Observations From Pap Litigation Consultations

Abstract

Papanicolaou test litigation in the United States reflects widespread societal expectations that even occasional cervical screening should prevent nearly all cervical cancers in screened women. Scientific evidence clearly shows that these expectations are unfounded, especially for increasingly prevalent glandular cervical cancers and for more rapidly progressive cervical cancers in younger women. Reviews of Papanicolaou test slides involved in litigation repeatedly show 1 or more of 3 cytologic patterns: difficult-to-interpret abnormal glandular cell groups, difficult-tointerpret hyperchromatic crowded cell groups, and/or difficult-to-locate or -interpret abnormal immature metaplastic squamous cells. Multipleslide blinded reviews, supported by professional organization guidelines, should be used to identify and differentiate culpable medical errors from factors primarily associated with the inherent limitations of human screening and interpretation. In the authors' opinion, remaining US cases of cervical cancer are most likely to be prevented or minimized by more widespread utilization of cotesting with US Food and Drug AdministrationYapproved methods of liquid-based cytology and high-risk human papillomavirus DNA testing.T he Papanicolaou test is the most successful cancer screening test in medical history. 1 The twin goals of cervical screening are (1) to detect and ablate cervical precancer and (2) to detect and minimize the stage at diagnosis of cases of already invasive cervical cancer. 2 Papanicolaou test litigation consultations provide opportunities for valuable insights into both the natural history of cervical carcinogenesis and the limitations of current cervical screening methods and practices. 3 Although the demonstrated capability of cytology-based screening to detect and prevent or downstage invasive cervical cancer (CxCa) is significantly less for both glandular cervical cancers 4,5 and for more rapidly progressive cervical cancers in younger women, 6 there is, nevertheless, a strong public presumption that almost any cervical screening should essentially guarantee that almost all cervical cancers will be prevented. 3 This presumption that cervical screening should prevent almost all cervical cancers in screened women forms the basis for screened patients' consideration of legal recourse after a cervical cancer diagnosis. In our opinion, the same unfounded presumption that cervical screening should reliably prevent almost all cervical cancers strongly influences most consultants asked by plaintiffs to review durable slide evidence after a diagnosis of CxCa and to ascertain whether a culpable medical error occurred. The multiple-slide blinded rescreening (MSBR) method 3,7Y10 has been developed to improve the objectivity of retrospective reviews of litigated Papanicolaou cases and has had some success in helping to adjudicate and resolve disputed cases. Newer cervical screening technologies also have the potential to help achieve cervical screening performance and outcomes that more closely approach...

Type 1 and type 2 cervical carcinomas: some cervical cancers are more difficult to prevent with screening

“…Rather than attempting to use newer screening methods to improve screening of young women, the tendency has been to use the limited successes to date as a reason to screen less or even to cease screening. The public does not necessarily share these pessimistic expectations, to judge from public reactions to diagnoses of interval cervical cancers in screened young women 37 or to the substantial number of cases of younger women we have encountered in Pap litigation consultations 9 . In examining follow‐up histopathology specimens, we have observed that a number of these invasive cancers in screened young women are characterized by small or inconspicuous precancerous intraepithelial surface lesions (Figure 2b).…”

“…The minority of cervical cancers that are less reliably prevented with standard screening protocols can still sometimes be prevented with either more frequent screening or by screening utilizing more sensitive methods of screening 3 (Table 1). This subset of cervical cancers is disproportionately represented among interval cervical cancers arising in previously screened women and in our active Pap test litigation consultation practice, 9 in which the widespread misimpression often arises that almost all cervical cancers are slow growing and readily preventable with only periodic routine screening 10 . In order to focus greater attention on the unique screening challenges presented by the subset of less preventable cervical cancers, we began some time ago the practice of referring to them collectively as ‘type 2 cervical cancers’.…”

Cytology and Human Papillomavirus Screening Test Results Associated With 2827 Histopathologic Diagnoses of Cervical Intraepithelial Neoplasia 2/3

“…Routine cotesting has been formally advocated by 2 of the authors as an approach judged most likely to minimize false-negative screening test results and cervical cancer diagnoses in screened women. 43 Earlier additional HPV test results at more than 4 months to 3 years before the CIN 2/3 diagnoses were also available in 454 patients; 83% (n ¼ 377) had at least one prior positive result, likely reflecting the current consensus that persistent hrHPV infection is a prerequisite for development of CIN 2/3. [44][45][46][47] On the other hand, 24.2% (110 of 454) of patients with earlier HPV test results had at least one negative result.…”

Adherence to practice guidelines for atypical glandular cells on cervical cytology

“…These findings suggest that adherence to practice guidelines by clinicians may be influenced by cytopathologist recommendations. Instituting standardized management guidelines on AGC cytology reports could increase compliance and decrease litigation, which is more common with Paps containing glandular abnormalities 19. For example, the statements: “Recommend cervical, endocervical and endometrial evaluation” for women ≥35 years and “Recommend cervical and endocervical evaluation, and, if clinically indicated, endometrial evaluation” for women <35 years could be included on AGC cytology reports.…”