38 Plaintiffs File an Infuse Bone Graft Lawsuit in California

On May 31, 2013, a total of 38 plaintiffs filed an Infuse bone graft lawsuit against defendants Medtronic Inc., Wyeth Inc., Pfizer Inc., and others. According to court documents, the plaintiffs all allegedly suffered serious injuries after going through surgery in which the Infuse bone graft was used. The case is currently proceeding in the Superior Court of the State of California, for the County of Los Angeles.

The Infuse bone graft is a genetically engineered protein that helps regulate bone growth and healing. The FDA approved the product in 2002 for use in lower spine surgeries and to help treat degenerative disc disease. In July 2008, however, the agency released a public health notification alerting healthcare practitioners of complications associated with Infuse bone grafts.

Facts of Infuse bone graft lawsuit

According to court documents, all of the plaintiffs had the Infuse implanted to treat spinal conditions, but afterwards suffered debilitating injuries.

Those Infuse bone graft injuries included:

• Back pain
• Nerve damage
• Heterotopic bone growth (growth of bone in unusual places)

The plaintiffs are from various states, including California, New Jersey, Texas, Tennessee, Indiana, Illinois, New York, Colorado, North Carolina, Oklahoma, Georgia, Oregon, Alabama, Michigan, Ohio, Nevada, Arizona, Pennsylvania, Kansas, Mississippi, and Connecticut.

Medtronic Infuse bone graft complications

The plaintiffs claim in this Infuse bone graft lawsuit that the surgeons used Infuse in an off-label manner—for procedures not approved by the FDA. They state that the surgeons did so because the defendants improperly promoted the product for such uses, even though they didn’t have the FDA’s approval to do so.

The genetically engineered protein that makes up Infuse is called “rhBMP-2,” and was developed by Wyeth (a wholly owned subsidiary of Pfizer) as a commercially viable bone protein that stimulates bone growth. The FDA approved Infuse as a medical device containing an absorbable collagen sponge treated with rHBMP-2, for one limited use—an Anterior Lumbar Interbody Fusion procedure, in which the L4-S1 region of the lumbar spine is fused. The procedure is primarily used to treat pain resulting from disc collapse. The surgeon approaches the spine from an incision in the abdomen.

The plaintiffs claim that the FDA’s limited approval was based on concerns about potential adverse events that had already been reported with the product at the time of approval. Yet Infuse has been used in numerous other lumbar spine surgical procedures for which it was not approved, including Posterior Lumbar Interbody Fusion, which is used to treat nerve compression and back pain from a number of causes. The approach, however, is different, as the surgeon makes the incision in the back.

Other surgeries for which the Infuse was allegedly used illegally include:

• Posterolateral Fusion
• Transforaminal Lumbar Interbody Fusion
• Cervical spine placements of Infuse
• Thoracic spine placements of Infuse

Defendants failed to warn of Medtronic Infuse bone graft complications

The plaintiffs go on to state that some of the complications that can arise from the illegal use of Infuse include excessive bone growth, and bone growth where it is not desired. They state that the defendants did not do enough to warn the medical community of the potential risks of using the product for non-approved procedures, and instead, actually provided doctors with misleading and false studies showing unfounded support for off-label usage.

In 2006, a medical article in Spine noted that rhBMP-2 may stimulate bone growth in areas in which bone is not desired, especially as the material leaks into such spaces. They added that the release of such material into the soft tissues stimulates a rapid, potentially life-threatening inflammatory reaction. Some of the adverse events reported include life-threatening swelling in patient’s throats and necks following cervical spine procedures.

The Infuse bone graft lawsuit plaintiffs bring counts of manufacturing defect, failure to warn, design defect, negligence, fraud, intentional misrepresentation, California unfair competition law, breach of warranties, negligence per se, and strict liability. They seek general, specific, economic, non-economic, and punitive damages.