A federal judge in Michigan has denied Medtronic’s Inc.’s motion to dismiss fraud claims asserted in a lawsuit involving its PrimeAdvanced spinal-cord stimulator implant.
According to a complaint filed in the U.S. District Court, Eastern District of Michigan, Janet Canary suffered serious injuries in connection with a February 2008 motor vehicle accident. (Case No. 16-11742)
In the ensuing years, Canary underwent several surgeries to address those injuries. Subsequently, her physicians recommended Medtronic’s PrimeAdvanced system to alleviate chronic neck and back pain.
Prior to having the device implanted, Canary informed her physician and a Medtronic sales rep of her latex and rubber allergy. The Medtronic representative allegedly said allergies did not prevent implantation and that no patients had experienced such a reaction.
Canary received the PrimeAdvanced system on May 16, 2013, and had it activated on May 22nd. Shortly thereafter, Canary allegedly began to experience hives over her entire body, trouble breathing, and swallowing. Her doctor prescribed medication for those symptoms.
On May 26, 2013, Canary informed Medtronic’s sales representative that she was having an allergic reaction to the spinal cord stimulator, including a fever, vomiting, difficulty breathing, swelling of her hands and face, and hives. According to Canary, the sales rep stated that another patient had experienced a similar spinal-cord stimulator injury was now on medication.
On May 28, 2013, Canary was admitted to the ICU with abdominal pain and bowel inflammation. She had the spinal-cord stimulator removed on June 13, 2013.
Canary’s spinal-cord stimulator implant lawsuit relies on the testimony of her treating physicians:
On the other hand, two of Medtronic’s three expert witnesses testified that the stimulator was to “a reasonable degree of medical certainty” not the cause of Canary’s medical issues.
Medtronic moved to have the fraud claims dismissed, asserting Canary had failed to show causation. However, Judge Nancy Edmunds disagreed, writing in her November 13th decision that Canary’s evidence supported an inference that the implant caused her allergic reaction Additionally, she noted that Medtronic evidence did not rule out the spinal-cord stimulator as the cause.
“Medtronic’s own experts, who have opined that to a reasonable degree of certainty the stimulator did not cause the allergic reaction, did not eliminate the possibility that it could have done so,” Judge Edmunds. “In sum, Canary has set forth sufficient evidence on causation to survive summary judgment.”
Spinal-cord stimulators, including Medtronic’s PrimeAdvanced system, are indicated to treat a wide variety of chronic pain disorders. In general, these systems consist of a pulse generator implanted into the back or abdomen and a lead placed into the spine’s epidural space. Once activated, the devices emit low-voltage electronic pulses that block pain signals from traveling between the spinal cord and brain.
The market for spinal-cord stimulator implants has grown significantly in recent years, as the devices promise opioid-free relief for chronic pain.
According to the Associated Press, however, the U.S. Food & Drug Administration has received over 80,000 spinal-cord stimulator injury reports since 2008, including infections, shocks, burns, and deaths. Many patients also reported that the implants had actually worsened their pain.
Furthermore, the FDA has announced 50 spinal-cord stimulator recalls since 2005. Roughly half the recalls involved stimulators made by Medtronic, although none warned of injuries or deaths.
In 2011, the U.S. Department of Justice joined a whistleblower lawsuit that accused Medtronic of providing doctors with powerful financial inducements to push spinal-cord stimulators on their patients. Medtronic settled the spinal-cord stimulator lawsuit in 2015, but did not admit to any wrongdoing.