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Medtronic Paid Millions to Manipulate InFUSE Studies, Senate Finance Committee Investigation Finds

Outside a Medtronic building

Washington, D.C., October 31, 2012 – Baum Hedlund Aristei & Goldman reports that the U.S. Senate Finance Committee issued a lengthy report on Thursday showing that medical device maker Medtronic, Inc. paid doctors hundreds of millions of dollars to manipulate studies and write favorable articles on the company’s popular bone graft product, InFUSE.

The report is based on a 16-month investigation conducted by Senate Finance Committee Chairman Max Baucus (D–Mont.) and senior Finance Committee member, Senator Chuck Grassley (R–Iowa). The bipartisan investigation centered on questionable ties between Medtronic and the doctors hired by the device maker as consultants to study and review InFUSE. The report revealed that Medtronic paid doctors $210 million over 15 years to edit and “in some cases, write” parts of studies on INFUSE that were published in various media outlets and medical journals.

The investigation’s major findings state that Medtronic failed to publicly disclose that they had close financial ties to the doctors they hired to perform studies and reviews on InFUSE. Additionally, Medtronic studies that ended up in medical journals did not include the serious risks of dangerous side effects associated with the use of InFUSE. Internal company documents that were turned over to investigators actually show a Medtronic employee recommending that a detailed table showing InFUSE complications from a clinical trial not be published in a 2005 article for the Journal of Bone and Joint Surgery. Furthermore, Medtronic officials were involved in every aspect of shaping content for medical journal articles on InFUSE, often going so far as to insert language highlighting the pain associated with alternative treatments.

“Medtronic’s actions violate the trust patients have in their medical care,” said Senator Baucus in Thursday’s press release. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at risk when companies distort facts the way Medtronic has. Patients everywhere will be better served by a more open, honest system without this kind of collusion.”

According to Medtronic, over half of a million people have been treated with the InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device since it was approved by the U.S. Food and Drug Administration (FDA) in 2002 to help fuse vertebrae in the lower spine in order to treat degenerative disc disease.

InFUSE is widely used by doctors in procedures that are considered “off-label,” or for purposes not specifically approved by the FDA. While doctors are allowed to use products off-label, companies are legally prohibited from marketing their products to doctors for off label use. Thursday’s report is just another chapter in an ongoing scandal surrounding Medtronic’s marketing practices.

“This represents a similar refrain to what the public is used to hearing about pharmaceutical companies and medical device makers,” says Ronald L. M.  Goldman, veteran trial lawyer and shareholder of Baum Hedlund Aristei & Goldman, currently handling numerous Medtronic InFUSE and Stryker OP-1 Putty medical device injury cases.

Mr. Goldman stated further, “Our long experience litigating on behalf of consumers convinces us that there is a disturbing trend among medical device and drug manufacturers to spend more on marketing and less on science; that the marketing departments control the data released, and sometimes overrule the science, in the interests of profits over truth and safety.  Sadly, too many doctors, for big fees, are willingly complicit, resulting too often in devastating harm to patients.”

In August, a California state court judge issued a ruling in favor of a woman severely injured by InFUSE side effects, allowing her lawsuit against Medtronic to proceed. The lawsuit, filed by Baum Hedlund Aristei & Goldman on behalf of California resident April Cabana, accuses Medtronic of illegally promoting InFUSE for off-label use. Ms. Cabana claims that she was severely injured in an off-label surgery using InFUSE and another bone growth product. The ruling in California is believed to be the first in the U.S. to address the issue of preemption regarding InFUSE in a summary judgment motion.

Anyone experiencing severe pain or excessive bone growth after being implanted with a BMP (bone morphogenetic protein) medical device during spinal fusion or neck surgery, should contact lawyers specifically handling this litigation to seek maximum compensation for their injuries.


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