CORRECTION AND CLARIFICATION APPENDED

Five medical device makers accused of illegally paying physicians to use their products revealed millions of dollars in financial ties to 16 Harvard physicians, two affiliated hospitals, and the Harvard Medical School, according to disclosures posted on the companies’ Web sites last week.

Medical School professors Richard D. Scott and Thomas S. Thornhill had the largest physician consulting arrangements disclosed by the companies, receiving $6.7 million each since the beginning of 2007 from DePuy Orthopaedics. [SEE CLARIFICATION BELOW]

Michael Drewniak, a spokesman for the prosecutor, said the companies had violated federal law in some of their arrangements, but would not discuss individual physicians or organizations, citing policy not to comment on ongoing investigations.

“We are continuing our investigation into the conduct of particular doctors,” he said. “We never identify targets of our investigation until or unless they are charged.”

The companies were accused of conspiring to violate federal anti-kickback laws that prohibit payments to physicians that might encourage them to use a product.

Thornhill and Scott, both surgeons at Brigham and Women’s Hospital, did not return requests for an interview, but they wrote in a statement this week that the disclosed payments were royalties from intellectual property they had licensed to DePuy in 1986 and 1991. They also wrote they had donated all consulting payments to charity and would receive no royalties from the company for implants used at the Brigham.

Consulting payments can induce physicians to make treatment decisions because of financial ties—and not necessarily in the patient’s interest—according to Merrill Goozner, director of the Integrity in Science program at the Center for Science in the Public Interest, a non-profit consumer group.

“If people are getting consulting fees on a basis of individual operations performed, they have an incentive not to evaluate whether you need the operation,” he said. “That’s the concern.”

William C. Kolter, a senior vice president at medical device manufacturer Biomet, which was charged in the case, said orthopedics companies often have to consult surgeons.

“In many cases, the [Food and Drug Administration] requires clinical data,” Kolter said. “It certainly was not our intent to use contracts strategically for marketing purposes. Working with surgeons is a necessity [and] not a strategy.”

Zimmer, another company involved in the litigation, disclosed an $8,673,997 payment for the first 10 months of the year to Harvard affiliate Massachusetts General Hospital.

The hospital released a statement saying the payments were royalties for technology licensed to the company and that the hospital receives no royalties when its doctors use Zimmer’s products.

The five manufacturers, which also include Smith & Nephew and Stryker, disclosed the arrangements last week as part of an agreement to avoid federal prosecution that was announced in late September. The agreement did not mandate disclosure of consulting prior to 2007.

Together the companies make close to 95 percent of the U.S. market in orthopedic devices, according to information from the Department of Justice.

—Staff writer Clifford M. Marks can be reached at cmarks@fas.harvard.edu.

CORRECTION: A sub-headline accompanying the Nov. 7 news article, which was published in print as "HMS Doctors Linked to Scandal" and retitled online "Medical Device Companies Report Payments to HMS Doctors," incorrectly stated that medical device makers implicated in a federal investigation had been accused of illegally paying millions to Harvard doctors. In fact, the accusations did not specifically reference Harvard physicians, although the companies have listed financial ties to Harvard doctors among legally required disclosures.

CLARIFICATION: The second paragraph of the Nov. 7 news article "Medical Device Companies Report Payments to HMS Doctors" stated that Thornhill and Scott received $6.7 million each since the beginning of 2007 from DePuy Orthopedics. They received this money as royalty fees for their hip and knee replacement products.