Report Claims Medtronic Shaped Bone Graft Studies
The Senate Finance Committee released a new report based on thousands of documents from Medtronic Inc. that questions the integrity of medical research that suggested the company’s Infuse bone graft device was safe when used off-label.
The Infuse bone graft, used to promote the fusion of vertebrae in order to diminish back pain, was approved by the U.S. Food and Drug Administration in 2002 for use during one specific type of spinal surgery. However, the device – which at one time brought in $800 million in sales for Medtronic - also became popular in other surgeries, including neck procedures, after articles in a number of medical journals touted its off-label use, writes The Wall Street Journal (subscription required).
Doctors may use drugs and medical products off-label at their discretion; companies, however, may not market products for unapproved or off-label uses.
Injuries caused by the drug’s off-label use have led to a number of Infuse bone graft lawsuits since 2008. Some of these injuries have ranged from nerve damage, erectile dysfunction, and increased cancer risk, to additional surgeries and death.
The Senate Finance Committee report alleges that Medtronic was "heavily involved in drafting, editing and shaping the content of medical journal articles” that suggested Infuse was safe and effective for off-label purposes. While it had been previously known that Medtronic had financial relationships with several doctors who discussed Infuse in their journal articles, the Senate report revealed that four of the article authors were paid between $22 million and $34 million each by the company between 1996 and 2010, the Journal reports.
A limited liability company that was linked to two other authors also received $65 million during that time. In total, the Senate report claims that the study authors received $210 million – money that the company says was for unrelated work.
In a statement, Medtronic said most of the payments were “royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments.”
The Senate report also found instances in which Medtronic employees made recommendations to the study authors that removed information that might cast Infuse in a negative light. One suggested edit to a 2005 journal article removed a list of side effects associated with Infuse, while edits to another piece by Medtronic marketing officials suggested that Infuse was better for patients than bone harvested from their pelvises, writes the Journal.
Medtronic says it disagrees with most of the report findings and with “any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events.”
If you or a loved one has been harmed by a medical device like Infuse after an off-label surgery, there may be legal options worth pursuing. Call Sokolove Law today for a free legal consultation regarding an Infuse bone graft lawsuit.
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