When time is running out: a delayed diagnosis of breast cancer may leave patients with little hope of recovery. Here's how to prove the physician's negligence.

Few people can say that they never knew a woman with breast cancer. The disease is expected to occur in about 12 percent of American women. (1) Each year, 193,700 new cases are reported, and 40,600 deaths occur. (2)

Despite the pervasiveness of the disease and the wide availability of information about early detection and treatment, failure to diagnose breast cancer remains the most common medical negligence claim in the United States. (3) In part, this is because the risk factors, such as age and childbearing history, are not clear-cut; in fact, 80 percent of women with breast cancer have none of them. (4) Most failure-to-diagnose claims are brought because the patient reported minor symptoms that the physician did not consider significant, or the physician failed to follow up with the patient. (5)

To represent a client with breast cancer effectively, you need an in-depth understanding of the nature and terminology of the disease, methods of treatment, and available diagnostic studies and their technological limitations. (6) While you conduct the necessary research and work with your experts, keep some basic principles in mind.

Carcinomas of the breast are generally formed from the epithelium, or lining, of mammary ducts and lobules. Ductal carcinomas, which account for about three-quarters of breast cancer cases, originate in the cells lining the ducts that bring milk to the nipple. Lobular carcinomas originate in the milk-secreting glands. Both types may be noninvasive (in situ), meaning the cancer is confined to its point of origin, or invasive, meaning it spreads to lymph nodes and throughout the lymph system. Ductal and lobular carcinomas are two distinct cancers with different clinical characteristics that may affect how they are treated. (7)

Doctors describe the severity of cancer in terms of stages, using the "tumor, node, metastasis" (TNM) classification system. (8) A breast cancer is assigned T, N, and M values based on how large the primary tumor is (T), whether lymph nodes are involved (N), and whether the cancer has metastasized, or spread beyond the breast (M0-M1). Then the cancer is designated by a stage number, I through IV. For example, patients with Stage I cancers--tumors measuring two centimeters or less in diameter (T1), with no nodal involvement (N0) and no metastasis (M0)--have the best prognosis. (9)

Physicians determine stages clinically or pathologically. Clinical staging depends on the doctor's physical examination and is often inaccurate, especially with regard to nodal involvement. Pathological staging entails microscopic analysis of the tissue, usually rendering a more definitive result.

In 60 percent of failure-to-diagnose cases, the patient visits her physician complaining of a small, painless lesion or mass she discovered in her breast. In most of the remaining cases, the physician discovers the lesion during a clinical breast exam. (10)

If the mass does not resolve within one menstrual cycle--or immediately after a mass is discovered in a postmenopausal woman (11)--the physician must rule out all possibility of a malignancy, usually starting with a diagnostic mammogram. However, as one study found, four out of five women who filed failure-to-diagnose claims had either negative or equivocal mammogram results, (12) so when there is a suspicious palpable mass, the standard of care requires that other diagnostic studies be conducted as well. (13)

The first step is to determine whether the mass is either solid or a cyst. This can usually be done by fine-needle aspiration or an ultrasound examination. If the mass is solid, a biopsy is necessary to exclude the possibility of a malignancy. (14) A fine-needle biopsy can be performed, but some studies have reported high false-negative results, particularly when the tumor is small. (15) The physician may also refer the patient to a surgeon for a biopsy, after which tissue is frozen and examined by a pathologist.

A third option is to remove the mass with an image-guided large-core needle. A recent study concluded that this method is an effective diagnostic alternative to surgical removal of suspicious, nonpalpable breast abnormalities. (16)

Where the delay in diagnosis is directly attributable to the physician, the case facts generally follow one of two common patterns. In many cases, the physician does not appreciate the significance of the physical findings from the clinical breast exam and fails to order further diagnostic studies. In other cases, the doctor fails to follow up with the patient. For example, he or she may fail to communicate tests results, schedule future appointments when results are inconclusive, or confirm whether the patient saw a specialist she was referred to. Many months later, the malignancy is discovered.

Evidence of the doctor's delay in making the diagnosis will form the cornerstone of your case. You will need to determine the stage at which the cancer could have been diagnosed and treated, compared with the stage at which it actually was diagnosed. The longer the delay, the stronger the possibility that the cancer could have been treated successfully if it had been diagnosed earlier.

A patient with Stage I cancer has only a 20 percent to 25 percent chance of progressing to Stage II if the disease is properly treated on time. (17) Stage I carcinomas are associated with the highest rate of survival; (18) with chemotherapy, the five-year survival rate is higher than 90 percent.

The average delay in failure to diagnose breast cancer is 14 months after the patient first discovered the mass. (19) Generally, potential plaintiffs whose diagnosis was delayed for more than a year deserve the closest scrutiny. A 20-year study of breast cancer litigation showed that 95 percent of the plaintiffs were in at least Stage II. (20) A delay of less than nine months to a year may pose causation problems: It will be more difficult to prove that the doctor's inaction reduced the patient's chance of survival.

The defendants

Most malpractice actions for failure to diagnose breast cancer are filed against the primary care physician--the gynecologist, internist, or family practitioner--from whom the patient has routinely sought treatment. (21) Claims against the radiologist who conducted or read the mammogram now account for the largest number of claims against any one specialty. (22)

Primary care physician. Most diagnostic delay cases arise because the physician relied solely on mammographic results and failed to adequately consider the patient's medical history. Also, the standard of care requires the doctor to order additional diagnostic studies when he or she has found a palpable mass in the breast but the mammogram yields negative results. Therefore, you should determine what the primary care physician did and what he or she documented in the patient's medical record.

If the patient visited the doctor with a lesion, did the physician make adequate inquiries about symptoms? With a pre-menopausal patient, did the doctor ask about the relationship of the lesion to her menstrual cycle, or about nipple discharge or changes in breast size? (23) Did the physician perform a clinical examination by palpating the entire breast in an overlapping pattern of vertical strips while the patient was lying down? (24) Did the examination last at least three minutes, as some authorities have recommended? (25)

If a mass is located during the exam, did the physician diagram the lump and note its location and when it was first detected? Did he or she document its consistency, texture, and mobility? A cancerous tumor is likely to be hard, have indistinct borders, and be fixed rather than movable.

Also, did the physician order additional diagnostic studies and ensure that the patient underwent the procedures? If the doctor referred the patient to a specialist, he or she should follow up on that referral. Also determine whether the primary care physician reviewed the client's laboratory and radiology results and followed up on any abnormalities.

In addition to evaluating the patient's complaints and the results of the clinical breast examination, the physician should consider the patient's age and medical history in making a diagnosis and assessing the need for further diagnostic studies. More than 80 percent of breast cancers occur in women over 40. (26) If the patient began menstruating before age 12, gave birth to her first child after age 30, or was over 55 at the onset of menopause, she has a higher than average risk of developing breast cancer, due to the effects of reproductive hormones.

The patient is also at greater risk if she has had breast cancer previously or if she has radial scars from an earlier biopsy, a proliferative benign breast disease, or any mammographic abnormalities such as a clinically suspicious mass. Also find out whether your client has had prolonged exposure to environmental factors linked to breast cancer and, if so, whether she revealed this to her physician.

A family history of breast cancer at an early age, especially in close relatives such as a mother or sister, places the patient at a much higher risk for breast cancer. (27) Despite the significance of the patient's family history, one recent study showed that only 12 percent of physicians documented this information in the patient's record. (28) If your client's family history of cancer is absent from her medical record, you have strong evidence that the physician ignored her increased risk.

Radiologist. Although the radiologist often has limited contact with the patient, this specialist may be the primary defendant. The radiologist is responsible for interpreting results of mammograms and other film studies such as X-rays and bone scans, which are used to determine whether the cancer has spread beyond the breast.

Many suits against radiologists arise from mammograms that lead to inaccurate diagnoses. Radiologists attribute the high rate of false-negative results to the limitations of the technology, but in some cases the radiologist fails to take into account the patient's medical history--and therefore her risk for the disease--when interpreting the mammogram.

In an attempt to standardize the terminology that radiologists use in evaluating mammograms, the American College of Radiology has published the Breast Imaging Reporting and Data System (BI-RADS). It categorizes mammographic results on a scale between 0 and 5.

A result of 0 represents an incomplete assessment, calling for additional imaging evaluation, while a result of 5 indicates a high likelihood of malignancy. (29) A result of 3 indicates a "probably benign" lesion with a maximum 2 percent possibility of cancer. (30)

While one study concluded that a category 3 lesion may be safely monitored without biopsy, (31) the radiologist and primary care physician should work together to determine the appropriate follow-up care for the patient, which may include additional physical examination and imaging studies. The primary care physician--or the radiologist if the patient is self-referred-- has a duty to inform the patient of this low risk of cancer and refer her to a surgeon if she concludes that it is unacceptable. (32)

The Mammography Quality Standards Act sets federal rules that radiologists must follow. (33) Its 1998 reauthorization act requires that a patient be provided a summary of her mammography results in plain language. (34)

Make sure that your client received and understood the summary. If the results were equivocal--for example, a BI-RADS rating of 3--determine whether the risks of malignancy were adequately explained to her and whether any alternative diagnostic studies were suggested.

Also find out whether the client's primary care physician was advised of the mammography results and whether the two doctors consulted about the need for further diagnostic testing.

In pursuing a claim against a radiologist, determine whether he or she relied on mammography alone in evaluating a palpable breast mass--not prudent practice given the high incidence of false negatives. In a deposition, explore whether the radiologist used proper evaluation methods.

For example, the radiologist has an obligation to obtain the patient's prior mammograms and review them in conjunction with a new one. (35) He or she also must obtain the patient's medical history and evaluate her mammogram in the context of her risk factors for breast cancer--including age, prior medical history, and family history for cancer. Find out whether the radiologist continued the evaluation until a breast cancer diagnosis was proved or excluded.

Also ask whether the radiologist had a system to ensure that the patient and primary care physician were promptly notified of the results. In one recent study of lawsuits against radiologists for failure to diagnose breast cancer, the researchers found that 80 percent of the time, the specialist failed to convey the results to the physician who ordered the test. (36)

The under-40 client

While women under 40 have a lower risk for breast cancer, their cancers are often more aggressive, (37) so a delayed diagnosis may affect them more significantly.

Younger women who die from the disease are deprived of a larger part of their average life expectancy and anticipated income and are more likely to be survived by minor children. Because cases involving younger women present distinctive issues, they merit special attention.

Often, the primary care physician is not suspicious of a lump in the breast of a younger woman because most malignancies occur in women over 50, so he or she is likely to base the diagnosis solely on a clinical breast exam, or the exam and a mammogram. (38) This approach, however, is inadequate.

First, hormonal fluctuations in pre-menopausal women can alter the results of a clinical breast exam. (39) Also, because younger women have denser breasts than older women, masses are sometimes more difficult to feel. (40)

Mammography is also likely to be an inadequate diagnostic tool in women under 40. Their higher breast density results in more false negatives and equivocal results. (41) And due to conflicting opinions regarding the optimal age to get a baseline mammogram, many women under 40 who develop a breast lesion do not have earlier test results to compare to new ones.

In the typical delayed-diagnosis case involving a woman under 40, the patient has a lump and her physician orders a mammogram, which produces a false negative result.

The physician, relying on the patient's relative youth, concludes that the mass is the result of hormones or some other benign condition and fails to order other diagnostic studies. (42) However, a physical examination with unimpressive findings and a negative mammogram are insufficient to rule out breast cancer in a woman under 40 whose mass does not disappear in 30 days. (43)

Regardless of the patient's age, the physician must continue testing until he or she can eliminate the possibility that the mass is cancerous.

Defenses

Breast density. The defendant physician may claim at trial that the patient's breast density impaired an accurate diagnosis from both the clinical breast exam and the mammogram. Check her medical records to determine whether, at the time of the examination, the physician documented that breast density made conducting the exam difficult.

Unresponsive tumor. The defendant may assert that even if the cancer had been diagnosed earlier, the outcome would have been the same because the cancer was unresponsive to treatment.

To combat this defense, have your expert interpret your client's blood chemistry levels after chemotherapy. If they improved, this may be evidence that the cancer responded to treatment. You also can argue that the response would have been even better had the tumor been smaller when treatment began.

Managed care. A recent report by medical malpractice insurers attributes the increase in failure-to-diagnose claims to, among other factors, managed care practices that discourage doctors from making referrals or ordering additional diagnostic procedures. (44) The defendant may raise managed care issues as mitigating circumstances at trial. Few studies have examined the impact of managed care on these cases, but one study of women age 65 or older concluded that HMO enrollees were less likely to have a delayed diagnosis than participants in fee-for-service plans. (45)

The patient's negligence. The patient has a responsibility to participate in her own medical care and to report to her doctor any changes in breast conditions. The defendant may try to use your client's conduct as a defense.

Determine whether she routinely performed breast self-examinations and whether she learned her technique from the defendant. Find out whether any of her actions contributed to the delay in diagnosis. If your client failed to keep physician appointments or follow her doctor's instructions to, for example, return for another examination if she detected changes in her breasts, her claim may be far more difficult to prove. Likewise, if your client habitually put off seeking medical treatment until a crisis arose, the jury may find that she contributed to the delayed diagnosis.

On the other hand, if she accepted responsibility for her own health by examining her breasts regularly and visiting her primary care physician annually, the jury is likely to view her more favorably.

Centuries after it was first recognized, breast cancer remains the leading cause of cancer death in women. (46) Despite increased awareness of the importance of early detection, thousands of new cases will be diagnosed each year, and of those, some will be made too late.

Prepare your breast cancer case using documents available from the ATLA Exchange.

The documents listed below from cases alleging failure to timely diagnose breast cancer, and many others on topics pertaining to medical negligence litigation, are available from the ATLA Exchange.

For more information, visit the Exchange Web site at exchange.atla. org, or contact the Exchange by phone at [phone] or by fax at [phone].

Ball v. Shanahan. Testimony of plaintiffs' oncology expert and defendant's expert. (No. LR461.)

Bennett v. McGrath. The parties' depositions of defendant's cancer surgery expert. (No. LR508.)

Borgren v. United States. Plaintiff's trial brief and proposed findings of fact and conclusions of law in a Federal Tort Claims Act case. (No. PN146.)

Condon v. Anne Arundel Medical Center. Complaint and motion in limine in a case against a hospital pathologist. (No. EX1905.)

Daigle v. Ami/St. Jude Hospital. Deposition of plaintiffs' oncology expert in a case alleging that a radiologist misread a mammogram. (No. LR2762.)

Davis v. Shapiro. Deposition of defendant's experts. (No. 4422.)

Doe v. Western Queens Community Hospital. Trial transcript excerpts containing testimony of breast surgery expert who testified for the plaintiff. (No. LR3403.)

Fatex v. Georgetown College. Deposition of plaintiffs standard of care expert. (No. 3623.)

Ferrence v. Lin. Second amended complaint in a case alleging failure to diagnose the continuing growth of plaintiffs breast cancer. (No. EX0611.)

Finley v. Culligan. Plaintiffs' brief regarding a jury instruction and alternative methods of treatment, and plaintiffs' appellate reply brief. (Nos. EX0305, EX0309.)

Fubini v. Seidler. Trial testimony of the defendant's radiology expert. (No. ex6090.w.)

Gorman v. LaRoche. Deposition transcripts of the parties' experts, (No. LR470.)

Harris v. Greater Baltimore Medical Center. Deposition of plaintiffs expert. (No. 4418.)

Haynes v. Hammack. Deposition of defendant's expert in a breast cancer surgery case. (No. 3875.)

Ienna v. PHP Healthcare Corp. Testimony of defendant's forensic pathology expert. (No. 1771.)

Lewis v. Virginia Physicians, Inc. Defense expert's deposition in a case alleging that plaintiff's breast cancer went undiagnosed despite a mammogram. (No. 3853.)

O'Dell v. Somerset OB/GYN Associates. Testimony of defendant's standard of care expert. (No. 3223.)

Stewart v. Lanzalotti. Deposition of defendant's expert in case alleging that treating doctor failed to diagnose plaintiff's breast cancer despite symptom of bloody nipple discharge. (No. 3848.)

Warehime v. Franks. Deposition of defendant's standard of care expert in a case alleging nipple necrosis and post-operative complications after breast cancer surgery. (No. 3156.)

Watts v. Miller. Plaintiff's amended complaint and response to a memorandum in support of a motion for partial summary judgment, in a case alleging failure to complete a proper biopsy procedure and failure to completely remove a cancer in a simple mastectomy. (No. EX10.167.)

L313 1MMA 

Notes

(1.) Mary B. Barton et al., Does This Patient Have Breast Cancer? The Screening Clinical Breast Examination: Should It Be Done? How? 282 JAMA 1270, 1271 (1999).

(2.) Cancer Screening Guidelines at a Glance, ATLANTA J.-CONST., Feb. 6, 2001, at C4.

(3.) PHYSICIAN INSURERS ASS'N OF AM., BREAST CANCER STUDY 1 (1995) (on file with authors) [hereafter PIAA STUDY].

(4.) AM. COLL. OF OBSTETRICIANS & GYNECOLOGISTS, PRECIS V: AN UPDATE IN OBSTETRICS AND GYNECOLOGY 301 (1994).

(5.) PIAA STUDY, supra note 3, at 14.

(6.) For an overview of breast cancer for the non-physician, see generally STEVE AUSTIN & CATHY HITCHCOCK, BREAST CANCER: WHAT YOU SHOULD KNOW (BUT MAY NOT BE TOLD) ABOUT PREVENTION, DIAGNOSIS, AND TREATMENT (1994); CHARLES B. SIMONE, BREAST HEALTH (1995).

(7.) See generally DIAGNOSIS AND MANAGEMENT OF BREAST CANCER (Marc E. Lippman et al. eds., 1998).

(8.) See generally AMERICAN JOINT COMM. ON CANCER, AJCC MANUAL FOR STAGING CANCER (5th ed. 1997).

(9.) Id. at 173-76.

(10.) PIAA STUDY, supra note 3, at 11.

(11.) Blake Cady et al., Evaluation of Common Breast Problems: Guidance for Primary Care Providers, 48 CA: CANCER J. CLINICIANS 49, 51 (1998).

(12.) PIAA STUDY, supra note 3, at 5.

(13.) Jane Rose Osuch, Abnormalities on Physical Examination, in DISEASES OF THE BREAST [section] 5.3, at 110, 113 (J.R. Harris et al. eds., 1996); Cady et al., supra note 11, at 53.

(14.) Cady et. al, supra note 11, at 56.

(15.) Id. at 54.

(16.) Jack E. Meyer et al., Large-Core Needle Biopsy of Nonpalpable Breast Lesions, 281 JAMA 1638 (1999).

(17.) Baine P. Kerr, Cell Proliferation: A New Key to the Cancer Causation Puzzle, 13 PROF. NEG. L. REP. 34 (1998).

(18.) DIAGNOSIS AND MANAGEMENT OF BREAST CANCER, supra note 7, at 276.

(19.) PIAA STUDY, supra note 3, at 14.

(20.) Kenneth A. Kern, Causes of Breast Cancer Malpractice Litigation: A 20-Year Civil Court Review, 127 ARCHIVES SURGERY 542, 543 (1992).

(21.) PIAA STUDY, supra note 3, at 10.

(22.) Id.

(23.) Rosary Morelli & Linda Ruma, Considerations in Defending Failure to Diagnose Breast Cancer Cases, Ninth Annual Symposium on Failure to Diagnose Breast Cancer, L.J. Seminars Press (1998).

(24.) See Barton et al., supra note 1, at 1276.

(25.) See, e.g., id. at 1277.

(26.) Council Report of Council on Scientific Affairs, Early Detection of Breast Cancer, 252 JAMA 3008 (1984).

(27.) See Barton et al., supra note 1, at 1271.

(28.) Robert Steyskal, Minimizing the Risk of Delayed Diagnosis of Breast Cancer, 1 MEDSCAPE WOMEN'S HEALTH (1996), available at womenshealth.medscape.com.

(29.) AM. COLL. RADIOLOGY, ILLUSTRATED BREAST IMAGING REPORTING AND DATA SYSTEM (BI-RADS) 180-81 (3d ed. 1998).

(30.) See Cady et al., supra note 11, at 58.

(31.) Susan G. Orel et al., BI-RADS Categorization as a Predictor of Malignancy, 211 RADIOLOGY 845 (1999).

(32.) See Cady et al., supra note 11, at 58.

(33.) 42 U.S.C. [section] 263b (1999); see also 21 C.F.R. [subsection] 900.1-900.9 (2001).

(34.) 42 U.S.C. [section] 263b(f)(1)(G)(ii)(IV) (1999).

(35.) American College of Radiology, Guidelines for Mammography, 38 AM. CANCER REV. BULL. 6 (1982).

(36.) William Boggs, Simple Steps Help Radiologists Avoid Liability Exposure on Breast Cancer Claims, MEDSCAPE (2000) (on file with authors).

(37.) Cheryl Weinstock, Breast Cancer and Young Women, AM. HEALTH, July/Aug. 1993, at 10-11.

(38.) See Osuch, supra note 13, at 111.

(39.) Id.

(40.) PIAA STUDY, supra note 3, at 19-20.

(41.) See Cady et al, supra note 11, at 53.

(42.) Sharon S. Lutz, Breast Cancer Litigation: When Is the Physician Liable? TRIAL, Dec. 1995, at 46; see also Kenneth A. Kern, The Delayed Diagnosis of Breast Cancer: Biologic, Technologic, and Sociologic Factors, 45 CONTEMP. SURGERY 286, 287-88 (1994).

(43.) See, e.g., Kern, supra note 42, at 288.

(44.) Bonnie Darves, Failure to Diagnose Claims on the Rise, WebMD BUS. MED. (June 12, 2000) (on file with authors).

(45.) Gerald F. Riley et al., Stage of Diagnosis and Treatment Patterns Among Older Women with Breast Cancer: An HMO and Fee-for-Service Comparison, 281 JAMA 720 (1999).

(46.) Courtney M. Townsend Jr., Breast Lumps, 32 CLINICAL SYMPOSIA 1 (1980).

Mia I. Frieder is a partner in Hilley & Frieder in Atlanta. Antoinette D. Johnson is a member of Smolar, Roseman & Seifter in Atlanta. They are the authors of Georgia Medical Malpractice: Practice and Procedure, to be published by Matthew-Bender in January 2002.