How does the FDA’s recall process affect injured victims?

On Behalf of | Mar 28, 2022 | Defective Medical Device Litigation |

The federal Food and Drug Administration oversees recalls of both pharmaceutical drugs and medical devices. Both go through a rigorous process of review and approval.

However, even with this process, sometimes drugs and medical devices still get out on the market and injure or sicken innocent patients. In other cases, there is something technically wrong with the product which makes it unlawful to keep it on the market as is.

Recalls are usually voluntary. Manufacturers have an obligation to pull products which they believe violate the FDA’s standards from the shelves. In some cases, the FDA may ask a manufacturer to perform a recall, but in most cases the manufacturer announces its intention to the FDA.

If a manufacturer chooses not to cooperate, then the FDA has the option to order a manufacturer to recall a product.

The process of recalling products in order to correct a health or safety issue or just to keep them out of the hands of innocent consumer is detailed and will depend a lot on the circumstances.

Not all recalls are created equal

It is important for injured victims to remember that not every FDA recall means that someone has actually gotten ill or injured because of a drug or medical device.

Sometimes, items get recalled simply because they violate FDA standards. However, there is little to no risk of someone actually having a health problem because of a defective product.

In other cases, the FDA determines that while a product poses some risks to health, the chances of a serious and permanent injury are slim.

On a related point, it is important to distinguish a recall from a voluntary market withdrawal. A manufacturer may withdraw a product from the market, but that does not mean that the product violated FDA standards.

In general, information from recalls can be helpful to victims of defective drugs or medical devices. However, a recall cannot by itself prove that a product caused a person’s injury. Likewise, a product that is still on the market and not under recall may well be dangerous.

Either way, recalls alone are not means for victims to get compensation for the injuries. They would have to file an appropriate civil lawsuit in court.