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Clark Love & Hutson

The Nationally Recognized Plaintiffs Litigation
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The Nationally Recognized Plaintiffs Litigation Law Firm

How are defective drugs classified?

On Behalf of | May 12, 2023 | Dangerous Drug Litigation, Defective Product Litigation |

When you hear that a drug you are taking is being recalled, you may necessarily feel concerned and scared about the potential harm. You have a right to expect that the drugs you are prescribed to be safe.

When a drug company learns of a defect with one of its products, it can voluntarily recall the drug from the market. If it does not voluntarily recall the drug, the Food and Drug Administration (FDA) can request that it recall the drug.

Three classes of recalls

When the drug is recalled, the FDA classifies the recall and continues to monitor the situation. There are three different classes of recall. Drugs are classified based on the likelihood of a serious injury or death occurring because of the defect.

A drug receives a class I recall when it is determined that the drug could cause serious health problems or death, while a drug that receives a class II recall means it could cause a temporary health problem or there is a slight chance of a serious health problem.

A class III recall is reserved for drugs that violate FDA manufacturing or label laws but are unlikely to cause any major health problems.

Recalls are not always announced

You may be surprised to know that a drug you are taking could have been recalled without you knowing. The FDA typically only announces defective drug recalls when the drug is likely to cause a serious health problem, or it is a drug that many people are taking.

If you do find out that you are taking a defective drug and are harmed by it, you could receive compensation through a product liability lawsuit. Potential forms of compensation include medical expenses, wage loss and pain and suffering.

The complexities of litigation

Preparing to sue can be challenging, because you must figure out which party is most directly responsible for your harm. It could be the drug manufacturer, your primary care doctor or another appropriate party.

Although you may face challenges like this, defective drugs can cause you serious harm and the legal system gives you an avenue to pursue compensation for this harm.