Overview of how the FDA classifies recalls

| Aug 15, 2019 | Medical Product Liability

Previous posts here have discussed how the United States Food and Drug Administration regulates both medications and medical devices that are on the American market. While the FDA ideally weeds out dangerous products during its approval process, the process does not, and really cannot, stop all unsafe drugs and other medical devices from hitting the shelves. As a result, like other agencies committed to the safety of consumer products, the FDA from time to time issues recalls or, more properly speaking, persuades a manufacturer to voluntarily recall a product.

The best advice to someone who has a recalled drug or device is to follow the manufacturer’s instructions. However, it is important for patients in Northern Georgia to pay careful attention to how the FDA classifies its recalls. This information may be helpful to an injured patient when deciding whether to file a medical product liability case down the road.

The most serious classification of recall is Class I, which indicates that the recalled product has a serious enough safety defect that it could cause a patient to die or suffer a major and permanent injury. A Class II recall indicates that the product may sicken a person, albeit temporarily, or cause a significant injury. The least serious type of recall, Class III, simply indicates that a drug runs afoul of technical regulations, but there is no reason to believe it is actually harmful to patients.

Some devices and drugs do receive Class I status, even in this age when modern manufacturing processes can greatly improve the safety of medicine overall. Particularly if it involves a product subject to a Class I recall, someone who feels he or she was injured due to a defective medical product may have legal options.