Last Month, the United States Senate Finance Committee reported that medical device manufacturer, Medtronic, Inc. paid authors over $200 million to manipulate the data reported in medical studies. Medtronic paid these industry leaders to promote Infuse bone graft for uses not approved by the Food and Drug Administration (FDA) which violates the agency’s regulations.
Infuse Bone Graft is a genetically engineered product that converts stem cells into bone cells. Designed to grow bones, Infuse is made up of three parts: recombinant engineered human bone morphogenetic protein-2 (RhBMP-2), a sponge manufactured from bone Type 1 collagen which is a natural carrier for delivery, and a cage which holds the BMP-soaked sponges that gradually release and reabsorb the protein.
Infuse was approved by the FDA in 2002 for use in dental, oral and spinal surgeries with an anterior (frontal) approach. Infuse was not approved for anterior (back) approach spinal surgeries, because too many patients experienced complications in the 1999 clinical trials.
Some neck surgeries and other types of procedures in which Infuse was used were performed “off-label,” which is the term applied to describe the use of a product for a reason other than its intended purpose. . Some operations were anterior approach spinal surgery.
The FDA permits doctors to use drugs and medical devices off-label as they see fit. However, medical device manufacturers are prohibited from promoting off-label use.
Medtronic funded at least 13 key studies during the last 15 years that not only promoted off-label use, but also downplayed serious risks associated with Infuse. These risks included infection, back pain, leg pain, and male sterility.
Neck surgeries involving Infuse have been known to lead to difficulty swallowing, breathing and speaking. Some neck surgery patients were required to undergo additional surgeries to correct problems caused by Infuse.
For Medtronic, the $200 million spent on manipulating medical studies paid off. Off-label procedures made up 85 percent of the 500,000 surgeries performed using Infuse. These procedures contributed to Infuse bone graft becoming an $800-million-a-year product.
In July 2008, the FDA issued a public health warning to surgeons about reports of life-threatening complications associated with Infuse. Three years later, the North American Spine Society alleged in The Spine Journal that Medtronic failed to disclose serious side effects with Infuse bone graft. This publication prompted the Senate’s 2011 investigation into the misleading data funded by Medtronic.
Medtronic’s actions violate the trust patients have in their medical care,” said Sen. Max Baucus, D-Mont, in a statement.
Medtronic cooperated with the investigation and turned over 5,000 documents to the Senate. However, the company disagrees with the findings and denies “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.”
Earlier this year, Medtronic settled a lawsuit filed by shareholders alleging that the company made misleading claims about the Infuse bone graft product and downplayed the side effects. Medtronic is also facing numerous Infuse lawsuits brought on by patients who were injured as a result of off-label use of the popular bone graft.
On August 20, 2012, a California woman won her case against Medtronic alleging that her life altering injuries were caused by Medtronic’s promotion of off-label use. The plaintiff suffered debilitating spine injuries when her doctor combined Infuse with a Stryker product. The court stated that Medtronic’s senior management concealed company efforts to promote widespread off-label use of INFUSE Bone Graft.
Patients who received Infuse Bone Growth off-label from 2002 until June 2011 may be eligible to file an Infuse lawsuit. Individuals will likely be eligible to file suit if they have experienced uncontrolled bone growth, bone loss, swelling of the neck and throat, swelling of the back or chronic radicular pain.
Patients who received their Infuse BMP after June 2011 or who may not otherwise fit the criteria for Infuse BMP lawsuits may be eligible to file a medical malpractice suit instead.