Reducing Legal Risks In The

SALES AND MARKETING OF MEDICAL DEVICES

The Latest Information From the Front Lines on Enforcement Hotspots and Practical Compliance Strategies

Monday, November 17, 2003

About

Will Your Compliance Efforts Withstand Today's Enforcement Scrutiny?

Medical device companies have not escaped the heightened scrutiny that currently envelops corporate America. Ross Products' $622 million settlement of investigations into its sales practices is a wake up call to all in the device community. Further, Guidant's $92.4 million payment to the Federal Government in the wake of the Endovascular Technologies prosecution indicates that enforcement is real… and costly.

With more and more device companies coming under investigation for promotional practices and reimbursement and pricing issues, no company is immune from the specter of prosecution. Innovative means are being employed by enforcers to include companies in the widening net of prosecution, from the False Claims Act to the Economic Espionage Act to antitrust allegations.

In this high-stakes environment, even the most experienced corporate counsel, sales and marketing directors and compliance officers need a thorough understanding of the latest developments. This American Conference Institute publication will provide you with insight into the latest enforcement efforts, the newest targets and the most effective tactics for developing and maintaining a comprehensive compliance strategy. In-house counsel from various medical device companies, including those who authored the AdvaMed Code of Ethics, shared their experiences in creating and maintaining effective compliance strategies.

You'll get practical tips on the hottest issues of today… and tomorrow, including:
  • The impact of current laws on marketing practices
  • Red flags that attract enforcement scrutiny
  • Practical lessons from PhRma's Code of Ethics
  • Avoiding antitrust quagmires: what device companies must be aware of when contracting with GPOs
  • The precursor to effective marketing of any device: getting it right at the clinical trials stage
  • Critical reimbursement insight: avoiding scrutiny by mastering the Medicare maze

Contents & Contributors

About

Will Your Compliance Efforts Withstand Today's Enforcement Scrutiny?

Medical device companies have not escaped the heightened scrutiny that currently envelops corporate America. Ross Products' $622 million settlement of investigations into its sales practices is a wake up call to all in the device community. Further, Guidant's $92.4 million payment to the Federal Government in the wake of the Endovascular Technologies prosecution indicates that enforcement is real… and costly.

With more and more device companies coming under investigation for promotional practices and reimbursement and pricing issues, no company is immune from the specter of prosecution. Innovative means are being employed by enforcers to include companies in the widening net of prosecution, from the False Claims Act to the Economic Espionage Act to antitrust allegations.

In this high-stakes environment, even the most experienced corporate counsel, sales and marketing directors and compliance officers need a thorough understanding of the latest developments. This American Conference Institute publication will provide you with insight into the latest enforcement efforts, the newest targets and the most effective tactics for developing and maintaining a comprehensive compliance strategy. In-house counsel from various medical device companies, including those who authored the AdvaMed Code of Ethics, shared their experiences in creating and maintaining effective compliance strategies.

You'll get practical tips on the hottest issues of today… and tomorrow, including:
  • The impact of current laws on marketing practices
  • Red flags that attract enforcement scrutiny
  • Practical lessons from PhRma's Code of Ethics
  • Avoiding antitrust quagmires: what device companies must be aware of when contracting with GPOs
  • The precursor to effective marketing of any device: getting it right at the clinical trials stage
  • Critical reimbursement insight: avoiding scrutiny by mastering the Medicare maze

Contents & Contributors

THE IMPACT OF MEDICARE LAWS ON MARKETING OF MEDICAL DEVICES
Harvey A. Yampolsky, Arent Fox Kintner Plotkin & Kahn, PLLC

PROMOTION OF MEDICAL DEVICES BY LOCAL REPS: WHAT EVERY COMPLIANCE OFFICER NEEDS TO KNOW ABOUT THE REALITIES – AND THE RISKS
Teresa I. Ford, Law Offices of Teresa I. Ford, PC
James B. Rogan, Centerpulse Orthopedics Inc.

OIG COMPLIANCE PROGRAM GUIDANCE: APPLICATION TO DEVICE MANUFACTURERS
Paul E. Kalb, Sidley Austin Brown & Wood

PROTECTING AGAINST AND DEFEATING NOVEL PRODUCTS LIABILITY CLAIMS IN LIGHT OF THE OIG COMPLIANCE PROGRAM GUIDANCE FOR PHARMACEUTICAL MANUFACTURERS
Lori G. Cohen, Alston & Bird LLP
Christiana P. Callahan, Alston & Bird LLP

WHAT EVERY ONE IN THE MEDICAL TECHNOLOGY INDUSTRY NEEDS TO KNOW ABOUT THE NEW ADVAMED CODE OF ETHICS
Leigh-Ann Patterson, Nixon Peabody LLP

HOW TO NAVIGATE THE NEW ADVAMED CODE
William T. Fitzgerald, Alcon Laboratories, Inc.
Leigh-Ann Patterson, Nixon Peabody LLP
Kristine Rapp, Baxter Healthcare

POTENTIAL PITFALLS IN THE GPO/DEVICE MANUFACTURER RELATIONSHIP – AND HOW TO AVOID THEM
Rebecca L Jackson, Mayer, Brown, Rowe & Maw LLP

CONFLICTS OF INTEREST IN CLINICAL TRIALS
R. Michael Scarano, Jr., Foley & Lardner

STRUCTURING CLINICAL TRIALS
Bernard E. Statland, Arent Fox Kintner Plotkin & Kahn, PLLC

NEW PROCEDURES & TECHNOLOGY: THE HOSPITAL PERSPECTIVE
J. Mark Waxman, CareGroup, Inc.

EMERGING LEGAL THEORIES IN GOVERNMENT INVESTIGATIONS
Sheva Sanders, Medtronic, Inc.

WHEN ENFORCEMENT TURNS CRIMINAL: DEFENDING THE COMPANY AND ITS EMPLOYEES
John N. Nassikas, III, Arent Fox Kintner Plotkin & Kahn, PLLC

CONTRACTING ARRANGEMENTS WITH DISTRIBUTORS AND CUSTOMERS INCLUDING GPOS: THE ANTITRUST ROADMAP
Robert F. Leibenluft, Hogan & Hartson
F. Joseph Gormley, Hogan & Hartson

COVERAGE OF AND REIMBURSEMENT FOR MEDICAL DEVICES
Elizabeth Carder-Thompson, Reed Smith LLP

FALSE CLAIMS ACT PROSECUTIONS AGAINST MEDICAL DEVICE MANUFACTURERS AND SUPPLIERS
Carolyn J. McElroy, Mintz Levin Cohn Ferris Glovsky & Popeo

‘DOT.COM MEDICINE' – RISKS TO THE LEARNED INTERMEDIARY DEFENSE
James M. Wood, Reed Smith Crosby Heafey

UPDATING YOUR COMPLIANCE PROGRAM IN VIEW OF RECENT DEVELOPMENTS
Robert B. Ramsey, Buchanan Ingersoll

COMPLIANCE PROGRAMS – WHY NOW IS A GOOD TIME TO REEVALUATE
Ira H. Raphaelson, O'Melveny & Myers



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