Drug & Medical Device Recalls
The U.S. Food and Drug Administration must approve medications and medical devices before companies can sell these products to the public.
But that does not mean all drugs and devices on the market are safe.
This page explains the FDA recall process and how to protect your right to compensation from the drug or device manufacturer if you have been injured.
Drug Recalls
When a drug is found to be defective, a recall can be issued in one of three ways:
- Voluntarily by the manufacturer of the defective drug;
- By the manufacturer at the request of the FDA; or
- By the manufacturer following legal action by the FDA.
The recall is then classified according to the severity of the risk the drug poses to users:
- Class I Recall – exposure to the defective drug has a reasonable probability of causing serious adverse health consequences or death.
- Class II Recall – exposure may cause temporary or reversible adverse health effects, or only carry a remote possibility of harm.
- Class III Recall – defects are detected, but exposure is not likely to cause any adverse health consequences.
If faced with a drug recall, patients should first consult their doctor to evaluate their healthcare options and choose a safe course of action.
Medical Device Recalls
Similar procedures are used to recall defective medical devices. In the case of devices, however, the situation can be more complicated for patients.
When a device is surgically implanted, the patient must weigh the risk of additional surgery to remove the device against the risk of leaving the product in place.
In less severe cases, a recall may require inspecting, repairing, or simply monitoring the device for any health concerns.
Are Patients Protected?
Still, not all defective drugs and devices are recalled. Many potentially dangerous medical products are sold for years putting thousands of patients at continued risk. And even when a defective drug or device is removed from the market, injured victims are not necessarily compensated as part of the recall process. In these cases drug injury lawyers are needed to represent victims of serious side effects and pursue damages through litigation.
Your Legal Rights are Separate from the Recall Process
It is important to know that your legal rights are distinct from the drug or medical device recall process. In fact most of our defective drug and device lawsuits involve products that have not been subject to any recall actions and are still widely used.
Regardless of whether a product has been recalled, the law allows drug injury attorneys to present evidence that a product is defective and that victims should be compensated for their injuries.
Drug recall lawyers can show that the product suffers from one or more legal defects:
- Manufacturing defect – the drug or device departs from its intended design and causes harm to users.
- Design defect – the design of the drug or device itself presents an unreasonable risk of harm to users.
- Failure to warn – the drug or device did not include adequate instructions and warnings for safe use.
A drug recall lawyer may also present evidence of a manufacturer’s negligence, fraud, and breach of warranties, among other claims.
Recover Your Full Legal Damages
Most importantly, drug recall attorneys can help victims recover the full range of their legal damages. This includes medical expenses, pain and suffering, time away from work, emotional distress, and other damages that may not be accounted for during a drug or device recall.
Start with a Free Case Review
To find out if you have a claim, contact our experienced defective drug lawyers online or by calling 866-808-2424 for a free and confidential review of your case.