Medical recalls are issued in response to serious injuries or death caused by a defective medical device or drug.

What is the role of the FDA in Medical Recalls?

The Federal Food and Drug Administration, or FDA, regulates almost every step of the process for development, manufacturing, testing and marketing of medical devices and drugs. The FDA examines and reviews research and case studies relative to such products and offers or denies approval for medical devices and drugs. The safety regulation of pharmaceutical products is extremely important due to the potential risk associated with unsafe products.

The FDA will often continue to perform case studies even after approving a drug for sale. These case studies help determine the safety and effectiveness of the product. If extended case studies reveal dangerous side effects or conditions which raise concern about a product’s safety, the FDA may issue a warning or instruct the pharmaceutical company to strengthen the warning in the package labeling and inform medical providers about the potential dangers.

The FDA will issue a medical recall or instruct the pharmaceutical company to issue a medical recall of a product or drug if the danger to the public is found to outweigh the benefits derived from its use. This drastic step is generally in response to studies reviewed by the FDA indicating severe adverse events related to the use of the product.When a medical recall is issued, use of the product should be discontinued and the product will be removed from shelves and no longer available to consumers.

Classes of Medical Recalls by the FDA

When a medical recall is issued, the FDA evaluates the risks of the defect and codes the recall as a class I, II, or III medical recall to express the level of danger the recalled product presents. Medical recalls are placed in these classes using the following criteria:

• Class I Recall - a product has potential to cause serious injury or death
• Class II Recall - a device is not likely to cause serious injury or death, but may cause permanent damage
• Class III Recall - a device does present a risk, but is unlikely to cause injury or death

If you or a loved one has been seriously injured by a device or drug that has been recalled, contact a medical recall attorney for a FREE case evaluation by completing the form at right (recommended) or by calling the offices of Arnold & Itkin LLP at (866)222-2606.