DRUG OR DEVICE RECALLS

In the past decade, the public has been warned about the recall of numerous dangerous pharmaceutical drugs and defective medical devices. For many families affected by this, the warnings come too late. Frequently, a recall is only announced after many "adverse reactions" are reported.Guidant recently announced the recall of nearly 50,000 Guidant heart defibrillators that could short circuit without warning - failing to deliver the necessary shock to the heart.

The list goes on and questions continue and while some of the products have been subject to recall, others are under investigation.

In a product recall, a product is completely pulled off of the market. Recalls may be initiated by the manufacturer, by FDA request, or by FDA order under statutory authority. The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for ensuring the safety and effectiveness of all drugs and medical devices.

There are three levels of product recall. A Class I recall is announced when there is a reasonable probability that the use of or exposure to the recalled product will cause serious adverse health consequences or death. A Class II recall occurs where the use of or exposure to the recalled product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. A Class III recall is a situation in which use of or exposure to the recalled product is not likely to cause adverse health consequences.

A market withdrawal occurs when a product is implicated with a minor violation that would not be subject to FDA legal action. In that situation, the manufacturer removes the product from the market or corrects the violation.

If you or a family member have taken a medication that was subject to a recall, or have a medical device subject to a recall, it is critical to contact your health care provider to determine the steps you should take in protecting your health. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact us directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective drug and medical device cases and we welcome any questions you may have.