Conference Agenda Day 1

Wednesday, December 8, 2010

7:15 Registration & Welcoming Breakfast

8:15 Co-Chairs’ Opening Remarks

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

Gary McConnell
Vice President and Assistant General Counsel
Bayer (Pittsburgh, PA)

8:30 Preventing Emotion from Overcoming Reason When There Has Been a Drug or Device Recall: Effective Litigation and Risk Minimization Strategies

Sarah M. Padgitt
Senior Counsel
Baxter H ealthcare Corporation (Deerfield, IL)

David N. Royster
Assistant General Counsel, Global Business,
Litigation & Risk
Zimmer H oldings, Inc. (Warsaw, IN)

Michael X. Imbroscio
Partner
Covington & Burling LLP (Washington, DC)

David E. Dukes
Partner
Nelson Mullins LLP (Columbia, S.C.)

Moderator:

Kim M. Schmid
Managing Partner, Minneapolis
Bowman and Brooke LLP (Minneapolis, MN)

• Analyzing the nature of the recall
• 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
• Selecting neutral jurors
• identifying potentially dangerous jurors
• refining jury selection strategies during challenging times for large companies
• 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
• Positioning recall-related evidence that gets in to show that the company acted responsibly
• Assessing the level of public relations damage
• when and how to make effective use of media 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

9:45 MDL Insider Strategies: How to Define “Winning” the MDL and Best Methods to Achieve that “Win”

Teresa Cotton Santos
Assistant General Counsel Litigation
Eli Lilly & Company (Indianapolis, IN)

Michael K. Brown
Partner
Reed Smith LLP (Los Angeles, CA)

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

Christy Jones
Partner
Butler Snow O’Mara Stevens & Cannada PLLC
(Jackson, MS)

Fred T. Magaziner
Partner
Dechert LLP (Philadelphia, PA)

• What do we mean by “winning” anyway in this context?
• Once in the MDL....what cases should stay?
  • Are you - the individual case - in or are you out?
  • Scope of MDL; how defined by JPML and what to do about it
  • Transferring in/Transferring out- the tag-alongs and the opt-outs
• How to Ring the Bell for your client with the Bellwether (and avoid having your clock cleaned....)
  • Best methods for your internal analysis of candidates
  • What must you have at your fingertips for that analysis and how to get there using your MDL and the judge
  • Timing: when is the right time and how to weave into the Rule 26 Schedule
  • Staging, planning, making the selection process work for you
  • Working with the judge in the selection and overseeing of the process
  • Strategic venue and other such legal considerations
  • After the bellwether...what next? H ow to use the Bells to effectuate a global settlement
• Implementing effective procedural strategies for “winning” the MDL
  • Strategic scheduling: When to file your motions?
  • How limited should the discovery be–pros and cons to bifurcation, trifurcation, single issue approach
  • Causation, causation, causation - when and how to present
• Multiple defendants in an MDL – how to keep from stepping on toes
• Coordination with related state court proceedings
  • Make the simultaneous proceedings work for you rather than work you over
  • Help the Judges and competing camps of attorneys come together rather than pull you apart
• Practical strategies for effective coordination of remanded cases
  • Where and how to go/land when the big dance is over especially following the Bellwethers

11:00 Morning Coffee Break

11:45 How the Explosion of Social Media, Cloud Computing and New Forms of DTC Marketing are Changing the Products Liability Playing Field

Patrick L. Gibson
Assistant Counsel, Office of General Counsel
Merck & Co., Inc. (Kenilworth, NJ)

Kelly Falconer Goldberg
Corporate Counsel
Pfizer Inc. (New York, NY)

William B. Dodero
Senior Counsel
Bayer (Wayne, NJ)

Joseph Leghorn
Partner
Nixon Peabody LLP (Boston, MA)

Dave Rogers
Senior Manager
Ernst & Young LLP (Dallas, TX)

Moderator:

Rebecca Weinstein Bacon
Partner
Barlit Beck H erman Palenchar & Scott LLP (Chicago, IL)

• Understanding the potential pitfalls from internal and external social media sites
• Analyzing what information relating to your client can be found on different sites
• Examining the considerations behind the development of company social media and web policies
• Dissecting how companies are juggling greater information sharing with the underlying regulatory requirements
  • impact of current rules and guidance relating to risk warnings
  • analysis of the FDA’s recently proposed DTC rules
  • operating under subjective standards relating to television and radio ads
• Understanding the complexities of cloud computing, and key considerations for discovering information in the Cloud and associated risks
  • how to proactively limit discovery issues
• Controlling risks relating to discussion of adverse events and FDA compliance efforts
• Assessing the impact on the learned intermediary doctrine of:
  • active DTC marketing
  • widespread public use of information on blogs
• Anticipating and countering plaintiff strategies to make use of information on the web
  • identifying comments on blogs and medical web sites that may lend support to the manufacturer

1:00 Networking Luncheon for Speakers and Delegates Sponsored by:

BREAKOUT SESSION 1
Choose A or B | 2:15 pm

A. Managing the New Threat that Individual Corporate Officer Liability Poses to Pharmaceutical Companies Valli F. Baldassano Executive V.P. & Chief Compliance Officer Cephalon (Frazer, PA) James Doran Partner Waller Lansden Dortch & Davis, LLP (Nashville, TN) David L. Douglass Partner Shook Hardy LLP (Washington, D.C) Analyzing the standards for personal liability as applied in life sciences cases comparing state views relating to what is knowing or reckless conduct judicial assessments of what constitutes acting in bad faith 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 to recall or not to recall a product Understanding potential criminal liabilities under FCPA, RICO and other statutes Assessing what types of corporate conduct are coming under criminal scrutiny failures to report complaints or events to the FDA performance of unannounced recalls Scrutinizing recent treatment of individual officers in negotiated DOJ settlements Reviewing the products liabilitycase at hand to develop a successful big picture defense strategy that does not open the door to claims against individual corporate officers likelihood of and nature of potential government inquiries relating to the product determining whether plaintiff theories may focus on the conduct of any specific individuals incorporating trial strategies for minimizing subsequent risks to individual executives

B. Navigating the Fall-Out from Preemption: Preserving the Defense in Your Device Cases and Developing Strategies for FDA Testimony in Drug Litigation David Wise V.P. & General Counsel Cyberonics (Houston, TX) Patricia Lowry Partner Squire, Sanders & Dempsey L.L.P. (West Palm Beach, FL) Matthew Keenan Partner Shook Hardy LLP (Kansas City, MO) John P. Lavelle, Jr.  Partner Morgan Lewis LLP (Philadelphia, PA) Determining what device cases are good candidates for a preemption defense recent application of the Levine and Riegel decisions practical tips and strategies for preserving and making a preemption argument building a regulatory record which shows FDA involvement Developing strategies for admission of evidence relating to interactions with FDA over product labels, warnings and business conduct Deciphering when and how to introduce FDA evidence in pharmaceutical cases analyzing recent opinions construing Levine determining what will help the defense protecting FDA opinions from plaintiff challenges Combating plaintiff ’s use of FDA experts and regulatory history excluding testimony by plaintiff ’s regulatory expert

3:00 Afternoon Refreshment Break

 

BREAKOUT SESSION 2
Choose C or D | 3:15pm

C. Navigating Insurance Coverage and Defense Issues with Carriers While Defending a Life Sciences Lawsuit Stephen B. Harris Life Sciences Casualty Manager Chubb & Son (Whitehouse Station, NJ) Christopher M. Keefer Corporate Counsel and Director Biomet (Warsaw, IN) George Ng Senior Corporate Counsel Spectrum Pharmaceuticals, Inc. (Irvine, CA) Sonia M. Valdes Assistant Vice President Life Sciences Chubb & Son (Warren, NJ) Michael P. Bruyere Partner Fields H owell LLP (Atlanta, GA) Understanding the tension between coverage issues and defending the underlying litigation How decisions made during the underwriting process may affect claims handling and coverage Making an effective initial evaluation of claims the proper role of risk managers and risk management policies Teaming with carriers to select independent defense counsel and experts Getting engaged early in the case to develop, agree upon, and implement a comprehensive defense strategy Understanding the differences and similarities in the roles of defense and coverage counsel ethical standards Determining the proper flow and content of information concerns relating to attorney-client privilege and work product doctrines Potential impact of concurrent coverage litigation issues relating to overlapping coverage periods and policies settling with third parties while the main claims progress

D. Dissecting Evolving Claims against Generic Drugs and the Naming of Brand Manufacturers as Co-Defendants Jerry Jabbour Senior V. P., Head of Global Legal Affairs & U.S. General Counsel Wockhardt (Parsippany, NJ) Christine M. Riley Litigation Counsel Taro Pharmaceuticals (Hawthorne, NY) Steven Casey Partner Balch & Bingham LLP (Birmingham, AL) Paul W. Schmidt Partner Covington & Burling LLP (Washington, DC) Assessing recent US Supreme Court attempts to determine the legal duties of generic makers analyzing the Court’s inquiry relating to the duty to warn and liabilities for inadequate warnings Surveying current pharmacovigilance requirements for generics vs. conduct required of brand manufacturers Defense tactics for pointing to compliance with generic labeling requirements Techniques for successfully getting the generic defense perspective across to the judge/jury Anticipating the potential impact should the Supreme Court establish that the generic industry owes certain warning duties examining additional questions relating to potential continuing duties Analyzing current plaintiff theories of responsibility for generics How courts have viewed attempts to make brand manufacturers liable for generics post-Conte Responding as co-defendant when both brand and generic manufacturers are cited in the complaint

4:15 Alternative Litigation Strategies and Models
Directed at Reducing Legal Costs

Jason D. Maxwell
Vice President &
Associate General Counsel--Litigation
Cardinal H ealth (McGaw Park, IL )

Marla S. Persky
Senior Vice President, General Counsel and Secretary
Boehringer Ingelheim USA Corporation (Ridgefield, CT)

Marc A. Polk
Associate General Counsel/Litigation
Covidien (Mansfield, MA)

Erica Visokey
Assistant Counsel
Stryker (Mahwah, NJ)

Daniel Torpey
Partner
Ernst & Young LLP (Dallas, TX)

Moderator:

Diane E. Lifton
Partner
Hughes H ubbard & Reed LLP (New York, NY)

• Preventing litigation through developing methods for successful risk assessment
• Implementing tactics for getting rid of low level cases more quickly and inexpensively
• Fostering savings through more effective sharing of resources amongst the defense team
• Looking at whether the “virtual law firm” model has proven effective from a costs perspective
• Avoiding cookie-cutter approaches to document review and production
  • providing assurance with respect to the electronic discovery process, validating your data sets, and effective data collection strategies
  • empowering the litigation team to visualize the underlying data set and employ effective techniques to strategically analyze documents
  • successful methods for managing discovery that have resulted in lower costs
• Analyzing how legal fees are being structured
  • is the hourly rate really fading away?
  • looking at the latest trends and innovations in alternative fee arrangements
• Building some flexibility into the fixed fee or other alternative arrangement
• Budgeting to meet the client’s targeted costs
• Implementing revised law firm cost structures that will keep costs down
• Placing more effective emphasis on litigation avoidance
  • increasing awareness of potential products liability risks at different product life cycles
  • implementing more successful risk assessment protocols for regulatory and compliance decisions

5:30 pm Cocktail Reception Sponsored by: