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Synthes settles with New Jersey Attorney General by entering into a compliance agreement
Synthes Inc. announced on May 5 it has settled with the Attorney General of New Jersey regarding the subpoena its Synthes Spine subsidiary received in 2008 and subsequent inquiry into Synthes’ disclosure of the financial interests of some of the investigators involved in clinical trials for its ProDisc-L and ProDisc-C artificial spine disc products.
The FDA approved the ProDisc-L and ProDisc-C implants in 2006 and 2007, respectively.
For the settlement, Synthes, based in West Chester, Pa., entered into an Assurance of Voluntary Compliance (AVC) agreement with the State of New Jersey and its Division of Consumer Affairs that reinforces the company’s compliance policies regarding the monitoring, collection and dissemination of information about relevant financial relationships of its clinical investigators. The company entered into the AVC agreement voluntarily and did not admit any wrongdoing, according to a Synthes press release.
Synthes agreed to reimburse the state for its investigation costs totaling $236,000 and paid no fines or penalties, according to the release.
The safety and efficacy of the ProDisc products were reportedly not in question during the inquiry. The FDA was advised of results of the New Jersey inquiry and has not changed its conclusions that the ProDisc clinical studies are scientifically valid and that the ProDisc products are safe and effective, the Synthes release said.
In a press release from the Office of the Attorney General of New Jersey, Anne Milgram described the settlement as “landmark” and first of its kind to remove conflicts of interest from affecting clinical trials. Under the agreement Synthes must disclose future payments it makes to those investigators conducting clinical trials on its devices, as well as the investments those individuals hold in products being tested.
“It is outrageous that doctors who are testing and, in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make the devices,” Milgram said in the press release.
In a May 5 letter sent to Acting FDA Commissioner Joshua M. Sharfstein, MD, Milgram said she hoped the terms reached with Synthes might become “best practices” for device makers’ disclosures.
“I am gravely concerned about the conflicts of interest that pervade the medical device industry — particularly with respect to high-risk devices — and their deleterious effects upon consumers,” Milgram wrote.
She called upon the FDA to increase its oversight and enforcement of disclosures of conflicts of interest.
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