Medtronic Infuse Bone Graft Lawsuit Proceeds on Fraud Claim

On August 4th, the judge presiding over a Medtronic Infuse Bone Graft lawsuit struck a blow to the manufacturer in a product liability lawsuit pending in St. Louis.

Judge Carol E. Jackson, presiding over the personal injury lawsuit involving the Infuse Bone Graft device in the U.S. District Court for the Eastern District of Missouri, denied Medtronic’s motion to dismiss the plaintiff’s claims of fraud and intentional misrepresentation, her only claims remaining after an earlier March 2014 motion to dismiss.

The plaintiff underwent surgery in September 2007 and is now totally and permanently disabled as a result. In the surgery, involving a cervical discectomy and spinal fusion procedure, her surgeon made an off-label use of the Infuse device.

Shortly after the surgery the plaintiff began to experience severe and chronic numbness and pain, affecting her head, throat, neck, shoulders, and arms. As a result, she is unable to keep a job.

Medtronic allegedly marketed off-label use

According to the plaintiff’s complaint, her surgeon performed the spinal surgery without the use of the LT-Cage, a component of the Infuse Bone Graft.

She alleges that Medtronic intentionally marketed the Infuse Bone Graft device for off-label use. She asserts that Medtronic salespeople aggressively marketed to physicians by visiting them, misleading them into believing that into believing that the devise was safe for all spinal surgeries, and promoting use of the Infuse Bone Graft as safe even when used with a non-FDA-approved metal cage device.

How Infuse Bone Graft device works

The Infuse Bone Graft is used to repair spinal disc damages. It is intended to work by stimulating bone growth at the site of implantation. The Infuse Bone Graft comprises two parts: the LT-Cage, which is a small metallic cage, and an engineered human bone morphogenetic protein modeled after a protein that the human body naturally makes.

The protein is carried in a sponge made from a cow collagen. The sponge is inserted in the LT cage, which is, in turn, implanted between the vertebrae. The sponge then releases the protein gradually to provide a framework for new bone growth. The benefit of the device is that it is supposed eliminate an additional surgery to remove bone from a harvest site like the hip, which often comes with pain, complications, and an additional dose of anesthesia.

Claims against Medtronic

The Missouri plaintiff originally brought allegations of manufacturing and design defects, failure to warn, negligence, strict liability, fraud, intentional misrepresentation, and unfair competition. Earlier this year, Medtronic moved to dismiss all of the claims. The judge granted motion but allowed the plaintiff leave to amend her fraud and intentional misrepresentation claims, stating that they had not been alleged with sufficient detail to satisfy court rules.

The Missouri lawsuit is one of nearly a thousand cases still pending across the country. Some of the side effects that Infuse Bone Graft plaintiffs have alleged include excessive swelling of the throat, sterilization, and follow-up surgeries to correct complications.

This past May, Medtronic agreed to pay approximately $22 million to settle 950 claims involving Infuse Bone Graft problems and complications. Medtronic disclosed in its SEC filings that it estimates that law firms intend to file approximately another 2,600 lawsuits over the device.

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