A CBS investigation dating back to 2012 reported on many of the same concerns raised by Infuse Bone Graft lawsuits currently playing out in the legal system.

The Infuse Bone Graft System is a medical implant designed to help repair degenerative disc disorder. Degenerative disc disorder is a condition where the connective tissue discs that support and protect the spine fail due to age, injury, or illness.

Typically, degenerative disc disorder is treated with spinal fusion surgery, wherein surgeons join adjacent vertebrae together. Usually, redundant bone is harvested from elsewhere in the body to join the bones together.

The Infuse Bone Graft System is designed to save surgeons the step of harvesting bone. Instead, the Infuse Bone Graft System uses a bioengineered gel and a metal support cage to encourage the bones to grow together and support the bones during and after the process, respectively. The bioengineered gel from the Infuse Bone Graft System is also approved for use in dental and facial surgeries in the United States.

However, Infuse lawsuits hold that the Infuse Bone Graft System can cause serious complications. Uncontrolled bone growth has been reported in some patients, which can cause serious problems in the nerve-rich tissues of the spine.

Additionally, it has been alleged that when the Infuse Bone Graft System is used in the neck, it can cause life-threatening swelling, which could close a person’s airways.

Infuse lawsuits have also alleged more diverse systemic Infuse Bone Graft side effects, including cancer and male sterility. And allegations have surfaced that Medtronic Inc., the makers of the Infuse Bone Graft System, have relied on illegal means to promote their device.

The CBS article on the subject largely repeated the findings of a Senate investigation into the Infuse Bone Graft System. This Infuse Bone Graft System investigation stated that Infuse maker Medtronic Inc. illegally influenced the medical literature on Infuse.

Allegedly, Medtronic paid out more than $210 million in “consulting fees” to many doctors who wrote peer-reviewed papers on the Infuse Bone Graft System, or gave presentations at medical conferences on spinal fusion surgeries and related procedures. Allegedly, these funds were not properly disclosed as a potential conflict of interest in subsequent papers and presentations.

But allegations from the Senate’s investigation transcend mere financial impropriety. Allegedly, Medtronic directly exercised control over more than a half-dozen research papers on the Infuse Bone Graft System.

The Senate investigation’s report, as quoted by CBS article, stated that Medtronic told researchers not to go into “significant detail” about adverse events associated with the Infuse Bone Graft System. Allegedly, these 13 papers promoted the Infuse Bone Graft System for off-label usage, while downplaying risks and exaggerating the benefits of the Infuse Bone Graft System.

The allegation of off-label promotion for the Infuse Bone Graft System is a serious one. Under federal law, the makers of drugs and medical devices are legally obligated to thoroughly test their drugs and submit them for approval by the Food and Drug Administration, or FDA.

When a company like Medtronic receives FDA approval, the approval is typically only for the uses tested. For example, the Infuse Bone Graft System is only approved for use in spinal fusions in the lower back, and certain facial and dental surgeries.

However, physicians are allowed to use drugs and medical devices for purposes beyond their FDA approval according to their best judgment, a situation called “off-label” usage. Doctors often rely on peer-reviewed research when considering off-label usage for a medical device.

Medical implant producers like Medtronic are strictly forbidden from promoting their devices for such off-label uses. Allegedly, writing research articles through undisclosed payments could amount to a covert marketing campaign for the Infuse Bone Graft System, aggressively promoting off-label usage through backchannels.

Though Medtronic has disputed the findings made in the Senate investigation, thousands of Infuse lawsuits have been filed, which echo many of the allegations made in the Senate investigation and the CBS article.

These Infuse lawsuits typically hold that Medtronic Inc. engaged in an aggressive, clandestine marketing campaign to promote the Infuse Bone Graft System for off-label usage. These Infuse lawsuits further allege that this exposed thousands of patients to Infuse Bone Graft complications, some requiring surgical correction and some permanent.