

EARN CLE

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/CLE #DrugandMed twitter: @DrugandMed linkedin: ACI’s Drug and Medical Device Litigation

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DRUG&MEDICAL DEVICE

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All cancellations and changes must be submitted to customerservice@americanconference.com by November 26.

About us:

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

For over 35 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

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DRUG&MEDICAL DEVICE L I T I G AT I O N

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Planning Ahead for Live Conferences: C5’s All Secure Safety Plan We look forward to the time when we are able to welcome you back to our live conferences.

When you are ready to attend one of our conferences, you will see that a lot has changed. Social distancing and cleaning procedures that have now become a way of life for all of us are now the standard for how we will run our conferences. Our events will continue to offer unparalleled access to market leading intelligence and to the facilitation of a global exchange of expertise and now with a greater focus on the safety, health and well-being of all our guests.

As American Conference Institute and our partners begin to look forward to live events, we are committed to building and enhancing the planning and preparation with a view to offering our guests a safe place for live conference delivery. In addition, to ensure your safety, our event staff is fully vaccinated.

All our events will adhere to official government and local authority guidance in addition to venue or locationspecific regulations. Our live events will follow the commitments below.

Attendance Screening All attendees will need to assert that at the time that they first attend the conference and for the 14 days prior: y They are not experiencing COVID-19 symptoms. y Have not traveled from an area under a travel health advisory. y Have not provided care for or had close contact with any person with or reasonably suspected of having COVID-19, or with any person who traveled outside of your home country or to an area under a travel health advisory. y Have not been advised by any health authority, government agency or regulation to self-isolate due to possible exposure to COVID-19.

Link to COVID-19 symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/ symptoms.html We are closely monitoring industry best practices and will be evaluating further additional measures pertaining to vaccinations and on-site screening based on the advice of health authorities.

Enhanced Communication y Advance communication to all attendees on what to expect and prepare for at the conference: from registration to conference materials to room layout to food and beverage options and more. y Education and training for the team to ensure we provide a safe and secure conference experience. y Distribution of local health-resource information in advance of the event. y Ongoing communication and advance planning with the venue regarding enhanced cleaning and sanitizing measures, response strategies and other onsite protocols.

Increased Cleaning and Sanitation y Placement of hygiene stations throughout the conference including the registration area, meeting spaces and high frequency areas. y Availability of personal hygiene and safety products including facial coverings where available.

Safety and Physical Distancing y Physical distancing protocols such as limiting attendance, directional signage and markers throughout the conference. y A conference room layout with planned seating for appropriate physical distancing. y We continue to work closely with our venue partners to ensure the safety of our attendees. Please check back frequently as we monitor and evolve our plan in the weeks ahead.

Reduced Touchpoints y Reduction of the physical distribution of onsite materials. y Food and beverage options that ensure minimal handling and exposure.

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DRUG&MEDICAL DEVICE L I T I G AT I O N

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Can’t Attend In-Person?

Map Out Your Virtual Experience.

True Interaction from Start to Finish.

The Lobby is your starting point…

View the Schedule See What is “Happening Now”

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Access Conference Materials Accreditation Information

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Check Out Our Sponsors

The Sessions area contains the majority of the conference programming and networking events.

The 1:1 Networking is a fast-paced opportunity to meet new people and expand your professional network.

Plan to visit the Expo often.

It will be open before, during, and after the conference.

CHEVRON-DOUBLE-RIGHT Attend live sessions, ask questions, comment in the chat function, and take part in live polling.

Enter this area to be paired up at random with other attendees for a quick video meet-up.

Use this opportunity to explore new products and services from leading providers, and meet with new and existing partners over video chat.

View Related Conferences

Emma McAdam VP, Government Affairs

Janet Smith VP, General Counsel

Olivia Thomson Chief Compliance Officer

Luis Santos Director

Ramesh Kumar Partner

CHAIR

Jean Roux VP, Business Development

Patricia Harden Head of Sanctions Miyuki Johnson VP, Manufacturing

Lisa Dunkin Assistant General Counsel, Litigation Zimmer Biomet

Maximize Your Conference Experience

Update your profile

Review your profile, upload a picture and connect your social media accounts to personalize your presence.

People tab

You can also engage with other attendees directly. Find a person in the attendee list to send a message and/or an invitation to a video chat.

Polling

Weigh in and seize the opportunity to benchmark with industry peers in real-time.

Use the Chat feature to engage with fellow attendees, speakers and sponsors.

Turn your camera on

for roundtable sessions, networking events and video chats for a more engaging virtual connection.

Make Connections Join scheduled “1:1 Networking” sessions. They are an interactive way to expand your network of peers.

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Engage with solution providers of all kinds by visiting the “Expo” to watch videos and live demonstrations, and for face-to-face conversations.

Use the “People” tab to create new relationships and strengthen existing ones within your industry.

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DRUG&MEDICAL DEVICE L I T I G AT I O N

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THANK YOU TO OUR SPONSORS Main Day Cocktail Sponsor:

Supporting Sponsors:

King & Spalding is an international law firm with more than 1,200 lawyers in 22 offices globally.

Our Pharmaceutical & Medical Device Litigation Team helps manufacturers navigate the litigation life cycle, from risk assessments through trial and appeal. Working with more than 300 lawyers and professionals who devote all or a substantial portion of their practices to life-sciences clients, we know the industry and governing laws better than anyone. With over 175 lawyers across the world, our Product Liability team, which was named a Practice Group of the Year by Law360 for seven of the last eight years (including 2020), leverages knowledge of the complex science and technology behind today’s products to deliver litigation victories. We handle the most significant individual, multidistrict, mass tort and class action lawsuits for pharmaceutical and medical device companies. We offer our clients a depth of trial experience that is increasingly unusual in firms of our size. While many firms can “litigate” cases, we try product cases each year in some of the most challenging jurisdictions for corporate clients. For more information, please visit www.kslaw.com

Home to a former U.S. Attorney General and numerous former high-ranking prosecutors, Covington’s Anti-Corruption team partners with clients to develop global strategies for cross-border anti-corruption compliance and to respond to multi-jurisdictional investigations.

Lead Sponsor + Luncheon Sponsor:

Greenberg Traurig, LLP’s Pharmaceutical, Medical Device & Health Care Litigation Practice is a premier life sciences litigation team, unique in its involvement in most of the top mass torts and class actions facing the pharmaceutical and medical device industries. GT’s team serves as national, regional, trial, and settlement counsel for industry leaders, and regularly tries cases involving cutting-edge legal, medical, and scientific issues in high-stakes settings. Distinguished by its depth of experience, geographic breadth, and thorough understanding of the industry, this nationwide team of 90+ litigators and trial veterans delivers top-of-class client service. www.gtlaw.com

Welcome Cocktail Sponsor: Barnes & Thornburg has extensive and ongoing experience managing and litigating the largest and most significant drug, device and consumer product mass torts facing manufacturers and sellers today. Our lawyers excel at strategic counseling, and have coordinated some of the largest mass tort resolutions in history.

We have the results-driven approach, resources and expertise to help you address the evolving challenges you face. www.btlaw.com

Lanyard Sponsor:

Across both counseling and investigations, our anti-corruption team is able to provide “24-hour” real-time support to our clients with seamless coordination across the Americas, Europe, Asia, and Africa. Our team has handled matters throughout the world, including in Brazil, China, Eastern Europe, Germany, India, Indonesia, Mexico, the Middle East, Russia, South Korea, and the UK. Our practice and track record of success have garnered the attention of some of the world’s leading legal ranking publications, including Global Investigations Review and Chambers USA, which highlight our exceptional individuals and collective anti-corruption counseling, investigations, and enforcement experience in the U.S. and abroad. www.cov.com/en/practices-and-industries/practices/litigation-and-investigations/ anticorruption--fcpa Dechert is a leading global law firm with 22 offices around the world.

We advise on matters and transactions of the greatest complexity, bringing energy, creativity and efficient management of legal issues to deliver commercial and practical advice for clients. For further information, click here.

DLA Piper’s award-winning life sciences team is one of the most accomplished in the world. We operate across more than 30 jurisdictions to represent clients in the fields of biopharmaceutical, medical device, research, and diagnostics. We succeed by applying the unique experience and knowledge of our team members to the challenges faced by each client, whether it be product liability and mass tort litigation, licensing and distribution, regulatory compliance, government investigations, IP enforcement, M&A, or clinical trial advice. www.dlapiper.com/en/us/ Morgan Lewis is a global law firm with more than 2,200 legal professionals in 31 offices worldwide. With more than 250 international partners and counsel who focus on the life sciences industry, Morgan Lewis has one of the most comprehensive practices in this area. We are unsurpassed in our global understanding of the business, regulatory, intellectual property, litigation, and related issues that our clients face along the product life cycle, from innovation and emerging business issues, through research and development, regulatory approval, product reimbursement, marketing and distribution, to fraud and abuse, product liability and intellectual property litigation, to mergers and acquisitions, collaborations, and outsourcing. Morgan Lewis offers extensive capabilities and decades of experience coordinating complex national litigation, in addition to providing efficient, powerful solutions for the increasingly demanding discovery environment. We are nationally recognized for our leadership and innovation in developing alternative fee structures. For more information, please visit www.morganlewis.com.

Faegre Drinker is a top 50 firm designed for clients.

With more than 1,300 experienced attorneys, consultants and professionals in 21 locations in the United States, London and Shanghai, we have the strength to solve your most complex transactional, litigation and regulatory challenges wherever you need us.

Clients are at the start — and the heart — of everything we do. Our culture is firmly rooted in relentless client focus and mutual trust that empowers collaboration. We deliver excellence — without arrogance. We are committed to our communities and to building a diverse and inclusive firm that reflects those communities and our clients.

hands-helping BECOME A SPONSOR With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com

Morrison & Foerster is the destination firm for class actions and mass torts and counsel of choice for industry leaders. Our team has a long and successful track record in defending large class actions and mass tort litigation. With a strategic and comprehensive life-cycle approach, we counsel clients from pre-product launch to post-market representation in the medical device, pharmaceutical, food and dietary supplement, biotechnology, healthcare technology, and cosmetic industries. We help our clients stay U.S. FDAcompliant and optimally positioned for maximum coverage and reimbursement, entry into new global markets, and further research and development. We are the complete life-cycle counsel for navigating compliance with regulated products.

With a well-earned reputation as a litigation powerhouse, Shook, Hardy & Bacon is the go-to firm for the world’s leading health, science and technology companies. In addition to fielding the largest product liability practice in the world, Shook handles commercial litigation, environmental and toxic tort, and intellectual property disputes for the pharmaceutical and medical device, food and beverage, and consumer goods industries. While its high-stakes, complex litigation expertise is second to none, the firm also has the regulatory compliance and risk management experience upon which companies have come to rely. Established in Kansas City in 1889, Shook has grown to approximately 500 attorneys and 200 research analysts and paraprofessionals, many of whom have advanced scientific and technical degrees. Shook’s offices are strategically located in Atlanta, Boston, Chicago, Denver, Houston, Kansas City, London, Los Angeles, Miami, Orange County, Philadelphia, San Francisco, Seattle, St. Louis, Tampa and Washington, DC. www.shb.com

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Associate Sponsors: Butler Snow LLP is a full-service law firm with more than 360 attorneys and advisors collaborating across a network of 27 offices in the United States, Europe and Asia. Ranked as a leading firm for client relations and one of America’s Top 100 law firms in the BTI Power Rankings, Butler Snow is recognized as one of the nation’s top law firms for client service. The firm was recently ranked 48th out of 650 firms in the BTI Client Relationship Scorecard for understanding client business, anticipating client needs, unprompted communication, legal skills, quality and keeping clients informed. The firm’s Pharmaceutical, Medical Device & Healthcare Litigation Group was selected as Benchmark Litigation’s 2018 Product Liability Group of the Year and shortlisted for the honor in 2017 and 2019. The team is recognized nationally by a variety of publications, including Chambers & Partners USA, The Legal 500: US, and LMG Life Sciences. For more information, visit www.butlersnow.com or follow the firm on Twitter @Butler_Snow.

CELEBRATING 120 YEARS

Carlton Fields has more than 330 attorneys and consultants serving clients from offices throughout the United States.

Carlton Fields defends Fortune 100 manufacturers in highstakes mass tort and product liability litigation in state and federal courts nationwide. For more than 30 years, we have helped market-leading clients win or resolve these lawsuits from beginning to end. We have tried more than 100 cases to juries in courts around the country, and work closely with Carlton Fields’ appellate lawyers, many of whom are board certified in appellate law and focus on mass tort and product liability issues.

For additional information, visit www.carltonfields.com.

Crowell & Moring LLP is an international law firm with offices in the United States, Europe, MENA, and Asia that represents clients in litigation and arbitration, regulatory and policy, and transactional and corporate matters. The firm is internationally recognized for its representation of Fortune 500 companies in high-stakes litigation and governmentfacing matters, as well as its ongoing commitment to pro bono service and diversity, equity, and inclusion.

Based in New Orleans and Baton Rouge, Irwin Fritchie Urquhart & Moore LLC has a diverse, nationwide practice in pharmaceutical and medical device litigation. Clients have trusted Irwin Fritchie to serve as national coordinating counsel, national trial counsel, and national and international science counsel in a variety of mass torts, often working together in litigation teams with other premier law firms. Irwin Fritchie provides the highest quality work at a tremendous value to its clients. For more information, please visit www.irwinllc.com.

Norton Rose Fulbright is a global law firm with more than 4,000 lawyers based in Europe, the United States, Canada, Latin America, Asia, Australia, the Middle East and Africa. Our life sciences product liability team has a national presence and our lawyers have extensive experience defending individual cases, as well as coordinating and defending multi-jurisdictional product liability dockets, and serving as national trial counsel, national coordinating counsel, national discovery counsel and regional trial counsel for our clients. We have served our clients in some of the largest product liability litigation filed in the country, including Fen-phen, Vioxx, Actos, Baycol, Yaz, PPA, and pediatric vaccines, just to name a few. Our team works as a global unit which provides significant efficiency, and cost savings to our clients when mass torts have an “outside US” component. The team is recognized by Chambers & Partners for US Nationwide product liability and mass tort work. www.nortonrosefulbright.com Reed Smith’s life sciences team is committed to anticipating and solving legal challenges so you can focus on what you do best: improving quality of life and saving lives. In addition to our skilled life sciences transactional and regulatory lawyers, our highly-regarded, fullservice life sciences litigation practice features a deep bench of seasoned trial lawyers and appellate specialists. For more than 40 years, Reed Smith has served as national, strategic, trial, and science counsel to the top global pharmaceutical and medical device manufacturers in single plaintiff and complex litigation matters, and is regularly recognized for its successes in high-profile product liability and mass tort litigations. https://www.reedsmith.com/en

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For more than 35 years Segal McCambridge has been in the forefront of defending clients in the Life Sciences arena. Constantly evolving to stay ahead of the Plaintiffs’ Bar, Segal McCambridge stays true to its founding principles: aggressive, effective, and cost-efficient defense of its clients.

Thompson Coburn is a full-service law firm with more than 400 attorneys in Chicago, Dallas, Los Angeles, New York, St. Louis, Washington, D.C., and Southern Illinois. In 2019, the firm was recognized by the Association of Corporate Counsel as an ACC Value Champion, which recognizes “best-in-class” innovations that drive value and dramatically improve efficiencies within corporate law departments. Thompson Coburn is one of just 65 firms in the country to receive Mansfield 3.0 “Plus” status under a national initiative to increase the representation of diverse lawyers in law firm leadership. Thompson Coburn’s Product Liability group represents drug and medical device companies in national and regional litigation across the country including multidistrict litigation.

Troutman Pepper’s Health Sciences Department litigation partners are national leaders in defending companies across the pharmaceutical and medical device supply chains. As one of the largest cross-practice teams focused predominantly on health care and life science sectors, we draw from our deep sector experience to craft scientifically compelling litigation strategies and oversee complex litigation for many of the leading pharmaceutical, medical device, and life science companies on product liability and other claims involving thousands of cases.

Tucker Ellis LLP is built on longstanding client and professional relationships, with more than 220 attorneys located in Chicago, Cleveland, Columbus, Los Angeles, San Francisco, and St. Louis. In every engagement, the Tucker Ellis culture ensures that our clients benefit from the efforts of teams that are aligned with client objectives. Our Health & Life Sciences attorneys present a distinctive combination of medical, scientific, and technical knowledge and decades of industry experience. They are respected nationally and sought out for their innovative guidance, courtroom skills, and resoundingly practical approach to our clients’ most difficult issues.

At Ulmer, the focus is on exceeding client expectations and delivering superior, customized legal solutions for an exceptional value. The firm is a leader in defending classaction, multidistrict, and mass tort litigation concerning drugs, biologics, medical devices, and dietary supplements. Ulmer attorneys have served as lead national defense counsel in high-impact litigation involving antidepressants, contraceptives, testosterone replacement therapy, pain medications, oncology drugs, gastrointestinal products, ADHD medications, pelvic mesh products, glucose monitoring products, weight management products, and performance training supplements. They also counsel pharmaceutical, medical device, and dietary supplement companies on regulatory and risk management matters. The practice is strengthened by its many attorneys with degrees in various scientific disciplines. Learn more at Ulmer.com.

Major multinational corporations have trusted Winston & Strawn for decades to aggressively defend their products and reputations in the face of some of the most significant high-profile liability and mass tort claims in the country involving substantial exposure. Winston has a track record of success in the pharmaceutical and medical device space, whether that be directing national strategy for the defense of products in many jurisdictions, MDLs and coordinated proceedings, or appearing locally in product liability trials.

Premium Exhibitor: www.golkow.com

Exhibitor: Élan Legal Media™ is a leading legal marketing agency providing marketing solutions for law firms, class action administrators, and litigation funds. The company is made up of nimble, innovative professionals that bring the most advanced advertising research and technologies to the legal space. From full-service law firm advertising to data-driven legal notification, Élan Legal Media has the capabilities to do it all.

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