Medical device maker Medtronic Inc. (NYSE: MDT) says 14 patients have died from complications caused by its SynchroMed implantable pain pump. The pump is used to deliver analgesic drugs directly to the spinal fluid in patients with intractable pain or severe spasticity.
Although the SynchroMed pump has been classified by the Food and Drug Administration as a Class I recall, meaning there was a “reasonable probability” that it could cause serious health problems or even death, the company is not recommending that the pump be removed. Over 200,000 SynchroMed devices have been implanted worldwide, according to Medtronic.
The company has identified four issues with the pain pump that cause the improper mixing of medications prior to their injection into patients.
“It is reasonable to expect that the resulting unintended drug delivery is a contributing factor to adverse events involving overdose and underdose.These adverse events will vary depending on the drug being infused, but could include lack of therapeutic effectiveness, confusion or altered mental state, sleepiness, nausea, respiratory depression, coma or death,” the company said in a warning letter to physicians last month.
Despite the risks, some doctors and patients said they would continue to use the pump. Without a pump, painkillers would have to be taken orally or by injection, which some patients can’t tolerate.
“Most of my patients, if I told them I wanted to take their pump out because of potential problems, they would say ‘Leave it in until you know for sure,’ ” Dr. Diane Chappuis of the Courage Kenny Rehabilitation Institute told the Minneapolis Star Tribune. “That is not to say that some patients don’t have a problem or two with their pump. But most of our patients don’t have a problem.”
Eleven of the 14 deaths were attributed to patients being inadvertently injected with drugs. Two patient deaths were caused by a drug blockage and one is blamed on an electrical short in the device. The deaths occurred between 1996 and April of this year.
“The SynchroMed Implantable Infusion System continues to demonstrate strong overall reliability, and Medtronic remains confident in its ability to deliver safe and effective therapy. Patients and caregivers should be aware of the signs and symptoms associated with intrathecal drug therapy complications and contact their physicians immediately if they hear a device alarm or experience symptoms of a drug overdose or underdose,” the company said in a press release Wednesday that made no mention of the patient deaths.
Meanwhile, a San Diego based law firm that is well known for its litigation in the health care industry has filed a class action lawsuit against Medtronic for securities fraud.
Robbins Geller Rudman & Dowd claim Medtronic knowingly misled investors about its Infuse Bone Graft, which was approved by the FDA to reduce pain and complications caused by spinal fusions to treat degenerative disc disease. The lawsuit alleges company officials “engaged in a scheme with certain researchers to downplay the risks and side effects associated with Infuse.”
Last week Yale researchers found “substantial evidence of reporting bias” in Medtronic sponsored studies of Infuse. Two independent reviews conducted by Yale that were published in the Annals of Internal Medicine found little or no evidence that Infuse was better than an older method for spurring bone growth.
Doctors use bone grafts to promote bone growth after spinal fusion surgeries. The FDA approved Infuse in 2002 for spinal fusions in the lower back. It has been used on more than 1 million patients. Sales of Infuse reached nearly $1 billion a year before falling to $528 million, after questions were raised about its effectiveness in the Spine Journal.
“The take-home message from this debacle … is that the public needs better safeguards against conflicted and tainted medical research,” said Dr. Eugene Carragee, editor-in-chief of the Journal. “Medtronic-sponsored surgeons may have to finally retire the line that ‘this product is completely safe, don’t worry about it,’ but I would not count on it.”Tags: Infuse, Medtronic, SynchroMed