A spine surgeon who was spearheading the development of a new artificial disc decided to use it to help a colleague with back pain. When he inserted the device, the patient's original pain went away but now he had pain in a new area. The patient sued, and the judge in the case ruled the surgeon had failed to follow his own recommendations for inserting the disc. The patient was awarded $650,000 plus legal costs.
Virginia spine surgeon Hallett H. Mathews, MD, was principal investigator for the Maverick, Medtronic's artificial disc that was going through the FDA clearance process at the time. Highly regarded by colleagues, Dr. Mathews had served on the board of directors of the North American Spine Society. When Connecticut spine surgeon Eric M. Garver, MD, told him he was suffering from chronic pain in his back and left leg, Dr. Mathews agreed to personally insert the Maverick disc in him.
The new device made the pain go away, but afterwards Dr. Garver started experiencing pain in a new area on the other side of his body. Patrick Mastroianni, MD, a Connecticut neurosurgeon who operated on Dr. Garver 2 weeks after the original surgery, said he retrieved a bone fragment the size of an olive that was lodged next to the disc and appeared to be pressing against the nerve root in his spine.
Removing the fragment alleviated some of Dr. Garver's pain, but the pain still could not be controlled, even by taking multiple drugs every day. Dr. Garver blamed Dr. Mathews and sued him in state court. Dr. Mathews would not settle the case, insisting he had been careful when inserting the artificial disc and had not violated the standard of care. Furthermore, he disagreed that he had left the bone fragment behind and also questioned whether it was causing the pain.
The judge disagreed with Dr. Mathews's version of the facts and ruled that he had violated his own standard of care. The standard for inserting the Maverick, formulated in part by the defendant himself, required that the disc space be "meticulously cleared of materials that might be driven into nerves behind the disc space by insertion of the artificial disc," the judge wrote.
Thomas Albro, an attorney for Dr. Garver, said Dr. Mathews had helped his client, but only to a point. "He had been suffering significant pain and Dr. Mathews successfully relieved it," the attorney said. "The problem was there was new pain after surgery." Michael Goodman, an attorney for Dr. Mathews, declined to comment.
After years of planning, the Maverick never reached the U.S. market. Before it could complete the FDA clearance process, Medtronic's competitor, Synthes, won a patent infringement lawsuit against Medtronic over the Maverick. Medtronic, which had been selling the Maverick around the world, withdrew it from all markets.