Two U.S. Senators have told Medtronic Inc. (NYSE:MDT) to fork over documents relating to an ongoing investigation into the company’s controversial Infuse bone-growth system.
In a letter, Sens. Max Baucus (D-Mont.) and Charles Grassley (R-Iowa) demanded access to internal correspondence between doctors on the company’s payroll who published studies on Infuse, as well as documents outlining the millions paid to researchers.
"Reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling," Senator Baucus said in a statement. "We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits."
The expanded investigation comes on the heels of allegations that Medtronic’s paid consultants may have concealed Infuse’s potential to increase infertility risk in men.
The most recent findings regarding male infertility were in stark contrast to earlier research funded by MDT, the New York Times reported. Medtronic’s research notes sterility-related complications, but attributes them to surgical technique rather than to the product.
The letter the Senators sent to newly-appointed chairman & CEO Omar Ishrak notes two additional side effects: abnormal bone growth and swelling in the neck and throat. The risks are all listed on the product’s FDA approved product label, Medtronic spokesman Steve Cragle told MassDevice.
The Infuse line has been under investigation since 2008 for concerns that the product’s marketing promoted off-label use, which a U.S. Dept. of Justice probe estimated could account for up to 80 percent of the product’s sales.
The bone growth product line 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 its Infuse bone graft material.
In March the U.S. Food & Drug Administration put the kaibosh on MDT’s Amplify spine device, which was designed to address concerns about off-label use of the Infuse device, over concerns linking Amplify to cancer risks.
The Infuse system, which has been widely used to fuse spinal vertebrae during surgeries since 2002 and sales of which are expected to top $900 million this year, has yet to undergo recall.
Medtronic has until July 11 to respond to the request.