A popular—and frequently litigated—implantable medical device has come under congressional scrutiny after allegations of data suppression arose. Medtronic manufacturers and markets the Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device and the Infuse Bone Graft, a two-part product, for joint surgeries. The Minneapolis Star Tribune released a special report on April 10, 2016, raising allegations that the company failed to disclose important safety information from a study that was shut down without explanation.
How does it work?
Infuse contains a bioactive solution that is mixed with water right in the operating room. This solution is an engineered version of the bone morphogenetic protein (BMP), which causes bone formation. Prior to using the engineered BMP, patients with certain issues like degenerative disc disease were forced to undergo multiple surgeries so that a bone graft could be created from living bone in the hip. Infuse’s solution is inserted into a titanium case that is placed between vertebrae.
Medtronic hoped that the Infuse device would be approved for different types of surgeries, broadening its application in the lucrative field of spinal surgeries. Doctors who performed surgeries using the device reported adverse events, and Medtronic reviewed the records of 3,600 patients. Over 1,000 issues were reported, from minor problems to four patient deaths. Medtronic shut down the study without providing data about it to the FDA. Medical device manufacturers are required to report injuries that are possibly related to their products within 30 days of learning of them.
Executives told the Star Tribune that the data was not purposely hidden. They claim that the adverse events database was internally misfiled and discovered five years later, then reported to the FDA. Medtronic maintains that its procedures have been improved and that no patients were harmed by the failure to report.
Some concerns have been raised regarding the specific type of BMP used, rhBMP-2. Some critics believed that not enough was known about the safety of the compound, and pointed out that doctors might use it in a way that has not been adequately evaluated for safety. After Infuse was approved for fusion of bones in the lower spine in a procedure performed through the patient’s stomach, surgeons began using the product in different ways. Some fused bones in the neck, some fused more than two bones, and some approached the surgery from the back. The Star Tribune reported that between 2003 and 2007, at least 85 percent of the BMP surgeries performed in the U.S. were for uses not reviewed for safety and effectiveness.
Medtronic’s response, Senate attention
Medtronic responded to the Star Tribune’s article, vehemently maintaining that the article made false insinuations and left out important information. The company stated that the Star Tribune left out a large amount of the information in the “extensive account of what transpired.” Medtronic defended its actions, stating that the data was immediately assessed and reported when it was discovered five years later, and emphasized that patient safety is a priority.
The matter caught Senator Al Franken’s (D-Minn) eye, and he asked both Medtronic and FDA Commissioner Dr. Robert Califf to provide details information about the injuries that were allegedly covered up. He also requested an explanation about the correlation between injuries and approved versus unapproved uses, and asked if the rate of injury was consistent with other data. He also suggested that medical device surveillance should be strengthened to ensure patient safety.
Issues with Infuse are nothing new to the world of medical device litigation. In 2014, the company settled 950 lawsuits for $22 million. Another suit was filed in June 2015, which specifically alleged that Medtronic marketed the product for use in types of surgeries that were not previously researched. Humana even filed a suit against Medtronic for federal racketeering, claiming that Medtronic reportedly conspired with physicians to promote off-label uses for the device.