What Is a Medical Device Recall and What Does that Mean for You?
Posted in Product Recall on August 9, 2021
Medical devices, such as pacemakers, hip implants, and monitoring machines, are subject to strict regulations and testing before being placed on the market. If a device is found to be defective after its release, the manufacturer or U.S. Food and Drug Administration (FDA) usually issues a recall for the product. However, a medical device recall can come too late for some patients, and the device can cause severe injuries and illnesses. In these situations, injured patients may have grounds for a lawsuit against the manufacturer of the defective device.
FDA Guidelines for Medical Device Recalls
When a medical device company realizes that there is something wrong with one of their products, it can issue a correction or removal action to remove it from the market and remedy the issue. A recall occurs when a manufacturer needs to correct or remove a medical device that violates FDA law. This may occur when a device has a serious defect and cause harm to a patient.
Types of actions that may be considered recalls include the following.
- Repairing a defective device
- Permanently destroying the device
- Relabeling the device
- Inspecting the device for potential issues
- Readjusting the device’s settings
- Notifying patients of a device issue
- Monitoring patients for potential health problems caused by the device
In most cases, a company voluntarily recalls a defective medical device on its own and takes the necessary steps to warn patients of the product’s dangers. The company will also need to contact the FDA and notify the agency of the issue. The FDA will then ask the company to provide a strategy to address the issue and monitors the recall to ensure that it is effective. In some cases, the FDA may force a company to recall a product if the device may lead to significant health problems or death and the manufacturer refuses to remove it.
What to Do If You’ve Been Injured by a Recalled Medical Device
If a medical device that you are using has been recalled and you suffered an injury due to the product’s defect, you may have grounds for legal action. Through a product liability lawsuit against the device’s manufacturer, you can recover compensation for the economic and non-economic losses you sustained due to your injury. These may include past and future medical expenses, lost wages, and physical and emotional pain and suffering.
To secure compensation in a Missouri product liability claim, you will need to gather enough evidence to establish four key facts.
- You were injured or suffered losses.
- The medical device is defective.
- The product’s defect caused your injuries.
- You were using the product as the manufacturer intended.
As soon as you realize that you have been injured by a recalled medical device, it is important to remain calm and find help. Seek medical attention as soon as possible and save all records related to your treatment, injuries, and replacement device, if applicable. Start a journal and record how the injury has impacted your financial, physical, and emotional well-being each day. After receiving treatment for your injury, contact a Kansas City product liability attorney as soon as possible.
A lawyer can provide several benefits to your case, including resources to conduct an investigation and access to expert witnesses who can testify on your behalf. Your attorney can also gather enough evidence to craft a compelling case for your right to compensation. Speak to a lawyer as soon as possible following your injury to discuss your claim and legal options.