Bone Graft Lawsuits Mount as Victims Say Medtronic Concealed Off-Label Risks

By Staff Writer

In the past few months, angry patients, doctors and personal injury lawyers have been turning up the heat on Memphis-based medical device maker Medtronic, Inc.

Even well known physician and daytime TV show host Dr. Oz is scheduled to testify against Medtronic in a lawsuit filed against their rival Edwards Lifesciences Corp. Medtronic claims that Edwards “violated heart-valve patents” back in 2011, stealing the idea from Medtronic and profiting off the device.

However, Medtronic has much more pressing legal issues to deal with than a patent violation.

Currently, there are over 100 pending lawsuits against Medtronic, filed by patients who allege they suffered or are suffering from severe complications, physical pain and financial losses after having the Infuse bone graft implanted in an “off-label” surgery.

The Infuse product is manufactured by Medtronic’s spine division, Sofamor Danek, out of Memphis, Tennessee. In the bone graft procedure, the small metal cage is inserted in between the discs in your back, and is designed to treat degenerative disc disease.

According to CBS News, Medtronic’s Infuse bone grafts have been used in over half a million patients since its FDA approval in 2002. Off-label usage of the Infuse system accounts for up to 95% of product sales, and has brought in billions of dollars in profit for the company.

Although the Infuse was only approved for spinal, oral and dental graft operations, in most cases the device is used in neck surgeries and similar procedures, which has led to serious health complications in a number of patients, including nerve damage, problems breathing or swallowing, paralysis and other chronic debilitating side effects.

Furthermore, back in October 2012, the U.S. Senate determined that Medtronic failed to report the catastrophic complications linked to off-label Infuse operations—despite knowing that these side effects were indeed possible, as alleged by The Spine Journal—and even paid kickbacks totaling $210 million to doctors and authors of their bone graft studies from 1996 to 2010.

“Medtronic’s actions violate the trust patients have in their medical care,” said Sen. Max Baucus, in a statement. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”

Medtronic continues to deny allegations that they intentionally endangered patient safety.

We encourage you to learn more about the Senate ruling on Infuse to decide for yourself. And if you have had an “off-label” procedure involving a Medtronic Infuse device, talk to a Memphis bone graft injury attorney today.

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