Pre-Conference Workshops

Workshop A — Focus Group on MDL Defense Strategies: Developing a Tactical Tool-Kit for Managing Unique MDL Challenges and Combatting Meritless Claims

Dec 5, 2022 9:00am – 12:30pm

Speakers

Bill Childs
Assistant General Counsel, Litigation
3M (St. Paul, Minnesota)

Jennifer Stevenson
Partner
Shook Hardy & Bacon LLP (Kansas City, MO)

Kristen Fournier
Partner
King & Spalding LLP (New York, NY)

Workshop B — Diversity Equity & Inclusion Solution Room for the Life Sciences Products Liability Defense Bar: How Life Sciences Companies and Their Law Firm Partners Can Collaborate to Implement Successful DEI Initiatives

Dec 5, 2022 1:30pm – 5:00pm

Speakers

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

Megan Rodgers
Partner
Covington & Burling LLP (Palo Alto, CA)

Day 1 - Tuesday, December 6, 2022

8:15
Co-Chairs’ Opening Remarks
8:30
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
9:45

Fireside Chat:

Examining New Proposed MDL Rule Changes and What They Will Mean for Practitioners
10:15
Morning Coffee Break
10:45
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
11:30

Litigation Strategy Alert

Understanding How New Rule 702 Amendments Will Impact the Future Admissibility of Expert Testimony
12:30
Assessing the Impact of the Recent Supreme Court Session on the Drug and Medical Device Industry and Upcoming Preemption Battles
1:15
Networking Luncheon
2:15
Drug and Medical Device Litigator Think-Tank: “What I Wish Was Done Differently During the Regulatory Approval Process”
3:00
Afternoon Break
3:15

BREAKOUT SESSIONS (CHOOSE A OR B)

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

B — Understanding how OTC Drug and Consumer Health Class Actions are Providing Clues on The Plaintiffs Bar’s Next Plan of Attack for the Rx World
4:15

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
5:00

BREAKOUT SESSIONS (CHOOSE A OR B)

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

B — Gearing Up for the ESG Litigation and Enforcement Wave: Understanding the Nexus Between Products Liability and ESG
6:00
Conference Adjourns

Day 2 - Wednesday, December 7, 2022

8:45
Co-Chairs’ Welcome Back and Recap of Day 1
9:00
Lessons Learned from this Year’s Top MDLs: Key Defense Strategies from 3M Ear Plugs, Opioids and Zantac MDLs
10:00
Morning Coffee Break
10:30
And Now a Word from Our Judges: Judicial Perspectives on Managing Life Sciences Mass Tort Proceedings
11:30
Examining the Impact of Social Media and Voluntary Reporting on Today’s Drug and Device Product Liability Litigation Landscape
12:00
Networking Luncheon
1:00
Examining Risks and Liabilities Associated with New Cutting Edge MedTech and HealthTech
2:00
When Products Liability and Enforcement Converge: Building a Holistic Defense Strategy for Tackling a Multi-Pronged Litigation
2:45
Afternoon Break
3:00
What Would You Do If?… Seasoned Drug and Medical Device Product Liability Litigators Share Lessons on Avoiding Ethical Compliance Traps
4:00
Conference Concludes

Day 1 - Tuesday, December 6, 2022

8:15
Co-Chairs’ Opening Remarks
8:30
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

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

9:45

Fireside Chat:

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

Judge Robert M. Dow, Jr.
District Judge
U.S. District Court, N.D. Illinois
Chair, MDL Rules Subcommittee (Chicago, IL)

10:15
Morning Coffee Break
10:45
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

  • 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?

11:30

Litigation Strategy Alert

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

  • 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

12:30
Assessing the Impact of the Recent Supreme Court Session on the Drug and Medical Device Industry and Upcoming Preemption Battles

  • 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.

1:15
Networking Luncheon
2:15
Drug and Medical Device Litigator Think-Tank: “What I Wish Was Done Differently During the Regulatory Approval Process”

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

3:00
Afternoon Break
3:15

BREAKOUT SESSIONS (CHOOSE A OR B)

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

B — Understanding how OTC Drug and Consumer Health Class Actions are Providing Clues on The Plaintiffs Bar’s Next Plan of Attack for the Rx World

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 — Understanding how OTC Drug and Consumer Health Class Actions are Providing Clues on The Plaintiffs Bar’s Next Plan of Attack for the Rx World

  • 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?

4:15

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

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

5:00

BREAKOUT SESSIONS (CHOOSE A OR B)

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

B — Gearing Up for the ESG Litigation and Enforcement Wave: Understanding the Nexus Between Products Liability and ESG

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

  • 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

B — Gearing Up for the ESG Litigation and Enforcement Wave: Understanding the Nexus Between Products Liability and ESG

With mandatory ESG reporting fast approaching, many drug and medical device companies may become ESG litigation targets if their reporting is incomplete or misleading.  This panel will closely examine:

  • The latest proposed rules by the SEC for mandatory reporting related to several key areas of ESG
  • The specific climate change/sustainability disclosure rules going into effect in 2023
  • The actions that life science companies should be taking to ensure processes and systems are in place to collect accurate and verifiable data
  • How drug and device companies should be best positioning themselves to respond to ESG reporting requirements
  • Understanding what you might include in your annual disclosures that could open you up to litigation and enforcement
  • Ensuring the transparent reporting of product liability litigation metrics which may affect a life science company’s ESG rating and impact investor interest

6:00
Conference Adjourns

Day 2 - Wednesday, December 7, 2022

8:45
Co-Chairs’ Welcome Back and Recap of Day 1
9:00
Lessons Learned from this Year’s Top MDLs: Key Defense Strategies from 3M Ear Plugs, Opioids and Zantac MDLs

i. 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

10:00
Morning Coffee Break
10:30
And Now a Word from Our Judges: Judicial Perspectives on Managing Life Sciences Mass Tort Proceedings

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

11:30
Examining the Impact of Social Media and Voluntary Reporting on Today’s Drug and Device Product Liability Litigation Landscape

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

12:00
Networking Luncheon
1:00
Examining Risks and Liabilities Associated with New Cutting Edge MedTech and HealthTech

  • 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

2:00
When Products Liability and Enforcement Converge: Building a Holistic Defense Strategy for Tackling a Multi-Pronged Litigation

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

2:45
Afternoon Break
3:00
What Would You Do If?… Seasoned Drug and Medical Device Product Liability Litigators Share Lessons on Avoiding Ethical Compliance Traps

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

Workshop A — Focus Group on MDL Defense Strategies: Developing a Tactical Tool-Kit for Managing Unique MDL Challenges and Combatting Meritless Claims

Dec 5, 2022 9:00am – 12:30pm

Bill Childs
Assistant General Counsel, Litigation
3M (St. Paul, Minnesota)

Jennifer Stevenson
Partner
Shook Hardy & Bacon LLP (Kansas City, MO)

Kristen Fournier
Partner
King & Spalding LLP (New York, NY)

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 — Diversity Equity & Inclusion Solution Room for the Life Sciences Products Liability Defense Bar: How Life Sciences Companies and Their Law Firm Partners Can Collaborate to Implement Successful DEI Initiatives

Dec 5, 2022 1:30pm – 5:00pm

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

Megan Rodgers
Partner
Covington & Burling LLP (Palo Alto, CA)

What is it about?

Successful diversity, equity and inclusion initiatives are far more complex than merely generating a list of general objectives. Implementing effective DE&I programs for the life sciences products liability defense bar requires a dedication to building these initiatives into your company’s DNA and operating behaviors. As many in the legal industry have seen however, this is not always as simple as it sounds, and often requires a commitment to collaboration between life sciences companies and their law firm partners. Join this important workshop for a discussion of what DE&I initiatives are currently working to yield lasting effects and overcoming the latest challenges life sciences companies and law firms are facing in this endeavor. Gain and share insights on topics including:

  • 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
  • Understanding how life science companies and their outside firms can efficiently share tools, best practices and resources to create an advantageous DE+I infrastructure and ecosystem
  • 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
  • What role is the judiciary taking in influencing diversity in appointments of leadership positions on MDL and trial teams?