(WMC-TV) - Twelve lawsuits were filed Thursday against Memphis-based Medtronic after lawyers say the company illegally promoted a popular product used in spinal fusion surgeries.
The product is called Infuse and it is made by Medtronic's spine division, Sofamor Danek, which is based in Memphis.
The procedure features a small metal cage that is inserted in between the discs in your back. It is designed to treat degenerative disc disease.
It was approved by the FDA back in 2002.
"The FDA approved this product in a manner that was safe. But that option isn't done very many times in the U.S," said lawyer David Gray.
Gray is one of the lawyers filing the lawsuits against Medtronic.
The lawsuits claim the company is promoting an off-label use of Infuse.
Lawyers say the Infuse procedure was approved by the FDA to be surgically placed through the belly of a patient, and not the back of a patient.
"When they go through the back, the operation is in the vicinity of nerves that spin off and go to the legs and this is when we see that bony over growth of the spine and onto people's nerves," Gray added.
In this case, there are 10 clients from Ohio and two from Kentucky.
Lawyers filed the suits in Memphis because the city is the base of Medtronic's spine division.
David Gray says many of his clients are suffering lifetime damage from the small metal cage.
"It's disabling them. Some of our clients are paralyzed, some are disabled and unable to function or work. Some have had surgeries trying to fix this problem," Gray explained.
Last October, the U.S. Senate also investigated this Infuse bone graft and determined that Medtronic manipulated studies and inaccurately represented the procedures' risks.
In a statement, Medtronic told Action News 5 that they have not seen the lawsuits but patient safety is its top priority.
Medtronic says the safety profile reported to the FDA and detailed in product labeling support the continued safe use of the Infuse bone graft.
The following is Medtronic's statement:
We haven't seen the lawsuits, but we stand behind our product and are prepared to vigorously defend it in court. Since the product was approved in 2002, Medtronic has communicated the risks of INFUSE through our FDA-approved package insert.
Patient safety is our top priority, and INFUSE Bone Graft has been found to be safe and effective by the FDA for specific uses in the spine*. Medtronic strongly believes that the safety profile reported to the FDA and detailed in product labeling support the continued safe use of INFUSE Bone Graft for approved indications.
The FDA-approved indications are:
1. In combination with Medtronic's LT-CAGE(r) Lumbar Tapered Fusion Device, INTER FIX(tm) Threaded Fusion Device, or INTER FIX(tm) RP Threaded Fusion Device, in anterior lumbar interbody spinal fusion procedures to treat skeletally mature patients with degenerative disc disease (DDD) at a single level from L2-S1;
2. In treating acute, open tibial shaft fractures in skeletally mature patients that have been stabilized with IM nail fixation after appropriate wound management (within 14 days after the initial fracture); and
3. In oral maxillofacial (OMF) procedures as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.
To read more about last year's senate ruling on Infuse, click here: http://www.finance.senate.gov/newsroom/chairman/release/?id=b1d112cb-230f-4c2e-ae55-13550074fe86
To read more about the lawsuits filed against Medtronic, click here: http://www.bluegrassinjury.com/infuse-bone-graft/
To find out more about the Medtronic, click here: http://www.medtronic.com/index.htm
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