What is a Drug or Medical Device Recall?

A recall of a dangerous drug (usually a prescription medication) or a medical device (typically used in surgery) happens when side effects occur that cause serious health problems, and even death, in patients who took a drug or had a medical device used on them. If the company, or doctor, was negligent in prescribing the drug or designing the device, they can be held liable if their product later harms someone. A recall occurs, either voluntarily or involuntarily, when numerous victims are impacted negatively by the product, and it has to be either removed from the market, or its potential side effects need to be made known to potential users so they can evaluate the risks. Victims are often entitled to compensation for their injuries or suffering when products are recalled.



What is a Bad Drug Recall?

Drug recalls are usually mandated by the FDA, when long-term side effects of using certain medications are discovered after users have been taking them for some time. Heart attacks and birth defects are often the primary cause of the drug recall lawsuits that are the subject of class actions, but individual harm to a smaller group of users can still trigger legal liability for a variety of unforeseen health problems. In some cases, the makers of these drugs are aware of the risks of side effects, but do not provide the information necessary for people to determine if the drug side effects should prevent them from taking it.



What is a Medical Device Recall?

Medical Devices cover a broad range of equipment, instruments, and implants used by health care providers aimed to improve patients' health and treatment outcomes. The Food and Drug Administration, or more commonly known as the FDA, determines if a medical device is safe to be used on patients. The FDA determines the safety of a device based the information provided by the device manufacturer and their own investigation. Even after the FDA has approved a medical device, however, the device can be found defective causing serious pain, injury, and sometimes even death. The manufacturer of the device is responsible to ensure the safety of the device and required to report any defects or potential risks, even ones that occur long after the device is released. The device will be pulled out of the market and the FDA will then regulate the device recall. In some cases, medical device makers will issue a voluntary recall upon learning of risks from the use of their device.



Does this Happen Often?

Though virtually thousands of Medical Devices are approved each year through the FDA process, there are a considerable number of recalls each year as well. In 2013 alone, 63 devices were recalled by the FDA because there was a serious risk of injury or death. It has been noted that the number of device recalls has been on the rise in the last few years, either from the companies that released them or from regulatory agencies like the FDA. Consumer watchdog groups and attorneys are also responsible for bringing the dangers of medical devices and drugs to view. Many of the side effects of these devices are not fully known until many victims have been injured and seek medical attention for their injuries.



What Should You Do if Harmed by a Medical Device or Dangerous Drug?

Know that you have rights to protect yourself from dangerous drugs and defective medical devices. If you have suffered an injury or are experiencing abnormal side effects from a medical device or a prescription drug, you should first contact your physician immediately. You should find out if any type of recall or FDA warning has been issued. In many cases, you may be able to receive compensation for your suffering and medical bills. Device manufacturers are responsible for the liability whether or not the product has been recalled. Contact a product liability attorney or class action lawyer that specializes in these cases to see if you may be entitled to compensation.