Kentucky Family Sues Hospital, Company Over Defective Medical Device

Kentucky Family Sues Hospital, Company Over Defective Medical DeviceA family from Louisville, Kentucky, has sued the medical device maker Medtronic and the region's Norton Hospital after one woman allegedly suffered from severely disabling complications of a bio-engineered bone-graft device, the Courier Journal reports.

According to the news source, the lawsuit, which was filed on Thursday, May 10, in Jefferson Circuit Court, claims Crystal Stevens was left permanently disabled do to extensive nerve damage allegedly caused by Medtronic's Infuse device, which was implanted in her during spinal surgery in 2006. Stevens' defective medical device lawyer added that Stevens must be reclined or flat on her back for the better part of the day, and is heavily dependent on her husband for day-to-day activities.

The attorney added that this most recent case is one of dozens he and other lawyers are preparing for with similar complications that have been linked to Infuse.

The device, which is composed of "bone morphogenetic protein," is delivered into the spaces between vertebrae as a liquid held in place by a cage. As the liquid forms a solid, it grows to the bone, and in turn creates a bond between vertebrae. However, if the expansion during the solidification phase grows beyond the size of its cage, it can lead to Stevens' condition, according to the media outlet.

Stevens' lawyer stated that Infuse was introduced to her spine in an "unconsented, off-label surgery" by officials at Norton Hospital. The U.S. Food and Drug Administration approved the medical device for a very specific type of spinal surgery, which the lawsuit claims was not the operation Stevens underwent. While performing the surgery for off-label uses is not illegal, the lawsuit alleges in certain cases, use of Infuse can lead to uncontrolled bone growth near the highway of spinal nerves that run along vertebrae.

"When spinal nerves are compressed … a patient can experience … extreme and debilitating pain in the legs and back, which is precisely what happened to plaintiff Crystal Stevens," according to the lawsuit.

The complaint also contends that Medtronic made light of the serious risks that had been linked to Infuse, and "actively and illegally" promoted use of the device for off-label purposes.

Medtronic has had its products rejected by the FDA in the past, including one heart device that was designed to treat a common heart disorder, but was later linked to potentially raising the risk of strokes.