2nd National Seminar on Reducing Legal Risks in the

Sales and Marketing of Medical Devices

Practical Insight from the Front Lines on the Latest Enforcement Activity and Ongoing Compliance Strategies

Monday, November 15, 2004

About

Is your company's compliance program effective and adaptable to today's ever-changing enforcement environment?

Medical device companies are in the crosshairs of enforcers and plaintiffs' attorneys across the country. Recent headlines illustrate the culture of scrutiny that the pharmaceutical and medical device industries are subjected to. Significant settlements continue to be negotiated on the matter of alleged inappropriate promotion of products. Moreover, it has been intimated that medical device companies are engaging in the same fraud that has prompted significant settlements in the pharmaceutical industry, prompting the Department of Health and Human Services to declare that it will hasten investigations of alleged fraud and abuse in the medical device industry.

In the face of this commitment to prosecution, and with the specter of the penalties suffered by the pharmaceutical industry, it is clear that every medical device counsel, sales and marketing director, and compliance officer must have a complete understanding of the legal risks inherent in the sales and marketing of medical devices. You must have a sophisticated knowledge of reimbursement policies and know how to implement and maintain effective compliance guidelines. You must also monitor ongoing enforcement activity in the industry. And, you must do all these things while supporting the achievements of aggressive sales targets.

American Conference Institute's Second Annual Advanced Forum on Reducing Legal Risks in the Sales and Marketing of Medical Devices will provide you with front line insight from government policy makers, enforcers, industry personnel, and experienced medical device counsel on strategies for reducing risks and effective compliance techniques.

In-house counsel from various medical device companies will share their experiences over the past year in creating and maintaining effective compliance strategies. Expert outside attorneys will offer practical tips on the hottest issues of today…and tomorrow. And, the government enforcers will provide the critical insight that will tell you what's on the radar and what type of activity attracts government attention.

Contents & Contributors

About

Is your company's compliance program effective and adaptable to today's ever-changing enforcement environment?

Medical device companies are in the crosshairs of enforcers and plaintiffs' attorneys across the country. Recent headlines illustrate the culture of scrutiny that the pharmaceutical and medical device industries are subjected to. Significant settlements continue to be negotiated on the matter of alleged inappropriate promotion of products. Moreover, it has been intimated that medical device companies are engaging in the same fraud that has prompted significant settlements in the pharmaceutical industry, prompting the Department of Health and Human Services to declare that it will hasten investigations of alleged fraud and abuse in the medical device industry.

In the face of this commitment to prosecution, and with the specter of the penalties suffered by the pharmaceutical industry, it is clear that every medical device counsel, sales and marketing director, and compliance officer must have a complete understanding of the legal risks inherent in the sales and marketing of medical devices. You must have a sophisticated knowledge of reimbursement policies and know how to implement and maintain effective compliance guidelines. You must also monitor ongoing enforcement activity in the industry. And, you must do all these things while supporting the achievements of aggressive sales targets.

American Conference Institute's Second Annual Advanced Forum on Reducing Legal Risks in the Sales and Marketing of Medical Devices will provide you with front line insight from government policy makers, enforcers, industry personnel, and experienced medical device counsel on strategies for reducing risks and effective compliance techniques.

In-house counsel from various medical device companies will share their experiences over the past year in creating and maintaining effective compliance strategies. Expert outside attorneys will offer practical tips on the hottest issues of today…and tomorrow. And, the government enforcers will provide the critical insight that will tell you what's on the radar and what type of activity attracts government attention.

Contents & Contributors

ADVAMED CODE OF ETHICS: ONE YEAR LATER
William T. Fitzgerald, Alcon Laboratories, Inc.
Bradley J. Tandy, Biomet, Inc.
Kristine Rapp, Hospira

LEGAL CHALLENGES IN THE USE AND BILLING OF INVESTIGATIONAL MEDICAL DEVICES IN CLINICAL TRIALS
Michael R. Scarano, Jr., Foley & Lardner

REIMBURSEMENT SUPPORT: WHAT IS PERMISSIBLE?
Robert B. Ramsey, III, Buchanan Ingersoll

THE IMPACT OF RECENT ENFORCEMENT ACTIVITY ON CIVIL LIABILITY
Lori Cohen, Alston & Bird

THE IMPACT OF RECENT ENFORCEMENT ACTIVITY ON CIVIL LIABILITY
George E. McDavid, Reed Smith LLP
Jennifer L. Bradshaw, Reed Smith LLP

ANTITRUST ISSUES IN HOSPITAL AND GPO ARRANGEMENTS: ENGAGING WITH THE GOVERNMENT
Michael H. Knight, Federal Trade Commission

EMERGING ANTITRUST ISSUES IN HOSPITAL AND GPO ARRANGEMENTS
Scott Stein, Sidley, Austin, Brown & Wood LLP

GROUP PURCHASING ORGANIZATIONS (GPOS) AND THEIR ROLE IN THE SUPPLY-SIDE OF THE HEALTHCARE
Rebecca L. Jackson, Mayer Brown Rowe & Mawe

HOSPITAL GROUP PURCHASING: HOW TO MAINTAIN INNOVATION AND COST SAVINGS
David A. Balto, Robins Kaplan Miller & Ciresi

THE IMPACT OF MMA ON MARKETING MEDICAL DEVICES
Larri Short, Arent Fox PLLC

COMPLIANCE PROGRAMS – WHY NOW IS A GOOD TIME TO REEVALUATE
Ira Raphaelson, O'Melveny & Myers
Michael T. Dyer, PricewaterhouseCoopers

MAINTAINING AN EFFECTIVE COMPLIANCE TRAINING INFRASTRUCTURE
Teresa I. Ford, Law Offices of Teresa I. Ford, PC

FDA UPDATE: THE NEW GUIDANCE ON DEVICES PROMOTION AND CURRENT ENFORCEMENT PRIORITIES
Marc J. Scheineson, Alston & Bird

PRESCRIPTION FOR SUCCESS: MASTERING THE PREEMPTION DOCTRINE
Joseph K. Hetrick, Dechert LLP
Will W. Sachse, Dechert LLP
Jennifer K. Green, Dechert LLP

FRAUD, ABUSE, FALSE CLAIMS, AND THE MEDICAL DEVICE INDUSTRY: AN OPINIONATED PRIMER
Joseph J. Leghorn, Nixon Peabody LLP
Amy R. George, Nixon Peabody LLP
Matthew Goulding, Nixon Peabody LLP



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0