Medical device makers aren�t allowed to market their products for uses that haven�t been approved by the FDA. But that doesn�t stop doctors from doing what they want with the stuff and telling their colleagues all about it.
Seems some spine surgeons with financial ties to Medtronic have touted the company�s Infuse Bone Graft (pictured) for use in surgeries of the cervical spine � a part of the spine for which the device, which prompts the growth of bone, has not been approved.
In July, the FDA sent out a letter to doctors warning of reports of �life threatening complications� when the device is used in the cervical spine.
The story lands on the front page of this morning�s WSJ.
Medtronic says it has been active in warning doctors of certain problems related to use of Infuse, which spurs bone growth. And the company points out that the rate of complications is low and, reports to the FDA of problems represent one-tenth of 1% of the units sold.
Three so-called whistleblower lawsuits filed by former Medtronic employees who allege that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic paid $40 million to settle two of the suits, and did not admit wrongdoing. A third suit is still pending, and alleges that doctors were paid inflated royalty payments and inappropriate consulting fees.
Medtronic says all payments to doctors are �fully compliant with the law,� and that the company has �rigorous processes� to ensure that all physician compensation is fair and at market value.
The complaint in the pending suit is online here; a response from the doctors named as defendants is here.
Photo via Medtronic
More info
