The U.S. 9th Circuit Court of Appeals recently made several rulings regarding the medical device manufacturer Medtronic and their spinal fusion devices. The court upheld a lawsuit that accused the company of misleading the FDA in order to gain clearance for the devices, but dismissed claims that Medtronic falsely marketed the devices and unlawfully compensated hospitals and doctors for using them.
The whistleblower lawsuit that was upheld centers around the company’s Infuse bone graft devices, which were formally approved by the FDA for vertebral body replacement use. However, the plaintiffs (which include a former sales rep and 28 U.S. states) allege that Medtronic fraudulently obtained this clearance because they did not disclose that the devices were actually designed for use in the cervical spine, which would have required more testing and research for approval.
According to the suit, devices meant for cervical use pose an entirely different set of risks and safety concerns. If they would have disclosed this intended use from the start, the FDA would have required the company to undergo the Class III approval process, which is much more intensive than the Class II approval they were initially granted.
When asked for comment, a spokesperson from Medtronic said via email that the company agreed with the court’s decision to dismiss some of the claims against the company. With regard to the upheld suit, the spokesperson said that the company is “confident in the merits of our case and intend to defend ourselves vigorously against these baseless allegations.”
Metronic’s main defense against the suit was that the False Claims Act was not a valid basis for a claim regarding FDA fraud. However, the appellate court released a memorandum following their ruling in which they stated that “”These considerations — intended use, similarity to a predicate device, and different questions about safety — are precisely those that the FDA considers in granting Class II certification.”
In February, Medtronic’s executive board said on an earnings call that the company’s spinal and cranial division had posted a third-quarter revenue decline of 3.2 percent, and that the resurgence of COVID-19 and its variants had largely hindered the number of voluntary procedures performed over the winter months.
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