Device maker, Medtronic, just asked a federal judge to reconsider a ruling in a lawsuit involving its bone growth protein product, Infuse.
Medtronic asked Judge G. Murray Snow, U.S. District Court for Arizona, to dismiss the lawsuit on the grounds that Infuse is protected under federal preemption, a legal concept that has protected a number of medical device makers in liability lawsuits brought over devices approved by the U.S. Food and Drug Administration (FDA), MassDevice.com reported.
This August, Judge Snow ruled that federal preemption does not apply in a case in which Medtronic is accused of marketing Infuse off-label; the plaintiff accused Medtronic of touting Infuse for procedures that were not FDA-approved, according to MassDevice.com. Another injury lawsuit is scheduled to proceed against Medtronic over its Infuse product when an Arizona district judge ruled that federal preemption did not apply in that case, which accused Medtronic of off-label marketing, according to MassDevice.com. Plaintiffs’ attorneys are using the somewhat new tactic to successfully sue medical device makers over injuries resulting from uses for which devices are not approved.
The effect of preemption “vanishes when the plaintiff brings a claim against a manufacturer that arises out of a use that has not be reviewed by the FDA but has been promoted by the manufacturer,” Snow wrote. “Any medical device manufacturer that misleadingly promotes its products for uses never approved by the FDA, and then fails to report to the FDA significant adverse events associated with those non-approved uses of the device, should be held accountable for severe injuries caused by the device,” he added, according to MassDevice.com.
The controversial bone graft product is a synthetic, or genetically engineered, recombinant human Bone Morphogenetic Protein (rhBMP-2) approved by the FDA in 2002 for specific uses. Specifically, Infuse was designed to stimulate spine growth in patients who suffer from lower spinal degenerative disease and was approved for use in one type of spinal surgery and some dental procedures. Infuse is not approved for use on the upper, or cervical spine; however, the bone graft product is widely used in off label procedures. On July 1, 2008 the FDA issued a notification warning about the product’s ties to serious complications when used in cervical spinal fusions.
While physicians are free to prescribe medical devices and drugs for off label purposes as they see fit, it is illegal for Medtronic, or any device or drug maker, to market a product for uses that have not been approved by the FDA.
Infuse has been associated with a number of adverse reactions, such as:
- Bone dissolution
- Cauda Equina Syndrome (“Horse Tail” Syndrome)
- Compressed airways
- Difficulty swallowing, breathing, and/or speaking
- Gastrointestinal Problems
- Excessive swelling in the neck
- Increased cancer risks
- Male infertility, sterility
- Nerve injuries and nerve damage
- Pain, chronic pain
- Retrograde ejaculation
- Swelling of the neck resulting in injury or death
- Uncontrolled bone growth
- Worsened back and leg pain
Medtronic’s marketing of Infuse has been the focus of growing controversy and there are concerns over how Infuse research was conducted, such as that it was Medtronic-funded. Medtronic has been accused of promoting Infuse off label, of downplaying the device’s risks, and of overstating Infuse benefits. This led to a Senate probe, the FDA warning, and independent studies.