Breaking the limits of the risks for the human body, health or even the life of the patient, as assumed by the pharmaceutical producers, by using a drug off label, for its side effects, in another purpose or even against the purpose for which the drug was authorized by the National Agency of Medicine and Medical Devices, is not in itself illegal if the off label use has the common consent of both the doctor and the patient for a treatment and only for a treatment which, although a spread procedure, has little or no scientific support. But if the patient is subjected to unreasonable risks, endangering his body, health or life beyond the possible benefits of the treatment, without being informed about the lack of scientific support, the doctor is liable not only for malpractice (civil medical liability) but also for a criminal offence.
TCTAP A-071 Cardiac Intervention with Off-Label Use of Medical Devices in Congenital Heart Disease
