DRUG and Medical Device Litigation Earn CLE ETHICS Expert Strategies for Leading Litigators & In-House Counsel Credits

Added Networking Opportunities with DECEMBER 9-11, 2013 | Marriott Marquis | New York, NY In-House Counsel 18th Annual DRUG and Medical Device Litigation Earn CLE ETHICS Expert Strategies for Leading Litigators & In-House Counsel Credits

Distinguished Co-Chairs The must attend drug and medical device litigation event that will provide expert insights unavailable at any other forum, including Catherine Kassenoff Michael Parini Executive Counsel and Senior Vice President & how to: Executive Director - Chief Litigation Counsel • UTILIZE an innovator liability theory when arguing for generic preemption Head of U.S. Litigation and Pfizer Inc Government Investigations • Successfully REMOVE a putative class case from state to federal court Boehringer Ingelheim USA Corp • DEVELOP effective strategies for MANAGING unexpected product Judicial Insights safety risks and issues arising from efforts to obtain discovery crossing international boundaries The Honorable The Honorable William S. Duffey, Jr. Christopher Nuechterlein • CULTIVATE a media relations strategy to face an adverse event or District Judge, N.D. Georgia Magistrate Judge, N.D. Indiana government investigation head on

The Honorable The Honorable • USE complex scientific evidence to persuade the jury that use of the David Herndon Cynthia M. Rufe product did not cause the plaintiff’s injury Chief Judge, S.D. Illinois District Judge, E.D. Pennsylvania • COMMUNICATE new information promptly to health care The Honorable practitioners via “Dear Doctor” letters Richard Kramer The Honorable Judge John Tunheim • ESTABLISH in cross-examination that product risks were contained San Francisco Superior Court District Judge, on the label and were not withheld by the company District of Minnesota The Honorable Theodore A. McKee The Honorable Featuring a “who’s who” of in-house attorneys in the trenches Chief Judge Kaymani D. West of products liability litigation: U.S. Court of Appeals Magistrate Judge, for the Third Circuit District of South Carolina Abbott Medical Optics Celgene Corporation Medtronic Allergan Covidien Novartis Pharmaceuticals Corporation FDA Keynote Address Judicial Insights on Bayer Corporation C. R. Bard, Inc. Biogen Idec Daiichi Sankyo, Inc. Pfizer Inc. Kelsey A. Schaefer Multidistrict Litigation Biomet Eli Lilly and Company Purdue Pharma Associate Chief Counsel The Honorable for Enforcement John G. Heyburn II Boehringer Ingelheim GE Healthcare Teva Pharmaceuticals Office of Chief Counsel Chairman Bristol-Myers Squibb Co GlaxoSmithKline W.L. Gore U.S. Food and Drug Judicial Panel on Multidistrict Administration Litigation Cardinal Health Johnson & Johnson

Lead Sponsors: Cocktail Host: Supporting Sponsors:

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Register Now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed DISTINGUISHED FACULTY drawn from the best that the bar, the bench, and the industry haS to offer

CO-CHAIRS: Catherine Kassenoff Michael Parini Executive Counsel and Executive Director - Senior Vice President & Chief Litigation Counsel Head of U.S. Litigation and Government Investigations Pfizer Inc Boehringer Ingelheim USA Corp

Ailyn Abin Kathleen Erickson DiGiorno Brandee Kowalzyk Steven M. Selna Corporate Counsel, Litigation Senior Legal Director Partner Partner Celgene Corporation Medtronic, Inc. Nelson Mullins Riley & Scarborough LLP Drinker Biddle & Reath LLP Patricia A. Barbieri Jan Dodd The Honorable Richard Kramer Jeffrey B. Shapiro Deputy General Counsel, Partner Judge Partner Litigation and Employment Norton Rose Fulbright San Francisco Superior Court Arnstein & Lehr LLP Legal Affairs The Honorable William S. Duffey, Jr. Heidi Kraus Eric W. Sitarchuk Daiichi Sankyo, Inc. District Judge Partner Partner Kenneth F. Baum U.S. District Court, N.D. Georgia Fanelli Haag and Kilger PLLC Morgan, Lewis & Bockius LLP Partner Amy R. Fiterman John P. Lavelle, Jr. Kaspar Stoffelmayr Goldman Ismail Tomaselli Brennan Partner Partner Vice President & Associate General & Baum LLP Faegre Baker Daniels Morgan, Lewis & Bockius LLP Counsel Andrew T. Bayman Melissa A. Geist Jason D. Maxwell Bayer Corporation Partner Partner Vice President & Associate General Vincent A. Thomas, CPA, CFF, King & Spalding LLP Reed Smith LLP Counsel–Litigation CVA, ABV Erin M. Bosman Edward W. Gerecke Cardinal Health Senior Managing Director Partner Shareholder The Honorable Theodore A. McKee Forensic & Litigation Consulting Morrison & Foerster LLP Carlton Fields Chief Judge Co-Leader, U.S. Intellectual Donald P. Bunnin U.S. Court of Appeals for the Third Property Practice Charna Gerstenhaber FTI Consulting Senior Litigation Counsel Vice President and Head of Litigation Circuit Allergan, Inc. Novartis Pharmaceuticals Corporation Jennifer Mingus Mountcastle Brennan Torregrossa Debra L. Burns Partner Assistant General Counsel Julie Hardin GlaxoSmithKline Senior Counsel, Litigation/Investigations Partner Thompson Hine LLP GE Healthcare Reed Smith LLP Dwight O. Moxie The Honorable John Tunheim Abigail M. Butler Senior Counsel - Legal Department District Judge Jill Harrison U.S. District Court, Partner Counsel Allergan, Inc. Faegre Baker Daniels District of Minnesota W.L. Gore & Associates, Inc. The Honorable Christopher Lisbeth A. Warren Sharon L. Caffrey Max C. Heerman Nuechterlein Partner Magistrate Judge Assistant General Counsel Principal Litigation Counsel Johnson & Johnson Duane Morris LLP Medtronic, Inc. U.S. District Court, N.D. Indiana Alexander G. Calfo Michael Panagrossi Jonathan Wasserman The Honorable David Herndon Vice President & Associate General Partner Chief Judge Associate General Counsel Barnes & Thornburg LLP Purdue Pharma L.P. Counsel, Litigation & Government U.S. District Court, S.D. Illinois Investigations Candice Ciresi The Honorable John G. Heyburn II John J. Pease Bristol-Myers Squibb Co. Senior Corporate Counsel, Senior Counsel Chairman The Honorable Kaymani D. West Vascular Therapies Judicial Panel on Multidistrict Litigation Teva Pharmaceuticals Covidien Magistrate Judge Timothy Howard Steve Phillips U.S. District Court, Lori Cohen Assistant Counsel Special Counsel District of South Carolina Shareholder Merck & Co., Inc. Medtronic, Inc. Greenberg Traurig LLP John D. Winter Michael Howe Jennifer Quinn-Barabanov Partner Christopher D’Angelo Associate General Counsel Partner Patterson Belknap Webb & Tyler LLP Partner Biogen Idec Steptoe & Johnson LLP Montgomery, McCracken, Walker Robert K. Woo, Jr. Janet M. Richardson & Rhoads, LLP Michael Hulka Partner General Counsel, Lilly Oncology Division Counsel, Legal King & Spalding LLP Greg A. Dadika & ImClone Systems Abbott Medical Optics Inc. Associate General Counsel, Litigation Pamela J. Yates Senior Director, Assistant General The Honorable Cynthia M. Rufe C. R. Bard, Inc. Partner Counsel District Judge Kaye Scholer LLP Adam Deutsch Eli Lilly and Company U.S. District Court, E.D. Pennsylvania Vice President and Associate General Kevin Zielke James W. Huston Kelsey A. Schaefer Counsel - Litigation, Investigations Member Partner Associate Chief Counsel for Enforcement and Risk Management Dykema Gossett PLLC Morrison & Foerster LLP Office of Chief Counsel Biomet, Inc. Sidney Kanazawa U.S. Food and Drug Administration Ranjit S. Dhindsa Partner Kim M. Schmid Partner McGuireWoods LLP Executive Managing Partner Hollingsworth LLP Bowman and Brooke LLP

2 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed As Pressure on the Drug & Device Industries Continues to Mount, Be a Part of the Products Liability Event that Shapes Industry Policies and Strategies

For the past 17 years, leading drug and medical device lawyers have gathered in New York to network with their peers, and craft strategies to surmount new litigation challenges. Now in its 18th year, ACI’S DRUG AND MEDICAL DEVICE LITIGATION is widely regarded as the year’s premier products liability forum. Network with the “who’s who” of the products liability space This year’s speaking faculty is comprised of more than 20 in-house counsel, leading products liability litigators for the top law firms, prominent government enforcers, and renowned members of the state and federal bench, providing advice for defeating claims and litigating more efficiently. We are pleased to announce that Kelsey A. Schaefer, Associate Chief Counsel for Enforcement in the Office of General Counsel at the FDA will be offering keynote remarks. Hear how your industry peers are responding to Crises caused by adverse events and government investigations A crisis management plan is becoming increasingly important to drug and device manufacturers. When faced with a product recall, government investigation, or respected journal that negatively discusses one of your products, your company needs a proactive media relations strategy. In-house counsel must coordinate crisis efforts between the legal and business side of the business and know when to bring in the expertise of outside counsel or a PR firm. Expert speakers will help you to develop a crisis checklist to use before, during and after the manufacturer’s response. Highly tailored track sessions enable attendees to focus on core areas of interest In response to industry feedback, this year’s conference will feature two distinct tracks – one aimed at honing your trial strategies, and the other aimed at the biggest challenges faced by in-house drug and device attorneys. Over the course of an afternoon, attendees will learn the latest trial tactics, from Voir Dire to Daubert, with commentary by The Honorable John Tunheim. For attendees of the in-house track, challenges such as Case Management, Duty to Train, and Government Investigations will be addressed. Recurring highlights of this annual program include: • Multiple networking opportunities including lunches, breaks and cocktail receptions • Complimentary participation in the Pre-conference Speed Networking facilitated by in-house counsel • The Judicial Panel featuring 7 renowned state and federal jurists, each with distinguished records of industry mass torts oversight • Post-Conference Business Development Master Class on Selecting and Evaluating Outside Counsel

NEW THIS YEAR Pre-Conference Workshop – A 50-State Drug & Med Survey: Drilling Down into the State-Specific Legislation that Impacts Drug & Medical Device will provide an opportunity for practitioners to learn valuable fundamentals that will enable you to be a better advocate for your company and client and segue nicely into the rest of the program.

Since its inception, New York City has been the backdrop for Drug and Medical Device Litigation, providing many excellent networking opportunities for the 400+ drug and medical device industry professionals attending the conference. Register early to ensure best pricing. Group discounts are available. Call 1-888-224-2480, fax your registration to 1-877-927-1563, or visit us online at www.drugandmed.com.

Join the ACI: Drug and Medical Device Litigation group on LinkedIn to ‘meet’ your peers prior to the start of the conference; and follow us on Twitter @DrugandMed for industry news and exclusive discounts.

I look forward to seeing you in December! Kind Regards,

Stacey B. Evans, J.D. Senior Program Director

Pre-Conference Workshop: A 50-State Drug & Med Survey: Drilling Down into the State-Specific Legislation that Impacts Drug & Medical Device Litigation [including preemption, consumer fraud and patient safety] 9:30 a.m. – 12:30 p.m. (Registration and Continental Breakfast at 8:45 a.m.)

Edward W. Gerecke Shareholder Carlton Fields (Tampa, FL) With preemption at the forefront of all litigators’ minds, it can be Consumer Fraud difficult to keep track of all the different state legislation that can • Analyzing fraud on the FDA allegations impact your trial strategy. Additionally, practitioners struggle with • Preventing plaintiffs from presenting fraud on the FDA consumer fraud concerns and patient efficacy claims. This Pre- The process of selecting of outside counsel is crucial to the success evidence or failure of legal services performed by law firms for corporations. Conference Workshop will serve as an invaluable foundation for the • Insulating the manufacturer from liability for failure to warn remainder of the conference. Experts will discuss: The drug or device manufacturer needs to carefully vet potential claims when it has complied with FDA standards law firms and define the needs brought on by various cases. Preemption • Seeking a broad application of the Buckman fraud on the In-house counsel will give rarely heard insights on: • Applying preemption decisions in other industries to the drug FDA preemption decision to all claims that a manufacturer fraudulently withheld information from FDA • What is the process for becoming a manufacturer’s preferred and device industries provider? How do the “little guys” get in the game? • Understanding the interplay between preemption and the Patient Safety • Strategies for increasing outside counsel performance while FDA regulatory process • Exploring manufacturers’ duty with respect to patient safety decreasing cost • Dealing with state court judges in different jurisdictions • Determining what information must be communicated • What measures are in place to continue to optimize resources? • Minimizing the risks of penalizing innovative drug manufacturers to the public - metrics for effectiveness and efficiency • Pleading around preemption and how these cases are being • Educating plaintiff’s counsel on a product’s efficacy • What is an effective and fair way to assess counsel’s defended • Proactively approaching FDA to update a product’s performance? • Analyzing the Stengel decision and its application to medical label/black box warning device preemption • Updating labels to conform with brand manufacturers • Addressing parallel claims

Pre-Conference Group Speed Networking Facilitated by In-House Counsel 3:00 p.m. – 5:00 p.m. (Registration begins at 2:15 p.m.)

Ailyn Abin Donald P. Bunnin Lisbeth A. Warren Corporate Counsel, Litigation Senior Litigation Counsel Assistant General Counsel Celgene Corporation (Summit, NJ) Allergan, Inc. (Irvine, CA) Johnson & Johnson (New Brunswick, NJ) Steve Phillips Janet M. Richardson Special Counsel Division Counsel, Legal Medtronic, Inc. (Philadelphia, PA) Abbott Medical Optics Inc. (Santa Ana, CA)

Attendees at this year’s conference will be able to participate in a Topics of discussion will include: unique, interactive, networking session that serves as a great kickoff • Hellhole jurisdictions to the conference. Included in your registration cost, you can meet your industry peers from across the country, as you are divided into • Punitive damages topic-specific tables to meet and share insights with in-house counsel. • New and developing legal theories When the bell rings, attendees will move on to the next table, for a • Failure to warn different topic discussion. In-House counsel will offer their analysis • State and federal False Claims Act on the complex litigation challenges currently facing pharmaceutical • Generic and brand manufacturers as co-defendants and medical device manufacturers. As you begin to consider the issues • Managing jointly defended litigation with alliance or addressed at each table and meet new colleagues, you will immediately collaboration partners begin to reap the benefits of the leading products liability forum.

5:00 p.m. Pre-Registration and Welcoming Cocktail Reception Hosted by:

4 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed WEDNESDAY, DECEMBER 11, 2013

Post-Conference Business Development Master Class on Selecting and Evaluating Outside Counsel

3:30 p.m. – 5:30 p.m. (Registration begins at 3:15 p.m.)

Patricia A. Barbieri Kathleen Erickson DiGiorno Heidi Kraus Deputy General Counsel, Senior Legal Director Partner Litigation and Employment Medtronic, Inc (Minneapolis, MN) Fanelli Haag and Kilger PLLC Legal Affairs (former General Counsel Daiichi Sankyo, Inc. (Parsippany, NJ) Abon Pharmaceuticals LLC) The process of selecting of outside counsel is crucial to the success • Negotiating fee arrangements and monitoring performance or failure of legal services performed by law firms for corporations. and billing practices of outside counsel The drug or device manufacturer needs to carefully vet potential - outlining expectations law firms and define the needs brought on by various cases. • How important are Chambers rankings and surveys? In-house counsel will give rarely heard insights on: • In-house counsel pet peeves of their outside counsel – what • What is the process for becoming a manufacturer’s preferred behavior/activities/style should be avoided? provider? How do the “little guys” get in the game? • How do companies select which of their preferred providers • Strategies for increasing outside counsel performance while works on which case? decreasing cost • Understanding the growing partnership between the general • What measures are in place to continue to optimize resources? counsel and the CEO - metrics for effectiveness and efficiency • Matching the unique skill set of the attorney to the technical • What is an effective and fair way to assess counsel’s and legal demands of the matter in order to maximize the performance? results of your legal spend

WHO You Will Meet In-house counsel for: Attorneys practicing in: • pharmaceutical companies • pharmaceuticals • medical device companies • medical devices • biotech companies • products liability • health care organizations • mass tort • complex and multidistrict litigation • healthcare • complex class actions

American Conference Institute: The leading networking and information resource for counsel and senior executives.

Each year more than 21,000 in-house counsel, attorneys in private practice and other senior executives participate in ACI events – and the numbers keep growing. Guaranteed Value Based on Comprehensive Research ACI’s highly trained team of attorney-producers are dedicated, full-time, to developing the content and scope of our conferences based on comprehensive research with you and others facing similar challenges. We speak your language, ensuring that our programs provide strategic, cutting edge guidance on practical issues. Unparalleled Learning and Networking ACI understands that gaining perspectives from – and building relationships with – your fellow delegates during the breaks can be just as valuable as the structured conference sessions. ACI strives to make both the formal and informal aspects of your conference as productive as possible.

Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed 5 DAY 1: TUESDAY, DECEMBER 10, 2013

7:00 Registration & Welcome Breakfast • Addressing plaintiffs’ parallel claims - summary judgment motions 8:00 Co-Chairs’ Opening Remarks - discovery challenges - examples of claims Catherine Kassenoff • Can branded manufacturers be liable for failure to publish Executive Counsel and Executive Director - Head of in the PDR? U.S. Litigation and Government Investigations Boehringer Ingelheim USA Corp (Ridgefield, CT) 9:15 FDA Keynote Address Michael Parini Kelsey A. Schaefer Senior Vice President & Chief Litigation Counsel Associate Chief Counsel for Enforcement Pfizer Inc (New York, NY) Office of Chief Counsel U.S. Food and Drug Administration (Silver Spring, MD) 8:15 Case Study from Mensing to Bartlett: Determining Whether Design Defects Claims 9:55 Morning Coffee Break are Preempted for Generic Manufacturers and the Potential Liabilities Hosted by:

Catherine Kassenoff 10:10 Judicial Insights on Multidistrict Litigation Executive Counsel and Executive Director - Head of U.S. Litigation and Government Investigations The Honorable John G. Heyburn II Boehringer Ingelheim USA Corp (Ridgefield, CT) Chairman Judicial Panel on Multidistrict Litigation Erin M. Bosman Partner 10:40 Bolstering the Defense Position: Effectively Morrison & Foerster LLP (San Diego, CA) Defeating Class Certification Jan Dodd Michael Panagrossi Partner Associate General Counsel Norton Rose Fulbright (Los Angeles, CA) Purdue Pharma L.P. (Stamford, CT) John P. Lavelle, Jr. Jennifer Quinn-Barabanov Partner Partner Morgan, Lewis & Bockius LLP (Philadelphia, PA) Steptoe & Johnson LLP (Washington, DC) • Who is making the determination of a product’s efficacy? - FDA Amy R. Fiterman - plaintiff Partner - branded manufacturer Faegre Baker Daniels (Minneapolis, MN) - juries John D. Winter • Ensuring products are accompanied by the proper Partner labeling Patterson Belknap Webb & Tyler LLP (New York, NY) • Mirroring the safety label of the brand-name company and alerting the FDA whenever they learn of an adverse • Removing cases on the basis of the Class Action Fairness event related to their products Act (CAFA) • Clarifying the ‘failure to warn’ standard and its • Analyzing the growing trend of using Daubert motions application to drug safety to defeat class certification • Exploring the tension in the law where branded drugs are - plaintiff strategies for defending these challenges subject to certain product liability suits, but the generic • Successfully removing a putative class case from state versions are not to federal court • Analyzing efforts within the FDA and Congress to • Defeating plaintiff claims of numerosity, commonality, impose liability on generics typicality, and adequacy-of-representation • Crafting preemption arguments when there is no obvious • Refuting a plaintiff’s proof of class wide liability tied comment from the FDA to the drug or device • Utilizing the novel legal theory of innovator liability • Understanding Courts’ commonality standard and the • Pleading around preemption – how are negligent enforceability of class action waivers training/claims being defended? • Attacking class definition at the pleading stage – over • Understanding the implications of the Stengel decision breadth and ascertainability on device manufacturers’ preemption arguments • Defense tactics for presenting favorable economic analysis • Defining the manufacturer’s duty with respect to safety in class action litigation and public communication • Using denial of class cert offensively

6 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed 11:40 Crisis Management & Litigation Preparedness: • Cultivating a media relations strategy to face an adverse How Drug and Device Manufacturers Can event or government investigation head on Minimize Risk and Maintain Consistency When • Training on good document creation and retention practices • Analyzing the impact on the attorney-client privilege, Litigation Looms eDiscovery and document preservation Timothy Howard • Assessing the Science – Frequently overlooked concepts that must be applied to assess the strengths and weaknesses of the Assistant Counsel scientific basis for criticisms and support of the product Merck & Co., Inc. (North Wales, PA) • Coordinating crisis management efforts between the legal Jonathan Wasserman and business sides of the business Vice President & Associate General Counsel, • Developing a crisis checklist – considerations before Litigation & Government Investigations and after the manufacturer’s response Bristol-Myers Squibb Co. (New York, NY) • Responding once a medical journal tanks one of your products - FDA Kenneth F. Baum - talking to the press Partner - talking to employees and shareholders Goldman Ismail Tomaselli Brennan & Baum LLP • Preserving emails, drafts and other documents during the (Santa Monica, CA) flurry of media and investigatory activity • Protecting documents that will be subject to discovery Kevin Zielke • Tools to prevent the litigation from overtaking business Member objectives Dykema Gossett PLLC (Detroit, MI) • Assessing the business and reputational risks and consequences • Deciphering the science and working with sales and Moderated by: marketing teams to bring litigation sensitivity to the process • Bringing in outside counsel to gird yourself for the coming Melissa A. Geist litigation Partner Reed Smith LLP (Princeton, NJ) 12:50 Networking Lunch for Speakers and Delegates • Pre-Litigation Crisis Management – Developing a standard set of policies and procedures to counteract the silo mentality following a “signaling event” Hosted by:

Continuing Legal Education Credits Accreditation will be sought in those jurisdictions requested You are required to bring your state bar number to complete the CLE by the registrants which have continuing education appropriate state forms during the conference. CLE credits are Credits requirements. This course is identified as nontransitional processed in 4-8 weeks after a conference is held. for the purposes of CLE accreditation. ACI has a dedicated team which processes requests for state approval. ACI certifies that the activity has been approved for CLE credit by the Please note that event accreditation varies by state and ACI will make New York State Continuing Legal Education Board in the amount every effort to process your request. of 12.5 hours, including 0.5 ethics credits. An additional 3.5 credit Questions about CLE credits for your state? Visit our online CLE hours will apply to Master Class A and 2.5 credit hours to Master Help Center at www.americanconference.com/CLE. Class B participation. ACI certifies that this activity has been approved for CLE credit by the State Bar of California in the amount of 10.5 hours, including 0.5 ethics credits. An additional 3.0 credit hours will apply to Master Class A and 2.0 credit hours to Master Class B participation.

Conducting Successful Voir Dire In-House Round Table: and Selecting the Right Jury: Best Practices for Case A Novel Strategies, Tactics and B Management Ethical Considerations

Lori Cohen Debra L. Burns Shareholder Senior Counsel, Litigation/Investigations Greenberg Traurig LLP (Atlanta, GA) GE Healthcare (Wauwatosa, WI) Sidney Kanazawa Candice Ciresi Partner Senior Corporate Counsel, Vascular Therapies McGuireWoods LLP (Los Angeles, CA) Covidien (Plymouth, MN) With Commentary by: Jill Harrison Counsel The Honorable John Tunheim W.L. Gore & Associates, Inc. (Flagstaff, AZ) District Judge U.S. District Court, District of Minnesota Michael Howe • Understanding unique juror preconceptions in drug and Associate General Counsel device cases – how do these differ from traditional juror Biogen Idec (Weston, MA) attitudes? Jason D. Maxwell •Identifying problem jurors – product specific approaches Vice President & Associate General Counsel–Litigation •Exploring different methodologies and lines of questioning for selecting a jury Cardinal Health (McGaw Park, IL) •Ethical considerations in selecting and dismissing specific Moderated by: jurors •Addressing biases against large manufacturers and Julie Hardin minimizing the impact of negative media coverage Partner - gauging what jurors will not like about the manufacturer Reed Smith LLP (Houston, TX) • Effectively using jury questionnaires • Establishing an effective and beneficial relationship between • Framing questions for maximum information and candor in-house and outside counsel •Increasing the chance of selecting the right jury by knowing •Enhancing collaboration among the entire legal team, what to look for when retaining jury consultants streamlining communications and sharing of key information •Predicting juror favorability through psychological • Balancing government investigations with decreased monetary techniques resources • Analyzing the impact of runaway juries on verdicts in - protecting both the company and individual employees pending cases - doing more internally - best practices for reigning in runaway juries • Assigning in-house attorneys to monitor individual law firms • Managing unanticipated juror misconduct and managing those relationships • Preventing jurors from accessing electronic information •Retaining external lawyers that understand a drug or device’s about the case application process as well as the epidemiology of the product • Conveying to jurors the importance of having a culture in dispute of compliance and patient safety • Bringing the e-discovery process in-house and creating a competent e-discovery team • Techniques for resolving cases expeditiously • When is it cost effective to use national counsel? Regional counsel? - maximizing contribution of local counsel •Setting limits on outside counsel •More effectively sharing resources among the defense team •Successful methods for discovery that have resulted in lower costs •Placing more effective emphasis on litigation avoidance • Specifying how matters are to be staffed - limits on usage of new associates - client consent for changes in assigned attorneys - setting diversity requirements 3:15 p.m. Afternoon Refreshment Break Hosted by:

8 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed Breakout SESSION 2 | 3:30 p.m. - 4:30 p.m. (Choose C or D)

Controlling the Witness and the Combatting Claims Against Device Testimony: Practical Strategies for Manufacturers for Failure to Adequately C Conducting a Direct Examination D Train Physicians and Managing the of the Company Witness Proliferation of Dear Doctor Letters

Alexander G. Calfo Max C. Heerman Partner Principal Litigation Counsel Barnes & Thornburg LLP (Los Angeles, CA) Medtronic, Inc. (Minneapolis, MN) Ranjit S. Dhindsa Brandee Kowalzyk Partner Partner Hollingsworth LLP (Washington, DC) Nelson Mullins Riley & Scarborough LLP (Atlanta, GA) Jeffrey B. Shapiro James W. Huston Partner Partner Arnstein & Lehr LLP (Miami, FL) Morrison & Foerster LLP (San Diego, CA) With Commentary by: • Understanding the liability implications surrounding Dear Doctor Letters The Honorable John Tunheim - FDA draft guidance District Judge - communicating new information promptly to health care U.S. District Court, District of Minnesota practitioners •Is a Dear Doctor letter within the scope of the defendant’s • Selecting an effective expert witness: detailing the duty to warn? characteristics of a persuasive defense expert witness – - causation evidence what characteristics to look for and what to avoid • Defending against plaintiffs’ “failure-to-communicate” claims •Structuring testimony for court – discussing potential subjects for direct and cross • Addressing negligence claims at the outset of a potential lawsuit •Ensuring that the expert can explain the entire theory of the case in a clear concise fashion during his or her •Providing training on new and emerging medical devices testimony – low tech and high tech approaches and novel technologies • Personalizing and humanizing the company •Determining what constitutes “adequate” training in the minds of the Court • Utilizing repetition to help the issue sink in with the jury - taking affirmative action to train - strategic use of demonstratives and exhibits and court rules about pre-trial disclosure •Hiring a consultant surgeon to host training sessions and demonstrate a live procedure • Getting the expert to truthfully (and favorably) provide relevant history • Mitigating the liability risks of sales reps in the operating room •Showing that the company endeavored to do what was best for patient safety and took immediate action in light •Disseminating a prep guide for physicians with different of patient safety concerns techniques to use, issues that they have seen with the product •Using complex scientific evidence to persuade the jury • Who is at the front line of communication when a physician that use of the product did not cause the plaintiff’s injury has a specific targeted question about the device itself? •Understanding when to use medical journal reports, noting evidentiary state court limitations • Establishing fertile ground for cross-examination • Keeping track of information that is communicated to the expert for privilege purposes •Ethical obligations of counsel when utilizing experts in drug and device litigation •Demonstrating that company did not act irresponsibly in putting the product on the market •How to show that adverse event results were not statistically significant

Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed 9 Breakout Session 3 | 4:30 p.m. - 5:30 p.m. (Choose E or F)

Strategically Using Daubert in Post-Government Investigation, Now Cross-Examination to Establish What? Analyzing the Potential Litigation E Important Defense Themes F Ramifications for Pharmaceutical and Medical Device Manufacturers

Vincent A. Thomas, CPA, CFF, CVA, ABV Dwight O. Moxie Senior Managing Director Senior Counsel - Legal Department Forensic & Litigation Consulting Allergan, Inc. (Irvine, CA) Co-Leader, U.S. Intellectual Property Practice FTI Consulting (Chicago, IL) Steven M. Selna Partner Sharon L. Caffrey Drinker Biddle & Reath LLP (San Francisco, CA) Partner Duane Morris LLP (Philadelphia, PA) Eric W. Sitarchuk Partner Pamela J. Yates Morgan, Lewis & Bockius LLP (Philadelphia, PA) Partner • Handling derivative lawsuits stemming from a government Kaye Scholer LLP (Los Angeles, CA) fine/settlement - demonstrating that the company did not breach its fiduciary With Commentary by: duty to shareholders The Honorable John Tunheim • Combatting ambitious plaintiffs filing follow-on class action suits District Judge - practical strategies for keeping these suits at bay U.S. District Court, District of Minnesota • Minimizing the impact of a government investigation on a potential jury verdict • Deciding when to file a Daubert motion • Dealing with the expanded use of investigative subpoenas, • Utilizing the cross-examination to knock out the other broadened theories of liability, and pronounced criminal and side’s case law regulatory penalties • Positioning the company from a discovery standpoint • How does interagency coordination impact civil and for summary judgment government cases? • Avoiding the trap of reinforcing injury/loss • Defeating plaintiffs’ efforts to introduce evidence about • Challenging methodology through an analysis of the government enforcement actions in product liability cases underlying science • Handling parallel civil and government investigations • Focusing on assumed or inaccurate facts which the opposing expert may have relied on in forming his opinion 5:30 Conference Adjourns to Day 2 - discrediting through lack of expertise and/or preparation • Challenging the foundation of the plaintiff’s expert testimony by asking “how did you arrive at that conclusion?” • Developing a cross-examination methodology that creates a compelling trial record on each and every Daubert factor that may call into question the technical or scientific reliability of the proffered opinions • Persuading the court that the proffered opinions do not amount to scientific knowledge because they are not scientifically reliable • Highlighting areas where opposing expert agrees with your own expert to bolster your expert’s credibility • Understanding how governing law should shape the way you present to an expert • Challenging the quality of the peer review – determining the acceptable industry standard • How to impeach witness credibility - diluting the plaintiff witness opinion • What level of proof is expected when challenging an expert?

5:30 p.m. Networking Cocktail Reception Hosted by:

10 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed DAY 2: WEDNESDAY, DECEMBER 11, 2013

7:15 Registration & Networking Breakfast Robert K. Woo, Jr. Partner 8:00 Co-Chairs’ Opening Remarks King & Spalding LLP (Atlanta, GA)

8:15 United States v. Caronia One-Year Later: Moderated by: The Impact of the First Amendment Argument Abigail M. Butler on Off-Label Communication Partner Faegre Baker Daniels (Fort Wayne, IN) Michael Hulka General Counsel, Lilly Oncology & ImClone Systems • Determining factors for trying a case and how to select Senior Director, Assistant General Counsel which case to try Eli Lilly and Company (Indianapolis, IN) • Selecting issues that have the best chance of eliminating future claims Paul Kaufman • Understanding the purpose and benefits of a bellwether Assistant U.S. Attorney trial Chief of Civil Healthcare Fraud • Organizing your mass tort so that there is a fair and U.S. Attorney’s Office, Eastern District of New York objective way of moving the case along (Brooklyn, NY) • Ensuring that you have the right front-end logistics and procedural defense strategies in place John J. Pease • Implementing techniques for organizing and tracking a Senior Counsel voluminous amount of data Teva Pharmaceuticals (Horsham, PA) • When should tag alongs be transferred to an existing MDL? • Coordinating between state and federal court proceedings • Breaking down the Caronia decision and the current and implementing efficient processes for doing so state of off-label communication practices • Minimizing the enormous costs involved and the - truthful, non-misleading off-label speech gamesmanship that goes on for both sides • Analyzing the increasing claims against sales reps and • Analyzing what strategies are working well to move the the causes of action alleged MDL along more efficiently • Focusing on the ‘intent to misbrand’ rather than the ‘promotion of off-label use’ • Defending against plaintiffs using the regulatory 10:25 Morning Coffee Break limitations on drug and device marketing as a springboard for tortious claims Hosted by: • Exploring the current relationship between FDA and the manufacturers in light of Caronia 10:40 View from the Bench: Current Judicial Views on • Defining appropriate interactions between sales reps and physicians Pharmaceutical and Medical Device Litigation • Creating compliance protocols to reduce the risk The Honorable William S. Duffey, Jr. of off-label communications District Judge • Developing appropriate product promotion policies U.S. District Court, N.D. Georgia and responses to physicians’ unsolicited requests for information The Honorable David Herndon • Reigning in rogue sales reps who engage in illegal Chief Judge off-label promotion U.S. District Court, S.D. Illinois • Illustrating potential consequences of failing to abide by company policies and standards The Honorable Richard Kramer Judge 9:15 Exploring New Approaches to Bellwether San Francisco Superior Court Trial Selection Procedures and Emerging Best Practices for the Consolidation of Mass Torts The Honorable Theodore A. McKee Chief Judge Greg A. Dadika U.S. Court of Appeals for the Third Circuit Associate General Counsel, Litigation C. R. Bard, Inc. (Murray Hill, NJ) The Honorable Christopher Nuechterlein Magistrate Judge Charna Gerstenhaber U.S. District Court, N.D. Indiana Vice President and Head of Litigation Novartis Pharmaceuticals Corporation (East Hanover, NJ) The Honorable Cynthia M. Rufe District Judge Kim M. Schmid U.S. District Court, E.D. Pennsylvania Executive Managing Partner Bowman and Brooke LLP (Minneapolis, MN)

Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed 11 The Honorable Kaymani D. West 2:00 Afternoon Refreshment Break Magistrate Judge U.S. District Court, District of South Carolina 2:15 Coordinating Litigation Efforts Across Borders: Analyzing Product Liability Trends Outside the Moderated by: U.S. and the Impact on U.S.-Based Litigation Andrew T. Bayman Partner Adam Deutsch King & Spalding LLP (Atlanta, GA) Vice President and Associate General Counsel - Litigation, Investigations and Risk Management In products liability cases, there are often parallel federal and Biomet, Inc. (Warsaw, IN) state proceedings, with numerous depositions. When you have parallel cases addressing the same issues, which judge do you call? Kaspar Stoffelmayr Which time limits apply? If the state court action is ahead of Vice President & Associate General Counsel the federal action, do they defer? This session will offer a rare Bayer Corporation (Pittsburgh, PA) opportunity to hear the perspectives of renowned jurists from the state and federal bench, with an opportunity for attendees to Christopher D’Angelo ask questions. Gain valuable understanding of how members of Partner the bench coordinate and manage state and federal proceedings Montgomery, McCracken, Walker & Rhoads, LLP in pharmaceutical and device mass tort actions. (Philadelphia, PA) 12:00 Networking Luncheon for Speakers & Delegates • Assisting international legal teams with necessary product information and managing the cultural and language barriers 1:00 A Good Offense is the Best Defense: Effective Use • Identifying international jurisdictions that may be of Social Media in Products Liability Litigation potentially problematic for the drug or device manufacturer • Finding local attorneys who really understand the laws and Brennan Torregrossa regulations of the country you are being sued in Assistant General Counsel • Putting together defense packets that can be utilized in other GlaxoSmithKline (Philadelphia, PA) countries • Developing effective strategies for managing unexpected Jennifer Mingus Mountcastle product safety risks and issues arising from efforts to obtain Partner discovery crossing international boundaries Thompson Hine LLP (Columbus, OH) - depositions of foreign personnel - discovery of foreign labeling, regulatory, scientific, and • Uncovering inconsistencies in the plaintiff’s claim by corporate documents perusing social media sites for photos and videos • What impact does evidence related to your drug or device • Conducting a social media analysis of prospective jurors in a foreign countries have in the U.S.? before committing to a specific jury - determining what evidence is admissible and inadmissible • Understanding state laws regarding friending judges and • Analyzing the latest trends in the interplay between product government officials liability and criminal liability in Europe • Knowing when comments made online can become part • Using FDA approval as evidence of non-defectiveness of the evidentiary record outside the U.S. - alerting employees to the ramifications of tweets, blogs - educating non-U.S. judges and legislators and posts on potential litigation - coordination between communication of FDA and - establishing a corporate record retention policy applicable FDA-like entities in other countries to social media • Understanding foreign courts’ view on mass tort litigation • Meeting the requisite foundational elements of social media authentication 3:15 Main Conference Concludes • Making successful objections to keep out damaging posts and messages • Ensuring that uncovered information can be preserved, 3:30 p.m. – 5:30 p.m.

ETHICS stored and date stamped • Sending a retention letter to plaintiff’s counsel to prevent Post-Conference Business Development Master Class deletion of information or profiles from social media websites on Selecting and Evaluating Outside Counsel (see page 5 for details) Ethical Considerations • Delineating between ethical and unethical social media research when learning more about a plaintiff or juror • Finding information without a formal discovery process • Avoiding conduct that could be considered “pretexting” or deceptive as proscribed by state rules of professional conduct © American Conference Institute, 2013

12 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed CONFERENCE-AT-A-GLANCE

Pre-Conference Day One Day Two Monday, December 9, 2013 Tuesday, December 10, 2013 Wednesday, December 11, 2013

8:45 7:00 7:15 Workshop Registration Registration & Welcome Breakfast Registration & Networking Breakfast 9:30 8:00 8:00 A 50-State Drug & Med Survey: Drilling Co-Chairs’ Opening Remarks Co-Chairs’ Remarks Down into the State-Specific Legislation that Impacts Drug & Medical Device Litigation 8:15 8:15 [including preemption, consumer fraud Case Study from Mensing to Bartlett: United States v. Caronia One-Year Later: and patient safety] Determining Whether Design Defects The Impact of the First Amendment Claims are Preempted for Generic Argument on Off-Label Communication Manufacturers and the Potential Liabilities 9:15 9:15 Exploring New Approaches to Bellwether FDA Keynote Address Trial Selection Procedures and Emerging Best 9:55 Practices for the Consolidation of Mass Torts Morning Coffee Break 10:25 Morning Hosted by: Morning Coffee Break 10:10 Hosted by: Judicial Insights on Multidistrict Litigation 10:40 10:40 View from the Bench: Current Judicial Bolstering the Defense Position: Views on Pharmaceutical and Medical Device Effectively Defeating Class Certification Litigation 11:40 Crisis Management & Litigation Preparedness: How Drug and Device Manufacturers Can Minimize Risk and Maintain Consistency When Litigation Looms

2:15 12:50 12:00 Group Speed Networking Registration Networking Luncheon for Speakers and Delegates Networking Luncheon for Speakers and Delegates Hosted by: 3:00 1:00 Group Speed Networking 2:00 A Good Offense is the Best Defense: Facilitated by In-House Counsel BREAKOUT SESSION 1 (Choose A or B) Effective Use of Social Media in Products A. Conducting Successful Voir Dire and Liability Litigation Selecting the Right Jury: Novel Strategies, Tactics and Ethical Considerations 2:00 Afternoon Refreshment Break B. In-House Round Table: Best Practices for Case Management 2:15 Coordinating Litigation Efforts Across Borders: 3:15 Analyzing Product Liability Trends Outside the Afternoon Refreshment Break U.S. and the Impact on U.S.-Based Litigation Hosted by: 3:15 3:30 BREAKOUT SESSION 2 (Choose C or D) Main Conference Concludes C. Controlling the Witness and the Testimony: 3:30 Afternoon Practical Strategies for Conducting a Direct Post-Conference Business Development Master Examination of the Company Witness Class: In-House Counsel Perspective on Select- D. Combatting Claims Against Device ing and Evaluating Outside Counsel Manufacturers for Failure to Adequately Train Physicians and Managing the Proliferation of Dear Doctor Letters 4:30 BREAKOUT SESSION 3 (Choose E or F) E. Strategically Using Daubert in Cross- Examination to Establish Important Defense Themes F. Post-Government Investigation, Now What? Analyzing the Potential Litigation Ramifications for Pharmaceutical and Medical Device Manufacturers 5:00 5:30 Pre-Registration and Networking Cocktail Reception Welcoming Cocktail Reception Hosted by:

Evening Hosted by:

Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed 13 Sponsors The 18th Annual Drug & Medical Device Litigation Conference Appreciates The Support Of The Following Organizations

Lead Sponsors:

Greenberg Traurig LLP is one of the largest Morgan Lewis is a global law firm with 1,600 attorneys law firms in the United States with an in 24 offices worldwide. Our comprehensive life unprecedented domestic and global presence, sciences practice includes more than 200 lawyers, 1,750 attorneys and governmental affairs professionals, and more than 30 locations in the scientists and other technical specialists, many with advanced degrees, who have the United States, Latin America, Europe, the Middle East and Asia. As an integral part of the experience and capability to represent the full life cycle of FDA-regulated products. Our firm’s 600+ member litigation practice, GT’s Pharmaceutical, Medical Device & Health strength is our ability to work collaboratively across several practice areas, such as products Care Litigation team offers clients unmatched national coverage, as well as sophistication and liability, consumer fraud, government investigations and FDA regulatory counseling and experience in managing complex, high-profile cases for a wide range of clients. The more than compliance, to provide strategic solutions for the multi-faceted challenges our clients face. 100 attorney team is supported by complementary resources in the areas of health care law Morgan Lewis offers extensive capabilities and decades of experience coordinating complex and regulation, governmental investigations, governmental affairs and intellectual property. national litigation, in addition to providing efficient, powerful solutions for the increasingly For more information, please visit www.gtlaw.com. demanding discovery environment. We are nationally recognized for our leadership and innovation in developing alternative fee structures. For more information, please visit www.morganlewis.com.

Cocktail Hosted by:

King & Spalding is an international law firm with more than 800 lawyers in 17 offices across the United States, Europe, the Middle East and Asia. More than 300 of our lawyers, scientists and consultants are dedicated to representing life sciences companies, with specialized experience at every stage of the product life cycle. We add to this a range of trial experience that is increasingly unusual in large firms. Eleven King & Spalding lawyers were identified as ‘life sciences stars’ in the first-ever edition of LMG Life Sciences. In addition, the firm was recommended in the areas of FDA-medical device regulatory, government investigations/fraud & abuse and product liability. For more information, please visit www.kslaw.com.

Supporting Sponsors:

Dykema serves business entities worldwide on a wide range of Pharmaceutical and medical device companies turn to complex legal issues. Dykema lawyers and other professionals in Morrison & Foerster for their most important product 13 U.S. offices work in close partnership with clients to deliver liability matters. We have a keen understanding of the issues outstanding results, unparalleled service and exceptional value in every engagement. they face; the ability to convey their scientific and medical For more information, please visit www.dykema.com and follow Dykema on Twitter defenses to juries; and the know-how to advise on their regulatory, liability and recall issues. http://twitter.com/Dykema. www.mofo.com.

Global Sponsorship Opportunities Withe mor than 500 conferences in the United States, Europe, Asia Pacific, and Latin America, American Conference Institute (ACI) provides a diverse portfolio devoted to providing business intelligence to senior decision makers who need to respond to challenges spanning various industries in the US and around the world. As a member of our sponsorship faculty, your organization will be deemed as a partner. We will work closely with your organization to create the perfect business development solution catered exclusively to the needs of your practice group, business line or corporation. For more information about this program or our global portfolio of events, please contact: Wendy Tyler Head of Sales, American Conference Institute Tel: 212-352-3220 x5242 [email protected]

Conference Venue

Fresh from a multi-million dollar renovation, the New York Marriott Marquis brings the energy of Manhattan to your door, convenient to restaurants, Broadway Shows, and the heart of Times Square. NYC is the perfect backdrop for a December conference.

14 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed The 18th Annual Drug & Medical Device Litigation Conference Appreciates The Support Of The Following Organizations