The Pap smear, automated rescreening, and negligent nondisclosure.

Abstract

A new element in the Papanicolaou smear liability crisis is the recent US Food and Drug Administration approval of 2 automated rescreening devices. Their manufacturers have undertaken aggressive advertising in medical journals and in women's magazines, generating controversy about whether this positions such devices as the new standard of care and whether failure to offer such rescreening might lead to liability alleging to tort of negligent nondisclosure, with contributing opinions from pathologists' and manufacturers' counsels. Cases are cited in prenatal diagnostics and blood banking that established liability for failing to disclose diagnostic modalities used by at most only a minority of practitioners and, therefore, have not yet achieved standard-of-care status. It is concluded that informed consent for cervicovaginal smears should include disclosure of the availability of automated rescreening to reduce negligence liability.