A Medical Device Daily Staff Report

The New Jersey attorney general’s office reported that it has issued subpoenas to Synthes Spine (Zurich,Switzerland) and the Viscogliosi Brothers (VB; New York), in connection with an investigation of the clinical development, marketing and promotion of the Synthes ProDisc product line.

The ProDisc was the subject of an article in The New York Times last week concerning surgeons who had conducted the clinical research leading to FDA approval in 2006. Doctors at about half of the 17 research centers involved stood to profit if the ProDisc succeeded, according to confidential information from a patient’s lawsuit settled last year.

While the companies have said the researchers’ financial interests had no impact on the findings, what may be unclear is the disk maker’s legal obligation to inform the FDA of the researchers’ stakes, and whether it provided that information.

VB reportedly operated several funds in which the clinical researchers were investors.

In a statement, the Viscogliosi firm said, “Viscogliosi Brothers are proud of the fact that so many distinguished surgeons have invested in our funds,” and that “we at all times met all of our disclosure obligations.”

The state is looking into whether all disclosures were made regarding surgeons, including some licensed in New Jersey.