INFUSE Bone Graft Lawsuit
Medtronic’s INFUSE bone grafts have been used worldwide in bone surgery for years, but are now the target of patient and surgeon complaints, as well as an FDA inquiry. Patients who believe they have were not adequately warned about the dangers of INFUSE, and who have suffered injuries they believe were directly caused by the medical products, have filed INFUSE bone graft lawsuit actions.
In 2002, the U.S. Food and Drug Administration (FDA) approved INFUSE for use in certain spinal surgeries, including spinal fusion; in 2004, it was approved for use with traumatic tibia injuries; and in 2007, the FDA gave approval to utilize INFUSE Bone Grafts in certain dental procedures. In all cases, the product fills in spaces where bone is missing, fractured, or otherwise required.
Subsequently, INFUSE Bone Grafts have been linked to serious health concerns and complications, including an increased cancer risk. Manufacturer Medtronic has been accused of doctoring studies and overstating the product’s effectiveness. INFUSE Bone Grafts contain a manufactured version of a naturally occurring protein known as human bone morphogenetic protein (rhBMP-2). When injected, INFUSE is purported to promote bone growth, so patients do not have to harvest their own bone or accept donated materials for bone grafts.
Medtronic’s INFUSE bone graft is a relatively new product, and preliminary studies are only now emerging regarding its safety and efficacy. Not all the results are reassuring. One study, which was published in 2011 by Dr. Eugene J. Carragee, revealed that Medtronic’s billion-dollar product was linked to serious INFUSE bone graft complications.
Alleged INFUSE bone graft side effects include:
- Severe infection
- Male sterility
- Bone loss
- Urinary complications
- Tissue degeneration
- Increased cancer risk
Dr. Carragee also revealed allegedly unethical behavior by Medtronic, stating that the company had secretly funded several of the INFUSE studies. The U.S. Senate immediately launched an investigation, stating, “Medtronic’s actions violate the trust patients have in their medical care.”
The fallout for Medtronic has been widespread. INFUSE bone graft lawsuit actions have been filed around the United States, and Medtronic even faced a lawsuit brought by its own shareholders. The case involved company misconduct that resulted in the Department of Justice investigation, and a resulting fall in share prices. In March 2012, Medtronic announced that it would settle its shareholder’s claims for $85 million. At the time, the company also issued a statement to deny having committed any omission, misrepresentation, or other wrongdoing.
Medtronic misconduct leads to Senate investigation & FDA warnings
With new medical products, it often takes years for reports of problems to emerge; such seems to be the case with Medtronic’s INFUSE Bone Graft. The product was first approved in 2002, and between 2004 and 2008, the FDA received almost 40 adverse event reports of INFUSE bone graft complications. Patients reported a range of problems from inflammation in the neck and throat, to unexplained pain.
The first major warning came in 2008, when the FDA alerted the medical community that the safety and efficacy of rhBMP-2, the main ingredient in INFUSE, “have not been demonstrated” in cervical spine procedures. The public health advisory continued, “[The] “FDA recommends… that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.”
In 2011, Dr. Carragee’s study was published in The Spine Journal. Among other things, the editorial revealed that Medtronic had funded several studies, an involvement that called into question the objectivity of their findings. Furthermore, the company had paid $1 to $23 million per year to the studies’ head researchers. Soon after, the U.S. Senate announced that it would investigate Medtronic’s behavior.
In October 2012, the Senate announced results from its year-long inquiry: Medtronic had indeed paid researchers, and handsomely – the company had paid more than $200 million to the consultants. Senator Max Baucus (Dem-Montana) concluded, “Patients are at serious risk when companies distort the facts the way Medtronic has.”
Injured patients file Medtronic INFUSE Bone Graft lawsuits
Serious complications and Medtronic’s alleged misconduct have prompted dozens of patients to take legal action with the aid of an Infuse bone graft lawyer. Patients who have received INFUSE and have suffered side effects may file a lawsuit to recover compensatory and other damages; punitive damages, which are designed to punish Medtronic for willful and reckless disregard for public safety, are also possible.
INFUSE Bone Graft lawsuit plaintiffs level dozens of allegations against Medtronic. The most common include:
- That Medtronic manufactured and marketed a defective product;
- That Medtronic displayed negligence in its product design and manufacturing processes;
- That Medtronic fraudulently misrepresented the benefits of INFUSE;
- That Medtronic knew, or should have known, that INFUSE was unsafe;
- That Medtronic willfully concealed INFUSE complications;
- That Medtronic failed to warn the medical community or the public of possible INFUSE bone graft complications;
- That Medtronic failed to issue a recall and amend the INFUSE design.
Additionally, Medtronic is also charged with actively promoting its INFUSE bone graft for off-label use. In 2011, sales of INFUSE yielded $900 million — 85 percent of which was for off-label uses. Such unapproved use can cause serious problems for patients, as the FDA only approves new products based on specific safety testing and effectiveness from clinical trials. Therefore, unapproved uses are not proven to be safe or effective.
When the FDA approved the INFUSE Bone Graft for use in spinal surgery, it was only for use in one, specific procedure: anterior lumbar interbody fusion surgery (ALIF) for just one level of the lumbar spine (lower back). Despite the FDA’s restrictions, Medtronic promoted INFUSE for use in other, unapproved procedures. These included posterior lumbar interbody fusion surgery (PLIF), cervical spine (upper back) surgery, and multi-level spine surgery.
If proven, these allegations could result in punitive damages awarded to patients who suffered injury after off-label use of INFUSE, and who subsequently filed an individual or class action INFUSE bone graft lawsuit.
- CBS News, Report: Medtronic influenced studies on InFuse bone grafts, http://www.cbsnews.com/8301-204_162-57540533/report-medtronic-influenced-studies-on-infuse-bone-grafts/
- FDA, InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device - P000058, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083423.htm