A few months after settling federal allegations that they ran kickback schemes, five orthopedic device makers say their new procedures ensure that their interactions with surgeons are transparent, above-board and, above all, absolutely necessary to the development of new devices and technologies.
In a series of responses to emailed questions by AAOS Now, the journal of the American Academy of Orthopaedic Surgeons, Biomet Inc. president & CEO Jeffrey Binder; Joseph DeVivo, president of Smith & Nephew’s orthopaedic reconstruction division; David Dvorak, president & CEO of Zimmer Holdings Inc.; David Floyd, president of DePuy Orthopaedics Inc.; and Stryker Orthopaedics president Michael Mogul all say the medical device industry depends on close collaboration with physicians.
{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Binder_Jeffrey_100x100.jpg}Binder: “One thing that hasn’t changed is the need for industry to collaborate with surgeons in product development, clinical research, and training and education. We simply cannot make the kinds of improvements that benefit patients without close interaction. … We have completely isolated our sales force from any involvement in our consulting relationships. We do not want even the appearance of a link between our consultants and their current or potential business with the company as customers.”
{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/DeVivo_Joseph_100x100.jpg}DeVivo: “Smith & Nephew’s commitment to education, research, and clinical trials with our surgeon partners has not waned. What has changed and will ultimately benefit everyone is the new process in place to ensure that activities are consistent with behaviors. Our desire to develop and grow with surgeons continues, but there is a different protocol going forward.”
{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Dvorak_David_100x100.jpg}Dvorak: “The consideration that has guided all of our decisions during this time is the importance of preserving the best of the collaborative relationships that drive innovation in product development, clinical research, and education. These relationships between industry and the healthcare professional community have facilitated the improvement of patient outcomes, and Zimmer firmly believes they are critical for developing tomorrow’s solutions. … Zimmer recognizes and understands that we will never be able to fulfill our purpose and mission without proper collaboration with the healthcare professional community. Clearly, innovation in the research and development area is the lifeblood of our company.”
{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Floyd_David_100x100.jpg}Floyd: “Collaboration with orthopaedic surgeons and other healthcare professionals to develop new products and to educate surgeons about the availability and proper use of products will continue to be a hallmark of orthopaedics. Policies and procedures about how DePuy engages surgeons as consultants, compensates them, and documents the arrangement have improved and gotten more rigorous, but the core principles of working closely with surgeons in product development, education, and training haven’t changed. … DePuy has always felt that our interactions with surgeons as consultants have to be appropriate, above-board, and legitimate. Now we have to be able to demonstrate the validity of those interactions to interested outside parties such as the government and the public. We need to make clear that the surgeon and patient determine medical treatment and that the surgeon’s medical judgment is not clouded.”
{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Mogul_Michael_100x100.jpg}Mogul: “Stryker is actively working with our orthopaedic surgeon consultant/partners in product development, clinical research, and medical education. We have more robust systems to manage these activities after the last 18 months, but the activities remain a key part of how we develop, study, and train on our products.”
And when it comes to the Physician Payment Sunshine Act (PDF) wending its way through Capitol Hill, Dvorak and Binder said they hope any federal law regulating industry payment to doctors pre-empts local and state rules such as the Massachusetts gift ban:
Dvorak: “One concern we have expressed is that we believe that any federal law should deter states from enacting their own versions; physicians and companies should expect consistent disclosure requirements across all states.”
Binder: “If every state has its own set of disclosure laws, manufacturers will face unmanageable and expensive disclosure requirements that simply create costs while providing information of dubious value.”
Criminal charges were dismissed against DePuy, Smith & Nephew, Zimmer Holdings Inc. and Biomet Inc. at the end of March after they completed terms of deferred prosecution agreements reached in 2007 with the Jersey feds that saw them agree to pony up $311 million in civil settlements.
Stryker which voluntarily cooperated with the investigation, “satisfactorily completed” the terms of its non-prosecution agreement but didn’t take part in the civil settlement.
Prosecutors had accused the five device makers, which account for 95 percent of the hip and knee implant market, of improperly paying consulting fees to surgeons between 2002 and 2006 so the doctors would use the companies’ artificial hip and knee products.
