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Consulting Agreements with Physicians:
The Role of Bias and Compliance

Virginia Gibson

US Attorney’s Office

Norm Johanson, M.D.

Drexel University

Jorge Ochoa, Ph.D., P.E.

Exponent, Inc.

John Reiss, Ph.D. J.D.

Saul Ewing

Do consulting agreements with physicians result in the development or improvement of life saving products, or could they be kickback schemes rewarding high volume physicians for brand loyalty? Unlike drugs that usually are developed in company laboratories, medical devices frequently are created or improved by physicians. These physicians are involved in the design and development processes and are often hired to train colleagues in their use. As a result, many physicians may have a financial stake in the success of the device. Medical device manufactures frequently develop relationships with these physicians, as well as those who prescribe their products and act as opinion leaders within their field. Physicians may be compensated through royalty payments, consulting fees, speaking honorariums or subsidized trips to attend conferences and training sessions. Recently, the government has alleged that companies' payments are inducement to use the company's products, thereby making the payments illegal. How can you mitigate the likelihood of enforcement action while maintaining a competitive position in this very competitive industry?

Highlights that will be discussed by this panel include:

• Recent DOJ activities that have impacted the industry
• Increased compliance activities by medical device and pharmaceutical industry
• Handling conflict of interest in the academic setting
• Physician involvement with the industry and role of bias
• Value of physician input for the advancement of technology

Please join us for this panel presentation. A continental breakfast will be served at 7:30am.

Bios

Virginia Gibson

Virginia Gibson is Chief of the Civil Division of the United States Attorney's Office for the Eastern District of Pennsylvania, and also served as the Civil Chief and the Executive Assistant United States Attorney for the District of Delaware, where she supervised both criminal and civil health care fraud. Ms. Gibson has handled a wide range of government fraud matters, including health care, pharmaceutical, procurement, and consumer fraud matters, as well as environmental enforcement. Ms. Gibson teaches courses in health care fraud at Temple University School of Law and Widener Law School. Before joining the United States Attorney's Office, Ms. Gibson was associated with the Philadelphia firm of Drinker Biddle and Reath.

Norman A. Johanson, M.D.

Dr. Johanson is Chairman of the Department of Orthopaedic Surgery at Drexel University College of Medicine. He has a specialized clinical practice in hip and knee joint replacement, with emphasis on complex primary and revision surgery. He has been a leader in the field of orthopaedic outcomes assessment, and has worked with national organizations toward developing standardized patient administered questionnaires for the purpose of evaluating surgical results. Dr. Johanson has served on the Evidence-Based Practice Committee of the American Academy of Orthopaedic Surgeons and recently chaired a work group that authored a clinical guideline on the prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty. Dr. Johanson is currently President of the Philadelphia Orthopaedic Society and is on editorial boards of the Journal of Bone and Joint Surgery, the Journal of Arthroplasty, and the Pennsylvania Patient Safety Advisory.

Jorge Ochoa, Ph.D., P.E.

Dr. Ochoa is a Senior Managing Engineer at Exponent. He has over 17 years of broad experience in all R&D related areas of new product realization, from concept phase to market readiness. His specific expertise encompasses design of surgical instruments and techniques, as well as biomechanics, engineering biomaterials, and preclinical testing strategy. Prior to joining Exponent, Dr. Ochoa was Chief Technology Officer at Archus Orthopaedics, a privately held medical device start-up company. Before that, he spent 13 years at DePuy Orthopaedics, a division of Johnson & Johnson, in various roles of increasing responsibility within R&D including Vice President of R&D. His activities and responsibilities included new product development; customer needs analysis and support, M&A due diligence and integration, intellectual property analysis, and litigation support. Dr. Ochoa received his Ph.D. in Mechanical Engineering at Purdue University.

John Reiss, Ph.D., J.D.

Dr. Reiss is a partner at Saul Ewing. He concentrates his practice in health care matters including developing and implementing various forms of provider networks and managed care arrangements; corporate, partnership and contractual arrangements and ventures; Medicare, Medicaid, and other insurance coverage and payment issues; developing and implementing compliance audits and plans; FDA drug and device issues; certificate of need, licensure and other regulatory matters; and medical staff credentialing, disputes, and patient care problems. Previously, Dr. Reiss served as the Director of Office of Health Regulation, U.S. Department of Health and Human Services and as Assistant Commissioner for the New Jersey State Department of Health. While serving in the educational community, Dr. Reiss was Associate Professor of Economics at Stockton State College and also held the position of Assistant Professor of Economics at Allegheny College.