Day 1 - Tuesday, December 7, 2021

7:15
Breakfast and Registration
8:15
Co-Chairs’ Welcome Remarks
8:30
Drug and Medical Device 2021 Year in Review: How the Most Significant Product Liability Decisions of the Last Year are Impacting Your Clients and Cases
9:30
Navigating the New Hybrid World of Virtual/In-Person Trial Practice: Managing Shifting Client and Court Expectations and Implementing Strategies for Successful Outcomes
10:30
Morning Coffee Break
11:00
FDA Think Tank: Examining the Latest FDA Initiatives Influencing the Products Liability Sphere
12:00
Networking Luncheon — Sponsored by Greenberg Traurig
1:00

SPOTLIGHT ON MDLs

Taking Down the Rising Behemoth: Combatting Plaintiff Tactics That Are Transforming MDLs Into the Machines We See Today
2:30

SPOTLIGHT ON MDLs

Keys to Effectively Defending MDLs and Navigating the Remand Process from Transfer to Trial
3:45
Afternoon Refreshment Break
4:00
Creating a Roadmap for Post-Albrecht Preemption Using Takeaways from This Year’s Most Significant Rulings
4:45

BREAKOUT SESSIONS (CHOOSE A OR B)

A — Daubert Revisited: Examining Recent Proposed Amendments to Rule 702 and What They Could Mean for the Future of Drug and Device Litigation

B — Incorporating Key Points from the Recent NDMA Litigations Into Your Future Trial Practice (Zantac, Valsartan and Metformin)
5:30

BREAKOUT SESSIONS (CHOOSE A OR B)

A — Lessons Learned from Recent Developments in This Year’s Opioid Trials

B — Analyzing Risks and Theories of Potential Liability Associated with New Technologies, Digital Health and Artificial Intelligence
6:15
Conference Adjourns – Cocktail Party Hosted by King & Spalding

Day 2 - Wednesday, December 8, 2021

7:45
Continental Breakfast
8:30
Opening Remarks and Recap of Day 1
8:45
An Industry Under Attack: Addressing the Recent Rise of OTC Product Liability Litigation
9:45
Morning Coffee Break
10:00
Spotlight Speaker
10:30
A View From the Bench – 2021 Edition: Judicial Insights on Drug and Medical Device Products Liability Litigation and How Courts Are Adjusting to the Lingering Effects of the Pandemic
11:45
Assessing How the COVID-19 Pandemic is Impacting Juror Mindsets, Perceptions and Verdicts: What is the Data Showing?
12:30
Networking Luncheon
1:30
Diversity, Equity & Inclusion Town Hall: A Candid Discussion About Drivers of Successful DE&I Initiatives—What’s Working, What’s Not, and How We Can Do Better
2:30
Interactive Ethics Lab
3:30
Conference Concludes

Day 1 - Tuesday, December 7, 2021

7:15
Breakfast and Registration
8:15
Co-Chairs’ Welcome Remarks

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

Lisa Dunkin
Assistant General Counsel, Litigation
Zimmer Biomet (Fort Wayne, IN)

Co-Chairs’ welcome remarks.

8:30
Drug and Medical Device 2021 Year in Review: How the Most Significant Product Liability Decisions of the Last Year are Impacting Your Clients and Cases

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

Eric Santoro
Senior Counsel, Global Litigation
AstraZeneca (Philadelphia, PA)

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

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

Sarah Padgitt
Associate General Counsel
Baxter (Chicago, IL)

Moderator:

Lori Cohen
Law Firm Vice Chair
Co-Chair, Global Litigation Practice

Greenberg Traurig LLP (Atlanta, GA)

Our opening panel of esteemed in-house counsel will kick off this year’s event by engaging in an interactive discussion of the most important case law developments of the past year, their real-life impact on drug and medical device litigation practice, and 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

9:30
Navigating the New Hybrid World of Virtual/In-Person Trial Practice: Managing Shifting Client and Court Expectations and Implementing Strategies for Successful Outcomes

Jason Steinhart
Associate Vice President
Associate General Counsel, North American Litigation

Sanofi (Bridgewater, NJ)

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

Meredith Thornburgh White
Partner
Barnes & Thornburg LLP (Indianapolis, IN)

Kim Bueno
Attorney
Butler Snow LLP (Austin, TX)

Moderator:

Erin Bosman
Partner, Co-Chair of Class Actions and Mass Torts Practice Group
Morrison & Foerster LLP (San Diego, CA)

  • Examining what post-pandemic trial practice will look like in the mass torts arena
  • What aspects of trial practice will clients prefer to be done live/in-person vs. virtually?
  • How have in-house counsel expectations of their law firm counsel shifted amidst the recent transition to virtual trial practice, and how may their expectations continue to shift moving forward?
  • Are courts continuing to adopt virtual/zoom models for conferences, hearings and depositions?
  • Understanding when it is advantageous to request that something be in-person
  • How will these changing trends impact how law firm counsel manage things for their clients going forward?
  • Assessing the implications of continued aspects of virtual trial practice
    • How might having virtual aspects of jury trials impact the subpoena power of witnesses?

10:30
Morning Coffee Break
11:00
FDA Think Tank: Examining the Latest FDA Initiatives Influencing the Products Liability Sphere
Stacy Cline Amin

Stacy Amin
Partner
Co-Chair, FDA Regulatory & Compliance Practice

Morrison & Foerster LLP
Former Chief Counsel, Food and Drug Administration, 2018-2021 (Washington, DC)

Rebecca K. Wood
Partner
Global Life Sciences Leadership Council

Sidley Austin LLP
Former Chief Counsel, Food and Drug Administration (FDA) (Washington, DC)

Kristin M. Kaplan
Of Counsel
Shook Hardy & Bacon LLP (Kansas City, MO)

Moderator:

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

  • Examining FDA guidance related to controls on NDMA in Zantac and other drugs
  • Exploring what future FDA approval processes and timelines will look like moving forward
    • Should the industry expect to see accelerated approvals for new drugs outside of those intended to treat COVID-19? (E.g. recent accelerated approval of Alzheimer’s drug Aduhelm)
  • Understanding the path forward for companies that received EUAs during the pandemic: what happens once the public health emergency is over? How will EUAs need to be converted to traditional approvals?
  • How will the events of the last two years impact the FDA in the next coming year and priorities and initiatives moving forward?
  • What implications may recent developments have on future product liability litigation?

12:00
Networking Luncheon — Sponsored by Greenberg Traurig
1:00

SPOTLIGHT ON MDLs

Taking Down the Rising Behemoth: Combatting Plaintiff Tactics That Are Transforming MDLs Into the Machines We See Today

Lisa Dunkin
Assistant General Counsel, Litigation
Zimmer Biomet (Fort Wayne, IN)

Sean P. Fahey
Partner
Troutman Pepper (Philadelphia, PA)

Susan Sharko
Partner
Faegre Drinker Biddle & Reath LLP (Florham Park, NJ)

Andrew D. Kaplan
Partner
Crowell & Moring LLP (Washington, DC)

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

Moderator:

Douglas J. Moore
Member
Irwin Fritchie Urquhart & Moore LLC (New Orleans, LA)

Plaintiff Advertising

  • Developing concrete strategies to neutralize the effects of increasingly aggressive plaintiffs’ advertising – What are some of the specific things companies can do? Have there been any successful strategies thus far?
  • Limiting plaintiff advertising: taking an aggressive stance against false or misleading messages to the public

Third-Party Litigation Funding

  • Mitigating challenges created by Third-Party Litigation Funding (TPLF) in the mass tort arena
  • Proactive measures that companies can take to push back on the effects of TPLF
  • Recent state law strides towards requiring disclosure of TPLF agreements in civil lawsuits

Initial Census Forms

  • Examining how the data and analytics from initial census forms are being used to weed out meritless claims
  • How have the use of these forms 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, and how they may impact MDLs moving forward

Social Media

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

2:30

SPOTLIGHT ON MDLs

Keys to Effectively Defending MDLs and Navigating the Remand Process from Transfer to Trial

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

Cindy Aribisala
Senior Counsel
Gilead Sciences, Inc. (Foster City, CA)

Andrea Roberts Pierson
Partner
Faegre Drinker Biddle & Reath LLP

D’Lesli M. Davis
Partner
Norton Rose Fulbright US LLP (Dallas, TX)

Moderator:

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

  • Understanding the discrete challenges that MDLs present
  • 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
  • Understanding how defendants (manufacturers, distributors, retailers, etc.) can all play in the MDL sandbox without causing problems for each other
    • How to make sure pretrial orders are negotiated so that everyone’s interests are considered
    • How to coordinate arguments in briefings so as not to undercut one another
  • How to navigate the remand process from transfer to trial
    • Ensuring that the remand court’s docket is complete: practical considerations for how to designate material that will go to the remand court
    • Assessing whether there is any outstanding discovery that needs to be completed, and strategies for managing additional discovery in the remand court
    • Analyzing whether to file dispositive or evidentiary motions
    • Preparing the final pretrial order

3:45
Afternoon Refreshment Break
4:00
Creating a Roadmap for Post-Albrecht Preemption Using Takeaways from This Year’s Most Significant Rulings

Mitch Morinec
Shareholder
Segal McCambridge Singer & Mahoney (Chicago, IL)

Ilana H. Eisenstein
Partner
DLA Piper (Philadelphia, PA)

James M. Beck
Senior Life Sciences Policy Analyst
Reed Smith LLP (Philadelphia, PA)

Moderator:

Emily Ullman
Partner
Covington & Burling LLP (Washington, DC)

  • Analyzing key implications and takeaways of recent, significant post-Albrecht preemption rulings in the Zofran, Pradaxa, Incretin and Gadolinium litigations
    • In re Zofran Products Liability Litigation (D. Mass. June 1, 2021)
    • Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc. (Conn. Super. March 13, 2020)
    • In re Incretin-Based Therapies Products Liability Litigation (S.D. Cal.)
    • Gremo v. Bayer Corp. (D.N.J. Jun. 29, 2020)
  • Understanding the key challenges that are being ironed out by the courts post-Albrecht
  • Applying lessons learned from recent rulings to create a future roadmap for obtaining Albrecht preemption
  • Examining new theories that the plaintiffs’ bar is using to get around preemption and keep generic drug companies in litigation – and creative defense tactics to combat these new plaintiff theories

4:45

BREAKOUT SESSIONS (CHOOSE A OR B)

A — Daubert Revisited: Examining Recent Proposed Amendments to Rule 702 and What They Could Mean for the Future of Drug and Device Litigation

B — Incorporating Key Points from the Recent NDMA Litigations Into Your Future Trial Practice (Zantac, Valsartan and Metformin)

Session A

Christopher M. Guth
Senior Assistant General Counsel
Bayer (Pittsburgh, PA)

Rachel Weil
Partner
Reed Smith LLP (Philadelphia, PA)

Erik Snapp
Partner
Dechert LLP (Chicago, IL)

Eva Canaan
Partner
King & Spalding LLP (New York, NY)

Session B

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

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

A — Daubert Revisited: Examining Recent Proposed Amendments to Rule 702 and What They Could Mean for the Future of Drug and Device Litigation

  • Taking a look at what changes to the Daubert test may be coming down the pike
  • What are the specifics of the possible new rule changes being considered by the Federal Rules Committee?
  • What is the current status of these amendments? Where are they in the process?
  • What would this reform mean for future litigation?

B — Incorporating Key Points from the Recent NDMA Litigations Into Your Future Trial Practice (Zantac, Valsartan and Metformin)

Join this panel as they take a deep dive into the latest developments in the burning NDMA litigations, and how practitioners can incorporate takeaways from these litigations into their future trial practices. Our panelists will compare and contrast the unique elements of the Zantac, Valsartan and Metformin litigations, and will provide insights on each of their:

  • Distinctive litigation challenges
  • Significant and impactful macro issues
  • Notable judicial rulings
  • Lessons learned

5:30

BREAKOUT SESSIONS (CHOOSE A OR B)

A — Lessons Learned from Recent Developments in This Year’s Opioid Trials

B — Analyzing Risks and Theories of Potential Liability Associated with New Technologies, Digital Health and Artificial Intelligence

Session A

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

Tariq M. Naeem
Partner
Tucker Ellis LLP (Cleveland, OH)

Danielle Gentin Stock
Counsel
Dechert LLP (New York, NY)

Session B

Michele Suggs Adeleye
Vice President and AGC
Pfizer (New York, NY)

Shankar Duraiswamy
Partner
Covington & Burling LLP (Washington, DC)

Max Heerman
Senior Legal Counsel, Litigation
Medtronic (Washington, DC)

A — Lessons Learned from Recent Developments in This Year’s Opioid Trials

  • A comprehensive overview of the latest developments in this year’s opioid trials going forward in California, West Virginia, Oklahoma, Ohio, Washington, and New York
  • Examining notable verdicts, settlements, judicial rulings, and key takeaways from the various trials
  • Assessing nuances and unique elements of the opioid MDL
  • Examining new theories of tort liability being advanced and how these expansions of traditional confines of tort law may impact other areas of products liability litigation
  • What are we learning from these trials that will be useful to practitioners going forward?

B — Analyzing Risks and Theories of Potential Liability Associated with New Technologies, Digital Health and Artificial Intelligence

  • Analyzing the latest developments in digital health technologies and Artificial Intelligence currently being utilized in the medical and healthcare sectors
  • How are these new technologies being utilized in drug development, disease diagnosis processes, marketing strategies and beyond?
  • 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

6:15
Conference Adjourns – Cocktail Party Hosted by King & Spalding

Day 2 - Wednesday, December 8, 2021

7:45
Continental Breakfast
8:30
Opening Remarks and Recap of Day 1
8:45
An Industry Under Attack: Addressing the Recent Rise of OTC Product Liability Litigation

Elizabeth Balakhani
Assistant General Counsel
GSK (Philadelphia, PA)

Sandra A. Edwards
Co-Chair, Product Liability & Mass Torts Practice
Winston & Strawn LLP (San Francisco, CA)

Kristen L. Richer
Partner
Barnes & Thornburg LLP (Los Angeles, CA)

Steven Weisburd
Shareholder
Carlton Fields, P.A. (Los Angeles, CA)

  • Examining the recent spike in OTC product liability litigation, increased scrutiny of chemical additives, and the role of consumer advocacy groups in targeting pharma and over-the-counter products
  • Assessing recent OTC product litigation (Bayer Roundup, One A Day Gummy Vitamins, sunscreen class actions): what lessons can be taken from these litigations that may apply to litigation in the Rx pharma space?
  • Addressing the recent trend of consumer advocacy groups performing their own testing on various OTC products that are spawning product recalls and litigations?
    • Understanding the role of these consumer advocacy groups and their coordination with the plaintiffs’ bar
    • Exploring recent challenges to the legitimacy of their testing and the science behind their studies (e.g. recent retraction of Valisure study that led to the Zantac recalls)
  • Taking a look at the recent withdrawal of titanium oxide from the safe food additive list: what will happen if this additive (used as a coating or filler on many tablets) is deemed unsafe for pharmaceutical products?

9:45
Morning Coffee Break
10:00
Spotlight Speaker

Robert Charrow
Shareholder
Greenberg Traurig LLP
Recent Former General Counsel, U.S. Department of Health & Human Services (HHS) (Washington, DC)

Spotlight speaker.

10:30
A View From the Bench – 2021 Edition: Judicial Insights on Drug and Medical Device Products Liability Litigation and How Courts Are Adjusting to the Lingering Effects of the Pandemic

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

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

Honorable John R. Tunheim
Chief Judge
U.S. District Court, D. Minnesota

Honorable Eduardo C. Robreno
Senior Judge
U.S. District Court, E.D. Pennsylvania

Honorable William F. Highberger
Superior Court Judge
Los Angeles County Superior Court

Moderator:

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

Hear from a panel of esteemed judges on topics including:

  • What continuing effects of the pandemic are being seen on their dockets, court functions and the JPML in general?
  • What to expect in their courtrooms going forward as far as facets of trial practice being virtual vs. live?
  • What arguments have they found most effective and persuasive when presiding over a drug or medical device products liability case?
  • What works and doesn’t work in their courtroom with regard to jury instructions, voir dire and opening/closing statements?
  • Examples they have seen of poor witness selection, inability to connect with a jury, and good vs. bad lawyering

11:45
Assessing How the COVID-19 Pandemic is Impacting Juror Mindsets, Perceptions and Verdicts: What is the Data Showing?

Christina Marinakis, J.D., Psy.D.
Shareholder / Director – Jury Research
Litigation Insights (Los Angeles, CA)

Lyn Pruitt
Partner
DLA Piper (Dallas, TX)

Maithilee K. Pathak, PhD JD
Partner
R&D Strategic Solutions (Cumming GA)

  • Will post- COVID good will towards pharmaceutical and medical device companies actually play out at trial?
  • Are we seeing discrepancies between juror attitudes towards drug companies vs. device companies?
  • How to relate juror reluctance to sit on a jury during the pandemic to how their perspectives would be while actually sitting on the jury?
  • Are we seeing any correlation between vaccine hesitancy and juror perceptions of drug companies?
  • Analyzing data about people who are hesitant to get vaccinated and whether they tend to have a worse view of pharma companies? What can we glean from including the question “have you been vaccinated?” on a juror questionnaire?

12:30
Networking Luncheon
1:30
Diversity, Equity & Inclusion Town Hall: A Candid Discussion About Drivers of Successful DE&I Initiatives—What’s Working, What’s Not, and How We Can Do Better

Adrienne M. Hollander
Assistant General Counsel
American Regent Inc., a Daiichi Sankyo Group Company (Shirley, NY)

John Lewis, Jr.
Partner
Shook Hardy & Bacon LLP (Houston, TX)

Let your voice be heard in this unique “open floor” session, designed to give attendees an opportunity to grab the microphone and add to the dialogue on successful DEI initiatives.

Topics of discussion will include:

  • Implementing 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
  • Best practices for evaluating a firm’s efforts in promoting diversity
  • How can companies manage and capitalize on generational diversity in the workplace?
  • Shifting From Diversity and Inclusion to Diversity, Equity, and Inclusion – what does equity in the workplace look like?

2:30
Interactive Ethics Lab
Adam Bassing

Adam Bassing
Head of Global Litigation
UCB, Inc. (Smyrna, GA)

Aileen Fair
Senior Corporate Counsel, Litigation & Government Investigations
Bristol Myers Squibb (Princeton, NJ)

Test your ethics skills with a series of anonymous polling questions on sensitive, complex hypothetical scenarios. Discover how your approach to tackling ethical dilemmas in drug and medical device litigation compares to your peers, and benefit from a practical discussion of the polling results and important takeaways for your practice.

3:30
Conference Concludes