Medical Device Whistleblower Suit Linked to “Devastating” Injuries Case
A medical device manufacturer that has faced whistleblower suits in the past has yet another one on its hands. The whistleblower bringing the qui tam case alleges that false claims were submitted by the company to Medicare, Medicaid, and other government health care programs resulting from unapproved, off-label usages of their bone-growth implants.
Medtronic is one of the world’s largest medical device companies, making surgical products such as the INFUSE Bone Graft, which is used in combination with their VERTE-STACK Spinal System. According to the FDA, this combination of surgical implants is approved for use in the thoracic (middle) and lumbar (lower) spine. The implants are meant for people who suffer from damaged vertebrae due to tumors or trauma located in these areas of the spine. However, the device has never been approved for use in the cervical spine, meaning the neck, and therein lies the beginning of the story.
A Hollywood screenwriter had the Medtronic device implanted in his neck in 2009 to relieve pain and numbness in his hands. He then developed horrible problems resulting from the implant, including extreme pain and weakness in his hands, arms, and neck. His injuries were characterized as “devastating” to his life. The screenwriter settled the case in July of 2016 with the University of California, the parent of the UCLA Medical Center where the surgery was done, for $4.2 million, and with Medtronic for an undisclosed amount. Neither party has admitted any wrongdoing.
At least 6,000 people are or have been involved in suits against Medtronic for INFUSE-related injuries.
One of the charges which has been brought is that Medtronic knowingly marketed the medical device for unapproved usages in the cervical spine. Medtronic paid out $68 million in INFUSE-related litigation during the fiscal years of 2015 and 2016 alone.
Now we have a whistleblower alleging that the deliberate marketing of the device for unapproved uses to government health care programs has resulted in false claims running into the hundreds of millions of dollars paid to Medtronic. Normally, medical devices are less tightly regulated by the FDA once they are cleared for use. But this case appears to involve a blatant disregard for the off-label usage ban.
A Boston health care think-tank doctor has been following the case. Dr. Vikas Saini, president of the Lown Institute, commented, “[The devices] were labeled, ‘not for cervical spine use,’ and yet in everything about them, including emails from their marketing folks, it makes clear that they were meant to be and were used in the cervical spine.”
The whistleblower’s name is currently listed only as the “Dan Abrams Co., LLC.” At least one source has speculated that the plaintiffs are actually present and/or former Medtronic employees.
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