A California judge has cleared the way for a Medtronic Infuse bone graft lawsuit, finding that the claim is not pre-empted by federal laws, despite a controversial Supreme Court decision that shielded many medical device manufacturers from litigation over dangerous products that were approved by the FDA.
Los Angeles Superior Court Judge Michael Linfield ruled this week that a lawsuit filed against Medtronic by April Cabana can move forward over injuries she sustained from off-label use of Medtronic Infuse.
Judge Linfield determined that the Medtronic bone graft lawsuit is not pre-empted by federal law that protects manufacturers when a device is approved by the FDA, because Cabana alleges that Medtronic illegally promoted the product “off-label” for uses that were never approved by the FDA, and the claim is not based on state consumer protection laws.
In 2008, the Supreme Court ruled in Riegel v. Medtronic that in most cases medical device manufacturers can not be held liable through product liability lawsuits for design defects, if a device was approved by the FDA through the pre-market approval process, which is legally known as preemption.
Judge Linfield found that preemption does not apply to the claim, which alleges that off-label marketing led to the plaintiff’s Medtronic Infuse complications.
Cabana’s lawsuit indicates that Medtronic promoted Infuse illegally to get doctors to use it for non-approved uses and even used paid consultants to teach doctors how to use Infuse for off-label uses. The lawsuit claims to have evidence to back up those allegations.
Medtronic Infuse is a bone morphogenetic protein (BMP), which is used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae. It is promoted as an alternative to bone graft procedures where bone is harvested from another part of the body or from cadavers.
The FDA approved the Infuse bone graft in 2002, indicating that it should only be used during spinal surgery for a single-level anterior lumbar fusion, where the spine is approached from the front. However, it has been widely used during other types of spinal surgery, which has been found to carry a risk of severe inflammation, airway compression, nerve damage and other health problems.
As increased attention has been focused on Infuse problems, Medtronic’s profits on the substance have fallen off. The first quarter of this year saw only $141 million in Infuse shares, compared to $174 million the year before.
A large number of similar lawsuits over the Medtronic bone graft have been filed by individuals throughout the United States, who allege that off-label use of the product caused severe injuries after spinal fusion surgery.