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Infuse Bone Graft Linked to Surgical Complications
Each year, an estimated half million people undergo spinal surgery to repair and stabilize the spine after experiencing damaged discs or to remedy the condition of scoliosis.
"Infuse Bone Graft" is a biologically engineered liquid that is used to promote bone growth in spine-repair surgery. It's become a best seller for Medtronic Inc. of Minneapolis, estimated to have brought in $815 million in the fiscal year that ended April 2008, according to the Wall Street Journal.
But there have been reports of Infuse Bone Graft complications that have occurred during off-label use, specifically in surgery in the neck.
In July 2008, the Food and Drug Administration warned doctors that using Infuse in the neck could lead to serious complications. The agency reports it has received 38 adverse health reports over the use of Infuse Bone Graft around the neck, including swelling and difficulty breathing and swallowing.
In some cases there were unwanted bone growths near nerves or outside the site that was supposed to fuse. Patients experienced pain and inflammation, and in some cases had to have their surgery repeated.
Medtronic says it takes the reports seriously, but the company says it doesn't track off-label use, even though Infuse is reported to be used widely off-label.
When a California woman died in August 2008, after undergoing spinal-fusion surgery using Infuse Bone Graft, Medtronic says it was not aware for more than three months that a patient had died - not until the family filed a lawsuit.
The family of Shirley Nisbet has sued alleging that the surgery to her neck used Infuse even though it wasn't approved by the FDA for such a procedure. After her surgery, the suit says, Ms. Nisbet went into respiratory arrest and a coma and was kept alive by artificial means until she died.
That off-label use is being investigated by the U.S. Department of Justice.
Medtronic is supposed to report adverse events to the agency, whether or not they agree that the product caused the adverse health event.
But a spokesman for the Kaiser Hospital in California, where Ms. Nisbet had her surgery, said it did not report the death to Medtronic because it didn't consider the product to be the cause of death.
Infuse has become a success for Fridley, MN.- based Medtronic since it was approved for use in the lower back and in some dental applications in 2002, but doctors can use an FDA-approved device any way they see fit.
Three "whistleblower" lawsuits accused the company of illegally marketing Infuse. The former employees said Medtronic paid inducements to surgeons to use the medical device.
Medtronic agreed to pay $40 million to settle two of the cases, filed in federal district court in Memphis. But the company did not admit any wrongdoing.
Marketing for off-label use is not allowed under the FDA.
In December 2008, two former employees of Medtronic Inc. filed a whistle-blower suit against the company, alleging lucrative financial relationships between it and seven doctors at the Twin Cities Spine Center, a Minneapolis practice that's reported to be one of the largest in the country.
The suit, filed in December 2008 in U.S. District Court in Boston by two former Medtronic employees, alleges that the medical device company and the doctors signed consulting and royalty agreements for the doctors to use Medtronic's "Infuse Bone Graft" products in ways not yet approved by the U.S. Food and Drug Administration, the Star Tribune reported.
In one document, a proposed consulting agreement showed Medtronic promised to pay spine doctors $4,000 a day for "services performed." That arrangement was not to exceed $80,000 a year.
Before Infuse was approved in 2002, most spinal fusions involved taking bone from patient hip bone or from cadavers.
In 2002, four surgeons wrote a favorable report for the Web site Spine Universe, which provides educational material for spine surgeons. The authors all reported they had very good results in the neck area.
At least three of the four authors had financial relationships with Medtronic, according to follow up disclosures to medical journals.
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