In an unexpected move, the Department of Justice has suspended its four-year civil and criminal investigation into allegations of off-label marketing by Medtronic Inc. concerning its Infuse bone graft product. No charges have been issued and there was no settlement reached after the company was notified by the U.S. Attorney for the District of Massachusetts that the probe was over.
Details of the complaint were revealed in a qui tam lawsuit. A qui tam is a whistle-blower action filed alleging fraud committed against the U.S. government under the False Claims Act. In this case, the whistle-blower alleged the company paid kickbacks to promote off-label use of the Infuse bone graft and paid doctors to promote the product in professional and scientific journals.
The complaint alleges Medtronic secretly paid doctors anywhere from $12 to $16 million to devise reports that downplayed serious risks related to Infuse. Some of those financial conflicts were not fully disclosed. Last June, an editor at Spine Journal said the authors of 13 papers downplayed the complication rates of the drug by 10 to 50 times.
The company has faced accusations for years that it engaged in improper marketing of Infuse. Last month shareholders were paid $85 million to settle a Minnesota class action lawsuit alleging Medtronic lied to investors about the company’s marketing tactics. Medtronic has denied any wrongdoing.
Approved in 2002, Infuse has brought Medtronic annual sales in excess of $700 million. Infuse is a bio-engineered product that stimulates bone growth in order to fuse two vertebrae, however more than 80 percent of Infuse was used off-label, or for a purpose it did not receive FDA approval. Doctors can use a drug off-label but the company cannot advertise or promote that use.
The FDA received numerous complaints after doctors used Infuse on vertebrae in the neck or for cervical spinal fusion causing complications including respiratory difficulties, swelling, nerve damage, cancer, sterility in men, and deaths.
The huge payments to doctors are part of the reason the Physician Payment Sunshine Act was implemented. The legislation will require all payments made to doctors by drug and device companies be disclosed and made public.