Co-Chairs’ Opening Remarks

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

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

Lora Spencer
Principal Litigation & Investigations Counsel
Medtronic (Minneapolis, MN)

Co-chairs’ opening remarks.

Coffee and Q+A with Our In-House Counsel on “What’s Keeping You Up at Night”: The Top 5 Things to Watch in the Current Products Liability Defense Environment

Candace Camarata
Associate General Counsel
Becton, Dickinson and Company (New York, NY)

Greg A. Dadika
Vice-President, Litigation, Governmental Investigations, and Risk Management
Boehringer Ingelheim (Ridgefield, CT)

Christiana Jacxsens
Corporate Vice President, Deputy General Counsel, Head of Investigations and Litigation
B. Braun Medical (Atlanta, GA)

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

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

Moderator:

Marcella Ducca
Co-Chair, Atlanta Products Liability Litigation Group
Greenberg Traurig LLP (Atlanta, GA)

Our opening session will deliver insights from key biopharmaceutical and medical device counsel on their top product liability litigation challenges and concerns. At the end of the segment, participate in an interactive Q+A that will allow you to ask your most pressing questions and add to the dialogue.

Topics to be discussed will include:

• Critical case law developments of the last year impacting the products liability sphere
• Legislative changes that will impact litigation in this space (including California’s new legislation on settlement agreements and confidentiality)
• Novel plaintiffs’ bar tactics keeping the defense bar on their toes
• Controlling and managing litigation costs, and the latest developments in third-party litigation funding
• MDL management and resolution challenges

Fireside Chat

Examining New Proposed MDL Rule Changes and What They Will Mean for Practitioners

Judge Robin Rosenberg
District Judge
U.S. District Court, S.D. of Florida
Chair, Civil Rules Advisory Committee
Chair, MDL Rules Subcommittee

Interviewed by:

Paul LaFata
Partner
Dechert LLP

Examining new proposed MDL rule changes and what they will mean for practitioners.

Morning Coffee Break

Overcoming the Trials and Tribulations of Plaintiff Census Forms and Registries: What’s Working, What’s Not, and How Proposed MDL Rule Changes May Improve the System

Sean P. Fahey
Partner | Leader, Health Sciences Litigation Practice Group
Troutman Pepper (Philadelphia, PA)

Christine Kain
Partner
Faegre Drinker Biddle & Reath LLP (Minneapolis, MN)

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

Megan Pizor
General Counsel
Litigation Management, Inc. (Mayfield Heights, OH)

• How has the use of plaintiff census forms and registries been playing out in recent prominent MDLs?
• How is the data in these forms impacting judicial decisions and future proceedings?
• Assessing the pros and cons of these census registries: are they actually working as intended?
• Addressing collateral issues: how are these census registries impacting the tolling of Statute of Limitations?
• Devising defense strategies to effectively move cases off census registries
• Examining recent proposed MDL rule changes that aim to improve early vetting of claims
  • What will the new rules require with regard to early proofs of product use and injury, and how might this impact the efficiency of plaintiff registries?

Litigation Strategy Alert

Understanding How New Rule 702 Amendments Will Impact the Future Admissibility of Expert Testimony

Michelle M. Bufano
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)

Michael Hecht
Partner
Venable (Baltimore, MD)

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

Lora Spencer
Principal Litigation & Investigations Counsel
Medtronic (Minneapolis, MN)

Moderator:

Timothy Daniels
Partner
Irwin Fritchie Urquhart & Moore LLC (New Orleans, LA)

• Analyzing the specifics of the new rule amendments expected to take effect December 1, 2023
• Examining the evolution of the Daubert standard and its application over the years, and why there was a need for a rule change
• How will the Rule 702 amendment actually affect admissibility of expert testimony?
• 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

Assessing the Impact of the Recent Supreme Court Session on the Drug and Medical Device Industry and Upcoming Preemption Battles

Eric Alexander
Partner
Reed Smith LLP

Ruben Gonzalez
Attorney
Faegre Drinker Biddle & Reath LLP (Chicago, IL)

Matthew Kelly
Shareholder
Segal McCambridge Singer & Mahoney (Chicago, IL)

Davis Walsh
Partner
McGuireWoods LLP (Richmond, VA)

Charlotte Taylor
Partner
Jones Day

• Looking Beyond Albrecht: Analyzing the potential implications of Dobbs v. Jackson Women’s Health Organization on future preemption battles involving state attempts to ban FDA-approved drugs
• Could the Court’s recent decision limiting the authority of the EPA potentially impact the FDA’s future ability to enforce their regulations in the drug and device space?
• Views from Supreme Court practitioners on how the current division in the court is impacting their approach to argument and their decisions on appellate issues, etc.

Networking Luncheon Sponsored by:

Drug and Medical Device Litigator Think-Tank: “What I Wish Was Done Differently During the Regulatory Approval Process”

David Ferrera
Partner
Nutter McClennen & Fish LLP (Boston, MA)

Tripp Haston
Partner
Bradley (Birmingham, AL)

Susanna Moldoveanu
Attorney
Butler Snow LLP (Memphis, TN)

In this unique session, a panel of drug and medical device product liability litigators will share challenges they have faced in litigation and reflect on what they wished their regulatory counsel would have done during the FDA pre-approval, approval or post-approval periods to prevent or mitigate the issues that developed down the road. The panelists will talk through scenarios where a more favorable outcome could have been achieved in litigation had the regulatory counsel done something differently with regard to:

• The drug or device review and approval process
• Product labeling
• Clinical trials
• Handling of post-approval challenges related to recalls and withdrawals

Maximizing the Chances of Success in a “Bet-the-Company” Product Liability Litigation

Amy Todd Klug
Associate General Counsel, Litigation & Corporate Operations, Legal Affairs
Daiichi Sankyo, Inc. (Basking Ridge, NJ)

Christina Marinakis
Jury Consulting & Strategy Advisor
IMS Consulting & Expert Services, LLC

Grant Worden
Partner
Torys LLP (Toronto, ON)

Mary Young
Partner
Norton Rose Fulbright US LLP (Minneapolis, MN)

Moderator:

Julie Park
Partner
Morrison Foerster LLP (San Diego, CA)

• Best practices for utilizing a mock trial in advance of litigation
• Identifying the processes and criteria for selecting the absolute best expert witnesses
• Tools for success in direct examinations and cross examinations
• Partnering with in-house counsel to make critical strategic decisions

Afternoon Break

BREAKOUT SESSIONS (CHOOSE A OR B)

A — Tactics for Combatting “Non-Traditional” Liability Theories in Drug and Medical Device Product Liability Cases

B — Addressing The Latest and Greatest in Plaintiffs’ Bar Attacks on OTC Drugs and Consumer Health Products

Track A:

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

Sandra Di lorio
Senior Litigation Counsel
Endo

Amy Vanni
Partner
McCarter & English LLP (Philadelphia, PA)

Steven Weisburd
Shareholder
Carlton Fields (Los Angeles, CA)

Track B:

Paul J. (PJ) Cosgrove
Partner | Co-Group Leader, Product Liability
Ulmer & Berne LLP (Cincinnati, OH)

Thomas Kurland
Counsel
Patterson Belknap Webb and Tyler LLP (New York, NY)

Stephen J. McConnell
Partner
Reed Smith LLP

A — Tactics for Combatting “Non-Traditional” Liability Theories in Drug and Medical Device Product Liability Cases

In recent years, the plaintiffs’ bar has increased their creative attempts to expand or circumvent traditional liability theories. This panel will explore new theories of tort liability, as well as how to best combat claims that expand the confines of traditional liability. Topics to be discussed include:

• How the defense bar can prepare for the latest plaintiff bar attempts to circumvent traditional liability theories in drug and medical device claims
• Examining “public nuisance” theory of how this is playing out in the courts today
• Assessing the recent trend of plaintiffs pushing “failure to warn” claims under the guise of “failure to report” adverse events to the FDA
  • Understanding the implications of Glover v. Bausch & Lomb, Inc., — A.3d –, 2022 WL 2035805 (Ct. S. Ct. Jun. 7, 2022)
• Analyzing the recent string of lawsuits against Gilead alleging that their life-saving HIV drug (Truvada) should have been replaced sooner with a better version
• Devising defense strategies to succeed against these non-traditional claims

B — Addressing The Latest and Greatest in Plaintiffs’ Bar Attacks on OTC Drugs and Consumer Health Products

• What lessons can be taken from OTC Class Actions OTC Class Actions that may apply to litigation in the Rx pharma space?
• Addressing the rising trend of consumer advocacy research labs (e.g. Valisure, Emery Pharma) performing their own testing on OTC products that are spawning product recalls and class litigations
• Understanding the role of these consumer advocacy groups and their behind-the-scenes coordination with the plaintiffs’ bar
• Navigating the unique challenges inherent to OTC/consumer product litigations, such as lack of prescriptions, receipts and written records of product use
• Examining the growing number of Tylenol lawsuits are now being filed against manufacturers of acetaminophen-based drugs: will this be the next big MDL?

BREAKOUT SESSIONS (CHOOSE A OR B)

A — Too Big to Close: Effective Strategies for Wrapping Up an Unyielding MDL and Navigating the Remand Process

B — Insights from Frontline Litigators on Current Juror Perceptions and Behaviors: Thoughts on the Post-Pandemic Juror Mindset

Track A:

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

Zane Riester
Senior Counsel
Johnson & Johnson (New Brunswick, NJ)

Track B:

Alana Bassin
Partner
Nelson Mullins Riley & Scarborough

Kimberly Martin
Partner
Bradley (Huntsville, AL)

Robert Simpson
Managing Partner
Shook Hardy & Bacon LLP (Hartford, CT)

A — Too Big to Close: Effective Strategies for Wrapping Up an Unyielding MDL and Navigating the Remand Process

• Identifying successful approaches for wrapping up an MDL that is massive and unyielding
  • Lessons gleaned from MDLs including opioids, PPI and Zantac
• Developing strategies for managing the unpaid claims remaining after settlement
• Effectively negotiating with plaintiff’s counsel to reach a culmination
• How to manage client’s expectations through the process
• Devising strategies for managing remand of remaining cases after MDL settlement

B — Insights from Frontline Litigators on Current Juror Perceptions and Behaviors: Thoughts on the Post-Pandemic Juror Mindset

• Assessing how juror mindsets, perceptions and verdicts are playing out as we emerge from the pandemic
  • Is the post-Covid good will towards life sciences companies waning, and did it ever really create an impact on trial outcomes and verdicts to begin with?
• Examining the correlation between vaccine skepticism and juror perceptions of drug companies
• What can we glean from the question “have you been vaccinated/ boosted?” on a juror questionnaire?
• First-hand insights on regional differences in juror perceptions of life sciences companies and verdicts
• Employing effective strategies to communicate to (and win over) jurors in today’s highly polarized socio-political climate

Conference Adjourns
Cocktail Reception Hosted by:

Co-Chairs’ Welcome Back and Recap of Day 1

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

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

Lora Spencer
Principal Litigation & Investigations Counsel
Medtronic (Minneapolis, MN)

Co-chairs’ welcome back and recap of Day 1.

Lessons Learned from this Year’s Top MDLs: Key Defense Strategies from 3M Ear Plugs, Opioids and Zantac MDLs

Christopher Carton
Managing Partner
Bowman & Brooke LLP (New Brunswick, NJ)

Sharon Desh
Partner
Winston & Strawn LLP (Chicago, IL)

Sabrina Gallo
Partner
Greenberg Traurig LLP, (Miami, FL)

Join us for an in-depth analysis into the latest developments in the year’s biggest and most complex MDLs. Our panelists will analyze the unique nuances of the 3M Ear Plug, Opioids and Zantac MDLs, and provide insights on each of their:

• Distinctive litigation challenges
• Effective trial tactics
• Significant macro issues
• Notable verdicts, settlements and judicial rulings
• Lessons learned that will be useful to practitioners going forward

Morning Coffee Break

And Now a Word from Our Judges: Judicial Perspectives on Managing Life Sciences Mass Tort Proceedings

Honorable Rex Burlison
Circuit Judge
22nd Judicial Circuit of MO

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

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

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

Moderator:

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

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
• 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

Examining the Impact of Social Media and Voluntary Reporting on Today’s Drug and Device Product Liability Litigation Landscape

Christopher G. Campbell
Partner
Chair, Product Liability and Mass Torts Practice
DLA Piper (Atlanta, GA)

Sarah Heineman
Senior Assistant General Counsel, Global Litigation
Bayer (Piitsburgh, PA)

In the wake of the recent Essure settlement, drug and medical device companies have become increasingly aware of the impact that consumer adverse events reports on social media platforms can have in spawning a products liability litigation. In this unique session, lead trial counsel for the Essure litigation and the in-house manager of the litigation will discuss:

• The impact of social media and voluntary adverse event reporting on medicine, innovation, and potential litigation
• Strategies for responding to a social media campaign against a medical product, and ways to focus the debate on more reliable science
• How regulators and the medical community can work together to discuss and address product risks while still encouraging new options for patients

Networking Luncheon

Examining Risks and Liabilities Associated with New Cutting Edge MedTech and HealthTech

Jessica Grant
Partner
Morrison Foerster LLP

Tim Hudson
Partner
Barnes & Thornburg LLP (Dallas, TX)

Robin Linley
Partner
Blake, Cassels & Graydon LLP (Toronto, ON)

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

• Analyzing the latest advancements in MedTech and HealthTech that are disrupting the industry
• Examining the latest developments in digital health apps and diagnostic tools, AI, surgical robotics, mRNA, CRISPR and combination drug and device products (e.g. “smart needles”)
• How are these new technologies being utilized in drug development and disease diagnosis and treatment processes?
• Examining the risks of new mistakes and liability risks associated with these new technologies, including cyber security challenges
• Ensuring proper protection to all relevant legally protected interests, and preparing to minimize future liabilities associated with new technologies

When Products Liability and Enforcement Converge: Building a Holistic Defense Strategy for Tackling a Multi-Pronged Litigation

Courtney Saleski
Partner
DLA Piper

Jacqueline Harrington
Partner
Dechert LLP (New York, NY)

Andrew Kaplan
Partner
Crowell & Moring (Washington, DC)

As often as not, mass tort litigations in the drug and medical device space turn into multi-pronged litigations which can include coinciding government enforcement actions by the DOJ or state AGs, as well as other types of class actions outside of the product liability litigation. This session will examine:

• How companies and their counsel can prepare for criminal and civil enforcement actions stemming from drug and device products liability
• Understanding how product liability and personal injury litigation interact with other types of litigations, as well as with economic loss claims and punitive class action claims
• Strategies for building a defense team and implementing a multi-faceted defense which will combat attacks from all sides

Afternoon Break

What Would You Do If?… Seasoned Drug and Medical Device Product Liability Litigators Share Lessons on Avoiding Ethical Compliance Traps

Sarah Padgitt
Associate General Counsel
Baxter (Chicago, IL)

Robyn Maguire
Partner
Barnes & Thornburg LLP

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.

Conference Concludes