Conference Agenda Day 2

Thursday December 10th, 2009

8:15 Co-Chairs’ Remarks

8:30 Impact of Stepped-Up Government Regulatory and Enforcement Activity on Product Claims and Litigation Strategies

Lauren Freeman-Bosworth
Legal Director
Merck and Co., Inc. (Kenilworth, NJ)

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

Daniel L. Ring
Partner
Mayer Brown LLP (Chicago, IL)

  • How increased FDA regulatory activity is impacting on current litigation
    • waging evidentiary battles to exclude subsequent FDA mandates relevant to the product
    • looking at what is getting admitted and what defense counsel are keeping out
  • Synchronizing civil litigation and concurrent government inquiries
    • analyzing your client’s big picture exposures
    • assessing potential corporate pressures to dispose of the government matter first
    • assigning counsel to their different roles
    • controlling the flow of information between the cases
    • excluding matters relating to a government enforcement action from the products liability case
    • ensuring strategies in one case do not negatively impact the other
    • considerations relating to minimizing potential awards of punitive damages
  • Current government enforcement priorities and how different types of inquiries may impact defending plaintiff lawsuits
    • advertising to consumers
    • sales force practices
    • marketing of misbranded or unapproved products
    • off-label promotion
    • manufacturing issues
    • False Claims Act, FCPA, and RICO violations
    • state attorney general actions
  • Having an accurate perception of how courts and juries will perceive theories of liability stemming from sales rep assertions and conduct
  • Assessing the impact on future litigation of increased transparency requirements
    • factoring enhanced data mining opportunities for plaintiff attorneys into defense strategies
    • anticipating increased focus on certain required reporting
    • adverse event reports
    • clinical trial documentation

 

9:15 Judicial Keynote Address

Hon. John G. Heyburn II
Chairman
United States Judicial Panel on Multidistrict Litigation

9:45 Morning Coffee Break

10:00 Avoiding Unnecessary Costs and Coordination Nightmares when Serving as or Working with Regional Counsel

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

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

Lisa Martinez-Wolmart
Legal Director, Litigation
Merck & Co., Inc. (Kenilworth, NJ)

Abigail M. Butler
Partner
Baker & Daniels LLP (Fort Wayne, IN)

Moderator:
Richard Clay
Partner
Dinsmore & Shohl LLP (Louisville, KY)

  • Making the initial litigation assessment of the extent of the need for regional or local counsel
  • Examining how to maximize the contribution of local counsel
    • when local counsel may serve as the expert on local rules, practice, and state substantive law
    • different perspective of national coordinating counsel, in-house and insurance lawyers
  • Weighing the use of different models for coordinating national approaches to litigation
    • “mail drop” approach to local counsel
    • including regional and local counsel in brief preparation, and review of state law issues
    • using local counsel for substantive motion practice, settlement conferences, and at trial
    • assigning aspects of the case to different respective team members across regions
  • Following guidelines set by the client that pertain to regional counsel
  • Avoiding redundancies and ensuring that costs are not unnecessarily increased on the local level
  • Managing coordinated responses to discovery
  • Assigning clear responsibility for developing the client’s story
  • Avoiding turf wars and ethical problems
  • Ensuring clear communicating over matters such as:
    • who is supervising, who is responsible, who will appear in court, whose name will be on the pleadings, etc.
  • Top 10 things not to do when working as or with regional counsel

 

11:00 View from the Bench: Spotlight on Recent MDL Litigation

The Honorable W. Royal Furgeson, Jr.
JPML Multidistrict Panel Judge
United States District Court for the
Northern District of Texas

Chief Judge David R. Herndon
United States District Court for the
Southern District of Illinois

The Honorable David A. Katz
United States District Court
Northern District of Ohio

The Honorable John R. Tunheim
U.S. District Court
District of Minnesota

The Honorable Sandra Mazer Moss
Coordinating Judge, Complex Litigation Center
Court of Common Pleas
Philadelphia

Moderator:

Andrew T. Bayman
Partner
King & Spalding LLP (Atlanta, GA)

12:15 Networking Luncheon for Speakers and Delegates Sponsored by: Shook Hardy

1:30 Focusing on Making Successful Motions to Dismiss in light of Changing Plaintiff Complaint Thresholds

Katharine R. Latimer
Partner
Hollingsworth LLP (Washington, DC)

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

  • Taking advantage of the improving defense environment under Twombly-Iqbal
    • recent trends in plaintiff “shotgun” approaches to litigation
    • looking at current pleading standard requirements
    • deciphering how the standards vary and tracking developments in different jurisdictions and individual courts
  • Scrutinizing and dissecting the plaintiff ’s complaint
    • assessing whether plaintiff is making conclusory statements
    • is the complaint plausible?
    • is it specific enough, or general?
    • is the product identified properly?
  • Effective strategies where several manufacturers are named in the complaint
    • cost-saving tactics for improperly named defendants
    • splitting the costs of an Iqbal-Twombly motion
  • Seeking precedents for assessing on a case-by-case basis whether the court will decide that a complaint states enough factual material
  • Weighing the impact of ultimate judicial determination that a claim is conclusory
    • dismissals with or without prejudice
    • potential risk that plaintiff will amend a dismissed complaint and claim more specific facts
  • Shifting costs to the plaintiff when the complaint is re-pleaded

2:15 Afternoon Refreshment Break

2:30 Preparing to Defend Cases in High-Risk Jurisdictions or in Emerging Hot-Button Areas for Manufacturers

Mary-Alice Barrett
Senior Counsel - Litigation
Hoffmann-La Roche (Nutley, NJ)

Charlene Gallagher
Industry Representative, Advisory Commission for Childhood Vaccines
Former Senior Division Counsel for Vaccines
Wyeth/Pfizer (Berwyn, PA)

Keri L. Arnold
Partner
Arnold & Porter LLP (New York, NY)

Melissa Foster Bird
Partner
Nelson Mullins LLP (Charleston, SC)

Rene L. Siemens
Partner
Pillsbury Winthrop Shaw Pittman LLP (Los Angeles, CA)

  • Assessing what jurisdictions may pose unique problems for defense arguments
    • weighing the potential impact of different types of news stories or events
    • surmounting a crisis atmosphere
  • Leveling the playing field at trial in plaintiff-oriented jurisdictions
  • Employing tailored jury selection techniques
  • Trying a case to a small town jury while keeping one eye on the appellate court
    • mounting a rigorous defense that overcomes any need to take an initially defensive posture
  • Facing the increased risks associated with clinical trials
    • how greater transparency of data is being used by plaintiffs
    • current best practices for structuring and policing trials
    • protecting yourself via use of insurance and indemnities
  • Understanding the unique statutory framework that applies to vaccine claims
  • Lessons and strategies learned from defending recent claims that childhood vaccines cause the development of autistic spectrum disorders
  • Determining applicable statutes of limitations in vaccine cases
  • Defining the unique considerations that apply to defense strategies in the vaccine context
  • Understanding the potential implications of Bruesewitz v. Wyeth
    • analyzing which way the Supreme Court will rule
  • Preparing for other emerging areas for plaintiff claims
    • trends in “nuisance” lawsuits
    • claims that drugs negatively impact certain ethnic groups
    • suicide-related claims
    • attempts to revive expired claims in certain jurisdictions
    • plaintiff strategies for building cases out of recent contamination allegations
  • claims relating to the role of foreign suppliers and international outsourcing
  • Examining the practical impact of recent attempts by groups of plaintiff attorneys to better coordinate their activities

 

3:45 Group Meet-Ups Part 2: Reconvening to Apply Lessons Learned and Answer Hypotheticals (in-house counsel facilitators)

Mary-Alice Barrett
Senior Counsel - Litigation
Hoffmann-La Roche (Nutley, NJ)

Jerry G. Bradford
Associate General Counsel
Alcon Laboratories, Inc. (Fort Worth, TX)

Greg Dadika
Assistant General Counsel, Litigation
C.R. Bard (Murray H ill, NJ)

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

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

Christopher M. Keefer
Corporate Counsel and Director
Biomet (Warsaw, IN)

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

Stephen S. Phillips
Special Counsel
Medtronic, Inc. (Fridley, MN)

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

William A. Scharff Jr.
Vice-President, Assistant General Counsel
Chief Litigation Counsel
Allergan Inc. (Irvine, CA)

Co-facilitators:

J. Christopher Allen, Jr.
Partner
Nixon Peabody LLP (Boston, MA)

James W. Weller
Partner
Nixon Peabody LLP
(Jericho, NY)

The Meet-Up groups created on December 7th will now reconvene to review the hypotheticals in light of all the information-sharing that has taken place over the past two days. Each small group and its in-house counsel facilitator will work through complex challenges currently presented in drug and device product liability litigation and come away with practical strategies for overcoming the obstacles. This hands-on setting will provides excellent opportunities for sharing information, developing best practices, and forming bonds with other attendees on an individual level.

5:00 Conference Concludes