A drug recall may be administered by the Food and Drug Administration (FDA) when an unsafe medication or drug reaches the public consumer market. Unsafe drug recalls require a drug manufacturer to stop distributing the drug and to remove the product from the market.
A drug recall involves a notice that advises the public that a certain product is dangerous. The manufacturer can issues these notifications in several different ways, including:
- Through the news; and
- In federal government publications.
The FDA monitors mostly drug safety. Specifically, the FDA has a branch called the Center for Drug Evaluation and Research (CDER).
The CDER analyzes drug products in order to evaluate the safety, grade, and effectiveness of a product. Although it does not actually test the drugs, the CDER does interact with the drug manufacturing companies in order to ensure that medications and other medical products are safe for use by the general public.
What Should I Do if I Have a Recalled Product?
Although most individuals try to be mindful consumers, anyone can purchase a product that is later recalled. If an individual discovers that one of their products is subject to an FDA recall, they should not panic.
It may be possible that the product only poses a threat to pregnant women, to immunocompromised patients or to another limited group of the population. If a recall involves a drug, it is important for an individual to consult with their physician to resolve whether or not they should keep taking the medication or if they will require a new prescription.
If, after an individual analyzes the situation, they believe the product may pose a threat to them, they should stop ingesting it. If the product is not perishable, such as cosmetics or pills, an individual may want to keep the product secure, away from children, and away from other drugs or cosmetics.
It may be helpful to keep the item in case it serves as evidence in a later lawsuit. If, however, a product is perishable, such as greens or meats, an individual may want to throw it away after they save the receipt and any appropriate labels.
It is important for an individual to inform their physician of any health problems that result from the recalled product as soon as possible. Once the individual is healed, they may be able to sue the product manufacturer for damages.
The FDA recall list can be found on their website. The laws governing these issues are very complex and an individual will likely need the assistance of a drug recalls lawyer.
What Does the Process for Drug Recalls by the FDA Involve?
An FDA recall begins when an FDA employee determines that a product that it regulates may be a threat to public health. The FDA can determine the danger of a product in many ways, including:
- The producing company finds a defect in their product and contacts the FDA;
- The FDA obtains reports of health problems that stem from a certain product;
- The Centers for Disease Control (CDC) detects a trending health problem related to an FDA-regulated product; or
- FDA employees inspect the factory and determine whether there is a likelihood that issues will arise.
Once the FDA determines that a recall will be needed, it will operate with the manufacturer to confirm that the product is pulled from clinics, physicians’ offices, and shops. In many cases, this occurs without the public knowing.
The FDA will only involve the media in situations where the potential damage the product may cause is serious. There is always information about FDA recalls on their website.
What Types of Products are Monitored by the FDA?
Generally, the FDA observes numerous types of products for the need for different types of drug recalls. Drug recalls examples may include:
- Prescription and non-prescription drugs or medicines;
- Medical devices, especially radiological products and devices that emit radiation; and
Typically, the FDA must approve these types of products before they may be distributed to the public. It is important to note that, just because the FDA has approved a product, it does not mean that the product is always 100% safe.
For example, even if a product is safe, it may become dangerous because of other factors, such as a lack of clear instructions or warnings. In addition, FDA-approved products may also become unsafe over time or when used in conjunction with another product.
What Are the FDA Recall Classifications?
The FDA has three drug recalls classes, including:
- Class I: Recalls for products that may cause severe injury or death;
- Class II: Recalls for products that might cause severe injury or temporary illness; and
- Class III: Recalls for products that are not likely to cause injury or illness but violate FDA regulations.
What Items are Commonly Subject to FDA Recalls?
FDA recalls are commonly issued for products that present an immediate danger to the public, which may include, but is not limited to:
- Dangerous foods;
- Unsafe drugs; and
- Other similar products.
The FDA may also issue recalls for non-food or drug items, which may include:
What if I Have Been Injured From a Defective Drug?
If an individual has suffered damages from a defective drug, they may have several options to recover for their injuries and economic losses, including:
- Filing a private civil lawsuit against the company: This will require written proof of an individual’s injuries and economic losses, such as hospital bills, medical costs, lost wages, etc.;
- These claims may also involve a complicated interaction of several legal theories, including:
- If the drug has injured many individuals, it might also be possible to initiate a class action lawsuit for defective products; and
- Initiating a drug recall with the FDA: Registering a drug defect with the FDA usually involves filling out Reporting Form 3500;
- The reporting requirements and necessary forms may vary according to whether the report is being filed by:
- an individual consumer;
- a medical professional; or
- a healthcare organization.
An individual should be aware that the timing of an injury may occasionally restrict the amount of recovery that is available to them. For example, if an individual’s injuries occurred after the public recall was already issued, it may be argued that the individual assumed the risk by continuing to use the product even after it was recalled.
On the other hand, an individual may be able to recover for their losses if the recall notice from the company was published in a manner that was indistinct or challenging for the general public to access.
Do I Need a Lawyer for Drug Recalls?
If you have suffered injury from a recalled drug or if you have any questions or concerns about a drug recall, it is important to consult with a defective products lawyer. Your lawyer can assist you with obtaining legal recovery for your injuries or losses that are connected to an unsafe drug or a drug recall.
The laws that govern drug recalls may vary by state. In addition, FDA recalls are subject to change and are frequently updated.
Your attorney will review your situation, research the applicable laws, and determine what legal remedies may apply to your case. If you have to file a lawsuit or a class action lawsuit, your attorney will represent you throughout the legal process.