An unprecedented Oregon Department of Justice investigation has stepped into an ethical minefield with national implications: When should patients know about a doctor’s payments from companies whose products they use, and whose responsibility is it to tell them?
The state recently concluded a court case against two Salem doctors who put heart implants into patients without telling them that a manufacturer’s training program put a sales representative into the operating room. The DOJ accused the doctors in the civil case of having “misrepresented” their services as “for the exclusive benefit of the patient” and “concealing” from patients payments that created a potential “incentive” to use Biotronik implants — defibrillators and pacemakers. The surgeons received between $400 and $1,250 for implant surgeries when a trainee was present.
Drug and device companies face increasing scrutiny over their payments to doctors, including speaking and consulting fees. But several experts say this is the first time doctors have faced state enforcement action for failing to tell patients about “actual or potential” conflicts that “should have been disclosed.” Experts say the Oregon case sends a message — but local providers are still trying to figure out what that message means.
Under the Aug. 1 settlement with the Justice Department, cardiologists Matthew Fedor and Kyong Turk admitted no wrongdoing but agreed to pay $25,000 each and inform future patients of any payments from a drug or device maker in connection with their services to that patient and when admitting sales representative trainees to the operating room.
Want to publish your own articles on DistilINFO Publications?
Send us an email, we will get in touch with you.
Turk, retired in Hawaii, did not respond to requests for comment. Fedor, in a statement, said he didn’t think the law called for the disclosures to patients. “I hold the well-being of my patients in the highest regard and believe that my decisions regarding their care were and are appropriate.”
At Biotronik’s U.S. headquarters in Lake Oswego, president Jake Langer called the state’s case unfair and detrimental to good health care.
“We are really clean when it comes to our relationships with physicians,” he said. He blamed the first-of-its-kind case on overzealous prosecutors trying “to set up a new law” without going to the Legislature.
Portland cardiologist Sandra Lewis, past president of the American College of Cardiology, Oregon chapter, said her group is aware of this case, and it has “vast implications” for doctors and patient disclosures.
“Where are the lines on this? What is the doctor’s responsibility? I think there may be some unintended consequences from this.”
Susan Chimonas of Columbia University’s Center on Medicine as a Profession said industry pay to doctors increasingly is online, but doctors should also disclose them to patients directly.
“A growing body of scientific evidence shows that even small industry payments can shape physicians’ treatment decisions,” she said. “If physicians want to maintain patients’ trust, then transparency is a minimum ethical requirement.”
Date: August 16, 2013