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Medtronic Infuse Bone-Growth
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Following Infuse Settlement, Medtronic Reports 54% Drop in Profits

May 21, 2014

Medtronic's reported net earnings fell 54 percent in the fourth quarter which ended on April 25, 2014, RTT News reports. The drop in earnings includes the company's Infuse product liability settlement as well as a one-time, non-cash $746 million pre-tax litigation charge related to the company's global patent deal with Edwards Lifesciences Corp. Medtronic's fourth-quarter reported net earnings last year were $969 million, or $0.95; this fourth-quarter those earnings have dropped to $448 million, or $0.44 a share.

The company is facing mounting litigation over its Infuse bone growth product. Currently, there are almost 1,000 lawsuits filed over Infuse. Last week, Medtronic said it would be settling 950 claims for $22 million. It will also be setting aside $140 million in anticipation of an additional 3,800 lawsuits.

Infuse is an artificial bone growth product that was approved by the U.S. Food and Drug Administration in 2002. Instead of harvesting bone from a patient's one body as with a traditional bone graft, Infuse uses bone morphogenetic protein-2, or BMP-2, to stimulate bone growth in the spine. Complications associated with Infuse include an increased risk of cancer, retrograde ejaculation that may lead to male sterility, and excess bone growth. The FDA has received over 6,500 reports of adverse related to Infuse since its release, an analysis by Journal Sentinel/MedPage Today shows.

Off-label use of Infuse is a safety issue that is cited in a number of lawsuits. Infuse is only approved for a specific type of lumbar fusion surgery, but research shows that the product is used in a non-approved manner, such as in the cervical spine, up to 80 percent of the time. In 2008, the FDA warned that using Infuse off-label in the cervical spine could lead to life-threatening airway complications such as difficulty breathing and swelling of the neck and throat.

Last year, researchers published findings in the Annals of Internal Medicine indicating that there was no benefit to using Infuse over a conventional bone graft. The researchers noted that the product may expose patients to serious risks.

Infuse came under fire in June 2011, after a group of spine experts publicly rebuked Medtronic-funded studies over the product. In an issue of the Spine Journal, the researchers noted that complications with Infuse were 10 to 50 times higher than reported in the Medtronic studies. It was also revealed that the authors of those papers were paid millions of dollars in royalties. In 2012, a United States Senate investigation found that Medtronic employees had helped write and edit the studies promoting Infuse.

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