Product liability occurs when a consumer good presents an unreasonable danger to the public. However, such liability can raise weightier concerns when the product is a medical device.
Recent reports note a rise in serious medical device recall events. This fact draws increased attention to how the U.S. Food and Drug Administration and device manufacturers handle and classify these situations.
The three different classes of recalls
A recall occurs when a manufacturer attempts to fix a device that violates FDA safety laws. The manufacturer can remove the device from the market or leave the device on the market while taking corrective action to repair the issue.
A Class I recall refers to a medical device that could cause severe injury or death to a user. Because of the danger, companies more often remove the product from the marketplace and alert consumers.
Class II recalls are for devices that can cause serious injury or temporary illness, but death is unlikely. Devices under Class III recalls violate safety regulations but are unlikely to result in illness or injury.
The recall process
The FDA oversees the sale of medical devices and monitors their safety. However, unlike pharmaceuticals, manufacturers might not have to submit clinical trial data prior to device approval. A company may not learn about problems until consumers file complaints.
Companies usually recall a device voluntarily and must notify the FDA after doing so. The agency assigns the class after the recall, which may happen months later.
The FDA has a Medical Device Recall Database to alert the public. Since the agency usually does not discover recalls until a manufacturer notifies them, consumers must monitor their own devices to catch early dangers.