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Drug Medical Device 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
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