Agenda Overview | Group Meet-up | Workshops | Day 1 | Day 2

8:30 Co-Chairs’ Opening Remarks

Barbara Ashley
Principal Litigation Counsel
Medtronic, Inc. (Fridley, MN)

Monique Hunt McWilliams
Assistant General Counsel
Eli Lilly and Company (Indianapolis, IN)

8:45 Applying Favorable Recent Judicial Decisions and
         Policy Trends to Strengthen Your Class Actions Defense Strategies

Christopher L. Gaenzle
Assistant General Counsel
Pfi zer Inc. (New York, NY)

Leah Lorber
Assistant General Counsel Policy & Director,
Public Policy & Advocacy
GlaxoSmithKline (Washington, DC)

J. Russell Jackson
Partner
Skadden, Arps, Slate, Meagher & Flom LLP
(New York, NY)

Brian Troyer
Partner
Thompson Hine LLP (Cleveland, OH)

• Assessing how the Supreme Court’s decision in Wal-Mart v. Dukes supports the mounting of defenses to claims against the industry
  • dissecting what claims belong in a 23(b)(2) class
  • understanding the commonality standard adopted by the Court
• Analyzing the Court’s position on the burden of proof for class action proponents
• Anticipating how lower courts will apply the Court’s “rigorous analysis” standard
• Considering whether Daubert will be applied to expert testimony at the class certifi cation stage
• Examining whether arbitration may be a tool for resolving some plaintiff claims after Concepcion
  • enforceability of class action waivers
• Applying recent decisions rejecting “economic loss” or “diminished value” claims against life sciences companies
  • understanding whether product safety is at issue in economic loss class actions
• Attacking the class defi nition at the pleading stage: overbreadth and ascertainability
• Defense tactics for presenting favorable economic analysis in class action litigation
• Effective venue strategies following recent interpretations of CAFA in the Circuit Courts
• How to use the denial of class certifi cation offensively even after Smith v. Bayer Corp.
• Looking at recent public policy and legislative initiatives and how legal reform may impact on manufacturer liabilities

9:45 Spotlight Remarks: Case Management and Settlement of Pharmaceutical Mass Tort Litigation

Francis McGovern
Professor
Duke Law School and Advisor to the U.S. JPMDL

Professor McGovern’s name is virtually synonymous with “mass claim” litigation. As a court-appointed special master or neutral expert, he has developed solutions in most of the signifi cant mass claim litigation in the U.S., including his current work involving the silicone gel breast implant litigation. Seeing that these mass claims would take years to reach and proceed through trial at tremendous expense to the parties and courts, Professor McGovern pioneered new roles for court-appointed special masters as “case managers” and “settlement masters.” As a case manager, he organizes the pretrial administration of a case, and uses ADR techniques to help the parties agree on effi cient discovery approaches and schedules. To facilitate his efforts, Professor McGovern has created very sophisticated computerized models of the valuation of these massive claims.

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10:15 Morning Coffee Break

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10:30 Personal Liability Concerns for Life Sciences Counsel and other Industry Professionalss

Karl Buch Senior Corp. Counsel
Pfi zer, Inc. (New York, NY)

Jean Holloway
VP & Deputy General Counsel
Medtronic (Fridley, MN)

Shannon Klinger
VP Legal & Intellectual Property and General Counsel,
North America
Sandoz (Princeton, NJ)

Andy Rittenberg
Senior Director Corporate Legal Affairs
Gilead Sciences (Foster City, CA)

Michael L. Koon
Partner
Shook Hardy & Bacon LLP (Kansas City, MO & Washington, DC)

Moderator:

Lori G. Cohen
Shareholder
Greenberg Traurig LLP (Atlanta, GA)

• Analyzing what may constitute “fraud on the FDA” and the standards for personal liability that apply to conduct in drug and device companies
  • comparing state views relating to what is knowing or reckless conduct
  • judicial assessments of what constitutes acting in bad faith
  • applying the Park Doctrine criteria released earlier this year by FDA
• Dissecting recent government prosecutions naming individual executives as defendants
  • how marketing activities by the company may expose executives to personal liability
  • individual accountability for decisions relating to manufacturing quality
  • failures to report complaints or events to the FDA
• Scrutinizing recent treatment of individual offi cers in negotiated DOJ settlements
  • potential exclusion from federal healthcare programs
• Developing a successful big picture defense strategy in products liability cases that does not open the door to claims against individual corporate offi cers
  • determining whether plaintiff theories may focus on the conduct of any specifi c individuals
  • incorporating trial strategies for minimizing subsequent risks to individual executives
• Juggling concerns relating to individual offi cers with protecting the client in the matter at hand
  

11:45 Creating Exit Strategies for Mass Torts and Selecting the Most Advantageous Settlement Model

Greg Dadika
Assistant General Counsel, Litigation
C.R. Bard, Inc. (Murray Hill, NJ)

Adam Deutsch
Vice President and Associate General Counsel, Litigation
Biomet (Warsaw, IN)

Michael Panagrossi
Associate General Counsel
Purdue Pharma (Stamford, CT)

Madeleine M. McDonough
Partner
Shook Hardy & Bacon LLP
(Washington, DC and Kansas City, MO)

Robb Patryk
Partner
Hughes Hubbard & Reed LLP (New York, NY)

Moderator

John P. Hooper
Partner
Reed Smith LLP (New York, NY)

• Is settlement a better option?
  • conducting a litigation risk assessment that provides apotential range of loss and quantifi es the likelihood of that loss
  • developing a preliminary settlement analysis identifying the potential range for the cost of the settlement and the likelihood that a settlement would eliminate all or some of that risk
• Determining client’s willingness to consider resolution vs.continued litigation
  • does the benefi t of a settlement outweigh the risk oflitigation?
  • is a settlement a viable fi nancial option for the client?
  • what impact would a settlement have on the client’s customers, shareholders, investors, business partners, reputation in the marketplace and public opinion?
  • would a settlement impact the client’s defense of other products?
  • can you minimize the risk that a settlement will make the client a target for the plaintiff ’s bar in the future?
• Developing a settlement strategy and determining the appropriate settlement model if settlement is the best option
  • when is the best time to execute on a strategic settlement initiative?
  • which adversary or adversaries would make the best settlement partner(s)?
  • are you better off with a big tent global settlement or developing a more narrowly focused settlement requiring multiple deals?
  • which settlement model will best reduce future claims (“the tail”)?
  • is there a class action vehicle available to provide a release for all or part of the liability?
• Designing a settlement model
  • which settlement model will best enable you to limit overall exposure and cost? -
  • will conduct changes be a part of the overall resolution or will it be limited to fi nancial recovery?
  • will the model provide you with the release you need?
  • does it comply with statutory and other reporting requirements and will it survive judicial scrutiny?
• Executing on the settlement
  • preparing internal and to the extent necessary external communication plans
  • maintain drafting control over all agreements and internally articulate and draft the critical sections of the settlement agreement even before you negotiate
  • addressing your adversaries’ important issues (payment and timing of payment) as early as possible to obtain leverage/credibility on issue important to your client
  • negotiating confi dentiality up front and attempting to make it unilateral
  • tactics for leaving on good terms to facilitate partnering to deliver the deal

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1:00 Networking Luncheon for Speakers and Delegates

Sponsored by:

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2:30
A Defense Tactics for Generic and Brand Pharmaceutical Companies after Mensing and Levine	B Combating Negative Perceptions when Selecting and Communicating with Jurors
John Duff Senior Director Legal Actavis (Morristown, NJ)	Ken Broda-Bahm, Ph.D. Senior Litigation Consultant Persuasion Strategies (Denver, CO)
Christine Riley Litigation Counsel Taro Pharmaceuticals (Hawthorne, NY)	Robert H. Alexander, Jr. Principal The Law Offi ce of Robert H. Alexander, Jr., P.C. (Oklahoma City, OK)
Randall L. Christian Partner Bowman & Brooke LLP (Austin, TX)	W. Ray Persons Partner King & Spalding LLP (Atlanta, GA)
Paul Schmidt Partner Covington & Burling LLP (Washington, DC)	Linda S. Svitak Partner Faegre & Benson LLP (Minneapolis, MN)
Moderator: Mary Nold Larimore Partner Ice Miller LLP (Indianapolis, IN)
Assessing how the Court in Mensing determined the legal duties of generic makers analyzing the Court’s inquiry relating to the duty to warn and liabilities for inadequate warnings dissecting Mensing’s impact on plaintiff state law claims How the court reconciled the Mensing decision with the holding in Levine I know it when I see it: the presumption against preemption Surveying current pharmacovigilance requirements for generics vs. conduct required of brand manufacturers Defense tactics for pointing to compliance with requirements and getting the generic defense perspective across to the judge/jury Will Mensing breathe new life into Conte? Tactics for responding as co-defendant when both brand and generic manufacturers are cited in the complaint understanding how disunion on the defense side can lead to bad results working together in the courtroom with co-defendant brand or generic tactics for presenting a united front on warning, testing and other issues Post-Levine procedural and evidentiary strategies for brand manufacturers navigating contrasting treatment of FDA evidence in different courts the impact of Dobbs v. Wyeth on the viability of preemption under Levine	Tactics for creating opportunities to share positive information Educating jurors to think positively about the drug approval process Assessing how juror perceptions may vary by age, region, and ethnicity Analyzing the social climate for your client in a particular case - gauging what jurors will not like about your client - impact of the company’s DTC advertising on attitudes Incorporating useful jury research into your trial strategies Employing tailored jury selection techniques in high-risk cases and plaintiff-oriented jurisdictions Putting adverse events in context Arguing persuasively about product risks and studies Techniques for demonstrating a philosophy of compliance

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10:15 Morning Coffee Break

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3:30
C Proactive Litigation Strategies for Responding to Government Investigations and Increased Regulatory Enforcement	D Navigating Unclear Disclosure Obligations for Life Sciences Companies and Counsel
Howard Cyr Senior Counsel, Legal Affairs Teva Pharmaceuticals (North Wales, PA)	Brennan Torregrossa Assistant General Counsel GlaxoSmithKline (Philadelphia, PA)
Perry Goldman Vice President, Legal Affairs Actelion Pharmaceuticals (South San Francisco, CA)	Gay Parks Rainville Partner Pepper Hamilton LLP (Philadelphia, PA)
Ashok David Marin Senior Counsel, Global Compliance GE Healthcare (Princeton, NJ)
Luke Mette Deputy General Counsel, Litigation AstraZeneca (Wilmington, DE)
Paul J. Kaufman Chief of Civil Health Care Fraud U.S. Attorney’s Offi ce, Eastern District of New York
Paul Kaufman Assistant U.S. Attorney Eastern District of Pennsylvania
John Dodds Partner Morgan Lewis LLP (Philadelphia, PA)
Current government enforcement landscape enforcement priorities False Claims Act violations – impact of recent amendments, rise of state False Claims Acts Foreign Corrupt Practices Act violations – focus on medical device industry State Attorney General/OMIG actions enhanced whistleblower incentives and opportunities focus of recent investigations and settlements kickbacks marketing of misbranded or unapproved products off-label promotion manufacturing issues New theories of liability and investigative techniques Best practices for responding to a government investigation successful recent defense tactics how to handle whistleblowers Meeting special challenges where it is alleged that a product had not secured appropriate FDA approvals Best practices for handling parallel civil litigation and government investigations controlling the fl ow of information between the cases	Assessing how the Supreme Court’s decision in Matrixx impacts on the industry Drilling down to assess what Matrixx requires companies to disclose what needs to be included in corporate press releases? how do you operate now, in areas where there are no bright-line standards? assessing the body of prior disclosures to determine materiality potential impact on clinical trials Implementing a plan for improved internal analysis and external reporting of adverse events Forecasting how the Supreme Court’s inquiry into the particular actions of one biotech company will be held to apply to other industry conduct Analyzing how courts will consider questions of statistical signifi cance is the presence or absence of statistical signifi cance even material? Applying SEC rule 10b-5 to information known to life sciences clients what information may be relevant to investors? Anticipating what types of corporate statements will be construed as misleading because they omit negative data Public relations strategies for when a drug has had numerous adverse events How counsel should balance the ethical obligation to report various types of wrongdoing with the duty to preserve client confi dences discerning what data is confi dential

4:30
E Diversity: What are Corporate Counsel Looking for and has it Fallen by the Wayside?	F Post-Recall Defense Strategies for Drug and Device Litigators
Monique Hunt McWilliams Assistant General Counsel Eli Lilly and Company (Indianapolis, IN)	Howard Dorfman Vice President & General Counsel Ferring Pharmaceuticals (Parsippany, NJ)
Alan W. Tamarelli, Jr. Assistant Counsel Merck & Co., Inc. (North Wales, PA)	Janet Richardson Division Counsel Abbott Medical Optics (Santa Ana, CA)
Diane E. Lifton Partner Hughes Hubbard & Reed LLP (New York, NY)	Anthony P. Tinari Senior Vice President and General Counsel ConvaTec (Skillman, NJ)
	Tarek Ismail Partner Goldman Ismail Tomaselli Brennan & Baum LLP (Chicago, IL)
	John Dames Partner Drinker Biddle & Reath LLP (Chicago, IL)
What specifi c evidence of diversity is being sought from outside counsel? how have these needs changed/evolved? Weighing whether law fi rm layoffs have dealt a setback to recent progress impact of the recession Defi ning “good faith efforts” General trends they are looking for their firms to embrace tapping the diversity talent pool proof of tangible diversity growth Diversity expectations with regards to: firm size relationship partners breakdown of teams “Best practices” that the clients are looking for Assessing the impact of the virtual law firm on diversity Keeping on track when there is staff turnover Factoring work-life balance programs within the demands of high stakes litigation Particular challenges for small and mid-size firms	Analyzing the nature of the recall or withdrawal determining what if any safety issues are involved Developing your recall trial strategy vs. defending a product still on the market coordinating mass torts defense with related regulatory actions and investigations walking the client through potential negative trial considerations Excluding matters relating to the recall at trial evidentiary strategies for keeping things out under Rule 407 exceptions to the Rule and recent judicial interpretations Determining whether the company’s interactions with FDA helps to show responsible conduct Favorably positioning recall-related evidence that gets in to the trial Assessing the level of public relations damage to your client when and how to make effective use of consultants Walking the client through the difficult issues Steps for preventing jurors from becoming biased against the manufacturer Weighing the potential impact when your competitor has undergone a recall analyzing products and facts for similarities Tailoring a causation defense that will be effective for putting the recall in a proper context

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5:30 Networking Cocktail Reception

Sponsored by:

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