Medtronic Scores a Big Legal Win

A federal judge in Ohio has dismissed hundreds of Infuse bone graft lawsuits, which claimed off-label use of the device.  

Nancy Crotti

Hundreds of plaintiffs failed to prove that they had a valid claim against Medtronic when it came to alleged off-label use of Infuse bone graft devices, U.S. District Court Judge Timothy S. Black in southern Ohio said in a court order issued last week.

The case involved several hundred patients of Cincinnati orthopedic surgeon Atiq Durrani, who fled the country for Pakistan after his 2013 indictment regarding the procedures.

FDA granted Medtronic a PMA for Infuse in 2002, approving it only for use in a single-level fusion in the L4-S1 region of the lumbar spine via the anterior lumbar interbody fusion procedure and in combination with the LT-Cage.

Infuse is Medtronic's tradename for its recombinant bone morphogenic protein-2 (rhBMP-2) product, a genetically engineered version of a naturally occurring protein that stimulates bone growth and gives surgeons some control over where that growth occurs. FDA gave limited approval for its use in 2002 as an alternative to conventional spinal fusion to treat degenerative disc disease and open fractures on the tibia, and for some oral and dental procedures, but off-label use of the device became commonplace, with MedPageToday at one point estimating that as much as 80% of Medtronic's Infuse product had been used for off-label applications. (FDA approved using Infuse with two additional indications in December 2015.)

Some of the plaintiffs in the cases against Medtronic that were dismissed last week were implanted with Infuse without the LT-Cage, according to court papers. Some were subjected to a posterior surgical approach. Others had Infuse implanted in multiple levels of the spine, and some had it implanted in their cervical or thoracic spines.

The law does not prohibit such off-label uses, Black wrote. Plaintiffs did not provide enough details when it came to what was wrong with the device, and maintaining they had no access to such information did not entitle them to obtaining it through the lawsuits, he added. The court also found that the PMA covered both the bone-growth component and the cage, even when used separately.

"Several courts throughout the country have examined this exact issue and have held that 'the FDA established specific federal requirements for the Infuse Device, even when the Infuse Protein is used alone,'" Black wrote. He also said that Ohio state law did not supersede federal law, and that even if Medtronic reported adverse events related to Infuse to FDA, the agency is not required by law to make those public.

The judge also took the plaintiffs to task for essentially talking out of both sides of their collective mouth. They alternately argued that Durrani, acting as Medtronic's agent, had committed fraud because he knew of the risks of using Infuse and did not convey those risks to the patients. They also argued that Medtronic committed fraud because it did not tell Durrani of those risks, Black wrote. 

Cincinnati-based West Chester Hospital and its parent company, UC Health, agreed in October 2015 to pay $4.1 million to settle allegations that West Chester Hospital violated the False Claims Act by billing federal healthcare programs for costs associated with medically unnecessary spinal surgeries performed between 2009 and 2013 by Durrani.

The Star Tribune of Minneapolis reported in April that Medtronic failed to alert FDA to more than 1000 adverse events related to Infuse between 2006 and 2008. Medtronic has been mired with lawsuits and Senate probes over Infuse, whose use has been hotly debated among the medical and legal communities.

Company employees discovered the adverse events--including four deaths--in a retrospective chart review of Infuse, but shut down the study in spring 2008 without reporting them to FDA, the Star Tribune said. Most of those employees have since left the company, leaving current officials befuddled by the failure to report.

Nancy Crotti is a contributor to Qmed.

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[Image courtesy of Salvatore Vuono on FreeDigitalPhotos.net]