When Medtronic marketed their bone graft product for unapproved uses, they neglected to tell doctors about the potential complications. As a result, Medtronic faces devastating lawsuits. Doctors may use medical devices as they see fit, but the manufacturers may not promote or market their products for unapproved uses as Medtronic did. These “off-label” uses produced approximately 90 percent of the $800 million in revenue from the Infuse Bone Graft in 2011.
Medtronic Infuse Bone Graft was FDA approved in 2002 for use during lower spine repair surgery to stimulate bone growth. A genetically altered protein, Infuse Bone Graft helps to build bone tissue and is used to fuse vertebrae in the lower spine. Medtronic promoted the unapproved use of Infuse Bone Graft for surgery to the upper spine or neck. Complications included: excessive bone growth; difficulty swallowing, breathing and speaking; swelling of the neck and throat tissue; cancer; sterility in males; infection; cyst formation and death. Medtronic is also accused of helping author studies of their device, which downplayed the risks and side effects according to a U.S. Senate investigation published in October 2012. Additionally, it is claimed that medical literature regarding safety was ghostwritten by doctors who Medtronic paid large sums of compensation.
More than 100 patients have filed lawsuits claiming serious injury from use of the Medtronic Infuse Bone Graft. They allege that Medtronic misrepresented the product and failed to warn about the dangers and complications of the product. The spinal complication rate from use of the Infuse Bone Graft device reached 59% according to research (MedtronicBoneGraftLawyers.com). Medtronic has been able to avoid some trials using the argument that Supreme Court rulings almost always prohibit patients from suing in state courts for malfunctions of FDA-approved devices. Several judges in state and federal courts have recently let cases move forward. This sets the stage for appeals that could end in another Supreme Court case (StarTribune.com).
In 2008 the FDA warned doctors of the potential dangers of the Medtronic Infuse Bone Graft. Doctors and patients are now seeking alternatives due to the severe side effects of the Medtronic Infuse Bone Graft. Unfortunately, knowledge of complications comes after many have already been affected by complications and lost their trust in the medical system. Some of those affected cannot return to work or complete their normal daily tasks. They are not only faced with an altered future, but also must endure the financial burden associated with lost wages and increased medical bills.