In this study, in an effort to find ways to improve clinical decision-making by physicians in breast cancer diagnosis, the key medical and legal issues in breast cancer litigation involving pregnancy were identified.
Dr. M. M. Hamer is a radiologist with Montgomery
Radiology Associates, and Dr. B.C. Hamer is a consultant to
Baptist Health, Montgomery, AL.
Pregnant patients in the process of being examined for possible
breast cancer may require a higher degree of scrutiny from their
physicians. In this study, in an effort to find ways to improve
clinical decision-making by physicians in breast cancer diagnosis,
the key medical and legal issues in breast cancer litigation
involving pregnancy were identified.
While studying breast cancer litigation cases,
it was found that one subset of claims varied from the major set.
This article focuses on this subset of pregnancy and breast cancer
litigation cases with attention to claims, injury, and awards.To
our knowledge, there is little information on breast cancer
litigation cases involving pregnancy. NORCAL Mutual Insurance
Company presents a detailed description of a single pregnancy
breast cancer litigation case.
Other studies provide limited information such as the percent of
patients with breast cancer who are pregnant, or a brief clinical
review of the cases.
Materials and methods
Breast cancer litigation cases involving pregnancy were acquired
by searching a medical-legal database
between 1985 and 1998, cross-matching the terms
. This computer search resulted in 26 cases, of which one case was
irrelevant and was disqualified (since the breast cancer occurred
more than 1 year postpartum), yielding a total of 25 cases for this
These 25 cases were categorized by: (1) case number, (2) the
year the case was published in the database (usually within a year
from the date the case closed), (3) the patient's age at the time
of the alleged negligence, (4) patient history (e.g., lump
history), (5) the defendants by specialty, (6) the claims, (7) the
time delay in the diagnosis of breast cancer, (8) patient injury,
(9) patient treatment, (10) the method of resolution (verdict or
settlement), and (11) plaintiff award/compensation. This
information was compared to other breast cancer litigation data.
Some variables, such as the patient's age, delay in diagnosis,
and awards, were quantified. Other variables, such as defendants
and claims, were coded for the presence or absence of the variable.
Complete information was not available for all variables.
Therefore, statistical calculations were applied to the available
subset of data. Measures of central tendency, such as mean and
median, were used to determine summary statistics for the data
sets. Statistical comparative tests were not performed with the
study data due to the small sample sizes.
The Medical Malpractice Verdicts, Settlements & Experts
database contains information gathered from three main sources: (1)
state jury verdict publishers, (2) miscellaneous sources including
court records, and (3) attorneys. The state jury verdict
publishers' data source favors verdict over settlement information.
Also, the attorney data source affects the data and skews it in
favor of the plaintiff. Hence, this data source should not be
considered complete or perfectly balanced.
Statistical analysis was not performed with the study data
because of the small sample sizes. The percentages or ratios
calculated with the study data can be compared with findings from
other similar studies in order to develop a working hypothesis for
The patients in this study ranged in age from 27 to 44 years,
with an average age of 34 years. As a group, these patients were
approximately 10 to 11 years younger, on average, than the patients
associated with the breast cancer litigation cases discussed in the
Hamer et al
In this study, a lump is defined to include: a lump, a mass, a
thickening, fullness, swelling, or an enlarged breast. All 25
patients, or 100% of the study cases, alleged that a breast lump
was not diagnosed correctly. Approximately 74% of all patients in
the Hamer et al study
claimed that a breast lump was not diagnosed correctly.
The patients discovered 72% of lumps, while 12% were discovered
by physicians/nurses, and 16% were not specified. In both the Hamer
and the PIAA
studies, lumps were found by the patient in 60% of cases.
Reasons the patient claimed that physicians did not follow up on
breast lumps, or followed them up incorrectly, included: (1) lump
was assigned a benign diagnosis (56%), (2) breast lump was not
acknowledged by the doctor (12%), (3) failure to ensure follow-up
(12%), (4) reliance on negative imaging tests (12%), and (5)
miscellaneous reasons (8%).
In the Hamer et al
studies, dismissing the lump as benign was reported in 58% and 35%
of the cases, respectively.
A mammogram was performed in 7 of the 25 (28%) cases, of which
there were no known cases of failure to read a mammogram correctly.
Plaintiffs claimed failure to order a mammogram in 3 of the 25
(12%) cases. In one case, a radiologist refused a mammogram due to
lactation. Ultrasound (US) was performed in only one known case.
There was only one claim of failure to order a US exam.
All 25 plaintiffs in this study alleged failure to diagnose a
breast lump correctly. Common claim subcategories include failure
to: (1) biopsy a lump (32%), (2) obtain a second opinion (16%), and
(3) order a mammogram (12%). There were no claims of failure to
properly treat breast cancer.
The more common types of treatment included (1) mastectomy
(83%), (2) chemotherapy (60%), (3) radiation therapy (24%), and (4)
bone marrow transplant (8%).
The alleged delay in failure to diagnose breast cancer ranged
from 2 months to a little more than 2 years. The corresponding
average time delay was 12.2 months.
In the Hamer et al
studies, the corresponding average time delays were 15 and 14
The most common types of alleged injury include: (1) terminal
condition/ death (67%), (2) metastases (to sites including axillary
lymph nodes) (55%), and (3) abortion (16%). The terminal
condition/death rate of 67% is more than double the corresponding
rate of 31% for cases in the Hamer et al
Defendant information was not specified for about half of the
cases in this study, but it appears that obstetricians and
gynecologists are more likely to be involved than other specialty
Methods of resolution
The cases were adjudicated as follows: 52% by verdict, 44% by
settlement, and 4% were dismissed.
The mean/median award for these breast cancer litigation
subcategories were: pregnancy (25 cases) $1,136,000/$675,000; death
(16 cases) $1,608,000/$1,000,000; and abortion (3 cases)
The pregnancy award amounts are approximately three times
greater than the corresponding award amounts in the Hamer et al
Policy for follow-up of palable findings
For all cases in this study, patients claimed failure to
diagnose a breast lump correctly. Hence, it is important that
medical personnel have a policy for follow-up of breast lumps and a
comprehensive system of communication to ensure the follow-up of
Guidelines and risk management suggestions regarding breast
issues are provided by several authors.
notes the unusual presentation of some breast cancers in his
litigation population; he emphasizes that obscure physical findings
frequently led to a failure to appreciate the real problem.
Age and injury
Overall, the plaintiffs in these breast cancer litigation cases
involving pregnancy were young, with a high percentage of death
cases. In his study of failure to diagnose breast cancer, Cady
also found that patients were young and had advanced disease.
Injury and awards
The higher awards in this study compared with general breast
are probably due to the increased severity of the patient's
disability/injury, namely death. This finding is consistent with
the findings of Brennan et al.
Breast imaging in pregnant patients
Breast imaging can help in the care of pregnant patients with
breast lumps. Pregnant and lactating women do not always have dense
breasts, and mammography can be performed without substantial
concern for the limitations of breast density. Mammography can be
as useful in these women as it is in other women with breast signs
For example, Liberman et al
reported that mammographic findings were present in 78% (18 of 23)
of the cases.
Also, clinicians appear to be reluctant to use breast imaging in
pregnant patients; however, this can lead to a delay in diagnosis.
Ultrasound is the modality of choice for initial analysis of such a
breast mass in younger pregnant patients. Mammography with
shielding of the abdomen is recommended if there is suspicion of
Presentation of breast cancer in pregnant patients
Clinical data shows that comparing pregnant patients with breast
cancer with nonpregnant patients with breast cancer reveals no
difference in survival.
Pregnancy does not worsen the prognosis of breast cancer; rather,
it is hypothesized that it obscures the disease and allows it to
progress to a more advanced stage at presentation.
coupled with Cady's study
prompts medical personnel to have a higher index of concern when
dealing with pregnant patients who have obscure or vague
Breast cancer litigation cases involving pregnancy, when
compared with breast cancer litigation cases in general, are more
likely to: (1) claim failure to diagnosis a lump correctly, (2)
involve younger patients, (3) result in a terminal condition or
death, and (4) have higher award amounts.
The finding that pregnancy does not worsen the prognosis of
breast cancer and the hypothesis that it may obscure the disease
and allow it to progress to a more advanced stage at presentation
coupled with the results of Dr. Cady's study
and other similar findings
should encourage medical personnel to approach the pregnant patient
with a breast lump with a higher index of concern.
The authors would like to thank Charles Kaufman, JD for his
legal advice in the preparation of this article.