Although new innovations in medicine seem to be a daily occurrence, the path to progress is not always without setbacks. In fact, the U.S. Food and Drug Administration's website contains a site called MedWatch where consumers can submit an online report of adverse reactions or potential problems with medical products. The website contains features such as safety alerts and educational resources.
Medical providers also have a duty to report potentially defective or dangerous medical products to the FDA. In fact, federal rules require hospitals to report serious injuries caused by potentially defective medical devices to both the manufacturer and the FDA within 10 days of the incident. Unfortunately, a recent inspection report prepared by FDA officials suggests that many hospitals are failing to follow those reporting rules.
When suggesting medical procedures or devices to a patient, a doctor must provide complete information. Without knowledge of both the potential benefits and risks from a procedure, a patient cannot give his or her informed consent. It also follows that doctors are expected to stay current on safety warnings concerning medications and medical devices. A doctor who recommends a treatment to patient because he or she was ignorant of the potentially adverse consequences might be deemed negligent.
The specific standard of medical care is established by the services that other reasonably skilled professionals in the same medical community would provide. Our Florida medical malpractice law firm has helped many patients who suffered injuries at the hands of negligent doctors. We utilize medical experts to explain the technical aspects of the applicable standard of care. Our lawyers then interweave that testimony into a persuasive theory of the case, utilizing technology to present evidence to the jury in a compelling way.
Source: MedCityNews, “FDA raps hospitals over protocol lapses for medical device-related injuries, deaths,” Chad Terhune, Oct. 28, 2016