The pap smear, automated rescreening, and negligent nondisclosure

A new element in the Papanicolaou smear liability crisis is the recent US F ood and Drug Administration approval of 2 automated rescreening devices. Th eir manufacturers have undertaken aggressive advertising in medical journal s and in women's magazines, generating controversy about whether this posit ions such devices as the new standard of care and whether failure to offer such rescreening might lead to liability alleging the tort of negligent non disclosure, 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 achi eved standard-of-care status. It is concluded that informed consent for cer vicovaginal smears should include disclosure of the availability of automat ed rescreening to reduce negligence liability.