According to several American law firms, the Infuse bone graft product liability lawsuits may cost Medtronic Inc. more than $120 million.

According to the May 6 issue of the St. Paul Business Journal, Medtronic announced plans to record a charge between $120 and $140 million, which will be used to settle hundreds of Infuse bone graft lawsuits, brought against the company due to complications stemming from its bone graft product.

Medtronic also agreed to pay $22 million to settle approximately 950 bone graft lawsuits, but still maintains that there is nothing wrong with their company policies or marketing practices. The reported settlement amount will be recorded in Medtronic’s fourth-quarter results and will possibly resolve 1,200 lawsuits that have been filed. This amount also accounts for a possible upcoming amount of 2,600 Medtronic lawsuits that the company’s lawyers expect to be filed.

Most of these lawsuits allege that Medtronic’s Infuse Bone Graft had caused spinal injuries after they were used for off-label purposes. When the product received approval from the U.S. Food & Drug Administration (FDA) in 2002, it was only approved to treat specific spinal conditions. However, it has been discovered through the years that the product had been used popularly for cervical spinal surgeries, when the product is only approved for lower back surgeries and select dental procedures. The Infuse Bone Graft is most commonly used to treat degenerative disc disease and to treat open fractures on the tibia.

The mechanism behind this device contains a recombinant human bone morphogenetic protein (rhRMP). This protein is genetically engineered to initiate bone growth in specific areas of the spine. The purpose of this product was to replace damaged spinal discs, and to give surgeons some control of where the bone regrows in the patient’s body. However, due to the body’s natural production of bone growth or recovery, the Infuse can only be used safely for approved spinal procedures. Otherwise, the patients could face the possibilities of the Infuse causing spinal growth to occur too quickly, which would contradict the rest of their spine’s structure.

Infuse class action lawsuit investigations revealed that Medtronic went around to different hospitals or health care institutes, advertising the Infuse to be able to treat a variety of back problems. The Senate Finance Committee also discovered an issue with most of the initial research Medtronic used in its marketing campaign. The allegations over the supportive research indicated that about 11 physicians and researchers who wrote the positive reviews or recommendations were reportedly paid $210 million in royalties and consulting fees.

In lieu of this information, the Senate committee members also accused Medtronic of deliberately manipulating studies to hide any adverse reactions to possible side effects that Infuse may cause, and to promote the product for off-label purposes.

Overview of Medtronic Bone Graft Complications

Medtronic’s Infuse Bone Graft was marketed and sold as an alternative to harvesting bone particles from the hip for to be used in spinal surgeries, which caused it to become popular among patients. However, after an investigation conducted by the U.S. Department of Justice, it has been discovered that Medtronic was encouraging physicians to use this product for off-label purposes, which had generated over $3 billion dollars in sales for the manufacturer.

Complications reported for using the Infuse for off-label purposes this product can cause severe side effects which could compromise the health of patients. These complications include but are not limited to:

• Difficulty Breathing, Swallowing or Speaking
• Compression of the Airway
• Respiratory Depression
• Nerve Damage
• Death
• Swelling of the neck and throat
• Infection
• Bone injury
• Infertility
• Cyst formation
• Cancer

The FDA notes that most Medtronic Infuse complications typically occur between two to fourteen days following their surgeries.