While it’s virtually impossible for drug manufacturers to ensure that the medications they make available are fully safe for every individual, pharmaceutical companies do have a responsibility to the public to ensure that their products are reasonably safe. They also have to make sure the information that’s available about their drugs is completely accurate.
The United States Food and Drug Administration (FDA) oversees the release of medications and medical devices onto the market. The FDA can issue warnings and take other actions. Pharmaceutical companies often make voluntary recalls of their dangerous or defective products. There are instances, though, in which the FDA may step in and issue a recall instead.
What are the classifications of recalls?
There are three classes of recalls, according to the FDA.
- Class I: These are serious recalls that can result in a patient’s significant health problems or death.
- Class II: The FDA perceives these defects or dangers to be moderately serious. They believe that they have a slight chance of serious problems.
- Class III: These are minor issues such as label or manufacturing violations that are unlikely to cause patients problems.
Consumers harmed by defective or dangerous drugs may experience lifelong complications from taking them. These adverse side effects can be costly to treat. They may result in a patient’s unnecessary pain and suffering, a decline in their quality of life and missed work. It’s not uncommon for individuals who experience these issues to wonder if they have a legal claim.
You must show that the medication wasn’t prepared or appropriately labeled to have a valid pharmaceutical liability claim. You may be able to file such a claim if you can prove that manufacturers didn’t fully warn medical professionals about the dangers associated with your medication as well. Your attorney can help you assess whether you have a valid claim in your case.