Medtronic Bone Graft Lawsuit Remanded to MO State Court

A Medtronic bone graft lawsuit filed over complications associated with an off-label spinal fusion procedure will be remanded back to state court, according to a ruling handed down by Senior Judge Ortrie D. Smith. The Missouri district judge found that a surgeon named as defendant on the claim was not fraudulently joined and that the case does not arise under federal law.

Judge Smith of the U.S. District Court for the Western District of Missouri stated that the charges brought against the surgeon and Medtronic do not “turn on substantial questions of federal law” and therefore do not “justify resort to the experience, solicitude, and hope of uniformity that a federal forum offers on federal issues.”

Medtronic had originally moved the complaint to federal court, contending that the plaintiff’s surgeon (Dr. Mark Ipsen), who was also a resident of Missouri, was fraudulently joined. The company further argued that the doctor was fraudulently joined because some of claimant’s causes of action against him contradicted accusations leveled against Medtronic.

However, the Missouri judge concluded, “The question is not whether Plaintiffs will prevail against Dr. Ipsen; the question is whether they might. Plaintiffs have presented facts and law suggesting that Dr. Ipsen might be liable… the possibility that a state court will incorrectly resolve a state claim is not, by itself, enough to trigger the federal courts’ jurisdiction.”

Details of Medtronic bone graft lawsuit

The plaintiffs, Mark Goade and his spouse, sued Dr. Mark Ipsen and Medtronic, claiming that the Infuse bone graft was used in a manner that had not been approved by the U.S. Food and Drug Administration, and therefore was an unauthorized off-label use.

Counts of design defect, strict products liability, failure to warn, negligence, misrepresentation, breach of express and implied warranties, and violation of the Missouri Merchandising Practices Act against Medtronic were leveled in the case. The surgeon was accused of fraud, medical malpractice, and failure to obtain informed consent.

Infuse bone graft use and complications

The Medtronic Infuse bone graft is comprised of two parts: a protein that is naturally made in the human body, plus a carrier for delivery. The protein used in the graft is rhBMP-2 (a recombinant human bone morphogenetic protein-2), a bio-engineered version that is used to regulate bone growth and healing. The bone graft was FDA approved in 2002 for limited spinal fusion procedures using a frontal approach. However, an estimated 85% of Infuse bone graft surgery is considered off-label. According to Medtronic statistics, Infuse has been used in more than 500,000 patients and is used by around 2,300 surgeons in the United States.

In 2011, Medical News Today reported that the Senate Finance Committee had been investigating kickbacks paid to surgeons who were told to overlook Infuse bone graft complications.

Senate Chairman Max Baucus said: “Reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling. We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits.”

Independent researchers and post-marketing reports have linked Infuse bone graft procedures with male sterility, an increased risk of cancer, urinary problems, ectopic bone growth, infection and bone degeneration.