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Synthes receives subpoena from New Jersey Attorney General
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Synthes Spine Inc. a subsidiary of Synthes Inc., has received an administrative subpoena from the Attorney General of New Jersey, Synthes announced in a press release.
Under the subpoena, Synthes Spine Inc. is ordered to deliver certain documents and information concerning its ProDisc line of products. Synthes plans to cooperate fully in responding to the subpoena, the release said.
According to the press release, the Attorney General of New Jersey is investigating the clinical development, marketing and promotion of the ProDisc line of products, including professional service and consulting agreements.
At this point, Synthes does not know when the investigation will conclude, the release noted.
The state also subpoenaed Viscogliosi Brothers LLC, a New York-based investment firm that generated the start-up capital for the company that originally owned the ProDisc device, according to a press release from the New Jersey Office of the Attorney General (OAG).
Viscogliosi Brothers formed Spinal Solutions Inc., which originally owned the ProDisc device, and operated several investment funds for which Spine Solutions was the main asset. Switzerland-based Synthes Inc. acquired Spinal Solutions in 2003, and markets ProDisc through Synthes Spine.
According to the OAG press release, the subpoenas were issued on Feb. 4 in New York and Pennsylvania and seek information spanning from Jan. 1, 1999, through the present.
In the subpoenas, the OAG requests information concerning the investment backing that funded ProDisc's development. The state is also seeking information concerning physician participation in, and the results of, clinical studies of ProDisc.
It was largely on the basis of clinical study results presented in 2005 that the U.S. Food and Drug Administration approved ProDisc for commercial sale and distribution, the release stated.
A principal focus of the state's inquiry is whether required disclosures were made for surgeons — including some licensed to practice in New Jersey — who endorsed ProDisc as researchers and who also had an investment interest in the device.
The Affirmative Litigation Unit within the Division of Law is conducting the state's investigation, according to the release.