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A product liability lawsuit has been filed by a Michigan man who alleges that a Medtronic Infuse bone graft caused him to experience severe complications after it was implanted in his spine for an unapproved use, causing excessive bone growth and leaving him with extreme pain and weakness.
The complaint (PDF) was filed by Clinton Thorn in the U.S. District Court for the Western District of Michigan on March 1, alleging that Medtronic illegally promoted use of the Infuse BMP (bone morphogenetic protein) for spinal surgeries that the FDA had not determined were safe or effective, resulting in his doctor performing an “off-label” spine operation with the bone graft product.
Medtronic Infuse is a bioengineered bone protein, which was introduced in 2002 as an alternative to traditional bone graft surgery, where bone is harvested from another part of the body or a cadaver to encourage the fusion of spinal vertebrae. Although the bone graft product was only approved for use during lumbar fusion surgery involving an anterior approach, the product has been widely used off-label, causing a number of patients to experience serious complications from Medtronic Infuse.
Thorn’s complaint is one of a growing number of Medtronic Infuse bone graft lawsuits filed in courts throughout the United States, alleging that the manufacturer failed to adequately warn about the risk of excessive bone growth from Infuse side effects, which can cause nerves to become compressed and potentially lead to severe pain, paralysis, nerve damage, airway compression, retrograde ejaculations, urinary retention and possibly increase the risk of cancer.
According to allegations raised in this latest lawsuit, Thorn was implanted with the Medtronic Infuse bone graft in 2010 during posterior-approach spine surgery. After it was implanted, the complaint indicates that Thorn experienced “exuberant” bone growth onto or around the spinal cord, causing compressed nerves and resulting in “intractable pain and weakness” in Thorn’s legs and back.
Congressional Report Found Medtronic Manipulated Infuse Studies
Medtronic has been accused of illegally marketing Infuse and downplaying the possible risks associated with off-label use of the bone graft product.
Last year, a congressional investigation determined that Medtronic paid $210 million to study authors that failed to include data on Infuse complications in their reports. Those authors not only failed to disclose links to Medtronic, but the investigation also determined that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published.
“Because of Medtronic’s wrongful conduct, hundreds of patients, like Clinton Thorn, underwent surgeries without knowing the risks created by off-label use of Infuse,” the lawsuit claims. “These patients’ doctors were persuaded by Medtronic and Medtronic’s consultant ‘opinion leaders,’ who are paid physician promoters, and Medtronic sales representatives, to use Infuse for dangerous off-label uses such as posterior lumbar fusion surgery.”
Off-label use occurs when a doctor uses a medical device or drug for a purpose that has not been approved by the FDA. While doctors are legally allowed to do this, medical device manufacturers and drug companies are not allowed to promote their drugs for those purposes.
In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving a large number of reports involving deaths and other complications that resulted from swelling of the neck and breathing difficulties. The growth of excess bone around the spine following Medtronic Infuse surgery may result in permanent nerve damage and other complications.
Thorn suffered severe bodily injuries and lost income, according to the claim. He has undergone revision surgery to remove excess bone and will likely undergo more in the future. The lawsuit also claims he now faces a significantly higher risk of cancer.
The lawsuit accuses Medtronic of breach of warranty, negligence, and failure to warn.