Medtronic Manipulated Studies to Promote Bone Growth Product Infuse, According to U.S. Senate Panel Report

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Parker Waichman LLP is alerting the public to a report by the Senate Finance Committee about Medtronic Infuse Bone Graft. According to the newly released report, Medtronic manipulated data to promote its bone growth product, Infuse. The report also found that company has paid $210 million to Infuse researchers, although this information was never disclosed in the medical journals. Infuse has become a controversial product in recent years due to reports that Medtronic concealed serious side effects such as male sterility.

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According to report in Bloomberg Businessweek, the Senate Finance Committee report found that Medtronic has paid Infuse researchers a total of $210 million in royalties and consulting fees.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is reporting that Medtronic manipulated studies about Infuse to overstate its benefits and hide serious side effects, according to a report by the Senate Finance Committee. The report also showed that Infuse researchers have received millions of dollars in royalties from Medtronic, but never disclosed this information in their papers.

According to report in Bloomberg Businessweek, the Senate Finance Committee report found that Medtronic has paid Infuse researchers a total of $210 million in royalties and consulting fees. Furthermore, these financial ties were never revealed in their papers discussing the safety of Infuse. To make matters worse, the report also shows that Medtronic manipulated these studies to promote the device. Senator Charles Grassley, a Republican from Iowa, stated that “Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic.” Medtronic manipulated at least 11 medical journals about Infuse, the Senate Panel said in their report. For instance, the report says that language was inserted into the papers to suggest that Infuse was superior to a traditional bone graft, which uses bone from the patient’s own body.

Committee chairman Senator Max Baucus, a Montana Democrat, criticized Medtronic’s unethical behavior, stating that “Medtronic’s actions violate the trust patients have in their medical care.” Baucus went on to say that “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.”

The Senate investigation was at least partially influenced by a special issue of the The Spine Journal published last summer; the journal criticized Medtronic and its paid researchers for omitting serious side effects associated with Infuse, including male sterility.

Medtronic Infuse was approved in 2002 to help stimulate bone growth in the lower parts of the spine. Unlike a traditional bone graft, which harvests bone from a patient’s pelvis, Infuse uses a bone morphogenetic protein (rhBMP-2).

Parker Waichman LLP is currently offering free legal consultations to victims of Medtronic Infuse Bone Graft Injuries. If you or a loved one suffered a serious complication or injury after receiving Medtronic Infuse, please contact their office by visiting the firm's Medtronic Infuse injury page at Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636

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Gary Falkowitz, Managing Attorney
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