10th Anniversary

Drug and Medical Device Litigation

Expert Strategies for Leading Litigators & In-House Counsel

Monday, December 12, 2005

About

Every year, in the second week of December, leaders from the drug and medical device industries converge on New York City to review the year's legal developments and to plan ahead for what's coming.

This year, the maelstrom continues: COX-2 inhibitors and SSRIs. Defibrillator defects. MDL and the FDA's Drug Safety Oversight Board. The Class Action Fairness Act.

And it doesn't end there. Now, the perennial march of new and innovative claims against the drug and medical device industries is set against the backdrop of massive policy changes at the FDA, shifting and more aggressive priorities in the plaintiffs' bar, and increased public and political scrutiny. For 10 years, only one event has consistently provided you with the proper forum to share with industry authorities the leading-edge thinking on the issues that shape litigation, the evolving theories behind new claims, and the guiding principles for minimizing damage in times of crisis. Only one event truly enhances your ability to proactively and effectively defend your client. That event is ACI's Drug and Medical Device Litigation.

This year's 10th Anniversary Drug and Medical Device Litigation publication will cover critical issues, including:
  • Plaintiffs' latest theories - including fraud and abuse and products liability
  • Minimizing litigation damage in response to post-market adverse events
  • Cross-examination approaches to effectively communicate with your jury

Contents & Contributors

About

Every year, in the second week of December, leaders from the drug and medical device industries converge on New York City to review the year's legal developments and to plan ahead for what's coming.

This year, the maelstrom continues: COX-2 inhibitors and SSRIs. Defibrillator defects. MDL and the FDA's Drug Safety Oversight Board. The Class Action Fairness Act.

And it doesn't end there. Now, the perennial march of new and innovative claims against the drug and medical device industries is set against the backdrop of massive policy changes at the FDA, shifting and more aggressive priorities in the plaintiffs' bar, and increased public and political scrutiny. For 10 years, only one event has consistently provided you with the proper forum to share with industry authorities the leading-edge thinking on the issues that shape litigation, the evolving theories behind new claims, and the guiding principles for minimizing damage in times of crisis. Only one event truly enhances your ability to proactively and effectively defend your client. That event is ACI's Drug and Medical Device Litigation.

This year's 10th Anniversary Drug and Medical Device Litigation publication will cover critical issues, including:
  • Plaintiffs' latest theories - including fraud and abuse and products liability
  • Minimizing litigation damage in response to post-market adverse events
  • Cross-examination approaches to effectively communicate with your jury

Contents & Contributors


CURRENT PHARMACEUTICAL REGULATORY AND POLICY ISSUES - LITIGATION IMPACT
Karen McDonnell, Wyeth Pharmaceuticals, Inc.

GOING BEYOND TRADITIONAL PRODUCT LIABILITY CLAIMS: CONSUMER PROTECTION ACTIONS
George A. Lehner, Pepper Hamilton, LLP

NEW DEFENDANTS IN TRADITIONAL LITIGATION
James D. Pagliaro, Morgan, Lewis & Bockius LLP

THE NEW SHERIFFS IN TOWN: HOW STATE ATTORNEYS GENERAL "REGULATE" THE PHARMACEUTICAL INDUSTRY
James B. Irwin, Irwin, Fritchie, Urquhart & Moore LLC

DRUG SAFETY AFTER VIOXX
Daniel E. Troy, Sidley Austin Brown & Wood LLP

RECALL SYSTEM
Thomas J. Stukane, Schering-Plough Corporation

DRUG & MEDICAL DEVICE RECALLS
W. Kennedy Simpson, Thompson Miller & Simpson PLC

MEDICAL MONITORING LESSONS LEARNED
Kim M. Catullo, Gibbons, Del Deo, Dolan, Griffinger & Vecchione, P.C.
Michelle M. Bufano, Gibbons, Del Deo, Dolan, Griffinger & Vecchione, P.C.

MEDICAL MONITORING - THE LATEST THREAT TO PHARMACEUTICAL COMPANIES?
Joseph Hetrick, Dechert, LLP
Allison M. Sgroi, Dechert, LLP

RESPONDING TO POST-MARKET EVENTS: MINIMIZING LITIGATION DAMAGE
Linda Svitak, Faegre & Benson LLP
Charna Gerstenhaber, Novartis Pharmaceuticals Corporation
Doedy Klar, Alcon Laboratories, Inc.

IN HOUSE PERPECTIVE ON THE PREEMPTION DOCTRINE
Mark T. Piazza, Depuy Orthopaedics, Inc. (a Johnson & Johnson Company)

PREEMPTION DEFENSES: THE LATEST INFORMATION AND STRATEGIES: WILL IT EVER MAKE SENSE?
Joseph J. Leghorn, Nixon Peabody LLP
Vivian Quinn, Nixon Peabody LLP
Tracey B. Ehlers, Nixon Peabody LLP

CRISIS MANAGEMENT CONTROLLING THE CORPORATE MESSAGE AND LIMITING NEGATIVE EXPOSURE: IN-HOUSE COUNSEL'S TOP TEN ISSUES
Tanya Dobash, Taro Pharmaceuticals U.S.A., Inc.

HIGH STAKES COMMUNICATIONS
Richard Levick, Levick Strategic Communications

CRISIS COMMUNICATIONS IN A "TEAM SPORT"
Paul Oestreicher, Ph.D., Hill & Knowlton

CRISIS MANAGEMENT CONTROLLING THE CORPORATE MESSAGE AND LIMITING NEGATIVE EXPOSURE
Kim Moore, Irwin, Fritchie, Urquhart & Moore LLC

CROSS-EXAMINATION OF EXPERT WITNESSES
Diane Sullivan, Dechert LLP

INSURANCE COVERAGE CONUNDRUM - WORKING TOWARD A BETTER RELATIONSHIP
Lee Farrow, ACE Medical Risk
Richard P. Lewis, Anderson, Kill & Olick, P.C.

BERMUDA FORMS AND COVERAGE FOR DRUG AND MEDICAL DEVICE LIABILITY
Richard P. Lewis, Anderson, Kill & Olick, P.C.

LITIGATING CLAIMS UNDER THE CLASS ACTION FAIRNESS ACT
John L. Sander, Schering-Plough Corporation
Sheila Birnbaum, Skadden, Arps, Slate, Meagher & Flom LLP
Diane Lifton, Gibbons, Del Deo, Dolan, Griffinger & Vecchione, P.C.

AN UPDATE ON OFF-LABEL USE AND PROMOTION
Harvey L. Kaplan, Shook, Hardy & Bacon LLP Jon A. Strongman, Shook, Hardy & Bacon LLP

PEREZ V. WYETH REVISITED: THE NEW JERSEY SURPREME COURT STILL STANDS ALONE
Connie Matteo, Porzio, Bromberg & Newman P.C.
John W. Leardi, Porzio, Bromberg & Newman P.C.
Scott S. Liebman, Porzio, Bromberg & Newman P.C.

IMPACT OF DTC ADVERTISING ON THE LEARNED INTERMEDIARY DOCTRINE
Paul F. Strain, Venable LLC

INTERNATIONAL REGULATORY AND LITIGATION STRATEGIES
Eric Duranson, Sanofi Pasteur S.A.

MEDICAL DEVICES AND DIRECT TO CONSUMER PROMOTION SMART AND SAFE PRACTICES
Joseph Leghorn, Nixon Peabody LLP
Tavares M. Brewington, Nixon Peabody LLP
Amy R. George, Nixon Peabody LLP

ADVERTISING, PROMOTION & CME NAVIGATING THE "SAFE HARBORS"
Carlton E. Wessel, Pfizer, Inc.
Claudia Hinrichsen, Nixon Peabody LLP
Vivian Quinn, Nixon Peabody LLP
Melissa Tearney, Nixon Peabody LLP
James W. Ladner, St. Jude Medical, Inc.
Austin B. Byrd, Smith and Nephew, Inc.



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