Countless people in the United States rely on medical devices daily to help them live happily and comfortably. It is no wonder, then, that defects in these devices can have far-reaching and unfortunate consequences. Discomfort, injury, and even death can result when a medical device on which people rely is designed or manufactured improperly, yet sometimes manufacturers may skip important testing to hustle products onto the market. Such behavior is reckless and disregards the manufacturers’ collective duty to ensure the safety of their products.
Devices such as hip and knee implants, permanent birth control devices, transvaginal mesh, power morcellators, or blood glucose monitors have been defectively manufactured or designed in the past, resulting in harm to those who relied on those devices to live.
The Food and Drug Administration (FDA) states that it receives several hundred thousand reports of deaths, injuries, and malfunctions each year that are suspected to be associated with defective medical devices. Further, it reports that the annual number of medical device recalls increased by 97 percent (almost doubled) between 2003 and 2012. The FDA attributes this increase to enhanced awareness by firms that produce the devices (including those that have been cited for violations of reporting requirements) as well as efforts by the FDA’s Center for Disease and Radiological health to improve device safety.
Legal Rights of Those Harmed
If an entity manufactures, distributes, or sells a medical device, and a defect in the device is a substantial factor in causing harm to a person, that entity can be held liable for damages caused by the device. Such harm is not uncommon and much work needs to be done to ensure that injured users of medical devices are compensated for their injuries. If you or someone you know has been harmed by an improperly designed medical device, please contact our office so we can work toward recovery.