Cervical Cancer And The Misdiagnosed Pap Smear, continued
By: Ron Perey
I. CERVICAL CANCER
Cervical cancer is a progressive disease which, assuming that annual cervical Pap smears have been obtained and correctly interpreted on a regular basis, is first observed as a few atypical cells (cells with enlarged or irregularly-shaped nuclei). Then it progresses to mild dysplasia, and from mild dysplasia to moderate dysplasia, severe dysplasia, carcinoma in situ, invasive cancer, and metastatic cancer. This progression may reverse itself while the degree of dysplasia is only mild, or possibly even moderate. However, once the degree of dysplasia is between moderate and severe, the progression can no longer routinely be reversed. The only way to halt the progression is to surgically remove the developing cancer. This progressive disease is virtually one-hundred percent (100%) curable if it is completely removed before it has progressed to invasive cervical cancer. Treatment may be as simple as a cervical cone biopsy.
Once invasive cervical cancer develops, it is only a matter of time before there are metastases (spread) to other organs. Once the disease has spread to other organs, treatment involves not only major surgery, but also chemotherapy and/or radiation therapy, depending on the medical staging of the disease. Moreover, the risk of long term injury, permanent disability, and death increases dramatically with higher disease stages. Any delay in diagnosis or treatment of developing cancer allows the disease to progress, proliferate and spread; increases the risk of the cancer becoming invasive and metastatic; increases the extent and severity of surgical treatment (hysterectomy, modified radical hysterectomy, or radical hysterectomy and lymphadenectomy), and adjuvant treatment (chemotherapy and/or radiation therapy); and significantly increases the risk of permanent disability and/or death.
II. THE CERVICAL PAP SMEAR
The Pap smear, named after George Papanicolaou, is a cytologic test most widely known for its use in detecting pre-cancerous or early cancerous lesions of the cervix or vagina. The great benefit of the annual Pap test is that it can detect pre-cancerous lesions (precursors to cervical cancer), usually long before any malignancy develops or, if cancer is beginning to develop, the Pap smear can detect it at an early stage before it becomes invasive. There is no other test for women, and no equivalent test for men, which can predict the development of cancer in its pre-malignant or early stages. If pre-cancerous cells (evidence of early cancer) are detected, they can usually be removed entirely by means of a relatively simple cervical cone biopsy or laser procedure. Because cervical cancer, once it has become invasive, has a poor prognostic outcome, the chief benefit of the Pap smear is its ability to prevent cervical cancer from becoming invasive by detecting cellular conditions which may develop into invasive cervical cancer if left untreated. If pre-invasive cervical cancer is treated early, before it has invaded several layers of the cervix or spread to other body organs, there is nearly a 100% cure rate.
Annual Pap smears, competently collected by a woman's physician and competently screened and interpreted by a laboratory will prevent the development of invasive cervical cancer. Unfortunately, for reasons of expediency and economics, the quality of Pap smear screening is notoriously abysmal. Screening Pap smears is not a profit center for a laboratory. Instead, it is used as a "loss leader" by commercial laboratories in order to get the more lucrative blood and body fluid work.
Over the past forty years, the Pap test has reduced the death rate of cervical cancer by 70%, primarily as a result of early diagnosis. This year about 17,000 women will develop cervical cancer, about 7,000 will die of the disease. Most of these women do not have to die. However, for the Pap smear to have any value, a satisfactory sample of cervical cells must be taken and the smear must be interpreted correctly. The failure to detect abnormal atypical cells on a Pap smear can result in a woman developing invasive cervical cancer. In order for the Pap smear to be of any real benefit, abnormal cellular changes must be detected before they become cancerous. By the time invasive cancer has developed, the Pap smear has lost its value as a diagnostic tool. The medical clinician who takes the Pap smear relies completely upon a competent and correct interpretation of the Pap smear when treating a patient. The Pap smear should be done annually. If there are two consecutive abnormal Pap smears with atypical cells, or one abnormal Pap smear with clinical symptoms of bleeding or persistent inflammation, the medical standard of care requires a colposcopic examination and biopsy of the cervix for a definitive diagnosis.
The cervical smear, or Papanicolaou (Pap) test for cervical cancer, is one of the most common laboratory tests performed in the United States. It is inexpensive, painless, efficient, accurate and very effective in detecting cervical cancer, or more importantly, precursors to cancer in the uterine cervix[1]. An annual Pap smear, if properly collected, preserved, stained and interpreted, can identify atypical, abnormal and dysplastic endocervical cells which are precursors to invasive cancer. If dysplastic endocervical cells are identified in the Pap smear test, a visual examination of the uterine cervix by colposcope (colposcopy) and a cervical biopsy (tissue sample) can be definitively diagnostic of the developing cancer or malignant cancer. The Pap test, when properly conducted, has the potential to virtually eliminate cervical cancer which afflicts 2 out of every 100,000 women. However, it has not achieved that laudable objective largely because of clinical and laboratory negligence. In the United States 41,000,000 women are "screened" for cervical cancer every year, resulting in the detection of 40,000 to 50,000 cases of dysplasia or curable pre-cancerous lesions. Since the introduction of the Pap test in 1943, the death rate in the United States from cervical cancer has decreased about 70%. False-negative reports (laboratory reports which fail to identify abnormal cells) are widespread and reportedly occur in 16% to 40% of all Pap tests. The word "false-negative" is a medical euphemism for negligence. Nevertheless, the Pap smear test has reduced the incidence of cervical cancer and deaths from cervical cancer dramatically. If properly conducted, the Pap test can accurately detect cervical dysplasia 98% of the time and, by simple surgery the pre-cancerous lesion can be removed and cured before invasion of cervical cancer develops. It is believed that 90% of all cervical cancer deaths are preventable with the Pap test[2].
III. MEDICAL MALPRACTICE CLAIM FOR DELAYED DIAGNOSIS OF CANCER
Approximately 95% of all cervical Pap smears are negative for cancer or dysplasia. Cervical cancer is a slow-growing disease and it is believed that the natural growth history of cervical cancer is 7 to 15 years. My experience with these cases has convinced me that a woman who has had annual Pap tests over a period of years and subsequently develops cervical cancer, probably has a medical malpractice claim for delayed diagnosis either against her physician or the laboratory that interpreted her Pap smear slides. Most Pap smear slides in Washington are interpreted by certified cytotechnologists and are seldom seen by pathologists, except when the cytotechnologist diagnoses the presence of atypical or abnormal cells. The only other instance that a pathologist will examine a Pap smear slide is if the laboratory conducts a quality assurance program which requires rescreening of a certain percentage of all slides initially determined to be negative. Most laboratories subject 10% of all negative slides to this rescreening procedure.
In a delayed diagnosis of cancer case the damages typically consist of a loss or reduction of the patient's chance of survival. Herskovitz v. Group Health, 99 Wn.2d 609, 664 P.2d 474 (1983) (failure to timely diagnose lung cancer which reduced patient's chance of survival from 39% to 25%). See also Mayhue v. Sparkman, 653 N.E.2d 1384 (Indiana 1995). The patient may also recover damages for anxiety arising from a reasonable fear of contracting cancer in the future or dying from cancer as a result of the delayed diagnosis or misdiagnosis by the physician or laboratory. Sorenson v. Raymark Industries, 51 Wn. App. 954, 756 P.2d 740 (1988). See also Zueger v. Public Health Hospital District, 57 Wn. App. 584, 789 P.2d 326 (1990); Koker v. Armstrong Cork, Inc., 60 Wn. App. 466, 804 P.2d 659 (1991); and Medical Malpractice: "Loss of a Chance Causality," 54 A.L.R.4th 36 (1987). A recent opinion from a New Jersey appellate court held that a cause of action for increased risk of dying from metastasized cancer accrues when the metastasis occurs. Karol v. Berkow, 603 A.2d 547 (N.J. Super. Ct. App. Div. 1992). However, in cases involving a delayed diagnosis of cervical cancer based on a misdiagnosed Pap smear, there is not only a claim for a reduced chance of survival, but also for contracting the cancer itself. This is true because if the slides had been correctly diagnosed and treated, the patient never would have developed invasive cancer.
IV. THE STATUTE OF LIMITATIONS
Often the clinical or laboratory negligence in a delayed diagnosis of cancer case occurred many years before the actual diagnosis, sometimes 5 to 10 years earlier. The Washington medical malpractice statute of limitations for any health care provided after June 25, 1976, provides as follows:
RCW 4.16.350 Any civil action for damages for injury occurring as a result of health care which is provided after June 25, 1976 against ... [a physician or laboratory] based upon alleged professional negligence shall be commenced within three years of the act or omission alleged to have caused the injury or condition, or one year of the time the patient or his representative discovered or reasonably should have discovered that the injury or condition was caused by said act or omission, whichever period expires later, except that in no event shall an action be commenced more than eight years after said act or omission: Provided, that the time for commencement of an action is tolled upon proof of fraud, intentional concealment, or the presence of a foreign body not intended to have a therapeutic or diagnostic purpose of effect. [Emphasis added.]
Because developing cancer is a latent and progressive disease with a natural life of 10-15 years (unless accelerated by HPV), the 8 year statute of repose may elapse before the patient discovers she has cancer, and before she discovers the misdiagnosis, and before she discovers she even has a valid claim for damages for medical malpractice. However, the period of limitation may be extended beyond the 8 year statute of repose by the continuous course of medical treatment rule announced recently by the Washington Supreme Court in the case of Caughell v. Group Health Cooperative, 124 Wn. 2d. 217, 876 P.2d 898 (1994). See also Garcia Alano v. Guttman Breast Diagnostic Institute, 590 N.Y.S.2d 453 (App. Div. 1992).
V. INVESTIGATION OF THE CLAIM
In order to determine whether a claim exists against a physician or the cytology laboratory, the lawyer must collect all of the woman's medical records and Pap smear reports. Additionally, and more importantly, the lawyer must immediately collect all existing Pap smear slides and tissue samples. It is important to collect these slides and tissue blocks immediately, because they are often destroyed within a relatively short period of time. When the Pap smear slides are collected from the various laboratories it is essential to request all slides for your client under all of her names, i.e., maiden name, married name and subsequent married names. It is also essential to obtain copies of all the cytology reports and laboratory requisition forms from both the clinician and the laboratory because you will find handwritten notes on each copy. The national standard now requires negative slides to be kept only 5 years, and any slides that are other than negative must be kept for 20 years. However, not all laboratories comply with this protocol.
The medical records must be promptly analyzed and a list prepared which summarizes all Pap smear tests, including for each Pap smear slide the date collected, the laboratory that interpreted the slide, the diagnosis, the laboratory recommendation and the clinical history follow-up. Then, the medical records, the summary and the existing Pap smear and tissue slides must be submitted for evaluation to a cytopathologist who will advise you whether the Pap smear slides were properly collected, preserved, stained and interpreted. An obstetrician/gynecologist should be retained to review the medical records and express an opinion with regard to the quality of the clinical care and proximate cause.
The woman's physician may have been negligent for failing to observe, note, act, or follow-up on the laboratory's recommendation or the patient's clinical signs of developing cancer, e.g., bleeding and pain on intercourse, a lump, a nodule, a friable cervix, uncontrolled and persistent inflammation, HPV (human papilloma virus). Even if the physician was not negligent in his or her clinical care and differential diagnosis, there may be negligence regarding the collection or preservation of the Pap smear. But the investigation does not stop there because the laboratory which stained and interpreted the Pap smear slides may have been negligent in its interpretation, recommendation or follow-up.
VI. CYTOLOGY TERMINOLOGY
One of the persistent problems in Pap smear diagnosis and interpretation is the words used by the cytology laboratory to communicate the diagnosis to the clinician. The clinician must be able to comprehend the meaning and significance of the terminology used by the laboratory in its diagnosis and recommendation. Often, however, the laboratory is trying to communicate one thing and the clinician interprets something entirely different from the report. The terminology used by the laboratories over the years is not uniform and is very confusing. The terminology differs from laboratory to laboratory and state to state. One will see words such as: negative; normal; normal cytology; within normal limits; benign; atypical; unsatisfactory; negative-atypical; atypical-negative; atypical-suspicious; abnormal; reactive cells; mild dysplasia; moderate dysplasia; severe dysplasia; cervical intraepithelial neoplasia; atypical squamous metaplasia; benign-no significant cellular abnormalities; and atypia of undetermined significance. There is no uniformity in the definition of these terms.
VII. PAP SMEAR CLASSIFICATION SYSTEMS
During the past five or six years there has been an effort by the medical community to create a uniform terminology and classification system for Pap smear diagnosis and recommended follow-up care. However, chaos continues to prevail in this area because there is considerable overlap and conflict between the various classification systems. Within academic circles, the prevailing modern classification is the Bethesda System. However, the oldest classification, and reportedly the most frequently used and understood by clinical physicians, is the Papanicolaou classification system. The Papanicolaou classification system has five classes of diagnoses. However, there is no uniformity of classification in the Papanicolaou classification system or any other system and, therefore, the descriptive diagnostic readings (morphologic descriptions) are the most important information contained on a laboratory's Pap smear report.
VIII. THE PAPANICOLAOU CLASSIFICATION SYSTEM
The following is a summary of the Papanicolaou Classification System and the correlative histologic diagnosis.
Classification Histologic Diagnosis
Class I Negative; no abnormal or atypical cells.
Lab recommendation: annual Pap smear.
Class II Atypical cells present, but below the level of cervical neoplasia. Atypical cells of undetermined significance. Possible bacterial infection. Human papilloma virus (HPV). Inflammation and/or possible infection. Not suggestive of malignancy.
Lab recommendation: treat infection and repeat within 3 to 6 months.
Class III Dysplasia; this is a pre-cancerous condition and 100% curable.
Lab recommendation: colposcopy and biopsy.
Class IV Severe dysplasia; squamous carcinoma in situ. Strongly suggestive of malignancy.
Lab recommendation: colposcopy, biopsy and surgery.
Class V Abnormal cells consistent with micro-invasive or invasive squamous carcinoma. Cytology conclusive for malignancy.
Lab recommendation: colposcopy, biopsy and surgery.
IX. TREATMENT RECOMMENDATION ON PAP SMEAR REPORT
Regardless of the classification system used or the terminology used, the most important thing to the patient is that there is a proper interpretation of the Pap smear slide, a proper recommendation by the laboratory, and a proper clinical follow-up by the patient's physician. If the Pap smear slide is interpreted as anything other than negative, there is a generally-recognized follow-up protocol or recommendation that the laboratory should place in the comments on the cytology report. However, for reasons that defy comprehension, some laboratories give no recommendation at all.
X. MEDICAL MALPRACTICE
If a woman develops cervical cancer and undergoes a hysterectomy or dies, there is almost certainly a claim for medical malpractice, unless the woman utterly failed to get even periodic Pap smears. In my judgment, the base value of a cervical cancer case is $300,000.00 for a woman who is deemed "cured" by the hysterectomy.
The areas of physician and laboratory negligence to be investigated are as follows:
Physician Negligence
· Improper sampling/scraping
· Improper identification
· Incomplete history
· Incomplete follow-up
Laboratory Negligence
· Improper Pap smear processing, including identification, staining and reviewing of history of previous Pap smear slides
· Inexperience, overwork or lack of training and supervision of cytotechnologist
· Erroneous interpretation by cytotechnologist or pathologist
· Erroneous comments and recommendations by cytotechnologist or pathologist
· Absence of quality assurance program
· Failure to follow up on recommendation to clinicial
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[1] For a clear and concise summary of the Pap test and its limitations see the article by Dr. Leopold Koss entitled The Papanicolaou Test for Cervical Cancer Detection - A Triumph and a Tragedy, Journal of the American Medical Association (JAMA), February 3, 1989, Volume 261, No. 5 pp.737-743. For the definitive work on cytology see Dr. Koss' 2 Volume treatise Diagnostic Cytology (4th edition, 1992, J.P. Lippincott Company.). Dr. Koss is probably the leading and most widely respected cytopathologist in the world.
[2] For an excellent piece of investigative journalism which prompted reforms in Pap smear protocols and cytology laboratories in the United States, see the article written by Walt Bogdanich in The Wall Street Journal on February 3, 1989.
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