When a person undergoes a medical procedure involving the use of a medical device, they trust it is safe and effective. Unfortunately, this is not always the case. When it becomes clear that a medical device is causing unexpected harm to patients, a medical device manufacturer must take measures to address such serious problems. One such method is a Medical Device Recall.
A medical device manufacturer, not the Food and Drug Administration, is responsible for the safety of the medical devices it makes. Accordingly, when a medical device is found to pose a risk to health, to be defective, or both, the manufacturer of the device may voluntarily recall that device to avoid further harm to consumers. If a manufacturer neglects its obligations and refuses to recall a device voluntarily, the FDA can require it to do so.
Medical device recalls are extremely important because they notify consumers and medical providers that a potential issue exists. A recall may also provide instructions, such as:
- Stop using the device
- Destroy the device
- Check the device — collect and inspect for defects
- Adjust the device — such as change a setting
- Repair the device — fix a problem
- Use the device only in particular circumstances
If a device has been implanted into a patient — such as a pacemaker, artificial hip or knee — the recall might require that the patient be monitored closely, or that the patient and medical provider discuss removing and replacing the device.
If a consumer suffers harm caused by a defective medical device, the manufacturer of the device may be legally responsible for damage to the health and well-being of the consumer. For example, financial compensation can be given to injured patients for lost wages, medical bills, and pain and suffering caused by the defective device.
In the unfortunate case that a person dies as the result of a defective medical device, the surviving family of the victim may be able to file a wrongful death claim against the manufacturer of the medical device.
If you have suffered painful or life-threatening side effects from a pharmaceutical drug or medical device, we can help. We have a wide range of experience with these cases. We know what legal strategies can help you recover maximum compensation for your injuries. We build strong cases and are ready to fight them in court. Large drug and medical device companies often have a nearly unlimited amount of funds at their disposal for their defense. We have the resources to stay the course and fight for you. To find out how you can benefit from the services of our highly experienced Lexington, Orangeburg, and Columbia dangerous drugs and devices attorney, call Lee Injury Law for a free legal consultation at 803-500-0000.