On behalf of Mike Clancy
The prior post in our Chicago, IL Personal Injury Law Firm Blog touched on the widespread issue of complications caused by vaginal mesh. It has become a prevalent problem that has garnered national attention, but it started with a simple off-label procedure that caught on before the risks were well-known.
The Food and Drug Administration does regulate medical devices that are sold within the United States. There is an approval process in place to regulate the devices that are sold as well as the uses that they can be marketed for. Off-label uses are one area that has less stringent standards, according to patient advocates.
An off-label use occurs when a medical device is used for a purpose other than the one that it was intended or marketed for. In order for a manufacturer to market an off-label use for profit, the device manufacturer must receive FDA approval. This approval requires that manufacturers prove that the device is only similar to one already on the market. This means that stringent testing isn’t necessary.
This limited approval only extends to manufacturers. Doctor’s are not under the same restrictions. According to Christy Foreman with the FDA’s Center for Devices and Radiological Health, it isn’t the FDA’s place to direct how doctors treat a patient. Thus, doctors are allowed to use medical devices for off-label purposes.
Although doctors have this freedom, it doesn’t mean that they are exempt from liability. It is the victim who pays for an off-label use that goes wrong, but these patients may have a claim against the doctor or the device manufacturer. A Chicago product liability attorney can help determine any possible claims for damages involving a medical device.
Source: Star Tribune, “Device use expands through adaptation, innovation,” Jim Spencer, Dec. 2, 2013
See original article:
Off-label medical device uses: innovation with a price tag II