MEDIA ALERT: March 8, 2010

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Off-Label Treatment in Orthopaedic Medicine
Media briefing brings experts together to talk about off-label
practices and policies

NEW ORLEANS—The American Academy of Orthopaedic Surgeons (AAOS) at its 2010 Annual Meeting will host a media briefing to discuss the intricacies of treatment decisions, the FDA approval process and physician-directed care. The briefing, which will be held on Thursday, March 11, 2010, from 2:30 p.m. to 3:00 p.m. in Room 206 of the Morial Convention Center, will give reporters a chance to ask panelists questions and hear a variety of perspectives on the practice of medicine within and outside of the framework of federally-approved use.

“Physicians are charged with making the best treatment decision for each individual patient. The challenge is negotiating the anecdotal wisdom of practice and expertise with constantly updated research and federal guidelines.” Said Dr. Michael J. Yaszemski, MD. “But, it is in all of our best interests to get it right through continuing education, additional research and improved approval processes. Even the FDA will admit that their guidelines do not take the place of a physicians’ expertise about his or her patient. So, together, we need to continue to work together in new ways to improve the standard of care and our patients’ quality of life.” Dr. Yaszemski is a practicing orthopaedic surgeon at the Mayo Clinic.

The AAOS has a position statement on off label use that serves as a reference point for its 36,000 members.

The briefing participants include:

• Moderator Michael J. Yaszemski, MD, Ph.D.
• A. Seth Greenwald, D.Phil.(Oxon)
• B. Sonny Bal, MD, member of the AAOS Medical Liability Committee
• Kathleen McDermott, JD, a nationally recognized health care attorney based in Washington, D.C.  
• George Muschler, MD
• Jeffrey Fischgrund, editor of the Journal of the American Academy of Orthopaedic Surgeons

Corresponding New Research

• Dr. Greenwald and Dr. Yaszemski will present highlights of a symposium they are hosting at the Annual Meeting that examines a law that brought medical device oversight under the U.S. Food and Drug Administration and how it affects physician-directed treatment. Learn more about the symposium.

• Dr. Bal will discuss the current state of liability that a surgeon assumes when using orthopaedic implants in an off-label manner. Learn more.

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