Navigating Medical Device Product Liability in Obstetrics and Gynecology

Medical devices are an essential component of the practice of obstetrics and gynecology. These devices may, at times, suffer from a defect or failure, which could result in a product liability lawsuit when associated with patient harm. Medical device product liability lawsuits are directed toward the device manufacturer when a patient suffers harm because of a device. Device manufacturers may, however, attempt to focus liability on the health care professional, pointing litigation toward a medical malpractice claim. Health care professionals may face direct liability for a patient's injury when using a device off-label, by failing to follow previously issued device warnings, or by serving as a paid consultant or advocate of a defective device. With an increasing number of devices receiving U.S. Food and Drug Administration approval annually, defects in, failures of, and recalls of these devices will invariably occur. Although litigation for a patient's injury caused by a medical device is generally directed toward the manufacturer, health care professionals should be familiar with potential liability risks in their practice.