Senators Say Medtronic Manipulated Bone Product Data
A Senate Finance Committee report has accused Medtronic Inc., the world’s biggest maker of heart-rhythm devices, of ghost-writing medical papers and paying physicians hundreds of millions of dollars to promote the use of its bone-growth product, Infuse.
The report highlighted a $210 million “consulting and royalty” program in which Medtronic paid doctors and researchers to write papers about the product, which is used to promote bone growth after spinal surgery. The authors of the studies, according to the report, never revealed their links to the company. The Senate panel also accused Medtronic of directly shaping at least 11 medical journal articles concerning the product.
The Senate Finance Committee Chairman, Senator Max Baucus (D-Montana), said that the report reveals that Medtronic violated the trust patients should have in their medical care. “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,” he told Bloomberg News.
The product was approved in 2002. In 2011, Spine Journal published studies that claimed the bone growth product raised risks of infertility, cancer, and infections. Thirteen clinical trials funded by Medtronic had shown no side effects associated with the product. The U.S. Food and Drug Administration (FDA), on the other hand, had received reports that showed as many as half of patients had complications that included infections, cysts, pain, and cancer, according to Bloomberg.
The company has also been accused of promoting the product for unapproved uses. The Senate report contends that up to 85 percent of Infuse’s use might have been for procedures unapproved by regulators.
If you’ve suffered side effects from the use of Medtronic’s Infuse, you may be entitled to compensation for damages. The product liability attorneys in Florida at Farah & Farah have extensive experience in dealing with large medical device manufacturers and pharmaceutical companies. If you think you have a case, please call us at (800) 533-3555 for a free and confidential consultation.