Medtronic (NYSE:MDT) revealed that California attorney general Kamala Harris wants it to cough up documents on its controversial Infuse bone growth protein.
Its the latest in a line of subpoenas dating back to October 2008, when Massachusetts AG Martha Coakley requested documents related to Infuse.
The Golden State issued its subpoena Oct. 14. Medtronic also noted "several inquiries from the United States Senate Finance Committee" in the filing.
Infuse has been problematic for Medtronic this year, beginning when the company was sued by its employees over allegations that the Fridley, Minn.-based company kept them in the dark about problems related to the morphogenetic compound, which may include excessive bone-growth, heightened cancer risk and male sterility.
The Spine Journal‘s (PDF) June issue was devoted entirely to exposing problems with growth proteins, including a repudiation of some of the research surrounding Infuse. The journal’s investigation found that 13 Medtronic-backed studies down-played or omitted entirely evidence of safety risks from Infuse.
The ensuing clamor spurred federal investigations into allegations that Medtronic’s paid consultants may have concealed Infuse’s risks. The din grew loud enough that Medtronic CEO Omar Ishrak’s first official statement when he took the corner office in June was a response to the challenges leveled against Infuse.
Riding on a wave of accusations against the company and researchers on its payroll, Medtronic paid Yale University $2.5 million to conduct an independent study of the Infuse orthobiologic protein, which is used in spinal surgeries. The Yale team recently tapped think tanks in Oregon and the U.K. to conduct independent reviews, expected to drop next summer.
The Infuse product, also mired in the U.S. Dept. of Justice’s probe of alleged off-label marketing of Medtronic’s bone growth product line, brought in $900 million for MDT in its most recent fiscal year.
In March the U.S. Food & Drug Administration put the kibosh on MDT’s Amplify spine device, which was designed to address concerns about off-label use of the Infuse device.
Shares of MDT stock were down 2 percent to $35.62 in morning trading today.
