Agenda

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Pre-Conference Workshops
Workshop A — MDL Defense Strategy War Room: Developing a Tactical Tool-Kit for Managing Unique MDL Challenges and Combatting Meritless Claims
Dec 4, 2023 9:00am – 12:30 PM
Speakers

Ben Hulse
Partner
Norton Rose Fulbright US LLP

Sean Gugerty
Partner
Goodell, DeVries, Leech & Dann LLP
Workshop B — 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”
Dec 4, 2023 1:30pm – 05:00 PM
Speakers

Lora Spencer
Principal Litigation & Investigations Counsel
Medtronic

Christopher M. Guth
Senior Assistant General Counsel
Bayer

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

Patricia A. Barbieri
SVP, General Counsel and Secretary, Legal and Corporate Affairs
Daiichi Sankyo

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

Bill Childs
Assistant General Counsel, Litigation
3M

Richard W. Silbert
Vice President, Legal Strategy & Public Health Initiatives
Purdue Pharma L.P.
Day 1 - Tuesday, December 5, 2023
Day 2 - Wednesday, December 6, 2023
Day 1 - Tuesday, December 5, 2023
8:30 |
Co-Chairs’ Opening Remarks |
8:45 |
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![]() Mary-Alice Barrett ![]() Lisa A. Dunkin ![]() Ashley Garry Moderator:![]() Marcella Ducca 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:
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9:45 |
Examining How Proposed New Rule 16.1 Will Transform the Future of MDL Case Management![]() Daniel Healey ![]() Harley Ratliff ![]() Janet Kwuon ![]() John Beisner
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10:45 |
Morning Coffee Break |
11:15 |
Spotlight on Artificial IntelligenceUncovering the Product Liability Risks Associated with AI in Drug Development and Medical Device Usage![]() Ashley Carr ![]() Erin Bosman 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:
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12:15 |
Navigating the Opportunities and Perils of AI-Assisted Legal Representation and Trial Practice![]() Marc Hennes ![]() Anita Modak-Truran ![]() Davis Walsh
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1:00 |
Networking Luncheon Sponsored by:
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2:00 |
Key Takeaways from this Year’s Top MDLs: Impactful Rulings and Hot Opinions from the Tylenol, Zantac and Exactech MDLs![]() Jonathan Tam ![]() Andrew Kaplan ![]() Steven Boranian ![]() Jessica Davidson Join us for a deep dive into three of this year’s biggest MDLs – Zantac, Tylenol and Exactech. Our panelists will analyze the nuances of these three MDLs and provide insights on how developments in recent OTC MDLs may impact the future of prescription pharmaceuticals. Tune in for an analysis of each of these MDL’s:
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3:00 |
Bankruptcy As a Mass Tort Resolution Vehicle: Weighing the Benefits and Risks of this Growing Litigation Strategy![]() Rachel A. Farnsworth ![]() Michael Pompeo ![]() Daniel Pariser
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3:45 |
Afternoon Break |
4:00 |
BREAKOUT SESSIONS (CHOOSE A OR B)A — Daubert in Doubt: Devising a Plan for New Rule 702 Implementation and Working With Experts After the Recent Amendments
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4:45 |
BREAKOUT SESSIONS (CHOOSE A OR B)A — Innovative Tactics for Persuading Juries That Pharma and Med Device Companies Are Not Bad Actors
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5:45 |
Conference Adjourns
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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![]() Honorable Karen K. Caldwell ![]() Honorable Brian R. Martinotti ![]() Honorable John R. Tunheim ![]() Honorable Kristine Baker ![]() Honorable Abbe F. Fletman Moderator:![]() Andrew T. (Andy) Bayman A panel of distinguished jurists with some of the liveliest drug and medical device litigation dockets in the country will:
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9:45 |
Morning Coffee Break |
10:15 |
BREAKOUT SESSIONS (CHOOSE A OR B)A — Navigating the Interplay of MDLs and Parallel State Court Proceedings
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11:15 |
BREAKOUT SESSIONS (CHOOSE A OR B)A — FDA in the Crosshairs: What Recent Court Activity and State Litigation Over Mifepristone Means for the Future of Agency Deference
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12:00 |
BREAKOUT SESSIONS (CHOOSE A OR B)A — Examining the Rise in “Non-Traditional” Liability Theories in Drug and Medical Device Product Liability Cases
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1:00 |
Networking Luncheon |
2:00 |
Exploring Critical International Developments Impacting Drug and Device Product Liability Litigation in Foreign Jurisdictions![]() Teresa Griffin ![]() Grant Worden ![]() Jill Lawrie
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2:45 |
Afternoon Break |
3:00 |
Diversity Equity & Inclusion Strategy Session: How Life Sciences Companies and Their Law Firm Partners Can Collaborate to Implement Successful DEI Initiatives![]() Kenita Barrow ![]() Jennifer A. Prioleau ![]() Eric White
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4:00 |
Where the Rules Meet the Road: Seasoned Drug and Medical Device Product Liability Litigators Share Lessons on Avoiding Ethical Compliance Traps![]() Celeste Coco-Ewing 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. |
5:00 |
Conference Concludes |
Workshop A — MDL Defense Strategy War Room: Developing a Tactical Tool-Kit for Managing Unique MDL Challenges and Combatting Meritless Claims

Ben Hulse
Partner
Norton Rose Fulbright US LLP

Sean Gugerty
Partner
Goodell, DeVries, Leech & Dann LLP
What is it about?
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
- Understanding techniques judges are currently using to affect settlement agreements
- Understanding how defendants (manufacturers, distributors, retailers, etc.) can all play in the MDL sandbox without causing problems for each other
Workshop B — 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”

Lora Spencer
Principal Litigation & Investigations Counsel
Medtronic

Christopher M. Guth
Senior Assistant General Counsel
Bayer

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

Patricia A. Barbieri
SVP, General Counsel and Secretary, Legal and Corporate Affairs
Daiichi Sankyo

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

Bill Childs
Assistant General Counsel, Litigation
3M

Richard W. Silbert
Vice President, Legal Strategy & Public Health Initiatives
Purdue Pharma L.P.
What is it about?
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
- Finding the right talent with time-proven strategies
- Considerations in selecting outside counsel
- Evaluating the appropriateness of work product
- Reconciling firm capabilities versus individual attorney reputation and ability
Communication
- Communicating value and collaboration between corporate legal and outside counsel
- 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