7th National Forum on Reducing Legal Risks in the

Sale and Marketing of Medical Devices

Tuesday, June 17, 2008

About

The recent federal subpoenas and resulting Deferred Prosecution Agreements (DPAs) between government enforcers and major medical device companies sent a clear message to the device industry : United States Attorney's Offices across the nation are investigating device-consultant relationships and reviewing them with a fine-tooth comb. The financial punishments are severe enough, but the long-term costs of federal monitoring are staggering.

In addition, the SEC is extending its long arm into foreign business practices by reviewing business activities abroad and holding device companies liable for the actions of its global sales force and third-party distributors. The domino-effect of an FCPA investigation can leave your business fighting domestic and foreign subpoenas for years.

For their part, the FDA is reacting to increasing claims of off-label marketing, and the new direct-to-consumer campaigns from device companies demand federal review. Finally, both the state and federal government are proposing—and passing—an unprecedented number of statutes and regulations designed to increase transparency and public access to business practices, all of which affect your bottom line.

These developments are having devastating effects and ramifications on the device industry and these and other business practices will surely spark a new round of government scrutiny and subpoenas. There has never been a more important time to benchmark your compliance policies and ensure that they utilize the best available practices to effectively combat the significant risks involved in the sales and marketing of devices.

In response, the American Conference Institute has specifically designed this publication from the 7th National Forum on Reducing Legal Risks in the Sales and Marketing of Medical Devices to provide you with a sophisticated and comprehensive understanding of the most difficult and costly compliance issues facing device companies today , along with practical strategies for tackling these challenges. This publication features an unparalleled faculty of government enforcers who will give you the most up-to-date information on the triggers that will spark the next round of scrutiny.

  • Examine the DPAs and elucidate the practices every company needs to implement to prevent being on the receiving end of the next round of subpoenas
  • Insulate your company from the kinds of business activities, even inadvertent, that bring the SEC to your door
  • Protect necessary relationships with physicians without crossing the fine line into inappropriate practices
  • Compare and contrast your existing compliance program to successful and effective programs that work to see how yours measures up

Contents & Contributors

About

The recent federal subpoenas and resulting Deferred Prosecution Agreements (DPAs) between government enforcers and major medical device companies sent a clear message to the device industry : United States Attorney's Offices across the nation are investigating device-consultant relationships and reviewing them with a fine-tooth comb. The financial punishments are severe enough, but the long-term costs of federal monitoring are staggering.

In addition, the SEC is extending its long arm into foreign business practices by reviewing business activities abroad and holding device companies liable for the actions of its global sales force and third-party distributors. The domino-effect of an FCPA investigation can leave your business fighting domestic and foreign subpoenas for years.

For their part, the FDA is reacting to increasing claims of off-label marketing, and the new direct-to-consumer campaigns from device companies demand federal review. Finally, both the state and federal government are proposing—and passing—an unprecedented number of statutes and regulations designed to increase transparency and public access to business practices, all of which affect your bottom line.

These developments are having devastating effects and ramifications on the device industry and these and other business practices will surely spark a new round of government scrutiny and subpoenas. There has never been a more important time to benchmark your compliance policies and ensure that they utilize the best available practices to effectively combat the significant risks involved in the sales and marketing of devices.

In response, the American Conference Institute has specifically designed this publication from the 7th National Forum on Reducing Legal Risks in the Sales and Marketing of Medical Devices to provide you with a sophisticated and comprehensive understanding of the most difficult and costly compliance issues facing device companies today , along with practical strategies for tackling these challenges. This publication features an unparalleled faculty of government enforcers who will give you the most up-to-date information on the triggers that will spark the next round of scrutiny.

  • Examine the DPAs and elucidate the practices every company needs to implement to prevent being on the receiving end of the next round of subpoenas
  • Insulate your company from the kinds of business activities, even inadvertent, that bring the SEC to your door
  • Protect necessary relationships with physicians without crossing the fine line into inappropriate practices
  • Compare and contrast your existing compliance program to successful and effective programs that work to see how yours measures up

Contents & Contributors

SUMMARY OF DOJ AND OIG IMPOSED REQUIREMENTS ON DEVICE COMPANIES FROM DOJ INVESTIGATION INTO ARRANGEMENTS WITH ORTHOPEDIC SURGEONS
Kathleen McDermott, Sonnenschein Nath & Rosenthal LLP (Washington, DC)

RISKY BUSINESS: GIFTS, CHARITABLE DONATIONS, EDUCATIONAL GRANTS, CLINICAL/MEDICAL RESEARCH
Melissa Beare, Advanced Neuromodulation Systems, Inc. (Plano, TX)

MEDICAL DEVICES AND THE U.S. FOREIGN CORRUPT PRACTICES ACT
John C. Keeney, Jr., Hogan & Hartson LLP (Washington, DC)

PERSPECTIVES ON THE COSTS OF FCPA VIOLATIONS AND HOW TO AVOID THEM
Michael Shepard, HellerEhrman LLP (San Francisco, CA)

RECENT JUDICIAL AND LEGISLATIVE DEVELOPMENTS IN PHARMACEUTICAL AND MEDICAL DEVICE LITIGATION: PREEMPTION AND SUNSHINE
Steven J. Ellison, Faegre & Benson LLP (Minneapolis, MN)

LEGISLATIVE SCRUTINY OF THE MEDICAL DEVICE INDUSTRY: KEYS TO PREPARING FOR AN EVER-CHANGING LEGAL AND REGULATORY LANDSCAPE
Jennifer A. Romanski, Porzio, Bromberg & Newman P.C. (Morristown, NJ)

REDUCING LEGAL RISKS IN THE SALE AND MARKETING OF MEDICAL DEVICES
Casper Uldriks, Center for Device and Radiological Health (Rockville, MD)

OFF-LABEL LIABILITY ISSUES FOR MEDICAL DEVICE MANUFACTURERS
Peter Henderson, GE Healthcare (Wauwatosa, WI)
Janet Richardson, Advanced Medical Optics, Inc. (Santa Ana, CA)
Jennifer Bragg, King & Spalding LLP (Washington, DC)

TV, RADIO, PRINT AND THE INTERNET: IDENTIFYING BUSINESS PARAMETERS FOR DEVICE MANUFACTURERS’ NEW FORAY INTO DTC MARKETING
Ann Simoneau, Center for Device and Radiological Health (Rockville, MD)

DTC MARKETING: FDA VS. FTC JURISDICTION
Anthony G. Brazil, Morris Polich and Purdy LLP (Los Angeles, CA)

LIMITING LIABILITY THROUGH EFFECTIVE TRAINING, MONITORING AND CONTROLLING OF THE SALES FORCE
Jody A. Gleason, GE Healthcare Integrated IT Solutions (Barrington, IL)

LIMITING LIABILITY THROUGH EFFECTIVE TRAINING, MONITORING AND CONTROLLING OF THE SALES FORCE
Brian K. French, Nixon Peabody LLP (Boston, MA)

FOSTERING A COMPANY WIDE CULTURE OF COMPLIANCE
Jill Mason, Advanced Neuromodulation Systems, Inc. (Plano, TX)

COMPLIANCE FROM THE OUTSIDE LOOKING IN: HOW TO MOST EFFECTIVELY ASSIST YOUR DEVICE CLIENTS WITH THEIR COMPLIANCE INITIATIVES
Teresa I. Ford, Law Offices of Teresa Ford, PC (Houston, TX)

AVOIDING THE LEGAL PITFALLS ASSOCIATED WITH DEVICE REIMBURSEMENT
Alison W. Shuren, Arent Fox LLP (Washington, DC)

AVOIDING LEGAL PITFALLS IN DEVICE REIMBURSEMENT
Jeffrey Bush, Corporate Reimbursement, BD (Franklin Lakes, NJ)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0