Co-Chairs’ Opening Remarks

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
Associate General Counsel
Genentech

Lisa A. Dunkin
Vice President & Associate General Counsel, Litigation
Zimmer Biomet

Ashley Garry
Senior Counsel
Viatris

Moderator:

Marcella Ducca
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

Examining How Proposed New Rule 16.1 Will Transform the Future of MDL Case Management

Daniel Healey
Senior Corporate Counsel
Pfizer Inc.

Harley Ratliff
Partner
Shook Hardy & Bacon

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

Morning Coffee Break

Spotlight on Artificial Intelligence

Uncovering the Product Liability Risks Associated with AI in Drug Development and Medical Device Usage

Ashley Carr
Partner
DLA Piper

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

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
  

Navigating the Opportunities and Perils of AI-Assisted Legal Representation and Trial Practice

Marc Hennes
Head of Legal Investigations | Litigation
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
  • Chronologizing medical records
  • Motion/brief development
  • Creating demonstratives at trial
• Addressing the obvious and not-so-obvious risks associated with AI-assisted legal representation
• 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
• Understanding how litigators can use the latest AI tools practically and effectively while avoiding ethical and compliance pain points and pitfalls

Networking Luncheon Sponsored by:

Key Takeaways from this Year’s Top MDLs: Impactful Rulings and Hot Opinions from the Tylenol, Zantac and Exactech MDLs

Jonathan Tam
Partner
Dechert LLP

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

Steven Boranian
Partner
Reed Smith LLP

Jessica Davidson
Partner
Skadden, Arps, Slate, Meagher & Flom LLP

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:

• Significant rulings on preemption, Daubert and Statute of Limitations
• Distinctive litigation challenges and macro issues
• Commonly used defenses and effective trial tactics
• Lessons learned that will be useful to practitioners going forward

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

Rachel A. Farnsworth
Senior Counsel | Litigation & Government Investigations
Bristol Myers Squibb

Michael Pompeo
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

Afternoon Break

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

B — Understanding When and How to Successfully Engage the FDA in Your Case

Track A

Leah Lorber
Assistant General Counsel
GlaxoSmithKline

Wendy West Feinstein
Partner
Morgan, Lewis & Bockius LLP

JT Larson
Partner
Barnes & Thornburg LLP

Track B

Shannon Beamer
Partner
Venable LLP

Sean Burke
Partner
Duane Morris LLP

A — Daubert in Doubt: Devising a Plan for New Rule 702 Implementation and Working With Experts After the Recent Amendments

• 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

B — Understanding When and How to Successfully Engage the FDA in Your Case

• 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

BREAKOUT SESSIONS (CHOOSE A OR B)

A — Innovative Tactics for Persuading Juries That Pharma and Med Device Companies Are Not Bad Actors

B — Spotlight on PFAS: Addressing Emerging Threats of Litigation Arising from Forever Chemicals

Track A

Jean Patterson
Assistant General Counsel
Beckton Dickinson

Zane Riester
Senior Counsel
Johnson & Johnson

Eric Rumanek
Partner
Troutman Pepper

Jennifer Saulino
Partner
Sidley Austin LLP

Track B

Libretta (Libby) Stennes
Shareholder
Greenberg Traurig LLP

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

Joseph Petrosinelli
Partner
Williams & Connolly LLP

A — Innovative Tactics for Persuading Juries That Pharma and Med Device Companies Are Not Bad Actors

• 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

B — Spotlight on PFAS: Addressing Emerging Threats of Litigation Arising from Forever Chemicals

• Contaminant class actions: what every defense attorney for a drug or medical device company needs to know about PFAS, heavy metals, and titanium dioxide
• 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, TiO2 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

Conference Adjourns
Cocktail Reception Sponsored by:

Co-Chairs’ Opening Remarks

Coffee and Q+A With Our Esteemed Judges: Judicial Perspectives on Managing Life Sciences Mass Tort Proceedings

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
Chief Judge
U.S. District Court, D. Minnesota (Minneapolis, MN)

Honorable Kristine Baker
District Judge U.S. District Court
District of Arkansas

Honorable Abbe F. Fletman
Judge
Philadelphia Court of Common Pleas

Moderator:

Andrew T. (Andy) Bayman
Partner
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
• 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

BREAKOUT SESSIONS (CHOOSE A OR B)

A — Navigating the Interplay of MDLs and Parallel State Court Proceedings

B — Developing an “In The Trenches” Approach to Battling Reptile Theory

Track A

Sarah Padgitt
Associate General Counsel
Baxter

Thomas Kurland
Partner, Litigation, Products Liability and Brand Protection
Patterson Belknap Webb and Tyler LLP

Track B

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

Judge Booker Shaw
Partner
Thompson Coburn LLP

Bill Childs
Assistant General Counsel, Litigation
3M

A — Navigating the Interplay of MDLs and Parallel State Court Proceedings

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

B — Developing an “In The Trenches” Approach to Battling Reptile Theory

• 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

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

B — Crafting Successful Jurisdiction, Standing and Preemption Arguments at the Motion to Dismiss Stage

Track A

Larissa A. Eustice
Senior Assistant General Counsel
Bayer

Katherine Unger Davis
Partner
Dechert LLP

Michael Leard
Partner
Nutter McClennen & Fish LLP

Track B

John Lavelle
Partner
Morgan Lewis & Bockius LLP

Steven Weisburd
Shareholder
Carlton Fields, P.A.

A — FDA in the Crosshairs: What Recent Court Activity and State Litigation Over Mifepristone Means for the Future of Agency Deference

• 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

B — Crafting Successful Jurisdiction, Standing and Preemption Arguments at the Motion to Dismiss Stage

• 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

BREAKOUT SESSIONS (CHOOSE A OR B)

A — Examining the Rise in “Non-Traditional” Liability Theories in Drug and Medical Device Product Liability Cases

B — Advanced Settlement Strategies for Drug and Device Product Liability Class Actions and MDLs

Track A

Justin Witzmann
Director, Legal Affairs - Global Litigation
Nuvasive

Jessica Grant
Partner
Shook, Hardy & Bacon LLP

Julie Park
Partner
Morrison Foerster LLP

Track B

Russell “Chip” Gaudreau
Partner
King & Spalding LLP

Greg Dadika
Vice-President, Litigation, Governmental Investigations, and Risk Management
Boehringer Ingelheim

Terri Reiskin
Partner
Nelson Mullins Riley & Scarborough

Elizabeth Mitchell
Associate General Counsel, Global Litigation
Smith & Nephew

Ethan Greene
Managing Partner
Reisman Greene Theis LLP

A — Examining the Rise in “Non-Traditional” Liability Theories in Drug and Medical Device Product Liability Cases

• 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

B — Advanced Settlement Strategies for Drug and Device Product Liability Class Actions and MDLs

• 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

Networking Luncheon

Exploring Critical International Developments Impacting Drug and Device Product Liability Litigation in Foreign Jurisdictions

Teresa Griffin
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

Afternoon Break

Diversity Equity & Inclusion Strategy Session: How Life Sciences Companies and Their Law Firm Partners Can Collaborate to Implement Successful DEI Initiatives

Kenita Barrow
Deputy General Counsel
Otsuka Pharmaceutical

Jennifer A. Prioleau
SVP, Chief Legal Officer
B. Braun Medical Inc

Eric White
Partner
Winston & Strawn LLP

• Turning ideas into action: Implementing policies and practices in your products liability defense department that will truly effect change and promote a diverse workplace
• Identifying how in-house and outside counsel can work together to successfully attract and keep diverse talent in our practices and on trial teams
• Understanding what specific evidence of diversity in-house legal departments at drug and medical device companies are seeking from outside counsel when vetting and choosing law firms to represent them
• Best practices for evaluating a firm’s efforts in promoting diversity
• Collaboration in recruitment: How life sciences companies can work with their outside counsel to consider how prospective diverse talent can meet joint objectives
• Closing gaps in business development opportunities: how life science companies and law firm counsel can facilitate more chances for diverse lawyers to develop closer relationships with their clients

Where the Rules Meet the Road: Seasoned Drug and Medical Device Product Liability Litigators Share Lessons on Avoiding Ethical Compliance Traps

Celeste Coco-Ewing
Partner
Irwin Fritchie Urquhart Moore & Daniels LLC

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