The INFUSE Bone Graft, which was once believed to be a game changer in bone surgery, has come under fire, as has Medtronic, the product's manufacturer. Originally approved by the Food and Drug Administration (FDA) in 2002 for use in certain spinal procedures, the INFUSE Bone Graft contains a synthetic protein called recombinant human bone morphogenetic protein (rhBMP-2) that makes it ideal for promoting bone growth. Following the approval for spinal applications, it was approved in 2004 for tibia repairs and in 2007 for dental procedures. The graft is used to fill in spaces where bone is needed.
However, a growing number of individuals have suffered injury as a result of receiving an INFUSE Bone Graft and subsequently filed lawsuits against Medtronic. Plaintiffs accuse the manufacturer of intentionally concealing dangerous side effects and encouraging unapproved uses of the bone graft. The product has been promoted for off-label uses in certain spinal surgeries — a practice that drew two whistle-blower lawsuits and a $40 million settlement with the Department of Justice in 2006. INFUSE also has been linked to infection, bone and nerve injury, sterility, urinary problems and possibly even an increased cancer risk.
A number of people filed lawsuits after suffering complications from an INFUSE Bone Graft. They accuse the manufacturer of concealing side effects and encouraging unapproved uses of the product.
Status of INFUSE Bone Graft Lawsuits
Hundreds of lawsuits, including INFUSE bone graft claims, have been filed against Medtronic in state and federal courts. Medtronic has offices in Tempe, Ariz., and many of the lawsuits have been filed in that state. The device maker has moved several cases, which were initially filed in Arizona state court, to the U.S. District Court for the District of Arizona. To date, the federal judicial panel has not centralized cases in multidistrict litigation. But case filings are steadily increasing, and the court may find it necessary to streamline case management.
In addition to the lawsuits from patients who have suffered, Medtronic recently settled a suit from its own shareholders. In March 2012, Medtronic announced it would pay $85 million to its shareholders to settle a suit regarding the claims that led to the DOJ investigation and the subsequent drop in stock prices. Under the settlement, Medtronic denied any misrepresentation, omissions and any other wrongdoing.
Why People File INFUSE Bone Graft Claims
Thousands of patients and their families are considering filing claims against Medtronic over injuries, the company's questionable business practices in promoting INFUSE, as well as allegations that the company hid reports of adverse effects from the medical community. Patients who underwent procedures with INFUSE Bone Graft and have experienced painful side effects may have legal options. These patients can speak with an experienced lawyer to determine if they can receive compensation for lost wages and medical expenses, and punitive damages.
Plaintiffs are also claiming punitive damages as a result of Medtronic's willful and intentional marketing of unapproved, off-label uses of the product and for concealing dangerous side effects. The FDA approved INFUSE for use only with anterior lumbar interbody fusion (ALIF) surgery in a single level of the lower back (lumbar spine). However, Medtronic promoted INFUSE for use in unapproved procedures such as multi-level spine surgery, upper back (cervical spine) surgery and posterior lumbar interbody fusion (PLIF) surgery.
It also promoted and sponsored studies claiming there were little to no side effects associated with the product. An independent review of medical studies revealed that serious and sometimes fatal side effects were caused by the active ingredient in INFUSE, recombinant human bone morphogenetic protein (rhBMP-2). As a result of its aggressive and misleading marketing of the product, in 2011, 85 percent of INFUSE sales were for off-label uses and the company's sales soared to $900 million.
In July 2011, April Cabana filed a claim against Medtronic for injuries she endured after undergoing two surgeries to treat her lower back pain. During the second procedure, the surgeon used INFUSE bone graft to fuse her spine. Neither of the procedures removed her pain, the suit claims, and they both made the pain so unbearable that, at the young age of 34, Cabana was unable to work and had to go on disability. The suit also cites research from the July 2011 issue of The Spine Journal that states: “INFUSE Bone Graft can cause severe problems with nerves and spinal cords" and "off-label use of INFUSE Bone Graft can lead to severe side effects.”
In October of that same year, an unnamed vascular surgeon also filed suit against Medtronic for injuries suffered while being administered the INFUSE Bone Graft material. The suit claims that the “product caused permanent injuries, destroyed her health and ended her career” after she underwent a spinal implantation procedure in February 2009. By August 2009, the surgeon reported new symptoms, including a burning pain down her right leg. Months later, the pain spread to her left side, leaving her debilitated and unable to work.
|In complaints filed against Medtronic, plaintiffs accuse the company of:
|Manufacturing a defective product
|Failure to warn
|Negligence for faulty product design and manufacturing
|Failure to recall the defective product and fix faulty design
|Fraud for misrepresenting the benefits of the device
|Concealing side effects
|Breach of express and implied warranty
FDA Warnings and a Senate Investigation
The company that developed INFUSE now sees itself attacked on multiple fronts. In 2008, the FDA published a notice to health care practitioners about the potential dangers of INFUSE, stating that the safety and effectiveness of its main ingredient “have not been demonstrated” for use in cervical spine procedures. The notice came after the agency received nearly 40 reports of complications from the use of INFUSE from 2004 to 2008. Patients reported experiencing swelling in the throat and neck, which compressed the air passages and the nerves in the neck. Some were forced to undergo emergency procedures to clear the blocked airways, including intubation, tracheotomy and surgery to drain the swelling.
"FDA recommends," the advisory reads, "that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies."
While the DOJ and FDA have taken their swings at Medtronic, the U.S. Senate appears to be next. In October 2012, the Senate Finance Committee announced the results of its own year-long investigation into the company's history of alleged kickbacks and false advertising. The investigation showed that Medtronic paid study authors — who were supposed to be examining the efficacy of INFUSE — more than $200 million in consulting fees.
In a statement about the investigation, Sen. Max Baucus, D-Mont., said: “Patients are at serious risk when companies distort the facts the way Medtronic has.” He also stated that the actions Medtronic took to promote INFUSE “violate the trust patients have in their medical care."