Responsabilità medica in caso di prescrizione di farmaco potenzialmente dannoso in mancanza di consenso informato della paziente

Abstract

The “informed consent” can be defined as the consent by a patient to a surgical or medical procedure after achieving an understanding of the relevant medical facts and the risks involved. This means that the physicians must inform the patient in a complete, correct, and adequate way. The informed consent is absolutely essential when possible teratogenic effects of a drug are concerned. We describe a case of a patient whom has been prescribed clomiphene to induce ovulation. The woman eventually got pregnant, but the newborn resulted affected by severe malformations. The physicians who prescribed the drug were accused of malpractice, because they did not correctly informed the woman about teratogenic risks associated with the drug. These risks are in fact well known: available data from clinical studies suggest that clomiphene treatment, especially after several cycles, might be associated with a slightly higher risk of neural tube defects and severe hypospadias in the offspring.