Unsafe medical devices can cause serious injuries and death. Defective devices can have a profound impact on patients and their families.
The United States Food and Drug Administration (FDA) handles medical device recalls. The way that a recall is handled depends on several factors, including the type of device and the kind of problem. In many cases, none of the options available will provide an easy solution for the patients who are stuck having to deal with the defective device.
Problems with devices
The problems that occur with medical devices vary greatly. Some devices can fail, which is often devastating if the device was implanted in a patient. Other devices might not work properly, which can be life-threatening if the device is used to test for a serious condition or correct a serious condition. A pacemaker that isn’t functioning properly is an example of a device that could have fatal implications.
Methods of addressing the issue vary
The type of defect affects how the recall is handled. In the case of implanted devices, the doctor might consult with the patient to let them know the risks and advantages of leaving the device in or having it replaced. If a potentially defective device is left in the patient, he or she will usually be monitored closely. Some devices might be pulled off of the market so that no new patients will use them. If the issue leading to the recall can be corrected, the correction might take the place of pulling the device completely off the market.
Three classes of recalls
There are three classes of recalls for defective medical devices. Class III is the least serious since it isn’t likely that the device will lead to injury or death. Class II recalls are a bit more serious since they can lead to conditions that are reversible or temporary. Class I recalls are the most serious because they are associated with a reasonable chance of death or injury.
Compensation for harm
It might be possible to seek compensation if you are harmed by a defective medical device. It is important to review the statute of limitations to determine if your claim is still within the time limit. You also need to determine who is liable for the harm. This could be the device manufacturer or the doctor, depending on the circumstances.
An experienced attorney can help you understand what your legal rights are and what options you have.