Drugs and Medical Device Recalls
The Food and Drug Administration and Medical Devices
The Food and Drug Administration (FDA) is responsible for reviewing and recalling medical devices along with food, drugs, and cosmetics. A "medical device" is any tool a doctor may use to treat a patient. Since there are such a wide variety of medical devices, the FDA divides them into three classes:
- Class I: Devices that are important to treatment and probably will not cause serious injury. These include things like surgical gloves and scalpels.
- Class II: Devices that are important to treatment and when used as directed will probably not cause serious injury to the patient. Class II devices include powered wheelchairs and surgical pumps.
- Class III: Devices that support or sustain human life, and for which general controls are not sufficient to assure safety. Examples of Class III devices include pacemakers and bone implants.
Medical Device Recalls
The FDA issues a recall when it learns that a medical device presents a danger to patient health. Sometimes the FDA learns about these defects through its own investigation, other times the medical device manufacturer will contact the FDA of its own accord.
Once the FDA recalls a device, it will work with the manufacturer to ensure that the device is taken off the market. If the defect is relatively minor, and has mild consequences, the FDA may choose to remove the devices from the market at the wholesale level only. Many consumers never find out about these kinds of recalls, although all medical device recalls are available on the FDA's website.
However, if the defect is more severe, the FDA may recall the device from retail stores or even from the patients' homes. This is a particular problem for patients with recalled devices already implanted in their bodies. In fact, many patients who had artificial hips, pacemakers, or trans-vaginal mesh implanted required additional treatment or surgeries to remove the defective devices.
What to Do if Your Medical Device is Recalled
If your medical device is subject to an FDA recall, you should consult with three different professionals as soon as possible.
- Your Doctor: Since the device you have will no longer work, you need to review your options. You may require additional surgery to replace the defective device.
- Your Health Insurance Company: Find out what is covered and what you will need to pay out of pocket.
- An attorney: You may be able to sue the medical device manufacturer if they were not careful enough in designing and creating the product.
Products liability for medical devices is a complicated field, and a lawsuit against a medical device manufacturer would involve the manufacturer, your consulting doctor, a surgeon, and the FDA. In addition, many patients have already filed class action lawsuits against these manufacturers for similar injuries.
A Final Note on FDA Approval for Medical Devices
In theory, every manufacturer must prove to the FDA that the device they wish to sell is safe and medically viable. This is known as the premarket approval (PMA) process. However, an alternative to PMA known as the 510(k) process is available for certain products, and subsequent legislation has made it easier for manufacturers to use this alternative, which does not require the same rigorous testing as PMA. This has raised some concern among doctors, patients, and economists who claim that the looser regulations allow medical device manufacturers to put unsafe devices on the market.
Congress, the FDA, and the Government Accountability Office are reviewing the process by which devices gain approval and considering new regulations. The solution they ultimately choose is likely to impact the rights of patients who have been, and will be, harmed by unsafe medical devices. Keep checking back here, or on the FDA's website, for updates.
Now that you understand how a medical device recall works, the next step is to understand whether or not you have an injury caused by a medical device and if you can or should pursue compensation for that injury. The first step is having your claim reviewed by an attorney experienced in the area of medical device and product liability litigation. When you fully understand your options, you can go back to focusing on what matters most: your health.