Join the life sciences products angle-double-right liability community for its must-attend gathering of the year!

24th Annual Conference on DRUG& MEDICAL DEVICE LITIGATION

MAIN CONFERENCE: December 10–11, 2019 PRE-CONFERENCE WORKSHOPS: December 9, 2019 EARN CLE/Ethics New York Marriott Marquis | New York, NY CREDITS

Benefit from the Insights of Our Distinguished Co-Chairs: Larissa A. Eustice Matthew L. Stennes Senior Legal Counsel Vice President, Chief Litigation Bayer & Investigations Counsel Medtronic

Learn from Renowned Jurists:

Honorable Karen K. Caldwell Honorable Loretta A. Preska Honorable Claire C. Cecchi Chief Judge Senior Judge Judge U.S. District Court, E.D. Kentucky U.S. District Court, S.D.N.Y. U.S. District Court, D.N.J. Panel Judge Judicial Panel on Multidistrict Honorable Patti B. Saris Litigation (JPML) Chief Judge U.S. District Court, D. Mass.

Network and Benchmark with Representatives from 20+ Leading Drug and Medical Device Companies Including:

Bayer Carestream Health Medtronic Purdue Pharma Becton, Dickinson and Company Daiichi Sankyo Mylan Teleflex Biogen Eli Lilly & Co. Nuvasive Teva Pharmaceuticals Boehringer-Ingelheim Endo Pharmaceuticals Olympus Corporation UCB, Inc. of the Americas Bristol-Myers Squibb GSK Zimmer Biomet Pfizer Cardinal Health LivaNova

a C5 Group Company Register Now | DRUGANDMED.COM | 888 224 2480 Business Information in a Global Context  Be part of a community of peers fighting the same What’s NEW litigation challenges with a goal of keeping safe and for 2019? effective therapies on the market for the patients who rely on them.  share-square Dear Colleague: TWO NEW BREAKOUT TRACKS: In-depth coverage on the We are so pleased to be co-chairing American Conference Institute’s business and practice of drug th and medical device products 24 Annual Conference on Drug & Medical Device Litigation. This liability litigation conference is the only event which brings together an exceptional in-house faculty, the top defense firms representing biopharmaceutical and medical device companies, experienced jurists from around the country, the FDA, and the DOJ. File-Alt MDL CASE STUDY: Analysis of With hundreds of attendees expected from across the United States, the unique nuances of today’s we hope that you will join us this December to meet and reconnect with 3 most significant MDLs peers, acquire firsthand insights from industry experts, and acquire invaluable strategies to surmount the latest litigation challenges being faced by the drug and medical device products liability defense bar. Search Designed for both networking and masters-level strategy sharing, our SPECIAL FOCUS SESSIONS: th Advanced discussions 24 iteration includes in-house representatives from Bayer, Carestream on preemption, new FDA Health, Daiichi Sankyo, Endo Pharmaceuticals, Fitbit, Johnson & developments, emerging Johnson, Medtronic, Mylan, Nuvasive, Pfizer, Teleflex and many more technologies and AI — who will share the methods that have worked for them in recent battles, and provide specific advice for both defeating claims and for litigating efficiently and cost-effectively. Additionally, to give a 360 degree view of UNIVERSITY the challenges facing the industry, attendees will have the opportunity to hear from a leading panel of judges, as well as the FDA on the agency’s JPML JUDICIAL INSIGHTS: The Hon. Karen K. Caldwell latest initiatives and the DOJ on criminal enforcement stemming from will discuss MDL practice and civil products liability. management

Faced with ever-evolving tactics from the plaintiffs’ bar and amplified scrutiny by the public and the government, there is simply no room for error in this no-holds-barred fight. Comments SPOTLIGHT INTERVIEW: Be part of a community of peers fighting the same litigation challenges Hear from a a seasoned with a goal of keeping safe and effective therapies on the market for FDA expert witness the patients who rely on them. We look forward to seeing you and your contemporaries for another exclamation successful conference! CRISIS MANAGEMENT Sincerely, RESPONSE LIVE: Join PR experts, in-house counsel and law firm counsel as they discuss steps for managing a PR crisis and diffusing negative Larissa A. Eustice Matthew L. Stennes media exposure before and Senior Legal Counsel Vice President, Chief Litigation during a trial Bayer & Investigations Counsel Medtronic

2 Join the Conversation @DrugandMed #DrugandMed | ACI: Drug and Medical Device Litigation AGENDA-AT-A-GLANCE

Pre-Conference Workshops Monday, December 9, 2019 8:00 | Morning Workshop Registration and Continental Breakfast 8:30 Workshop A: Defense Counsel Only War Room 2:00 Workshop C: Drug and Medical Device In House Counsel Master Class on “The Three C’s” – Cost, Competency and Communication 8:30 Workshop B: FDA 101: A Comprehensive Guide to FDA Approvals, Recalls, Labeling and More 2:00 Workshop D: “Next Gen” Workshop: Training New Lawyers to Become Key Assets to the Future Products Liability Bar 5:30 | Pre-Registration and Welcoming Cocktail Reception

Main Conference Day 1 Tuesday, December 10, 2019 7:00 | Registration and Welcome Breakfast 8:00 Opening Remarks 8:15 Drug and Medical Device Year in Review: How the Most Influential Product Liability Decisions of the Last Year are Impacting Your Clients and Cases 9:30 FDA THINK TANK: Analyzing New FDA Guidance on Recalls, 510K Reform, Artificial Intelligence, and Real World Evidence 10:15 | Morning Coffee Break Hosted by

10:30 In the Aftermath of Albrecht: Implications of the Supreme Court’s Ruling on Preemption for Pharmaceutical Products Liability Litigation 11:15 Determining When and How to Pursue Preemption Defenses for 510(k) and PMA Devices 12:00 | Networking Luncheon 1:00 MDL CASE STUDY: Analyzing the Unique Nuances of Today’s Three Most Significant MDLs 2:00 Developing Techniques for Managing MDL Complexities: Obtaining Tools for Identifying, Controlling and Reducing Meritless Claims 3:15 | Refreshment Break

3:30 Breakout Sessions A TRACK 1 Combatting Extreme Jury Verdicts: Navigating Extraneous TRACK 2 Mitigating Challenges Created by Third-Party Litigation Funding in Factors That Are Influencing Juror Findings the Mass Tort Arena

4:15 Breakout Sessions B TRACK 1 Mock Litigation Exercise: An “In The Trenches” Approach to TRACK 2 Crisis Management Response Live: Managing Public Relations Battling Reptile Theory and Overcoming Negative Media Exposure Before and During a Trial

5:00 Breakout Sessions C TRACK 1 Incorporating Innovative Thinking and Outside-the-Box Problem TRACK 2 Evaluating and Controlling E-Discovery Costs and Minimizing the Solving Into Your Trial Strategy Impact of New Data Privacy Laws on Discovery Spend 5:45 | Conference Adjourns to Cocktail Party Hosted by

Main Conference Day 2 Wednesday, December 11, 2019 7:15 | Continental Breakfast 8:00 Opening Remarks and Recap of Day One 8:15 THE FEDERAL COURTS DIVIDED: Overcoming Challenges to Jurisdiction in the Continuing Aftermath of BMS 9:00 A VIEW FROM THE BENCH: Judicial Insights into Drug and Medical Device Products Liability Litigation 10:15 | Morning Coffee Break 10:30 Incorporating Diversity and Inclusion into Your Trial Team: An Honest Discussion of What’s Working, What’s Not and How We Can Do Better 11:30 Critical Insights from a FDA Expert Witness: Frank Lessons from a Decade of Pharmaceutical Litigation 12:00 | Networking Lunch 1:00 New Technologies and AI: Predicting Risks and Liabilities Associated with 3D Printing, Digital Diagnostic Healthcare Apps and Surgical Robotics 2:15 An Interview With the Enforcers: Government Enforcement Priorities and Their Link to the Realm of Drug and Device Product Liability Litigation 3:30 | Refreshment Break 3:45 (Audience Polling) INTERACTIVE ETHICS DRILLS: Overcoming Ethical Dilemmas in Drug and Medical Device Litigation 4:45 | Conference Ends

a C5 Group Company Register Now | DRUGANDMED.COM | 888 224 2480 Business Information in a Global Context 3 ADVISORY BOARD AND DISTINGUISHED FACULTY Check the program at DrugandMed.com often as faculty information will be continuously updated.

ACI Drug and Med Advisory Board: Patricia A. Barbieri Debra L. Burns Malini Moorthy SVP, General Counsel and Secretary Senior Counsel Litigation/Investigations Vice President and Chief Deputy Daiichi Sankyo, Inc. (Parsippany, NY) GE Healthcare (Wauwatosa, WI) General Counsel Medtronic (Minneapolis, MN) Mary-Alice Barrett Jill Harrison Associate Director, Assistant General Counsel General Counsel Medical Products Division Richard W. Silbert Genentech (Little Falls, NJ) W. L. Gore & Associates, Inc. (Flagstaff, AZ) V.P., Chief Legal Strategist Purdue Pharma L.P. (Stamford, CT) Donald P. Bunnin Associate Vice President, Senior Counsel – Litigation & Medical Aesthetics Allergan, Inc. (Irvine, CA)

Distinguished Faculty: Jenni Peacock Rachel Gallagher Senior Assistant Attorney General Director, Legal Counsel CO-CHAIRS Consumer Protection Division Teva Pharmaceuticals USA (Horsham, PA) Office of the Tennessee Attorney General Ashley Garry Larissa A. Eustice (Nashville, TN) Senior Legal Counsel Litigation & Legal Compliance Counsel Bayer (Whippany, NJ) Gregg Shapiro Eli Lilly & Co. (Indianapolis, IN) Chief, Affirmative Civil Enforcement Kailee Goold Matthew L. Stennes U.S. Attorney’s Office, D. Mass. (Boston, MA) Senior Counsel Vice President, Cardinal Health (Columbus, OH) Chief Litigation & Investigations Counsel Paul Singer Medtronic (Minneapolis, MN) Chief, Consumer Protection Division Daniel Healey Office of the Texas Attorney General Senior Corporate Counsel MEMBERS OF THE JUDICIARY (Austin, TX) Pfizer Inc. (New York, NY) Gregory Jackson Honorable Karen K. Caldwell IN-HOUSE COUNSEL Chief Judge Vice President, Litigation U.S. District Court, E.D. Kentucky Adam C. Bassing Nuvasive (San Diego, CA) Panel Judge Associate General Counsel, Legal Affairs Jobina Jones-McDonnell Judicial Panel on Multidistrict Litigation UCB, Inc. (Smyrna, GA) Senior Counsel, Litigation and Risk (JPML) (Lexington, KY) Endo Pharmaceuticals (Malvern, PA) Daniel Curto Honorable Claire C. Cecchi Sr. Director, Litigation Counsel Paul Joseph Judge Biogen (Boston, MA) Of Counsel, Government Solutions Practice U.S. District Court, D.N.J. (Newark, NJ) Group Howard Cyr Foley & Lardner LLP (Washington, D.C.) Honorable Loretta A. Preska Assistant General Counsel – Recent Associate Chief Counsel for Senior Judge Global Litigation Counsel Enforcement, U.S. Food and Drug U.S. District Court, S.D.N.Y. (New York, NY) Teleflex (Wayne, PA) Administration (FDA) Honorable Patti B. Saris Greg A. Dadika Amy Todd Klug Chief Judge Deputy Chief Litigation Counsel Associate General Counsel, U.S. District Court, D. Mass. (Boston, MA) Becton, Dickinson and Company Litigation & Corporate Operations Legal Affairs (Franklin Lakes, NJ) GOVERNMENT REPRESENTATIVES Daiichi Sankyo, Inc. (Basking Ridge, NJ) D'Lesli M. Davis David M. Eskew Donald LeGower Partner Senior Counsel, Litigation Chief, Health Care & Government Fraud Unit Norton Rose Fulbright US LLP (Dallas, TX) U.S. Attorney’s Office, D. N.J (Newark, NJ) Bristol-Myers Squibb (Lawrenceville, NJ) Terrence (Terry) J. Dee Ross S. Goldstein Julie M. Lewis Partner General Counsel & Corporate Secretary Senior Litigation Counsel McDermott Will & Emery LLP(Chicago, IL) Carestream Health (Rochester, NY) Consumer Protection Branch U.S. Department of Justice Sandra Di lorio Stacey Dixon Mahone (Washington, D.C.) Litigation Counsel VP Assistant General Counsel, Litigation & Endo Pharmaceuticals (Malvern, PA) Compliance David Hart Green Thumb Industries (GTI) (Chicago, IL) Assistant Attorney-in-Charge of the Health Lisa M. Dunkin Fraud Unit/Consumer Protection Section Senior Litigation Counsel Bradley Matta Oregon Department of Justice (Salem, OR) Associate Litigation Counsel Zimmer Biomet (Fort Wayne, IN) Mylan (Canonsburg, PA) Deborah Martin Owens Larissa A. Eustice Amanda Perez Executive Director of Diversity & Inclusion Senior Legal Counsel New York City Bar Association (New York, NY) Assistant General Counsel Bayer (Whippany, NJ) Pfizer (New York, NY)

4 Join the Conversation @DrugandMed #DrugandMed | ACI: Drug and Medical Device Litigation 400+ 10+ 25+ 3 Attendees Esteemed Judges & Companies on the Days of Networking Government Enforcers Faculty & Advisory Board

DISTINGUISHED FACULTY Michelle M. Bufano Stephen E. Marshall Partner Partner Franklin T. Pyle III Patterson Belknap Webb and Tyler LLP Venable LLP (Baltimore, MD) Assistant General Counsel (New York, NY) Olympus Corporation of the Americas Douglas J. Moore (Center Valley, PA) Adrienne Byard Member Partner Irwin Fritchie Urquhart & Moore LLC Richard W. Silbert Shook, Hardy & Bacon LLP (Kansas City, MO) (New Orleans, LA) Vice President, Chief Legal Strategist Purdue Pharma L.P. (Stamford, CT) Andrew L. Campbell Kenneth A. Murphy Partner Partner Keyna Skeffington Faegre Baker Daniels LLP (Indianapolis, IN) Drinker Biddle & Reath LLP (Philadelphia, PA) Senior Vice President and General Counsel LivaNova PLC (United Kingdom) Randall L. Christian David F. Norden Managing Partner Troutman Sanders LLP (Atlanta, GA) Michael R. Smith Bowman and Brooke LLP (Austin, TX) Associate General Counsel Gregory Ostfeld Olympus Corporation of the Americas Hayden Coleman Shareholder (Center Valley, PA) Partner Greenberg Traurig LLP (Chicago, IL) Dechert LLP (New York, NY) Matthew L. Stennes Harley V. Ratliff Vice President, Paul J. (PJ) Cosgrove Partner Chief Litigation & Investigations Counsel Partner Shook, Hardy & Bacon LLP (Kansas City, MO) Ulmer & Berne LLP (Cincinnati, OH) Medtronic (Minneapolis, MN) Shevon D.B. Rockett Sheea Sybblis Lori Cohen Partner Senior Counsel Co-Chair, Global Litigation Dorsey & Whitney LLP (New York, NY) Boehringer-Ingelheim (New York, NY) Chair, Pharmaceutical, Medical Device & Health Care Litigation Group Sara B. Roitman Brennan Torregrossa Chair, Trial Practice Group Counsel Senior Vice President, Head of Global Greenberg Traurig LLP (Atlanta, GA) Dechert LLP (Chicago, IL) Litigation Mildred Segura GSK (Philadelphia, PA) Geoffrey M. Drake Partner Partner Colleen Casey Voshell King & Spalding LLP (Atlanta, GA) Reed Smith LLP (Los Angeles, CA) Senior Managing Director – Cara Edwards Jeffrey M. Senger Technology/Discovery Partner FTI Consulting (Philadelphia, PA) Partner DLA Piper Sidley Austin LLP (Washington, DC) LAW FIRM COUNSEL Wendy West Feinstein Bart Sullivan Partner Partner Mark E. Anderson Morgan, Lewis & Bockius LLP (Pittsburgh, PA) Fox Smith LLC (St. Louis, MO) Partner McGuireWoods LLP (Raleigh, NC) Sarah Johnston Andrew Tauber Partner Partner Andrew T. (Andy) Bayman Barnes & Thornburg LLP (Los Angeles, CA) Mayer Brown LLP (Chicago, IL) Partner King & Spalding LLP (Atlanta, GA) Andrew D. Kaplan Sara Tucker Partner Partner James Stephen Bennett Crowell & Moring LLP (Washington, DC) Womble Bond Dickinson (US) LLP Partner (Atlanta, GA) Faegre Baker Daniels LLP (Fort Wayne, IN) John P. Lavelle, Jr. Partner Steven Weisburd Barbara R. Binis Morgan Lewis & Bockius LLP Shareholder Partner (Philadelphia, PA) Carlton Fields (Los Angeles, CA) Reed Smith LLP (Philadelphia, PA) Deborah Livornese Robert K. (Bobby) Woo Sheila S. Boston Counsel Partner Partner Hyman, Phelps & McNamara, P.C. King & Spalding LLP (Atlanta, GA) Arnold & Porter (New York, NY) (Washington, D.C.)

a C5 Group Company Register Now | DRUGANDMED.COM | 888 224 2480 Business Information in a Global Context 5 Pre-Conference Workshops Monday, December 9, 2019 8:30 – 12:00

Workshop A Defense Counsel Only War Room

Richard W. Silbert Geoffrey M. Drake Adam C. Bassing Vice President, Chief Legal Strategist Partner Associate General Counsel, Purdue Pharma L.P. (Stamford, CT) King & Spalding LLP (Atlanta, GA) Legal Affairs UCB, Inc. (Smyrna, GA)

Open to defense counsel only — Join your peers for a state-of-the-industry analysis and candid discussion about the latest and greatest in plaintiffs’ bar tactics, as well as lessons learned from 2019’s biggest defense victories. In-house and law firm defense counsel are encouraged to participate in this unique, interactive networking session that will set the stage for the topics discussed in depth throughout the event and provide you with valuable takeaways about what your peers from around the country are seeing from the plaintiffs’ bar.

• Analyzing select mass torts, bellwether trials and key state court • Key players: identifying which plaintiff firms are currently driving litigation, proceedings (including state MDLs) from around the country: as well as the frequently testifying experts to look out for what tactics are plaintiffs’ attorneys using? • Deconstructing recent noteworthy jury verdicts: what language and • Assessing drugs or devices which may be ripe for products liability themes are resonating with today’s jurors? litigation in 2020 in light of adverse event reports, social media postings • Devising effective tactics for winning cases in unfriendly jurisdictions and attorney advertising • Identifying and effecting key settlement strategies • Developing strategies for successful motions to dismiss and other dispositive motions OR

Workshop B FDA 101: A Comprehensive Guide to FDA Approvals, Recalls, Labeling and More

Deborah Livornese Stephanie Philbin Counsel Partner Hyman, Phelps & McNamara, P.C. (Washington, D.C.) Goodwin Procter LLP(Washington, D.C.)

Products liability litigation concerning pharmaceutical products and medical devices often hinges on what happened during the FDA pre-approval, approval, or post-approval periods. This comprehensive pre-conference workshop will provide training on critical components of the FDA approval and post-approval periods. From new drug applications to 510Ks to labeling requirements to good manufacturing practices and post approval concerns related to recalls and withdrawals, this workshop will provide you with the critical FDA regulatory foundation essential to the advancement of your products liability practice.

Points of discussion will include:

• Examining the components of the FDA drug review and approval process • Comprehending the influence of cGMPs (Current Good Manufacturing that have the greatest impact on products liability cases Practices) in products liability litigation • Understanding the pivotal role of the label in matters of preemption and • Analyzing how adverse events reports and recalls play into the scope of a defense strategies products liability action • Exploring the importance of clinical trials and findings

Medical Devices • Determining premarket approvals • Exploring the 510(k)-clearance process

12:30 – 2:00 Workshop Luncheon: Available to Participants Attending Both Morning and Afternoon Workshop Sessions

6 Join the Conversation @DrugandMed #DrugandMed | ACI: Drug and Medical Device Litigation Pre-Conference Workshops Monday, December 9, 2019 2:00 – 5:30

Workshop C Cost, Competency and Communication Working Group: Drug and Medical Device In-House Counsel Speak on "The Three C's" Howard Cyr Bradley A. Matta Assistant General Counsel – Associate Litigation Counsel Global Litigation Counsel Mylan (Canonsburg, PA) Teleflex (Wayne, PA) Gregory Jackson Keyna Skeffington Vice President, Litigation Senior Vice President and General Counsel Nuvasive (San Diego, CA) LivaNova PLC (United Kingdom) Sandra Di lorio Rachel Gallagher Litigation Counsel Director, Legal Counsel Endo Pharmaceuticals Teva Pharmaceuticals USA (Horsham, PA) (Malvern, PA) Kailee Goold Senior Counsel Cardinal Health (Columbus, OH) Esteemed members of ACI’s Drug and Medical Device Litigation In-House Counsel Faculty will lead this new and comprehensive workshop. This unique, interactive discussion will provide exclusive, and intimate networking and benchmarking opportunities that will shed light on the expectations of in-house counsel from their law firm partners. It is also a vehicle for other in-house counsel to benchmark their current “3C’s” strategies with the workshop presenters.

Cost • Evaluating the appropriateness of work product • Reconciling firm capabilities versus individual attorney reputation and ability • Monitoring legal spend and balancing the budget • Establishing best practices for cost reduction to enhance Communication predictability for cash flow purposes • • Identifying processes to assist with budgeting, fee arrangements Communicating value and collaboration between corporate legal and billing and outside counsel • • Examining the value of licensing deals and structures Establishing the desired level of commitment, availability and responsiveness early-on in the relationship Competency • Succinctly focusing on shared, pragmatic business goals • Determining preferences for formality of correspondence and • Finding the right talent with time-proven strategies practical versus academic guidance • Considerations in selecting outside counsel

COMMENT-ALT

“I enjoy attending ACI’s Drug and Med because of the quality presentations, and the interaction with the lawyers and clients that I’ve had the opportunity to work with for so many years.” – Goodell DeVries Leech & Dann LLP

a C5 Group Company Register Now | DRUGANDMED.COM | 888 224 2480 Business Information in a Global Context 7 Main Conference Day 1 Tuesday, December 10, 2019

7:00 | Breakfast and Registration Focus on the FDA

8:00 9:30 Co-Chairs’ Opening Remarks FDA THINK TANK: Analyzing New FDA Guidance on Recalls, 510K Reform, Artificial Intelligence, and Real World Evidence Larissa A. Eustice Senior Legal Counsel Paul Joseph Bayer (Whippany, NJ) Of Counsel, Government Solutions Practice Group Foley & Lardner LLP (Washington, D.C.) Matthew L. Stennes Recent Associate Chief Counsel for Enforcement, U.S. Food Vice President, Chief Litigation & Investigations Counsel and Drug Administration (FDA) Medtronic (Minneapolis, MN) Jeffrey M. Senger Partner 8:15 Sidley Austin LLP (Washington, DC) Drug and Medical Device Year in Review: How the Most Join this think-tank of industry insiders as they discuss the latest guidances, Influential Product Liability Decisions of the Last Year are initiatives and developments at FDA influencing the products liability sphere, including new pronouncements on voluntary recalls, 510K device approvals, Impacting Your Clients and Cases Artificial Intelligence and the use of real-world data (RWD) to generate real-world evidence (RWE). This session will conclude with an interactive Larissa A. Eustice Q&A addressing how this activity will affect our approach to drug and Senior Legal Counsel device litigation. Bayer (Whippany, NJ) Matthew L. Stennes 10:15 | Morning Coffee Break Vice President, Chief Litigation & Investigations Counsel Medtronic (Minneapolis, MN) State of the Union on Preemption Amy Todd Klug 10:30 Associate General Counsel, Litigation & Corporate Operations In the Aftermath of Albrecht: Implications of the Supreme Legal Affairs Court’s Ruling on Preemption for Pharmaceutical Products Daiichi Sankyo (Basking Ridge, NJ) Liability Litigation Brennan Torregrossa Ashley Garry Stephen E. Marshall Senior Vice President, Head of Global Litigation Litigation & Legal Partner GSK (Philadelphia, PA) Compliance Counsel Venable LLP Moderator: Eli Lilly & Co. (Baltimore, MD) (Indianapolis, IN) Andrew L. Campbell Lori Cohen Michelle M. Bufano Partner Co-Chair, Global Litigation Partner Faegre Baker Chair, Pharmaceutical, Medical Device Patterson Belknap Daniels LLP & Health Care Litigation Group Webb and Tyler LLP (Indianapolis, IN) Chair, Trial Practice Group (New York, NY) Greenberg Traurig LLP (Atlanta, GA) • Implications of the Supreme Court’s ruling on life sciences products Our esteemed in-house counsel panelists will engage in an interactive liability litigation discussion of the most important case law developments of the past • Aspects of Albrecht that will likely be the subject of future litigation year and explore their real-life impact on drug and medical device litigation • Potential application of Albrecht to future factual disputes encountered practice as well as their implications and influence on future decisions, not only in the context of implied preemption, but of express preemption trends and strategies in this arena. • Possible jurisprudential implications of the Supreme Court’s ruling Points of discussion will include: 11:15 • A survey of the year’s most significant and influential court decisions involving drug and medical device claims Determining When and How to Pursue Preemption Defenses • Pending decisions that may have the most foreseeable future impact for 510(k) and PMA Devices • How practitioners can update their practice and litigation strategies in Howard Cyr John P. Lavelle, Jr. response to the latest developments Assistant General Partner Counsel – Global Morgan Lewis & Bockius Litigation Counsel LLP (Philadelphia, PA) Teleflex (Wayne, PA) Paul J. (PJ) Cosgrove Gregory Ostfeld Partner Shareholder Ulmer & Berne LLP Greenberg Traurig LLP (Cincinnati, OH) (Chicago, IL) Despite the Supreme Court’s steady dismantling of Medtronic v. Lohr, medical device companies still face difficulty in establishing preemption for 510(k) devices. This panel will examine the latest 510 (k) preemption efforts and strategies for navigating preemption motions for PMA devices.

8 Join the Conversation @DrugandMed #DrugandMed | ACI: Drug and Medical Device Litigation • Exploring the latest efforts around achieving preemption for 510(k) devices 2:00 • How the defense bar can leverage the recent Utah state court’s ruling in Developing Techniques for Managing MDL Complexities: Kelsey v. Alcon in future litigation Obtaining Tools for Identifying, Controlling and Reducing • Demonstrating device-specific preemption requirements • Positioning your case so as to effectively and successfully preserve Meritless Claims the preemption issue for appeal in 510(k) cases Hayden Coleman Sarah Johnston • Developing proven strategies for pursuing preemption defenses for Partner Partner PMA devices Dechert LLP Barnes & Thornburg LLP (New York, NY) (Los Angeles, CA) 12:00 | Net working Lunch Hosted by: Lisa M. Dunkin Harley V. Ratliff Senior Litigation Counsel Partner Zimmer Biomet Shook, Hardy & Bacon (Fort Wayne, IN) LLP (Kansas City, MO) Focus on the MDL Paradigm Moderator: 1:00 James Stephen Bennett MDL CASE STUDY: Analyzing the Unique Nuances of Partner Today’s Three Most Significant MDLs Faegre Baker Daniels LLP (Fort Wayne, IN) Julie M. Lewis Douglas J. Moore • Examining various techniques for managing MDL complexities General Counsel & Member • Using social media and online investigation tools to identify and control Corporate Secretary Irwin Fritchie Urquhart meritless claims early on Carestream Health & Moore LLC • Effectively utilizing screening orders, lone pine orders and lexecon waivers (Rochester, NY) (New Orleans, LA) • Developing tactics for approaching negotiations with plaintiffs’ counsel Sara B. Roitman Steven Weisburd throughout the MDL process Counsel Shareholder • Devising strategies for managing remand of remaining cases after Dechert LLP Carlton Fields MDL settlement (Chicago, IL) (Los Angeles, CA) This panel will examine three MDLs that the pharmaceutical and medical 3:15 | Refreshment Break device industries are very closely watching — In Re: National Prescription Opiate Litigation (MDL No. 2804 (opioids), Johnson & Johnson Talcum Hosted by: Powder MDL 2738 (talc); and 3M Company Combat Arms Earplug MDL 2885 (3M combat ear plugs). The panelists will compare and contrast the unique elements of these MDLs, and provide insights on: • Each of their distinctive litigation challenges • Successful plaintiff tactics and defense strategies • Notable judicial rulings and key takeaways

3:30 Breakout Sessions A

The Practice of Drug and Medical Device Litigation: The Business of Drug and Medical Device Litigation: Strategies for Combatting the Complexities of Understanding the True Costs of the Today’s Products Liability Landscape New Products Liability Environment Track 1 Track 2 Combatting Extreme Jury Verdicts: Navigating Extraneous Mitigating Challenges Created by Third-Party Litigation Factors That are Influencing Juror Findings Funding (TPLF) in the Mass Tort Arena Andrew D. Kaplan Daniel Healey Partner Senior Corporate Counsel Crowell & Moring LLP (Washington, DC) Pfizer Inc. (New York, NY) Sheila S. Boston Barbara R. Binis David Norden Partner Partner Troutman Sanders LLP Arnold & Porter (New York, NY) Reed Smith LLP (Atlanta, GA) (Philadelphia, PA) In the current political environment, the public’s distrust in big corporations, shorter attention spans and increased willingness to accept “alternative This panel will examine the actions that drug and device companies can facts” are all leading to more instances of the extreme and seemingly take to mitigate the challenges created by TPLF in the mass tort arena. vengeful jury verdicts. This panel will provide trial presentation strategies Discussion points will include: aimed at combatting this escalating and worrisome trend. • Challenges created by TPLF • Framing your narrative to reach today’s jurors • Proactive measures that companies can take to push back on • Overcoming juror biases and predispositions the effects of TPLF • Decreasing risks of extreme verdicts • Recent state law strides towards requiring disclosure of TPLF agreements in civil lawsuits

a C5 Group Company Register Now | DRUGANDMED.COM | 888 224 2480 Business Information in a Global Context 9 4:15 Breakout Sessions B Track 1 Track 2 Mock Litigation Exercise: An “In The Trenches” Approach Crisis Management Response Live: Managing Public to Battling Reptile Theory Relations and Overcoming Negative Media Exposure Before and During a Trial Jobina Jones-McDonnell Senior Counsel, Litigation and Risk Richard S. Levick Kristie Kuhl Endo Pharmaceuticals (Malvern, PA) Chairman & CEO Managing Partner, Health LEVICK Finn Partners Robert K. (Bobby) Woo (Washington, D.C.) (Fairfield, CT) Partner King & Spalding LLP (Atlanta, GA) Richard W. Silbert Vice President, Chief Legal Strategist Kenneth A. Murphy Purdue Pharma L.P. (Stamford, CT) Partner Drinker Biddle & Reath LLP (Philadelphia, PA) In this session, two PR experts, an in-house counsel and a law firm attorney will discuss steps for managing a PR crisis and diffusing negative media The Reptile “fear-based” approach is especially dangerous in drug and exposure. Topics of discussion will include: device product liability cases, given today’s negative public perception of life sciences companies. To help you develop effective strategies for • Establishing a communications infrastructure combatting reptile strategy from the earliest phases of litigation, our • Building the crisis management team panelists will engage in a mock corporate deposition and demonstrate • Monitoring the online social channels first-hand tactics for: • Involving members of the press • Diffusing plaintiff counsel attempts to utilize reptile approach before it • Tailoring responses to the specific medium gains traction • Communicating with those who treat the patients • Responding to plaintiff counsel questions aimed at rattling even the most • Collaborating with the regulatory body charged with complying with seasoned corporate witnesses standards set by the FDA • Asking questions on redirect which combat reptile approach • Tracking, monitoring and reassessing threats • Creating your own evidence to be used in negotiations for deposition designations 5:00 Breakout Sessions C Track 1 Track 2 Incorporating Innovative Thinking and Outside-the-Box Evaluating and Controlling E-Discovery Costs and Minimizing Problem Solving Into Your Trial Strategy the Impact of New Data Privacy Laws on Discovery Spend Franklin T. Pyle III Daniel Curto Moderator: Assistant General Counsel Sr. Director, Olympus Corporation of the Americas (Center Valley, PA) Litigation Counsel Colleen Casey Voshell Biogen (Boston, MA) Senior Managing Director Kailee Goold – Technology/Discovery Senior Counsel Bart Sullivan FTI Consulting Cardinal Health (Columbus, OH) Partner (Philadelphia, PA) Fox Smith D'Lesli M. Davis (St. Louis, MO) Partner Norton Rose Fulbright US LLP (Dallas, TX) On an annual basis, the approximate budget for discovery in the United States is $40 billion — and the majority of that discovery is comprised of electronically Stacey Dixon Mahone stored information (ESI). This is a tremendous corporate expenditure layered VP Assistant General Counsel, Litigation & Compliance with complications from the latest data privacy laws, which are posing a new Green Thumb Industries (GTI) (Chicago, IL) challenges. This panel will provide valuable insights on: • Understanding the necessity for critical thinking and creativity • Accurately measuring and evaluating e-discovery spend in developing your trial strategy • Identifying costs hidden within individual cases or dispersed among • Incorporating creative ways to approach a case which will help different departments to avoid a long litigation path • Strategies for managing e-discovery costs in-house vs. sending • Presenting new arguments to the court, or presenting old everything out to a third-party vendor or law firm arguments in a new and innovative way • Identifying key areas where you can capture and reduce your spend • Engaging in outside-the-box problem solving when faced with • Assessing how recent data privacy laws such as GDPR and California’s litigation hurdles data privacy regs are impacting e-discovery discovery spend

5:45 | Conference Adjourns to Day Two Cocktail Party Hosted by:

10 Join the Conversation @DrugandMed #DrugandMed | ACI: Drug and Medical Device Litigation Main Conference Day 2 Wednesday, December 11, 2019

7:15 | Continental Breakfast Moderator: Hosted by: Andrew T. (Andy) Bayman Partner 8:00 King & Spalding LLP Opening Remarks and Recap of Day One Hear from a panel of esteemed judges on what arguments the courts find most effective and persuasive when presiding over a drug or medical device 8:15 products liability case. Gain valuable judicial insights on what works and doesn’t work in jury instructions, voir dire and opening/closing statements, THE FEDERAL COURTS DIVIDED: Overcoming Challenges as well as examples of poor witness selection, inability to connect with a to Jurisdiction in the Continuing Aftermath of BMS jury, and good vs. bad lawyering.

Donald LeGower 10:15 | Morning Coffee Break Senior Counsel, Litigation Bristol-Myers Squibb (Lawrenceville, NJ) 10:30 Adrienne Byard DIVERSITY & INCLUSION Partner Incorporating Diversity and Inclusion into Your Trial Team: Shook, Hardy & Bacon LLP (Kansas City, MO) An Honest Discussion of What’s Working, What’s Not and Andrew Tauber How We Can Do Better Partner Greg A. Dadika Mayer Brown LLP (Chicago, IL) Deputy Chief Litigation Counsel Becton, Dickinson and Company (Franklin Lakes, NJ) Cara Edwards Partner Shevon D.B. Rockett DLA Piper (New York, NY) Partner Dorsey & Whitney LLP (New York, NY) In the two years since the Supreme Court’s ruling on jurisdiction in BMS, the District Courts remain divided over its application. This panel will examine Deborah Martin Owens the latest rulings on jurisdiction, and address such hot button questions as: Executive Director of Diversity & Inclusion New York City Bar Association (New York, NY) • When does mere registration to do business expose an out-of-state corporation to general personal jurisdiction? Amanda Perez • Whether product-specific, as opposed to plaintiff-specific, in-state Assistant General Counsel contacts can support specific jurisdiction over claims brought by Pfizer (New York, NY) out-of-state plaintiffs • Does personal jurisdiction allow for nationwide class actions, Many in-house legal departments have espoused a commitment to representing out-of-state absent class members, against diversity and have made it clear that diversity matters when vetting and out-of-state corporate defendants? choosing law firms to represent them. However, implementing a truly diverse trial team can prove challenging. Join this panel for an honest • Whether “stream of commerce” specific personal jurisdiction, based discussion of specific ways that law firms and companies can effectuate entirely on third-party transfers of allegedly injurious products, exists diversity and inclusion together. where a defendant has not engaged in any in-state activity concerning those products • Implementing policies and practices that will truly effect change and promote a diverse workplace 9:00 • Understanding what specific evidence of diversity companies are seeking from outside counsel A VIEW FROM THE BENCH: Judicial Insights into Drug and • Best practices for evaluating a firm’s efforts in promoting diversity Medical Device Products Liability Litigation 11:30 Honorable Karen K. Caldwell Chief Judge Critical Insights from a FDA Expert Witness: Frank Lessons U.S. District Court, Eastern District of Kentucky from a Decade of Pharmaceutical Litigation Panel Judge Judicial Panel on Multidistrict Litigation (JPML) Susan Allen MD, MPH (Lexington, KY) Regulatory and Compliance Consultant Honorable Patti B. Saris Randall L. Christian Managing Partner Chief Judge Bowman and Brooke LLP (Austin, TX) U.S. District Court, District of Massachusetts (Boston, MA) Tune in for an interview with Dr. Susan Allen, a seasoned FDA expert Honorable Loretta A. Preska witness with years of experience working on and testifying in drug litigation Senior Judge cases. Dr. Allen will share candid insights with a well-known pharmaceutical U.S. District Court, S.D.N.Y. (New York, NY) trial lawyer on how to identify the right FDA expert for a case, things to do and to avoid when interacting with an expert witness, what a seasoned Honorable Claire C. Cecchi expert witness will be looking for in you and your team when deciding to Judge take on a case, and how best to work with and prepare an expert witness U.S. District Court, District of New Jersey (Newark, NJ) for each stage of litigation.

12:00 | Networking Lunch

a C5 Group Company Register Now | DRUGANDMED.COM | 888 224 2480 Business Information in a Global Context 11 1:00 • Preparing for criminal and civil enforcement actions stemming from New Technologies and AI: Predicting Risks and Liabilities drug and device products liability • How they identify companies for investigations, and when and why they Associated with 3D Printing, Digital Diagnostic Healthcare choose to prosecute Apps and Surgical Robotics • Best practices for responding to a government investigation • Sheea Sybblis Sara Tucker Practical considerations for in-house and law firm counsel when faced with DOJ or AG actions Senior Counsel Partner Boehringer-Ingelheim Womble Bond Dickinson (New York, NY) (US) LLP (Atlanta, GA) 3:30 | Afternoon Refreshment Break

Mildred Segura Terrence (Terry) J. Dee 3:45 | Audience Polling Partner Partner ETHICS Reed Smith LLP McDermott Will & Emery INTERACTIVE ETHICS DRILLS: Overcoming Ethical (Los Angeles, CA) LLP (Chicago, IL) Dilemmas in Drug and Medical Device Litigation Every industry is being affected by advances in technology including artificial intelligence, robotics and the Internet of Things — and the medical Michael R. Smith and healthcare sectors are no exception. The progression of digital health Associate General Counsel innovation, the growing market of IoT and BodyTech/wearable devices are Olympus Corporation of the Americas (Center Valley, PA) likely to have a significant impact on the product liability regime. This panel will engage in a discussion of these technological advancements, including: Adam C. Bassing Mark E. Anderson Associate General Counsel, Partner • Prospective litigation and tort liability threats associated with the Legal Affairs McGuireWoods LLP marketing and distribution of medical and health apps that may not perform as intended or advertised UCB, Inc. (Smyrna, GA) (Raleigh, NC) • Emerging trends in surgical robotics product liability litigation Test your ethical skills with a series of anonymous polling questions on • Lessons learned from recent recalls of 3D printing devices sensitive, complex hypothetical scenarios. Discover how your approach to • Theories of potential liability related to the design, development, tackling ethical dilemmas in drug and medical device litigation compares to functioning, maintaining and updating of these products your peers, and benefit from a practical discussion of the polling results and important takeaways for your practice. 2:15 An Interview with the Enforcers: Government Enforcement 4:45 | Main Conference Concludes Priorities and Their Link to the Realm of Drug and Device Product Liability Litigation David M. Eskew CONTINUING LEGAL EDUCATION CREDITS Chief, Health Care & Government Fraud Unit U.S. Attorney’s Office, District of New Jersey (Newark, NJ) EARN CLE/ETHICS Accreditation will be sought in those jurisdictions CREDITS requested by the registrants which have Jenni Peacock continuing education requirements. This course Senior Assistant Attorney General is identified as nontransitional for the purposes of CLE accreditation. Consumer Protection Division ACI certifies that the activity has been approved for CLE credit by the New Office of the Tennessee Attorney General (Nashville, TN) York State Continuing Legal Education Board. ACI certifies that this activity has been approved for CLE credit bythe Ross S. Goldstein State Bar of California. Senior Litigation Counsel, Consumer Protection Branch U.S. Department of Justice (Washington, D.C.) You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4-8 weeks Gregg Shapiro after a conference is held. Chief, Affirmative Civil Enforcement ACI has a dedicated team which processes requests for state approval. U.S. Attorney’s Office, District of Massachusetts Please note that event accreditation varies by state and ACI will make (Boston, MA) every effort to process your request. Questions about CLE credits for your state? Visit our online CLE Help David Hart Center at www.americanconference.com/CLE Assistant Attorney General Assistant Attorney-in-Charge of the Health Fraud Unit/Consumer Protection Section The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading Oregon Department of Justice (Salem, OR) global events and business intelligence company. Paul Singer For over 30 years, C5 Group has provided the opportunities that bring together business Chief, Consumer Protection Division leaders, professionals and international experts from around the world to learn, meet, Office of the Texas Attorney General (Austin, TX) network and make the contacts that create the opportunities. Our conferences and related products connect the power of people with the power of Moderator: information, a powerful combination for business growth and success. Wendy West Feinstein Partner Morgan, Lewis & Bockius LLP (Pittsburgh, PA) Join Our Email List to Stay Connected  SIGN UP TO RECEIVE EXCLUSIVE DISCOUNTS, OFFERS AND Join our panel of esteemed government enforcers as they share pointed insights on: PROGRAM UPDATES AmericanConference.com/DMOptin

12 Join the Conversation @DrugandMed #DrugandMed | ACI: Drug and Medical Device Litigation THANK YOU TO OUR SPONSORS

Lead Sponsors

Supporting Sponsors

Associate Sponsors

Sponsored By

Media Partner

With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: handshake American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to Global challenges around the world. Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. Sponsorship For more information please contact us at: American Conference Institute Opportunities [email protected]

COMMENT-ALT “There is no better forum for leading edge thinking on today’s most pressing drug and med litigation challenges.” – Director, Government Investigations Merck & Co., Inc.

a C5 Group Company Register Now | DRUGANDMED.COM | 888 224 2480 Business Information in a Global Context 13 THANK YOU TO OUR SPONSORS

Barnes & Thornburg’s extensive Dechert is a global specialist law firm. Focused FTI Technology solves data- drug and medical device practice on sectors with the greatest complexities, related business challenges, with has been addressing clients’ needs in an efficient and results legal intricacies and highest regulatory demands, we expertise in legal and regulatory matters. As data grow in driven manner for more than 30 years. As national trial excel in delivering practical commercial judgment and size and complexity, we help organizations better govern, counsel in high-stakes pharmaceutical and medical device deep legal expertise for our client’s most crucial matters. secure, find, analyze and rapidly make sense of information. litigation for Fortune 500 companies, we have the resources Our work is widely recognized, with 32 standout practices Innovative technology, expert services and tenacious noted by Chambers Global, including global-wide rankings problem solving provide our global clients with defensible and expertise to help you address the evolving challenges and repeatable solutions. Organizations rely on us to root you face. www.btlaw.com for corporate investigations and anti-corruption. In an increasingly challenging environment, clients look to us out fraud, maintain regulatory compliance, reduce legal and IT costs, protect sensitive materials, quickly find facts and Bowman and Brooke LLP to serve them in ways that are faster, sharper and leaner without compromising excellence. Dechert’s corporate harness organizational data to create business value. Learn is a nationally recognized investigations, white collar crime and compliance team more at www.FTITechnology.com trial firm with one of the largest product liability practices in includes former federal prosecutors as well as former the country. The firm’s Pharmaceutical and Medical Device government regulators and compliance officers with deep Founded in 2006, Golkow Litigation Litigation practice is comprised of experienced, nationally Services is a global leader in court experience in both preventing and resolving anti-corruption reporting, litigation support and trial recognized trial lawyers serving as national, regional compliance issues. With companies facing unprecedented and local counsel in high-profile individual and mass tort consulting services. Specializing in highly scrutiny of their business conduct, Dechert has the global technical real-time transcription for the pharmaceutical and litigation. Whether we are preparing and defending company team and resources to help clients find answers to difficult medical device industry, Golkow has provided deposition witnesses in the areas of regulatory, drug safety, clinical questions and creative solutions to high-stakes problems. and video services in all 50 states and over 25 countries. trials, medical affairs and marketing, assisting our clients For more information, visit www.dechert.com As a preferred provider of court reporting services for in assessing their product warnings and package inserts hundreds of national MDLs and other consolidated matters, to meet FDA compliance, or navigating complex legal DLA Piper’s life sciences sector team is one Golkow services law firms across the country on a daily challenges, we aggressively defend our clients based on the of the largest and most active of any law basis providing a web-based repository, streaming internet unique requirements of each case. With a passion and drive firm. Operating as one team across more depositions and a proprietary Picture-in-Picture trial ready for mastering complex medical, scientific, epidemiological, than 30 jurisdictions, we combine subject work product. With offices across the country, Golkow engineering and regulatory issues, Bowman and Brooke’s matter experience with considerable knowledge of the sector, has expertise handling complex and multi-party litigation. lawyers deliver legal representation that is innovative, cost- including the scientific, medical, regulatory, commercial and Our dedicated case management team is committed to enforcement environments facing our biopharmaceutical, delivering personalized client services around the clock and effective and complementary to our clients’ core business across the globe. www.golkow.com objectives. The firm’s attorneys defend a variety of corporate medical device, research and diagnostics clients. Our clients, including many Global 500 companies, in widely team includes award-winning lawyers practicing litigation, compliance and investigations, IP strategy and enforcement, Greenberg Traurig, LLP is publicized catastrophic injury and wrongful death matters, M&A, licensing and distribution and clinical trial advice. an international law firm with and other complex litigation throughout all 50 states. For www.dlapiper.com/en/us/ approximately 2100 attorneys in 41 locations in the United more information, please visit www.bowmanandbrooke.com. States, Latin America, Europe, Asia, and the Middle East, and is consistently among the largest firms in the U.S. on the Law 360 400 and among the Top 20 on the Am Law Global 100. With over 1,400 lawyers in 31 offices Dorsey & Whitney LLP has GT’s Pharmaceutical, Medical Device & Health Care Litigation across North America, Europe, the approximately 585 lawyers Practice regularly serves as national, regional, special trial, or Middle East and Asia, Bryan Cave practicing in 19 locations science counsel – in both mass torts and individual cases – to Leighton Paisner LLP is a fully integrated global law firm that throughout the United States, Canada, Europe, and Asia. leading life sciences companies that produce innovative, life- provides clients with connected legal advice, wherever and From patents to products liability, finance to FDA, Dorsey has saving products. An integral part of the firm’s 700+ attorney whenever they need it. The firm is known for its relationship- a long and prominent reputation for providing sophisticated, Global Litigation Practice, this group of attorneys was driven, collaborative culture, diverse legal experience and effective, and efficient legal counsel to leading healthcare recognized as The American Lawyer’s 2018 “Product Liability industry-shaping innovation and offers clients one of the companies around the world. https://www.dorsey.com/ Litigation Department of the Year.” www.gtlaw.com most active M&A, real estate, financial services, litigation and corporate risk practices in the world. www.bclplaw.com Drinker Biddle & Reath LLP is a Based in New Orleans and national law firm with more than Baton Rouge, Irwin Fritchie 600 lawyers. We handle all types and aspects of products Urquhart & Moore LLC has Butler Snow LLP is a full-service liability litigation and frequently serve as trial counsel and a diverse, nationwide practice in pharmaceutical and medical law firm with more than 360 national coordinating counsel in suits defending prescription device litigation. Clients have trusted Irwin Fritchie to serve attorneys and advisors collaborating across a network of as national coordinating counsel, national trial counsel, and drugs, over the-counter drugs and medical devices national and international science counsel in a variety of mass 27 offices in the United States, Europe and Asia. Ranked including orthopedic implants, antibiotics, contraceptives as a leading firm for client relations and one of America’s torts, often working together in litigation teams with other and antipsychotics. For more information, please visit premier law firms. Irwin Fritchie provides the highest quality Top 100 law firms in the BTI Power Rankings, Butler Snow www.drinkerbiddle.com. work at a tremendous value to its clients. For more information, is recognized as one of the nation’s top law firms for client please visit www.irwinllc.com. service. The firm was recently ranked 48th out of 650 firms Faegre Baker Daniels’ product in the BTI Client Relationship Scorecard for understanding liability lawyers represent King & Spalding is client business, anticipating client needs, unprompted pharmaceutical and medical device an international law communication, legal skills, quality and keeping clients manufacturers in all 50 states, Canada and Europe. With firm with more than 1,000 lawyers in 20 offices globally. informed. The firm’s Pharmaceutical, Medical Device & 750 lawyers and consultants in the U.S., U.K. and China, Our Pharmaceutical & Medical Device Litigation Team Healthcare Litigation Group was selected as Benchmark our firm offers integrated services to help achieve the goals helps manufacturers navigate the litigation life cycle, from Litigation’s 2018 Product Liability Group of the Year and of life science companies ranging from emerging startups risk assessments through trial and appeal. Working with to multinational corporations. With a nationwide ranking in more than 300 lawyers and professionals who devote all shortlisted for the honor in 2017 and 2019. The team is or a substantial portion of their practices to life-sciences recognized nationally by a variety of publications, including Chambers USA 2019, our product liability litigation team has served as national, regional and local defense counsel clients, we know the industry and governing laws better than Chambers & Partners USA, The Legal 500: US, and LMG Life anyone. With over 175 lawyers across the world, our Product Sciences. For more information, visit www.butlersnow.com in major pharmaceutical and medical device product Liability team, which Law360 named in 2018 as Practice or follow the firm on Twitter @Butler_Snow. liability litigation. Our professionals aggressively defend Group of the Year for the sixth consecutive year, leverages claims in complex mass tort, toxic tort, multidistrict and knowledge of the complex science and technology behind class action litigation. In addition, we counsel clients on today’s products to deliver litigation victories. We handle Compex Legal Services, Inc. is a National product liability risk management, regulatory compliance, Record Retrieval and Medical Record the most significant individual, multidistrict, mass tort and reimbursement and more. Our practice is supported by our class action lawsuits for pharmaceutical and medical device Summarization Company. We have national health and life sciences industry team that includes companies. We offer our clients a depth of trial experience supported law firms in retrieving all types of records for consultants from our advisory and advocacy division based that is increasingly unusual in firms of our size. While many more than 40 years and work with over 3,500 law firms. in Washington, D.C., Faegre Baker Daniels Consulting. For firms can “litigate” cases, we try product cases each year Headquartered in Torrance California with 40 offices in 16 more information, please visit FaegreBD.com. in some of the most challenging jurisdictions for corporate states to assist in the retrieval records process. We have the clients. For more information, please visit www.kslaw.com knowledge of Jurisdictional and Fee Requirements to get the Comfortable before a jury or job done. arguing a complex MDL motion, Mayer Brown is a global legal Fox Galvin attorneys serve in a variety of roles on drugs and services provider defending Simplifying Multi-Plaintiff Class Action and Case clients in the full array of product liability and mass tort Management for 25 years offering paralegal support to medical device litigation. From our central St. Louis location, actions with extensive experience advising medical device manage multi-plaintiff class-action and complex cases/ we have experience bringing great results and value as lead and pharmaceutical manufacturers. Our nationally recognized lawsuits. State-of-the-art scalable platform allows our trial counsel, on discovery teams and as local/liaison counsel. practice draws upon a deep bench of trial lawyers, a wealth clients to check their status every step of the way and Our team has been involved in some of the biggest drug and of multi-district and complex litigation experience, a robust the ability to grow from a single plaintiff to thousands of medical device cases, from factor concentrates, diabetes regulatory team and a leading Supreme Court and appellate drugs, birth control pills and cholesterol medications to hip plaintiffs. practice to provide clients with an holistic approach to implants, pacemaker leads and urinary incontinence devices. protecting their interests. Our global capabilities offer clients Compex Legal Services, Inc. has the knowledge + process We have served as national settlement counsel, lead litigators, a cohesive multi-jurisdictional, multidisciplinary product + technology to handle your needs. We offer end-to-end and discovery counsel. With FoxGalvin, it’s our people, liability practice that avoids duplication of effort, enhances case management covering interrogatory extracts, record but your voice. And the outcomes speak for themselves. consistency and maximizes cost-effectiveness. Please visit retrieval, record review, deposition reporting. cpxlegal.com www.foxgalvin.com www.mayerbrown.com for more information.

14 Join the Conversation @DrugandMed #DrugandMed | ACI: Drug and Medical Device Litigation Morgan Lewis is a global law Reed Smith’s life sciences team processes and markets, and exceptional knowledge of the science firm with more than 2,200 is committed to anticipating and and technologies underlying these systems. In addition to our strong legal professionals in 31 offices worldwide. With more than solving legal challenges so you can litigation experience, we provide liability counseling to promote 250 international partners and counsel who focus on the focus on what you do best: improving product safety and minimize future liability exposure. We analyze life sciences industry, Morgan Lewis has one of the most and saving lives. In addition to our skilled life sciences design and manufacturing processes; test protocols and quality comprehensive practices in this area. We are unsurpassed in transactional and regulatory lawyers, our highly-regarded, full- assurance programs; advise on insurance coverage; draft product our global understanding of the business, regulatory, intellectual service life sciences litigation practice features a deep bench warnings and instructions; review warranty, disclaimer and indemnity property, litigation, and related issues that our clients face along of seasoned trial lawyers and appellate specialists. For more language in vendor and customer agreements; develop programs for the product life cycle, from innovation and emerging business than 40 years, Reed Smith has served as national, strategic, proper document retention and post-sale product retrofits or recalls; issues, through research and development, regulatory approval, trial, and science counsel to the top global pharmaceutical and ensure regulatory compliance. We are established leaders in the product reimbursement, marketing and distribution, to fraud and medical device manufacturers in single plaintiff and bar. Several of our attorneys hold leadership positions in organizations complex litigation matters, and is regularly recognized for including the American College of Trial Lawyers, Product Liability and abuse, product liability and intellectual property litigation, Advisory Council. www.troutman.com to mergers and acquisitions, collaborations, and outsourcing. its successes in high-profile product liability and mass tort litigations. https://www.reedsmith.com/en Morgan Lewis offers extensive capabilities and decades of At Ulmer, the focus is on exceeding client experience coordinating complex national litigation, in addition expectations and delivering superior, to providing efficient, powerful solutions for the increasingly With a well-earned reputation as a litigation powerhouse, Shook, Hardy & customized legal solutions for an exceptional demanding discovery environment. We are nationally value. The firm is a leader in defending class-action, multidistrict, and recognized for our leadership and innovation in developing Bacon is the go-to firm for the world’s leading health, science and technology companies. In addition mass tort litigation concerning drugs, biologics, medical devices, and alternative fee structures. For more information, please visit to fielding the largest product liability practice in the world, dietary supplements. Ulmer attorneys have served as lead national www.morganlewis.com. Shook handles commercial litigation, environmental and toxic defense counsel in high-impact litigation involving antidepressants, tort, and intellectual property disputes for the pharmaceutical contraceptives, testosterone replacement therapy, pain medications, NightOwl Discovery helps and medical device, food and beverage, and consumer goods oncology drugs, gastrointestinal products, ADHD medications, pelvic global organizations navigate industries. While its high-stakes, complex litigation expertise mesh products, glucose monitoring products, weight management the challenging landscape of is second to none, the firm also has the regulatory compliance products, and performance training supplements. They also counsel enterprise data for legal, security, and compliance teams. The and risk management experience upon which companies pharmaceutical, medical device, and dietary supplement companies combination of NightOwl’s unique and customizable portfolio have come to rely. Established in Kansas City in 1889, Shook on regulatory and risk management matters. The practice is management approach, and its expert global consultancy solve has grown to approximately 500 attorneys and 200 research strengthened by its many attorneys with degrees in various scientific the challenging issues that come when managing complex analysts and paraprofessionals, many of whom have advanced disciplines. Learn more at Ulmer.com. data portfolios in response to litigation, investigations or scientific and technical degrees. Shook’s offices are strategically compliance needs. NightOwlDiscovery.com located in Atlanta, Chicago, Denver, Houston, Kansas City, Venable has one of the most active and London, Los Angeles, Miami, Orange County, Philadelphia, San respected product liability practices in the Norton Rose Fulbright Francisco, Seattle, Tampa and Washington, DC. www.shb.com United States and is well known for its defense of pharmaceutical is a global law firm with and medical device manufacturers. Our team has 60 attorneys, more than 4,000 lawyers We're not a traditional law firm. including 20 partners and counsel with trial team experience in based in Europe, the United States, Canada, Latin America, SouthBank Legal is a different pharmaceutical product liability litigation. In addition to our trial Asia, Australia, the Middle East and Africa. Our life sciences kind of law firm. We focus on work, we have extensive experience serving as national coordinating product liability team has a national presence and our lawyers what matters to you by blending big-picture strategy with counsel and in all other aspects of pharmaceutical mass tort have extensive experience defending individual cases, as well detailed execution, sophistication with approachability, and litigation including leading expert witness teams, developing as coordinating and defending multi-jurisdictional product an entrepreneurial attitude with cost-conscious tactics. company witnesses, managing briefing teams, and handling liability dockets, and serving as national trial counsel, Whether you're a corporation, small business, or individual, eDiscovery. The group is the recipient of the 2017 Chambers USA national coordinating counsel, national discovery counsel you will get the same treatment: a smart, responsive, and Client Service Award for Products Liability and Mass Torts and was and regional trial counsel for our clients. We have served agile legal team by your side every step of the way. on BTI Consulting’s 2017 and 2018 Power Rankings for the best our clients in some of the largest product liability litigation An exceptional team on your side. client relationships. www.venable.com filed in the country, including Fen-phen, Vioxx, Actos, Baycol, BigLaw experience. Federal clerkships. Top-ranked law Yaz, PPA, and pediatric vaccines, just to name a few. Our schools. The attorneys at SouthBank Legal have the team works as a global unit which provides significant credentials you expect to find at a top law firm, and the efficiency, and cost savings to our clients when mass torts approachability you want in a colleague. We love advocating Venue Information have an “outside US” component. The team is recognized by for our clients - and it shows. southbank.legal Chambers & Partners for US Nationwide product liability and Hotel: New York Marriott Marquis mass tort work. www.nortonrosefulbright.com Troutman Sanders has a long-standing Address: 1535 Broadway, New York, NY, 10036 record of successfully defending clients Patterson Belknap Webb & in pharmaceutical and medical device Telephone: 1-877-303-0104 or 1-212-398-1900 Tyler LLP is based in New litigation. We have handled high-stakes pharmaceutical and York City with approximately 200 lawyers delivering a full medical device litigation for over 30 years. We defend major Online: AmericanConference.com/DrugandMed/Venue range of services across more than 20 practice groups in pharmaceutical and medical device manufacturers in claims both litigation and commercial law. More than half of the involving surgical devices, orthopedic implants, cosmetic American Conference Institute is pleased to offer our attorneys at Patterson Belknap are devoted to litigation. Our devices and prescription drugs. We have extensive expertise delegates a negotiated rate* for hotel rooms at New York litigating partners have tried hundreds of cases, including in handling mass tort litigation for our clients, who are Marriott Marquis. To take advantage of these rates, please many of the most complex in their fields. We frequently serve among the largest and most well-known pharmaceutical and contact the hotel directly by November 18th, and quote "ACI's medical device companies in the world. Our attorneys have as national and regional litigation counsel for the nation’s extensive first-chair trial experience and regularly serve as Drug & Med Conference". largest pharmaceutical and medical device companies in national counsel and regional counsel. Our defense strategies products liability matters. www.pbwt.com involve an in-depth understanding of our clients’ products, *Discounted rate is subject to availability. 3 Ways to Register ONLINE:  EMAIL:  PHONE:  DrugandMed.com [email protected] 1-888-224-2480

Pricing and Registration Information: Conference Code 710L20-NYC Register & Pay by Register & Pay by Register & Pay after September 27, 2019 October 25, 2019 October 25, 2019 Bringing a Team? Conference Only $2295 $2495 $2695 3 - 4 10% Conference Discount

Workshops $600 (Each) 5 - 6 15% Conference Discount

SPECIAL IN-HOUSE RATE 7 20% Conference Discount Conference Only $1695 $1795 $1895 8 or more Call 888-224-2480 All program participants will receive an online link to access the conference materials as part of their registration fee. Special Discount Additional copies of the Conference Materials available for $199 per copy. ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more To update your contact information and preferences, please visit www.AmericanConference.com/preference-center/. information, please email or call customer service. Terms and Conditions Payment Policy Delegate Substitutions and Cancellations Payment must be received in full by the program date to ensure admittance. All discounts You must notify us by email at least 48 hrs. in advance of the conference if you If you prefer, you may request a refund of fees paid less the applicable cancellation will be applied to the Program Only fee (excluding add-ons), cannot be combined with any wish to send a substitute participant. If you are unable to find a substitute, please fee. No credits or refunds will be given for cancellations received within 10 days of other offer, and must be paid in full at time of order. Group discounts available to 3 or more notify us in writing no later than 10 days prior to the conference date and a credit the conference start date. No liability is assumed by American Conference Institute individuals employed by the same organization, who register at the same time. voucher will be issued to you for the full amount paid, redeemable against any other for changes in program date, content, speakers or venue. American Conference ACI conference in the next 12 months. Delegates may not “share” a pass between Institute reserves the right to cancel any conference it deems necessary and will, in multiple attendees without prior authorization. such event, make a full refund of any registration fee, but will not be responsible for © American Conference Institute, 2019 All cancelled conference registrations will be subject to a cancellation fee of $350 airfare, hotel or other costs incurred by registrants. and applicable taxes. Any product extensions (inclusive of workshops, receptions, masterclasses, etc.) will be subject to a cancellation fee of $50 and applicable taxes. 24th Annual Conference on

MAIN CONFERENCE: DRUG& MEDICAL DEVICE December 10–11, 2019 PRE-CONFERENCE WORKSHOPS: LITIGATION December 9, 2019 New York Marriott Marquis New York, NY

American Conference Institute Attention Mailroom Update your Contact Information 45 West 25th Street, 11th Floor If undeliverable to addressee, please forward to: If you would like us to change any of your details, New York, NY 10010 COUNSEL, LITIGATION/PRODUCTS LIABILITY please email [email protected] ATTORNEY and reference the conference code on the brochure.

REGISTRATION CODE

B00-710-710L20.WEB

Lead Sponsors

Supporting Sponsors

Associate Sponsors

Sponsored By