28th Annual Conference on Drug & Medical Device Litigation - DS

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28th Annual Conference on

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

December 5–6, 2023 | NY Marriott Marquis, New York, NY

Distinguished 2023 Co-Chairs: Daniel Healey

Jobina Jones-McDonnell

Senior Corporate Counsel Pfizer

Vice President, Assistant General Counsel - Litigation and Risk Endo Pharmaceuticals

Sarah Padgitt

Associate General Counsel Baxter

Network and Benchmark with Representatives from 20+ Leading Drug and Medical Device Companies Including: 3M Bayer Baxter B. Braun Medical Inc. Beckton Dickinson and Company

Boehringer Ingelheim Bristol Myers Squibb Daiichi Sankyo Eli Lilly and Company Endo Pharmaceuticals Genentech

GlaxoSmithKline Johnson & Johnson Medtronic Merck Novartis Nuvasive

Otsuka Pharmaceutical Pfizer Purdue Pharma Smith & Nephew Viatris Zimmer Biomet

Benefit from Our Pre-Conference Workshops | December 4, 2023 Workshop A: MDL Defense Strategy War Room: Developing a Tactical Tool-Kit for Managing Unique MDL Challenges and Combatting Meritless Claims

Workshop B: Cost, Competency, and Communication: Esteemed Members of the Drug and Med Advisory Board Speak on Their Expectations of Law Firm Partners With Regard to the “Three C's"

See page 6 for details.

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DRUG&MEDICAL DEVICE

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ACI’s Drug & Medical Device Conference is THE must attend premier conference for attorneys practicing in the drug and medical device space.”

LORA SPENCER, PRINCIPAL LITIGATION COUNSEL, MEDTRONIC

For 28 years, ACI’s “Drug and Med” conference has brought together hundreds of products liability defense stakeholders from industry, private practice, and government to collaborate and strategize on the current products liability landscape as well as to anticipate what is next on the horizon.

We invite you to join us this December to meet and reconnect with colleagues and acquire invaluable insights to surmount the latest product liability litigation challenges facing the drug and medical device community today.

Our esteemed 2023 faculty will provide invaluable information on the product liability risks associated with AI in drug development and medical device usage, the potential impact of new MDL case management changes under proposed FRCP 16.1, and the benefits and risks of utilizing bankruptcy as a mass tort resolution vehicle.

Through our sophisticated panels, you will also gain insights on, when and how to successfully engage the FDA in your case, working with experts after the new Rule 702 amendments and critical international developments impacting drug and device product liability litigation in foreign jurisdictions.

We look forward to seeing you in New York City for the life sciences products liability defense bar's most valuable gathering of the year.

ACI's Drug and Med Advisory Board Patricia A. Barbieri SVP, General Counsel and Secretary Daiichi Sankyo, Inc.

Bill Childs Assistant General Counsel, Litigation 3M

Zane Riester Senior Counsel Johnson & Johnson

Mary-Alice Barrett Associate General Counsel Genentech

Christopher M. Guth Senior Assistant General Counsel Bayer

Richard W. Silbert V.P., Chief Legal Strategist Purdue Pharma L.P.

Debra L. Burns Senior Counsel Litigation/ Investigations GE Healthcare

Donald LeGower Vice President | Litigation & Gov’t Investigations Bristol-Myers Squibb

Lora Spencer Principal Litigation & Investigations Counsel Medtronic

Candace Camarata Associate General Counsel Becton, Dickinson and Company

Jobina Jones-McDonnell Vice President, Assistant General Counsel - Litigation and Risk Endo Pharmaceuticals

Brennan Torregrossa Senior Vice President, Head of Global Litigation GSK

Sarah Padgitt Associate General Counsel Baxter

2 | LINKEDIN ACI Drug and Medical Device Litigation

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

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LEAD & LUNCHEON SPONSOR

Get ready for…

LEAD & COCKTAIL RECEPTION SPONSOR

Handshake-alt 400+

Attendees

20+

Revamped Panel Discussions

65+

Speakers

Including 25+ In-House Counsel from Industry Leading Companies

3

SUPPORTING SPONSORS

Days of Networking

What’s NEW for 2023

LANYARD SPONSOR

POCKET AGENDA SPONSOR

Comments-alt TWO Days of In-Depth Break Out Sessions 20 main conference sessions providing enhanced learning opportunities to deliver critical information on the topics most pressing to you.

ASSOCIATE SPONSORS

Marquee Focus Sessions on Artificial Intelligence Advanced, cutting-edge discussions on the product liability risks of AI-usage in drug and device development, and the opportunities and perils of AI-assisted legal representation.

Spotlight on Proposed New Rule 16.1 Seasoned MDL practitioners will shed light on how newly proposed FRCP 16.1 will transform the future of MDL case management.

MDL Case Studies – 2023 Edition An assessment of the year’s biggest and most complex MDLs: lessons learned from Tylenol, Zantac and Exactech.

Horizons: A Global Outlook on globe-africa Broadening Drug & Device Product Liability Litigation An exploration of critical international developments impacting drug and device product liability litigation in foreign jurisdictions.

PREMIUM EXHIBITORS

CONFERENCE SPONSOR

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DISTINGUISHED FACULTY ESTEEMED CO-CHAIRS

IN-HOUSE COUNSEL

Daniel Healey Senior Corporate Counsel Pfizer Jobina Jones-McDonnell Vice President, Assistant General Counsel - Litigation and Risk Endo Pharmaceuticals Sarah Padgitt Associate General Counsel Baxter RENOWNED JURISTS Honorable Karen K. Caldwell Chief Judge U.S. District Court, E.D. Kentucky Chair Judicial Panel on Multidistrict Litigation (JPML) Honorable Kristine Baker District Judge U.S. District Court, District of Arkansas Honorable Brian R. Martinotti District Judge U.S. District Court, District of New Jersey Honorable John R. Tunheim District Judge U.S. District Court, District of Minnesota Honorable Abbe F. Fletman Judge Philadelphia Court of Common Pleas Honorable Brian H. May Circuit Judge, Division 1 St. Louis County Circuit Court

4 | LINKEDIN ACI Drug and Medical Device Litigation

Patricia A. Barbieri SVP, General Counsel and Secretary Legal and Corporate Affairs Daiichi Sankyo Mary-Alice Barrett Associate General Counsel Genentech Bill Childs Assistant General Counsel, Litigation 3M Greg Dadika Vice-President, Litigation, Governmental Investigations & Risk Management Boehringer Ingelheim Lisa M. Dunkin Vice President & Associate General Counsel, Litigation Zimmer Biomet Larissa A. Eustice Senior Assistant General Counsel Bayer Rachel A. Farnsworth Senior Counsel | Litigation & Government Investigations Bristol Myers Squibb Rachel Gallagher Associate General Counsel Teleflex

Jonathan Jung General Counsel Prinston Pharmaceutical Michelle Kitchen Senior Manager, IP eDiscovery Novartis Donald LeGower Vice President | Litigation & Gov’t Investigations Bristol-Myers Squibb Leah Lorber Assistant General Counsel GlaxoSmithKline Elizabeth Mitchell Associate General Counsel, Global Litigation Smith & Nephew Sarah Padgitt Associate General Counsel Baxter Jean Patterson Assistant General Counsel Becton Dickinson Sarah H. Richardson Senior Litigation Counsel W.L. Gore & Associates Zane Riester Senior Counsel Johnson & Johnson Richard Silbert Vice President, Legal Strategy & Public Health Initiatives Purdue Pharma L.P.

Ashley Garry Senior Counsel Viatris

Lora Spencer Principal Global Litigation & Investigations Counsel Medtronic

Daniel Healey Senior Corporate Counsel Pfizer

Brennan Torregrossa Senior Vice President, Litigation, Employment, Digital, and Privacy GlaxoSmithKline

Jobina Jones-McDonnell Vice President, Assistant General Counsel Litigation and Risk Endo Pharmaceuticals

Justin Witzmann Director, Legal Affairs Global Litigation Nuvasive

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

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LAW FIRM ATTORNEYS Colleen Baime Partner Baker & McKenzie LLP Andrew T. (Andy) Bayman Partner King & Spalding LLP

Highlights

Sponsors

Sean Gugerty Partner Goodell, DeVries, Leech & Dann LLP Anne Gruner Attorney Duane Morris LLP

John Beisner Partner Skadden, Arps, Slate, Meagher & Flom LLP

Matt Holian Partner; Co-Chair, Global Life Sciences Sector DLA Piper LLP

Steven Boranian Partner Reed Smith LLP

Ben Hulse Partner Norton Rose Fulbright US LLP

Erin Bosman Partner, Co-Chair, Class Actions and Mass Torts Practice Group Morrison & Foerster LLP

Michael Imbroscio Partner Covington & Burling LLP

Ashley Carr Partner DLA Piper LLP Celeste Coco-Ewing Partner Irwin Fritchie Urquhart Moore & Daniels LLC Lawrence Cooke Partner Venable LLP Patrick Corr Partner Faegre Drinker Biddle & Reath LLP Paul (P.J.) Cosgrove Partner Ulmer & Berne LLP Jessica Davidson Partner Skadden, Arps, Slate, Meagher & Flom LLP

Andrew Kaplan Partner, Chair of Mass Tort, Product, and Consumer Litigation Group Crowell & Moring LLP Christopher Kaufman Partner Shook, Hardy & Bacon LLP Thomas Kurland Partner, Litigation, Products Liability and Brand Protection Patterson Belknap Webb & Tyler LLP Janet Kwuon Partner, Co-Chair of Life Sciences Industry Group Reed Smith LLP JT Larson Partner Barnes & Thornburg LLP John Lavelle Partner Morgan, Lewis & Bockius LLP

Katherine Unger Davis Partner Dechert LLP

Jill Lawrie Partner Blake, Cassels & Graydon LLP

Wendy West Feinstein Partner Morgan, Lewis & Bockius LLP

Daniel Lazaro Counsel Buchanan Ingersoll & Rooney PC

Russell “Chip” Gaudreau Partner King & Spalding LLP

Michael Leard Partner Nutter McClennen & Fish LLP

Ethan Greene Managing Partner Reisman Greene Theis LLP

Anita Modak-Truran Partner Butler Snow LLP

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Faculty

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Daniel Pariser Partner Arnold & Porter Julie Park Partner Morrison & Foerster LLP Joseph Petrosinelli Partner Williams & Connolly LLP Harley Ratliff Partner Shook, Hardy & Bacon LLP Patrick Reilly Partner Faegre Drinker Biddle & Reath LLP Terri Reiskin Partner Nelson Mullins Riley & Scarborough Eric Rumanek Partner Troutman Pepper Jennifer Saulino Partner Sidley Austin LLP Judge Booker Shaw Partner Thompson Coburn LLP Libretta (Libby) Stennes Shareholder Greenberg Traurig LLP Sara Thompson Shareholder Greenberg Traurig LLP Emily Van Tuyl Partner Dechert LLP Davis Walsh Partner McGuireWoods LLP Steven Weisburd Shareholder Carlton Fields, P.A. Grant Worden Partner Torys LLP CONSULTANTS Keith C. Pounds, PhD Senior Jury Consultant IMS Dan Troy Managing Director Berkeley Research Group

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In-Depth Pre-Conference Workshops MONDAY, DECEMBER 4, 2023

Workshop A

Workshop B

9:00 – 12:30

1:30 – 5:00

MDL Defense Strategy War Room: Developing a Tactical Tool-Kit for Managing Unique MDL Challenges and Combatting Meritless Claims

Cost, Competency and Communication Working Group: Esteemed Members of the Drug and Med Advisory Board Speak on Their Expectations of Law Firm Partners With Regard to the “Three C's"

microphone-alt Ben Hulse, Partner, Norton Rose Fulbright US LLP Sean Gugerty, Partner, Goodell, DeVries, Leech & Dann LLP

microphone-alt Lora Spencer, Principal Global Litigation & Investigations Counsel, Medtronic

Michael Imbroscio, Partner, Covington & Burling LLP

Bill Childs, Assistant General Counsel, Litigation, 3M Patricia A. Barbieri, SVP, General Counsel and Secretary, Legal and Corporate Affairs, Daiichi Sankyo

Be part of this defense-counsel only strategy session where we will examine the discrete challenges that mass-tort MDLs present. Join us and develop effective tactics for every phase of litigation. Our esteemed workshop panelists will highlight emerging changes and challenges arising in MDL practice in the last year and will guide you through best practices for case management, screening procedures and settlement negotiations. Attend this comprehensive workshop and gain invaluable tools for: • Implementing effective strategies for managing discovery, scheduling, case management, pre-trial motions, and bellwether considerations unique to consolidated proceedings • Developing tactics for approaching negotiations with plaintiffs’ counsel throughout the MDL process • Strategically using screening orders and lone pine orders to limit meritless filings • Using social media and online investigation tools to identify and control meritless claims early on • Developing an aggressive bellwether trial selection strategy to help cull meritless cases • Interlocutory appeals: identifying issues most likely to be raised on appeal as well as best methods to seek reconsideration or appeal of a court ruling • Navigating the remand process from transfer to trial • Utilizing technological innovations (including AI software) to assess and project settlement values of individual cases

Brennan Torregrossa, Senior Vice President, Litigation, Employment, Digital, and Privacy, GlaxoSmithKline Donald LeGower, Vice President | Litigation & Gov’t Investigations, Bristol-Myers Squibb Richard Silbert, Vice President, Legal Strategy & Public Health Initiatives, Purdue Pharma L.P. Esteemed members of ACI’s Drug and Medical Device Litigation Advisory Board will lead this new and comprehensive workshop. This unique, interactive discussion will provide exclusive, and intimate networking and benchmarking opportunities that will shed light on the expectations of in-house counsel from their law firm partners. It is also a vehicle for other in-house counsel to benchmark their current “3C’s” strategies with the workshop presenters.

Cost • Monitoring legal spend and balancing the budget • Establishing best practices for cost reduction to enhance predictability for cash flow purposes • Identifying processes to assist with budgeting, fee arrangements and billing • Examining the value of licensing deals and structures Competency

• Understanding techniques judges are currently using to affect settlement agreements

• Finding the right talent with time-proven strategies

• Understanding how defendants (manufacturers, distributors, retailers, etc.) can all play in the MDL sandbox without causing problems for each other

• Evaluating the appropriateness of work product

• Considerations in selecting outside counsel • Reconciling firm capabilities versus individual attorney reputation and ability Communication • Communicating value and collaboration between corporate legal and outside counsel

Media Partner

• Establishing the desired level of commitment, availability and responsiveness early-on in the relationship • Succinctly focusing on shared, pragmatic business goals • Determining preferences for formality of correspondence and practical versus academic guidance

6 | LINKEDIN ACI Drug and Medical Device Litigation

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Main Conference Day 1 TUESDAY, DECEMBER 5, 2023

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10:45

8:30

Jobina Jones-McDonnell, Vice President, Assistant General Counsel - Litigation and Risk, Endo Pharmaceuticals Sarah Padgitt, Associate General Counsel, Baxter 8:45

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Morning Coffee Break

SPOTLIGHT ON ARTIFICIAL INTELLIGENCE

Co-Chairs’ Opening Remarks microphone-alt Daniel Healey, Senior Corporate Counsel, Pfizer

Faculty

11:15

Uncovering the Product Liability Risks Associated with AI in Drug Development and Medical Device Usage microphone-alt Ashley Carr, Partner, DLA Piper

Drug and Medical Device Year in Review: Shining a Light on the Top 10 Court Cases Impacting the Life Sciences Product Liability Sphere in 2023

Erin Bosman, Partner, Co-Chair, Class Actions and Mass Torts Practice Group, Morrison & Foerster LLP

microphone-alt Mary-Alice Barrett, Associate General Counsel, Genentech

Lora Spencer, Principal Global Litigation & Investigations Counsel, Medtronic

Lisa M. Dunkin, Vice President & Associate General Counsel, Litigation, Zimmer Biomet Ashley Garry, Senior Counsel, Viatris Rachel Gallagher, Associate General Counsel, Teleflex Sarah H. Richardson, Senior Litigation Counsel, W.L. Gore & Associates Moderator: Sara Thompson, Shareholder, Greenberg Traurig LLP Our opening session will deliver insights from key biopharmaceutical and medical device in-house counsel on the most important case law developments of the past year. They will explore their real-life impact on drug and medical device litigation practice as well as their implications and influence on future decisions, trends, and strategies in this arena.

Points of discussion will include: • 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 9:45

Examining How Proposed New Rule 16.1 Will Transform the Future of MDL Case Management microphone-alt Harley Ratliff, Partner, Shook, Hardy & Bacon LLP Janet Kwuon, Partner, Co-Chair of Life Sciences Industry Group, Reed Smith LLP John Beisner, Partner, Skadden, Arps, Slate, Meagher & Flom LLP • Assessing newly proposed FRCP 16.1 and the status of its approval • Analyzing how the new rule will impact early case management procedures in MDLs • “Just, Speedy and Inexpensive” – examining how the newly proposed MDL rule reforms may restore life to Rule 1 in MDLs and mass torts • Understanding how the new rule may be applied differently in different case settings and in different MDL proceedings

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Daniel Lazaro, Counsel, Buchanan Ingersoll & Rooney PC

AI is rapidly transforming the Life Sciences industry, with applications being used in both drug development and in diagnostics which allow for greater predictability of disease. While these groundbreaking developments are cause for excitement, concerns abound as to the accuracy of these AI applications, the associated risks and the potential product liability implications. This panel will delve into topics including: • Examining the current legal and regulatory landscape governing AI use in the pharmaceutical and medical device space • Analyzing the FDA’s most recent April 2023 guidance on AI/ML-Enabled Device Software Functions » What potential product liability risks does this new guidance flag for life science companies?

• Taking a look at existing case law which sheds light on how the legal system will treat product liability claims made against an AI-enabled medical device » What are the theories of liability involved? » What precedent exists suggesting that AI-driven software programs do constitute “products” subjectable to PL claims?

• Evaluating liability for AI-enabled drug development • Understanding how companies can issue spot areas of potential PL risk associated with the use of AI, and address them up front 12:15

Navigating the Opportunities and Perils of AI-Assisted Legal Representation and Trial Practice microphone-alt Michelle Kitchen, Senior Manager, IP eDiscovery, Novartis Anita Modak-Truran, Partner, Butler Snow LLP Davis Walsh, Partner, McGuireWoods LLP • Examining the latest ways that AI tools are being used in legal representation and trial practice in drug and device product liability litigation » Document review

» Motion/brief development

» Chronologizing medical records

» Creating demonstratives at trial

• Addressing the obvious and not-so-obvious risks associated with AI-assisted legal representation Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

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• Navigating judicial oversight of AI usage in litigation and trial prep » Addressing the recent trend of judges ordering lawyers to sign AI pledges disclosing their usage

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Tune in for an analysis of each of these MDL’s: • Significant rulings on preemption, Daubert, and more • Distinctive litigation approaches and macro issues

• Understanding how litigators can use the latest AI tools practically and effectively while avoiding ethical and compliance pain points and pitfalls

• Analysis of common issues – and some not so common

1:00

3:00

• Lessons learned

Bankruptcy As a Mass Tort Resolution Vehicle: Weighing the Benefits and Risks of this Growing Litigation Strategy

Networking Luncheon Sponsored by 2:00

Key Takeaways from Three of This Year’s MDLs: Impactful Rulings and Hot Opinions from the Acetaminophen, Zantac and Exactech MDLs microphone-alt Emily Van Tuyl, Partner, Dechert LLP Andrew Kaplan, Partner, Chair of Mass Tort, Product, and Consumer Litigation Group, Crowell & Moring LLP Steven Boranian, Partner, Reed Smith LLP Join us for a deep dive into three MDLs – Acetaminophen, Zantac, and Exactech. Our panelists will analyze significant orders in these three MDLs and provide insights on how recent developments in these MDLs may impact the future of prescription and OTC pharmaceuticals.

microphone-alt Rachel A. Farnsworth, Senior Counsel | Litigation & Government Investigations, Bristol Myers Squibb Patrick Corr, Partner, Faegre Drinker Biddle & Reath LLP Daniel Pariser, Partner, Arnold & Porter • Analyzing the recent trend of drug and device manufacturer defendants attempting to exit multidistrict litigation by filing for bankruptcy • Exploring the benefits and risks associated with using bankruptcy strategies to exit mass tort litigation • Understanding the risks for future post-bankruptcy product liability plaintiffs • Examining the jurisprudence around utilizing bankruptcy as a mass tort exit strategy and forecasting how this strategy will play out in the future 3:45

Afternoon Break

AFTERNOON BREAKOUT SESSIONS 4:00

4:00

Daubert in Doubt: Devising a Plan for New

A Rule 702 Implementation and Working With Experts After the Recent Amendments

microphone-alt Leah Lorber, Assistant General Counsel, GlaxoSmithKline Wendy West Feinstein, Partner, Morgan, Lewis & Bockius LLP JT Larson, Partner, Barnes & Thornburg LLP • Understanding what defense counsel can do to ensure that judges are actually implementing and applying the new Rule 702 changes going forward • Navigating states that adopt a hybrid version of the new rule • What should practitioners now focus on when offering expert testimony under the new amendments?

• Analyzing recent decisions in which courts have addressed, referenced or relied upon the new rule • Practice pointers for relying on the right Rule 702 cases in your arguments now that many of them will no longer be applicable • Best practices for hiring, working with and preparing expert witnesses following the new rule amendments

8 | LINKEDIN ACI Drug and Medical Device Litigation

Understanding When and How to

B Successfully Engage the FDA in Your Case microphone-alt Lawrence Cooke, Partner, Venable LLP Anne Gruner, Attorney, Duane Morris LLP • Examining scenarios when it is beneficial to seek out FDA involvement in your case • Assessing when and how to solicit FDA support in your defense (e.g. through the court, FDA subpoenas, back channels, etc.)

• Developing a strategic plan for obtaining evidence (documents and testimony) from FDA » Understanding how to get the court involved in obtaining that evidence • Analyzing the use of FDA based evidence in your case, including 510k clearances, letters to file, warning letters and integrity holds.

• Considering the public narrative and plaintiff’s portrayal of the FDA and how that can impact the issues in your case.

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AFTERNOON BREAKOUT SESSIONS 4:45

4:45

Spotlight on PFAS: Addressing Emerging

A Pharma and Med Device Companies Are Not

B Threats of Litigation Arising from So-Called

microphone-alt Jean Patterson, Assistant General Counsel, Becton Dickinson

microphone-alt Libretta (Libby) Stennes, Shareholder, Greenberg Traurig LLP

Innovative Tactics for Persuading Juries That Bad Actors

Zane Riester, Senior Counsel, Johnson & Johnson Eric Rumanek, Partner, Troutman Pepper

“Forever Chemicals”

Matt Holian, Partner; Co-Chair, Global Life Sciences Sector, DLA Piper LLP Joseph Petrosinelli, Partner, Williams & Connolly LLP

Jennifer Saulino, Partner, Sidley Austin LLP • Strategies for motions in limine: how to convince the court that your client should not be viewed the same as other defendants without negatively impacting your co-defendants’ cases?

• Trial presentation strategies for framing your narrative to reach today’s jurors • Overcoming juror biases and predispositions about life sciences companies in today’s social and political climate • Decreasing risks of extreme verdicts by changing the narrative

• Contaminant class actions: what every defense attorney for a drug or medical device company needs to know about PFAS and other emerging contaminants • Understanding the legal nuances of contaminant litigations » 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 • Examining the latest trends in Prop 65 activity that the pharmaceutical and medical device industries should be paying attention to

5:45

Conference Adjourns, Cocktail Reception Sponsored by

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Main Conference Day 2 WEDNESDAY, DECEMBER 6, 2023

8:30

Co-Chairs’ Opening Remarks 8:45

Coffee and Q+A With Our Esteemed Judges: Judicial Perspectives on Managing Life Sciences Mass Tort Proceedings microphone-alt Honorable Karen K. Caldwell, Chief Judge, U.S. District Court, E.D. Kentucky, Chair, Judicial Panel on Multidistrict Litigation (JPML) Honorable Brian R. Martinotti, District Judge, U.S. District Court, District of New Jersey Honorable John R. Tunheim, District Judge, U.S. District Court, District of Minnesota Honorable Kristine Baker, District Judge, U.S. District Court, District of Arkansas Honorable Abbe F. Fletman, Judge, Philadelphia Court of Common Pleas Honorable Brian H. May, Circuit Judge, Division 1, St. Louis County Circuit Court Moderator: Andrew T. (Andy) Bayman, District Judge, King & Spalding LLP A panel of distinguished jurists with some of the liveliest drug and medical device litigation dockets in the country will: • Provide valuable insights on how they manage MDLs and coordinated proceedings • Identify the challenges of resolving mass tort proceedings from their perspective 9:45

• Shed light on what arguments and litigation practices have worked and not worked in their courtrooms, as well as areas for improvement by counsel who appear before them

Morning Coffee Break

MORNING BREAKOUT SESSIONS 10:15

10:15

Navigating the Interplay of MDLs and Parallel

Developing an “In The Trenches” Approach to

A State Court Proceedings

B Battling Reptile Theory

microphone-alt Larissa A. Eustice, Senior Assistant General Counsel, Bayer

microphone-alt Bill Childs, Assistant General Counsel, Litigation, 3M

Katherine Unger Davis, Partner, Dechert LLP

Paul (P.J.) Cosgrove, Partner, Ulmer & Berne LLP

Michael Leard, Partner, Nutter McClennen & Fish LLP

Judge Booker Shaw, Partner, Thompson Coburn LLP

Colleen Baime, Partner, Baker & McKenzie LLP

Keith C. Pounds, PhD, Senior Jury Consultant, IMS

• Examining the recent trend of plaintiffs dismissing MDL claims mid-trial and moving them to state courts in unfavorable jurisdictions (e.g Zantac MDL) » What efforts can drug and device companies (and their counsel) make to prevent this from happening? » Understanding how you can best deal with the aftermath if/when this does happen • Tools and strategies for effective coordination between the federal and state courts regarding » Scheduling hearings » Conducting and completing discovery » Avoiding inconsistent federal and state rulings » Accomplishing resolution of all cases nationwide

10 | LINKEDIN ACI Drug and Medical Device Litigation

• Developing effective strategies for combatting reptile theory from the earliest phases of litigation • Diffusing plaintiff counsel attempts to utilize reptile approach before it gains traction • Tactics for responding to plaintiff counsel questions aimed at rattling even the most seasoned corporate witnesses • Asking questions on redirect which combat reptile approach • Creating your own evidence to be used in negotiations for deposition designations

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MORNING BREAKOUT SESSIONS 11:15

11:15

FDA in the Crosshairs: What Recent Court

Crafting Successful Jurisdiction, Standing

A Activity and State Litigation Over Mifepristone

B and Preemption Arguments at the Motion to

microphone-alt Sarah Padgitt, Associate General Counsel, Baxter

microphone-alt John Lavelle, Partner, Morgan, Lewis & Bockius LLP

Means for the Future of Agency Deference

Thomas Kurland, Partner, Patterson Belknap Webb & Tyler LLP Dan Troy, Managing Director, Berkeley Research Group Following the Supreme Court’s decision in Dobbs, we saw a recent groundbreaking ruling by the Northern District of Texas when it suspended FDA’s longtime approval of the abortion pill, mifepristone.

This is also set against the backdrop of both red and blue states suing FDA regarding the drug. This panel will engage in an exploration of: • The rising appetite of courts to revoke agency authorities • What this may mean for the role and discretion of judges in future drug and medical device product liability cases • The fallout of the overturning of Roe and how courts are looking at preemption battles involving state attempts to ban FDA-approved drugs

Dismiss Stage

Steven Weisburd, Shareholder, Carlton Fields, P.A. Jessica Davidson, Partner, Skadden, Arps, Slate, Meagher & Flom LLP Jonathan Jung, General Counsel, Prinston Pharmaceutical • 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 drug and device product liability class actions, as well as how to manage and overcome them • Incorporating takeaways from the latest preemption rulings into your class action litigation practices and strategies 12:15

Advanced Settlement Strategies for Drug and

• What this year’s activity could potentially mean for the future of FDA deference

B Device Product Liability Class Actions and MDLs

12:15

microphone-alt Russell “Chip” Gaudreau, Partner, King & Spalding LLP

Examining the Rise in “Non-Traditional”

A Liability Theories in Drug and Medical Device Product Liability Cases

Greg Dadika, Vice-President, Litigation, Governmental Investigations & Risk Management, Boehringer Ingelheim Terri Reiskin, Partner, Nelson Mullins Riley & Scarborough

microphone-alt Justin Witzmann, Director, Legal Affairs - Global Litigation, Nuvasive

Elizabeth Mitchell Associate General Counsel, Global Litigation, Smith & Nephew

Christopher Kaufman, Partner, Shook, Hardy & Bacon LLP

Ethan Greene, Managing Partner, Reisman Greene Theis LLP

Julie Park, Partner, Morrison & Foerster LLP • How the defense bar can prepare for the latest plaintiff bar attempts to circumvent traditional liability theories in drug and medical device claims • Examining the latest ways plaintiffs are manipulating the following theories and how to combat them: » Public nuisance » Misbranding » Failure to warn/failure to report

• Identifying common challenges arising in drug and device product liability 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

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The ACI Drug & Medical Device Conference is a must-attend conference to stay up-to-date – and even ahead of the curve – on the most important litigation and legal topics in this space. The panels are presented by the country’s leading law firm and in-house counsel, and are timely, informative, and engaging.”

CHRIS GUTH, SENIOR ASSISTANT GENERAL COUNSEL, BAYER

1:15

Networking Luncheon

2:15

Exploring Critical International

globe-africa Developments Impacting Drug and Device Product Liability Litigation in Foreign Jurisdictions

3:00

Where the Rules Meet the Road: Seasoned Drug and Medical Device Product Liability Litigators Share Lessons on Avoiding Ethical Compliance Traps microphone-alt Celeste Coco-Ewing, Partner, Irwin Fritchie Urquhart Moore & Daniels LLC Jobina Jones-McDonnell, Vice President, Assistant General Counsel - Litigation and Risk, Endo Pharmaceuticals

microphone-alt Patrick Reilly, Partner, Faegre Drinker Biddle & Reath LLP Grant Worden, Partner, Torys LLP Jill Lawrie, Partner, Blake, Cassels & Graydon LLP • Examining the advent and implementation of the EU Collective Redress Directive » What impact will this have on the future of drug and medical device product liability class actions in Europe? » What are the perceived risks of this Directive for US drug and device manufacturers? » Preparing to combat the rise in collective actions that drug and device companies will face in Europe as the plaintiffs’ bar sets up new overseas firms to take advantage of the new directive • Analyzing recent developments in Canada which have changed how product liability cases are being handled there » What US in-house counsel and their law firm partners need to know about coordinating litigations in Canadian jurisdictions » Exploring cross-border concerns for US and Canadian counsel who work in tandem on a product liability litigation

12 | LINKEDIN ACI Drug and Medical Device Litigation

This panel of drug and device litigators will lead a polling exercise of “what would you do” to test your ethics skills using sensitive, complex hypothetical scenarios. Discover how your approach to tackling ethical dilemmas in drug and medical device litigation compares to your peers.

Benefit from a practical discussion of the polling results and important takeaways for your practice.

4:00

Conference Concludes

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

Advisory Board

Highlights

Sponsors

LEAD & LUNCHEON SPONSOR:

ASSOCIATE SPONSORS:

Greenberg Traurig, LLP’s Pharmaceutical, Medical Device & Health Care Litigation Practice is a premier life sciences litigation team, involved in pharmaceutical and medical device industries’ top mass torts and class actions. As national, regional, trial, and settlement counsel for industry leaders, GT’s team routinely tries cases involving cutting-edge medical and scientific issues. Distinguished by its depth of experience and thorough understanding of the industry, this nationwide team of 140+ litigators deliver top-of-class client service. www.gtlaw.com

Barnes & Thornburg’s Product Liability and Mass Torts practice has extensive experience managing and litigating the largest and most significant drug, device, and consumer product mass torts facing manufacturers and sellers today. Our lawyers likewise excel at managing risk in product and company acquisitions, and throughout product lifecycles. In that role we have negotiated and executed some of the largest mass tort resolutions in history, and advised on some of the largest pharmaceutical acquisitions and divestitures of the last few years. We have the results-driven approach, resources, and expertise to help address the evolving challenges you face. www.btlaw.com

LEAD & COCKTAIL RECEPTION SPONSOR: King & Spalding handles the most significant individual, multidistrict, mass tort and class action lawsuits for pharmaceutical and medical device companies. Our 175+ lawyer Product Liability team (ranked Band 1 in Chambers USA) includes a deep bench of firstchair trial attorneys that tries multiple products cases each year in some of the most challenging jurisdictions. We also have a dedicated strategic resolution team that has favorably resolved some of the largest litigations in recent history.

SUPPORTING SPONSORS: Dechert is a global law firm that advises asset managers, financial institutions and corporations on issues critical to managing their business and their capital – from high-stakes litigation to complex transactions and regulatory matters. We answer questions that seem unsolvable, develop deal structures that are new to the market and protect clients’ rights in extreme situations. Our 1,000+ lawyers across 21 offices globally focus on the financial services, private equity, private credit, real estate, life sciences and technology sectors.

DLA Piper is a global law firm with lawyers located in more than 40 countries internationally. Our team has experience in high-exposure product liability actions for life sciences companies along with the resources necessary to manage complex, consolidated, and large volume mass tort litigation.

We are known for our bold and creative strategies, which have resulted in numerous, mass-tort ending court rulings. We offer services to match our clients’ business lifecycles - combining counsel with industry insights.

Morgan Lewis is a global law firm with more than 2,200 lawyers and specialists in 30+ offices worldwide. Our firm offers one of the largest, most comprehensive life sciences teams comprised of more than 250 global partners and counsel. Among our services, we represent life sciences companies in the full range of litigation matters. We try high-risk cases against aggressive adversaries and serve as counsel to pharmaceutical and medical device clients in large-scale and serial litigation. For more information, please visit www.morganlewis.com.

Morrison Foerster is the destination firm for class actions and mass torts. With a strategic and comprehensive lifecycle approach, our team has a long and successful track record handling high-stakes cases that threaten a company’s brand reputation, business model, and bottom line. We help our clients stay U.S. FDA-compliant and optimally positioned for maximum coverage and reimbursement, entry into new global markets, and further research and development.

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, toxic tort, and intellectual property disputes for the pharmaceutical and medical device industries. Established in 1889, Shook has 19 offices with approximately 530 attorneys and 180 research analysts and paraprofessionals, many of whom have advanced scientific and technical degrees. www.shb.com The Mass Torts, Insurance and Consumer Litigation Group at Skadden has been involved in many of the significant complex tort and consumer fraud litigations of the last 30 years, many of which are considered “bet-the-company” matters. The group pioneered the “national counsel” model of handling mass tort litigation and has strong relationships with local defense lawyers in virtually every state.

LANYARD SPONSOR: Faegre Drinker is a top 50 firm designed for clients.

With 1,200 attorneys and consulting professionals, we have the strength to solve your most complex transactional, litigation and regulatory challenges wherever you need us.

With more than 130 dedicated professionals, our product liability and mass torts practice offers deep experience managing global, national, and regional matters, from individual cases to mass torts and class actions. We are driven to protect our clients' products, brands and bottom line with goal-driven strategies to avoid and resolve disputes.

POCKET AGENDA: Reed Smith’s life sciences team is committed to anticipating and solving legal challenges so you can focus on what you do best: improving and saving lives. In addition to our skilled life sciences transactional and regulatory lawyers, our highly-regarded, full service 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.

Blakes is at the forefront of product liability defence and has one of the most experienced teams in Canada. We are trusted advisors to many leading multinational pharmaceutical and medical device companies. Our clients trust us to act for them in multiprovincial class proceedings/mass torts alleging product liability, misrepresentations and breaches of consumer protection and other statutes, and claims worth hundreds of millions of dollars for personal injuries, medical monitoring, health-care costs and disgorgement remedies.

Carlton Fields has approximately 330 attorneys and government and financial services consultants serving clients from offices in California, Connecticut, Florida, Georgia, New Jersey, New York, and Washington, D.C. Known for its national litigation practice, Carlton Fields defends Fortune 100 manufacturers in high-stakes mass tort and product liability litigation in state and federal courts nationwide, including matters involving talc and opioid, asbestos, tobacco, automotive, and pharmaceuticals and medical device issues.

Butler Snow LLP is a full-service law firm with over 400 attorneys collaborating across a network of 28 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, including being named to the Client Service A-Team for three consecutive years.

Crowell & Moring is an international law firm with operations in the United States, Europe, MENA, and Asia. Drawing on significant government, business, industry and legal experience, the firm helps clients capitalize on opportunities and provides creative solutions to complex litigation and arbitration, regulatory and policy, and corporate and transactional issues. The firm is consistently recognized for its commitment to pro bono service as well as its programs and initiatives to advance diversity, equity and inclusion.

IMS Consulting & Expert Services has delivered strategic legal consulting to leading global law firms and Fortune 500 companies for 30+ years in more than 43,000 cases and 6,000 trials. IMS provides attorneys with the essential tools needed to win complex disputes: thematic stories, expert testimony, juror insights, compelling visuals, and seamless presentations. With locations in major US and UK markets and expertise in remote hearings, IMS is primed to support every phase of litigation, arbitration, and mediation worldwide. More at expertservices.com Irwin Fritchie Urquhart Moore & Daniels LLC serves as national, regional, and local counsel for public companies, privately owned businesses, governmental entities, non-profit organizations, individuals, and insurers with civil litigation needs. We were founded in 2000 by six partners from one of the oldest firms in New Orleans who had a collective vision of creating a firm that would provide the highest level of service to our clients. Learn more at www.irwinfritchie.com McGuireWoods LLP is a leading international law firm with 1,100 lawyers in 21 offices worldwide. It continuously ranks among the top firms in Financial Times’ prestigious North America Innovative Lawyers report. The firm has been recognized 17 times on BTI Consulting’s Client Service A-Team — elite firms singled out for client service excellence based on unprompted feedback from clients in major companies. For more information, visit www.mcguirewoods.com.

Nelson Mullins is a diversified Nationwide law firm of more than 1,000 attorneys, policy advisors, and professionals across 33 offices serving clients in more than 100 practice areas. Together, we serve as trusted advisors to clients across a range of business sectors with client relationship fundamentals of quality, dependability, solution-oriented service, and value.

The US pharma/medical device litigation landscape is the most dangerous in the world – and NRF has represented clients in some of the largest MDLs ever filed, including the Sartans, PPIs, Actos, Vioxx and Mesh, acting as national trial and coordinating counsel, and heading national pharmacovigilance and resolution teams. NRF is also one of the few firms that regularly represents clients in the latest high-stakes area – the deluge of TPP economic loss class action litigation.

Nutter’s Product Liability Defense practice group has a proven track record of successfully resolving complex cases. For decades, product liability defense has been a cornerstone of Nutter’s thriving litigation practice. Leading multinational companies have turned to Nutter to defend cases in domestic and international courts involving allegedly defective medical devices, pharmaceuticals, consumer healthcare products, and more. This approach has led to several major defense verdicts as well as numerous pre-trial dismissals and favorable settlements.

Faculty

Agenda

Venue

Pricing

Patterson Belknap delivers a full range of services in both litigation and commercial law. Our litigation practice includes experienced trial lawyers who represent pharmaceutical, consumer product, and medical device manufacturers in complex products liability matters. Our products liability team regularly serves as trial, appellate, and national coordinating counsel for many of the nation’s largest pharmaceutical medical device and consumer products manufacturers and is widely known as a go-to firm for drug and device litigation.

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. Thompson Coburn is committed to creating and fostering a diverse and inclusive workplace culture that recognizes the contributions of individuals from varied backgrounds. Thompson Coburn’s Product Liability group represents drug and medical device companies in national and regional litigation across the country including multidistrict litigation.

Torys is an international business law firm known for its sophisticated counsel, best-in-class client service and the most cohesive cross-border team in the market. We are proud of the caliber of our thinking. With offices in Toronto, Calgary, Montréal, New York and Halifax, we bring together the sharpest legal minds to solve clients’ toughest problems and help them stay ahead of the curve.

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.

Ulmer is a leader in defending class-action, 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. Learn more at Ulmer.com.

Venable is a firm of trusted advisors serving businesses, organizations, and individuals in many of the most important aspects of their work. Our capabilities span virtually every industry and all areas of regulatory and government affairs, corporate and business law, intellectual property, and complex litigation. With more than 850 professionals delivering services around the world, we help clients connect quickly and effectively to the experience and insights key to achieving their most pressing objectives.

Major multinational corporations have trusted Winston & Strawn for decades to aggressively defend their pharmaceutical products and medical devices, as well as their reputations, in the face of some of the most significant high-profile product liability and mass tort claims in the country involving substantial exposure. Our lawyers have a long track record of success not only in taking cases to trial, but also in directing national strategies in MDLs and coordinated proceedings or serving as lead local counsel.

PREMIUM EXHIBITORS: For 60 years, Barry Nilsson has been shaping a better legal experience. With more than 200 specialist lawyers, our national Insurance & Health practice combines deep industry knowledge with local expertise and the highest standards of client service. We partner with insurers, brokers, self-insureds and re-insurers to tailor legal strategies to achieve the best possible outcomes across all lines of insurance, within a broad range of industries.

Golkow is a global leader specializing in court reporting, litigation support and trial consulting services in multi-party and complex litigation matters.

We offer unparalleled services for every stage of litigation by pairing client needs with reporter expertise, as well as providing experienced trial consultants to assist you and your team in preparing and presenting the most compelling case. From creating and maintaining case/client protocols to providing cost-effective pricing to meet the needs of valued clients, our team is your team.

WIT Legal has redefined the expert witness industry by bringing experts in the highest demand together under one virtual roof. WIT is the only expert witness agency representing the world’s leading testifying experts in complex legal matters. We work on cases involving some of the most recognized companies today, and our experts include academics, C-Suite executives, and former regulators who can address issues in a wide range of cases involving IP, M&As, compliance, and more.

DRUG&MEDICAL DEVICE

Advisory Board

L I T I G AT I O N

Highlights

Sponsors

Faculty

Agenda

Venue

Pricing

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