27th Annual Conference on Drug & Medical Device Litigation - WEB

Join us in NYC for the life sciences industry’s premier products liability conference.

ACI’s Drug and Medical Device Litigation conference is the meeting place for the greatest minds of the pharmaceutical and medical device product liability defense bar. Each year, for over a quarter of a century, ACI’s “Drug and Med” conference has brought together hundreds of products liability defense stakeholders from industry, private practice, and government to network, collaborate, and strategize on the current products liability landscape as well as to anticipate what is next on the horizon.

We invite you to join us this December to meet and reconnect with colleagues and acquire invaluable insights to surmount the drug and medical device products liability defense community's latest litigation challenges.

Our esteemed 2022 faculty will provide invaluable information on the potential impact of newly proposed MDL rule changes, overcoming the challenges of plaintiff census forms and registries, and how new Rule 702 amendments will impact future strategies for offering expert testimony. Through our sophisticated panels, you will also gain insights on how the recent Supreme Court session may impact future preemption battles, as well as tactical tools for combatting “non-traditional” liability claims, bet-the-company litigations, and the increasing liability risks associated with new, cutting edge MedTech.

Reserve your seat and be a part of the annual “go-to” forum that sets the standards for drug and medical device product liability litigation practice.

We look forward to seeing you in New York City for the life sciences products liability defense bar's most valuable gatherings of the year.

ACI's Drug and Med Advisory Board

Bristol-Myers Squibb (Lawrenceville, NJ)

Patricia A. Barbieri SVP, General Counsel and Secretary Daiichi Sankyo, Inc. (Parsippany, NY)

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

Debra L. Burns Senior Counsel Litigation/Investigations GE Healthcare

Christopher M. Guth

Senior Assistant General Counsel Bayer (Pittsburgh, PA)

Donald LeGower Assistant General Counsel Litigation and Government Investigations

Richard W. Silbert V.P., Chief Legal Strategist Purdue Pharma L.P. (Stamford, CT)

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

ready for…

Handshake-alt

15+ Revamped Panel Discussions

60+ Speakers

400+ Attendees 3 Days of Networking

Including over Two Dozen Faculty Members from Industry and The Judiciary

What’s NEW for 2022 burn

Fireside Chat About New Proposed MDL Rule Changes

Judge Robert Dow, the Chair of the MDL Rules Subcommittee, will share insights on what new potential MDL rule changes could mean for practitioners.

Focus Session on Plaintiff Census Forms and Registries

An examination of how plaintiff census forms and registries are playing out in current MDLs as well as collateral challenges practitioners should be prepared for.

Drug and Medical Device Litigator Think-Tank

A panel of drug and medical device product liability litigators will share challenges they have faced in litigation and reflect on what they wish their FDA regulatory counsel would have done differently during the product approval phases.

Spotlight on “Non-Traditional” Liability Theories

A deep dive into the latest plaintiffs’ bar attempts to expand or circumvent traditional liability theories in drug and medical device product liability cases.

“Bet the Company” Litigation Strategy Session

A panel of top-notch trial attorneys share proven strategies for maximizing the chances of success in a bet-the-company product liability litigation.

MDL Case Studies –2022 Edition

An assessment of the year’s biggest and most complex MDLs: lessons learned from 3M Ear Plugs, Opioids, and Zantac.

DISTINGUISED FACULTY

ESTEEMED CO-CHAIRS

Mary-Alice Barrett

Associate General Counsel Genentech (Little Falls, NJ)

Donald LeGower

Vice President, Litigation and Government Investigations Bristol-Myers Squibb (Lawrenceville, NJ)

Lora Spencer

Principal Litigation & Investigations Counsel Medtronic (Minneapolis, MN)

RENOWNED JURISTS

Karen K. Caldwell

Chief Judge U.S. District Court, E.D. Kentucky Chair of 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)

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

Honorable Rex Burlison Circuit Judge 22nd Judicial Circuit of MO (St. Louis, MO)

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

IN-HOUSE COUNSEL

Mary-Alice Barrett

Associate General Counsel Genentech (Little Falls, NJ)

Adam Bassing

Head of Global Litigation UCB, Inc. (Atlanta, GA)

Candace Camarata

Associate General Counsel Becton, Dickinson and Company (Franklin Lakes, NJ)

Bill Childs

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

Greg A. Dadika

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

Sandra Di Iorio

Senior Litigation Counsel Endo Pharmaceuticals (Malvern, PA)

Sarah Heineman

Senior Assistant General Counsel, Global Litigation Bayer (Pittsburgh, PA)

Christiana Jacxsens

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

Marcela Kirberger

Executive Vice President, General Counsel & Corporate Secretary Elanco (Indianapolis, IN)

Amy Todd Klug

Executive Associate General Counsel, Litigation Daiichi Sankyo, Inc. (Basking Ridge, NJ)

Donald LeGower

Vice President – Litigation & Government Investigations Bristol Myers Squibb (Lawrenceville, NJ)

Sarah Padgitt

Associate General Counsel Baxter

Zane Riester

Senior Counsel Johnson & Johnson (New Brunswick, NJ)

Lora Spencer

Principal Litigation Counsel | Global Legal | Litigation & Investigations Medtronic (Minneapolis, MN)

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

Justin Witzmann

Director, Legal Affairs, Global Litigation Nuvasive (San Diego, CA)

LAW FIR M ATTORNEYS

Eric Alexander Partner

Reed Smith LLP (Washington, DC)

Alana Bassin Partner

Nelson Mullins Riley & Scarborough (Minneapolis, MN)

Mr. Andrew T. (Andy) Bayman Partner

King & Spalding LLP (Atlanta, GA)

Michelle Bufano Partner

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

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

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

Paul J. (PJ) Cosgrove Partner

Ulmer & Berne LLP (Cincinnati, OH)

Timothy Daniels Partner

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

Sharon Desh Partner

Winston & Strawn LLP (Chicago, IL)

Jan Dodd Shareholder Carlton Fields (Los Angeles, CA)

Marcella Ducca Partner

Greenberg Traurig LLP (Atlanta, GA)

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

Wendy West Feinstein Partner

Morgan Lewis & Bockius LLP (Pittsburgh, PA)

David Ferrera Partner

Nutter McClennen & Fish LLP (Boston, MA)

Ms. Kristen Fournier Partner

King & Spalding LLP (New York, NY)

Sabrina Gallo Partner

Greenberg Traurig LLP (Miami, FL)

John Galvin Partner

Thompson Coburn LLP (St. Louis, MO)

Ruben Gonzalez Attorney

Faegre Drinker Biddle & Reath LLP (Chicago, IL)

Jessica Grant Partner

Morrison Foerster LLP (San Diego, CA)

Jacqueline Harrington Partner

Dechert LLP (New York, NY)

Tripp Haston Partner Bradley (Birmingham, AL)

Michael Hecht Partner Venable (Baltimore, MD)

Tim Hudson Partner

Barnes & Thornburg LLP (Dallas, TX)

Ms. Nilda Isidro Shareholder

Greenberg Traurig LLP (New York, NY)

Christine Kain Partner

Faegre Drinker Biddle & Reath LLP (Minneapolis, MN)

Andrew D. Kaplan Partner

Crowell & Moring LLP (Washington, DC)

Matthew Kelly Shareholder

Segal McCambridge Singer & Mahoney (Chicago, IL)

Thomas Kurland Counsel

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

Paul LaFata Partner Dechert LLP (New York, NY)

John P. Lavelle, Jr. Partner

Morgan Lewis & Bockius LLP (Philadelphia, PA)

Robin Linley Partner

Blake, Cassels & Graydon LLP (Toronto, ON)

Kimberly Martin Partner

Bradley (Huntsville, AL)

Robyn Maguire Partner

Barnes & Thornburg LLP (Washington, DC)

Stephen J. McConnell Partner

Reed Smith LLP (Philadelphia, PA)

Susanna Moldoveanu Attorney Butler Snow LLP

Rosevelie Márquez Morales Diversity, Equity & Inclusion Director – Americas

Hogan Lovells US LLP

Julie Park Partner

Morrison Foerster LLP (San Diego, CA)

Megan Rodgers Partner

Covington & Burling LLP (Palo Alto, CA)

Courtney Saleski Partner DLA Piper

Robert Simpson

Managing Partner

Shook Hardy & Bacon LLP (Hartford, CT)

David Sneed Partner

Covington & Burling LLP (Washington, DC)

Jennifer Stevenson Partner

Shook Hardy & Bacon LLP (Kansas City, MO)

Charlotte Taylor Partner Jones Day Amy Vanni Partner

McCarter & English LLP (Philadelphia, PA)

Davis Walsh Partner

McGuireWoods LLP (Richmond, VA)

Grant Worden Partner

Torys LLP (Toronto, ON)

Mary Young Partner

Norton Rose Fulbright US LLP (Minneapolis, MN)

CONSULTANCIES

Christina Marinakis

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

Megan Pizor General Counsel

Litigation Management, Inc. (Cleveland, OH)

In-Depth Pre-Conference Working Groups

MONDAY, DECEMBER 5, 2022

Workshop A

9:00 – 12:30

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

microphone-alt Bill Childs, Assistant General Counsel, Litigation, 3M

Jennifer Stevenson, Partner, Shook Hardy & Bacon LLP

LLP

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

Workshop B

1:30 – 5:00

• 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

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

microphone-alt Mary-Alice Barrett, Associate General Counsel, Genentech

Megan Rodgers, Partner, Covington & Burling LLP

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? 5:00 Welcome Reception Hosted by

Ms. Kristen Fournier, Partner, King & Spalding

Rosevelie Márquez Morales, Diversity, Equity & Inclusion Director – Americas, Hogan Lovells US LLP

Main Conference Day 1

TUESDAY, DECEMBER 6, 2022

8:15

Co-Chairs’ Opening Remarks

microphone-alt Mary-Alice Barrett, Associate General Counse , Genentech

Donald LeGower, Vice President – Litigation & Government Investigations, Bristol Myers Squibb

Lora Spencer, Principal Litigation & Investigations Counsel, Medtronic

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

microphone-alt Candace Camarata, Associate General Counsel, Becton, Dickinson and Company

Brennan Torregrossa, Senior Vice President, Litigation, GSK

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

Donald LeGower, Vice President – Litigation & Government Investigations, Bristol Myers Squibb

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

MODERATOR: Marcella Ducca, Partner, Greenberg Traurig LLP

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 affect 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

burn

9:45

Fireside Chat: Examining New Proposed MDL

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

microphone-alt John P. Lavelle, Jr., Partner, Morgan Lewis & Bockius LLP

Christine Kain, Partner, Faegre Drinker Biddle & Reath LLP

Sean Fahey, Partner | Leader, Health Sciences Litigation Practice Group, Troutman Pepper

Megan Pizor, General Counsel, Litigation Management, Inc.

• 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 challenges: Understanding how census registries are affecting 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 11:30

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

microphone Lora Spencer, Principal Litigation & Investigations Counsel, Medtronic

Michelle Bufano, Partner, Patterson Belknap Webb and Tyler LLP

David Sneed, Partner, Covington & Burling LLP

Michael Hecht, Partner, Venable

MODERATOR: Timothy Daniels, Partner, Irwin Fritchie Urquhart & Moore LLC

• Analyzing the specifics of the new rule amendments expected to take effect December 1, 2023

Rule

Changes and What They Will Mean for Practitioners

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

INTERVIEWED BY: Paul LaFata, Partner, Dechert LLP

10:15 Morning Coffee Break

• 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

microphone-alt Matthew Kelly, Shareholder, Segal McCambridge Singer & Mahoney

Davis Walsh, Partner, McGuireWoods LLP

Ruben Gonzalez, Attorney, Faegre Drinker Biddle & Reath LLP

Eric Alexander, Partner, Reed Smith LLP

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.

Utensils

1:30

Networking Luncheon Sponsored by 2:30

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

microphone-alt David Ferrera, Partner, Nutter McClennen & Fish LLP

Tripp Haston, Partner, Bradley Susanna Moldoveanu, Attorney, Butler Snow LLP

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 was 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

3:15

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

microphone-alt Amy Todd Klug, Executive Associate General Counsel, Litigation, Daiichi Sankyo, Inc.

Mary Young, Partner, Norton Rose Fulbright US LLP

Grant Worden, Partner, Torys LLP

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

MODERATOR: Julie Park, Partner , Morrison Foerster LLP

• 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

4:15 Afternoon Break

4:30

AFTERNOON BREAKOUT SESSIONS

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

microphone-alt Sandra Di lorio, Senior Litigation Counsel, Endo Pharmaceuticals

Wendy West Feinstein, Partner, Morgan Lewis & Bockius LLP

Amy Vanni, Partner, McCarter & English LLP

Steven Weisburd, Shareholder, Carlton Fields

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 recent lawsuits against Gilead alleging that Truvada should have been replaced sooner with a better version

• Devising defense strategies to succeed against these non-traditional claims

5:30

A

microphone-alt

• 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

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

microphone Paul J. (PJ) Cosgrove, Partner, Ulmer & Berne LLP

Thomas Kurland, Counsel, Patterson Belknap Webb and Tyler LLP

Stephen J. McConnell, Partner, Reed Smith LLP

• Assessing the latest emerging OTC product litigations: what lessons can be taken from these litigations 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?

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

microphone Robert Simpson, Managing Partner, Shook Hardy & Bacon LLP

Kimberly Martin, Partner, Bradley

Alana Bassin, Partner, Nelson Mullins Riley & Scarborough

• 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

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

Zane Riester, Senior Counsel, Johnson & Johnson John Galvin, Partner, Thompson Coburn LLP

Main Conference 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

microphone-alt Sabrina Gallo, Partner, Greenberg Traurig LLP

Sharon Desh, Partner, Winston & Strawn LLP

Christopher Carton, Managing Partner, Bowman & Brooke LLP

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

microphone-alt Karen K. Caldwell, Chief Judge, U.S. District Court, E.D. Kentucky Chair of 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)

Honorable Rex Burlison, Circuit Judge, 22nd Judicial Circuit of MO (St. Louis, MO)

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

MODERATOR: Mr. Andrew T. (Andy) Bayman, Partner, King & Spalding LLP

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

microphone-alt Sarah Heineman, Senior Assistant General Counsel, Global Litigation, Bayer

Christopher G. Campbell, Partner, Chair, Product Liability and Mass Torts Practice, DLA Piper

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

microphone-alt Justin Witzmann, Director, Legal Affairs – Global Litigation, Nuvasive

Tim Hudson, Partner, Barnes & Thornburg LLP

Jessica Grant, Partner, Morrison Foerster LLP

Robin Linley, Partner, Blake, Cassels & Graydon LLP

• 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

microphone-alt Courtney Saleski, Partner, DLA Piper

Jacqueline Harrington, Partner, Dechert LLP

Andrew D. Kaplan, Partner, Crowell & Moring LLP

Mass tort life sciences products liability litigation sometimes dovetails with tangential DOJ enforcement activity. This session will examine:

• How companies and their counsel can prepare for criminal and civil enforcement actions stemming from drug and device products liability

• How product liability and personal injury litigation interact with other types of litigations

• 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

microphone-alt Sarah Padgitt, Associate General Counse, Baxter 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.

4:00 Conference Concludes

Media Partners:

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

EARN CLE/ CREDITS

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.AmericanConference.com/Accreditation/CLE/

LEAD SPONSOR:

King & Spalding handles the most significant individual, multidistrict, mass tort and class action lawsuits for pharmaceutical and medical device companies. Our 175+ lawyer Product Liability team (ranked Tier 1 in Chambers USA) tries multiple product cases each year in some of the most challenging jurisdictions for corporate clients.

ASSOCIATE SPONSORS:

Troutman Pepper’s Health Sciences Department litigation partners are national leaders in defending companies across the pharmaceutical and medical device supply chains. As one of the largest cross-practice teams focused predominantly on health care and life science sectors, we draw from our deep sector experience to craft scientifically compelling litigation strategies and oversee complex litigation for many of the leading pharmaceutical, medical device, and life science companies on product liability and other claims involving thousands of cases.

Litigation Management, Inc. (LMI) is a legal and medical data analytics company and trusted, long-term partner of Fortune 100 and 500 corporations and leading law firms, specializing in legal and medical data management. With more than 38 years of experience, our legal, medical and technology consultants and professionals redefine client service by providing innovative solutions and high-quality deliverables. LMI partners with clients – plaintiff counsel, defense counsel, judges, mediators, and more – in matters ranging from single cases to mass torts. Services include: Legal Data Analytics & Technology Solutions, Litigation Census & Fact Sheets, Medical Record Collection & Review, Medical Chronologies, Case Management & Settlement, and Regulatory & Compliance.

VENUE INFORMATION

NY Marriott Marquis

1535 Broadway, New York, NY 10036 1-212-398-1900

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ACI’s Drug & Med”.

Please note that the guest room block cut-off date is November 14, 2022 After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

FREE Registration GUARANTEE

y A full credit note for you, or a colleague to attend another event.

y A full refund. All cancellations and changes must be submitted to customerservice@americanconference.com by Nov. 25, 2022.

PLEASE NOTE THE FOLLOWING PANDEMIC-RELATED PROTOCOLS:

ACI conferences and events will be organized in accordance with the latest health and safety regulations, guidelines, and recommendations, directed by the CDC and local government authorities. Attendees are advised to consider their personal health needs.

About

Attendees are asked to self-screen in the days leading up to, before and after attending an ACI event and/or conference. We will continue to monitor the health situation and relevant authorities. Changes to health and safety measures may be made by ACI at any time as required.

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company. For over 35 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities. Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

WORRY

Polling

Enter this area to be paired up at random with other attendees for a quick video meet-up.

Plan to visit the Expo often. It will be open before, during, and after the conference.

Use this opportunity to explore new products and services from leading providers, and meet with new and existing partners over video chat.

Turn your camera on for roundtable sessions, networking events and video chats for a more engaging virtual connection.

Join scheduled “1:1 Networking” sessions. They are an interactive way to expand your network of peers.

Engage with solution providers of all kinds by visiting the “Expo” to watch videos and live demonstrations, and for face-to-face conversations.

Use the “People” tab to create new relationships and strengthen existing ones within your industry.

Mary-Alice Barrett Associate General Counsel Genentech

Donald LeGower Vice President,

and Government Investigations Bristol-Myers Squibb

Lora Spencer Principal Litigation & Investigations Counsel Medtronic