Doctor reviews edited by Medtronic

A congressional study alleges that Medtronic paid over $200 million to edit and otherwise manipulate the results of at least thirteen different studies related to its Infuse’s efficacy and safety.

Medtronic Infuse lands in more trouble with Senate Report


Infuse, the Medtronic produced synthetic liquid bone morphogenetic protein (or BMP), has been under Senate investigation since June 2011. The report looked at over 5,000 internal company documents and revealed a disturbing trend. Medtronic, while paying outside study authors $210 million, edited and otherwise manipulated the results of at least thirteen different studies.  The senators’ final study specifically alleged that Medtronic, in addition to substantially editing articles on its spine-fusion product, paid this large sum to authors for “consulting, royalty and other miscellaneous arrangements” between 1996 and 2010.


No Mention of Complications


None of the Medtronic sponsored studies listed any of the serious and potentially side effects of Infuse that have made the drug maker the target of civil litigation and Congressional investigation. These side effects include swelling of the neck and/or throat tissue, difficulty swallowing, breathing and speaking, compression of the Airway, respiratory depression, nerve damage, male sterility, increased risk of cancer, infections, bone dissolution and worsened back and leg pain.


Senate Report Allegations


The report of the Senate Finance committee found that one of the world’s largest medical device makers failed to disclose its financial ties to the authors of thirteen studies. Further, the company engaged in a pattern of distortion of the studies by editing and manipulating the results.


Using internal Medtronic documents, the Senate report alleges that a Medtronic employee recommended that negative side effects of Infuse not be published in the Journal of Bone and Joint Surgery. The published articled omitted the negative side effects.


These latest allegations follow on the heels of similar reports of wrongdoing at Medtronic in the buildup to the approval of Infuse and the marketing of the drug after its approval. The FDA approved Infuse in 2002. Since that time sales of the drug have reached $800 million in 2011. Over half a million patients received Infuse in 2011. In addition to the Senate investigation, there has been a U.S. Depart of Justice investigation, and several published reports of Medtronic’s abusive marketing of Infuse for off label procedures.


If you or your loved one has received Infuse in the cervical or neck area and suffered swelling of the neck and/or throat tissue, nerve damage or other serious complications after the procedure, time may be limited to enforce your legal rights.  The lawyers of Slater Slater Schulman LLP are here to help. Please call us to discuss your potential Medtronic Infuse lawsuit at 1-800-251-6990 or fill out the form on the right of this page and someone from our office will contact you to discuss your case.



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