Earlier today, we noted that the DOJ is looking into possible off-label marketing of a Medtronic device called Infuse. But while the law prohibits companies from pitching their wares for unapproved uses, doctors are free to use drugs and devices off-label if they think it’s in the patient’s interest.
To wit: The deposition of a South Dakota surgeon in the case of a patient patient who says she suffered serious complications when Infuse was implanted in her neck, a common use not approved by FDA.
“I can implant this pen inside someone’s brain, if I want, and the patient allows me to do it,” said Dr. Wilson Asfora, when asked about FDA regulations and how they impact the practice of medicine. “The FDA can’t stop me from doing that.”
Asfora did not operate on the patient who is suing. He was deposed because he once employed the surgeon who did operate. He did not return telephone calls to his office seeking comment.
This story brings up an interesting point. In reality, Dr. Asfora is absolutely right. There isn’t anything that the FDA can do to prevent him from implanting his pen in a patient’s head. His statement should make one consider the overall purpose of the lawsuit, however. The culture of surgical medicine is built to be aggressive, take leaps, and shed accountability. Anyone that has ever had a discussion with a surgeon will tell you that you can’t “tell” them anything. They are the experts. How, then, is this surgeon’s obvious carelessness regarding consequences of his actions the responsibility of the device company?