Are you the victim of a poorly designed medical device? While the Food and Drugs Administration would have you believe that all medical devices approved by the administration is relatively safe, the fact is that a single defect in such an item is capable of changing the patient’s life forever. In the worst case scenarios, the insertion of a defective medical device can further exacerbate a patient’s condition, with some situations even leading to death.
By definition, a medical device is any product engineered to help treat or detect an illness or health-related abnormality. A well made medical device can significantly improve the chances of treating a patient and vice versa.
A medical device is deemed fit for public use when it has been approved by a division of the Food and Drugs Administration known as the Center for Devices and Radiological Health (CDRH). This division conducts tests and studies on prototypes of medical devices for years before releasing the product to the public. According to the CDRH, a medical device should not only be effective in treating or detecting an ailment, but should also be safe for long term use.
Occasionally, a defect in a medical device may tragically escape the scrutiny of the CDRH division. In cases like these, the problem will not be hidden for long especially when widespread use of the defective device results in plenty of suffering and death of patients. In situations like these, the FDA can either issue a mandatory product recall or the manufacturer of said product may also opt to voluntarily recall the offending medical devices.
One example of a medical device that was released to the public without complete testing is metal on metal hip replacement devices. Although the devices are considered high risk, they received a 510(k) clearance to bypass clinical trials, ultimately meaning that they were not tested adequately before being used on patients.
Despite warning labels and limited testing, the bottom line is that manufacturers of medical devices are responsible for any injury or death caused by each and every product released into the market. For the sake of the patients, regulations are already set in place where all medical device manufacturers must ensure that all products released must pass safety and efficacy testing, failing which said manufacturer is undoubtedly liable.
Bruce Hagen is an attorney who specializes in injuries caused by defective medical devices – especially hip replacement injury cases. If you or a loved one is currently suffering from a serious injury or fatality as a result of a dangerous medical device, contact us as soon as possible and have an experienced attorney explain your legal rights and the actions that can be taken to compensate you for your injuries.