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7:30 | Registration and Breakfast

8:30 | Welcome Remarks

8:45 | Hot Topics in the Drug & Device Industry: What Keeps In-House Counsel Awake at Night

  • Government and media scrutiny of Pharmaceutical pricing
  • Proposed legislation
  • Valeant/Turing
  • Patient assistance programs
  • Impact of biosimilars
  • Litigation Funding
  • Trends in litigation
  • Recent cases addressing Personal Jurisdiction
  • Volume of personal injury and mass tort matters

Jim Frederick, Partner, Goodell Devries

Connie Matteo, Assistant General Counsel, Pfizer

David Layfer, Senior Counsel, Business Legal, AbbVie

Eric Alexander, Partner, Reed Smith

9:45 | Risk Management Strategies for Pre-Litigation and Early Litigation

  • Strategies and practical tactics for managing and minimizing risks in this critical timeframe
  • Practical tips on internal company communications, FDA and labeling issues, and marketing issues

Michael Hecht, Partner, Venable LLP

Frank O’Hara, Office of General Counsel, Merck

10:45 | Break

11:00 | Experts

From vetting, discrediting, cross-examining and, hopefully, excluding plaintiff’s experts to identifying, interviewing, developing and presenting defense experts who will ably assist during the pretrial process and effectively communicate complex medical and scientific concepts at trial, the role of expert testimony in drug and device cases cannot be underestimated. In light of the continued evolution of drug and device litigation, our panel will discuss key considerations on the use and abuse of expert testimony from both the outside and in-house counsel perspectives and offer practical strategies aimed to increase your likelihood of success in this battle.

James Mizgala, Partner, Tucker Ellis LLP

Ronni Fuchs, Partner, Pepper Hamilton LLP

Matthew Silversten, Deputy General Counsel, Astellas US LLC

Hon. Mark I. Bernstein, recently retired from Philadelphia Court of Common Pleas

12:00 | Preemption: The Struggle Continues on All Fronts

  • PMA medical device – components, off-label promotion; parallel claim developments.
  • Non-PMA medical device – Buckman; design changes as “impossible”; possibly add other preemption developments that don’t fall into these other categories, such as duty to recall, IDE devices, minor categories of devices; and OTC drugs
  • Innovator drugs – non-CBE warning claims; Buckman; design changes as “impossible”
  • Generic drugs – demise of both FDA rulemaking and Justice Scalia; duty to update (including where we go should preemption fail); parallel claims

James Beck, Counsel, Reed Smith

Stephen McConnell, Partner, Reed Smith

Steve Phillips, Special Counsel, Medtronic

Donald LeGower, Senior Counsel, Litigation, Bristol-Myers Squibb

1:00 | Lunch – sponsored by Segal McCambridge Singer & Mahoney

2:00 | Be Prepared: Best Practices, Tips and Strategies for Trial Preparation

  • Initial planning
  • What if it is a bellwether trial in a larger mass tort?
  • Strategy for written discovery
  • Strategy for depositions
  • Strategy for Pretrial motions
  • Handling deposition designations
  • Handling exhibits

Sherry Knutson, Partner, Tucker Ellis LLP

Craig Thompson, Partner, Venable LLP

Jeff Lilly, Partner, Gordon & Rees LLP

Beth Rose, Partner, Sills Cummis PC

3:00 | Trial: Voir Dire and Jury Selection

  • Reaching Your Audience: An Overview of juror attitudes and experiences with Pharmaceutical companies and Medical Devices
  • Embracing the Reptile: How to use fear to motivate jurors to side with the Defense.
  • Identify your worst and hide your best: Sample questionnaire and voir dire questions from drug & device cases to uncover juror bias without exposing your good jurors.
  • When Voir Dire is Limited: Strategies and techniques for jury selection in jurisdictions without attorney voir dire
  • Tales from the War Zone: Roundtable discussion of successes and failures in the field

Christina Marinakas, J.D., Psy.D., Director Jury Research, Litigation Insights

Walter (Pete) Swayze, III, Shareholder, Segal McCambridge Singer & Mahoney

Amy Rudd, Partner, Dechert LLP

4:00 | Break

4:15 | New FDA Guidance For Medical Device Manufacturers and What It Means For Your Business

This presentation will focus on three inter-related recent announcements from the FDA:

  • Benefit-Risk Factors Considered in Compliance Determinations for Approved Products
  • Benefit-Risk Factors Considered in Pre-Market Assessments
  • Modifications to the Unique Device Labeling Rule

Abby Sacunas, Member, Cozen O’Connor

Gabriel Holdsman, General Counsel US, Senior VP Legal Operations, BTG International, Inc.

5:15 | Protecting Confidential Information: Corporate Counsel’s Ethical Obligations

  • Costs of loss of confidential information to businesses
  • History of how modern communications technology has shaped regulations relating to confidentiality
  • Discussion of ABA Model Rule 1.6(c) and its associated comments, which create an express obligation to protect confidential information.
  • Discussion of the adoption of Model Rule 1.6(c) by state legal regulatory bodies
  • Steps in-house counsel can take to ensure their external counsel complies with new rules
  • Steps in-house counsel can take to ensure compliance within their own organizations

Peter Norman, Co-Founder, Winnieware LLC

6:15 | Adjourn

6:30 | Cocktail Reception – sponsored by Dechert

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