Cervical Cancer And The Misdiagnosed Pap Smear
By: Ron Perey
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 an inexpensive, painless, efficient, accurate and very effective test for detecting cervical cancer, or more importantly, precursors to cervical cancer. Attached to this paper is an article by Dr. Leopold Koss entitled The Papanicolaou Test for Cervical Cancer Detection - A Triumph and a Tragedy. Dr. Koss is the leading cytopathologist in the world and his article is the definitive article on the Pap test (Attachment 1). An annual Pap smear, which is 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 test, a visual examination by colposcope (colposcopy) and a cone biopsy (conization) can be definitively diagnostic and 100% curative of the developing cancer. Attached to this paper is a diagram depicting how a Pap smear is collected and how a colposcopy is conducted (Attachment 5).
The Pap test, when properly conducted, has the potential to virtually eliminate cervical cancer which afflicts 1.6 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. Each year there are about 17,000 new cases of invasive cervical cancer and 7,000 deaths from cervical cancer. 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 occur in 16% to 40% of all Pap tests. 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 98% of cervical dysplasia and, therefore, prevent most cervical cancer. It is believed that 90% of all cervical cancer deaths are preventable with the Pap test. Attached to this paper is an article written by Walt Bogdanich of the Wall Street Journal on February 3, 1989. This is an excellent piece of investigative journalism and it prompted reforms in Pap smear protocols and cytology laboratories in the United States (Attachment 2).
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 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 re-screening of a certain percentage of all slides initially determined to be negative. Most laboratories subject 10% of all negative slides to this rescreening procedure. Attached to this paper is a Bibliography of selected publications relevant to cytology, Pap smears and cervical cancer (Attachment 8).
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 chances of survival from 39% to 25%). 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.2nd 547 (N.J. Super. Ct. App. Div. 1992).
Often the clinical or laboratory negligence in a delayed diagnosis of cancer case occurred many years before the actual diagnosis, sometimes 10, 12 or 15 years earlier. The 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 cervical cancer is a latent and progressive disease with a natural life of 10-15 years (unless accelerated by HPV), the statute of limitations may have elapsed before the patient discovers she has cancer, before she discovers the misdiagnosis of the Pap smear, and before she discovers she even has a valid claim for damages for medical malpractice.
In order to determine whether a claim exists against a physician or the 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 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 five 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 summarizing all Pap tests, including for each Pap smear slide the date collected, the laboratory that interpreted the slide, the diagnosis, the laboratory recommendation and the clinical follow-up. Then, the medical records, the summary of Pap smears and the existing Pap smear slides must be submitted for review and evaluation to appropriate medical experts. An OB/GYN should be retained to review the medical records and express an opinion with regard to the quality of the clinical care. A cytopathologist and a cytotechnologist should be retained to examine, interpret, and express opinions regarding the Pap smear slides and tissue samples, and whether they were properly collected, preserved, stained and interpreted.
The physician may be negligent for failing to observe, note or act on the laboratory's recommendation or the patient's clinical signs of developing cancer, e.g., bleeding and pain on intercourse, lumps, friable cervix, uncontrolled and persistent inflammation, or 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.
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 laboratories over the years is not uniform and is very confusing. The terminology differs from laboratory to laboratory and state to state. You 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; benign-no significant cellular abnormalities; and atypia of undetermined significance. There is no uniformity in the definition of these terms. Attached to this paper is a Glossary of Cytology Terminology, which may help clarify the definitions of these terms (Attachment 3).
During the past five or six years there has been an effort by the medical community to create a uniform classification system and terminology for Pap smear diagnoses and recommended follow-up care. However, chaos continues to prevail in this area. Attached to this paper are two tables entitled "Comparison of Pap Smear Classification Systems" (Attachment 6) and "PSIP Table of Comparable Diagnoses and Recommended Follow-Up" (Attachment 7). These tables list the various classification systems, terminology and follow-up recommendations. As you will note, there is considerable overlap and conflict between the various classification systems. Within academic circles, the prevailing "modern" classification method is the Bethesda System. However, the oldest and still the most common system of classification used by laboratories, which is allegedly understood by most clinicians, is the Papanicolaou classification system. The Papanicolaou classification system has five classes of diagnoses:
Classification Histologic Diagnosis
Class I Negative; no abnormal or atypical cells; normal.
Class II Atypical cells present, but below the level of cervical neoplasia. Reactive squamous cells; suspected condyloma acuminatum (HPV); cannot exclude dysplasia; inflammation and/or possible infection. Not suggestive of malignancy.
Class III Abnormal cells consistent with dysplasia; mild dysplasia (CIN I) and moderate dysplasia (CIN II). HPV often present. This is a pre-cancerous condition and 100% curable.
Class IV Abnormal cells consistent with carcinoma in situ; severe dysplasia; squamous carcinoma in situ (CIN III). HPV often present.
Class V Abnormal cells consistent with micro-invasive or invasive squamous carcinoma. HPV often present.
Irrespective 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 that the laboratory should place in the comments on the cytology report. The standard recommendations and clinical follow-up for each of the five classes is as follows:
Classification Clinical Follow-up
Class I Routine annual Pap smear.
Class II Repeat Pap smear in one year or sooner if indicated clinically; or repeat in 3-6 months if there is suspicion of dysplasia or condyloma (HPV).
Class III, IV & IV Perform colposcopy/biopsy if there is mild dysplasia, moderate dysplasia, severe dysplasia, HPV, squamous carcinoma in situ or invasive squamous carcinoma. Depending upon the pathology report from the biopsy specimen, the physician will decide whether to follow-up with a conization, hysterectomy or radiation therapy and/or chemotherapy.
Another critical protocol to understand is staging of cervical cancer, because staging is an attempt to determine the extent of the cancer from a clinical examination. That is, the physician attempts to determine by palpation, visual examination, colposcopy and biopsy, whether the cancer is invasive and whether it has metastasized to other tissue and distant organs. The generally recognized staging classification system was approved in 1988 by the Federation of Gynaecology and Obstetrics (FIGO). The stages are as follows:
Stage Description
O Carcinoma in situ; intraepithelial carcinoma.
I Carcinoma confined to the cervix.
IA Microinvasive carcinoma. Pre-clinical carcinomas of the cervix, diagnosed only by microscopy. Tumor size no greater than 5mm. in depth and 7mm. in horizontal spread.
IB Lesions of greater dimensions than 5mm. x 7mm., whether seen clinically or not.
II Carcinoma extends beyond cervix but not onto the pelvic wall (involves vagina but not lower third).
IIA No obvious parametrial involvement (connective tissue around uterus).
IIB Obvious parametrial involvement.
III Carcinoma extends onto the pelvic wall. On rectal examination, there is no cancer-free space between the tumor and pelvic wall. The tumor involves the lower third of the vagina.
IIIA No extension to the pelvic wall.
IIIB Extension to the pelvic wall and/or hydronephrosis or nonfunctioning kidney.
IV Carcinoma has extended beyond the pelvis or involves the bladder and rectum.
IVA Spread to adjacent organs.
IVB Spread to distant organs.
ACOG Technical Bulletin No. 138, December 1989, "Diagnosis and Management of Invasive Cervical Carcinomas."
The generally recommended treatment corresponding to the stage of the cervical cancer is as follows:
Stage Treatment
I, IA, II & IIA Radiation therapy and conservative surgery are equally effective.
IB, II & IIA Radical hysterectomy and pelvic lymphadenectomy or irradiation therapy.
IIB, III & IV Radiation.
IVA High dose whole pelvis external radiation, intracavity radiation or radiation with pelvic exenteration.
IVB Systemic chemotherapy.
NOTE: No known chemotherapeutic agent has been proven effective in the adjuvant treatment of patients with advanced cervical cancer.
The generally accepted five-year survival rate of patients with carcinoma of the uterine cervix is as follows:
Stage 5 Year Survival
I 70-90%
II 50-60%
III 25-35%
IV 5-15%
All stages 50-70%
The areas of physician and laboratory negligence to be investigated are as follows:
PHYSICIAN ERROR
· Improper sampling
· 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
· Improper interpretation by cytotechnologist or pathologist
· Improper comments and recommendations by cytotechnologist or pathologist
· Absence of quality assurance program
· Failure to follow up on recommendation to clinician
The following is a list of some of the Washington cases which involved claims of cervical cancer and misdiagnosed Pap smears. There are no reported appellate cases.
Parish v. Donaldson & Puget Sound Institute of Pathology, et al., King County No. 82 2 04850 0. This file has been archived with the following reference: Reel No. 55739 A; Frame No. 1275.
Jones v. Hoag, King County No. 82-2-04850-0. This file has been archived. The plaintiff's lawyers were Michael Hunsinger (Seattle) and Ronald Neubauer (Seattle).
Baldwin v. Puget Sound Institute of Pathology, et al., King County No. 84 2 18708 5. This file has been archived with the following reference: Reel No. S6781; Frame No. 1392.
Arbuckle v. Puget Sound Institute of Pathology, et al., King County No. 86 2 13431 0. This case has been archived with the following reference: Reel No. S7832; Frame No. 13. The plaintiff's lawyer was Mary Ann Ottinger (Seattle). Case settled.
Garwood v. Unnamed Pathology Laboratory, (Spokane, WA March 1988). The plaintiff's lawyer was Dan McKelvey (Seattle). Case settled for $500,000.
Patterson v. Puget Sound Institute of Pathology, et al., King County No. 87 2 19441 8. The plaintiff's lawyers were originally Laura Jaeger (Federal Way) and Mary Ann Ottinger (Seattle). Mary Ann Ottinger withdrew and Richard Kilpatrick (Bellevue) substituted as co-counsel with Laura Jaeger. Case settled.
McKeough v. Group Health, King County No. 90-2-23301-4. The plaintiff's lawyer was Chris Pence (Seattle). Settled.
Haskins v. Group Health and Olympic Medical Laboratories, Inc., Kitsap County No. 89-2-01081-1. The plaintiff's lawyer was Bill Rush (Tacoma). Case settled.
Lattin v. Associated Pathologists, P.C. and Thomas J. McNamara, M.D., Snohomish County No. 93-2-01220-7. The plaintiff's lawyer was Tom Golden (Seattle). Case active.
Mack v. Puget Sound Institute of Pathology, et al., King County No. 93-2-03876-3. The plaintiff's lawyer was Ron Perey (Seattle). Case settled.
The following is a list of appellate cases from foreign jurisdiction involving cervical cancer and misdiagnosed Pap smears:
Kramer (Stephen C.), Estate of Kramer (Jennie Roland), as Next Friend of Kramer (Geoffrey, Lyndsey) v. Lewisville Memorial Hospital, 1993 WL 233532 (Tex., June 30, 1993) (No. D-2680). UNPUBLISHED CASE.
Todd v. Planned Parenthood, 853 S.W. 2d 124 (Tex.App.-Dallas, Mar. 29, 1993) (No. 05-92-01113-CV).
Antunes v. Sookhakitch, 146 Ill.2d 477, 588 N.E. 2d 1111, 167 Ill.Dec. 981 (Ill., Jan. 30, 1992) (No. 68848).
Akers v. Alonzo, 1991 WL 156401 (Ohio App., Aug 1, 1991) (No. 90CA8). UNPUBLISHED CASE.
Parker v. Clickener, 193 Ga.App. 321, 387 S.E. 2d 587 (Ga.App., Oct. 16, 1989) (No. A89A1028).
Scalere v. Stenson, 211 Cal.App.3d 1446, 260 Cal.Rptr. 152 (Cal.App. 2 Dist., July 07, 1989) (No. B026033).
Richman v. National Health Laboratories, Inc., 235 Va. 353, 367 S.E. 2d 508 (Va., Apr. 22, 1988) (No. 850174).
Attached to this paper is a collection of 10 abstracts of legal cases involving cervical cancer, one abstract involving breast cancer and one abstract involving bone cancer (Attachment 4).
ATTACHMENTS
1. Koss, Leopold G. M.D. The Papanicolaou Test for Cervical Cancer Detection - A Triumph and a Tragedy. Journal of American Medical Association, February 3, 1989, Vol. 261, No. 5. pp. 737-743.
2. Bogdanich, Walt., Lax Laboratories: The Pap Test Misses Much Cervical Cancer Through Lab's Errors, The Wall Street Journal, Nov. 2, 1987.
3. Glossary of Cytology Terminology.
4. Abstracts of 10 cervical cancer cases, 1 breast cancer case and 1 bone cancer case.
5. Diagram entitled: "Technique for Obtaining a Pap Smear vs. Colposcopy and Endocervical Curettage."
6. "Comparison of Pap Smear Classification System."
7. "PSIP Table of Comparable Diagnoses and Recommended Follow-Up," prepared by Puget Sound Institute of Pathology.
8. Bibliography.
Ron Perey
Seattle, WA
July, 1993
Misread Pap Smear Case
Settled for $3,000,000
Settlement for the estate of a woman who died of cancer after her Pap smear was allegedly misread. Her estate sued the medical laboratory that interpreted the Pap smear, alleging that defendants had negligently misread and misrepresented it as normal when it had shown grossly abnormal cells. Plaintiff also claimed that the laboratory's slide-screening policies showed reckless disregard for its clients' health. Robert E. Sanders and John M. Dosker, both of Covington, KY, and Martin J. Huelsmann, Highland Heights, KY, represented plaintiff.
Saunders v. Cancer Screening Servs., U.S. Dist. Ct., E.D. Ky., Nos. 88-214, 88-227, Aug. 30, 1991.
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