Product News and Recalls

Legal inquiries ongoing into Medtronic Infuse bone implant

Despite Minnesota-based Medtronic’s announcement that the federal government has closed its investigation into the marketing of a bone growth agent called Infuse, the company’s legal troubles are not over.

According to an article in the Pioneer Press, a number of other legal inquiries are ongoing into claims that the company promoted Infuse for off-label uses, despite reports that such uses were causing serious and permanent injuries to patients.

They include a subpoena the California Attorney General’s office issued in 2011, and several inquires from the U.S. Senate Finance Committee.

In addition, widespread lawsuits allege that patients who received the off-label procedures weren’t warned of the potential risks, and suffered side effects including chronic pain and uncontrolled bone growth in the spinal canal.

A joint investigation by MedPage Today and the Milwaukee Journal Sentinel previously found that doctors involved in research articles for the devices received millions of dollars in royalties from other Medtronic products.

And in 2006, according to MedPage Today, Medtronic agreed to pay $40 million to settle a U.S. Department of Justice lawsuit that alleged the company paid kickbacks to doctors to get them to use Medtronic spinal products. The government alleged payments took the form of sham consulting agreements, sham royalty agreements and lavish trips.

According to a New York Times report, U.S. Army officials provided the Justice Department with the results of a military investigation into the experimental use of Infuse on dozens of soldiers at Walter Reed Army Medical Center in Washington, D.C., as a part of the federal investigation.

The Army’s 2008 report on that investigation found that a former military doctor, Dr. Timothy R. Kuklo, had overstated Infuse’s benefit in a medical journal study that examined its use in the treatment of solders whose shin bones had been severely shattered by explosive devices in Iraq, and forged the signatures of that study’s co-authors. Kuklo later became a Medtronic consultant, the New York Times says.

Lopez McHugh is currently investigating Medtronic Infuse lawsuits, based on the above allegations and other information indicating problems with this medical device. If you have ongoing pain after use of a Medtronic Infuse procedure, contact a medical device attorney at Lopez McHugh to find out if you have a claim.

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