Medtronic Inc., the maker of several medical devices, announced on Wednesday that the federal investigation into its InFuse bone graft product has been closed, The Associated Press reports.
The company, which is the largest medical device maker in the world, was under the microscope of the U.S. Department of Justice and the U.S. Attorney for the District of Massachusetts. The investigation began when the government subpoenaed documents from the company in October 2008.
The product uses a genetically engineered protein that stimulates bone growth, which can be used to heal a number of ailments. Last year, Medtronic began taking fire from one medical journal, as it asserted that Medtronic made light of the risks that had been linked to InFuse, and did not make public the millions of dollars the company allegedly spent to hire authors to write the initial studies of the medical device. The product has helped the company bring the most revenue from its spinal business, which makes up the second-largest arm of the company.
Still, the attacks from the medical community drastically lowered sales of InFuse.
The FDA approved InFuse for spinal, oral and dental graft procedures, but the device was most commonly used in neck and spinal patients. Although physicians are allowed to use the drugs for off label purposes at their best judgment, many patients have filed complaints against the company after such procedures led to pain, swelling and further surgeries.
Most recently, Medtronic paid the Minneapolis Firefighters Relief Association – one of its shareholders – $85 million to settle a federal class-action lawsuit, according to Reuters.
The group alleged Medtronic did not publicly report how much of its revenue came from potentially dangerous “off-label” uses, and did not disclose the dangerous side effects that had been linked to such uses.