A company under fire for producing faulty hip-replacement parts that could cause patients to need second surgeries has paid out more than $80.8 million to 200 physicians across the country since 2009 for promotion, research and consultation, a review by C-HIT shows. (Read payments here.)
(Click here to read a related story, Recall Surgeries Panic Patients.)
The doctors who have been compensated by DePuy Orthopaedics include a prominent New Haven-area orthopedic surgeon and the chairman of orthopaedic surgery at the University of Connecticut Health Center, who have received more than $140,000 in total since last year, records show.
While physicians defend the payments, consumer advocates say they pose a conflict of interest that can color a doctor’s decision-making.
New Haven area orthopedist Dr. John Irving acknowledged that he has had to notify about 30 patients that he implanted a recently-recalled hip replacement part in them that could cause them to need second surgeries. Irving has received more than $80,900 in consultant’s payments since 2009 from the device’s manufacturer, DePuy, which is now under scrutiny from the FDA.
In addition to Irving, of The Orthopaedic Group, Dr. Jay Lieberman, chairman of orthopaedic surgery at the UConn Health Center, received close to $60,000 from DePuy. Lieberman said he did not use the recalled device.
A third Connecticut physician, Dr. Richard Bernstein, a hand surgeon in The Orthopaedic Group, received $9,377 from DePuy. He did not return a message left at his office.
DePuy, a division of Johnson & Johnson, has come under fire in the past several months in connection with its worldwide recall of a hip implant device known as Acetabular ASR XL, which was used on 37,000 patients in the U.S. At the same time, DePuy recalled another hip implant system that was used outside of the US. The two recalls affected 93,000 people worldwide. This summer DePuy received a warning letter from the FDA regarding its unapproved marketing of TruMatch Personalized Solutions System—a surgical-assist software system—and off-label promotion of Corail Hip System, a hip-implant product.
The company discloses payments to doctors on its website, categorizing them as consulting pay, product royalty payments, or compensation for research, meals, airfare and other expenses. The disclosures show that DePuy paid $47.9 million to physicians in 2009, and $32.9 million through September of this year. Some surgeons collected more than $1 million from the company this year, even as concerns were rising about the safety of some of its products.
In 2007, the U.S. Department of Justice filed criminal complaints again four major medical device companies, including DePuy, alleging they were paying kickbacks to doctors for using their products. The charges were dropped last year after the companies paid fines and agreed to pay physicians only for legitimate consulting services.
But, the most recent DePuy payment disclosures show significant payouts continue, raising questions about whether they compromise relationships between patients and their doctors.
Irving and Lieberman defended the payments as reimbursement for legitimate work. Irving said his pay was “an administrative fee for collecting data for the company on hip and knee implants.”
In an interview, Irving said that he resented any “inference” about a potential conflict between taking payments from the company and using its products, which he also highlights on his website.
Lieberman said the $59,920 he received from DePuy was for research, consulting on the development of new implants, and helping DePuy teach orthopedic surgeons how to do implants. He declined to name the companies whose products he uses.
Health consumer advocates point to the potential for conflicts of interest in manufacturers paying doctors, especially those who use and promote products made by the company that employs them.
Jean Rexford, executive director of the Connecticut Center for Patient Safety, said doctors “can think they’re not influenced” by the companies that give them money.
“But the reality is, it’s human beings,” she said. “We are influenced. If somebody does something nice for me, I’m nicer to them than someone who hasn’t done something nice to me.”
Gregory E. Demske, an assistant inspector general for legal affairs, testified before a Senate committee in 2008 that “relationships between physicians and the health care industry, including pharmaceutical and device manufactures and suppliers, can advance medical science and benefit patients.’’
Demske, who works in the Office of Inspector General for the U.S. Dept. of Health and Human Services, said, “However, in an environment where physicians routinely receive substantial compensation from medical device companies through stock options, royalty agreements, consulting agreements, research grants and fellowships, evidence suggests that there is a significant risk that such payments will improperly influence medical decision-making.’’
Demske pointed to studies done in national medical journals that “found that such financial industry-physician relationships are pervasive and that the impulse to reciprocate for even small gifts has a powerful influence on behavior.’’
Lieberman, who directs the New England Musculoskeletal Institute, based at the UConn Health Center, said, “I don’t have any problems taking money from implant companies to do appropriate studies. If you want to make sure the implants are best for the patient, you need to work with the companies because they are making the implants.”
“People are worried about these conflicts of interest. We are concerned about them, too,” Lieberman said. But, he added, “It’s important to understand that not every relationship between a company and an orthopedic surgeon is untoward. Disclosure is the critical element in that relationship.”
Irving said he uses products for hip implants made by several companies, but mainly uses DePuy because it makes “four out of the six best-performing” hip implant parts in the world.
He said he discloses to his patients that he is paid by DePuy for data collection, in a waiver patients sign that grants permission for him to give their data to the company. He called the data-collecting “extremely time consuming.”
Irving’s website features his use of two DePuy products, the Corail Hip replacement system and the S-ROM. The website doesn’t mention his financial ties to the company that makes them. He said he has worked for DePuy as a consultant on implant development and teaching surgical techniques, but hasn’t done either “in several years.”
He said he used the recalled device, ASR XL, because the metal-on-metal construction showed promise for lasting a long time—what he called the best option for “an immortal hip.” It turned out not to be the case for some patients.
Three of Irving’s 30 patients need second surgeries, referred to as revisions, two of which already have been done. Irving said that there are another two cases “that I’m watching” to see if surgery will eventually be required.
Irving said he did the ASR XL implants over the last two to four years at Yale-New Haven and Milford Hospitals. Most hip implants are expected to last 10 to 20 years before an additional surgery is needed, he said, adding that he does between 150 and 200 annually.
The DePuy disclosures of payments to doctors were required in the Justice Department agreement during a period when major medical device companies had to submit to monitoring of their financial activities. DePuy paid a fine of $84.7 million, which was based on revenues. The other three companies fined were Biomet Orthopedics, Smith & Nephew, and Zimmer Holdings, for a total of $310 million. A fifth, Stryker Corporation, was not fined because it cooperated with the criminal investigation. The five firms represent 95 percent of the hip and knee implant market.
During the monitoring period, the companies were required to post payments to doctors. DePuy has continued to do so after the charges were dropped.
Dr. Courtland Lewis, director of quality and research at the Connecticut Joint Replacement Institute at St. Francis Hospital in Hartford, said he appeared on a Zimmer, Inc., list of consulting doctors a few years ago, in connection with a $175,000 grant for a multi-year study. Lewis, who at that time worked at Hartford Hospital and a UCONN Health Center resident proposed the research and applied for the funding. The company hadn’t asked them to do the research.
“A couple of pages down, one of these consultants was making way more than that,” he said.
He said he draws a distinction between doctors paid for research, and those who receive money for services such as touting a product at a medical convention, while failing to disclose a financial relationship with the product manufacturer.
Lewis said he is now participating in a research project spearheaded by the University of Massachusetts and funded by Biomet, Inc., another device manufacturer. He said research on implants costs “millions and millions of dollars,” and the federal government doesn’t tend to fund such research, increasing the need for corporate payments to physicians.
Lorie Gawreluk, DePuy’s vice president for worldwide communications, said that patients benefit when doctors offer ideas for products, and company engineers design devices to reflect surgeons’ expert opinions.
“If those collaborations didn’t happen, medical innovation would not be as effective,” she said.
“Would you ever expect a doctor to have a great idea and not get paid for it?” she added. “Would you ever expect a doctor to come and give lectures to our sales force and other physicians and not get paid? So, we pay them for their time.”
Early this year, the American Academy of Orthopaedic Surgeons adopted a new conflict of interest disclosure system “in response to increasing public and governmental scrutiny of the relationships between orthopaedic surgeons and industry,” according to its website. Participation is mandatory for its board members, program presenters, and authors of materials it disseminates. The organization encourages its other members to voluntarily participate.
The disclosures of payments is “a significant departure” from previous organization policy, the website states.
Dr. Lewis, of St. Francis, said he believes national profession organizations have responded well in the aftermath of the Department of Justice agreement with the manufacturers. He called it “the best thing that has happened” as a result.
“Good luck getting up at a national meeting these days and forgetting to put up a disclosure slide,” he said. He added that the AAOS has “very detailed” disclosure rules. ‘We’re taking it very seriously. Nobody wants to get in trouble with the Department of Justice.”
Senior Writer Lisa Chedekel contributed to this story.
Peggy McCarthy can be reached .
(Read DePuy Payments here)