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Drug and Medical Device Litigation Agenda

Morning of Tuesday December 9th

Pre-Conference Workshop A:

Sponsored by Reed Smith

9:00 a.m. - 12:30 p.m.
(Registration opens at 8:30 a.m.)

Master Class on Managing the Intersection of Product Liability Cases with Government Investigations and Enforcement Actions

William E. Craco
Senior Counsel
JOHNSON & JOHNSON (New Brunswick, NJ)

Edward Hanover,
Corporate Counsel
NOVO NORDISK (Princeton, NJ)

Michael K. Brown
Partner
REED SMITH LLP (Los Angeles, CA)

Eric A. Dubelier
Partner
REED SMITH LLP (Washington, DC)

Thomas H. Suddath, Jr.
Partner
REED SMITH LLP (Philadelphia, PA)

Moderator:
Barbara R. Binis
Partner
REED SMITH LLP (Philadelphia, PA)

One of the biggest challenges faced by pharmaceutical and medical device manufacturers is the rapid increase in government investigations and enforcement actions. Not only must manufactures fear settlements that can cost millions and/or exclusion from government programs, but now they must also contend with the impact of these investigations on product liability litigation. Government investigations often follow on the heels of product liability litigation or in some cases inspire it. As government investigations figure more prominently in plaintiffs’ arguments, and as the plaintiff ’s bar steps-up efforts to partner with State Attorneys General, it becomes increasingly important for drug and device companies to account for the influence of government investigations when developing product liability defense strategies.

Master class leaders will identify how government enforcement activities are finding their way into civil litigation and provide strategies and insights into how drug and device manufacturers can tackle this new challenge. Points of discussion will include:

Examining the influence of government investigations on product liability cases and vice versa

  • Developing strategies to address plaintiffs’ efforts to leverage government settlements in product liability cases
  • Strategies to address plaintiffs’ use of depositions and discovery in product liability litigation as gathering expeditions for other cases
  • Preparing for third-party payor and reimbursement claims that follow product liability litigation

Preparing for and surviving government investigations and enforcement actions

  • Proactively preparing for a potential government investigation in the wake of product liability litigation
  • Managing litigation holds and other efforts to preserve evidence
  • Communicating with government agencies during the course of the investigation and responding to investigative demands and subpoenas
  • Coordinating the civil litigation and the government litigation
    • synchronizing the efforts of the civil and government litigation teams
    • ensuring strategies in one case do not negatively affect the other

Negotiating and living with government settlements

  • Managing the negotiation of multiple state AG actions
  • Negotiating and structuring Deferred Prosecution Agreements (DPAs) and Corporate Integrity Agreements (CIAs) to be as minimally burdensome as possible
  • Working with a monitor
  • Understanding the effect of the monitoring relationship on privilege

Afternoon of Tuesday December 9th

Pre-Conference Workshop B:

Sponsored by Nixon Peabody LLP

1:30 p.m. - 5:00 p.m.
(Registration opens at 1:00 p.m.)

Master Class on Minimizing Risks of Off-Label Communications in an Uncertain Legal Landscape

Ellen Rosenberg
Vice President and Senior Counsel
SHIRE PHARMACEUTICALS (Wayne, PA)

Peter Rother
Deputy General Counsel & Chief Compliance Officer
AGA MEDICAL CORPORATION (Plymouth, MN)

Devin Smith
Associate General Counsel
EMD SERONO, INC. (Rockland, MA)

J. Christopher Allen, Jr.
Attorney
NIXON PEABODY LLP (Boston, MA)

Vivian M. Quinn
Partner
NIXON PEABODY LLP (Buffalo, NY)

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

Claims of improper, off-label promotion fuel investigations by state and federal prosecutors and provide fodder for Congressional hearings. Not only must companies contend with government investigations, but allegations of improper off-label activity on the part of pharmaceutical and medical device manufacturers are more often becoming the bases of personal injury actions, as well as consumer fraud class action lawsuits. Yet, off-label use of FDA regulated drugs and medical devices is permissible, and may, as the FDA has acknowledged, be the standard of care. In order to walk the tightrope between permissible off label use and improper off-label promotion, it is critical for drug and device manufactures to correctly identify what is and is not permissible and then take the necessary steps to ensure that off-label violations do not occur.

This master class will explore the recent proliferation of off-label government investigations and their impact on product liability litigation. Attendees will learn how to identify potentially problematic activities, how to prevent violations from occurring and how to manage ethical challenges. Topics will include:

Identifying impermissible off-label activity and minimizing legal risks

  • Drawing the line between lawful scientific exchange and off-label promotion
  • Asserting your First Amendment rights with respect to off-label communications
    • defending speech as non-commercial or permissible
  • Reconciling existing and proposed off-label regulations with the First Amendment
    • how does the identity or motivation of the speaker or the setting of the speech affect First Amendment protections?
  • Outlining the provisions of the proposed FDA Draft Guidance on scientific reprints – what is the FDA proposing and why?
  • Determining whether the FDA’s Draft Guidance relating to peer-reviewed literature provides a workable “safe harbor?”
    • will it offer real protections from government enforcement actions, as well as civil claims?
  • Modifying current re-print practices in accordance with the draft guidance
  • Identifying “risky” activities and minimizing exposure
  • Effectively addressing concerns raised by “standard of care” off-label usage where there are known adverse consequences from such usage
    • what are the civil liability consequences?
  • Creating compliance protocols to control off-label communications

Managing product liability risks based on off-label usage

  • Determining the extent to which off-label activities affect the dynamics at trial
  • Weighing the strength of traditional defenses in off-label usage cases
  • Advancing your case to the jury in spite of, or even by taking advantage of, the off-label situation presented
  • Assessing the impact of government enforcement on litigation
  • Asserting off-label use as a defense
  • Defending the manufacturer in light of the new preemption landscape

Ethical Considerations

  • Responding to physician inquiries concerning off-label usage and patient care
  • Assessing potentially different ethical and legal obligations when dealing with public health and regulatory concerns compared to individual patient care
  • Navigating conflicts between the FDA’s responsibility to protect the public health and physicians’ responsibilities to protect individuals’ health
  • Disclosing adverse events or outcomes in a patient population when off-label usage is widespread
  • How can different ethical considerations inform interpretation and enforcement of off-label regulation?

5:00
Pre-Registration & Welcoming Cocktail Reception

Hosted By: King & Spalding

Wednesday December 10th, 2008

7:15
Registration & Breakfast

8:00
Co-Chairs' Opening Remarks

William J. Ruane
Vice President and Associate General Counsel - Litigation
WYETH (Madison, NJ)

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

8:10
Successfully Asserting the Preemption Defense Post-Riegel and in Anticipation of Levine

Vijay V. Bondada
Senior Corporate Counsel, Litigation
PFIZER INC (New York, NY)

David G. Martin
Vice President and Senior Counsel, Litigation
MEDTRONIC, INC. (Minneapolis, MN)

John P. Lavelle, Jr.
Partner
BALLARD SPAHR ANDREWS & INGERSOLL, LLP (Philadelphia, PA)

Madeleine M. McDonough
Partner
SHOOK, HARDY & BACON L.L.P. (Kansas City, MO)

Moderator:
Stephen A. Wood
Partner
KELLEY DRYE & WARREN LLP (Chicago, IL)

  • Charting the viability of the preemption defense in different jurisdictions
  • Developments in preemption for medical devices following the Riegel decision
    • how are courts applying Riegel in subsequent cases?
    • rethinking the approval process in light of the protection offered to PMA-approved devices
    • defending claims for manufacturing defects/failure to satisfy federal requirements
  • Managing the practical implications of the Second and Sixth Circuit Court split resulting from the Kent decision
    • preparing for increased forum shopping
    • MDL strategy
    • effect of fraud on the FDA claims – can these effects be empirically established?
  • Examining FDA’s proposed amendments to the “Changes Being Effected” regulations and Congress’s push to resolve the issue
  • Exploring the implications of Riegel for CBE arguments
  • Countering plaintiffs’ CBE arguments
    • interpreting “new” risk information
    • how should companies treat newly discovered safety information?
    • best practices for maneuvering through label changes
  • Anticipating the Court’s decision in Levine
    • what positions were set forth at oral arguments?
    • what were the Justices’ questions?
  • Developing a strong preemption defense in the current legal landscape
    • presenting the regulatory evidence
    • demonstrating the document trail between the company and the FDA
    • admitting evidence of the manufacturer’s diligence during label negotiations after a preemption motion has been lost
    • crafting preemption arguments for situations where there is no obvious comment from the FDA
  • Restructuring regulatory processes in light of recent Supreme Court and federal circuit decisions
    • maintaining a regulatory process that incorporates preemption considerations
  • Predicting changes to the legal landscape after Levine is decided
    • how will plaintiffs’ counsel try to circumvent preemption?
    • preparing for legislative work arounds

9:15 a.m.
Combating Jurors' Negative Perceptions of the Industry and the FDA

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

Elpidio "PD" Villarreal
Vice President and Associate General Counsel,
Litigation & Conflict Management
SCHERING-PLOUGH CORPORATION (Kenilworth, NJ)

Reiko Hasuike, Ph.D.
Partner
R&D STRATEGIC SOLUTIONS (Manhattan Beach, CA)

Diane P. Sullivan
Partner
DECHERT LLP (Princeton, NJ)

Changing public perceptions

  • Educating the public about the drug approval process
  • Creating opportunities to share positive information about the industry

Winning over jurors during the course of a trial

  • Assessing the impact of the social climate, the region, politics, etc… on jurors
  • How do juror perceptions differ by generation, ethnicity or region?
  • Understanding juror perceptions of drug companies, the FDA and the FDA approval process
    • what are the bases for their perceptions?
    • what practical effect does FDA approval of a product have on a jury?
  • Gauging the effect of DTC advertising on juror attitudes
  • What do jurors like and what don’t they like in drug and device litigation?
  • Demonstrating drug and device companies’ charitable giving and good works to a jury

Conducting jury research

  • Mastering the mechanics of effective jury research
    • determining when to conduct jury research
    • exploring different methods for conducting jury research
    • structuring the research so as to obtain information that will be useful at trial
    • selecting issues to be tested with mock jurors
  • Assigning responsibility for jury research
    • when does in-house counsel take the lead?
    • when does outside counsel take the lead?
  • Conducting jury research cost effectively
  • Evaluating the work of jury consultants

10:15 a.m.
Morning Coffee Break

10:30 a.m.
Overcoming Attempts to Weaken the Learned Intermediary Doctrine

Julie Coletti
Director and SeniorCounsel
BAYER CORPORATION (Pittsburgh, PA)

John Delli Venneri
Partner
BALLARD SPAHR ANDREWS & INGERSOLL, LLP (Voorhees, NJ)

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

Madeline M. Sherry
Director
GIBBONS P.C.

Moderator:
Mark Herrmann
Partner
JONES DAY (Chicago, IL)

  • Surveying the learned intermediary doctrine landscape
    • developing judicial standards and their impact on the doctrine
    • o what effect will State of West Virginia Ex. Rel. Johnson & Johnson v. Karl have on other courts’ interpretation of the doctrine?
  • Examining whether the learned intermediary doctrine applies with equal force to prescription drugs and medical devices
  • Is there a “heeding presumption” in the learned intermediary context, and if so, what does it mean?
  • Developing warnings that will satisfy the learned intermediary doctrine
    • what should be included in the warnings?
    • going beyond warning labels – what are the implications of reaching out to physicians directly or training them?
    • what new warning obligations may result from the Karl decision?
    • should package inserts quantify risks?
  • Examining the interplay between the learned intermediary doctrine and the sophisticated user defense
  • Beating back plaintiffs' strategies to negate the learned intermediary doctrine
  • Assessing the impact of DTC advertising on the learned intermediary doctrine
    • what is the strength of the doctrine when there is active marketing of a product?
  • Controlling DTC advertising and other marketing efforts
  • Charting recent legislative proposals and their impact on the learned intermediary doctrine

11:30 Administering and Managing Litigation Holds

Tracey Garland Vinson
Counsel
Bayer Corporation

Paul E. Benson
Partner
MICHAEL BEST & FRIEDRICH LLP (Milwaukee, WI)

Albert G. Bixler
Member
ECKERT SEAMANS CHERIN & MELLOTT, LLC (Philadelphia, PA)

  • Effective methods for structuring a litigation hold
    • preparing the hold language
    • determining who to send the hold memo to
    • getting employees to understand the importance of and necessity of complying with hold memos
  • Understanding the constraints of in-house counsel and potential resistance to large scale litigation holds
  • Managing litigation holds for new technology such as instant messaging, collaboration websites and integrated voice technology
  • Recognizing the consequences of retaining documents pursuant to litigation holds
    • possessing documents that would have otherwise been destroyed pursuant to document retention plans
    • o can you limit your exposure in these types of situations?
  • Avoiding court sanctions

12:30 FDA Keynote Address

Gerald Masoudi
FDA Chief Counsel
FOOD AND DRUG ADMINISTRATION (Rockville, MD)

Mr. Masoudi will discuss the future of drug and medical device litigation.

1:00 p.m.
Networking Luncheon for Speakers and Delegates

Hosted by Greenberg Traurig, LLP

2:15 p.m.
Breakout Session 1

Choose Either A or B

TRACK A
Reducing and Managing Costs Associated With Product Liability Litigation:

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

Erica Visokey
Assistant Counsel
STRYKER CORPORATION (Mahwah, NJ)

Diane E. Lifton
Partner
HUGHES HUBBARD & REED LLP (New York, NY)

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

Managing outside counsel fees

  • 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?
    • Placing controls on outside counsel
      • what types of limits should be set?
    • Managing outside counsel through budgeting
      • creating realistic and accurate budgets
    • Do flat fees really exist?
      • what alternative billing arrangements are out there and have people been successful in using them?
    • Using e-billing programs and integrating them into your daily practice

    Managing discovery costs

    • 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

TRACK B
Presenting Corporate Witnesses in the Best Light Before the Jury and the Press

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

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

Ingrid A. Briant
Partner
ARNOLD & PORTER LLP (Denver, CO)

Bernard Taylor, Sr.
Partner
ALSTON & BIRD LLP (Atlanta, GA)

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

Through mock preparations of commonly problematic corporate witnesses – such as the habitual bad email writer, the disgruntled ex-employee, and the unwilling employee – this panel will demonstrate how in-house and outside counsel can overcome typical challenges to developing strong corporate witnesses.

  • Convincing corporate witnesses of the importance and seriousness of the litigation
  • Avoiding corporate witness testimony that will conflict with the themes of the case
      • involving company witnesses in the creating and telling of the “company story”
  • Preserving testimony in long, drawn-out cases
      • developing a direct examination outline
  • Designating employees as witnesses in key departments in anticipation of litigation
  • Managing difficult personalities
  • Working with witnesses now working for other companies
      • coordinating with current employers’ counsel
    • Preparing for 30(b)(6) depositions
        • narrowing the scope of the plaintiff’s deposition request
        • choosing the witness(es)
        • creating a standing panel of witnesses
    • Preventing witness “burn-out”
    • Dividing the labor between in-house and outside counsel
    • Overcoming media attacks on company witnesses

3:30 p.m.
Afternoon Refreshment Break Hosted by: Gibbons

3:45 p.m.
BREAKOUT SESSION 2 (choose C or D)

TRACK C
Working Effectively With Insurance Carriers and Maximizing Recoveries

Jonathan M. Cohen
Partner
GILBERT RANDOLPH LLP (Washington, DC)

John E. Heintz
Partner
KELLEY DRYE & WARREN LLP (Washington, DC)

Jill Wadlund
President
BERKLEY LIFE SCIENCES, LLC (Ewing, NJ)

  • 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
  • Maximizing recovery from carriers
  • Developing a partnership with the carrier
  • Recognizing the importance of early involvement – establishing a defense strategy from the onset
  • Preserving evidence and allowing for product inspection
  • Understanding what factors drive formalities in the claims process
  • Choosing 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

TRACK D
Developing the Optimal Internal and External Scientific Expert Witnesses Through the Coordination of In-House and Outside Counsel Efforts

Mary-Alice Barrett
Senior Counsel
ROCHE (Nutley, NJ)

Jennifer E. Dubas
Senior Attorney – Litigation
WYETH (Collegeville, PA)

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

Ronn B. Kreps
Partner
FULBRIGHT & JAWORSKI LLP (Minneapolis, MN)

Jane F. Thorpe
Partner
ALSTON & BIRD LLP (Atlanta, GA)

  • Defining in-house counsel’s role in expert witness development
    • identifying internal scientific experts
    • spotting potential conflicts among experts
  • Developing an expert witness team
    • who will manage scientific experts and their testimony?
    • how will this be coordinated with the general litigation team?
    • Factors to consider when choosing experts
  • Prepping experts on company or product information
    • managing documents experts will be confronted with at trial
    • Reconciling disagreements between internal experts and outside defense experts
    • Synchronizing expert testimony with regulatory obligations when litigation involves products that are still on the market
  • Planning and implementing the causation phase of the case
    • determining how hard to fight general causation
    • should a company attack its own studies?
    • distinguishing between causation and association
    • preventing plaintiffs’ attorneys from turning “risk” information into evidence of causation

5:00pm
Conference Adjourns
Networking Cocktail Reception

Hosted by Dechert

Thursday December 11th, 2008

7:15
Networking Breakfast

8:00 a.m.
Co-Chairs’ Remarks

8:10 a.m.
Assessing Congressional and Political Influence on Product Liability Litigation

James W.A. Ladner
Associate General Counsel
ST. JUDE MEDICAL, INC. (St. Paul, MN)

Anand Agneshwar
Partner
ARNOLD & PORTER LLP (New York, NY)

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

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

  • Outlining key issues currently in play before Congress
  • Identifying legislative efforts which threaten to undermine critical defenses to product liability litigation
  • Recognizing how increased political and Congressional scrutiny is affecting FDA practices
    • living under the FDA’s new regulatory regime
  • What regulatory developments at the FDA can be expected following the election?
  • Examining Congressional efforts to place pressure on the industry
    • hearings and investigations
    • how does Congress choose which issues it will investigate?
    • changes in industry practices resulting from hearings and investigations
    • how do these investigations impact civil litigation?
  • Assessing the impact of the new administration on the industry and product liability litigation
    • where does the new administration stand on the issues?
    • what specific proposals of this administration will affect the industry?
    • predicting how these proposals will play out in Congress
    • how will Congressional proposals be met by the new administration?
  • Preparing an industry response in the event of a Congressional backlash

9:15 a.m.
View From the Bench – Judicial Views on Medical Products Litigation Today

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.

The Honorable Mark E. Fuller
Chief Judge
UNITED STATES DISTRICT COURT FOR THE
MIDDLE DISTRICT OF ALABAMA (Montgomery, AL)

The Honorable Harry D. Leinenweber
Senior United States District Judge
UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS (Chicago, IL)

The Honorable Charles R. Wolle
Senior United States District Judge
UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF IOWA (Des Moines, IA)

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

The Honorable Janis Graham Jack
United States District Judge
UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF TEXAS (Corpus Christi, TX)

The Honorable Marcia S. Krieger
United States District Judge
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO (Denver, CO)

The Honorable John R. Tunheim
United States District Judge
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MINNESOTA (Minneapolis, MN)

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

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

  • Class certification and deciding cases early, including preemption and summary judgment
  • What warrants sanctions for discovery violations?
  • Applying Daubert and Frye standards to plaintiff ’s causation experts
  • Coordinating state and federal cases
  • Choice of law issues
  • Protective orders
  • Instructing juries on punitive damages
  • MDL type courts at the state level
  • Consolidated trials, regular and reverse bifurcation, and other novel ways of trial management

11:00 a.m.
Morning Coffee Break

11:15 a.m.
Countering New and Creative Plaintiffs’ Theories of Liability

George A. Lehner
Partner
PEPPER HAMILTON LLP (Washington, DC)

Joseph J. Ortego
Partner
NIXON PEABODY LLP (New York, NY)

Sean P. Wajert
Partner
DECHERT LLP (Philadelphia, PA)

Consumer fraud/economic injury claims

  • Tackling key battleground issues in consumer fraud cases
    • Reliance
    • Causation
    • class certification
  • Tailoring the defense of the case to deal with the unique nature of no injury claims
    • utilizing carefully crafted motions to dismiss
  • Employing defense strategies used in cases where manufacturers successfully defeated plaintiffs’ consumer fraud allegations

Clinical trials

  • Understanding how plaintiffs are using clinical trial information to support product liability claims
  • Developing a strategic, long-term plan to protect clinical trial information from turning into fodder for the plaintiff ’s case
    • training employees to recognize the litigation potential arising from clinical trials
    • maintaining protocols as to the language and terms that will be used in clinical trial reports
  • Limiting mass tort/class action exposure

Medical monitoring

  • What new claims are plaintiffs making?
  • How are courts deciding medical monitoring cases?
    • how are courts defining “harm” and “damages” in these cases?
  • Effectively arguing against the validity of a medical monitoring class

Products manufactured outside the United States

  • How are plaintiffs using recent contamination allegations to build product liability cases?
  • Preparing for more traditional manufacturing defect claims
  • Defeating plaintiffs’ efforts to make the case about where the product is from
  • Defending cases involving foreign suppliers or manufacturers
    • overcoming difficulties in personal jurisdiction for non-U.S. parties

Other emerging theories

  • Civil RICO allegations
  • New issues presented by the advent of personalized medicine

12:30 p.m.
Networking Luncheon for Speakers and Delegates

Hosted by Covington & Burling LLP

1:45 p.m.
Anticipating the Proliferation of Mass Tort Litigation Outside the U.S.: International Class Action and Product Liability Litigation Trends

Christian Bouckaert
Partner
BOUCKAERT ORMEN PASSEMARD SPORTES (Paris, France)

S. Gordon McKee
Partner
BLAKE CASSELS & GRAYDON LLP (Toronto, Canada)

Simon J. Castley
Partner
SHOOK, HARDY & BACON L.L.P. (London, England)

  • Preparing for the growing risk of product liability litigation in other countries
    • understanding the differences between U.S. and European product liability laws
    • recognizing the differences between U.S. and Canadian product liability laws and how litigation is conducted in the two countries
    • status of class action initiatives outside the U.S.
    • identifying jurisdictions to watch out for
  • Minimizing the risks posed by expanding international efforts to allow large-scale litigation
  • Do U.S. claimant class action firms see Europe and Canada as fertile territory for U.S. mass tort techniques?
  • Countering the plaintiff ’s bar’s efforts to coordinate global product liability claims
    • challenging venue
    • managing documentary and oral discovery
    • reconciling the pace of non-U.S. cases with U.S. MDL deadlines
    • expert witness disclosures
    • settlement
    • assessing the impact of decisions in non-U.S. cases on U.S. cases and vice versa
  • Helping global employees prepare for the litigation risks brought by the move towards American-style class action litigation

2:45 p.m.
Afternoon Refreshment Break

3:00 p.m.
Defending Liability Claims in Cases Involving Both Innovator and Generic Manufacturers

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

Bridget M. Ahmann
Partner
FAEGRE & BENSON LLP (Minneapolis, MN)

Deborah E. Lewis
Special Counsel
SEDGWICK, DETERT, MORAN & ARNOLD LLP (Dallas, TX)

Jeffrey F. Peck
Partner
ULMER & BERNE LLP (Cincinnati, OH)

Moderator:
Howard L. Dorfman
Counsel
ROPES & GRAY LLP (New York, NY)

  • Understanding the arguments behind innovator liability for generic products
    • plaintiff ’s bar’s theories of liability
    • generic manufacturers’ theories of liability
  • Where do courts stand on branded liability for generics?
    • understanding the traditional rule set forth in Foster v. American Home Products Corporation and its progeny
    • examining the effect of the Philadelphia Court of Common Pleas’ decision in Clark v. Pfizer Inc
    • utilizing the preemption defense for generic manufacturers
  • Presenting a unified defense – innovator and generic manufacturers working together to defeat liability claims
  • Defending product liability claims when the innovator company is out of the litigation
    • reexamining how generics conduct pharmacovigilance

4:00 p.m.
Ethical Considerations When Developing Creative Mass Tort Settlements

Howard M. Erichson
Professor of Law
FORDHAM UNIVERSITY SCHOOL OF LAW (New York, NY)

Theodore V.H. Mayer
Partner
HUGHES HUBBARD & REED LLP (New York, NY)

  • Understanding the different settlement models available and why certain models work best for certain types of cases
  • Factors to consider when making a settlement decision
  • Creative strategies for settling mass torts
    • analyzing recent Cox-2 settlements
    • examining the Vioxx program
    • how was it put together?
    • what factors made this approach the right one for this case?
    • why is this settlement working?
  • Ethical considerations associated with recent Cox-2 settlements
    • recommendation of the settlement to a plaintiffs’ firm’s eligible clients
  • Applying the aggregate settlement rule for mass torts and settlements that restrict future practice
    • examining the nuances of Rules of Professional Conduct 1.8(g), 1.7, and 5.6(b)
    • how can a defendant achieve a measure of closure?
  • Are these settlements enforceable?
  • Drafting settlement language that will comply with ethics standards

5:15 p.m. Conference Ends