Pap Smear Litigation

Background
The Pap test is a study for the early detection of cancer cells which involves collecting material from areas of the body that shed cells or in which shed cells collect, especially in the cervix and the vagina. This material is then prepared for microscopic study by special staining. Analysis of the cells is extremely helpful in diagnosing cancer. Early symptomatic cervical cancer can be detected by cytological examination Cytology is the science that deals with the formation structure and function of cells. Cervical smears obtained during routine annual pelvic examinations undergo cytological examination.

The Pap test was introduced in the l930s by Dr. George Papanicolaou.The Papanicolaou (Pap) test can detect over 90% of early cervical neoplasias (cell irregularities), and its use has reduced deaths from cervical cancer by more than 50% through recognition and treatment of pre-invasive cancer. Pre-invasive cancer is a stage of a malignancy in which the neoplastic cells have not invaded adjacent tissues. A neoplasm is a new and abnormal formation of tissues as a tumor or a growth. It serves no useful function, but grows at the expense of the healthy organism. Cervical cancer could be eliminated as a cause of death if all women had an annual Pap test. Unfortunately fewer than 49% of all women take the test. Controversy regarding cervical cancer screening concerns the upper age limit for screening and the appropriate frequency. Most guidelines recommend that screening begin when a woman becomes sexually active or by age 18. Because mortality increases with advancing age it seems imprudent not to screen older women. Most cancer organizations recommend that screening be done on a yearly basis until there have been three consecutive normal examinations.

Legal Liability Associated with the Pap Smear Test

The Process
The Pap smear screening begins with the gynecologist who takes a smear of cells from the vagina, the cervix and the endocervix, which cells are then placed on slides and submitted to a laboratory. At the laboratory, a cytotechnologist stains the cells so that normal blood cells can be distinguished from the cells in question. At that point, the cells are examined under a microscope. The cytotechnologist does not try to diagnose the cancer, but rather identifies and marks abnormal cells for the pathologist to review. If no abnormal cells are found, the Pap smear is reported as normal and no further action is taken. The normal finding is reported back to the gynecologist. The abnormal cells are read by a pathologist who describes the nature of the abnormal cells— cancerous or pre-cancerous — and of course reports back to the gynecologist.

The Problem
The question of legal liability typically arises when one or more Pap smears are reported as normal. Thereafter, symptoms develop including irregular bleeding and unusual vaginal discharge, and cancer is diagnosed. Obviously, the question is the accuracy of the reading by the cytotechnologist or the pathologist of the slides in the first place. A later review of the slides often reveals that in fact there were pre-cancerous or cancerous cells found on slides previously determined to be normal. Because of the frequency of misread slides by cytotechnologists, Congress in l988 amended the Clinical Laboratory Improvement Act (CLIA), which regulates matters such as employee supervision, workload limits, proficiency testing and quality control procedures. Under the CLIA, a cytotechnologist may not read more than 100 slides in a 24-hour period. However, the American Society of Cytopathology suggests that a "reasonable limit" would be no more than 50 slides per day. The CLA requires that at least 10 % of all slides interpreted as normal be re-screened. Finally, the regulations require laboratories to keep slides for at least 5 years, and the reports for 10 years. These regulations, while helpful in establishing minimum standards that should be met by all labs reading Pap smears, provide the laboratory with a potential defense to a negligence action, namely that the mistake was an expected, excusable error since all regulations were complied with under the requirements of the CLIA. Of course, if the plaintiff can establish that the laboratory failed to meet even these minimum standards, the plaintiff's case is much stronger.

Proving The Misread Pap Smear Slide Was the Cause of Substantial Damages
In most states, the plaintiff must either prove that the ultimate harm would not have occurred but for the cytotechnologist or pathologist's negligence. Thus, if plaintiff had a terminal cancer, plaintiff would have to establish that there was at least a 51% chance of surviving with appropriate treatment.

This informational piece was prepared by Monheit, Silverman & Fodera. If you would like more information on this topic, call us at (800) 220-LAW1, or use the "Do I Have A Case?" button on this web site.

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