Cervical Cancer And The Misdiagnosed Pap Smear

When Cervical Cancer is Not Diagnosed in Time

At Perey Law Group, our lawyers pursue fair compensation for people who have suffered complications due to a cervical cancer misdiagnosis. We represent people in Seattle and throughout Washington.

Contact us today for a free consultation to discuss your case with an experienced attorney.

The cervical smear, or Papanicolaou (Pap) test for cervical cancer, is one of the most common laboratory tests performed in the U.S. It is an inexpensive, painless and accurate test for detecting cervical cancer or, more importantly, precursors to cervical cancer.

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.

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 U.S., 41 million 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.

When is it a Medical Malpractice Claim?

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:

  • 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.

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


[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.