Helpful Information

FAILURE TO DIAGNOSE OVARIAN AND CERVICAL CANCER
Sylvester James, Jr. and Michael J. Mohlman

I. INTRODUCTION

Cases based on a failure to diagnose cancer, particularly ovarian and cervical cancer, present very difficult issues for both the medical and legal practitioner. The greatest difficulty for both the lawyer and the doctor is that, oftentimes, these cancers produce no symptoms until they are quite progressed.

The difficulty of making this medical diagnosis often translates into the basis of a legal defense. A defendant physician might very readily attempt to defend her failure to diagnose an ovarian or cervical cancer by blaming the nature of the cancer itself. Further, there are still large numbers of potential jurors who believe that, "If you get the big "C," you’re going to die anyhow," despite objective evidence to the contrary,

Attorneys seeking to represent clients in cases in failure to diagnose ovarian or cervical cancer cases should be very cautious. As in any medical negligence case, there must be sufficient evidence of a breach of the standard of care, causation and resultant damages. Whether the standard of care has, in fact, been breached is obviously a factual determination particular to the specific case. If the case is, in fact, trial worthy, the damages will be catastrophic. Causation, however, may be difficult to prove.

To determine if a prospective case is worth filing, the attorney should evaluate the case specifics: Is the client one with whom a jury will relate and believe? Is the alleged breach by the physician, office person or lab? How long was the delay in diagnosis? Ultimately, however, you must wrestle with the medical issues to determine whether to pursue such cases. Therefore, it is important to have a working understanding of how ovarian and cervical cancers are diagnosed by physicians.

II. MEDICAL DIAGNOSIS OF OVARIAN AND CERVICAL CANCER

Diagnosing ovarian and cervical cancers may not be as simple or straightforward as one might expect. Accurate and timely medical diagnosis may be impeded by such factors as anatomy, diagnostic tests and screening devices, and vague and non-specific symptomatology. Although there are some similarities in the methodology of diagnosing ovarian and cervical cancers, there are also significant differences.

When a woman first presents to her physician’s office, she will usually be asked to complete a "new patient" or intake form asking for her family history, complaints, and other pertinent matters. This form often lands at the bottom of the chart and may not be reviewed by the doctor over long periods of time. Thus, the doctor may miss important issues in reaching a diagnosis. It is important to ask the doctor at deposition when, or even if, they last reviewed this form and how it impacted their diagnosis.

Prior to examination, the patient should again be asked to describe any current symptoms or problems. In conjunction with the history and knowledge of risk factors, this information could lead the doctor to formulate a differential diagnosis.

Occasionally, your client will insist that she made certain complaints to her doctor, but those complaints are not in the office notes. Because the notes are prepared at the time of the office visit, juries often believe that they accurately reflect everything said during that visit. Proceed with caution when alleging that your client said or did anything that the doctor did not record. If the allegation cannot be substantiated, the client’s credibility could be seriously damaged.

Depending on the combination of history, risk factors and reported symptoms, the doctor may include ovarian or cervical cancer on her differential diagnosis. If cancer is on the differential diagnosis, then the physician may be obligated to employ those tools available to rule it either out or in.

A. OVARIAN CANCER

Diagnosing ovarian cancer presents unique and difficult challenges for the practicing physician. Diagnosis is made difficult because, when a tumor develops in an ovary, there is ample room for it to spread and expand before it becomes symptomatic. Patients can often have benign or cancerous tumors grow to the size of softballs or bigger before they are noticed by either the patient or the practitioner. Unfortunately, when a cancerous tumor is that advanced, the cancer is relatively incurable.

1. Risk Factors

As with any diagnosis, the physician must analyze such independent variable factors as history, risk factors, and symptoms. Some risk factors for ovarian cancer can be controlled, while others cannot.

a. Risk Factors That Cannot Be Controlled

The risk of ovarian cancer increases with age. Although younger woman can and do develop ovarian cancer, most women who do have reached menopause.

Family history is a significant factor in assessing a woman’s risk of developing ovarian cancer. Women who have a close relative (mother, sister, grandmother) who have developed this cancer have a much higher lifetime risk of developing this cancer themselves. In addition, women who have been previously diagnosed with breast cancer are also at increased risk for developing ovarian cancer.

The American Cancer Society estimates that approximately 9% of ovarian cancer cases are due to genetic mutations of genes known as BRCA1 and BRCA2. Both of these genes are related to breast cancer. The American Cancer Society estimates that between 56% and 87% of women who inherited these gene mutations would develop breast cancer by the age of 70. The ovarian cancer risk for women with these same genes is estimated to be between 17% and 44%. Therefore, women with a strong family history of breast cancer and a risk of ovarian or breast cancer may be candidates for genetic testing to determine whether or not they carry the BRCA gene mutations.

HNPCC is an inherited condition that leads to a slightly higher risk for developing ovarian cancer. In addition to increased risk of ovarian cancer, HNPCC also puts women at very high risk for colon cancer and endometrial cancer.

Women who begin menstruating before age 12 or those who do not reach menopause until after age 50 are at increased risks for ovarian cancer and breast cancer. Such women have more lifetime menstrual and those who have more menstrual cycles are at higher risk for ovarian and breast cancer.

b. Ovarian Cancer Risk Factors That Can Be Controlled

Having children after the age of 30 or never having children at all increases the risk for ovarian and breast cancer. Pregnancy decreases the risks for these cancers because there is an interruption in menstrual cycles during pregnancy.

Some research suggests that the use of talc or talcum powder applied to sanitary napkins, diaphragms, condoms or directly to genitals directly increases a woman’s risk for ovarian cancer. Many talcum powders in the past were contaminated with asbestos, which may explain the increase in ovarian cancer risk. Even today, talc has structural similarities to asbestos.

Studies have shown that long-term use of estrogen replacement therapy may slightly increase the risk of ovarian cancer.

Some studies show that cigarette smoking is associated with an increased risk of ovarian cancer.

2. Signs and Symptoms

The greatest difficulty with diagnosing ovarian cancer is that its symptoms are often very non-specific. The most commonly reported symptom is back pain. Other frequently reported symptoms include general malaise and fatigue, bloating, constipation, abdominal pain and urinary urgency. Most women with ovarian cancer have at least two of these symptoms.

As the disease progresses, other symptoms may be reported. These include prolonged swelling of the abdomen, abdominal pain and cramping, a feeling of pelvic pressure, vaginal bleeding and leg pain.

Unfortunately, all of these symptoms can be associated with a myriad of other conditions. Abdominal size, for example, can simply be a matter of age and weight. The fact that the symptomatology is so general and non-specific may affect the willingness or desire of a physician to test every patient making such complaints for cancer. Insurance companies may decline to pay for these tests unless clearly indicated and patients are even less willing to bear the cost when, in the vast majority of times, the tests will come back normal or not be instructive on the issue of ovarian cancer.

3. Pre-Diagnostic Tools

If, based on an understanding and knowledge of a patient’s history and risk factors, a physician includes ovarian cancer anywhere in her differential diagnosis, the standard of care may require further investigation.

The tools available to a physician to diagnose ovarian cancer are relatively limited. None of these tools are, however, diagnostic since only biopsy can conclusively diagnose ovarian cancers. The screening tools available to the physician include:

1. CA125 blood test;
2. Sonography;
3. CT scan; and
4. Pelvic exam.

1. CA125

CA125 is a blood test tool frequently used to screen for ovarian cancer. CA125 is a fairly non-specific test, but if that particular chemical is elevated in the blood stream, it can be a sign of a cancerous tumor. Infections and other conditions can also cause the chemical to be elevated, but ovarian cancer is one of those conditions.

2. Sonogram

Through the use of sound waves, sonograms leave an image of the ovaries. Sonograms are frequently ordered every one to two years on women aged 40 and older.

3. CT Scan

CT scans of the abdomen are very helpful in screening for ovarian cancer.

4. Pelvic Examination

In a pelvic exam, the physician inserts two fingers into the vagina to determine abnormalities in the shape or size of the uterus, vagina, ovaries, fallopian tubes, bladder and rectum. Sonograms have proven that pelvic exams are not always very good, and, generally, to feel an ovarian tumor on physical exam, the tumor would have to be quite advanced.

B. CERVICAL CANCER

The American Cancer Society estimates that about 10,520 cases of invasive cervical cancer will be diagnosed in 2004.Some researchers estimate that noninvasive cervical cancer is about 4 times more common than invasive cervical cancer. About 3,900 women will have died from cervical cancer in the United States in 2004.

1. Cervical Cancer Risk Factors

Human papillomavirus infection: The most important risk factor for cervical cancer is infection by the human papillomavirus (HPV). HPVs are a group of more than 100 types of viruses that can cause warts, or papillomas. Not all HPVs cause cancer. Some "high risk" HPVs, however, do increase a woman’s chance of developing cervical cancer. HPVs are passed from person to person by skin-to-skin sexual contact, including oral and anal sex. Condoms do not protect against HPV.

Smoking: Woman who smoke are about twice as likely as nonsmokers to get cervical cancer. Tobacco by-products have been found in the cervical mucus of women who smoke.

Human immunodeficiency virus: Because HIV damages the body’s immune system, it makes women more at risk for HPV infections.

Chlamydia infection: Some recent studies suggest that women whose blood test results show past or current Chlamydia infection are at greater risk for cervical cancer.

Diet: Women with diets low in fruit and vegetable may be at increased risk for cervical cancer. Likewise, overweight women are more likely to develop this cancer.

Oral contraceptives: There is evidence that long-term oral contraceptive use increases the risk of cervical cancer. Some research suggests a relationship between using oral contraceptives for five or more years and an increased risk of cervical cancer. The risk was nearly double in women who used oral contraceptives 10 years or longer.

Multiple pregnancies: Women who have had many full-term pregnancies have an increased risk of developing cervical cancer.

Family history: Like ovarian cancer, women with mothers or sisters who have had cervical cancer are at an increased risk.

2. Signs And Symptoms

As with ovarian cancer, early cervical cancers and pre-cancers usually show no signs or symptoms. Symptoms usually do not develop until the cancer has become invasive and invades nearby tissue. When this happens, the most common symptom is abnormal vaginal bleeding.

Unusual discharge from the vagina (separate from normal monthly menstruation) can also be a sign of cervical cancer. Such discharges may included blood spots or light bleeding and may occur between periods. Menstrual bleeding may also last longer and be heavier than usual.

Bleeding following intercourse, douching, or after a pelvic exam or pain during intercourse are common symptoms. All of theses signs and symptoms, however, may be caused by conditions other than cancer.

3. Tests

a. Pap test

Between 1955 and 1992, the number of cervical cancer deaths in the U.S. dropped by 74%. The death rate from cervical cancer continues to decrease about 2% per year. The main reason for this drop is the increased use and efficacy of the Pap test. The Pap test (also called a Pap smear) is a way to examine cells collected from the cervix (the lower, narrow end of the uterus). The main purpose of the Pap test is to find abnormal cells that may arise from cervical cancer or that may be present before cancer develops. During the Pap test, a small sample of cells is taken from the cervix with a wooden scraper or a small cervical brush. The cells are then sent to pathology for examination.

Most invasive cancers of the cervix can be prevented if women have regular Pap tests. As with most cancers, cancer of the cervix is more likely to be treated successfully if it is detected early.

Current guidelines recommend a Pap test at least once every three years, beginning about 3 years after the woman has sexual intercourse, but no later than age 21. Cervical cancer usually develops slowly and is extremely rare in women under the age of 25. Women ages 65 to 70 who have had at least three normal Pap tests and no abnormal results in the last 10 years may decide, after talking to their doctor, to stop having Pap tests.Likewise, women who have had a hysterectomy do not need a Pap test, unless the surgery was done for cancer or a precancerous lesion.

The five-year survival rate for cervical cancers that are caught early is nearly 100%. If it has spread to the lymph nodes or elsewhere, the survival rate becomes 92%. The overall (all stages combined) five-year relative survival rate for cervical cancer is about 71%.

Most labs use a standard set of terms called the Bethesda System to report Pap test results. Under the Bethesda System, Pap test results with no cell abnormalities are reported as "negative for intraepithelial lesion or malignancy." Samples with cell abnormalities are divided into several categories:

Atypical Squamous Cells (ASC): This term is used when it is not possible to tell (from microscopic examination) whether the abnormal cells are caused by an infection, another cause of irritation, or by a pre-cancer. The Pap test is usually repeated after several months, or other tests, such as colposcopy (explained below) and biopsy may be recommended, depending on the patient's history and the results of previous Pap tests. Some doctors recommend having an HPV test in this situation. If this test is negative, then only routine follow-up is needed. If it does show HPV, colposcopy is recommended.

Squamous Intraepithelial Lesions (SIL): These abnormalities are subdivided into low-grade SIL and high-grade SIL. All patients with a finding of a SIL should have colposcopy. High-grade SIL are less likely than low-grade SIL to go away without treatment and are more likely to eventually develop into cancer if they are not treated. Treatment, however, can cure all SIL and prevent true cancer from developing.

Squamous Cell Carcinoma: This cytology result indicates that the woman is likely to have an invasive squamous cell cancer. Further testing will be done to be sure of the diagnosis before doctors recommend treatments such as radiation therapy, chemotherapy, or radical surgery. Generally, a woman with SIL will have a colposcopy. If the biopsy shows SIL or dysplasia, steps will be taken to prevent actual cancer.

b. Colposcopy

If symptoms suggest cancer or if the Pap test shows abnormal cells, a colposcopy may be performed. In this procedure, the doctor views the cervix with a colposcope – an instrument with binocular-like magnification. The colposcope allows the doctor to view the surface of the cervix more clearly. If an abnormal area is found, a biopsy should be taken. If a Pap test shows SIL or, depending on her history, ASC, and no colposcopy is performed, you should inquire as to the physician’s rationale for not performing this relatively simple procedure.

In this procedure, also called a conization, the doctor removes a cone-shaped piece of tissue from the cervix. The base of the cone is formed by the ectocervix (outer part of the cervix) and the point is from the endocervical canal. The transformation zone (the border between the ectocervix and the endocervix) is within this cone. This is the area where pre-cancers and cancers are most likely to develop. The cone biopsy is also a treatment and can be used to remove pre-cancers and very early cancers.

d. Imaging studies

If cancer is found, plain chest x-rays will be performed to see if the cancer has spread to the lungs. A CT may be performed to give precise information about the size, shape and position of a tumor, and can find enlarged lymph nodes that may be cancerous. Many doctors feel that an MRI is better for evaluating cervical cancer than a CT scan.

III. LEGAL ANALYSIS OF FAILURE TO DIAGNOSE OVARIAN AND CERVICAL CANCER CASES

Because ovarian and cervical cancers are not readily susceptible to easy or early diagnosis, the lawyer’s job of evaluating cases based on the failure to diagnose such cancers can be very difficult. An analysis of such cases requires a thorough and educated review of the client’s complete medical history, a working knowledge of the relevant medicine and a review by a competent expert.

A. LEGAL CONSIDERATIONS

1. Standard of Care

The attorney, like the physician, must consider the risk factors and symptoms reported to the physician. The attorney must then determine whether, in light of the reported and recorded history and the known risk factors, the physician met the standard of care in diagnosing the cancer. For example, if a menopausal woman, with a family history of ovarian, cervical or breast cancer reports symptoms of bloating and general malaise and fatigue, the physician may have a duty to consider ovarian and cervical cancer in her differential diagnosis.

The standard of care, i.e., whether the defendant used that degree of skill and learning ordinarily used under the same or similar circumstances by the members of defendant’s profession, is a fact-based determination. Whether the standard of care was breached will likely depend on whether, under the circumstances, the physician put a clinical jigsaw puzzle together correctly and used the proper tools in order to reach a diagnosis. Only a qualified expert reviewing the totality of the facts and circumstances can make a final determination on this issue.

2. Causation

Most failure to diagnose cases will be filed as simple medical negligence actions. In many cancer cases, however, there is no clear-cut answer as to whether the client would have lived, or will live into the future, regardless of when and whether the cancer was caught. Even if a cancer is caught at its earliest stage, there is always a chance that the cancer will be fatal despite the best medical care. In this situation, the defendant doctor will almost inevitably argue that her negligence was not the cause of death. Rather, she will argue that the patient would have died regardless.

In this situation, you need to know whether your jurisdiction allows recovery for a lost chance of survival or similar cause of action. Traditionally, causation has been treated as a "yes-or-no" or "all-or-nothing" question: "Did the negligence cause the patient’s death?" In a cancer case, however, the "yes-or-no" version of reality does not match the real world "maybes," where a timely diagnosis does not guarantee a cure. It only increases the patient’s odds. This increased chance of recovery, however, has value and may entitle the patient to recover:

Because of the "maybes" involved, a plaintiff in a lost chance case is not required to show that the defendant doctor’s negligence was the "but for" cause of death. Rather, it is sufficient to prove that the patient lost a "statistically significant" chance of survival or recovery. If this proof is made, the recovery is reduced by the percentage chance lost by the patient. For example, if a delayed diagnosis caused the patient to go from a 75% chance of recovery to a 25% chance of recovery, the patient lost a 50% chance. Therefore, the damages calculated by the jury will be reduced by 50%.

3. Damages

Damages in failure to diagnose cancer cases can run the gamut from emotional distress to death. As a general rule, the more catastrophic the damages, the more significant the case. Further, practitioners should ask the question: "How would my client’s course have differed if the diagnosis had been made earlier?" If the answer is that your client would have simply gotten the same treatment earlier, the case should probably be declined. In short, unless the damages involve past or impending death or a significant lost chance of survival, the case may not be one to pursue.

4. Cases against auxiliary providers

Perhaps the better cases of failure to diagnose ovarian or cervical cancers are those based on failures by auxiliary providers. For example, if a pathology lab examining a Pap test slide fails to properly diagnose or to accurately report the findings of its evaluation, it is easier to show a breach of the standard of care. Further, the causation burden may be lessened because the failure may very well persist until a subsequent pap smear is done, which could be a year or more later. Practitioners should be very cautious about accepting or pursuing cases where the delay between diagnosis and discovery is not significant. We tend to reject any case where there is less than a one-year delay.

In cases where a pathology report or diagnosis is in issue, every effort should be made to obtain the original pathology slides. The original slides will be critical in determining whether the pathologist’s interpretation was correct and should be reviewed by your own expert before you decide to proceed with the case. Unfortunately, these slides are not readily produced and could be in one of several locations. They could be maintained by the patient’s primary care physician, her oncologist, or the lab that interpreted them. In extreme circumstances, a petition for pre-suit discovery may need to be filed in order to get the original slides.

5. Statute of limitations

The statute of limitations is another important consideration in cases involving the failure to diagnose cervical or ovarian cancer. In this age of "tort reform," the statute of limitations in medical negligence cases keeps getting shorter and shorter. It is quite possible that a patient may not even know about a missed diagnosis until two or more years after it was missed. In a state with no "discovery rule" or other exception to the statute of limitations, such a patient may be denied access to the courts. This unfortunate situation occurred in Missouri in the early 1990s.

In 1991, Ann Weiss had an abnormal Pap test but was never notified by her doctor. In 1995, she was diagnosed with endocervical cancer. She filed suit in 1996. The defendant doctor claimed that the suit was untimely in that it was filed more than two-years after the negligent act – the failure to inform her of the abnormal Pap test. Mrs. Weiss argued that her case should fall under a "discovery rule" and that her statute should start running only when she found out about the abnormal test results. Strictly interpreting the statute, the Missouri Supreme Court ruled that Mrs. Weiss’ case was barred by the statute of limitations. Shortly after this decision, the Missouri legislature added an exception to the Missouri medical negligence statute of limitations for cases where a patient is not informed of abnormal test results.

6. Issues of mitigation and/or comparative fault

Clients may be subject to attack on the issues of failure to mitigate and/or comparative fault. Clients can mitigate their chances of incurring ovarian and cervical cancers by avoiding controllable risk factors such as smoking and eating a healthy diet.

Defendants may attempt to compare the fault of the client by pointing out that she was non-compliant by failing to undergo regular Pap tests or to report symptoms that could have lead to a timely diagnosis.

In states using "modified comparative fault," where a client cannot recover if attributed 50% or more of the fault, practitioners should be very cautious when considering whether to take cases where comparative fault could be a legitimate defense.

IV. CONCLUSION

Any failure to diagnose cancer case can be difficult and expensive to pursue. Cases involving an alleged failure to diagnose ovarian cancer or cervical cancer can be particularly challenging. Before making a commitment to pursue such cases, thoroughly familiarize yourself with the medical issues, your client’s medical history and chart, and damage issues. Consult early with well-qualified experts and anticipate possible defenses.