Drug and Medical Device Litigation Seminar 2019
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Drug and Medical Device Litigation Ensuring Excellence in Defending Life Sciences Companies In addition to our usual first-rate, cutting- edge presentations, we will offer something new! Witness a trial reenactment of a famous immigration case, Chy Lung v. Freeman, 92 U.S. 275 (1876), as a special diversity and inclusion presentation. The cast will feature a prominent federal judge as well as members of the DRI Drug and Medical Device Committee Steering Committee. All attendees will receive general/professional practice CLE credit or diversity and inclusion CLE credit in the relevant states. May 16–17, 2019 Renaissance Washington, D.C., Downtown Hotel Washington, D.C. lease join us in our nation’s beautiful capital for the 2019 Drug and Medical Device Seminar. This seminar Pwill provide more opportunities than ever to network with in-house counsel, leading pharmaceutical and medical device lawyers, and friends old and new. You will also hear an FDA insider’s views regarding issues facing the industry and top appellate attorneys’ thoughts regarding recent and relevant decisions affecting how we defend our clients. These and other top-notch programs make this seminar the “go-to” event year after year for practitioners in the pharmaceutical and medical device defense arena. Register today! Sheila S. Boston Sara J. Gourley Program Chair Committee Chair Erik W. Snapp Gail Rodgers Program Vice Chair Committee Vice Chair Ted J. McDonald III Law Institute PRESENTED BY DRI’s Drug and Medical Device Committee THIS SEMINAR BROCHURE IS SPONSORED BY Register online now at dri.org or complete the form in the back. Drug and Medical Device Litigation Seminar | May 16–17, 2019 What You Will Learn An insider perspective of the U.S. Food and Drug Administration The most recent and relevant U.S. Supreme Court decisions affecting how we defend our clients How, if at all, the presidency of Donald J. Trump is affecting juror attitudes and decisions in our trials How outside counsel from different countries can work together with in-house counsel to develop strategies for cross-border class action litigations Strategies on how to cross-examine expert witnesses deftly The seminar provides an excellent opportunity “ for me to meet with clients and other counsel I work with in the life sciences field, in a setting… very conducive to the networking experience.” Use dri™ Dividends Points to reduce your registration fee: Recruit a member Attend a seminar Participate on a committee …and more! Visit dri.org, go to My DRI and click on DRI Dividends to see your balance. Get engaged, get recognized, and get rewarded. 1 Drug and Medical Device Litigation Seminar | May 16–17, 2019 PROGRAM SCHEDULE WEDNESDAY, MAY 15 8:25 a.m. Welcome and Introductions Ted J. McDonald III , McDonald Davidson PA, 2:00 p.m. Registration for In-House Overland Park, KS Breakout Session Attendees Sheila S. Boston , Arnold & Porter Kaye IN-HOUSE BREAKOUT Scholer LLP, New York, NY 2:00 p.m.–5:30 p.m. Sara J. Gourley , Sidley Austin LLP, Chicago, IL Seminar registration required; attendance strictly limited 8:30 a.m. to in-house counsel. No CLE available for this session. Join Jurors in the Age of Trump your in-house peers for a unique opportunity to discuss In today’s polarized political landscape, jurors topics of importance to in-house counsel. Exchange ideas are increasingly willing to discount objective while networking with colleagues in a forum designed for evidence, accept “alternative facts,” and make in-house counsel by in-house counsel. For more informa- emotion- biased decisions. An experienced trial PROGRAM SCHEDULE tion, email Gail Rodgers at [email protected]. lawyer, jury consultant, and in-house counsel will explain the social psychology of decision 5:00 p.m. Registration making and provide strategies to ensure that your trial presentation is effective. 5:30 p.m. First-Time Attendees Reception ♦❯ Rebecca M. (Becky) Fuentes, MS , R&D 6:00 p.m. Networking Reception Strategic Solutions, Salem, OR SPONSORED BY Dechert LLP Sherry A. Knutson , Tucker Ellis LLP, Chicago, IL King & Spalding Casey Westover , Abbott Laboratories, MRC Abbott Park, IL 7:30 p.m. Dine-Arounds | Join colleagues and friends 9:30 a.m. The New FDA: How It Affects Your at selected restaurants for dinner (on your Clients and Your Cases own), including a Potomac River Dinner Cruise The FDA is at an inflection point across the as an option. Electronic sign-up information most salient legal issues affecting regulated will be sent in advance of the seminar. industry. Ms. Wood will discuss top initiatives and developments at the new FDA under Com- THURSDAY, MAY 16 missioner Scott Gottlieb’s leadership that affect pharmaceutical and medical device companies. DRI For Life Her remarks will be followed by an intimate 6:30 a.m. | Run/Walk to the Supreme Court from the interview addressing key questions that affect hotel. Contact Erik Snapp at [email protected] for our approach to drug and device litigation. information. M. Ashley Garry , Eli Lilly and Co., Indianapolis, IN 7:30 a.m. Registration ♦❯ Rebecca K. Wood , Sidley Austin LLP, and 7:30 a.m. Continental Breakfast former Chief Counsel, U.S. Food & Drug SPONSORED BY Arnold & Porter Kaye Scholer LLP Administration, Washington, DC Nilan Johnson Lewis PA 10:20 a.m. Refreshment Break Reed Smith LLP SPONSORED BY Baker Donelson Bearman Caldwell & Berklowitz PC “I have been going for years, and find the content relevant to my practice.” 2 Drug and Medical Device Litigation Seminar | May 16–17, 2019 PROGRAM SCHEDULE 10:40 a.m. “22 Lewd Chinese Women”: A Diversity 12:30 p.m. Dine-Arounds | Join colleagues and friends and Inclusion CLE Historical Reenactment at selected restaurants for lunch (on your In 1874, a steamship from China arrived in the own). Sign-up information will be sent in port of San Francisco. State immigration offi- advance of the seminar. cials detained 22 Chinese women, concluding Supreme Court Tour that they were prostitutes because they were 1:00 p.m. | Space is limited. Attendees will be chosen Chinese and traveling alone. Legal proceedings by lottery on April 15. Only attendees who have followed, including a four-day trial and appeals registered for the seminar will be able to participate all the way to the Supreme Court, raising issues in the tour. Please sign up for the lottery by emailing of due process, human and civil rights, and the [email protected]. power of states to regulate immigration. See a dramatic reenactment of this historical case, SPONSORED BY Sidley Austin LLP Chy Lung v. Freeman, 92 U.S. 275 (1876); the 2:00 p.m. Young Lawyers Blockbuster (see page 4) script was created by Judge Denny Chin of the Second Circuit Court of Appeals. 2:30 p.m. Supreme Court Review The Honorable Raymond T. Chen , U.S. Court of Two top appellate advocates will discuss the Appeals for the Federal Circuit, Washington, DC effect of recent decisions on our practice and DRI Drug and Medical Device Committee daily life and how the most recent nominee has members and guest attorneys serving as cast influenced the disposition of the Court. SPONSORED BY DLP Piper LLP (US) Joseph R. Guerra , Sidley Austin LLP, Washington, DC 11:40 a.m. “So, You’re Just a Sales Rep?” Neal K. Katyal , Hogan Lovells US LLP, Many plaintiffs’ counsel attempt to paint sales Washington, DC representatives as immoral individuals who will 3:30 p.m. Refreshment Break say or do anything when meeting with phy- SPONSORED BY Venable LLP sicians, as long as they can “close a sale” and increase their bonuses. These individuals, how- 3:50 p.m. FDA Evidence in Device Cases: Friend or Foe? ever, are but one of many important resources Plaintiffs have successfully moved to bar dis- for the physicians, and the sales reps are well- cussion of FDA- related topics in device trials, aware of the consequences of stepping over including evidence of the 510(k) clearance, the the lines that plaintiffs’ counsel so desperately FDA’s actions leading to clearance, and inter- hope to prove the reps crossed. This session actions between the manufacturer and the will address the common themes and areas FDA. This panel will discuss how plaintiffs have that most sales reps will have to navigate when accomplished this and will propose ways of being examined. dealing with this frustrating trend. Joseph D. Cohen , Porter Hedges LLP, Lisa Marie Dunkin , Zimmer Biomet Inc., Houston, TX Warsaw, IN Jobina Jones-McDonnell , Endo Robert R. Simpson , Shipman & Goodwin LLP, Pharmaceuticals Inc., Malvern, PA Hartford, CT Michael C. Zogby , Drinker Biddle & Reath LLP, ♦❯ Marta L. Villarraga, PhD, RAC , Exponent, Florham Park, NJ Philadelphia, PA “It’s a great place to meet people in the industry… not just other lawyers.” 3 Drug and Medical Device Litigation Seminar | May 16–17, 2019 YOUNG LAWYERS BLOCKBUSTER Thursday, May 16, 2019, 2:00 p.m.–4:50 p.m. 2:00 p.m. Opening Remarks and Introductions importantly, how does the recall impact Christopher J. Kaufman , Shook Hardy & defense strategy? Bacon LLP, Kansas City, MO James K. Holder , Gordon Rees Scully Margaret C. O’Neill , Goodell DeVries Leech & Mansukhani LLP, San Francisco, CA Dann LLP, Philadelphia, PA 3:10 p.m. I’m a Member of a Pharmaceutical 2:10 p.m. #trendingnow: Use of Social Media in MDL Discovery Team! Now What?!? Drug and Medical Device Litigation Experience MDL Discovery 101 for young Hear practical tips on the use of social lawyers with perspective from both inside media and electronic data in pharmaceuti- and outside counsel. Topics will include the cal and device litigation, as well as the cur- “junior” lawyer’s discovery team role, pres- PROGRAM SCHEDULE rent state of the developing field of case law ervation and collection issues, working governing the discoverability and admissi- together to facilitate a smooth process, uti- bility of this type of information.