Doctors treated patients Tyler Simmonds and Laurie DeNeui with Infuse "off-label," in ways regulators hadn't approved. That's not illegal, so long as device makers don't actively promote such use. The patients' dramatically different outcomes illustrate two sides of the controversy over the product.
FOR
When Tyler Simmonds was 4 years old, surgeons removed a tumor in his brain. While technically a success, the procedure and other treatment left his spine severely compromised.
By his teens, he was so stooped over his ribs and hips permanently touched, according to his mom, Jeanette, of Rapid City, S.D. He was in pain, and the spine curvature compromised his breathing.
His parents agreed to a series of surgeries at Amplatz Children's Hospital in Minneapolis using Medtronic's Infuse "off-label."
"It's a hard thing," said Dr. David Polly, a surgeon at the University of Minnesota who treated Tyler, and a former Medtronic consultant. "If you had a child deteriorating and you were watching it, and the choice was to let him go, or do these things for which we don't have compelling data ... What would you do?"
For Jeanette Simmonds, there was only one choice. Doctors said Tyler, now 15, would suffocate within two to 10 years.
The surgeries were a success, and Tyler left the hospital a month ago. Now, his mom says, he wants to be a chef.
AGAINST
Laurie DeNeui is a sixth-grade schoolteacher who underwent neck surgery in 2005 after suffering from whiplash-related headaches.
Unbeknownst to DeNeui, her doctor used Infuse in her neck -- even though it is not approved for use in the cervical spine. In 2008, the Food and Drug Administration issued a warning that advised doctors against using Infuse in neck surgeries.
DeNeui, 46, of Rushmore, Minn., says if she had known the surgery was off-label she never would have consented to it.
After surgery, she found it hard to breathe, swallow and speak.
A raft of specialists, including those at the Mayo Clinic in Rochester, found that DeNeui had unusual swelling in her throat and that they couldn't help her.
"It feels like I have a jawbreaker in my throat," she says.
She sued her doctor and hospital in South Dakota but lost. Permanently disabled, DeNeui can no longer work.
"I'll never see the inside of a classroom again," she said. "I really hate Medtronic."
JANET MOORE
