Judge Rules To Allow Infuse Bone Graft Lawsuit To Proceed In Arizona

Arizona Federal District Judge G. Murray Snow ruled that Plaintiff Cristina Ramirez may proceed with her Infuse bone graft lawsuit against Medtronic, despite the company’s protests. In an October 24th order, the judge stated that a plaintiff cannot bring a claim that rests solely on non-disclosure of facts tied to pre-market approval.

However, in this case, the plaintiff suffered real physical injury – encountering uncontrolled bone growth following a lumbar fusion procedure where Medtronic’s InFuse was used off-label. The Medtronic InFuse lawsuit asserts claims of fraudulent misrepresentation, failure to warn, defective design, misrepresentation, negligence and breach of express warranty.

Federal law does not protect defendants who engage in illegal activity

Medtronic moved to dismiss the complaint entirely, arguing two main points. First of all, they stated they were protected by Section 360K of the Medical Devices Act, which prohibits states from imposing “any requirement which is different from, or in addition to, any requirement which relates to the safety or effectiveness of a Class III Pre-Market Approved medical device intended for human use.”

However, the judge felt this case was different. “When Medtronic allegedly violated federal law by engaging in off-label promotion that damaged the Plaintiff and thereby misbranded the InFuse device, it departed the realm of federal regulation and returned to the area of traditional state law,” the judge explained.

Perez vs. Nidek Co. case

The second defense Medtronic mounted consisted of a comparison to Perez vs. Nidek Co. In that case, the plaintiffs alleged the manufacturer was aware the device was being used off-label and did nothing to warn patients of the risks. The judge ruled in favor of the manufacturer, so Medtronic argued that, logically, the same verdict should be applied in this case.

Judge Snow argued that the Perez case does not apply because there were no injuries reported. The plaintiffs’ claims resulted “solely because the FDA status of the device was not disclosed to them,” the judge noted. Ramirez is not simply looking to cash-in on a perceived discrepancy in the law – but rather, her complaint alleges that off-label uses were promoted to her physicians resulting in the unsuccessful surgery that injured her.

History of Medtronic InFuse lawsuit allegations

According to CBS News, the Medtronic’s InFuse bone grafts have been used in half a million patients since FDA approval in 2002 and account for sales of about $800 million a year. Though the “approved” use is for spinal, oral and dental graft procedures, CBS reports that “most of the time, it has been used in neck surgeries and other procedures.” The Wall Street Journal indicates that InFuse is used off-label about 85% of the time.

Furthermore, Senate investigators uncovered that Medtronic paid study authors $210 million in consulting fees over 15 years. In 2011, the medical device manufacturer agreed to pay $23.5 million to resolve allegations by the Department of Justice that the company paid physicians to promote their pacemakers and defibrillators. During this time, the InFuse lawsuit allegations began to emerge following criticism of the InFuse system in a June 2011 issue of Spine Journal. The article alleged that Medtronic had made payments to doctors to keep them quiet about safety concerns. In 2012, Medtronic paid shareholders $85 million to resolve charges that they failed to disclose that 85% of their sales were related to off-label uses.

Currently, there are at least 100 similar lawsuits against Medtronic. Yet, their success in court will depend upon the specific injuries suffered and how the legal counsel approaches the case. Only plaintiffs with tangible, serious medical problems related to off-label use of the InFuse bone graft system will be considered.