Patients in West Virginia and across the U.S. benefit from medical devices, but the safety of these devices is not always guaranteed. There can be defects, and these fall under one of three categories: design, manufacturing, and marketing.
First of all, medical devices range from usually harmless Class I devices like elastic bandages to Class II devices like powered wheelchairs. Then there are the Class III devices, which are inherently risky: implanted pacemakers, defibrillators and breast implants, to name a few. With this distinction comes a difference in the level of FDA oversight. Those who are harmed by a medical device must take the class into account.
Design defects do not always harm patients. For example, an awkwardly located on/off switch on a defibrillator can be considered a defect. To link a defect to an injury, the courts will determine if the device is unreasonably dangerous for its intended or reasonably foreseeable uses.
Manufacturing defects arise at the manufacturing plant and may be the result of human error or poorly maintained machinery. They may form the basis for a claim if there was clearly an undue risk of harm. Marketing defects include incomplete product descriptions that lead to someone misusing the product or misunderstanding what it does.
Those who suffer a personal injury after using a medical device may file a product liability claim against the company that designed, made or marketed it. There are several steps to proving negligence, starting with the establishment of a duty of care and the argument that the defendant breached that duty. Victims may want to hire a lawyer to assist with the claim while they focus on their physical recovery. The lawyer may bring in investigators, expert witnesses and other third parties to strengthen the case.