What is an FDA recall?
The Food and Drug Administration (FDA) is tasked with the important job of protecting public health by regulating drugs, medical devices, food, cosmetic products, and more. One of the key tools that the FDA has in its arsenal is to issue a product recall. But what does it really mean when the FDA recalls a product? Here’s what you should know about recalls and the recall process—including the different kinds of recalls. We go over how recalls may affect dangerous drug lawsuits and how you can get legal help if you have been hurt by a medication.
Classes of FDA Recall
When the FDA receives evidence that a drug may not be safe for use, it may issue a recall to stop the sales and distribution of a drug. There are three classes of FDA recalls, in increasing order of severity:
- Class III recall. This is the lowest category of recall and indicates that, while the FDA has found a compelling reason to stop a drug from being sold, serious harm is less likely to result from contact or exposure to the drug.
- Class II recall. This type of recall means that the FDA has determined there is a likely risk of temporary health complications, or that there are chances for more serious health complications.
- Class I recall. Drugs under a class I recall are those that have been found to pose severe health problems or could cause death if used.
It is important to note that just because a drug is under the “lowest” recall warning—class III recall—it does not mean that it is not dangerous. For example, in 2008 certain transdermal fentanyl patches (fentanyl is a powerful synthetic opioid pain reliever) were under a class III recall because the patches could potentially leak fentanyl-infused gel. Anyone who came in contact with the leaked gel was at risk of dangerous health complications, including a potentially fatal overdose.
There are several ways that a recall of any class can begin. Sometimes, manufacturers will decide to recall a drug voluntarily. Companies that do so must report the recall to the FDA and submit progress reports until the recall is successful. The FDA may also request that a manufacturer recall a drug on a voluntary basis if it receives enough evidence to warrant a recall. If the company refuses, the FDA may legally attempt to order the company to issue a recall through the courts, and in rare cases, the FDA may seek legal approval to seize the drug directly.
How Drug Recalls Affect Your Lawsuit
While an FDA recall of any class may indicate that there is evidence that a drug may cause harm, a recall is not actually necessary for you to succeed in a lawsuit against a manufacturer. For example, if you have been hurt by an undisclosed side effect, or the company failed to warn doctors and consumers about a potential health complication and you have been hurt as a result, you may have grounds for a lawsuit—even if there is no recall or a recall is still pending.
However, the fact that a drug has been recalled doesn’t mean that there are always grounds to file a lawsuit, either. Not every poor medical outcome is the result of manufacturer negligence, even if a drug is under recall.
Get Legal Help Today
Regardless of drug recall status, the question of whether you have a legal case may best be answered by a personal injury attorney with experience handling dangerous drug lawsuits. By seeking the help of a dangerous drug lawyer who has the industry knowledge and legal skills to examine the facts in your case and advise you of your legal options, you will have the best chance at financial recovery for your injuries.
Wayne Wright LLP has been representing those who have been injured by dangerous drugs and defective medical device for decades, and we would like to help you begin the financial recovery process today. To speak to a legal professional about your case, call us today, use our contact form to send an email, or click the live chat box on this page right now.
What is an FDA recall?
Classes of FDA Recall
When the FDA receives evidence that a drug may not be safe for use, it may issue a recall to stop the sales and distribution of a drug. There are three classes of FDA recalls, in increasing order of severity:
- Class III recall. This is the lowest category of recall and indicates that, while the FDA has found a compelling reason to stop a drug from being sold, serious harm is less likely to result from contact or exposure to the drug.
- Class II recall. This type of recall means that the FDA has determined there is a likely risk of temporary health complications, or that there are chances for more serious health complications.
- Class I recall. Drugs under a class I recall are those that have been found to pose severe health problems or could cause death if used.
It is important to note that just because a drug is under the “lowest” recall warning—class III recall—it does not mean that it is not dangerous. For example, in 2008 certain transdermal fentanyl patches (fentanyl is a powerful synthetic opioid pain reliever) were under a class III recall because the patches could potentially leak fentanyl-infused gel. Anyone who came in contact with the leaked gel was at risk of dangerous health complications, including a potentially fatal overdose.
There are several ways that a recall of any class can begin. Sometimes, manufacturers will decide to recall a drug voluntarily. Companies that do so must report the recall to the FDA and submit progress reports until the recall is successful. The FDA may also request that a manufacturer recall a drug on a voluntary basis if it receives enough evidence to warrant a recall. If the company refuses, the FDA may legally attempt to order the company to issue a recall through the courts, and in rare cases, the FDA may seek legal approval to seize the drug directly.
How Drug Recalls Affect Your Lawsuit
While an FDA recall of any class may indicate that there is evidence that a drug may cause harm, a recall is not actually necessary for you to succeed in a lawsuit against a manufacturer. For example, if you have been hurt by an undisclosed side effect, or the company failed to warn doctors and consumers about a potential health complication and you have been hurt as a result, you may have grounds for a lawsuit—even if there is no recall or a recall is still pending.
However, the fact that a drug has been recalled doesn’t mean that there are always grounds to file a lawsuit, either. Not every poor medical outcome is the result of manufacturer negligence, even if a drug is under recall.
Get Legal Help Today
Regardless of drug recall status, the question of whether you have a legal case may best be answered by a personal injury attorney with experience handling dangerous drug lawsuits. By seeking the help of a dangerous drug lawyer who has the industry knowledge and legal skills to examine the facts in your case and advise you of your legal options, you will have the best chance at financial recovery for your injuries.
Wayne Wright LLP has been representing those who have been injured by dangerous drugs and defective medical device for decades, and we would like to help you begin the financial recovery process today. To speak to a legal professional about your case, call us today, use our contact form to send an email, or click the live chat box on this page right now.