Wednesday, November 21, 2007

More About Surgeons Who Received Large Payments from Joint Implant Manufacturers

The story about artificial joint manufacturers' payments to orthopedic surgeons and others just keeps bubbling along. We have previously posted (here, here, here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) just revealed they made to orthopedic surgeons and various academic and other organizations. The lists are here: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer.

A few intrepid reporters have pursued this story by looking for local surgeons on the lists. First, Bill Toland in the Pittsburgh Post-Gazette found some recipients of the companies' largesse, and what he learned from one was typical,

In Pittsburgh, Dr. James D'Antonio, of Greater Pittsburgh Orthopaedic Associates, has received $850,000 to $875,000 through the first 10 months of 2007 from Stryker. On his extensive resume is the development of a new alignment system for artificial knee joints, femoral research, and two decades of experience in knee and hip replacements, performing them at several regional hospitals.

Most of the money received this year, more than $600,000, was for royalties on intellectual properties he helped to develop.

'I could do a lot more surgery if I didn't do this for Stryker,' Dr. D'Antonio said in a phone interview. He also said that he's not beholden to Stryker's products because of the fees he collects.

'I use other implants,' he said. 'I don't hesitate to use other companies for a minute,' if they carry a product he feels is better suited for a surgery.

Toland recorded several other denials that the payments influenced which artificial joints the recipients chose to implant in patients, for example,

Zimmer, the largest of the joint manufacturers, paid out the most to Pittsburgh doctors, $1.16 million through Oct. 31.

Together, the nonprofit clinic and health provider AMD3 and its founder, Dr. Anthony M. DiGioia III, received at least $437,000 from Zimmer.

'As an independent physician, I am not rewarded by either the hospital or the implant company for using any specific products,' Dr. DiGioia said. He is not 'obligated or rewarded to use any of Zimmer's products.'

This week, Lindy Washburn of the North Jersey Media group looked into the situation in her area. Again, she found several surgeons who received large payments. They turned out to be involved with the design of particular devices,

Michael A. Kelly, chairman of the Department of Orthopedic Surgery at Hackensack University Medical Center, and Mark Hartzband, director of its Total Joint Replacement Service, were among the highest-paid consultants nationwide at Zimmer Inc. They also were the highest- paid New Jersey consultants to any orthopedic company.

Both were involved with the development of Zimmer's "female knee."

Zimmer paid Kelly, who is president of the American Knee Society, $1,043,028. It paid Hartzband $995,739, along with $20,619 to his Hartzband Joint Replacement Institute in Paramus.

Kelly and Hartzband, for example, both were listed as members of the design team for Zimmer's "female knee," introduced last year. They were involved in the clinical trials that led to federal approval for the device, and travel around the world to lecture and demonstrate surgical techniques. Hartzband also was a pioneer in minimally invasive hip replacement surgery, which Zimmer introduced in 2003.

HUMC, where the two operate, uses joints from three different companies, including Zimmer. Kelly, as chief of the department, plays a role in choosing the suppliers and is required to disclose any conflicts of interest, said Robert Garrett, the hospital's executive vice president and chief operating officer.

Hartzband, as a private practitioner, is not required to make such a disclosure, and Garrett said he was unaware of the amount Hartzband received.

Neither surgeon responded to messages left at their offices.

"Our policy has always been to get competitive bids on a product and get the best-quality products," Garrett said. "I don't have any reason to believe there's any kind of kickback involved. Dr. Kelly has always acted on behalf of patients and what's best for the patients -- the fact that we have three vendors is testament to that."

Then, John Dorschner of the Miami Herald reported from South Florida. Not surprisingly, he found one local doctor who received large payments, which again turned out to be related to his involvement in the development of a specific device.

A well-known Miami doctor who did Heat Coach Pat Riley's hip replacement surgery has received nearly $600,000 this year in fees from a company that makes artificial hips, according to documents published in connection with a federal kickback investigation.

Carlos Lavernia, medical director of the Orthopaedic Institute at Mercy Hospital, received $586,863 through Oct. 31 from Zimmer, an Indiana company that makes hip and knee replacements.

Lavernia received the most fees of doctors in South Florida, based on lists that revealed the fees of hundreds of doctors nationwide.

Lavernia said he has done nothing wrong. Zimmer is paying him royalties for a hip and knee implant system he designed. He is not paid royalties on devices he implants himself or any implants bought by Mercy, he told The Miami Herald in an e-mail. He said he uses products of all manufacturers, depending on what's best for the patient.

Lavernia told The Miami Herald he is 'currently in the process of developing a patient disclosure letter,' discussing his relationship with Zimmer.

Lavernia and Zimmer are closely connected.

He has given speeches at Zimmer's corporate headquarters in Warsaw, Ind. One of the talks he gave urged surgeons to better understand insurance reimbursement rates for implants so that they can get paid better.

According to a Zimmer press release, Lavernia co-authored a research paper that reported major advantages for Zimmer's Quad-Sparing Knee Replacement Procedure.

Mercy spokeswoman Rey said the hospital had no comment because it was a matter between Zimmer and Lavernia.
All these news reports suggest that the doctors who received the largest payments from the manufacturers of artificial hips and knees were involved in the design of specific products, and often received payments in the forms of royalties, presumably based on licensing agreements for patents they held. Apparently, most such agreements do not pay royalties for devices the surgeons personally implanted, and perhaps for any devices implanted at their hospital.

So far, discussion in the media of possible conflicts of interests caused by the device manufacturers' payments to surgeons has centered on concerns about whether surgeons who got payments from particular companies were more likely to to choose those companies' products for their patients. Some surgeons have denied conscious bias, and it appears that some of their royalty agreements were structured so that they were not paid directly for implants they themselves chose, or were chosen at their hospital.

However, an important issue that has so far not been discussed is the extent that the surgeons who received payments may have influenced other surgeons to use the products of the companies who paid them. It appears that many of the surgeons who got large payments were very well known, and some held prestigious academic posts. Some were in positions to influence trainees (medical students, interns, residents, and fellows) through their teaching. Some could influence the broader community of orthopedic surgeons by speaking and writing. There were examples above of payment recipients touring internationally to speak and teach about the joint implants they had designed, touring nationally to speak about reimbursement for joint implants, and authoring journal articles reporting research on the implants for which they received royalties. Whether the payment recipients revealed to their audiences the magnitude of the payments they were getting, or whether the payments were based on the number of devices the companies sold, which presumably is usually how patent royalties are paid, are all unknown.

The Miami Herald article stated, "for years, there have been unconfirmed rumors and rumblings about device companies paying doctors fees, sometimes for consulting, speaking or doing research on particular devices." This suggests that it was not exactly common knowledge that prominent orthopedic surgeons who taught or wrote about joint implants and related topics were being paid generous royalties by the companies who made the implants for each device sold.

Thus, it appears that surgeons who may have been paid royalties every time a specific device was sold may have had opportunities to influence the surgeons who made decisions about which devices to use. The surgeons who were paid royalties may not have let these decision-makers know their financial stake in the companies selling more devices.

We suspect that all the extent and magnitude of conflicts of interest generated by the the device manufacturers' payments have yet to be revealed.


Anonymous said...

All very smooth. It would appear that every surgeon in the field is doing some type of research or holds an intellectual property patent on the products used. This seems unlikely, and I would have to question if this claim is not an attempt to move scrutiny away from the payments being made to virtually all doctors in an effort to appear there is no conflict.

Steve Lucas

Anonymous said...


I logged on to make exactly the point you've just so pointedly addressed. If ALL these doctors are involved in re-design and tweaking of already-patented designs, are there new patents--on which they appear as inventor, or co-inventor--to substantiate their claims. Or, if they merely "discuss" with the manufacturer improvements that might be considered at some future time, they then become entitled to royalties for product improvement. A thorough search of patents, with special attention to inventor-patent holder-licensee might prove to be an interesting exercise for an intrepid investigative journalist. If a correlation does NOT exist, like you, I would suspect this is merely a new invention to direct money to thought-leaders under the guise of intellectual payoffs.


Anonymous said...

Why isn't Medicare looking into this suspicious behavior. There are very strick anti-kickback laws. Why aren't the doctors forced to return the money as penalties? Why are the rest of the doctors in the U.S. forced to follow anti-kickback laws when these doctors are laughing all the way to the bank?

Anonymous said...

Another aspect to take into consideration is the inabiility for small to medium orthopedic manufacturers to compete in this market by 'paying royalties' to Dr.s in order to obtain 'advice' on product improvement or speeches extolling the virtues of one product over another perhaps less expensive more valid alternative. This inability to spend hard earned money in 'consultation fees or royalties' keeps the market tight and clean for the big boys and inhibits free market growth. And has anyone noticed how even the OAAS has also received money? What about ex atty generals as watchdogs of the big boys in all this?!