"In a Connecticut courtroom a manufacturer's package insert for a laryngeal mask airway became a key piece of evidence in a medical malpractice lawsuit. When a medical malpractice lawsuit is brought the plaintiff must prove that a deviation from the standard of care, by the defendants, led to the injuries for which they are seeking a remedy. The standard of care is determined by the testimony of expert witnesses brought by both sides. It is then up to the jury to consider the testimony of the battling experts and decide what was THE standard of care and whether there was a deviation from it. The court itself does not determine the standard of care for the jury. In the case that follows, a manufacturers device manual/ insert was allowed into evidence in such way that the warnings in the insert itself were seemingly presented as a publication of the standard of care. While written materials like anesthesia textbook, research papers, professional association recommendations. guidelines and standards and even package manuals/inserts can be relied upon by expert witnesses when testifying as to standard of care, in and of themselves they do not establish the standard of care absent expert witness testimony."
