Samuel Zylstra, MD, MPH

Breast cancer is the number 1 most frequently misdiagnosed condition in malpractice claims, and failure to perform adequate and timely follow-up is often at the root of these cases.

This article considers lessons to be learned from 4 malpractice cases involving allegations of inadequate follow-up and misdiagnosis of breast cancer. We focus on specific red flags, and a “systems approach” to adequate follow-up of breast screening findings and patient complaints. We focus on these questions:

• Which are the most important factors in risk management related to breast cancer?
  
• What can you do to reduce your risk?
  

We analyzed 132 breast cancer cases closed by ProMutual Group of Boston, the total number of breast cancer cases closed by the company between January 1999 and December 2004. These cases closed with an aggregate indemnity payment of over $47 million, including 12 cases with payments of $1 million or more.

Defendant lineup

The 132 cases involved 279 defendants, including:

• 129 radiologists (46%),
  
• 78 women’s health professionals (ObGyns, internists, and family physicians; 28%),
  
• 43 surgeons (15%),
  
• 2 pathologists (1%), and
  
• 1 physician each from several different specialties.
  

Although the number of defendants included in this 6-year study differs only slightly from the number identified in an earlier 12-year study,¹ the percentages of cases attributable to women’s health practitioners (28%) and radiologists (46%) have reversed. In the older study, women’s health care providers were cited as defendants in 45% of cases and radiologists in 24%. The other percentages have remained constant.

Red flag high-risk patients, screen early and in-depth

Diagnosing breast cancer in its earliest stages is the most effective way to reduce risk of litigation, as well as morbidity and mortality. The first step is to identify the patients at high risk and take care to perform earlier, and perhaps more in-depth, screening for these women.

Kern’s triad of errors portends litigation

Kern² identified a “triad of errors” to beware:

• young age
  
• self-discovered breast mass
  
• negative mammogram.
  

When all 3 of these factors are present, litigation is especially likely.

Analyses of these breast cancer cases^1,3 reveals that patients with an eventual breast cancer diagnosis of stage II or higher are more likely to file claims (though claims are not limited to this group).

LUCY’S CLAIM

35 office visits and no screening

Lucy, age 66, was seen 35 times by her physician and other health care providers over an 8-year period. Although she had a positive family history of breast cancer, no clinical breast examination was conducted at any of the visits. Ultimately, a mammogram was performed and found to be suspicious for cancer. A biopsy was positive. One year later, she had widespread metastases and filed a malpractice claim. Defense experts faulted the physician for “failing to undertake any preventive care.”

The case closed with an indemnity payment in the $500,000 range.

Completely omitting breast cancer screening invites a lawsuit, but avoiding litigation is not as simple as performing regular screening.

You must be prepared to question negative test results when the clinical examination is positive, to listen to the patient, and to follow through to diagnosis each positive clinical finding and every complaint that the patient brings up.

Inadequate follow-up: Many and varied

FIONA’S CLAIM

Negative aspirate and palpable mass

Fiona, 33, presented to her ObGyn with a painful breast mass of 3 months’ duration. The ObGyn referred her to a surgeon, who performed a fine-needle aspiration. Cytology revealed neither cells nor fluid, and the surgeon diagnosed “residual fibrocystic changes.” Eighteen months later Fiona was diagnosed with metastases to the liver. Defense experts faulted the ObGyn for not following up on the negative fine-needle aspiration: “When a needle aspirate is negative or does not reveal fluid and a mass is palpated, the mass is cancer until proven otherwise.”

This case closed with an indemnity payment of roughly $500,000.

Failure to perform adequate and timely follow-up lies at the root of many breast cancer cases, according to successive studies by the risk management department of ProMutual Group. In some instances, a missed screening or diagnostic test was not rescheduled; in others, a mammogram or slide was misread or the wrong breast mass was excised.

In some lawsuits, the issue was the physician’s assumption of benign disease before cancer was ruled out.

 

Reality: Patients do detect malignancies by self-exam

Breast cancer can be difficult to diagnose in its earliest stages. Correct diagnosis may be preceded by multiple complementary examinations, the first of which is likely to be the patient’s breast self-examination. Although self-examination has been derided in some professional circles of late, many physicians are alerted to the presence of a breast mass only after a patient reports finding a “lump.”

Each such mass requires clinical investigation, starting with a breast exam to evaluate symmetry, contour, texture, nodularity, the mass itself, tenderness, and any nipple discharge.

Mammography is imperfect

Although mammography is the most widely used screening tool, its reliability is limited, particularly in young women, whose dense, fibroglandular tissue can obscure the diagnosis. The number of false-negative reports may make mammography a questionable diagnostic tool for symptomatic women—unless the results are positive.

No “best” technology

Ultrasound yields information about variations in tissue sound transmission, while cytology reveals the microscopic appearance of the cells and other tissue components.

Each assessment tool has its place and limitations, and these vary from patient to patient.

Lawsuit is likely if screening ends too soon

OLIVIA’S CLAIM

Negative mammogram, palpable mass

Olivia was 31 when she reported finding a mass in her breast. Her ObGyn examined her and noted “dense fibroglandular breast tissue with specific nodularity.” A diagnostic mammogram followed and was negative. When the physician observed no changes at a visit 2 months later, Olivia was told she need not return until her next annual examination. When she did, she was diagnosed with infiltrating ductal carcinoma.

After reviewing the case, defense experts noted, “It is common to find negative mammograms and yet have palpable masses that require either ultrasound or core biopsy for diagnosis. This patient had specific complaints at numerous intervals in the course of her clinical history. The physician’s inaction may have [been responsible for the] change in her clinical course.”

Olivia’s case closed with an indemnity payment of just under $1 million.

In the absence of comprehensive follow-up, a malpractice suit alleging “failure to diagnose breast cancer” is likely, as in Olivia’s case.

Misdiagnosis is another common cause of litigation. According to surveys conducted by the Physician Insurers Association of America (PIAA) in 1990 and 1995,^4,5 breast cancer is the number 1 most frequently misdiagnosed condition in malpractice claims. The most common reason given by expert reviewers in the PIAA study: “Physical findings failed to impress the physician.” Consider this example:

JACQUELINE’S CLAIM

Cancer or galactocele?

Jacqueline, 33, was told by her ObGyn that a breast mass discovered while she was in labor was a “clogged milk duct.” The medical record was not annotated. When the same mass was palpated postpartum, Jacqueline was told it was a sebaceous cyst. Again, the medical record failed to reflect the findings. One year later, Jacqueline changed physicians and underwent fine-needle aspiration, which confirmed malignancy.

Defense experts faulted the physician for his poor recordkeeping and failure to order a mammogram, ultrasound, or any follow-up despite the continued concerns of the patient.

This case closed with an indemnity payment in the $1 million range.

“Systems approach” to cutting risk of lawsuits

The cases of Lucy, Fiona, Olivia, and Jacqueline represent only some of the issues that give rise to malpractice claims. Since breast care is fragmented across medical specialties, a systematic approach is encouraged.

 

Systems form the basis of good risk management. The ProMutual Group advocates that every medical practice—whether office- or hospital-based—have a comprehensive risk management program that incorporates some or all of the following suggestions.

Annual exam not always enough

Even more frequent screening may be necessary if the patient has a specific breast complaint.

Every practice should have guidelines for these exams, including instructions on identifying women at risk because of personal or family history (ALGORITHM).

Ultrasound, MRI for young women

Younger, otherwise healthy women with unimpressive findings such as nodularities, nipple discharge, or tenderness deserve extra attention. The physician may want to consider additional diagnostic tests such as ultrasound or MRI for this group.

Never disregard a complaint

If a woman complains of discomfort or a self-detected mass, immediate evaluation is imperative. This includes pregnant patients; do not wait until after delivery to investigate an abnormality.

Use your own guidelines, but justify deviations from the norm

These may include earlier screening for women at risk, and need not match the recommendations of a nationally recognized group. However, in the event of a claim or suit, you will need to justify the reason for deviating from widely accepted guidelines.

Incorporate a systematic approach to diagnosis, treatment, referral (if required), and follow-up breast care.

Using an algorithm can help minimize error, confusion, and delays in care.

Assume cancer until it is ruled out

Consider diagnostic mammography and, when indicated, ultrasound imaging when the screening mammogram of a patient with a palpable mass is either negative or inconclusive.

A fine-needle aspiration or biopsy is a must to resolve indeterminate breast symptoms or inconclusive diagnostic breast imaging tests.

What not to say to patients

Do not assure the patient that a breast mass is benign until it is proven to be so.

Are you the “default PCP”? Screen for other cancers

When more than 1 physician is involved, someone needs to assume responsibility for the patient’s ongoing breast care. In a malpractice case, a doctor cannot simply claim that a routine mammogram or diagnostic test was deferred because it was assumed another physician would handle it.

In most cases, the patient’s primary care physician has the responsibility for her care.

ObGyn can be held to primary care physician standard. If the ObGyn is her only physician, the ObGyn may be held to a primary care standard—not only for breast and cervical cancer screening, but also for colorectal, skin, and other cancers.

Any physicians involved in a woman’s care should decide between them, as early in the process as possible, who will assume responsibility for ongoing care. According to the Agency for Healthcare Research and Quality,^6-9 that physician oversees follow-up, monitoring, and tracking women with abnormal findings, including those for whom a biopsy is recommended.

The designation of responsibility and accountability should be documented in the medical record.

The radiology facility’s responsibility. The facility that performs the patient’s mammograms must share responsibility with the designated physician for follow-up, monitoring, and tracking abnormal test results. Each facility should have a system for tracking positive mammogram findings and, according to the Agency for Healthcare Research and Quality, “a process for correlating findings with biopsy results.” It also has the duty to communicate urgent or significant findings to physicians and, under certain circumstances, to the patient directly.

If more than 1 physician is involved, everyone should know who is responsible for coordinating the patient’s ongoing care. Good communication is especially critical when abnormal findings are involved and additional imaging or more invasive testing is needed.

Document, document, document

ProMutual Group’s studies repeatedly show that inadequate records—whether paper or electronic—substantially reduce the chance for a successful defense.

Dr. Zylstra reports no financial relationships relevant to this article. Ms. Greenwald and Ms. Mondor are employees of ProMutual Group, Boston.

Breast cancer is the number 1 most frequently misdiagnosed condition in malpractice claims, and failure to perform adequate and timely follow-up is often at the root of these cases.

This article considers lessons to be learned from 4 malpractice cases involving allegations of inadequate follow-up and misdiagnosis of breast cancer. We focus on specific red flags, and a “systems approach” to adequate follow-up of breast screening findings and patient complaints. We focus on these questions:

• Which are the most important factors in risk management related to breast cancer?
  
• What can you do to reduce your risk?
  

We analyzed 132 breast cancer cases closed by ProMutual Group of Boston, the total number of breast cancer cases closed by the company between January 1999 and December 2004. These cases closed with an aggregate indemnity payment of over $47 million, including 12 cases with payments of $1 million or more.

Defendant lineup

The 132 cases involved 279 defendants, including:

• 129 radiologists (46%),
  
• 78 women’s health professionals (ObGyns, internists, and family physicians; 28%),
  
• 43 surgeons (15%),
  
• 2 pathologists (1%), and
  
• 1 physician each from several different specialties.
  

Although the number of defendants included in this 6-year study differs only slightly from the number identified in an earlier 12-year study,¹ the percentages of cases attributable to women’s health practitioners (28%) and radiologists (46%) have reversed. In the older study, women’s health care providers were cited as defendants in 45% of cases and radiologists in 24%. The other percentages have remained constant.

Red flag high-risk patients, screen early and in-depth

Diagnosing breast cancer in its earliest stages is the most effective way to reduce risk of litigation, as well as morbidity and mortality. The first step is to identify the patients at high risk and take care to perform earlier, and perhaps more in-depth, screening for these women.

Kern’s triad of errors portends litigation

Kern² identified a “triad of errors” to beware:

• young age
  
• self-discovered breast mass
  
• negative mammogram.
  

When all 3 of these factors are present, litigation is especially likely.

Analyses of these breast cancer cases^1,3 reveals that patients with an eventual breast cancer diagnosis of stage II or higher are more likely to file claims (though claims are not limited to this group).

LUCY’S CLAIM

35 office visits and no screening

Lucy, age 66, was seen 35 times by her physician and other health care providers over an 8-year period. Although she had a positive family history of breast cancer, no clinical breast examination was conducted at any of the visits. Ultimately, a mammogram was performed and found to be suspicious for cancer. A biopsy was positive. One year later, she had widespread metastases and filed a malpractice claim. Defense experts faulted the physician for “failing to undertake any preventive care.”

The case closed with an indemnity payment in the $500,000 range.

Completely omitting breast cancer screening invites a lawsuit, but avoiding litigation is not as simple as performing regular screening.

You must be prepared to question negative test results when the clinical examination is positive, to listen to the patient, and to follow through to diagnosis each positive clinical finding and every complaint that the patient brings up.

Inadequate follow-up: Many and varied

FIONA’S CLAIM

Negative aspirate and palpable mass

Fiona, 33, presented to her ObGyn with a painful breast mass of 3 months’ duration. The ObGyn referred her to a surgeon, who performed a fine-needle aspiration. Cytology revealed neither cells nor fluid, and the surgeon diagnosed “residual fibrocystic changes.” Eighteen months later Fiona was diagnosed with metastases to the liver. Defense experts faulted the ObGyn for not following up on the negative fine-needle aspiration: “When a needle aspirate is negative or does not reveal fluid and a mass is palpated, the mass is cancer until proven otherwise.”

This case closed with an indemnity payment of roughly $500,000.

Failure to perform adequate and timely follow-up lies at the root of many breast cancer cases, according to successive studies by the risk management department of ProMutual Group. In some instances, a missed screening or diagnostic test was not rescheduled; in others, a mammogram or slide was misread or the wrong breast mass was excised.

In some lawsuits, the issue was the physician’s assumption of benign disease before cancer was ruled out.

 

Reality: Patients do detect malignancies by self-exam

Breast cancer can be difficult to diagnose in its earliest stages. Correct diagnosis may be preceded by multiple complementary examinations, the first of which is likely to be the patient’s breast self-examination. Although self-examination has been derided in some professional circles of late, many physicians are alerted to the presence of a breast mass only after a patient reports finding a “lump.”

Each such mass requires clinical investigation, starting with a breast exam to evaluate symmetry, contour, texture, nodularity, the mass itself, tenderness, and any nipple discharge.

Mammography is imperfect

Although mammography is the most widely used screening tool, its reliability is limited, particularly in young women, whose dense, fibroglandular tissue can obscure the diagnosis. The number of false-negative reports may make mammography a questionable diagnostic tool for symptomatic women—unless the results are positive.

No “best” technology

Ultrasound yields information about variations in tissue sound transmission, while cytology reveals the microscopic appearance of the cells and other tissue components.

Each assessment tool has its place and limitations, and these vary from patient to patient.

Lawsuit is likely if screening ends too soon

OLIVIA’S CLAIM

Negative mammogram, palpable mass

Olivia was 31 when she reported finding a mass in her breast. Her ObGyn examined her and noted “dense fibroglandular breast tissue with specific nodularity.” A diagnostic mammogram followed and was negative. When the physician observed no changes at a visit 2 months later, Olivia was told she need not return until her next annual examination. When she did, she was diagnosed with infiltrating ductal carcinoma.

After reviewing the case, defense experts noted, “It is common to find negative mammograms and yet have palpable masses that require either ultrasound or core biopsy for diagnosis. This patient had specific complaints at numerous intervals in the course of her clinical history. The physician’s inaction may have [been responsible for the] change in her clinical course.”

Olivia’s case closed with an indemnity payment of just under $1 million.

In the absence of comprehensive follow-up, a malpractice suit alleging “failure to diagnose breast cancer” is likely, as in Olivia’s case.

Misdiagnosis is another common cause of litigation. According to surveys conducted by the Physician Insurers Association of America (PIAA) in 1990 and 1995,^4,5 breast cancer is the number 1 most frequently misdiagnosed condition in malpractice claims. The most common reason given by expert reviewers in the PIAA study: “Physical findings failed to impress the physician.” Consider this example:

JACQUELINE’S CLAIM

Cancer or galactocele?

Jacqueline, 33, was told by her ObGyn that a breast mass discovered while she was in labor was a “clogged milk duct.” The medical record was not annotated. When the same mass was palpated postpartum, Jacqueline was told it was a sebaceous cyst. Again, the medical record failed to reflect the findings. One year later, Jacqueline changed physicians and underwent fine-needle aspiration, which confirmed malignancy.

Defense experts faulted the physician for his poor recordkeeping and failure to order a mammogram, ultrasound, or any follow-up despite the continued concerns of the patient.

This case closed with an indemnity payment in the $1 million range.

“Systems approach” to cutting risk of lawsuits

The cases of Lucy, Fiona, Olivia, and Jacqueline represent only some of the issues that give rise to malpractice claims. Since breast care is fragmented across medical specialties, a systematic approach is encouraged.

 

Systems form the basis of good risk management. The ProMutual Group advocates that every medical practice—whether office- or hospital-based—have a comprehensive risk management program that incorporates some or all of the following suggestions.

Annual exam not always enough

Even more frequent screening may be necessary if the patient has a specific breast complaint.

Every practice should have guidelines for these exams, including instructions on identifying women at risk because of personal or family history (ALGORITHM).

Ultrasound, MRI for young women

Younger, otherwise healthy women with unimpressive findings such as nodularities, nipple discharge, or tenderness deserve extra attention. The physician may want to consider additional diagnostic tests such as ultrasound or MRI for this group.

Never disregard a complaint

If a woman complains of discomfort or a self-detected mass, immediate evaluation is imperative. This includes pregnant patients; do not wait until after delivery to investigate an abnormality.

Use your own guidelines, but justify deviations from the norm

These may include earlier screening for women at risk, and need not match the recommendations of a nationally recognized group. However, in the event of a claim or suit, you will need to justify the reason for deviating from widely accepted guidelines.

Incorporate a systematic approach to diagnosis, treatment, referral (if required), and follow-up breast care.

Using an algorithm can help minimize error, confusion, and delays in care.

Assume cancer until it is ruled out

Consider diagnostic mammography and, when indicated, ultrasound imaging when the screening mammogram of a patient with a palpable mass is either negative or inconclusive.

A fine-needle aspiration or biopsy is a must to resolve indeterminate breast symptoms or inconclusive diagnostic breast imaging tests.

What not to say to patients

Do not assure the patient that a breast mass is benign until it is proven to be so.

Are you the “default PCP”? Screen for other cancers

When more than 1 physician is involved, someone needs to assume responsibility for the patient’s ongoing breast care. In a malpractice case, a doctor cannot simply claim that a routine mammogram or diagnostic test was deferred because it was assumed another physician would handle it.

In most cases, the patient’s primary care physician has the responsibility for her care.

ObGyn can be held to primary care physician standard. If the ObGyn is her only physician, the ObGyn may be held to a primary care standard—not only for breast and cervical cancer screening, but also for colorectal, skin, and other cancers.

Any physicians involved in a woman’s care should decide between them, as early in the process as possible, who will assume responsibility for ongoing care. According to the Agency for Healthcare Research and Quality,^6-9 that physician oversees follow-up, monitoring, and tracking women with abnormal findings, including those for whom a biopsy is recommended.

The designation of responsibility and accountability should be documented in the medical record.

The radiology facility’s responsibility. The facility that performs the patient’s mammograms must share responsibility with the designated physician for follow-up, monitoring, and tracking abnormal test results. Each facility should have a system for tracking positive mammogram findings and, according to the Agency for Healthcare Research and Quality, “a process for correlating findings with biopsy results.” It also has the duty to communicate urgent or significant findings to physicians and, under certain circumstances, to the patient directly.

If more than 1 physician is involved, everyone should know who is responsible for coordinating the patient’s ongoing care. Good communication is especially critical when abnormal findings are involved and additional imaging or more invasive testing is needed.

Document, document, document

ProMutual Group’s studies repeatedly show that inadequate records—whether paper or electronic—substantially reduce the chance for a successful defense.

Dr. Zylstra reports no financial relationships relevant to this article. Ms. Greenwald and Ms. Mondor are employees of ProMutual Group, Boston.

Breast cancer is the number 1 most frequently misdiagnosed condition in malpractice claims, and failure to perform adequate and timely follow-up is often at the root of these cases.

This article considers lessons to be learned from 4 malpractice cases involving allegations of inadequate follow-up and misdiagnosis of breast cancer. We focus on specific red flags, and a “systems approach” to adequate follow-up of breast screening findings and patient complaints. We focus on these questions:

• Which are the most important factors in risk management related to breast cancer?
  
• What can you do to reduce your risk?
  

We analyzed 132 breast cancer cases closed by ProMutual Group of Boston, the total number of breast cancer cases closed by the company between January 1999 and December 2004. These cases closed with an aggregate indemnity payment of over $47 million, including 12 cases with payments of $1 million or more.

Defendant lineup

The 132 cases involved 279 defendants, including:

• 129 radiologists (46%),
  
• 78 women’s health professionals (ObGyns, internists, and family physicians; 28%),
  
• 43 surgeons (15%),
  
• 2 pathologists (1%), and
  
• 1 physician each from several different specialties.
  

Although the number of defendants included in this 6-year study differs only slightly from the number identified in an earlier 12-year study,¹ the percentages of cases attributable to women’s health practitioners (28%) and radiologists (46%) have reversed. In the older study, women’s health care providers were cited as defendants in 45% of cases and radiologists in 24%. The other percentages have remained constant.

Red flag high-risk patients, screen early and in-depth

Diagnosing breast cancer in its earliest stages is the most effective way to reduce risk of litigation, as well as morbidity and mortality. The first step is to identify the patients at high risk and take care to perform earlier, and perhaps more in-depth, screening for these women.

Kern’s triad of errors portends litigation

Kern² identified a “triad of errors” to beware:

• young age
  
• self-discovered breast mass
  
• negative mammogram.
  

When all 3 of these factors are present, litigation is especially likely.

Analyses of these breast cancer cases^1,3 reveals that patients with an eventual breast cancer diagnosis of stage II or higher are more likely to file claims (though claims are not limited to this group).

LUCY’S CLAIM

35 office visits and no screening

Lucy, age 66, was seen 35 times by her physician and other health care providers over an 8-year period. Although she had a positive family history of breast cancer, no clinical breast examination was conducted at any of the visits. Ultimately, a mammogram was performed and found to be suspicious for cancer. A biopsy was positive. One year later, she had widespread metastases and filed a malpractice claim. Defense experts faulted the physician for “failing to undertake any preventive care.”

The case closed with an indemnity payment in the $500,000 range.

Completely omitting breast cancer screening invites a lawsuit, but avoiding litigation is not as simple as performing regular screening.

You must be prepared to question negative test results when the clinical examination is positive, to listen to the patient, and to follow through to diagnosis each positive clinical finding and every complaint that the patient brings up.

Inadequate follow-up: Many and varied

FIONA’S CLAIM

Negative aspirate and palpable mass

Fiona, 33, presented to her ObGyn with a painful breast mass of 3 months’ duration. The ObGyn referred her to a surgeon, who performed a fine-needle aspiration. Cytology revealed neither cells nor fluid, and the surgeon diagnosed “residual fibrocystic changes.” Eighteen months later Fiona was diagnosed with metastases to the liver. Defense experts faulted the ObGyn for not following up on the negative fine-needle aspiration: “When a needle aspirate is negative or does not reveal fluid and a mass is palpated, the mass is cancer until proven otherwise.”

This case closed with an indemnity payment of roughly $500,000.

Failure to perform adequate and timely follow-up lies at the root of many breast cancer cases, according to successive studies by the risk management department of ProMutual Group. In some instances, a missed screening or diagnostic test was not rescheduled; in others, a mammogram or slide was misread or the wrong breast mass was excised.

In some lawsuits, the issue was the physician’s assumption of benign disease before cancer was ruled out.

 

Reality: Patients do detect malignancies by self-exam

Breast cancer can be difficult to diagnose in its earliest stages. Correct diagnosis may be preceded by multiple complementary examinations, the first of which is likely to be the patient’s breast self-examination. Although self-examination has been derided in some professional circles of late, many physicians are alerted to the presence of a breast mass only after a patient reports finding a “lump.”

Each such mass requires clinical investigation, starting with a breast exam to evaluate symmetry, contour, texture, nodularity, the mass itself, tenderness, and any nipple discharge.

Mammography is imperfect

Although mammography is the most widely used screening tool, its reliability is limited, particularly in young women, whose dense, fibroglandular tissue can obscure the diagnosis. The number of false-negative reports may make mammography a questionable diagnostic tool for symptomatic women—unless the results are positive.

No “best” technology

Ultrasound yields information about variations in tissue sound transmission, while cytology reveals the microscopic appearance of the cells and other tissue components.

Each assessment tool has its place and limitations, and these vary from patient to patient.

Lawsuit is likely if screening ends too soon

OLIVIA’S CLAIM

Negative mammogram, palpable mass

Olivia was 31 when she reported finding a mass in her breast. Her ObGyn examined her and noted “dense fibroglandular breast tissue with specific nodularity.” A diagnostic mammogram followed and was negative. When the physician observed no changes at a visit 2 months later, Olivia was told she need not return until her next annual examination. When she did, she was diagnosed with infiltrating ductal carcinoma.

After reviewing the case, defense experts noted, “It is common to find negative mammograms and yet have palpable masses that require either ultrasound or core biopsy for diagnosis. This patient had specific complaints at numerous intervals in the course of her clinical history. The physician’s inaction may have [been responsible for the] change in her clinical course.”

Olivia’s case closed with an indemnity payment of just under $1 million.

In the absence of comprehensive follow-up, a malpractice suit alleging “failure to diagnose breast cancer” is likely, as in Olivia’s case.

Misdiagnosis is another common cause of litigation. According to surveys conducted by the Physician Insurers Association of America (PIAA) in 1990 and 1995,^4,5 breast cancer is the number 1 most frequently misdiagnosed condition in malpractice claims. The most common reason given by expert reviewers in the PIAA study: “Physical findings failed to impress the physician.” Consider this example:

JACQUELINE’S CLAIM

Cancer or galactocele?

Jacqueline, 33, was told by her ObGyn that a breast mass discovered while she was in labor was a “clogged milk duct.” The medical record was not annotated. When the same mass was palpated postpartum, Jacqueline was told it was a sebaceous cyst. Again, the medical record failed to reflect the findings. One year later, Jacqueline changed physicians and underwent fine-needle aspiration, which confirmed malignancy.

Defense experts faulted the physician for his poor recordkeeping and failure to order a mammogram, ultrasound, or any follow-up despite the continued concerns of the patient.

This case closed with an indemnity payment in the $1 million range.

“Systems approach” to cutting risk of lawsuits

The cases of Lucy, Fiona, Olivia, and Jacqueline represent only some of the issues that give rise to malpractice claims. Since breast care is fragmented across medical specialties, a systematic approach is encouraged.

 

Systems form the basis of good risk management. The ProMutual Group advocates that every medical practice—whether office- or hospital-based—have a comprehensive risk management program that incorporates some or all of the following suggestions.

Annual exam not always enough

Even more frequent screening may be necessary if the patient has a specific breast complaint.

Every practice should have guidelines for these exams, including instructions on identifying women at risk because of personal or family history (ALGORITHM).

Ultrasound, MRI for young women

Younger, otherwise healthy women with unimpressive findings such as nodularities, nipple discharge, or tenderness deserve extra attention. The physician may want to consider additional diagnostic tests such as ultrasound or MRI for this group.

Never disregard a complaint

If a woman complains of discomfort or a self-detected mass, immediate evaluation is imperative. This includes pregnant patients; do not wait until after delivery to investigate an abnormality.

Use your own guidelines, but justify deviations from the norm

These may include earlier screening for women at risk, and need not match the recommendations of a nationally recognized group. However, in the event of a claim or suit, you will need to justify the reason for deviating from widely accepted guidelines.

Incorporate a systematic approach to diagnosis, treatment, referral (if required), and follow-up breast care.

Using an algorithm can help minimize error, confusion, and delays in care.

Assume cancer until it is ruled out

Consider diagnostic mammography and, when indicated, ultrasound imaging when the screening mammogram of a patient with a palpable mass is either negative or inconclusive.

A fine-needle aspiration or biopsy is a must to resolve indeterminate breast symptoms or inconclusive diagnostic breast imaging tests.

What not to say to patients

Do not assure the patient that a breast mass is benign until it is proven to be so.

Are you the “default PCP”? Screen for other cancers

When more than 1 physician is involved, someone needs to assume responsibility for the patient’s ongoing breast care. In a malpractice case, a doctor cannot simply claim that a routine mammogram or diagnostic test was deferred because it was assumed another physician would handle it.

In most cases, the patient’s primary care physician has the responsibility for her care.

ObGyn can be held to primary care physician standard. If the ObGyn is her only physician, the ObGyn may be held to a primary care standard—not only for breast and cervical cancer screening, but also for colorectal, skin, and other cancers.

Any physicians involved in a woman’s care should decide between them, as early in the process as possible, who will assume responsibility for ongoing care. According to the Agency for Healthcare Research and Quality,^6-9 that physician oversees follow-up, monitoring, and tracking women with abnormal findings, including those for whom a biopsy is recommended.

The designation of responsibility and accountability should be documented in the medical record.

The radiology facility’s responsibility. The facility that performs the patient’s mammograms must share responsibility with the designated physician for follow-up, monitoring, and tracking abnormal test results. Each facility should have a system for tracking positive mammogram findings and, according to the Agency for Healthcare Research and Quality, “a process for correlating findings with biopsy results.” It also has the duty to communicate urgent or significant findings to physicians and, under certain circumstances, to the patient directly.

If more than 1 physician is involved, everyone should know who is responsible for coordinating the patient’s ongoing care. Good communication is especially critical when abnormal findings are involved and additional imaging or more invasive testing is needed.

Document, document, document

ProMutual Group’s studies repeatedly show that inadequate records—whether paper or electronic—substantially reduce the chance for a successful defense.

Dr. Zylstra reports no financial relationships relevant to this article. Ms. Greenwald and Ms. Mondor are employees of ProMutual Group, Boston.

Clip-and-save shoulder dystocia documentation form
Practice recommendations

Among the intrapartum events that constitute bona fide emergencies, shoulder dystocia stands out. This obstetric emergency is the focus of an increasing number of medical liability cases. Most lawsuits involving shoulder dystocia allege negligence as the cause of the brachial plexus injury, fractured clavicle or humerus, or other injury. The defendant physicians named in these suits are often accused of inappropriately managing the prenatal or intrapartum course or the dystocia itself—or of inadequately documenting the steps taken to resolve the emergency.

To glean insights into the litigation process as it involves shoulder dystocia, we retrospectively reviewed all cases closed by the Boston-based ProMutual Group, a major liability insurance carrier, over a 7-year period. We wanted to learn more about the plaintiffs themselves, as well as the clinical and medicolegal factors that led to jury awards or indemnity payments. We also wanted data that could serve as the foundation for guidelines on how to proceed in the event of shoulder dystocia, as well as a documentation tool.

Brachial plexus injury not always caused by shoulder dystocia

Between 21% and 42% of shoulder dystocias involve an injury¹—usually brachial plexus injury. Plaintiff attorneys have manipulated this fact to attribute many cases of neonatal brachial plexus injury to mismanagement of shoulder dystocia by the obstetrician.

They fault the physician for failing to estimate fetal weight, perform a timely cesarean, use appropriate maneuvers correctly, or have a pediatrician present. They criticize nothing more resoundingly than use of “inappropriate” or “excessive” lateral traction to the fetal head.²

Nontraction injuries. The reality can be strikingly different, however. Some cases of brachial plexus injury involve no traction at all.

• Brachial plexus injuries have been reported in infants who had precipitate vaginal deliveries without any physical intervention by the obstetrician.²
• These injuries also have occurred in infants delivered via cesarean section.^1,3,4
• In some cases, brachial plexus injuries have affected the posterior arm of neonates whose anterior arm was involved in shoulder dystocia.^1,2,5-7

A retrospective study⁴ found that, of 39 cases of brachial plexus injury, only 17 were associated with shoulder dystocia. Similar findings have emerged from other studies.^2,3,8

 

Other causes. It is unclear how brachial plexus injuries occur in the absence of shoulder dystocia. Some think they arise in response to infectious agents such as toxoplasmosis, coxsackievirus, mumps, pertussis, or mycoplasma pneumonia.² Some assume a mechanical cause, such as fetal response to longstanding abnormal intrauterine pressure exerted by maternal conditions such as bicornate uterus and uterine fibroids, especially in the lower segment.^1,2

When brachial plexus injuries occur in the absence of shoulder dystocia, they likely originated before labor and delivery.⁴ Some experts suggest serial electromyelograms within the first 7 days of life to establish a prenatal rather than intrapartum etiology. A positive electromyelogram within 1 week of birth would suggest antepartum causation.^2,9

Recognizing risk factors for shoulder dystocia best way to reduce injury

Most brachial plexus injuries or impairments are associated with shoulder dystocia,⁹ and shoulder dystocia is the most common way brachial plexus injuries are introduced into litigation.

Decreasing the number of brachial plexusrelated liability cases, therefore, depends on decreasing the incidence of shoulder dystocia. Unfortunately, a failsafe method continues to elude both clinicians and researchers.^10-12

Retrospective studies have identified certain factors that may—but do not necessarily—increase the risk of shoulder dystocia.

Prenatal risk factors include high maternal or paternal birth weight, maternal obesity, excessive weight gain during pregnancy, advanced age, short stature, multiparity, postdates, prior shoulder dystocia, small pelvis, prior delivery of a macrosomic infant, gestational diabetes in an earlier pregnancy, abnormal blood sugars in the current pregnancy, or fetal macrosomia.^13,14-16

Intrapartum risk factors include a rapid or prolonged second stage, failure or arrest of descent, presence of considerable molding, and need for a midpelvic delivery.^10,15

Predictability. Prospective studies have not established the predictability of shoulder dystocia. A 2000 study¹⁷ showed that 55% of cases with 1 or more risk factors experienced shoulder dystocia. Predictability increases somewhat when both maternal diabetes and fetal macrosomia complicate pregnancy, since the rate of shoulder dystocia in women with diabetes is consistently higher than in nondiabetic gravidas. This becomes a significant issue when the infant weighs more than 4,000 g.

Indications for prophylactic cesarean in women with diabetes

In 1999, Wagner et al⁹ found that 70% of shoulder dystocias in women with diabetes occurred when the fetal weight exceeded 4,000 g. They concluded that cesarean delivery for infants with an estimated weight over 4,250 g would reduce the rate of shoulder dystocia by 75% and increase the cesarean delivery rate by 1%.

Others are more conservative. Gross and colleagues¹¹ suggested that, for every additional 26 cesarean deliveries, only 1 case of shoulder dystocia would be prevented.

Macrosomia. Most obstetricians and researchers still do not advocate prophylactic cesarean delivery for macrosomia alone because, by some estimates, 98% of macrosomic infants are delivered without difficulty.¹⁸ However, they do suggest that obstetricians at least consider the possibility of cesarean delivery for a macrosomic fetus when the woman has diabetes.

In a study completed in 2000, Skolbekken¹⁹ suggested a cutoff of 4,250 g for women with diabetes. Dildy²⁰ suggested limits of more than 4,500 g for diabetic women and more than 5,000 g for nondiabetic gravidas. However, Conway and Langer²¹ assert that a cutoff of 4,500 g is too liberal for women with diabetes and maintain that, at this cutoff, 40% of shoulder dystocias would not be prevented.

• Ultrasound measurements. Since estimates of fetal weight have a margin of error approaching 40%,⁹ others have chosen different parameters for determining fetal macrosomia in women with diabetes. In a retrospective study involving 31 women with gestational diabetes, Cohen et al²² found that subtracting the fetal biparietal diameter from the abdominal diameter—with both measurements obtained via ultrasound—yields a predictability score higher than estimated fetal weight. Specifically, if the difference between the 2 measurements is 2.6 cm or more, the rate of shoulder dystocia is high enough to warrant elective cesarean (FIGURE ).

FIGURE Using ultrasound measurements to predict macrosomia

A simple way to predict fetal macrosomia in women with diabetes is to subtract the fetal biparietal diameter (9.3 cm in the scan at left) from the abdominal diameter (average of 12.44 cm in the scan at right). If the difference exceeds 2.6 cm, elective cesarean is warranted. In this case it is 3.14 cm, indicating elective cesarean is warranted.

When dystocia occurs, have a plan and stick to it

Shoulder dystocia immediately places both mother and neonate at risk for temporary or permanent injury. Thus, it is imperative that all obstetricians and other health-care providers who deliver infants have a well developed plan of action for this emergency. They should immediately ask for obstetric assistance and instruct the mother to discontinue any pushing.

 

Attempts at vigorous downward traction should be avoided, and no fundal pressure should be applied, as these are known to increase the potential for brachial plexus injury. Gentle downward traction is considered the standard of care.¹⁷

The obstetrician’s goal is to free the impacted shoulder as quickly as possible, since a fetus can endure only 8 to 10 minutes of asphyxia before permanent neurologic damage occurs.¹⁷ The standard of care requires the obstetrician to know and use certain maneuvers to relieve shoulder dystocia. These maneuvers are designed to facilitate vaginal delivery and reduce the risk of permanent brachial plexus injury. The McRoberts maneuver, with flexion and slight rotation of the maternal hips onto the maternal abdomen, is the standard for initial relief of shoulder dystocia.^17,23

Factors that lead to litigation

In a review article, Hickson²⁴ cited factors that prompted families to file medical liability claims following perinatal injury. Some families observed that, in their search for the cause of an injury, they found 1 or more aspects of care to be inappropriate.

The desire for information, perception of being misled, anger with the medical profession, desire to prevent injuries to others, recognition of long-term sequelae, and advice by knowledgeable acquaintances, as well as the need for money, all appeared to contribute to the decision to file medical liability claims.

Convey the risks, and listen carefully. Communication problems between physicians and patients are a contributing factor. Even when physicians provide technically adequate care, families expect answers to their questions and want to feel as though they have been consulted about important medical decisions.²⁴ If these expectations are not met, even patients who have not experienced an adverse outcome may become angry and express dissatisfaction with care.²⁴

The need for communication is critical when shoulder dystocia results in neonatal injury. Empathizing with the family, helping them understand that most brachial plexus injuries are not long-term, and offering to answer their questions both at the moment and later, may help prevent litigation.

This type of communication can be difficult. It helps to realize that an acknowledgment of distress and concern is not an admission of guilt, and an explanation is not an apology.¹⁵ However, an absence of communication or an attempt by the physician to place blame may be perceived as an admission of guilt that gives rise to a lawsuit.

Action plan is what counts in court. A review by Gross et al¹¹ concluded that obstetricians should have a shoulder dystocia plan that enables an instant and orderly response. Also recommended is a protocol to help anticipate clinical problems and prevent medicolegal problems.

 

Gross and colleagues¹¹ found that the Ob/Gyns with the most defensible cases paid close attention to the patient’s history and prenatal course and, upon encountering dystocia, implemented at least 2 maneuvers (if necessary) and thoroughly documented their actions immediately after delivery.

Fetterman¹⁵ agreed, asserting that what counts in court is not so much whether the obstetrician employed the McRoberts maneuver before or after the Wood’s corkscrew maneuver but whether he or she had an action plan in mind, implemented that plan properly, and thoroughly documented the actions taken and the reasons underlying them.

Dissecting legal cases for clues to reduced risk

In the review of medicolegal cases for this article, we limited our search to cases closed between Jan 1, 1995, and Dec 31, 2002, using a computer to search for codes specific to shoulder dystocia as well as the phrases “shoulder dystocia,” “Erb’s palsy,” and “brachial plexus injury.” We identified 61 cases involving 117 defendants and created a data sheet to gather information on patient and physician demographics, medical and obstetric history, description of the incident, analysis rendered by defense and plaintiff experts, and legal and financial outcomes.

Of 117 defendants, 76 were obstetricians. There also were 16 hospitals, 15 corporations, 5 certified nurse-midwives, 1 family physician, 1 emergency physician, and 3 persons categorized as “other.” Age, race, and parity of the 61 plaintiffs are given in TABLE 1.

Twenty-six of the 61 cases, involving 74 defendants, closed with no payment. That is, they were either dismissed or closed with a jury verdict for the defense. The remaining 35 cases involved 43 defendants and were closed with an aggregate indemnity payment of $19.2 million. The mean payment was $445,000 per defendant.

 

Neonatal injury occurred in all 61 cases. Erb’s palsy was the overwhelming pediatric outcome (57 of 61 cases, or 93.4%), with an aggregate indemnity payment of $17.6 million. Fractured humerus was the outcome in 1 case, and 3 cases involved neonatal deaths.

Reasons for indemnity payments included:

• probable liability (18 defendants),
• plaintiff was sympathetic, likely to evoke an emotional response from the jury (8 defendants),
• clear liability (7 defendants),
• defendant would not have made a strong witness in his or her own defense (5 defendants),
• defendant had died or was too ill to stand trial (3 defendants),
• medical record had been altered (2 defendants),
• case was considered too inflammatory to risk a jury award (2 defendants), and
• policy limits were too low to risk a potentially high jury award (1 defendant).

Five defendants were involved in cases with multiple medicolegal issues that argued for settlement.

The effect of birth weight. Notably, 74% of infants involved in these cases were macrosomic (birth weight over 4,000 g). Except for neonatal injury (100%), no single maternal or fetal variable appears with greater frequency.

The mean indemnity in closed cases increased in direct proportion to fetal weight, ranging from $500,000 in cases involving infants whose birth weight was less than 4,000 g to $950,000 when the birth weight was 5,000 g or more.

Maternal factors seen with greatest frequency included obesity, excessive weight gain in pregnancy, and gestational diabetes. Analysis of prepregnant body mass index found that 19 women had a weight within the “obese” category, 18 of whom gave birth to macrosomic infants. Eight of these cases closed without indemnity payment and 10 closed with an aggregate indemnity payment of $6.5 million.

Forty-eight of the 61 plaintiffs (78.8%) exceeded the normal weight gain in pregnancy based on height and prepregnant weight. Twenty-nine of these cases closed with an aggregate indemnity payment of $16.6 million.

Influence of diabetes. Fifty-two of 61 plaintiffs underwent a glucose screening test. Of these, 23 went on to have a glucose tolerance test, with 12 testing positive for gestational diabetes. Further analysis revealed borderline screening glucose values in an additional 16 cases. These women were not considered diabetic by their obstetricians, were not retested for diabetes, and did not receive nutritional counseling. Macrosomic infants were born to 9 of the 12 patients with gestational diabetes and to 13 of the 16 borderline cases.

Of 28 cases with confirmed or suspected gestational diabetes, 14 women delivered infants weighing over 4,250 g; 11 of the 14 weighed more than 4,500 g.

In a comparison of cases involving diabetic and nondiabetic women who delivered infants weighing more than 4,250 g, 82% of the cases involving nondiabetic women closed without payment. Among cases involving diabetes (actual or borderline), the corresponding figure was 27.3%.

Labor and delivery interventions were cited in all cases. Oxytocin was used in 42 of the 61 cases (68.9%), forceps in 9 (14.8%), and vacuum extraction in 7 (11.5%). Suprapubic pressure was used in 37 cases (60.7%), fundal pressure in 9 (14.8%), and traction on the fetal head in 16 cases (26.2%).

In addition, defense experts determined that the McRoberts maneuver was used in 41 cases (67.2%) and the Wood’s corkscrew maneuver in 28 (45.9%).

Seven cases involved a second stage of labor exceeding 2.5 hours. The ratio of wins to losses decreased substantially with the use of oxytocin, forceps, fundal pressure, or a prolonged second stage.

Data were analyzed using selected variables thought to have an association with winning or losing cases and with indemnity (TABLE 2). No statistically significant models emerged. This is likely due to inadequate power (low number of cases) and the large number of interactions between variables relative to the outcomes evaluated.

TABLE 1

Plaintiff demographics

CHARACTERISTIC	ALL CASES (n = 61)	CASES WITH INDEMNITY (n = 35)
Mean age, in years (range)	28 (17–40)	29 (18–38)
Race (%)
White	35 (57)	21 (60)
Black	12 (20)	7 (20)
Hispanic	11 (18)	6 (17)
Asian	1 (2)	—
Unknown	2 (3)	1 (3)
Parity (%)
0	19 (31)	11 (31)
1	26 (43)	16 (46)
2	11 (18)	7 (20)
3	2 (3)	1 (3)
4	2 (3)	—
5	1 (2)	—

TABLE 2

Litigation outcomes for selected prenatal and intrapartum variables

CHARACTERISTIC	CLOSED WITHOUT INDEMNITY	CLOSED WITHOUT INDEMNITY PAYMENT	MEAN INDEMNITY ($)	TOTAL INDEMNITY ($)
Prenatal factors
Gestational diabetes	5	7	413,300	2,893,000
Adjusted diabetes	10	18	521,400	9,386,000
Obesity	8	13	651,300	8,466,000
Intrapartum factors
Prolonged second stage	1	6	707,700	4,247,000
Oxytocin induction	2	10	406,500	4,065,300
Oxytocin augmentation	15	15	737,000	11,100,000
Forceps delivery	1	8	552,100	4,416,800
Vacuum extraction	3	4	531,300	2,125,000
Episiotomy	20	30	579,400	17,382,100
McRoberts maneuver	20	21	542,900	11,400,300
Wood’s corkscrew maneuver	12	16	652,300	10,436,200
Suprapubic pressure	17	20	629,000	12,579,400
Traction to fetal head	7	9	665,500	5,989,500
Fundal pressure	4	7	660,700	4,625,000

4 factors raise risk of litigation

After reviewing the literature and analyzing the ProMutual data, we concluded that shoulder dystocia remains largely unpredictable. However, certain clinical factors are clearly associated with an increased risk for litigation:

• prenatal factors,
• labor and delivery interventions,
• maneuvers performed at the time of the dystocia, and
• fetal outcomes.

Prenatal factors. The most significant prenatal factors were maternal obesity, excessive weight gain in pregnancy, and, especially, diabetes and fetal macrosomia.

 

• Fetal macrosomia. Although most macrosomic infants deliver without complication, fetal macrosomia was involved in more than 72% of the cases reviewed. Because macrosomia represents a risk not only for shoulder dystocia but also for the litigation that may arise from it, it is important to:

• know and document the estimated fetal weight (EFW);
• discuss the risk of dystocia and its sequelae with the mother and her partner; and
• consider cesarean delivery for estimated fetal weights that suggest macrosomia (see the recommendations on page 82 for specifics).

It also is advisable to mobilize a team for the possibility of shoulder dystocia if vaginal delivery is attempted.

Preparing for the increased risk of a macrosomic fetus can be successful only if macrosomia is both diagnosed and anticipated.

Because macrosomia often is accompanied by maternal diabetes, serum glucose testing is recommended for all gravidas, with follow-up of both abnormal and borderline values.

Labor and delivery interventions were cited in all cases, with data indicating a decreasing ratio of wins to losses with the use of oxytocin, forceps, or fundal pressure, and prolonged second stage.

• Use of oxytocin to augment an already established labor carried less risk than oxytocin for labor induction. Ten of the 12 cases (83.3%) in which oxytocin was used for induction closed with an indemnity payment. However, of the 30 cases in which oxytocin was used for labor augmentation, 50% closed with payment.
• • Forceps and a prolonged second stage. Eight of 9 cases (88.9%) involving forceps and 6 of 7 cases (85.7%) involving a prolonged second stage closed with indemnity payment.

Consider cesarean delivery when the second stage is prolonged or labor fails to progress. Be cautious using forceps and vacuum extraction in these circumstances, and limit the number of attempts with either.

Maneuvers performed at the time of dystocia. The most common maneuverswere McRoberts, suprapubic pressure, and Wood’s corkscrew. The ratio of wins to losses decreased with traction of the fetal head and use of fundal pressure.

Part of the risk-management protocol for obstetricians should be appropriate use of McRoberts maneuver, suprapubic pressure, and Wood’s corkscrew, and cutting a large episiotomy. In addition, be careful not to push, pull, rotate the head, or apply fundal pressure.

Fetal outcomes. All cases involved neonatal injury (Erb’s palsy, fractured humerus) or death.

For this reason, we recommend an action plan that includes immediate pediatric or neonatal assessment of neuromuscular function of the infant’s anterior shoulder. Assess the Moro reflex and the possibility of brachial plexus injury and fractures of the clavicle and humerus. Also examine the placenta, send it to pathology, and perform a cord blood gas analysis.

Last words

Shoulder dystocia is the unfortunate complication of a small number of deliveries, but the focus of an increasing number of lawsuits. Because the neonatal injuries that so often accompany shoulder dystocia often lead to litigation, obstetricians should prepare to identify risk and help patients make informed choices. We should be prepared to manage this emergency whenever it occurs and thoroughly document actions.

Dr. Zylstra reports no financial relationships relevant to this article.

Clip-and-save shoulder dystocia documentation form
Practice recommendations

Among the intrapartum events that constitute bona fide emergencies, shoulder dystocia stands out. This obstetric emergency is the focus of an increasing number of medical liability cases. Most lawsuits involving shoulder dystocia allege negligence as the cause of the brachial plexus injury, fractured clavicle or humerus, or other injury. The defendant physicians named in these suits are often accused of inappropriately managing the prenatal or intrapartum course or the dystocia itself—or of inadequately documenting the steps taken to resolve the emergency.

To glean insights into the litigation process as it involves shoulder dystocia, we retrospectively reviewed all cases closed by the Boston-based ProMutual Group, a major liability insurance carrier, over a 7-year period. We wanted to learn more about the plaintiffs themselves, as well as the clinical and medicolegal factors that led to jury awards or indemnity payments. We also wanted data that could serve as the foundation for guidelines on how to proceed in the event of shoulder dystocia, as well as a documentation tool.

Brachial plexus injury not always caused by shoulder dystocia

Between 21% and 42% of shoulder dystocias involve an injury¹—usually brachial plexus injury. Plaintiff attorneys have manipulated this fact to attribute many cases of neonatal brachial plexus injury to mismanagement of shoulder dystocia by the obstetrician.

They fault the physician for failing to estimate fetal weight, perform a timely cesarean, use appropriate maneuvers correctly, or have a pediatrician present. They criticize nothing more resoundingly than use of “inappropriate” or “excessive” lateral traction to the fetal head.²

Nontraction injuries. The reality can be strikingly different, however. Some cases of brachial plexus injury involve no traction at all.

• Brachial plexus injuries have been reported in infants who had precipitate vaginal deliveries without any physical intervention by the obstetrician.²
• These injuries also have occurred in infants delivered via cesarean section.^1,3,4
• In some cases, brachial plexus injuries have affected the posterior arm of neonates whose anterior arm was involved in shoulder dystocia.^1,2,5-7

A retrospective study⁴ found that, of 39 cases of brachial plexus injury, only 17 were associated with shoulder dystocia. Similar findings have emerged from other studies.^2,3,8

 

Other causes. It is unclear how brachial plexus injuries occur in the absence of shoulder dystocia. Some think they arise in response to infectious agents such as toxoplasmosis, coxsackievirus, mumps, pertussis, or mycoplasma pneumonia.² Some assume a mechanical cause, such as fetal response to longstanding abnormal intrauterine pressure exerted by maternal conditions such as bicornate uterus and uterine fibroids, especially in the lower segment.^1,2

When brachial plexus injuries occur in the absence of shoulder dystocia, they likely originated before labor and delivery.⁴ Some experts suggest serial electromyelograms within the first 7 days of life to establish a prenatal rather than intrapartum etiology. A positive electromyelogram within 1 week of birth would suggest antepartum causation.^2,9

Recognizing risk factors for shoulder dystocia best way to reduce injury

Most brachial plexus injuries or impairments are associated with shoulder dystocia,⁹ and shoulder dystocia is the most common way brachial plexus injuries are introduced into litigation.

Decreasing the number of brachial plexusrelated liability cases, therefore, depends on decreasing the incidence of shoulder dystocia. Unfortunately, a failsafe method continues to elude both clinicians and researchers.^10-12

Retrospective studies have identified certain factors that may—but do not necessarily—increase the risk of shoulder dystocia.

Prenatal risk factors include high maternal or paternal birth weight, maternal obesity, excessive weight gain during pregnancy, advanced age, short stature, multiparity, postdates, prior shoulder dystocia, small pelvis, prior delivery of a macrosomic infant, gestational diabetes in an earlier pregnancy, abnormal blood sugars in the current pregnancy, or fetal macrosomia.^13,14-16

Intrapartum risk factors include a rapid or prolonged second stage, failure or arrest of descent, presence of considerable molding, and need for a midpelvic delivery.^10,15

Predictability. Prospective studies have not established the predictability of shoulder dystocia. A 2000 study¹⁷ showed that 55% of cases with 1 or more risk factors experienced shoulder dystocia. Predictability increases somewhat when both maternal diabetes and fetal macrosomia complicate pregnancy, since the rate of shoulder dystocia in women with diabetes is consistently higher than in nondiabetic gravidas. This becomes a significant issue when the infant weighs more than 4,000 g.

Indications for prophylactic cesarean in women with diabetes

In 1999, Wagner et al⁹ found that 70% of shoulder dystocias in women with diabetes occurred when the fetal weight exceeded 4,000 g. They concluded that cesarean delivery for infants with an estimated weight over 4,250 g would reduce the rate of shoulder dystocia by 75% and increase the cesarean delivery rate by 1%.

Others are more conservative. Gross and colleagues¹¹ suggested that, for every additional 26 cesarean deliveries, only 1 case of shoulder dystocia would be prevented.

Macrosomia. Most obstetricians and researchers still do not advocate prophylactic cesarean delivery for macrosomia alone because, by some estimates, 98% of macrosomic infants are delivered without difficulty.¹⁸ However, they do suggest that obstetricians at least consider the possibility of cesarean delivery for a macrosomic fetus when the woman has diabetes.

In a study completed in 2000, Skolbekken¹⁹ suggested a cutoff of 4,250 g for women with diabetes. Dildy²⁰ suggested limits of more than 4,500 g for diabetic women and more than 5,000 g for nondiabetic gravidas. However, Conway and Langer²¹ assert that a cutoff of 4,500 g is too liberal for women with diabetes and maintain that, at this cutoff, 40% of shoulder dystocias would not be prevented.

• Ultrasound measurements. Since estimates of fetal weight have a margin of error approaching 40%,⁹ others have chosen different parameters for determining fetal macrosomia in women with diabetes. In a retrospective study involving 31 women with gestational diabetes, Cohen et al²² found that subtracting the fetal biparietal diameter from the abdominal diameter—with both measurements obtained via ultrasound—yields a predictability score higher than estimated fetal weight. Specifically, if the difference between the 2 measurements is 2.6 cm or more, the rate of shoulder dystocia is high enough to warrant elective cesarean (FIGURE ).

FIGURE Using ultrasound measurements to predict macrosomia

A simple way to predict fetal macrosomia in women with diabetes is to subtract the fetal biparietal diameter (9.3 cm in the scan at left) from the abdominal diameter (average of 12.44 cm in the scan at right). If the difference exceeds 2.6 cm, elective cesarean is warranted. In this case it is 3.14 cm, indicating elective cesarean is warranted.

When dystocia occurs, have a plan and stick to it

Shoulder dystocia immediately places both mother and neonate at risk for temporary or permanent injury. Thus, it is imperative that all obstetricians and other health-care providers who deliver infants have a well developed plan of action for this emergency. They should immediately ask for obstetric assistance and instruct the mother to discontinue any pushing.

 

Attempts at vigorous downward traction should be avoided, and no fundal pressure should be applied, as these are known to increase the potential for brachial plexus injury. Gentle downward traction is considered the standard of care.¹⁷

The obstetrician’s goal is to free the impacted shoulder as quickly as possible, since a fetus can endure only 8 to 10 minutes of asphyxia before permanent neurologic damage occurs.¹⁷ The standard of care requires the obstetrician to know and use certain maneuvers to relieve shoulder dystocia. These maneuvers are designed to facilitate vaginal delivery and reduce the risk of permanent brachial plexus injury. The McRoberts maneuver, with flexion and slight rotation of the maternal hips onto the maternal abdomen, is the standard for initial relief of shoulder dystocia.^17,23

Factors that lead to litigation

In a review article, Hickson²⁴ cited factors that prompted families to file medical liability claims following perinatal injury. Some families observed that, in their search for the cause of an injury, they found 1 or more aspects of care to be inappropriate.

The desire for information, perception of being misled, anger with the medical profession, desire to prevent injuries to others, recognition of long-term sequelae, and advice by knowledgeable acquaintances, as well as the need for money, all appeared to contribute to the decision to file medical liability claims.

Convey the risks, and listen carefully. Communication problems between physicians and patients are a contributing factor. Even when physicians provide technically adequate care, families expect answers to their questions and want to feel as though they have been consulted about important medical decisions.²⁴ If these expectations are not met, even patients who have not experienced an adverse outcome may become angry and express dissatisfaction with care.²⁴

The need for communication is critical when shoulder dystocia results in neonatal injury. Empathizing with the family, helping them understand that most brachial plexus injuries are not long-term, and offering to answer their questions both at the moment and later, may help prevent litigation.

This type of communication can be difficult. It helps to realize that an acknowledgment of distress and concern is not an admission of guilt, and an explanation is not an apology.¹⁵ However, an absence of communication or an attempt by the physician to place blame may be perceived as an admission of guilt that gives rise to a lawsuit.

Action plan is what counts in court. A review by Gross et al¹¹ concluded that obstetricians should have a shoulder dystocia plan that enables an instant and orderly response. Also recommended is a protocol to help anticipate clinical problems and prevent medicolegal problems.

 

Gross and colleagues¹¹ found that the Ob/Gyns with the most defensible cases paid close attention to the patient’s history and prenatal course and, upon encountering dystocia, implemented at least 2 maneuvers (if necessary) and thoroughly documented their actions immediately after delivery.

Fetterman¹⁵ agreed, asserting that what counts in court is not so much whether the obstetrician employed the McRoberts maneuver before or after the Wood’s corkscrew maneuver but whether he or she had an action plan in mind, implemented that plan properly, and thoroughly documented the actions taken and the reasons underlying them.

Dissecting legal cases for clues to reduced risk

In the review of medicolegal cases for this article, we limited our search to cases closed between Jan 1, 1995, and Dec 31, 2002, using a computer to search for codes specific to shoulder dystocia as well as the phrases “shoulder dystocia,” “Erb’s palsy,” and “brachial plexus injury.” We identified 61 cases involving 117 defendants and created a data sheet to gather information on patient and physician demographics, medical and obstetric history, description of the incident, analysis rendered by defense and plaintiff experts, and legal and financial outcomes.

Of 117 defendants, 76 were obstetricians. There also were 16 hospitals, 15 corporations, 5 certified nurse-midwives, 1 family physician, 1 emergency physician, and 3 persons categorized as “other.” Age, race, and parity of the 61 plaintiffs are given in TABLE 1.

Twenty-six of the 61 cases, involving 74 defendants, closed with no payment. That is, they were either dismissed or closed with a jury verdict for the defense. The remaining 35 cases involved 43 defendants and were closed with an aggregate indemnity payment of $19.2 million. The mean payment was $445,000 per defendant.

 

Neonatal injury occurred in all 61 cases. Erb’s palsy was the overwhelming pediatric outcome (57 of 61 cases, or 93.4%), with an aggregate indemnity payment of $17.6 million. Fractured humerus was the outcome in 1 case, and 3 cases involved neonatal deaths.

Reasons for indemnity payments included:

• probable liability (18 defendants),
• plaintiff was sympathetic, likely to evoke an emotional response from the jury (8 defendants),
• clear liability (7 defendants),
• defendant would not have made a strong witness in his or her own defense (5 defendants),
• defendant had died or was too ill to stand trial (3 defendants),
• medical record had been altered (2 defendants),
• case was considered too inflammatory to risk a jury award (2 defendants), and
• policy limits were too low to risk a potentially high jury award (1 defendant).

Five defendants were involved in cases with multiple medicolegal issues that argued for settlement.

The effect of birth weight. Notably, 74% of infants involved in these cases were macrosomic (birth weight over 4,000 g). Except for neonatal injury (100%), no single maternal or fetal variable appears with greater frequency.

The mean indemnity in closed cases increased in direct proportion to fetal weight, ranging from $500,000 in cases involving infants whose birth weight was less than 4,000 g to $950,000 when the birth weight was 5,000 g or more.

Maternal factors seen with greatest frequency included obesity, excessive weight gain in pregnancy, and gestational diabetes. Analysis of prepregnant body mass index found that 19 women had a weight within the “obese” category, 18 of whom gave birth to macrosomic infants. Eight of these cases closed without indemnity payment and 10 closed with an aggregate indemnity payment of $6.5 million.

Forty-eight of the 61 plaintiffs (78.8%) exceeded the normal weight gain in pregnancy based on height and prepregnant weight. Twenty-nine of these cases closed with an aggregate indemnity payment of $16.6 million.

Influence of diabetes. Fifty-two of 61 plaintiffs underwent a glucose screening test. Of these, 23 went on to have a glucose tolerance test, with 12 testing positive for gestational diabetes. Further analysis revealed borderline screening glucose values in an additional 16 cases. These women were not considered diabetic by their obstetricians, were not retested for diabetes, and did not receive nutritional counseling. Macrosomic infants were born to 9 of the 12 patients with gestational diabetes and to 13 of the 16 borderline cases.

Of 28 cases with confirmed or suspected gestational diabetes, 14 women delivered infants weighing over 4,250 g; 11 of the 14 weighed more than 4,500 g.

In a comparison of cases involving diabetic and nondiabetic women who delivered infants weighing more than 4,250 g, 82% of the cases involving nondiabetic women closed without payment. Among cases involving diabetes (actual or borderline), the corresponding figure was 27.3%.

Labor and delivery interventions were cited in all cases. Oxytocin was used in 42 of the 61 cases (68.9%), forceps in 9 (14.8%), and vacuum extraction in 7 (11.5%). Suprapubic pressure was used in 37 cases (60.7%), fundal pressure in 9 (14.8%), and traction on the fetal head in 16 cases (26.2%).

In addition, defense experts determined that the McRoberts maneuver was used in 41 cases (67.2%) and the Wood’s corkscrew maneuver in 28 (45.9%).

Seven cases involved a second stage of labor exceeding 2.5 hours. The ratio of wins to losses decreased substantially with the use of oxytocin, forceps, fundal pressure, or a prolonged second stage.

Data were analyzed using selected variables thought to have an association with winning or losing cases and with indemnity (TABLE 2). No statistically significant models emerged. This is likely due to inadequate power (low number of cases) and the large number of interactions between variables relative to the outcomes evaluated.

TABLE 1

Plaintiff demographics

CHARACTERISTIC	ALL CASES (n = 61)	CASES WITH INDEMNITY (n = 35)
Mean age, in years (range)	28 (17–40)	29 (18–38)
Race (%)
White	35 (57)	21 (60)
Black	12 (20)	7 (20)
Hispanic	11 (18)	6 (17)
Asian	1 (2)	—
Unknown	2 (3)	1 (3)
Parity (%)
0	19 (31)	11 (31)
1	26 (43)	16 (46)
2	11 (18)	7 (20)
3	2 (3)	1 (3)
4	2 (3)	—
5	1 (2)	—

TABLE 2

Litigation outcomes for selected prenatal and intrapartum variables

CHARACTERISTIC	CLOSED WITHOUT INDEMNITY	CLOSED WITHOUT INDEMNITY PAYMENT	MEAN INDEMNITY ($)	TOTAL INDEMNITY ($)
Prenatal factors
Gestational diabetes	5	7	413,300	2,893,000
Adjusted diabetes	10	18	521,400	9,386,000
Obesity	8	13	651,300	8,466,000
Intrapartum factors
Prolonged second stage	1	6	707,700	4,247,000
Oxytocin induction	2	10	406,500	4,065,300
Oxytocin augmentation	15	15	737,000	11,100,000
Forceps delivery	1	8	552,100	4,416,800
Vacuum extraction	3	4	531,300	2,125,000
Episiotomy	20	30	579,400	17,382,100
McRoberts maneuver	20	21	542,900	11,400,300
Wood’s corkscrew maneuver	12	16	652,300	10,436,200
Suprapubic pressure	17	20	629,000	12,579,400
Traction to fetal head	7	9	665,500	5,989,500
Fundal pressure	4	7	660,700	4,625,000

4 factors raise risk of litigation

After reviewing the literature and analyzing the ProMutual data, we concluded that shoulder dystocia remains largely unpredictable. However, certain clinical factors are clearly associated with an increased risk for litigation:

• prenatal factors,
• labor and delivery interventions,
• maneuvers performed at the time of the dystocia, and
• fetal outcomes.

Prenatal factors. The most significant prenatal factors were maternal obesity, excessive weight gain in pregnancy, and, especially, diabetes and fetal macrosomia.

 

• Fetal macrosomia. Although most macrosomic infants deliver without complication, fetal macrosomia was involved in more than 72% of the cases reviewed. Because macrosomia represents a risk not only for shoulder dystocia but also for the litigation that may arise from it, it is important to:

• know and document the estimated fetal weight (EFW);
• discuss the risk of dystocia and its sequelae with the mother and her partner; and
• consider cesarean delivery for estimated fetal weights that suggest macrosomia (see the recommendations on page 82 for specifics).

It also is advisable to mobilize a team for the possibility of shoulder dystocia if vaginal delivery is attempted.

Preparing for the increased risk of a macrosomic fetus can be successful only if macrosomia is both diagnosed and anticipated.

Because macrosomia often is accompanied by maternal diabetes, serum glucose testing is recommended for all gravidas, with follow-up of both abnormal and borderline values.

Labor and delivery interventions were cited in all cases, with data indicating a decreasing ratio of wins to losses with the use of oxytocin, forceps, or fundal pressure, and prolonged second stage.

• Use of oxytocin to augment an already established labor carried less risk than oxytocin for labor induction. Ten of the 12 cases (83.3%) in which oxytocin was used for induction closed with an indemnity payment. However, of the 30 cases in which oxytocin was used for labor augmentation, 50% closed with payment.
• • Forceps and a prolonged second stage. Eight of 9 cases (88.9%) involving forceps and 6 of 7 cases (85.7%) involving a prolonged second stage closed with indemnity payment.

Consider cesarean delivery when the second stage is prolonged or labor fails to progress. Be cautious using forceps and vacuum extraction in these circumstances, and limit the number of attempts with either.

Maneuvers performed at the time of dystocia. The most common maneuverswere McRoberts, suprapubic pressure, and Wood’s corkscrew. The ratio of wins to losses decreased with traction of the fetal head and use of fundal pressure.

Part of the risk-management protocol for obstetricians should be appropriate use of McRoberts maneuver, suprapubic pressure, and Wood’s corkscrew, and cutting a large episiotomy. In addition, be careful not to push, pull, rotate the head, or apply fundal pressure.

Fetal outcomes. All cases involved neonatal injury (Erb’s palsy, fractured humerus) or death.

For this reason, we recommend an action plan that includes immediate pediatric or neonatal assessment of neuromuscular function of the infant’s anterior shoulder. Assess the Moro reflex and the possibility of brachial plexus injury and fractures of the clavicle and humerus. Also examine the placenta, send it to pathology, and perform a cord blood gas analysis.

Last words

Shoulder dystocia is the unfortunate complication of a small number of deliveries, but the focus of an increasing number of lawsuits. Because the neonatal injuries that so often accompany shoulder dystocia often lead to litigation, obstetricians should prepare to identify risk and help patients make informed choices. We should be prepared to manage this emergency whenever it occurs and thoroughly document actions.

Dr. Zylstra reports no financial relationships relevant to this article.

Clip-and-save shoulder dystocia documentation form
Practice recommendations

Among the intrapartum events that constitute bona fide emergencies, shoulder dystocia stands out. This obstetric emergency is the focus of an increasing number of medical liability cases. Most lawsuits involving shoulder dystocia allege negligence as the cause of the brachial plexus injury, fractured clavicle or humerus, or other injury. The defendant physicians named in these suits are often accused of inappropriately managing the prenatal or intrapartum course or the dystocia itself—or of inadequately documenting the steps taken to resolve the emergency.

To glean insights into the litigation process as it involves shoulder dystocia, we retrospectively reviewed all cases closed by the Boston-based ProMutual Group, a major liability insurance carrier, over a 7-year period. We wanted to learn more about the plaintiffs themselves, as well as the clinical and medicolegal factors that led to jury awards or indemnity payments. We also wanted data that could serve as the foundation for guidelines on how to proceed in the event of shoulder dystocia, as well as a documentation tool.

Brachial plexus injury not always caused by shoulder dystocia

Between 21% and 42% of shoulder dystocias involve an injury¹—usually brachial plexus injury. Plaintiff attorneys have manipulated this fact to attribute many cases of neonatal brachial plexus injury to mismanagement of shoulder dystocia by the obstetrician.

They fault the physician for failing to estimate fetal weight, perform a timely cesarean, use appropriate maneuvers correctly, or have a pediatrician present. They criticize nothing more resoundingly than use of “inappropriate” or “excessive” lateral traction to the fetal head.²

Nontraction injuries. The reality can be strikingly different, however. Some cases of brachial plexus injury involve no traction at all.

• Brachial plexus injuries have been reported in infants who had precipitate vaginal deliveries without any physical intervention by the obstetrician.²
• These injuries also have occurred in infants delivered via cesarean section.^1,3,4
• In some cases, brachial plexus injuries have affected the posterior arm of neonates whose anterior arm was involved in shoulder dystocia.^1,2,5-7

A retrospective study⁴ found that, of 39 cases of brachial plexus injury, only 17 were associated with shoulder dystocia. Similar findings have emerged from other studies.^2,3,8

 

Other causes. It is unclear how brachial plexus injuries occur in the absence of shoulder dystocia. Some think they arise in response to infectious agents such as toxoplasmosis, coxsackievirus, mumps, pertussis, or mycoplasma pneumonia.² Some assume a mechanical cause, such as fetal response to longstanding abnormal intrauterine pressure exerted by maternal conditions such as bicornate uterus and uterine fibroids, especially in the lower segment.^1,2

When brachial plexus injuries occur in the absence of shoulder dystocia, they likely originated before labor and delivery.⁴ Some experts suggest serial electromyelograms within the first 7 days of life to establish a prenatal rather than intrapartum etiology. A positive electromyelogram within 1 week of birth would suggest antepartum causation.^2,9

Recognizing risk factors for shoulder dystocia best way to reduce injury

Most brachial plexus injuries or impairments are associated with shoulder dystocia,⁹ and shoulder dystocia is the most common way brachial plexus injuries are introduced into litigation.

Decreasing the number of brachial plexusrelated liability cases, therefore, depends on decreasing the incidence of shoulder dystocia. Unfortunately, a failsafe method continues to elude both clinicians and researchers.^10-12

Retrospective studies have identified certain factors that may—but do not necessarily—increase the risk of shoulder dystocia.

Prenatal risk factors include high maternal or paternal birth weight, maternal obesity, excessive weight gain during pregnancy, advanced age, short stature, multiparity, postdates, prior shoulder dystocia, small pelvis, prior delivery of a macrosomic infant, gestational diabetes in an earlier pregnancy, abnormal blood sugars in the current pregnancy, or fetal macrosomia.^13,14-16

Intrapartum risk factors include a rapid or prolonged second stage, failure or arrest of descent, presence of considerable molding, and need for a midpelvic delivery.^10,15

Predictability. Prospective studies have not established the predictability of shoulder dystocia. A 2000 study¹⁷ showed that 55% of cases with 1 or more risk factors experienced shoulder dystocia. Predictability increases somewhat when both maternal diabetes and fetal macrosomia complicate pregnancy, since the rate of shoulder dystocia in women with diabetes is consistently higher than in nondiabetic gravidas. This becomes a significant issue when the infant weighs more than 4,000 g.

Indications for prophylactic cesarean in women with diabetes

In 1999, Wagner et al⁹ found that 70% of shoulder dystocias in women with diabetes occurred when the fetal weight exceeded 4,000 g. They concluded that cesarean delivery for infants with an estimated weight over 4,250 g would reduce the rate of shoulder dystocia by 75% and increase the cesarean delivery rate by 1%.

Others are more conservative. Gross and colleagues¹¹ suggested that, for every additional 26 cesarean deliveries, only 1 case of shoulder dystocia would be prevented.

Macrosomia. Most obstetricians and researchers still do not advocate prophylactic cesarean delivery for macrosomia alone because, by some estimates, 98% of macrosomic infants are delivered without difficulty.¹⁸ However, they do suggest that obstetricians at least consider the possibility of cesarean delivery for a macrosomic fetus when the woman has diabetes.

In a study completed in 2000, Skolbekken¹⁹ suggested a cutoff of 4,250 g for women with diabetes. Dildy²⁰ suggested limits of more than 4,500 g for diabetic women and more than 5,000 g for nondiabetic gravidas. However, Conway and Langer²¹ assert that a cutoff of 4,500 g is too liberal for women with diabetes and maintain that, at this cutoff, 40% of shoulder dystocias would not be prevented.

• Ultrasound measurements. Since estimates of fetal weight have a margin of error approaching 40%,⁹ others have chosen different parameters for determining fetal macrosomia in women with diabetes. In a retrospective study involving 31 women with gestational diabetes, Cohen et al²² found that subtracting the fetal biparietal diameter from the abdominal diameter—with both measurements obtained via ultrasound—yields a predictability score higher than estimated fetal weight. Specifically, if the difference between the 2 measurements is 2.6 cm or more, the rate of shoulder dystocia is high enough to warrant elective cesarean (FIGURE ).

FIGURE Using ultrasound measurements to predict macrosomia

A simple way to predict fetal macrosomia in women with diabetes is to subtract the fetal biparietal diameter (9.3 cm in the scan at left) from the abdominal diameter (average of 12.44 cm in the scan at right). If the difference exceeds 2.6 cm, elective cesarean is warranted. In this case it is 3.14 cm, indicating elective cesarean is warranted.

When dystocia occurs, have a plan and stick to it

Shoulder dystocia immediately places both mother and neonate at risk for temporary or permanent injury. Thus, it is imperative that all obstetricians and other health-care providers who deliver infants have a well developed plan of action for this emergency. They should immediately ask for obstetric assistance and instruct the mother to discontinue any pushing.

 

Attempts at vigorous downward traction should be avoided, and no fundal pressure should be applied, as these are known to increase the potential for brachial plexus injury. Gentle downward traction is considered the standard of care.¹⁷

The obstetrician’s goal is to free the impacted shoulder as quickly as possible, since a fetus can endure only 8 to 10 minutes of asphyxia before permanent neurologic damage occurs.¹⁷ The standard of care requires the obstetrician to know and use certain maneuvers to relieve shoulder dystocia. These maneuvers are designed to facilitate vaginal delivery and reduce the risk of permanent brachial plexus injury. The McRoberts maneuver, with flexion and slight rotation of the maternal hips onto the maternal abdomen, is the standard for initial relief of shoulder dystocia.^17,23

Factors that lead to litigation

In a review article, Hickson²⁴ cited factors that prompted families to file medical liability claims following perinatal injury. Some families observed that, in their search for the cause of an injury, they found 1 or more aspects of care to be inappropriate.

The desire for information, perception of being misled, anger with the medical profession, desire to prevent injuries to others, recognition of long-term sequelae, and advice by knowledgeable acquaintances, as well as the need for money, all appeared to contribute to the decision to file medical liability claims.

Convey the risks, and listen carefully. Communication problems between physicians and patients are a contributing factor. Even when physicians provide technically adequate care, families expect answers to their questions and want to feel as though they have been consulted about important medical decisions.²⁴ If these expectations are not met, even patients who have not experienced an adverse outcome may become angry and express dissatisfaction with care.²⁴

The need for communication is critical when shoulder dystocia results in neonatal injury. Empathizing with the family, helping them understand that most brachial plexus injuries are not long-term, and offering to answer their questions both at the moment and later, may help prevent litigation.

This type of communication can be difficult. It helps to realize that an acknowledgment of distress and concern is not an admission of guilt, and an explanation is not an apology.¹⁵ However, an absence of communication or an attempt by the physician to place blame may be perceived as an admission of guilt that gives rise to a lawsuit.

Action plan is what counts in court. A review by Gross et al¹¹ concluded that obstetricians should have a shoulder dystocia plan that enables an instant and orderly response. Also recommended is a protocol to help anticipate clinical problems and prevent medicolegal problems.

 

Gross and colleagues¹¹ found that the Ob/Gyns with the most defensible cases paid close attention to the patient’s history and prenatal course and, upon encountering dystocia, implemented at least 2 maneuvers (if necessary) and thoroughly documented their actions immediately after delivery.

Fetterman¹⁵ agreed, asserting that what counts in court is not so much whether the obstetrician employed the McRoberts maneuver before or after the Wood’s corkscrew maneuver but whether he or she had an action plan in mind, implemented that plan properly, and thoroughly documented the actions taken and the reasons underlying them.

Dissecting legal cases for clues to reduced risk

In the review of medicolegal cases for this article, we limited our search to cases closed between Jan 1, 1995, and Dec 31, 2002, using a computer to search for codes specific to shoulder dystocia as well as the phrases “shoulder dystocia,” “Erb’s palsy,” and “brachial plexus injury.” We identified 61 cases involving 117 defendants and created a data sheet to gather information on patient and physician demographics, medical and obstetric history, description of the incident, analysis rendered by defense and plaintiff experts, and legal and financial outcomes.

Of 117 defendants, 76 were obstetricians. There also were 16 hospitals, 15 corporations, 5 certified nurse-midwives, 1 family physician, 1 emergency physician, and 3 persons categorized as “other.” Age, race, and parity of the 61 plaintiffs are given in TABLE 1.

Twenty-six of the 61 cases, involving 74 defendants, closed with no payment. That is, they were either dismissed or closed with a jury verdict for the defense. The remaining 35 cases involved 43 defendants and were closed with an aggregate indemnity payment of $19.2 million. The mean payment was $445,000 per defendant.

 

Neonatal injury occurred in all 61 cases. Erb’s palsy was the overwhelming pediatric outcome (57 of 61 cases, or 93.4%), with an aggregate indemnity payment of $17.6 million. Fractured humerus was the outcome in 1 case, and 3 cases involved neonatal deaths.

Reasons for indemnity payments included:

• probable liability (18 defendants),
• plaintiff was sympathetic, likely to evoke an emotional response from the jury (8 defendants),
• clear liability (7 defendants),
• defendant would not have made a strong witness in his or her own defense (5 defendants),
• defendant had died or was too ill to stand trial (3 defendants),
• medical record had been altered (2 defendants),
• case was considered too inflammatory to risk a jury award (2 defendants), and
• policy limits were too low to risk a potentially high jury award (1 defendant).

Five defendants were involved in cases with multiple medicolegal issues that argued for settlement.

The effect of birth weight. Notably, 74% of infants involved in these cases were macrosomic (birth weight over 4,000 g). Except for neonatal injury (100%), no single maternal or fetal variable appears with greater frequency.

The mean indemnity in closed cases increased in direct proportion to fetal weight, ranging from $500,000 in cases involving infants whose birth weight was less than 4,000 g to $950,000 when the birth weight was 5,000 g or more.

Maternal factors seen with greatest frequency included obesity, excessive weight gain in pregnancy, and gestational diabetes. Analysis of prepregnant body mass index found that 19 women had a weight within the “obese” category, 18 of whom gave birth to macrosomic infants. Eight of these cases closed without indemnity payment and 10 closed with an aggregate indemnity payment of $6.5 million.

Forty-eight of the 61 plaintiffs (78.8%) exceeded the normal weight gain in pregnancy based on height and prepregnant weight. Twenty-nine of these cases closed with an aggregate indemnity payment of $16.6 million.

Influence of diabetes. Fifty-two of 61 plaintiffs underwent a glucose screening test. Of these, 23 went on to have a glucose tolerance test, with 12 testing positive for gestational diabetes. Further analysis revealed borderline screening glucose values in an additional 16 cases. These women were not considered diabetic by their obstetricians, were not retested for diabetes, and did not receive nutritional counseling. Macrosomic infants were born to 9 of the 12 patients with gestational diabetes and to 13 of the 16 borderline cases.

Of 28 cases with confirmed or suspected gestational diabetes, 14 women delivered infants weighing over 4,250 g; 11 of the 14 weighed more than 4,500 g.

In a comparison of cases involving diabetic and nondiabetic women who delivered infants weighing more than 4,250 g, 82% of the cases involving nondiabetic women closed without payment. Among cases involving diabetes (actual or borderline), the corresponding figure was 27.3%.

Labor and delivery interventions were cited in all cases. Oxytocin was used in 42 of the 61 cases (68.9%), forceps in 9 (14.8%), and vacuum extraction in 7 (11.5%). Suprapubic pressure was used in 37 cases (60.7%), fundal pressure in 9 (14.8%), and traction on the fetal head in 16 cases (26.2%).

In addition, defense experts determined that the McRoberts maneuver was used in 41 cases (67.2%) and the Wood’s corkscrew maneuver in 28 (45.9%).

Seven cases involved a second stage of labor exceeding 2.5 hours. The ratio of wins to losses decreased substantially with the use of oxytocin, forceps, fundal pressure, or a prolonged second stage.

Data were analyzed using selected variables thought to have an association with winning or losing cases and with indemnity (TABLE 2). No statistically significant models emerged. This is likely due to inadequate power (low number of cases) and the large number of interactions between variables relative to the outcomes evaluated.

TABLE 1

Plaintiff demographics

CHARACTERISTIC	ALL CASES (n = 61)	CASES WITH INDEMNITY (n = 35)
Mean age, in years (range)	28 (17–40)	29 (18–38)
Race (%)
White	35 (57)	21 (60)
Black	12 (20)	7 (20)
Hispanic	11 (18)	6 (17)
Asian	1 (2)	—
Unknown	2 (3)	1 (3)
Parity (%)
0	19 (31)	11 (31)
1	26 (43)	16 (46)
2	11 (18)	7 (20)
3	2 (3)	1 (3)
4	2 (3)	—
5	1 (2)	—

TABLE 2

Litigation outcomes for selected prenatal and intrapartum variables

CHARACTERISTIC	CLOSED WITHOUT INDEMNITY	CLOSED WITHOUT INDEMNITY PAYMENT	MEAN INDEMNITY ($)	TOTAL INDEMNITY ($)
Prenatal factors
Gestational diabetes	5	7	413,300	2,893,000
Adjusted diabetes	10	18	521,400	9,386,000
Obesity	8	13	651,300	8,466,000
Intrapartum factors
Prolonged second stage	1	6	707,700	4,247,000
Oxytocin induction	2	10	406,500	4,065,300
Oxytocin augmentation	15	15	737,000	11,100,000
Forceps delivery	1	8	552,100	4,416,800
Vacuum extraction	3	4	531,300	2,125,000
Episiotomy	20	30	579,400	17,382,100
McRoberts maneuver	20	21	542,900	11,400,300
Wood’s corkscrew maneuver	12	16	652,300	10,436,200
Suprapubic pressure	17	20	629,000	12,579,400
Traction to fetal head	7	9	665,500	5,989,500
Fundal pressure	4	7	660,700	4,625,000

4 factors raise risk of litigation

After reviewing the literature and analyzing the ProMutual data, we concluded that shoulder dystocia remains largely unpredictable. However, certain clinical factors are clearly associated with an increased risk for litigation:

• prenatal factors,
• labor and delivery interventions,
• maneuvers performed at the time of the dystocia, and
• fetal outcomes.

Prenatal factors. The most significant prenatal factors were maternal obesity, excessive weight gain in pregnancy, and, especially, diabetes and fetal macrosomia.

 

• Fetal macrosomia. Although most macrosomic infants deliver without complication, fetal macrosomia was involved in more than 72% of the cases reviewed. Because macrosomia represents a risk not only for shoulder dystocia but also for the litigation that may arise from it, it is important to:

• know and document the estimated fetal weight (EFW);
• discuss the risk of dystocia and its sequelae with the mother and her partner; and
• consider cesarean delivery for estimated fetal weights that suggest macrosomia (see the recommendations on page 82 for specifics).

It also is advisable to mobilize a team for the possibility of shoulder dystocia if vaginal delivery is attempted.

Preparing for the increased risk of a macrosomic fetus can be successful only if macrosomia is both diagnosed and anticipated.

Because macrosomia often is accompanied by maternal diabetes, serum glucose testing is recommended for all gravidas, with follow-up of both abnormal and borderline values.

Labor and delivery interventions were cited in all cases, with data indicating a decreasing ratio of wins to losses with the use of oxytocin, forceps, or fundal pressure, and prolonged second stage.

• Use of oxytocin to augment an already established labor carried less risk than oxytocin for labor induction. Ten of the 12 cases (83.3%) in which oxytocin was used for induction closed with an indemnity payment. However, of the 30 cases in which oxytocin was used for labor augmentation, 50% closed with payment.
• • Forceps and a prolonged second stage. Eight of 9 cases (88.9%) involving forceps and 6 of 7 cases (85.7%) involving a prolonged second stage closed with indemnity payment.

Consider cesarean delivery when the second stage is prolonged or labor fails to progress. Be cautious using forceps and vacuum extraction in these circumstances, and limit the number of attempts with either.

Maneuvers performed at the time of dystocia. The most common maneuverswere McRoberts, suprapubic pressure, and Wood’s corkscrew. The ratio of wins to losses decreased with traction of the fetal head and use of fundal pressure.

Part of the risk-management protocol for obstetricians should be appropriate use of McRoberts maneuver, suprapubic pressure, and Wood’s corkscrew, and cutting a large episiotomy. In addition, be careful not to push, pull, rotate the head, or apply fundal pressure.

Fetal outcomes. All cases involved neonatal injury (Erb’s palsy, fractured humerus) or death.

For this reason, we recommend an action plan that includes immediate pediatric or neonatal assessment of neuromuscular function of the infant’s anterior shoulder. Assess the Moro reflex and the possibility of brachial plexus injury and fractures of the clavicle and humerus. Also examine the placenta, send it to pathology, and perform a cord blood gas analysis.

Last words

Shoulder dystocia is the unfortunate complication of a small number of deliveries, but the focus of an increasing number of lawsuits. Because the neonatal injuries that so often accompany shoulder dystocia often lead to litigation, obstetricians should prepare to identify risk and help patients make informed choices. We should be prepared to manage this emergency whenever it occurs and thoroughly document actions.

Dr. Zylstra reports no financial relationships relevant to this article.