May 01, 2006
Off-label prosecutors target devices
In what may signal a new wave of government investigations, the US Attorney's Office in Philadelphia has issued a grand jury subpoena to a device firm— PA-based Synthes—over alleged off-label promotion practices.
Until now, off-label prosecutorial cases had been limited to drug makers. But prosecutors warned last October that their investigations were likely to spill over into the device arena.
HHS Office of the Inspector General senior counsel Jnatel Simmons says most government actions against medical device firms originate as qui tam actions or whistleblower lawsuits under the False Claims Act, which prohibits falsified claims for payment from being submitted to the government.
The latest subpoena demands that Synthes supply information on alleged off-label promotion practices involving its bone void filler Norian XR and related products.
Norian XR was cleared by the FDA in 2002 for its intended use on certain bony voids or defects that are not intrinsic to the stability of the bony structure.
The product was removed from the market in November 2004 after an FDA inspection and subsequent Warning Letter charged the company was marketing Norian XR for new intended uses without FDA approval.