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Justice Department issues subpoenas to two orthopedic implant manufacturers
The agency is again investigating consulting arrangements relating to hip or knee replacement procedures or procedures.
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The U.S. Department of Justice has issued subpoenas to two additional orthopedic implant manufacturers requesting documents related to consulting arrangements with surgeons.
Wright Medical Group Inc. announced on December 11 that it had received a subpoena from the Department of Justice (DOJ), through the U.S. Attorney for the District of New Jersey, requesting documents from January 1998 through the present. Specifically, the DOJ is seeking documents related to "any consulting and professional service agreements with orthopedic surgeons in connection with hip or knee joint replacement procedures or products," according to a press release from the company.
Exactech Inc. also announced on December 12 that it received a subpoena through the same office. The subpoena requests documents from 1998 through the present "related to consulting and professional service agreements between Exactech and orthopedic surgeons and other medical professionals," according to a press release from Exactech.
"Exactech believes the subpoena relates to an investigation the Department of Justice is conducting with respect to the use of such agreements and arrangements by orthopedic implant manufacturers and distributors," the release noted.
Both companies stated that they intend to fully cooperate with the DOJ's request.
Also, both companies noted they "... cannot estimate what, if any, impact this inquiry and any results from this inquiry could have on the company's current or future operating results, including its 2008 and 2009 financial outlook," the releases noted.
This latest action by the DOJ comes just a few months after it reached a settlement with five other orthopedic implant manufacturers relating to a similar investigation.
In September, Orthopedics Today reported that Zimmer, DePuy Orthopaedics, Biomet, Smith & Nephew and Stryker Orthopedics all agreed to adhere to new corporate compliance procedures and 18 months of oversight by a federal monitor appointed by the DOJ.
Zimmer, DePuy, Biomet, and Smith & Nephew all executed Deferred Prosecution Agreements with the New Jersey District Attorney's Office and agreed to pay a total of $311 million to settle government claims under the anti-kickback statute and the civil federal False Claims Act.
Stryker had voluntarily cooperated with the Attorney's Office before the others and instead entered into a Non-Prosecution Agreement with the DOJ. However, the agreement requires Stryker to implement the same reforms imposed on the other four companies, including 18 months of federal monitoring.