Once a medical device is on the market, doctors can use them for other, unapproved purposes. Given this running room, Medtronic allegedly touted to doctors the use of its Infuse Bone Graft for use in cervical spine surgeries. Three whistleblower suits have been filed by former Medronic employees asserting that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic has paid $40 million to settle two of the suits, and the third remains pending. It alleges that the doctors working with Medtronic received inflated royalty payments and inappropriate consulting fees. (We have previously reported on other odious industry practices, here and here.)
In July, the FDA sent out a warning letter to doctors warning of life-threatening complications when the device is used in the cervical spine. The complications arose from use of recombinant morphogenic proteins, which caused swelling of the neck and throat tissue and led to compression of the airway and the neurological structures of the neck. Patients suffered difficulties swallowing, breathing, or speaking, and required emergency medical care including intubation and tracheotomies.
If a surgeon were going to operate on your neck, would you want to know if a medical device manufacturer was paying him to use the product on you, money paid in addition to the surgical fees you are already paying?
If you can’t trust the folks wearing the white coats, who can you trust?
FDA Warning Letter, July 1, 2008
Wall Street Journal, September 4, 2008