September 4, 2008
"Infuse Bone Graft" Linked to Life-Threatening Complications
The FDA has received 38 reports that Medtronic Inc.'s "Infuse Bone Graft," typically used to encourage bone growth in spinal surgeries, causes neck and throat swelling--life threatening injuries. The Wall Street Journal has a lengthy article by David Armstrong and Thomas Burton on the topic and the related lawsuits. Here's an excerpt:
Doctors with financial relationships with Medtronic have written favorably about off-label uses of Infuse on Web sites, in medical journals and at educational meetings. Some of the most influential spine surgeons in the country are consultants to the company. Several of them benefit from sales of the product through royalty deals, according to disclosures they have made in professional journals and at medical meetings.
Three "whistleblower" lawsuits brought by former employees have alleged illegal marketing, seeking refunds for the federal government on Medicare and Medicaid payments to the company. The former employees, who share in any recovery under federal law, asserted in the suits that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, which were filed in federal district court in Memphis, Tenn., without admitting wrongdoing. One of the whistleblowers has challenged the company's agreement with the federal government, saying the sum is too small.
The lawsuit that hasn't been settled was filed last year in federal district court in Boston by two former Medtronic employees. It alleges that the company illegally marketed Infuse for off-label purposes through doctors who were paid inflated consulting fees and bogus royalty payments. Marketing off-label uses is not allowed under FDA regulations.
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