While the public is generally familiar with consumer product recalls, fewer people realize just how many medical device recalls occur every year in the US. Defective medical devices are responsible for thousands of injuries and deaths; however, that doesn't always mean that a defective medical device recall is openly publicized by the manufacturer or retailer. We here at the law offices of William C. Bibb have handled numerous defective medical device cases involving serious and even fatal injuries to patients.
The US Food and Drug Administration (FDA) is charged with monitoring the quality and safety of medical devices manufactured and sold in the United States. Consequently, it is also the duty of the FDA to establish and uphold regulations regarding recalls. According to the FDA, a medical device is recalled in instances where it is found to be defective and/or a health risk. It is explained that there are several different types of medical device recalls that can occur, and they do not all involve returning the product into question to the manufacture. Some recall procedures include but are not limited to:
- adjusting device settings
- contacting patients about device issues
- conducting device repairs
- evaluating patients for potential health problems
In cases involving implanted medical devices like pacemakers, physicians are often advised by device companies to alert their patients about the recall and discuss the potential pros and cons of leaving the device in place or removing it. There are also cases where a manufacturer or retailer will recall entire groups of products because they have not yet identified the exact medical devices that are defective.
The FDA notes that the agency does have the authority to require recalls when necessary; however, most defective medical device recalls are conducted voluntarily by manufacturers, distributors, and/or retailers. Learn more about some of the legal topics related to defective medical device injuries by visiting our website.