Wednesday December 9th, 2009

7:00 Registration & Welcoming Breakfast Hosted by King & Spalding

8:00 Co-Chairs’ Opening Remarks

Bradley E. Lerman
Sr. Vice President and Associate GC – Litigation
PFIZER INC (New York, NY)

Lisbeth Warren
Assistant General Counsel, Offi ce of General Counsel
JOHNSON & JOHNSON (New Brunswick, NJ)

8:10 Operating in an Aggressive Government Enforcement Climate: Ensuring Enforcement Activities Do Not Negatively Impact Product Liability Litigation and Vice Versa

Ted Acosta
Americas Leader – Life Sciences and Corporate Compliance
Ernst & Young

Anthony P. Tinari
Senior Vice President and General Counsel
CONVATEC INC. (Skillman, NJ)

Randall L. Christian
Shareholder
CLARK THOMAS & WINTERS (Austin, TX)

Kathleen O’Connor
Partner
DECHERT LLP (New York, NY)

Linda A. Willett
Partner, Chair of the Drug & Medical Device Practice Group
SEDGWICK DETERT MORAN & ARNOLD
(New York, NY)

  • Understanding federal and state government theories of liability
    • examining how the government uses its most powerful weapon – the False Claims Act and related qui tam suits
    • defending state AG investigations of alleged off-label promotion by sales reps
    • readying for the inevitable third-party payor and reimbursement claims that follow product liability litigation
    • identifying which activities the government intends to focus on in the upcoming year
  • Recognizing how interagency coordination impacts both civil and government cases
  • Tackling the alliance between plaintiffs’ attorneys and state attorneys general
  • What are plaintiffs’ theories of liability in civil cases where there is a companion government case?
    • when and how do plaintiffs’ counsel try to bring in information about the government case?
  • Defeating plaintiffs’ efforts to introduce evidence about government enforcement actions in the product liability case
    • overcoming the negative impact of this information if such evidence is deemed admissible
  • Preventing plaintiffs from using depositions and discovery in product liability litigation as gathering expeditions for other cases
  • Coordinating the civil litigation and the government litigation
    • selecting outside counsel
    • assigning outside counsel to the civil and government cases
    • synchronizing the efforts of the civil and government litigation teams
    • controlling the flow of information between civil product liability cases and government cases
    • preventing plaintiffs from exploiting any gaps
    • ensuring strategies in one case do not negatively affect the other
  • Resolving parallel proceedings without allowing a settlement in one case to negatively impact the other

9:30 Successfully Asserting a Preemption Defense and Managing Industry/FDA Relationships in a Post-Levine and Post-Riegel World

Howard M. Cyr
Senior Corporate Counsel-Litigation
WYETH (Collegeville, PA)

Mark Herrmann
Partner
JONES DAY (Chicago, IL)

Joseph J. Leghorn
Partner
NIXON PEABODY LLP (Boston, MA)

Michelle R. Mangrum
Partner
SHOOK, HARDY & BACON L.L.P. (Washington, DC)

  • Selecting cases that are good candidates for a preemption defense
    • surveying federal and state courts’ application of the Levine and Riegel decisions
    • how successful have manufacturers been in subsequent attempts to assert preemption?
    • how have plaintiffs’ strategies changed since Levine and Riegel were decided?
    • identifying which states have favorable preemption statutes
    • how have courts interpreted the “parallel requirements” exception to Riegel?
    • what are the defenses to plaintiffs’ allegations that a company violated “parallel requirements” under state law?
  • Practical tips and strategies for making a preemption argument
    • examining examples of labels/package inserts and how preemption can be applied
  • Beyond Lohr and Riegel – preemption for devices that are neither PMA nor 510(k) approved
  • Interacting with the FDA in light of recent preemption decisions
    • how should manufacturers be corresponding with the FDA?
    • determining whether and how much recent court decisions can be allowed to influence regulatory processes and decisions
    • documenting label related discussions
  • Building a regulatory record that shows FDA involvement
    • examples of what a regulatory file can look like
    • weighing the pros and cons of engaging the FDA more
    • taking discovery of the FDA
  • Evaluating adverse events and determining when to make label changes
    • what is the impact of Levine on CBE regulations?
    • proving that the FDA would not have approved a label change
  • Using recent FDA guidance on risk communications to justify label warnings
  • How will the new REMS procedure affect preemption?
  • Communicating to juries the level of FDA involvement with labeling in light of current public perceptions of the FDA
    • illustrating the big picture on how risks are communicated and products are labeled
  • Predicting legal, legislative and regulatory changes – what will preemption look like going forward?
    • how have changes in the administration and the FDA affected preemption?
    • what federal and state legislative efforts have been undertaken to invalidate the preemption defense?
    • how is industry working to fight attempts to undermine preemption?

10:30 Morning Refreshment Break

10:45 Procedural Strategies for Winning Cases

Brian Eckman
Litigation Counsel
BAUSCH & LOMB INCORPORATED (Rochester, NY)

Brian J. Leddin
Associate General Counsel, Compliance and Litigation
C. R. Bard, Inc. (Murray Hill, NJ)

Eric Anielak
Partner
SHOOK, HARDY & BACON L.L.P. (Kansas City, MO)

J. Gordon Cooney, Jr.
Partner
MORGAN, LEWIS & BOCKIUS LLP (Philadelphia, PA)

John C. Garde
Partner
McCARTER & ENGLISH, LLP (Newark, NJ)

  • Reducing the number of claims in a case before going to trial
    • using briefing and dispositive motions to whittle away the plaintiff ’s claims
  • Employing case screening procedures to separate out cases with potential merit
    • Lone Pine orders
    • other scheduling techniques that may have results similar to a Lone Pine order
  • Breaking-up multi-plaintiff cases and grouping cases for trial
  • Applying Iqbal and Twombly to drug and device cases
    • how are different courts interpreting the “plausibility” standard?
    • arguing why Iqbal should apply to claims that traditionally do not require amplification
    • getting state courts to recognize the Iqbal decision
  • Developing removal strategies
    • when do you make a motion to remove?
    • pre-lawsuit discussions as sufficient cause for removal
    • using CAFA as a basis for removal
    • making a fraudulent joinder motion
  • Resolving joint and several liability issues
  • Obtaining summary judgment on causation issues
  • Weighing the benefits and detriments of MDLs
    • successfully opting out of an MDL
    • steering your case to a favorable jurisdiction
  • Negotiating a scheduling order in an MDL
  • Understanding state coordinated proceeding mechanisms
    • what is the process for statewide mass torts in jurisdictions with these MDL-type systems?
    • coordination between federal and state courts
  • Coordinating state court proceedings with MDL proceedings and handling both consistently

 

12:00 Case Study of a Pharmaceutical Trial: Combating Plaintiffs’ Tactics and Developing a Winning Strategy Against Any Tough Opponent

Jan Dodd
Partner
KAYE SCHOLER LLP (Los Angeles, CA)

Andrea Roberts Pierson
Partner
BAKER & DANIELS LLP (Indianapolis, IN)

Lana Varney
Partner
FULBRIGHT & JAWORSKI LLP (Austin, TX)

This session provides a rare glimpse into the art and strategy of a trial through use of video clips of a well-known plaintiff’s attorney in action. Speakers will analyze the techniques, themes and attacks on corporate witnesses and defense expert witnesses routinely employed by plaintiffs’ counsel. Using real-life courtroom examples, defense counsel will learn how to counteract plaintiffs’ strategies and gain insight into how to defeat any challenging adversary. Points of discussion will include:

  • Identifying plaintiff’s themes launched in opening statement and reviewing how those themes are reinforced in cross-examinations
  • Preparing for the use of powerful graphics and other useful courtroom tools
  • Understanding how plaintiff ’s counsel cleverly characterizes the industry and the FDA
  • Watching examples of harsh cross-examination of company witnesses and learning effective tools to counteract plaintiff’s techniques
  • Common traps even expert witnesses fall into and learning how to avoid them
  • Developing your own winning strategy to overcome plaintiff ’s counsel’s most difficult arguments

 

1:15 Networking Luncheon for Speakers and Delegates Hosted by Greenberg Traurig

2:15  BREAKOUT SESSION 1
Choose A or B

A. Working Effectively With Insurance Carriers and Maximizing Recoveries

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

Susan Mussell
General Counsel and Corporate Secretary
STARKEY LABORATORIES, INC. (Eden Prairie, MN)

Terry Hackett
Partner
KERNS, FROST & PEARLMAN, LLC (Chicago, IL)

Kevin Quinley, CPCU
Vice President, Risk Services
BERKLEY LIFE SCIENCES, LLC (Woodbridge, VA)

  • Identifying available policies and what coverage consists of
    • what types of coverage is your company eligible for?
    • availability of coverage for biologic and pharmacogenomic products
  • What to look for when purchasing product liability insurance
    • provisions which should be included in the policy
  • Creating a risk management policy that will qualify the company for better insurance products
  • Working with risk managers to obtain the best policy for the company
  • Determining whether or not self-insurance is a viable option
  • Resolving gaps in coverage
  • Understanding recent changes to insurance law which may affect coverage
    • definition of occurrence
    • allocation of risk across multiple policies
    • class action settlements
  • Working with carriers in “bet the company” litigation
    • maximizing recovery from carriers
    • avoiding common pitfalls that could bar recovery
  • Recognizing the carrier’s interest in investigating the regulatory process
  • Selecting independent counsel
  • Communicating with the carrier without jeopardizing attorney/client privilege
    • what can a company disclose to an insurance carrier about the underlying litigation?
    • defending coverage disputes while preserving privilege

B. Developing Persuasive Defense Expert Witnesses

Ryan T. Scarborough
Partner
WILLIAMS & CONNOLLY LLP (Washington, DC)

  • Detailing the characteristics of a persuasive (defense) expert witness
    • preferred characteristics to look for
    • undesirable characteristics to avoid
  • Finding and vetting potential experts
    • it’s not what you know, it’s who you know
    • uncovering available resources
    • using medical journals and other resources within the medical community
    • in-house strategies for selecting research and litigation experts
    • employing expert witness consulting firms
  • Using in-house experts effectively
    • defining the scope of their testimony
    • reconciling disagreements between in-house and outside experts
  • Guiding the expert through the litigation process
    • preparing expert reports
    • deposition preparation
    • trial preparation
  • Addressing the criticisms of industry support of research and new laws requiring greater transparency of industry/physician relationships
    • exploring the limits of qualification and disqualification because of prior writings, payments, relationships, etc…
    • defusing the ammunition plaintiffs’ counsel now have
    • as a result of state physician payments disclosure laws
  • What do expert witnesses seek from defense counsel?
    • what makes a good or bad experience?

3:15 Afternoon Refreshment Break

3:30 BREAKOUT SESSION 2
Choose C or D

 C. Managing Litigation in a New Economy: Fighting Mounting Litigation With a Restricted Budget

Connie M. Matteo
Senior Corporate Counsel-Litigation
WYETH (Madison, NJ)

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

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

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

Daniel T. Torpey                    
Partner           
Ernst & Young

Moderator:
Andrew T. Bayman
Partner
KING & SPALDING (Atlanta, GA)

  • Controlling costs by keeping routine, pattern litigation under control
    • getting rid of low-level cases quickly
  • Techniques for resolving cases early and expeditiously
  • Determining which factors to consider when hiring outside counsel and how those factors will be weighed
    • firm reputation versus individual reputation
    • national versus regional counsel
    • when is it cost-effective to use national counsel?
    • role of the local counsel: can they handle supporting regional/national counsel?
    • entering into a preferred counsel relationship
    • ability of associates, clerks, and paralegals to work on a case
  • Examining the feasibility of the virtual law firm model from a cost perspective
  • Placing controls on outside counsel
    • what types of limits should be set?
  • Managing outside counsel through budgeting
    • creating detailed, realistic and accurate budgets
  • Developing an alternative fee arrangement that can accommodate the uncertainties inherent in litigation
  • Using e-billing programs and integrating them into your daily practice
  • Evaluating what work does not need to be done by a law firm and what can be outsourced
  • Preparing for the demands of discovery before litigation becomes an issue
  • Assuring quality control in document coding without absorbing the costs of high paid associates
  • Cutting e-discovery costs
    • conducting metrics to determine the efficiency of vendors
    • in-sourcing e-discovery work
    • comparing the services of different vendors

D. Disqualifying Plaintiff ’s Experts

Hope S. Freiwald
Partner
DECHERT LLP (Philadelphia, PA)

Paul W. Schmidt
Partner
COVINGTON & BURLING LLP (Washington, DC)

  • Using trends in the application of Daubert and Frye standards to develop an expert witness challenge strategy
    • survey of how states are applying Daubert and Frye
    • how are judges addressing substantive issues (if at all) in Daubert hearings?
  • Thinking about expert challenges at the onset – working Daubert/Frye into the deposition strategy
    • creating a record
    • laying the foundation for what is considered an appropriate scientific method
  • Specific and practical strategies for getting plaintiffs’ experts excluded
  • Challenging differential diagnosis
    • understanding the interplay between general and specific causation and differential diagnosis
    • existing case law that supports both plaintiff’s and defense’s positions
    • assuming differential diagnosis is permissible what must the plaintiff ’s expert do to satisfy Daubert standards for an acceptable differential diagnosis?
    • what lines of attack should defense attorneys consider in setting-up a motion for summary judgment or in making a compelling argument to the jury?
  • Attacking plaintiffs’ new line of “experts”
    • regulatory process experts
    • corporate ethics experts
  • Fair discovery for excluding plaintiffs’ witnesses – how much discovery are you really entitled to?

4:30 BREAKOUT SESSION 3
Choose E or F

E. Litigation Prevention and Risk Management: Developing Risk Assessment Protocols to Reduce the Probability and Costs of Litigation

Sheila Anne Denton
Legal, Executive Director
BOEHRINGER INGELHEIM USA CORP.
(Ridgefi eld, CT)

William Scarff, Jr.
Vice President, Assistant General Counsel
Chief Litigation Counsel
ALLERGAN, INC. (Irvine, CA)

Erica Visokey
Assistant Counsel
STRYKER (Mahwah, NJ)

Michael X. Imbroscio
Partner
COVINGTON & BURLING LLP (Washington, DC)

In the current economic climate, drug and device manufacturers are placing greater emphasis on litigation prevention and risk management, yet many litigation prevention programs are ineffective. In this session, you will learn the elements of a successful risk management program and how to implement it.

  • Developing an effective risk assessment protocol
    • at what stage of the product’s life cycle should a risk assessment be done?
    • when and if outside counsel should become involved in the process
    • identifying the product’s population and any inherent risks it may pose
  • Analyzing the vulnerabilities and their influence on other decisions
    • label warnings
    • doctor training

F. Selecting Jurors and Coping With Juror Misconduct

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

Dennis P. Stolle, JD, PhD
President
THEMEVISION LLC
Partner
BARNES & THORNBURG LLP (Indianapolis, IN)

As technology becomes more advanced, litigators have new tools at their disposal (in addition to traditional jury selection techniques) to make more informed juror selections. However, this same technology is also resulting in increased instances of juror misconduct. This session will examine new and long-standing jury selection techniques and will prepare you to manage unanticipated juror misconduct situations.

  • Using social networking sites such as Facebook, Linked-In and Twitter to aid jury selection
  • Examining the impact of economic climate on jurors’ perceptions of the industry
  • Recent developments in the law on juror challenges
  • Preventing jurors from accessing electronic information about the case
  • Spotting juror misconduct
    • how to handle misconduct when it happens

5:30 Cocktail Reception Hosted by:

Dechert