DAY 2 | Wednesday, DECEMBER 7, 2011 CONFERENCE AGENDA


8:30 Co-Chairs’ Remarks

8:45 Avoiding New Litigation Pitfalls Arising from Emergent Social Media

Nicole Maddox
Senior Associate Director, Senior Litigation Counsel
Boehringer-Ingelheim Pharmaceuticals, Inc.
(Ridgefi eld, CT)

John Unice
Counsel
Bayer (Pittsburgh, PA)

Shayna Cook
Partner Bartlit Beck Herman Palenchar & Scott LLP
(Chicago, IL)

Joseph Leghorn
Partner
Nixon Peabody LLP (Boston, MA)

  • How social networking sites are complicating things for drug and device litigators
    • social media evidence as a potential game-changer
  • understanding the power of this evidence to make or derail the plaintiff ’s case
  • Navigating risks relating to discussion of adverse events and FDA compliance efforts
    • wall posts on internal corporate sites
    • factoring in recent regulatory guidelines in the UK and forthcoming FDA guidance
  • Determining when communications made on Facebook, Twitter and other sites may be part of the evidentiary record of the case
    • obtaining information on screen names and web site usage
    • making discovery requests for posts on social media sites
    • following potential witnesses’ Twitter feeds
  • Meeting threshold requirements for admission of helpful social media evidence in court
  • Tactics for making successful objections to keep out potentially damaging posts and messages
  • Discovering what information exists on internal and external web sites that may be readily available for plaintiffs and jurors
    • tools for preventing juror bias
  • Anticipating challenges created as a result of efforts by clients to comply with regulatory requirements calling for greater transparency
    • current rules and guidance relating to risk warnings
    • DTC marketing requirements
  • How Sorrell vs. IMS Health and other judicial attempts to weigh privacy rights will impact on marketing and interactions with providers and patients
  • Assessing the impact on the learned intermediary doctrine of widespread public sharing and use of information on web sites and blogs
  • Anticipating plaintiff strategies to sway juries and techniques for avoiding juror bias
  • Defense tactics for utilizing comments on blogs and medical web sites to support the manufacturer

10:00 Morning Coffee Break

10:15 Implementing Strategic Tactics for Improving MDL Logistics and Efficiencies

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

Erica Visokey
Assistant Counsel
Stryker (Mahwah, NJ)

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

J. Joseph Tanner
Partner
Baker & Daniels LLP (Indianapolis, IN)

  • Entrance strategies: organizing an MDL so that it doesn’t become a runaway proceeding
    • techniques for federal/state coordination
  • Devising the right front-end logistical and procedural defense strategies
    • maneuvering for favorable forums
    • securing desirable timing and sequence of cases
    • managing early coordination challenges with other litigants
  • Managing a case with a very large number of plaintiffs in multiple jurisdictions
    • implementing optimal techniques for organizing and tracking data
  • Meeting the challenges of coordinating with multiple law firms
    • conducting meetings with 50 attorneys in the room
  • Focusing on the core issues to move the process forward
    • techniques for not getting bogged down on the side issues
    • special defense considerations when a product is still on the market
    • juggling cost concerns with the needs of the case
  • Maximizing the contribution of local counsel
    • when local counsel may serve as the expert on local rules, practice, and state substantive law
  • Weighing which cases warrant one-off treatment while avoiding lots of state court litigation
    • determining what facts merit separate consideration rather than the MDL route
  • Working with the overseeing judge in scheduling cases
  • Determining when tag-alongs should be transferred to an existing MDL
  • Navigating decision-making challenges where there are other defendants in the case
  • Effective coordination of remanded cases
  • Avoiding redundancies and ensuring that costs are not unnecessarily increased on the local level
  • 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.
  • What is working well? Investigating whether some courts
  • have found a method for resolving cases more rapidly

11:15 View from the Bench: Current Judicial Views on Medical Products Litigation

Hon. Brian Cogan
United States District Court Eastern
District of New York

Hon. Denise L. Cote
United States District Court
Southern District of New York

Hon. David R. Herndon
United States District Court
Southern District of Illinois

Hon. Ann D. Montgomery
United States District Court
District of Minnesota

Hon. David J. Waxse
United States District Court
District of Kansas

Moderator: Andrew

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

Renowned federal jurists experienced in mass tort and products liability litigation will provide their insights on the latest hot button medical product issues. Special attention will be paid to case management and coordination in complex multi-district litigation.


12:30 Networking Luncheon for Speakers and Delegates

1:30 Avoiding Mistakes When Using the Preemption Defense in Device Cases

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

John P. Lavelle, Jr.
Partner
Morgan Lewis LLP (Philadelphia, PA)

John D. Winter
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)

  • Knowing when to raise the defense
    • motion to dismiss vs. summary judgment
    • getting judicial notice of Premarket Approval
    • using manufacturing records to demonstrate product compliance
  • Analyzing recent efforts to evade preemption - attacking Premarket Approval for the device or component
    • “fraud on the FDA” arguments
    • claims that the company failed to comply with CGMPs
    • claims that the company violated federal regulation
    • evidence of warning letters and other regulatory activity
    • requests for more discovery
  • Navigating the circuit split regarding what plaintiffs must allege and prove to fi t through the narrow post-Riegel gap for parallel claims

2:15 Sorting Through the Science and Explaining Complex Medical Data

Malini Moorthy
Assistant General Counsel - Litigation
Pfizer Inc. (New York, NY)

Loren Brown
Partner
DLA Piper (New York, NY)

Carol Dan Browning
Member
Stites & Harbison, PLLC (Louisville, KY)

Amanda S. Kitts
Partner
Nelson Mullins Riley & Scarborough LLP (Columbia, SC)

  • Understanding the science of the case to “check” your experts
    • assessing any trends in science and medicine that may impact on litigation
  • Identifying the medical arguments that will make the best case for your client
  • Overcoming public perceptions of science - combating negative perceptions of the industry
    • tactics for creating opportunities to share positive information • Strategies to educate the jury about the complexities of the case they are about to hear
  • Proven methods to effectively and clearly communicate the defense theories
    • using visuals/graphics
    • knowing what will be effective with younger jurors
  • Selecting the best experts to relate to judges and juries
    • assessing how scientists will perform as witnesses
    • ensuring your expert is engaged in the case

3:00 Main Conference Concludes

3:15 Business Development Master Class Commences

In-House Perspectives on Selection and Evaluation of Outside Counsel see Pre-Conference Group Meet-Up & Master Class