29th Annual Conference on Drug & Medical Device Litigation - DS by C5Group

LITIGATION &DRUG MEDICAL DEVICE

December 3–4, 2024 | New York Marriott Marquis, New York, NY

2024

EILEEN M. HUNTER Vice President, Head of Global Litigation

Boston Scientific

CHRISTIANA JACXSENS

Deputy General Counsel B. Braun Medical Inc.

NETWORK AND BENCHMARK WITH REPRESENTATIVES FROM LEADING DRUG AND MEDICAL DEVICE COMPANIES INCLUDING:

Bayer Corporation

Beckton Dickinson and Company

Boehringer Ingelheim

Boston Scientific

Bristol Myers Squibb

Daiichi Sankyo

Endo Pharmaceuticals

Fresenius Medical Care

Genentech

GlaxoSmithKline

Johnson & Johnson

Medtronic Nuvasive

Olympus Corporation

Purdue Pharma

Smith & Nephew

Solventum

Teleflex Inc.

UCB Inc.

Viatris

WL Gore & Associates Inc.

Zimmer Biomet

Benefit from Our Pre-Conference Working Groups | December 2nd

Each working group offers 3.5 hours of dynamic and in-depth discussions on the essential components of effective MDL defense strategies, featuring insights from both in-house and outside counsel perspectives.

Working Group A

Mastering MDL Defense: Strategic Approaches to Overcome Complex Challenges and Dismiss Meritless Claims

See page 6 for details.

Working Group B

Demystifying and Defeating Junk Science in the Courtroom: Techniques to Identify and Challenge Unreliable Evidence

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

The Leading Gathering of Litigation and MDL Defense Counsel in the Life Science’s Industry

Mark your calendars for December 3-4 at the New York Marriott Marquis in New York City for the 29th edition of ACI’s Drug and Medical Device Litigation Conference! This event is your chance to connect with hundreds of products liability defense stakeholders from industry, private practice, and the Bench. Take advantage of extended networking opportunities and engage in interactive discussions to collaborate and strategize on the current products liability landscape and what lies ahead.

Join us this December to meet and reconnect with your colleagues and industry trailblazers. Gain invaluable insights through two full days of interactive discussions on the most critical product liability litigation challenges facing the drug and medical device community today. Our esteemed 2024 faculty will provide essential information on the product liability risks associated with AI in drug development, medical device usage, and litigation strategies.

We will also cover the impact of new MDL case management changes, navigating the new Rule 702 amendments, the benefits and risks of utilizing bankruptcy as a mass tort resolution vehicle, litigation exit strategies, and much more. Our content-rich program and sophisticated panel discussions will give you real-world insights on the most critical international developments impacting drug and device product liability litigation. Don’t miss out on the drug and medical device litigation defense bar's most valuable gathering of the year!

ACI's Drug and Med Advisory Board

Mary-Alice Barrett Associate General Counsel Genentech

Debra L. Burns Senior Counsel Litigation/ Investigations GE Healthcare

Candace Camarata Associate General Counsel Becton, Dickinson and Company

Bill Childs Assistant General Counsel, Litigation 3M

Christopher M. Guth Senior Assistant General Counsel Bayer

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

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

Sarah Padgitt Associate General Counsel Baxter

Zane Riester Senior Counsel Johnson & Johnson

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

Lora Spencer Principal Litigation & Investigations Counsel Medtronic

Brennan Torregrossa Senior Vice President, Head of Global Litigation GSK

Get ready for…

400+ Attendees

70+

Speakers

Including More Than 30 In-House Counsel from Leading Life Sciences Companies

Handshake-alt

20+ Content-Rich Panel Discussions

3 Full Days of Extended Networking

What’s NEW for 2024

Interactive Audience Polling

Provide input during these real-world case studies and in-depth strategy discussions with leading industry practitioners.

Case Study to Explore the Capabilities of AI in Analyzing Legal Proceedings

An AI tool and a Law Firm Senior Associate will examine a product liability Complaint and decide next steps for pleadings, client advisement and resolution strategies – audience will vote on the strategies.

UNIVERSITY

The End of Chevron Deference

Leading Supreme Court practitioners will guide a critical discussion on the current and future impact of the Supreme Court’s Loper Bright ruling.

Developing and Implementing Exit Strategies to Conclude Drug and Device Litigation

Addressing best practices for developing and implementing effective exit strategies and identifying common challenges in product liability settlements.

Key Insights from Groundbreaking Rulings

An exploration of the year’s biggest cases based on novel and non-traditional plaintiff theories.

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Navigating the New Rule 702 Amendments

Seasoned litigators discussing ways to leverage the amendments and transform how expert testimony is assessed.

DISTINGUISHED FACULTY

ESTEEMED CO-CHAIRS RENOWNED JURISTS

Eileen M. Hunter

Vice President, Head of Global Litigation Boston Scientific

Christiana Jacxsens

Deputy General Counsel B. Braun Medical Inc.

Mary-Alice Barrett

Associate General Counsel Genentech

Adam Bassing Head of Global Litigation UCB Inc.

Candace Camarata

Deputy Chief Litigation Counsel Becton, Dickinson and Company

Bill Childs

Assistant General Counsel, Head of Litigation Solventum

Greg Dadika

Vice-President, Litigation, Governmental Investigations & Risk Management Boehringer Ingelheim

Lisa Dunkin

Vice President & Associate General Counsel, Litigation Zimmer Biomet

Rachel A. Farnsworth

Senior Counsel | Litigation & Government Investigations Bristol Myers Squibb

Rachel Gallagher

Associate General Counsel Teleflex Inc.

IN-HOUSE COUNSEL

Christopher M. Guth

Honorable Karen K. Caldwell

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

Honorable Brian H. May

Circuit Judge, Division 1

St. Louis County Circuit Court

Senior Assistant General Counsel Bayer

Eileen M. Hunter

Vice President, Head of Global Litigation Boston Scientific

Christiana Jacxsens

Deputy General Counsel B. Braun Medical Inc.

Jobina Jones-McDonnell

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

Amy Todd Klug

General Counsel and Secretary, Head of Legal and Corporate Affairs Daiichi Sankyo, Inc.

William Lee

Global Head of Legal, Litigation and Investigations Olympus Corporation

Donald LeGower

Assistant General Counsel - Litigation and Government Investigations Bristol-Myers Squibb

Leah Lorber

Assistant General Counsel GSK

Patricia Rich

Senior Vice President, General Counsel - Global Care Delivery & US Litigation and Investigations Fresenius Medical Care

Sarah H. Richardson

Senior Litigation Counsel W.L. Gore & Associates

Zane Riester

Senior Counsel Johnson & Johnson

Danielle Rosen

Assistant General Counsel, Head of Litigation Daiichi Sankyo, Inc.

Richard Silbert

Vice President, Legal Strategy & Public Health Initiatives Purdue Pharma L.P.

Lora Spencer

Principal Litigation & Investigations Counsel Medtronic

Brennan Torregrossa

Senior Vice President, Head of Global Litigation GSK

Justin Witzmann

Director, Legal Affairs - Global Litigation Nuvasive

DISTINGUISHED FACULTY

LAW FIRM ATTORNEYS

Andrew T. (Andy) Bayman Partner

King & Spalding LLP

Jay Bhimani Partner

Dechert LLP

Erin M. Bosman Partner

Morrison & Foerster LLP

Lori G. Cohen Vice Chair

Greenberg Traurig LLP

Bryce Cooper Partner

Winston & Strawn LLP

D'Lesli M. Davis Head of Life Sciences and Healthcare, US and Co-Head of Product Liability and Consumer Disputes, US Norton Rose Fulbright US LLP

Marcella C. Ducca Shareholder

Greenberg Traurig LLP

David L. Ferrera Partner

Nutter McClennan & Fish LLP

Douglas E. Fleming III Partner

Dechert LLP

Kristen Renee Fournier Partner

King & Spalding LLP

Suzanne Galvin Partner

Thompson Coburn LLP

William P. Geraghty

Co-Chair, Product Liability Litigation Practice

Shook, Hardy & Bacon LLP

Ruben I. Gonzalez Partner

Faegre Drinker Biddle & Reath LLP

Jessica Grant Partner

Shook, Hardy & Bacon LLP

Caycee D. Hampton Shareholder

Carlton Fields, P.A.

Matthew D. Jacobson Partner

Reed Smith LLP

Maha M. Kabbash Partner

Tucker Ellis LLP

Andrew Kaplan Partner, Chair of Mass Tort, Product, and Consumer Litigation Group Crowell & Moring LLP

Thomas P. Kurland Partner

Patterson Belknap Webb & Tyler LLP

John P. Lavelle, Jr. Partner

Morgan, Lewis & Bockius LLP

John Q. Lewis Partner

Nelson Mullins Riley & Scarborough LLP

Brett Ashton Mason Partner

Troutman Pepper Hamilton Sanders LLP

Nicole Mantini Partner Torys LLP

Stephen J. McConnell Partner

Reed Smith LLP

Gregory E. Ostfeld Shareholder Greenberg Traurig LLP

Jason C. Rose Partner Venable LLP

Matthew Saxon Partner

Winston & Strawn LLP

Davis M. Walsh Partner McGuire Woods

Wendy West Feinstein Partner

Morgan, Lewis & Bockius LLP

IN-DEPTH PRE-CONFERENCE WORKING GROUPS

Monday, December 2, 2024

A9:00 am–12:30 pm (Registration opens at 8:30 am)

Mastering MDL Defense: Strategic Approaches to Overcome Complex Challenges and Dismiss

Meritless Claims

This interactive working group will provide you with the essentials of MDL defense. Workshop leaders will guide you through key components, leveraging the small-group setting, as you tackle the unique challenges of mass-tort MDLs, providing a robust foundation for broader conference discussions. Topics of discussion include:

• Best practices for case management, screening procedures and settlement negotiations

• 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

• Utilizing screening orders and lone pine orders to limit meritless filings

• Developing social media and online investigation tools to quickly identify and control meritless claims early on

• Developing an aggressive bellwether trial selection strategy to help cull meritless cases

• Quickly identifying issues most likely to be raised on appeal

• Navigating the remand process from transfer to trial

• Implementing and developing technological innovations to assess and project settlement values

• Understanding techniques that federal and state judges are currently using to affect settlement agreements

• Understanding how the defendants and the defense bar can improve organizational coordination

B1:30–5:00 pm (Registration opens at 1:00 pm)

Demystifying and Defeating Junk Science in the Courtroom: Techniques to Identify and Challenge Unreliable Evidence

Junk science – literature developed for litigation – continues to be problematic in drug and device litigation matters and is seen as a hindrance to innovation. Unchecked junk science erodes public trust, overwhelms the judicial system with meritless cases, and jeopardizes companies that produce essential device and pharmaceutical goods. In this comprehensive workshop, our experts will lead an interactive discussion on ways to recognize essential medical device products and pharmaceutical drugs and prevent junk science from entering the courtroom, such as:

• Examining the rise of consumer-based “damages only” claims that are based on junk science

• Determining the correlation between junk science and:

» Plaintiff advertising

» Litigation funding

• Exploring the methodologies associated with differential diagnosis and etiology

• Understanding how the lack of scientific sophistication leads to unreliable expert evidence that makes its way into the courtroom

• Deciphering legitimate scientific opinions from junk science

• Developing an understanding of the difference between medical causation and legal causation - and the scientific methodologies used to establish the causation

• Recognizing unrealistic product testing

• Preventing the admission of evidence that lacks relevant documentation, substantiation, and statistically significant data

• Rigorously scrutinizing questionable testing practices and potential conflicts of interest

MAIN CONFERENCE DAY 1

Tuesday, December 3, 2024

Opening Remarks from the Co-Chairs

Eileen M. Hunter Vice President, Head of Global Litigation

DRUG AND MEDICAL DEVICE LITIGATION YEAR IN REVIEW

2024 has been a pivotal year for drug and medical device litigation, marked by significant case law developments that have reshaped the landscape. This opening session will explore these critical changes, dissecting their real-world impacts and forecasting their influence on future litigation trends and strategies. Topics of discussion will include:

• Surveying the year’s most significant and influential court decisions involving drug and medical device claims

• Analyzing pending decisions that may have the most foreseeable future impact

• Updating practice and litigation strategies in response to the latest case law development

• Coordinating within the defense bar to “level the playing field”

TOWN HALL WITH THE SUPREME COURT PRACTITIONERS

William Lee

Global Head of Legal, Litigation and Investigations Olympus Corporation

Andrew Kaplan Partner, Chair of Mass Tort, Product, and Consumer Litigation Group Crowell & Moring LLP

and significantly altering regulatory enforcement capabilities.

Join us for this critical and interactive town hall session as our panel of Supreme Court practitioners delve into the far-reaching implications of this ruling. Topics of discussion will include:

• Understanding how the decision will affect the strategic decisions and operations of drug and device manufacturers

• Examining the new legal landscape and its demand on outside counsel

• Predicting the potential for new and renewed legal challenges to longstanding federal regulations

• Analyzing the likelihood and scope of increased litigation as a result of the ruling

Extended Networking Break

The End of Chevron Deference: Navigating the Post-Chevron Era in Drug and Device Litigation

The landmark Loper Bright decision marks the end of Chevron deference, a foundational principle of administrative law. This ruling is poised to transform the regulatory landscape for drug and device manufacturers, lower courts, and federal agencies, and expose numerous statutes to potential legal challenges

UNIVERSITY

AI v. ASSOCIATE: Rethinking the Role of AI in Legal Practice and Trial Strategy

Before this session, AI and a law firm associate will independently analyze a legal complaint to formulate strategies. This session will compare their recommendations, allowing for attendees to cast their vote and discuss the effectiveness of AI versus human legal analysis. Topics of discussion will include:

• Summarizing the facts of the Complaint

• Exploring and examining the legal theories

• Developing timelines for the next steps and pleadings

• Crafting questions to pose to the “client”

• Reviewing the litigants’ drafts of an Answer and Motion to Dismiss

SPOTLIGHT ON NOVEL THEORIES

Bill Childs Assistant General Counsel, Head of Litigation Solventum

Davis M. Walsh Partner McGuire Woods

Thomas P. Kurland Partner

Patterson Belknap Webb & Tyler LLP

Decoding Novel Cases: Key Insights from Groundbreaking Rulings in Gilead, BMS, Bartlett, and More

In this session, panelists will explore pivotal cases featuring non-traditional plaintiff theories, while dissecting significant rulings and their potential impact on future drug and medical device litigation. Topics of discussion will include:

• Examining and breaking down the “Duty to Innovate”, and the reduction or elimination of the requirement that there be a “design defect”

• Exploring the scope of a “Failure to Warn”, and identifying the characteristics of an adequate warning

• Reviewing the elements of alleged “Design Defects”, including:

» “Pre-approval” Buckets

» “Post-approval” Buckets

Networking Luncheon

TRACK 1

Bankruptcy as a Strategy in Mass Tort Litigation: The Risks and Rewards of a Settlement Approach

Jobina Jones-McDonnell

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

Richard W. Silbert

Vice President, Legal Strategy & Public Health Initiatives

Purdue Pharma L.P.

As massive verdicts and settlements become more common, bankruptcy emerges as a strategic solution for managing overwhelming liabilities. This interactive breakout will consider how drug and device manufacturers are using bankruptcy to resolve mass tort claims. Topics of discussion will include:

• Streamlining the handling of claims, which may lead to faster resolutions

• Establishing trusts to quickly and accurately dispose of the cases and compensate victims

• 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

• Overcoming the negative perceptions of companies utilizing bankruptcy to evade full responsibility

TRACK 2

Countering Plaintiff Strategies: Overcoming Expanded Liability Tactics

Christopher M. Guth

Senior Assistant General Counsel Bayer U.S.

Marcella C. Ducca

Shareholder

Greenberg Traurig LLP

John Q. Lewis

Partner

Nelson

Mullins Riley & Scarborough LLP

This session will explore how the plaintiff’s bar increasingly employs sophisticated methods to enhance their funding and expand their plaintiff pool. Panel leaders will emphasize the need for in-house counsel and their law firm counterparts to formulate strategies to counter these evolving tactics. Topics of discussion will include:

• Taking an aggressive stance against false or misleading messages delivered to the public through increasingly aggressive plaintiff advertising

• Mitigating the challenges created by third-party litigation funding to gain full disclosure and determine who really is making the settlement decisions

• Weeding out meritless claims with the data and analytics from initial census forms and registries

• Utilizing social media channels to recognize and eliminate claims that lack merit or actual injury

Always great to hear from judges and I thought it was incredibly helpful information."

CHIEF LEGAL COUNSEL, GLOBAL LITIGATION AND EMPLOYMENT, STRYKER

Excellent insight into current trial issues with major litigation of interest; very engaging.”

BREAKOUT SESSIONS B

TRACK 1

Defeating Reptile Theory: Early Strategies to Control Your Case

Rachel

Gallagher

Associate General Counsel Teleflex Inc.

Matthew Saxon

Partner

Winston & Strawn LLP

Reptilian strategy targets the defendant’s unsafe behavior form the outset, often subtly, making it crucial to recognize and counteract early. This session will discuss prompt case assessment and developing strong defense theories immediately. Topics of discussion will include:

• Identify the issues that indicate the presence of a reptile case

• Identify and approaching reptile theory through pleadings, written discovery and early motion practice

• Overcoming reptile attacks on the standard of care and other alleged “duties”

• Utilizing motions in limine to resolve issues outside the eyes and ears of the jury, and identify the evidence to be excluded

• Making use of voir dire to counteract plaintiff’s strategy

TRACK 2

From Nuclear Verdicts to Thermonuclear Verdicts: Evaluating the True Impact on Drug and Medical Device Manufacturers

Candace Camarata Deputy Chief Litigation Counsel

Becton, Dickinson and Company

William P. Geraghty Co-Chair, Product Liability Litigation Practice

Shook, Hardy & Bacon L.L.P.

D’Lesli M. Davis Head of Life Sciences and Healthcare, US and Co-Head of Product Liability and Consumer Disputes, US Norton Rose Fulbright US LLP

Gregory E. Ostfeld Shareholder Greenberg Traurig LLP

Verdicts are skyrocketing from $10 million to over $100 million, fueled by jury sympathy and societal trends favoring corporate accountability. This session will explore the factors fueling this thermonuclear verdicts, and offer strategies to present sound science in court to mitigate exposure. Topics of discussion will include:

• Preventing tactics that manipulate juror behavior and arbitrarily inflate damages

• Countering and blocking methods that plaintiff’s counsel often utilize to assess and calculate damages

• Reducing the effects of plaintiff advertising and third-party litigation funders that widen the gap for negotiating a reasonable settlement

• Requesting bifurcation of compensatory and punitive damages to prevent inflation of compensatory awards to punish defendants

General Counsel and Heads of Litigation Roundtable: Strategic Insights on Navigating Drug and Medical Device Litigation Challenges

Join this panel of esteemed General Counsel and Heads of Litigation from premier drug and medical device companies as they share critical perspectives on the strategic “big picture” challenges and trends set to define the industry in 2025, including:

• Aligning legal department activities with the strategic goals of the business – while striving to maintain an effective legal and litigation programs

• Evaluating and prioritizing risks for 2025

• Implementing cost-containment strategies that won’t diminish program effectiveness

• Examining the scope of legal exposure amid the increased risks associated with new product development and MDL/class action exposure

• Ensuring that all litigation matters are managed efficiently, with clear timelines, objectives, and resource allocation

• Identifying potential legal risks and implementing strategies to mitigate them through:

» Settlement negotiations

» Alternative dispute resolution

» Vigorous defense strategies

Conference Adjourns, Cocktail Reception

MAIN CONFERENCE DAY 2

Wednesday, December 4, 2024

Opening Remarks from the Co-Chairs

Eileen M. Hunter Vice President, Head of Global Litigation Boston Scientific

Counsel

A VIEW FROM THE BENCH: Judicial Perspectives on Navigating Drug and Medical Device Products Liability Litigation

During this highly anticipated panel, esteemed Members of the Bench will offer first-hand insights into the evolving landscape of Drug and Medical Device Litigation. Topics of discussion will include:

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

• Highlighting suggestions for speeding up the litigation process for lingering MDLs, class action and mass tort cases

• Offering thoughts and feedback on the new Rule 702 – and the consistency of the “gatekeeper” role

• Pinpointing what works and doesn’t work in their courtroom regarding jury instructions, voir dire and opening/closing statements

• Describing actual accounts of effective (and poor) witness examination, tips and tactics related to effective jury selection, and good vs. bad lawyering

Honorable Karen K. Caldwell

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

Honorable Brian H. May Circuit Judge, Division 1 St. Louis County Circuit Court

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

Navigating the New Rule 702 Amendments: Strategies for Expert Testimony in Drug and Medical Device Litigation

Rule 702’s landmark revision – the most significant in 25 years – transforms how expert testimony is assessed, reinforcing the judicial gatekeeper role and providing new tools to exclude unreliable opinions. This change aims to raise the admissibility standards, ensuring that only well-founded expert testimony reaches the jury. During this session, attendees will learn winning strategies for leveraging Rule 702’s amendments to enhance their litigation strategy and secure more favorable outcomes. Topics of discussion will include:

• Reviewing decisions in which courts have addressed, referenced or relied upon the new rule

• Identifying what defense counsel can do to ensure that judges are actually implementing and applying the new Rule 702 changes going forward

• Examining the new rule clarification stating that the proponent of expert testimony has the burden of establishing all criteria by a preponderance of the evidence

• Evaluating the tighter connection between experts’ opinions and the methods they use – to eliminate experts who exaggerate the conclusions

Christiana

BREAKOUT SESSIONS C

TRACK 1

PFAS and Forever Chemicals: Understanding the Complex Legal Nuances of Contaminant Litigations

Suzanne Galvin Partner

Thompson Coburn LLP

Matthew D. Jacobson Partner Reed Smith LLP

Nicole Mantini Partner Torys LLP

TRACK 2

AI in Drug Development and Medical Devices: Unpacking Liability Risks in the Life Sciences

Danielle Rosen Assistant General Counsel, Head of Litigation

Daiichi Sankyo, Inc.

Brett Ashton Mason Partner

Troutman Pepper

Hamilton Sanders LLP

Ruben I. Gonzalez Partner

Faegre Drinker Biddle & Reath LLP

Erin M. Bosman Partner

Morrison & Foerster LLP

PFAS contaminants are driving aggressive class action litigation, posing significant risks to drug and medical device manufacturers. Join this breakout to explore the latest developments in this developing area of the law. Topics of discussion will include:

• Analyzing the impact of the historic 3M and Dupont settlements

• Examining the trends in PFAS litigation against “downstream” manufacturers, distributors and retailers of PFAS-containing products

• Understanding the legal nuances and plaintiff theories in contaminant litigations, with corresponding defense tactics to counter

• 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

• Understanding ways to mitigate initial exposure for PFAS risks through insurance

AI is revolutionizing drug development and diagnostics by predicting diseases and identifying therapies from large-scale biometric data. However, this invites increased risks and potential product liability. Join this breakout as our session leaders explore:

• Investigating the legal and regulatory landscape governing AI use in the pharmaceutical and medical device space

• Reviewing the recent guidance on AI/ML-Enabled Device Software Functions and the potential product liability risks

• Evaluating liability for AI-enabled drug development

• Calibrating the approach to implementing and monitoring healthcare AI tools based on a careful assessment of the liability risk of each tool

• Examining case law on physical injury caused by AI or the malfunctioning of software embedded in medical devices

• Understanding how companies can issue spot areas of potential product liability risk associated with the use of AI, and address the risks up front

TRACK 1

Data Privacy Minefields: Mastering FDA Compliance and Privacy Standards for Drug and Device Manufacturers

Data privacy laws impact drug and medical device development, with pixel technology, biometric devices, and online portals posing major risks. Join this breakout to explore strategies for limiting litigation risk and preventing data breaches. Topics of discussion will include:

• Implementing encryption, access controls and other security measures to prevent unauthorized access to patient data

• Prioritizing data protection when choosing a vendor for FDA compliance assistance to meet standards effectively

• Managing compliance documentation and audit trails from risk assessments and internal audits

• Fortifying Data Security in the Supply Chain and in online portals

• Emerging legal issues with wearable and 3D printed devices

TRACK 2

Managing Multidistrict Litigation: How Proposed Rule 16.1 Could Transform Early MDL Management

Zane Riester Senior Counsel Johnson & Johnson

C. Rose Partner Venable LLP

Proposed Rule 16.1 attempts to guide early case management in MDLs, impacting litigation pace and costs. Permissive language like “should” instead of “must”, could lead to inconsistent applications. Join this breakout to explore the proposed rule’s impact and implications for procedures. Topics of discussion will include:

• Understanding how the new rule may be applied in different case settings and MDL proceedings

• Exploring the permissive, rather than mandatory language: does it eliminate the current uncertainty of MDL processes and procedures?

• Determining if the Proposed Rule limits or expands the discretion that District Judges have?

• Deciding if the Rule can help stem the tide of mass filings of meritless claims

• Reviewing the nonbinding language to determine if it only serves to perpetuate the uncertainty that exists in the world of MDLs?

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 40 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. Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

Jason

John P. Lavelle, Jr. Partner Morgan, Lewis & Bockius LLP

BREAKOUT SESSIONS E

TRACK 1

Driving Success in DEI: Strategies for Enhancing Diversity, Equity & Inclusion in Your Legal Teams

Mary-Alice Barrett

Associate General Counsel Genentech

Effective DEI initiatives go beyond setting objectives – they must be ingrained in a company’s DNA and daily operations. This requires commitment and collaboration between life sciences companies and their law firms. Join this breakout to explore successful DEI strategies and tackle the latest challenges in creating lasting impacts. Topics of discussion will include:

• Exploring ways to implement policies and practices that will truly effect change and promote a diverse workplace

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

• Identifying best practices for evaluating a firm’s efforts in promoting diversity

• Understanding how life science companies and their outside firms can efficiently share tools, best practices and resources to create an effective DEI infrastructure and ecosystem

• Identifying how in-house and outside counsel can work together to successfully attract and keep diverse talent in our practices and on trial teams

• Determining what’s working, what’s not, and how you can do better

TRACK 2

Mastering Jury Selection: A Hands-On Demonstration for Drug and Device Litigation

Rachel A. Farnsworth

Senior Corporate Counsel

| Litigation & Government Investigations

Bristol Myers Squibb

Jessica L. Grant Partner

Shook, Hardy & Bacon L.L.P.

Jury selection is crucial in drug and device product liability cases, with much at stake beyond just asking the right questions. Join this panel for an interactive, practical session featuring polling exercises to uncover best practices in jury selection. Topics of discussion will include:

• Identifying and “weeding out” potential jurors that appear to have a negative perception of large drug and device manufacturers

• Developing ways to get “undesirable” jurors removed for cause - versus peremptory challenges

• Determining how to identify “stealth” jurors that appear to be neutral but are actually plaintiff friendly

• Developing innovative tactics for overcoming juror biases and predispositions in today’s social and political climate

• Utilizing juror questionnaires to cut through barriers created by the courtroom setting and allow for the determination of juror biases on critical issues

• Tackling the tough issues in voir dire and questionnaires to weed out any predispositions

• Reviewing best practices for developing cause challenges

“Get Us Out of This!”: Developing and Implementing an Exit Strategy to Conclude Drug and Device Litigation

Winding down drug and device litigations like opioids, PPI, Zantac, and Roundup is a daunting task, but no company wants to be embroiled in massive litigation long term. This session will address best practices for developing and implementing an effective exit strategy and identify common challenges in product liability settlements. Topics of discussion will include:

• Conducting an early assessment of risk and exposure:

» Engaging key consulting experts early

• Aligning exit strategy with business goals

• Developing a case management schedule to limit claims and claimants:

» Instituting an effective and targeted motion practice

• Coordinating with parallel proceedings

• Building and maintaining working relationships among plaintiffs’ leadership:

» Looking at the pros and cons of separate settlement and litigation teams

» Examining the role of census registry (and PFS process) in facilitating discussions

• Creative mediation and settlement strategies

» Selection and engagement with mediator / settlement special master

Kristen Renee Fournier

King & Spalding LLP

Wendy West Feinstein Partner

Morgan, Lewis & Bockius LLP

Partner

Ethics Lab: Avoiding Ethical Compliance Traps in Drug and Medical Device Litigation

This interactive breakout session - led by drug and device litigators - will test your ethics skills with complex hypothetical scenarios. Compare your approach to ethical dilemmas with your peers and gain practical insights from the results. Topics of discussion will include:

• Determining what you would do in these hypothetical scenarios

• Deciding when you should take action (or not take action) for each example

• Encouraging and implementing inter-departmental cooperation for ethical concerns

Adam Bassing Head of Global Litigation UCB, Inc.

LEAD & COCKTAIL RECEPTION SPONSOR

LANYARD SPONSOR

SUPPORTING SPONSORS

LEAD & LUNCHEON SPONSOR

POCKET AGENDA SPONSOR

ASSOCIATE SPONSORS

CONFERENCE SPONSOR

PREMIUM EXHIBITORS

MEDIA PARTNERS

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 first-chair trial attorneys that tries multiple products cases each year in some of the most challenging jurisdictions. We also have a dedicated science team to combat “junk science” from the outset and craft powerful and persuasive scientific defenses

LEAD & LUNCHEON SPONSOR:

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 cuttingedge medical and scientific issues. Distinguished by its depth of experience and thorough understanding of the industry, this nationwide team of 130+ litigators deliver top-of-class client service. www.gtlaw.com

ASSOCIATE SPONSOR:

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.

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 crosspractice 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.

SUPPORTING SPONSOR:

Litigation powerhouse, Shook, Hardy & Bacon is the go-to firm for the world’s leading health, science and technology companies. In addition to fielding one of the largest product liability practices 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 540 attorneys and 180 research analysts and paraprofessionals, many of whom have advanced scientific and technical degrees. www.shb.com

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.

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