FDA Warnings

When a company or product manufacturer violates federal regulations, then the FDA may share a warning so that consumers know about the situation. These FDA warnings are particularly important for medical devices due to the potential health complications that can result from the continued use of these devices. 


If an FDA warning letter is issued, then it means that the manufacturer has been found to be in significant violation of the applicable federal regulations. Not only does the company need to respond and manage the situation promptly, but consumers also need to be aware of the potential danger of continuing to use the medical device.

Our team at Wormington & Bollinger is here to help if you need to file a product liability claim or device injury lawsuit. We invite you to reach out at your convenience to learn more about the ways you can benefit from available legal services.

How FDA Warnings Help Patients with Informed
Decision Making

There are different reasons why a medical device manufacturer might be in violation and receive an FDA warning. Common violations include:

• Inappropriate product claims
• Improper maintenance of complaint files
• Flawed controls for testing and safety

If a company has a serious violation, then the FDA will issue a warning letter to consumers. These warnings provide detailed information about the violation, and also request an immediate response from the manufacturer to take corrective action. 


Often, the most common violations for FDA warnings are related to medical devices. The truth is that consumers need to be warned, especially if the continued use of these products could result in serious injury.

There are several ways that FDA warning letters can be used:

• Prior notice indicating that the FDA might be taking regulatory actions in the future
• Evidence used for proof in a civil lawsuit or a product liability lawsuit

If you or a loved one is currently using a medical device with an FDA warning, then it might be time to hire an FDA warning attorney for legal advice. You might have a strong enough case for a device injury lawsuit, helping you receive compensation for medical bills, lost wages, and pain and suffering.

Is it Time to Hire an FDA Warnings Attorney?

How do you know when it’s time to seek legal assistance if you’ve been affected by devices with FDA warnings? The most direct way to determine if you have grounds for a case is to talk to an attorney who has experience with other similar cases.

An experienced lawyer will be able to review the details and information relating to your situation and then offer advice on the best way to approach your device injury lawsuit. The way the case is developed will play a critical role in the potential outcome you can achieve with your product liability claim. 

There is no cost to have a consultation with an experienced attorney. In fact, victims of medical device issues don’t have to pay anything upfront if they decide to move forward with the case. Instead, our attorneys work on a contingency basis, which means that we are paid a percentage of the settlement that is achieved.

What questions do you have about FDA warning letters and faulty medical devices? Reach out to us at Wormington & Bollinger to learn more about your legal rights. We invite you to contact us at your convenience to schedule a consultation.

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