Thursday December 10th, 2009

7:15 Networking Breakfast

8:00 Co-Chairs’ Remarks

8:10 Preparing for Anticipated Changes Under the New Administration

Timothy Pratt
Executive Vice President, Secretary and General Counsel
BOSTON SCIENTIFIC (Natick, MA)

Joyce A. Cowan
Partner
MORGAN, LEWIS & BOCKIUS LLP (Washington, DC)

The 2008 elections resulted in sweeping changes to the administration, Congress and federal and state agencies. The full impact of these changes remains to be seen, but drug and device manufacturers need to prepare for major changes to how the industry is regulated as well as to how those changes will affect the industry’s risk and litigation profile. Speakers will address the key issues currently in play, such as health care reform and preemption battles in Congress, changes in the FDA’s new leadership and regulatory/enforcement environment, government investigations, the Obama administration’s initiatives effect on the drug and device industry, and how industry and its lawyers can cope with these changing times.

9:15 Morning Refreshment Break

9:30 View From the Bench – Current Judicial Views on Medical Products Litigation

The Honorable Gerald Bard Tjoflat
United States Circuit Judge
UNITED STATES COURT OF APPEALS FOR THE
11TH CIRCUIT
(Jacksonville, FL)

The Honorable Ruben Castillo
United States District Judge
UNITED STATES DISTRICT COURT FOR THE
NORTHERN DISTRICT OF ILLINOIS (Chicago, IL)

The Honorable Denise Cote
United States District Judge
UNITED STATES DISTRICT COURT FOR THE
SOUTHERN DISTRICT OF NEW YORK
(New York, NY)

The Honorable Donovan W. Frank
United States District Judge
UNITED STATES DISTRICT COURT FOR THE
DISTRICT OF MINNESOTA (St. Paul, MN)

The Honorable James S. Gwin
United States District Judge
UNITED STATES DISTRICT COURT FOR THE
NORTHERN DISTRICT OF OHIO (Cleveland, OH)

The Honorable Mark I. Bernstein
Judge
COURT OF COMMON PLEAS (Philadelphia, PA)

The Honorable Randy Wilson
Judge
HARRIS COUNTY DISTRICT COURT (Houston, TX)

Moderator:
Lori G. Cohen
Shareholder
GREENBERG TRAURIG, LLP (Atlanta, GA)

Renowned federal and state jurists experienced in mass tort, products liability, and pharma- and device- related litigation will provide their insights on the latest hot button medical product issues. You cannot afford to miss this unique opportunity to hear the theories and defenses that are most effective, how to weigh evidence, and which arguments turn cases one way or another. Come prepared with your most important and pressing questions and concerns to get the most out of this interactive session. Topics of discussion will include:

  • Motion practice
  • Expectations of what is reasonable for e-discovery
  • What warrants sanctions for discovery violations?
  • Applying Daubert and Frye standards to plaintiff ’s causation experts
  • Ex-parte communications with doctors
  • Protective orders
  • Instructing juries on punitive damages
  • Establishing an MDL and setting discovery and trial schedules
    • coordinating state cases with a federal MDL
  • Selecting bellwether cases
  • Mass tort courts at the state level
  • Consolidated trials, regular and reverse bifurcation, and other novel methods of trial management

11:00 Balancing the Responsibility to Defend the Company With the Desire to Retain the Client: Litigating and Settling Cases When There Is a Co-Defendant Doctor

Richard Silbert
Vice President, Associate General Counsel
PURDUE PHARMA L.P. (Stamford, CT)

John Egan
Partner
RUBIN AND RUDMAN LLP (Boston, MA)

  • Evaluating business and other considerations when determining whether to implead or cross-claim against the physician
  • Communicating with the physician
    • when and under what circumstances is this permissible for the defense?
    • how have the new HIPAA regulations impacted communications?
  • How is overall defense strategy affected by a “hostile” as opposed to a “friendly” prescribing/treating physician?
  • Are joint defense agreements with the prescribing physician enforceable?
    • are they advisable?
  • How is diversity jurisdiction in federal court affected by the involvement of the doctor?
  • How does the involvement of the doctor affect defenses such as federal preemption and the learned intermediary doctrine?
  • How does the involvement of the doctor affect discovery strategy?
  • How can the prescribing physician be used as a de facto expert witness?
  • What rules of contribution and indemnity apply and how are they affected and applied when the prescribing physician is a party to the litigation?
  • Does the involvement of the physician affect settlement strategy?
    • how does it impact on deciding whether to go to formal mediation or other ADR?
    • how does it impact on the enforceability of Mary Carter and other similar settlement agreements?
  • Under the revised PHRMA and Advamed guidelines, if the manufacturing is in some way aiding the doctor’s defense, would this be considered a reportable benefit?

12:00 Networking Luncheon for Speakers and Delegates Hosted by

Covington & Burling LLP

1:15 Mediation and Settlement Strategies

John R. Allison
Assistant General Counsel
3M COMPANY (St. Paul, MN)

Wendy Hufford
Executive Vice President & Chief Litigation Counsel
CARDINAL HEALTH, INC. (Dublin, OH)

Kimberly S. Penner
Partner
PHILLIPS LYTLE LLP (New York, NY)

  • Setting a preliminary resolution strategy for multiple claims or cases
    • consolidated cases
    • cases in multiple jurisdictions
    • pre-filing claims
  • Deciding when to fight in court and when to pursue a settlement
  • Determining the precedential impact of a settlement before making the decision to settle
    • will talk of settlement result in more claims?
    • to what extent will a settlement make other settlements more difficult or expensive to achieve?
  • What is the right mix of settlement versus litigation, and what is the right timing for these strategies?
  • Structuring global settlements to protect against fraud
  • Quantifying total damages to arrive at a settlement value
    • developing a settlement matrix and approach that works for both sides
    • using data models and algorithms to prepare damage calculations and rebut plaintiffs’ calculations
    • using adverse event trending and other data to predict outcomes
  • Will mediation help achieve resolution?
    • choosing a mediator
    • preparing a mediation statement
    • crafting flexible strategies for the mediation
  • Negotiating the details after an agreement in principle has been reached
    • timing of payment and releases
    • opt-out clauses
    • indemnification clauses
  • Complying with the new Medicare Secondary Payer Reimbursement Act obligation to report claims made by Medicare-eligible claimants/plaintiffs

2:15 Afternoon Refreshment Break

2:30 Defending Generic Products

Alan Klein
Partner
DUANE MORRIS LLP (Philadelphia, PA)

Thomas Packer
Partner
GORDON & REES LLP
(San Francisco, CA/Portland, OR)

  • Overcoming plaintiffs’ attempts to place innovator R&D and regulatory obligations onto generic products
  • Understanding the role of the innovator’s research, clinical trials and pharmacovigilance in generic drug litigation
    • obtaining access to this information
  • Managing label changes
    • what is the generic’s responsibility and ability to effect label changes based on adverse events and new data?
  • Preemption for generics after Levine
    • using the innovator’s regulatory record to supportthe generic’s preemption defense
  • Developing a uniform defense among generics and the innovator
    • managing multiple claims against multiple defendants by multiple plaintiffs’ counsel
  • Communicating to the jury how and why generics are different

3:30 Working Group Session: Solving Product Liability Litigation Challenges

Through the use of hypotheticals, small groups will work through challenges commonly presented in drug and device product liability litigation to come away with practical strategies for overcoming frequently faced obstacles. Groups will be led by in-house counsel moderators and will provide a forum for advanced dialogue on confronting some of the more difficult issues faced by drug and device manufacturers in the course of litigation. This hands-on setting provides the perfect opportunity for sharing information, developing best practices, and getting to know other attendees on an individual level. Hypotheticals will be made available to attendees prior to the conference date. Confirmed in-house moderators include:

Jerry G. Bradford
Associate General Counsel
ALCON LABORATORIES, INC. (Fort Worth, TX)

Lisa M. Floro
Counsel
BAYER CORPORATION (Pittsburgh, PA)

Perry S. Goldman
Vice President, Legal Affairs
ACTELION PHARMACEUTICALS US, INC.
(South San Francisco, CA)

Kelly Harris Jerkovich
Corporate Counsel
DAIICHI SANKYO, INC. (Parsippany, NJ)

Christopher M. Keefer
Corporate Counsel and Director, Risk Management/Insurance
BIOMET, INC. (Warsaw, IN)

Monique Hunt McWilliams
Assistant General Counsel, Corporate Litigation
ELI LILLY AND COMPANY (Indianapolis, IN)

Douglas B. Miner
Associate Litigation Counsel
MYLAN INC. (Canonsburg, PA)

Janet Richardson
Division Counsel, Legal
ABBOTT MEDICAL OPTICS, INC. (Santa Ana, CA)

Teresa Cotton Santos
Assistant General Counsel
ELI LILLY & COMPANY (Indianapolis, IN)

Richard Silbert
Vice President, Associate General Counsel
PURDUE PHARMA L.P. (Stamford, CT)

Steven Sokolow
Vice President & Associate General Counsel
NOVARTIS CORPORATION (New York, NY)

Jason Steinhart
Senior Director & Assistant General Counsel, US Litigation
SANOFI-AVENTIS US (Bridgewater, NJ)

Erica Visokey
Assistant Counsel
STRYKER (Mahwah, NJ