Katrina McKenzie, sick and tired of suffering in constant hip pain, took the advice of her surgeon and had them replaced with experimental implants. She agreed to participate in a clinical study; with an understanding of the inherent risk involved and that her new hips could fail.
What she didn’t know was the manufacturer financing the study, Smith & Nephew, was paying her surgeon thousands of dollars a year in consulting fees.
Over the years, such payments made to doctors from drug companies and medical implant manufacturers have come under fire.
Hip-and-knee replacement surgery has exploded over the past decade, doubling to nearly 750,000 surgeries annually, fueling a multibillion-dollar implant industry with profit margins that are climbing to nearly 20 percent.
Many of the top leading orthopedic surgeons receive upwards of six and seven-figure annual payments, in the form of consulting deals, speaking fees and royalties from the makers of artificial hips and knees.
These deals – and the sizeable amounts – have prompted federal investigations and debates in Congress, which is considering legislation that would require companies to disclose the payments.
McKenzie has filed a lawsuit against her surgeon, Jonathan Garino, and the University of Pennsylvania Health System, alleging he botched her surgery and that the consulting fees he receives affects his decisions.
Penn and Garino responded, in court filings, that McKenzie received good care and the payments had no effect on her treatment.
The lawsuit goes to trial in August.
This is one case in many, as critics are concerned whether payments will present a conflict of interest by distorting doctors’ judgments on how to best treat their patients. In contrast, some admit payments to those surgeons who help design and patent artificial joints and other medical devices are legitimate.
When examining past deals, federal investigators found in some cases, large consulting fees were paid to doctors for little to no work, expensive trips were labeled as medical seminars and payments made directly to surgeons appeared to be for the purpose of convincing doctors to use the company’s product.
A New Jersey U.S. attorney filed criminal complaints, last year, alleging four of the largest artificial-joint makers conspired to violate a federal anti-kickback statute by paying surgeons to endorse and use their medical devices.
The companies – Biomet Inc., DePuy Orthopaedics, Smith & Nephew and Zimmer Holdings – without admitting any wrongdoing paid a settlement of $310 million. A fifth company, Stryker Corp., cooperated with the investigation and was not charged.
In 2007, fifty-one doctors received over $1 million each. 29 doctors and others received a total of $7.9 million last year. A majority of the money went to two of the region’s most prominent orthopedic surgeons.
Implant makers and others argue surgeons’ expertise assists and helps companies to develop better, longer-lasting products. While proponents say, doctors deserve to be paid for their contributions.
It is difficult for investigators to figure out which payments are legitimate and which ones are considered improper inducements intended to influence doctors to use their device.
The solution, many believe lies in better disclosure – so that patients know who is paying their surgeon – and how much. #