Cases involving allegedly dangerous or defective medical devices are particularly complex because they involve the patient, the healthcare providers or implanting physician, the medical device sales representative, and the manufacturer of the medical device in question. Additionally, nearly every medical device case includes an analysis of the safety and effectiveness of the device, as well as a close examination of the United States Food and Drug Administration (FDA) mandated 510(k) premarket clearance or premarket approval (PMA) process.
If a medical device is defective in design, manufacture, or warning and is determined to be the root cause of an injury to a patient or group of patients, those individuals will call the device manufacturers into question. It is critical to hire a firm experienced with these complicated issues. Our team at Hart McLaughlin & Eldridge has a long track-record of success navigating through the regulatory issues and delivering outstanding results for our clients.