Medicolegal Issues

Retained Foreign Body

A 15-year-old male adolescent was brought to the ED by his father for evaluation of lacerations on the teenager’s left forearm, which were caused by a shattered glass door. The accident happened approximately 45 minutes prior to the patient’s arrival at the ED. The patient was up to date on all of his immunizations, including tetanus, and had no significant medical history.

On physical examination, the patient’s vital signs were all normal. He was noted to have two lacerations on the volar aspect of the distal one-third of his left forearm. One laceration measured 2.5 cm, running diagonally on the forearm; the other laceration was approximately 2 cm, running horizontally on the forearm. The bleeding from both wound sites was easily controlled with pressure.

The emergency physician (EP) did not document a neurological examination of the left wrist and hand. He did, however, note that the patient had a 2+ radial pulse and good capillary refill. The EP irrigated the wounds thoroughly and sutured the two lacerations. There was no documentation on file of wound  exploration or imaging studies. The patient returned 1 week after discharge from the ED for a wound check, and again 6 weeks later. On both occasions, he continued to complain of pain and decreased function of his left thumb and index finger.

Since the patient’s condition did not improve, his father took him to an orthopedic surgeon. The orthopedist ordered a magnetic resonance imaging (MRI) study of the left forearm, which demonstrated a complete tear of one of the patient’s flexor tendons. The orthopedist thought it was too late to repair the tendon and referred the patient to physical therapy. As the patient continued to complain of pain and decreased function of his left thumb, he consulted a second orthopedist, who decided to surgically explore the wound to determine the cause of the patient’s continued pain and loss of thumb function. Surgical exploration revealed a piece of glass measuring 3.5 x 2 cm retained in the patient’s forearm. The orthopedist removed the glass, irrigated the wound thoroughly, and closed the incision, after which the patient’s thumb function improved considerably and his pain resolved.

The patient’s family sued the EP and the hospital, arguing that the wound should have been explored and the glass removed on the initial ED visit. They further stated that if these steps were performed initially, the patient would not have required multiple imaging studies and surgery. At trial, the jury returned a defense verdict.

Discussion

Approximately 11 million wounds are treated in US EDs each year.¹ Proper management of lacerations and wounds requires more than sutures or staples. The EP must also evaluate for associated injuries (eg, tendon laceration, vascular injury), and the possibility of a retained foreign body. It is also important to ensure the patient is up to date on his or her tetanus immunization.

As with most areas of medicine, a good history and physical examination are essential. The mechanism of injury will often be the first clue to the risk of a retained foreign body. For example, shattered glass or porcelain carries a much higher risk of retention compared to a laceration from a box cutter.

The age of the injury is also important in determining the best management approach and the risk of infection. In a study by Brancto,¹ wounds closed within 19 hours of injury had a 92% rate of healing without infection, compared to only 77% of those closed after 19 hours. In addition, determination of a patient’s allergy status to anesthetics and antibiotics ensures safe and appropriate treatment.

On physical examination, the wound should be described in sufficient detail (eg, length, shape), and a distal neurovascular examination should be completed and documented. This involves testing the patient’s motor strength, sensation, adequacy of pulses, and capillary refill. When examining the extremities, flexion and extension strength should also be assessed and documented.

After a wound is prepped and anesthetized, it should be explored. Often a patient may have excellent flexor or extensor strength on testing, but have a near-complete tendon laceration on visual inspection. Similarly, the wound should be explored for foreign bodies. It is important to identify and remove foreign bodies because of the associated increased risk of infection, pain, and delayed healing.¹ Occasionally, a wound may need to be extended to remove a foreign body.

Unfortunately, visual inspection of a wound, especially a deep one, is not highly sensitive. If a physician has a high index of suspicion for a retained foreign body but is unable to identify one on examination, imaging studies should be ordered. Conventional plain radiography, ultrasonography, computed tomography (CT), and MRI studies can all be used to identify foreign bodies. Each of these modalities has its unique advantages and disadvantages. A recent study by Pattamapaspong et al² compared the accuracy of radiography, CT, and MRI in detecting foreign bodies in the foot. In this study, researchers placed various types of foreign bodies, including fresh wood, dry wood, glass, porcelain, and plastic—all measuring  5 x 2 mm— in cadaver feet.² The overall sensitivity and specificity for foreign body detection was 29% and 100%, respectively, for radiographs; 63% and 98%, respectively, for CT; and 58% and 100%, respectively, for MRI.² Interestingly, CT was superior to MRI in identifying water-rich fresh wood.² A similar study by Aras et al³ compared the sensitivity of plain radiographs, CT, and ultrasound in detecting foreign bodies in the face. The foreign bodies used in this study measured 1 x 1 x 1 cm and included metal, glass, wood, stone, acrylic, graphite, and polyoxybenzylmethylenglycolanhydride (ie, Bakelite).³ In this study, ultrasound identified superficial foreign bodies with low radiopacity in body tissues more effectively than CT or plain radiographs.³ In a review by Karabay⁴ of traumatic wrist and hand injuries, ultrasound was considered the best modality to identify and locate both opaque and radiolucent foreign bodies in the soft tissue.

If a foreign body is identified but cannot be removed, consultation with a surgical service is required. Depending on the local referral pattern, this might be general surgery, plastic surgery, or hand surgery. Unless there is an acute nerve or vascular injury, patients rarely require immediate surgery. In most cases, the wound can be closed loosely until the surgeon can remove the foreign body in the operating room and/or with aid of fluoroscopy at a later time. Depending on the size, material, and location of the foreign body, the surgeon might even elect to simply observe.

The bottom-line lesson from this case: depending on the mechanism of injury, EPs must maintain a high index of suspicion for retained foreign bodies in traumatic wounds. In addition to wound exploration, imaging studies should be used in patients at high risk for a retained foreign body, such as those injured with broken glass or porcelain, but in whom no foreign body is found on wound exploration.

Ruptured Esophagus

A 78-year-old man presented to the ED with symptoms of choking and chest discomfort. The patient stated that he had experienced a sudden onset of difficulty swallowing, along with chest pain, while he was eating dinner at a restaurant earlier that evening. The patient initially thought he had a piece of carrot stuck in his throat. He denied any previous history of similar symptoms. He complained of mild shortness of breath, but denied any drooling or vomiting. His medical history was significant for hypertension, which was controlled with medication. He denied tobacco or alcohol use and had no known drug allergies.

On physical examination, the patient’s vital signs were: heart rate (HR), 106 beats/minute; blood pressure (BP), 144/82 mm Hg; respiratory rate, 22 breaths/minute, and temperature, 98.6°F. Oxygen saturation was 95% on room air. The patient’s oropharynx appeared normal and without foreign body obstruction; his lungs were clear to auscultation bilaterally; and his HR was tachycardic but with a regular rhythm. Other than mild diaphoresis, the remainder of the physical examination was normal.

The EP ordered a complete blood count (CBC), a basic metabolic profile (BMP), and a portable chest X-ray, which the EP interpreted as normal. In addition, an intravenous (IV) saline lock was placed, and the patient was given morphine 4 mg IV and ondansetron 4 mg IV. He was also placed on 2 L of oxygen via nasal cannula. Since the patient continued to complain of chest pain and dysphagia, the EP consulted with a gastroenterologist; unfortunately, there was no documentation of this.

The EP admitted the patient to the floor with a diagnosis of esophageal obstruction, probably secondary to a piece of carrot. During the night, the patient’s shortness of breath worsened, requiring an increase in supplemental oxygen. The next morning, the patient’s HR increased to 120 beats/minute; his BP dropped to 96/50 mm Hg, and he developed a low-grade fever. He was transferred to the intensive care unit, where he was started on IV fluid resuscitation with normal saline and broad spectrum antibiotics. A CT scan of the chest was also ordered, which revealed an esophageal perforation. The patient was taken immediately to the operating room; surgery revealed a large esophageal perforation with evidence of mediastinitis and gross contamination of the left hemithorax. The patient died 2 days later.

The patient’s family sued the EP for failure to diagnose and treat the esophageal perforation in a timely manner. The EP argued that the patient’s symptoms were consistent with an obstruction, not esophageal perforation. The defendant also argued that the initial chest X-ray was normal. The case was resolved for $800,000 prior to going to trial.

Discussion

Esophageal perforation is a true medical emergency that requires timely diagnosis and management because morbidity and mortality are directly related to the time to treatment. Unfortunately, esophageal perforation can be a difficult diagnosis due to its relative rarity and variability in clinical presentation.

More than 50% of all esophageal perforations are iatrogenic, primarily as a complication of endoscopy.¹ Other causes of perforation include spontaneous perforation or Boerhaave syndrome (15%), foreign body (12%), trauma (9%), and malignancy (1%).¹ Anatomically, perforation tends to occur in the areas of the esophagus that are most narrow—eg, cricopharyngeus muscle, area of broncho-aortic constriction, and esophagogastric junction.¹

Food impactions, not surprisingly, tend to occur in these same areas of the esophagus. In addition, there are structural esophageal abnormalities that increase the risk of food impaction, including diverticula, webs, rings, strictures, achalasia, and tumors.² Since food impaction can result in an esophageal perforation, there is a significant overlap in the initial presentation of these two conditions. However, in cases of perforation, signs and symptoms of shock predominate as time progresses due to esophageal contents leaking into the mediastinal and pleural spaces.

Patients with a food impaction will often complain of an acute onset of dysphagia, difficulty in handling secretions, choking, drooling, retrosternal fullness, regurgitation of undigested food, and wheezing.² Perforation can cause severe chest pain, tachypnea, dyspnea, fever, and shock.²

A chest X-ray is typically the initial imaging study for suspected esophageal perforation. Since most spontaneous perforations occur through the left posterolateral wall of the distal esophagus, a new left pleural effusion can frequently be seen on X-ray. Mediastinal emphysema is highly suspicious for perforation, but the condition takes time to develop; therefore, its absence on X-ray does not exclude perforation. In the setting of a normal chest X-ray and ongoing esophageal symptoms, further investigation is required, usually via CT scan or endoscopy. Computed tomography, because of its availability and speed, is usually the preferred study to confirm the diagnosis.

Once an esophageal perforation is confirmed or is highly suspected, the patient will require IV fluid resuscitation, IV broad-spectrum antibiotic treatment, and emergency surgical consultation. As previously stated, esophageal perforation is associated with a high mortality rate, and time is critical to successful management.

Retained Foreign Body

A 15-year-old male adolescent was brought to the ED by his father for evaluation of lacerations on the teenager’s left forearm, which were caused by a shattered glass door. The accident happened approximately 45 minutes prior to the patient’s arrival at the ED. The patient was up to date on all of his immunizations, including tetanus, and had no significant medical history.

On physical examination, the patient’s vital signs were all normal. He was noted to have two lacerations on the volar aspect of the distal one-third of his left forearm. One laceration measured 2.5 cm, running diagonally on the forearm; the other laceration was approximately 2 cm, running horizontally on the forearm. The bleeding from both wound sites was easily controlled with pressure.

The emergency physician (EP) did not document a neurological examination of the left wrist and hand. He did, however, note that the patient had a 2+ radial pulse and good capillary refill. The EP irrigated the wounds thoroughly and sutured the two lacerations. There was no documentation on file of wound  exploration or imaging studies. The patient returned 1 week after discharge from the ED for a wound check, and again 6 weeks later. On both occasions, he continued to complain of pain and decreased function of his left thumb and index finger.

Since the patient’s condition did not improve, his father took him to an orthopedic surgeon. The orthopedist ordered a magnetic resonance imaging (MRI) study of the left forearm, which demonstrated a complete tear of one of the patient’s flexor tendons. The orthopedist thought it was too late to repair the tendon and referred the patient to physical therapy. As the patient continued to complain of pain and decreased function of his left thumb, he consulted a second orthopedist, who decided to surgically explore the wound to determine the cause of the patient’s continued pain and loss of thumb function. Surgical exploration revealed a piece of glass measuring 3.5 x 2 cm retained in the patient’s forearm. The orthopedist removed the glass, irrigated the wound thoroughly, and closed the incision, after which the patient’s thumb function improved considerably and his pain resolved.

The patient’s family sued the EP and the hospital, arguing that the wound should have been explored and the glass removed on the initial ED visit. They further stated that if these steps were performed initially, the patient would not have required multiple imaging studies and surgery. At trial, the jury returned a defense verdict.

Discussion

Approximately 11 million wounds are treated in US EDs each year.¹ Proper management of lacerations and wounds requires more than sutures or staples. The EP must also evaluate for associated injuries (eg, tendon laceration, vascular injury), and the possibility of a retained foreign body. It is also important to ensure the patient is up to date on his or her tetanus immunization.

As with most areas of medicine, a good history and physical examination are essential. The mechanism of injury will often be the first clue to the risk of a retained foreign body. For example, shattered glass or porcelain carries a much higher risk of retention compared to a laceration from a box cutter.

The age of the injury is also important in determining the best management approach and the risk of infection. In a study by Brancto,¹ wounds closed within 19 hours of injury had a 92% rate of healing without infection, compared to only 77% of those closed after 19 hours. In addition, determination of a patient’s allergy status to anesthetics and antibiotics ensures safe and appropriate treatment.

On physical examination, the wound should be described in sufficient detail (eg, length, shape), and a distal neurovascular examination should be completed and documented. This involves testing the patient’s motor strength, sensation, adequacy of pulses, and capillary refill. When examining the extremities, flexion and extension strength should also be assessed and documented.

After a wound is prepped and anesthetized, it should be explored. Often a patient may have excellent flexor or extensor strength on testing, but have a near-complete tendon laceration on visual inspection. Similarly, the wound should be explored for foreign bodies. It is important to identify and remove foreign bodies because of the associated increased risk of infection, pain, and delayed healing.¹ Occasionally, a wound may need to be extended to remove a foreign body.

Unfortunately, visual inspection of a wound, especially a deep one, is not highly sensitive. If a physician has a high index of suspicion for a retained foreign body but is unable to identify one on examination, imaging studies should be ordered. Conventional plain radiography, ultrasonography, computed tomography (CT), and MRI studies can all be used to identify foreign bodies. Each of these modalities has its unique advantages and disadvantages. A recent study by Pattamapaspong et al² compared the accuracy of radiography, CT, and MRI in detecting foreign bodies in the foot. In this study, researchers placed various types of foreign bodies, including fresh wood, dry wood, glass, porcelain, and plastic—all measuring  5 x 2 mm— in cadaver feet.² The overall sensitivity and specificity for foreign body detection was 29% and 100%, respectively, for radiographs; 63% and 98%, respectively, for CT; and 58% and 100%, respectively, for MRI.² Interestingly, CT was superior to MRI in identifying water-rich fresh wood.² A similar study by Aras et al³ compared the sensitivity of plain radiographs, CT, and ultrasound in detecting foreign bodies in the face. The foreign bodies used in this study measured 1 x 1 x 1 cm and included metal, glass, wood, stone, acrylic, graphite, and polyoxybenzylmethylenglycolanhydride (ie, Bakelite).³ In this study, ultrasound identified superficial foreign bodies with low radiopacity in body tissues more effectively than CT or plain radiographs.³ In a review by Karabay⁴ of traumatic wrist and hand injuries, ultrasound was considered the best modality to identify and locate both opaque and radiolucent foreign bodies in the soft tissue.

If a foreign body is identified but cannot be removed, consultation with a surgical service is required. Depending on the local referral pattern, this might be general surgery, plastic surgery, or hand surgery. Unless there is an acute nerve or vascular injury, patients rarely require immediate surgery. In most cases, the wound can be closed loosely until the surgeon can remove the foreign body in the operating room and/or with aid of fluoroscopy at a later time. Depending on the size, material, and location of the foreign body, the surgeon might even elect to simply observe.

The bottom-line lesson from this case: depending on the mechanism of injury, EPs must maintain a high index of suspicion for retained foreign bodies in traumatic wounds. In addition to wound exploration, imaging studies should be used in patients at high risk for a retained foreign body, such as those injured with broken glass or porcelain, but in whom no foreign body is found on wound exploration.

Ruptured Esophagus

A 78-year-old man presented to the ED with symptoms of choking and chest discomfort. The patient stated that he had experienced a sudden onset of difficulty swallowing, along with chest pain, while he was eating dinner at a restaurant earlier that evening. The patient initially thought he had a piece of carrot stuck in his throat. He denied any previous history of similar symptoms. He complained of mild shortness of breath, but denied any drooling or vomiting. His medical history was significant for hypertension, which was controlled with medication. He denied tobacco or alcohol use and had no known drug allergies.

On physical examination, the patient’s vital signs were: heart rate (HR), 106 beats/minute; blood pressure (BP), 144/82 mm Hg; respiratory rate, 22 breaths/minute, and temperature, 98.6°F. Oxygen saturation was 95% on room air. The patient’s oropharynx appeared normal and without foreign body obstruction; his lungs were clear to auscultation bilaterally; and his HR was tachycardic but with a regular rhythm. Other than mild diaphoresis, the remainder of the physical examination was normal.

The EP ordered a complete blood count (CBC), a basic metabolic profile (BMP), and a portable chest X-ray, which the EP interpreted as normal. In addition, an intravenous (IV) saline lock was placed, and the patient was given morphine 4 mg IV and ondansetron 4 mg IV. He was also placed on 2 L of oxygen via nasal cannula. Since the patient continued to complain of chest pain and dysphagia, the EP consulted with a gastroenterologist; unfortunately, there was no documentation of this.

The EP admitted the patient to the floor with a diagnosis of esophageal obstruction, probably secondary to a piece of carrot. During the night, the patient’s shortness of breath worsened, requiring an increase in supplemental oxygen. The next morning, the patient’s HR increased to 120 beats/minute; his BP dropped to 96/50 mm Hg, and he developed a low-grade fever. He was transferred to the intensive care unit, where he was started on IV fluid resuscitation with normal saline and broad spectrum antibiotics. A CT scan of the chest was also ordered, which revealed an esophageal perforation. The patient was taken immediately to the operating room; surgery revealed a large esophageal perforation with evidence of mediastinitis and gross contamination of the left hemithorax. The patient died 2 days later.

The patient’s family sued the EP for failure to diagnose and treat the esophageal perforation in a timely manner. The EP argued that the patient’s symptoms were consistent with an obstruction, not esophageal perforation. The defendant also argued that the initial chest X-ray was normal. The case was resolved for $800,000 prior to going to trial.

Discussion

Esophageal perforation is a true medical emergency that requires timely diagnosis and management because morbidity and mortality are directly related to the time to treatment. Unfortunately, esophageal perforation can be a difficult diagnosis due to its relative rarity and variability in clinical presentation.

More than 50% of all esophageal perforations are iatrogenic, primarily as a complication of endoscopy.¹ Other causes of perforation include spontaneous perforation or Boerhaave syndrome (15%), foreign body (12%), trauma (9%), and malignancy (1%).¹ Anatomically, perforation tends to occur in the areas of the esophagus that are most narrow—eg, cricopharyngeus muscle, area of broncho-aortic constriction, and esophagogastric junction.¹

Food impactions, not surprisingly, tend to occur in these same areas of the esophagus. In addition, there are structural esophageal abnormalities that increase the risk of food impaction, including diverticula, webs, rings, strictures, achalasia, and tumors.² Since food impaction can result in an esophageal perforation, there is a significant overlap in the initial presentation of these two conditions. However, in cases of perforation, signs and symptoms of shock predominate as time progresses due to esophageal contents leaking into the mediastinal and pleural spaces.

Patients with a food impaction will often complain of an acute onset of dysphagia, difficulty in handling secretions, choking, drooling, retrosternal fullness, regurgitation of undigested food, and wheezing.² Perforation can cause severe chest pain, tachypnea, dyspnea, fever, and shock.²

A chest X-ray is typically the initial imaging study for suspected esophageal perforation. Since most spontaneous perforations occur through the left posterolateral wall of the distal esophagus, a new left pleural effusion can frequently be seen on X-ray. Mediastinal emphysema is highly suspicious for perforation, but the condition takes time to develop; therefore, its absence on X-ray does not exclude perforation. In the setting of a normal chest X-ray and ongoing esophageal symptoms, further investigation is required, usually via CT scan or endoscopy. Computed tomography, because of its availability and speed, is usually the preferred study to confirm the diagnosis.

Once an esophageal perforation is confirmed or is highly suspected, the patient will require IV fluid resuscitation, IV broad-spectrum antibiotic treatment, and emergency surgical consultation. As previously stated, esophageal perforation is associated with a high mortality rate, and time is critical to successful management.

Retained Foreign Body

A 15-year-old male adolescent was brought to the ED by his father for evaluation of lacerations on the teenager’s left forearm, which were caused by a shattered glass door. The accident happened approximately 45 minutes prior to the patient’s arrival at the ED. The patient was up to date on all of his immunizations, including tetanus, and had no significant medical history.

On physical examination, the patient’s vital signs were all normal. He was noted to have two lacerations on the volar aspect of the distal one-third of his left forearm. One laceration measured 2.5 cm, running diagonally on the forearm; the other laceration was approximately 2 cm, running horizontally on the forearm. The bleeding from both wound sites was easily controlled with pressure.

The emergency physician (EP) did not document a neurological examination of the left wrist and hand. He did, however, note that the patient had a 2+ radial pulse and good capillary refill. The EP irrigated the wounds thoroughly and sutured the two lacerations. There was no documentation on file of wound  exploration or imaging studies. The patient returned 1 week after discharge from the ED for a wound check, and again 6 weeks later. On both occasions, he continued to complain of pain and decreased function of his left thumb and index finger.

Since the patient’s condition did not improve, his father took him to an orthopedic surgeon. The orthopedist ordered a magnetic resonance imaging (MRI) study of the left forearm, which demonstrated a complete tear of one of the patient’s flexor tendons. The orthopedist thought it was too late to repair the tendon and referred the patient to physical therapy. As the patient continued to complain of pain and decreased function of his left thumb, he consulted a second orthopedist, who decided to surgically explore the wound to determine the cause of the patient’s continued pain and loss of thumb function. Surgical exploration revealed a piece of glass measuring 3.5 x 2 cm retained in the patient’s forearm. The orthopedist removed the glass, irrigated the wound thoroughly, and closed the incision, after which the patient’s thumb function improved considerably and his pain resolved.

The patient’s family sued the EP and the hospital, arguing that the wound should have been explored and the glass removed on the initial ED visit. They further stated that if these steps were performed initially, the patient would not have required multiple imaging studies and surgery. At trial, the jury returned a defense verdict.

Discussion

Approximately 11 million wounds are treated in US EDs each year.¹ Proper management of lacerations and wounds requires more than sutures or staples. The EP must also evaluate for associated injuries (eg, tendon laceration, vascular injury), and the possibility of a retained foreign body. It is also important to ensure the patient is up to date on his or her tetanus immunization.

As with most areas of medicine, a good history and physical examination are essential. The mechanism of injury will often be the first clue to the risk of a retained foreign body. For example, shattered glass or porcelain carries a much higher risk of retention compared to a laceration from a box cutter.

The age of the injury is also important in determining the best management approach and the risk of infection. In a study by Brancto,¹ wounds closed within 19 hours of injury had a 92% rate of healing without infection, compared to only 77% of those closed after 19 hours. In addition, determination of a patient’s allergy status to anesthetics and antibiotics ensures safe and appropriate treatment.

On physical examination, the wound should be described in sufficient detail (eg, length, shape), and a distal neurovascular examination should be completed and documented. This involves testing the patient’s motor strength, sensation, adequacy of pulses, and capillary refill. When examining the extremities, flexion and extension strength should also be assessed and documented.

After a wound is prepped and anesthetized, it should be explored. Often a patient may have excellent flexor or extensor strength on testing, but have a near-complete tendon laceration on visual inspection. Similarly, the wound should be explored for foreign bodies. It is important to identify and remove foreign bodies because of the associated increased risk of infection, pain, and delayed healing.¹ Occasionally, a wound may need to be extended to remove a foreign body.

Unfortunately, visual inspection of a wound, especially a deep one, is not highly sensitive. If a physician has a high index of suspicion for a retained foreign body but is unable to identify one on examination, imaging studies should be ordered. Conventional plain radiography, ultrasonography, computed tomography (CT), and MRI studies can all be used to identify foreign bodies. Each of these modalities has its unique advantages and disadvantages. A recent study by Pattamapaspong et al² compared the accuracy of radiography, CT, and MRI in detecting foreign bodies in the foot. In this study, researchers placed various types of foreign bodies, including fresh wood, dry wood, glass, porcelain, and plastic—all measuring  5 x 2 mm— in cadaver feet.² The overall sensitivity and specificity for foreign body detection was 29% and 100%, respectively, for radiographs; 63% and 98%, respectively, for CT; and 58% and 100%, respectively, for MRI.² Interestingly, CT was superior to MRI in identifying water-rich fresh wood.² A similar study by Aras et al³ compared the sensitivity of plain radiographs, CT, and ultrasound in detecting foreign bodies in the face. The foreign bodies used in this study measured 1 x 1 x 1 cm and included metal, glass, wood, stone, acrylic, graphite, and polyoxybenzylmethylenglycolanhydride (ie, Bakelite).³ In this study, ultrasound identified superficial foreign bodies with low radiopacity in body tissues more effectively than CT or plain radiographs.³ In a review by Karabay⁴ of traumatic wrist and hand injuries, ultrasound was considered the best modality to identify and locate both opaque and radiolucent foreign bodies in the soft tissue.

If a foreign body is identified but cannot be removed, consultation with a surgical service is required. Depending on the local referral pattern, this might be general surgery, plastic surgery, or hand surgery. Unless there is an acute nerve or vascular injury, patients rarely require immediate surgery. In most cases, the wound can be closed loosely until the surgeon can remove the foreign body in the operating room and/or with aid of fluoroscopy at a later time. Depending on the size, material, and location of the foreign body, the surgeon might even elect to simply observe.

The bottom-line lesson from this case: depending on the mechanism of injury, EPs must maintain a high index of suspicion for retained foreign bodies in traumatic wounds. In addition to wound exploration, imaging studies should be used in patients at high risk for a retained foreign body, such as those injured with broken glass or porcelain, but in whom no foreign body is found on wound exploration.

Ruptured Esophagus

A 78-year-old man presented to the ED with symptoms of choking and chest discomfort. The patient stated that he had experienced a sudden onset of difficulty swallowing, along with chest pain, while he was eating dinner at a restaurant earlier that evening. The patient initially thought he had a piece of carrot stuck in his throat. He denied any previous history of similar symptoms. He complained of mild shortness of breath, but denied any drooling or vomiting. His medical history was significant for hypertension, which was controlled with medication. He denied tobacco or alcohol use and had no known drug allergies.

On physical examination, the patient’s vital signs were: heart rate (HR), 106 beats/minute; blood pressure (BP), 144/82 mm Hg; respiratory rate, 22 breaths/minute, and temperature, 98.6°F. Oxygen saturation was 95% on room air. The patient’s oropharynx appeared normal and without foreign body obstruction; his lungs were clear to auscultation bilaterally; and his HR was tachycardic but with a regular rhythm. Other than mild diaphoresis, the remainder of the physical examination was normal.

The EP ordered a complete blood count (CBC), a basic metabolic profile (BMP), and a portable chest X-ray, which the EP interpreted as normal. In addition, an intravenous (IV) saline lock was placed, and the patient was given morphine 4 mg IV and ondansetron 4 mg IV. He was also placed on 2 L of oxygen via nasal cannula. Since the patient continued to complain of chest pain and dysphagia, the EP consulted with a gastroenterologist; unfortunately, there was no documentation of this.

The EP admitted the patient to the floor with a diagnosis of esophageal obstruction, probably secondary to a piece of carrot. During the night, the patient’s shortness of breath worsened, requiring an increase in supplemental oxygen. The next morning, the patient’s HR increased to 120 beats/minute; his BP dropped to 96/50 mm Hg, and he developed a low-grade fever. He was transferred to the intensive care unit, where he was started on IV fluid resuscitation with normal saline and broad spectrum antibiotics. A CT scan of the chest was also ordered, which revealed an esophageal perforation. The patient was taken immediately to the operating room; surgery revealed a large esophageal perforation with evidence of mediastinitis and gross contamination of the left hemithorax. The patient died 2 days later.

The patient’s family sued the EP for failure to diagnose and treat the esophageal perforation in a timely manner. The EP argued that the patient’s symptoms were consistent with an obstruction, not esophageal perforation. The defendant also argued that the initial chest X-ray was normal. The case was resolved for $800,000 prior to going to trial.

Discussion

Esophageal perforation is a true medical emergency that requires timely diagnosis and management because morbidity and mortality are directly related to the time to treatment. Unfortunately, esophageal perforation can be a difficult diagnosis due to its relative rarity and variability in clinical presentation.

More than 50% of all esophageal perforations are iatrogenic, primarily as a complication of endoscopy.¹ Other causes of perforation include spontaneous perforation or Boerhaave syndrome (15%), foreign body (12%), trauma (9%), and malignancy (1%).¹ Anatomically, perforation tends to occur in the areas of the esophagus that are most narrow—eg, cricopharyngeus muscle, area of broncho-aortic constriction, and esophagogastric junction.¹

Food impactions, not surprisingly, tend to occur in these same areas of the esophagus. In addition, there are structural esophageal abnormalities that increase the risk of food impaction, including diverticula, webs, rings, strictures, achalasia, and tumors.² Since food impaction can result in an esophageal perforation, there is a significant overlap in the initial presentation of these two conditions. However, in cases of perforation, signs and symptoms of shock predominate as time progresses due to esophageal contents leaking into the mediastinal and pleural spaces.

Patients with a food impaction will often complain of an acute onset of dysphagia, difficulty in handling secretions, choking, drooling, retrosternal fullness, regurgitation of undigested food, and wheezing.² Perforation can cause severe chest pain, tachypnea, dyspnea, fever, and shock.²

A chest X-ray is typically the initial imaging study for suspected esophageal perforation. Since most spontaneous perforations occur through the left posterolateral wall of the distal esophagus, a new left pleural effusion can frequently be seen on X-ray. Mediastinal emphysema is highly suspicious for perforation, but the condition takes time to develop; therefore, its absence on X-ray does not exclude perforation. In the setting of a normal chest X-ray and ongoing esophageal symptoms, further investigation is required, usually via CT scan or endoscopy. Computed tomography, because of its availability and speed, is usually the preferred study to confirm the diagnosis.

Once an esophageal perforation is confirmed or is highly suspected, the patient will require IV fluid resuscitation, IV broad-spectrum antibiotic treatment, and emergency surgical consultation. As previously stated, esophageal perforation is associated with a high mortality rate, and time is critical to successful management.

Receiving notice from a payor that you are being audited can be alarming. Questions will inevitably run through your mind, such as, Why? How? How much will this cost?

Understanding the types of payor audits and how to navigate the process can make answering those questions easier. In addition, advanced preparation and knowing when to engage legal counsel can be critical to a successful audit outcome.

Audit Types

There are three general types of audits that providers face: Medicare audits, Medicaid audits, and private payor audits.

Medicare audits: The agency responsible for Medicare audits is the Centers for Medicare & Medicaid Services (CMS). There are three types of Medicare audits. Comprehensive Error Rate Testing (CERT) audits focus on providers who deliver high-cost items or services, have high volume, and/or have atypical billing or coding practices. Private contractors perform Recovery Audit Contractor (RAC) program audits; these contractors are paid a percentage of the amount of any improper payment discovered. Finally, Zone Program Integrity Contractor (ZPIC) audits are the most serious of the three audit types. ZPIC audits are performed by CMS contractors who mine the provider’s data for compliance with Medicare coverage and coding policies, investigate fraud, and may prepare cases for civil or criminal referral to CMS or law enforcement agencies.

Medicaid audits: Medicaid audits evaluate compliance with both CMS and applicable state regulations and investigate fraud. Evidence of fraud will be reported to the state attorney general for further review and prosecution.

Private payor audits: Private payor audits consist of informal reviews and formal audits. These audits can be triggered by actual allegations or evidence of noncompliance, or they can be random, in which general compliance is assessed. Audit procedures are typically determined by contract or the payor’s provider handbook and in accordance with applicable state law. The process can consist of prepayment reviews, in which the sufficiency of a claim and its supporting documentation is determined before payment is made to the provider, or post-payment reviews, during which claims are analyzed after the provider has been paid to determine if an overpayment was made and the amount of such overpayment. In the event an overpayment is discovered, a recoupment will be sought from the provider.

Focus

Consistent billing by a provider of high volumes of certain high-level services, high volumes of evaluation and management services, or consistently referring patients for certain testing can create suspicion in mayors.

In recent years, the primary focus of audits has been medical necessity due to payor concerns about specific fraud and abuse issues. Documentation of medical necessity is required during an audit. However, proving medical necessity can be difficult as the definition of “medical necessity” can vary by payor and within a payor depending on the underlying plan. In addition, private payors often have arbitrary and vague guidelines for defining and determining medical necessity, particularly when dealing with physicians or ordering clinicians. For this reason, it is critical that providers read their payor contracts and manuals carefully. If those materials are unclear, it is best to confirm requirements with the payor.

Regardless of the definition, medical necessity is a precondition to coverage for all payors. Proof is required that the services were reasonable and necessary to diagnosis or treat a patient’s medical condition. To satisfy this standard, providers should document the diagnosis for all procedures performed and all diagnostic tests ordered. In the case of repeat procedures, providers should clearly note the outcome of the previous procedure and the basis for reordering.

Responding to an Audit Request

All audit requests must be taken very seriously. Payors tend to copy what other payors are doing, and a problematic audit with one payor can cause other payors to initiate their own audits. Therefore, it is critical to respond appropriately to each audit request. Also, auditors often only check a few billing records. If errors are found, they will then extrapolate those findings, and the provider may be penalized.

Upon receipt of an audit request, it is important to immediately engage legal counsel well-versed in handling payor audits. Having an attorney who understands the audit process and has experience responding to audit requests can help ensure the best possible audit outcome. A negative outcome could result in recovery of overpayments, civil and/or criminal penalties, and exclusion from government programs.

Providers should work with such legal counsel to review the audit request and supply everything reasonably requested. A concerted effort should be made to submit all information to the auditor at one time. If information is missing, the auditor may determine that a significant error rate exists, which could cause the auditor to review all CPT codes to calculate the overpayment made to the provider. If it is not possible to gather the requested material before the auditor’s deadline, an extension should be requested. Any extensions granted should be documented.

It is important that an audit response and supporting documentation be thorough, clear, and concise. It should be submitted in a manner that allows the auditor to quickly review the information and understand the provider’s arguments. It should clearly state what measures the provider has already taken to terminate existing problems and prevent future issues. Competent legal counsel will be able to address procedural, legal, or factual flaws in the auditor’s position.

Advanced Preparation

The best way to ensure compliance and audit readiness is to develop and implement a compliance plan well in advance of any audit. Experienced legal counsel should play a pivotal role in development of such plan. As always, periodic self-audits or independent audits are necessary to proactively identify compliance issues and mitigate their impact.

Finally, regular and periodic training and education should be conducted regarding audit response obligations and responsibilities. Performing these tasks will help ensure a smooth audit experience with minimal infractions and penalties. TH

Receiving notice from a payor that you are being audited can be alarming. Questions will inevitably run through your mind, such as, Why? How? How much will this cost?

Understanding the types of payor audits and how to navigate the process can make answering those questions easier. In addition, advanced preparation and knowing when to engage legal counsel can be critical to a successful audit outcome.

Audit Types

There are three general types of audits that providers face: Medicare audits, Medicaid audits, and private payor audits.

Medicare audits: The agency responsible for Medicare audits is the Centers for Medicare & Medicaid Services (CMS). There are three types of Medicare audits. Comprehensive Error Rate Testing (CERT) audits focus on providers who deliver high-cost items or services, have high volume, and/or have atypical billing or coding practices. Private contractors perform Recovery Audit Contractor (RAC) program audits; these contractors are paid a percentage of the amount of any improper payment discovered. Finally, Zone Program Integrity Contractor (ZPIC) audits are the most serious of the three audit types. ZPIC audits are performed by CMS contractors who mine the provider’s data for compliance with Medicare coverage and coding policies, investigate fraud, and may prepare cases for civil or criminal referral to CMS or law enforcement agencies.

Medicaid audits: Medicaid audits evaluate compliance with both CMS and applicable state regulations and investigate fraud. Evidence of fraud will be reported to the state attorney general for further review and prosecution.

Private payor audits: Private payor audits consist of informal reviews and formal audits. These audits can be triggered by actual allegations or evidence of noncompliance, or they can be random, in which general compliance is assessed. Audit procedures are typically determined by contract or the payor’s provider handbook and in accordance with applicable state law. The process can consist of prepayment reviews, in which the sufficiency of a claim and its supporting documentation is determined before payment is made to the provider, or post-payment reviews, during which claims are analyzed after the provider has been paid to determine if an overpayment was made and the amount of such overpayment. In the event an overpayment is discovered, a recoupment will be sought from the provider.

Focus

Consistent billing by a provider of high volumes of certain high-level services, high volumes of evaluation and management services, or consistently referring patients for certain testing can create suspicion in mayors.

In recent years, the primary focus of audits has been medical necessity due to payor concerns about specific fraud and abuse issues. Documentation of medical necessity is required during an audit. However, proving medical necessity can be difficult as the definition of “medical necessity” can vary by payor and within a payor depending on the underlying plan. In addition, private payors often have arbitrary and vague guidelines for defining and determining medical necessity, particularly when dealing with physicians or ordering clinicians. For this reason, it is critical that providers read their payor contracts and manuals carefully. If those materials are unclear, it is best to confirm requirements with the payor.

Regardless of the definition, medical necessity is a precondition to coverage for all payors. Proof is required that the services were reasonable and necessary to diagnosis or treat a patient’s medical condition. To satisfy this standard, providers should document the diagnosis for all procedures performed and all diagnostic tests ordered. In the case of repeat procedures, providers should clearly note the outcome of the previous procedure and the basis for reordering.

Responding to an Audit Request

All audit requests must be taken very seriously. Payors tend to copy what other payors are doing, and a problematic audit with one payor can cause other payors to initiate their own audits. Therefore, it is critical to respond appropriately to each audit request. Also, auditors often only check a few billing records. If errors are found, they will then extrapolate those findings, and the provider may be penalized.

Upon receipt of an audit request, it is important to immediately engage legal counsel well-versed in handling payor audits. Having an attorney who understands the audit process and has experience responding to audit requests can help ensure the best possible audit outcome. A negative outcome could result in recovery of overpayments, civil and/or criminal penalties, and exclusion from government programs.

Providers should work with such legal counsel to review the audit request and supply everything reasonably requested. A concerted effort should be made to submit all information to the auditor at one time. If information is missing, the auditor may determine that a significant error rate exists, which could cause the auditor to review all CPT codes to calculate the overpayment made to the provider. If it is not possible to gather the requested material before the auditor’s deadline, an extension should be requested. Any extensions granted should be documented.

It is important that an audit response and supporting documentation be thorough, clear, and concise. It should be submitted in a manner that allows the auditor to quickly review the information and understand the provider’s arguments. It should clearly state what measures the provider has already taken to terminate existing problems and prevent future issues. Competent legal counsel will be able to address procedural, legal, or factual flaws in the auditor’s position.

Advanced Preparation

The best way to ensure compliance and audit readiness is to develop and implement a compliance plan well in advance of any audit. Experienced legal counsel should play a pivotal role in development of such plan. As always, periodic self-audits or independent audits are necessary to proactively identify compliance issues and mitigate their impact.

Finally, regular and periodic training and education should be conducted regarding audit response obligations and responsibilities. Performing these tasks will help ensure a smooth audit experience with minimal infractions and penalties. TH

Receiving notice from a payor that you are being audited can be alarming. Questions will inevitably run through your mind, such as, Why? How? How much will this cost?

Understanding the types of payor audits and how to navigate the process can make answering those questions easier. In addition, advanced preparation and knowing when to engage legal counsel can be critical to a successful audit outcome.

Audit Types

There are three general types of audits that providers face: Medicare audits, Medicaid audits, and private payor audits.

Medicare audits: The agency responsible for Medicare audits is the Centers for Medicare & Medicaid Services (CMS). There are three types of Medicare audits. Comprehensive Error Rate Testing (CERT) audits focus on providers who deliver high-cost items or services, have high volume, and/or have atypical billing or coding practices. Private contractors perform Recovery Audit Contractor (RAC) program audits; these contractors are paid a percentage of the amount of any improper payment discovered. Finally, Zone Program Integrity Contractor (ZPIC) audits are the most serious of the three audit types. ZPIC audits are performed by CMS contractors who mine the provider’s data for compliance with Medicare coverage and coding policies, investigate fraud, and may prepare cases for civil or criminal referral to CMS or law enforcement agencies.

Medicaid audits: Medicaid audits evaluate compliance with both CMS and applicable state regulations and investigate fraud. Evidence of fraud will be reported to the state attorney general for further review and prosecution.

Private payor audits: Private payor audits consist of informal reviews and formal audits. These audits can be triggered by actual allegations or evidence of noncompliance, or they can be random, in which general compliance is assessed. Audit procedures are typically determined by contract or the payor’s provider handbook and in accordance with applicable state law. The process can consist of prepayment reviews, in which the sufficiency of a claim and its supporting documentation is determined before payment is made to the provider, or post-payment reviews, during which claims are analyzed after the provider has been paid to determine if an overpayment was made and the amount of such overpayment. In the event an overpayment is discovered, a recoupment will be sought from the provider.

Focus

Consistent billing by a provider of high volumes of certain high-level services, high volumes of evaluation and management services, or consistently referring patients for certain testing can create suspicion in mayors.

In recent years, the primary focus of audits has been medical necessity due to payor concerns about specific fraud and abuse issues. Documentation of medical necessity is required during an audit. However, proving medical necessity can be difficult as the definition of “medical necessity” can vary by payor and within a payor depending on the underlying plan. In addition, private payors often have arbitrary and vague guidelines for defining and determining medical necessity, particularly when dealing with physicians or ordering clinicians. For this reason, it is critical that providers read their payor contracts and manuals carefully. If those materials are unclear, it is best to confirm requirements with the payor.

Regardless of the definition, medical necessity is a precondition to coverage for all payors. Proof is required that the services were reasonable and necessary to diagnosis or treat a patient’s medical condition. To satisfy this standard, providers should document the diagnosis for all procedures performed and all diagnostic tests ordered. In the case of repeat procedures, providers should clearly note the outcome of the previous procedure and the basis for reordering.

Responding to an Audit Request

All audit requests must be taken very seriously. Payors tend to copy what other payors are doing, and a problematic audit with one payor can cause other payors to initiate their own audits. Therefore, it is critical to respond appropriately to each audit request. Also, auditors often only check a few billing records. If errors are found, they will then extrapolate those findings, and the provider may be penalized.

Upon receipt of an audit request, it is important to immediately engage legal counsel well-versed in handling payor audits. Having an attorney who understands the audit process and has experience responding to audit requests can help ensure the best possible audit outcome. A negative outcome could result in recovery of overpayments, civil and/or criminal penalties, and exclusion from government programs.

Providers should work with such legal counsel to review the audit request and supply everything reasonably requested. A concerted effort should be made to submit all information to the auditor at one time. If information is missing, the auditor may determine that a significant error rate exists, which could cause the auditor to review all CPT codes to calculate the overpayment made to the provider. If it is not possible to gather the requested material before the auditor’s deadline, an extension should be requested. Any extensions granted should be documented.

It is important that an audit response and supporting documentation be thorough, clear, and concise. It should be submitted in a manner that allows the auditor to quickly review the information and understand the provider’s arguments. It should clearly state what measures the provider has already taken to terminate existing problems and prevent future issues. Competent legal counsel will be able to address procedural, legal, or factual flaws in the auditor’s position.

Advanced Preparation

The best way to ensure compliance and audit readiness is to develop and implement a compliance plan well in advance of any audit. Experienced legal counsel should play a pivotal role in development of such plan. As always, periodic self-audits or independent audits are necessary to proactively identify compliance issues and mitigate their impact.

Finally, regular and periodic training and education should be conducted regarding audit response obligations and responsibilities. Performing these tasks will help ensure a smooth audit experience with minimal infractions and penalties. TH

Large scar after multiple procedures

A woman with a history of 3 cesarean deliveries, a tubal ligation reversal, and an abdominoplasty discussed treatment for a large uterine fibroid with her ObGyn. She wanted to avoid a large scar. The ObGyn informed the patient that a laparoscopic hysterectomy could not be promised until her pelvic area was inspected to see if minimally invasive surgery safely could be performed.

During surgery, the ObGyn discovered that pelvic adhesions had distorted the patient’s anatomy; he converted to laparotomy, which left a larger scar.

Two days after surgery, the patient was found to have a bowel injury and underwent additional surgery that included placement of surgical mesh, leaving an enlarged scar.

PATIENT'S CLAIM:

The ObGyn was negligent in injuring the patient’s bowel during hysterectomy and not detecting the injury intraoperatively. Her scars were larger because of the additional repair operation.

PHYSICIAN'S DEFENSE:

Bowel injury is a known complication of the procedure. Many bowel injuries are not detected intraoperatively. The ObGyn made every effort to prevent and check for injury during the procedure.

VERDICT:

An Illinois defense verdict was returned.

Uterus and bowel injured during D&C: $1.5M verdict

A 56-year-old woman underwent hysteroscopy and dilation and curettage (D&C). During the procedure, the gynecologist recognized that he had perforated the uterus and injured the bowel and called in a general surgeon to resect 5 cm of the bowel and repair the uterus.

PATIENT'S CLAIM:

The patient has a large abdominal scar and a chronically distended abdomen. She experienced a year of daily pain and suffering. The D&C was unnecessary and improperly performed: the standard of care is for the gynecologist to operate in a gentle manner; that did not occur.

PHYSICIAN'S DEFENSE:

The D&C was medically necessary. The gynecologist exercised the proper standard of care.

VERDICT:

A $1.5 million New Jersey verdict was returned. The jury found the D&C necessary, but determined that the gynecologist deviated from the accepted standard of care in his performance of the procedure.

Injured ureter allegedly not treated

On December 6, a 42-year-old woman underwent hysterectomy. Postoperatively, she reported increasing dysuria with pain and fever.

On December 13, a computed tomography (CT) scan suggested a partial ureter obstruction. Despite test results, the gynecologist elected to continue to monitor the patient.

The patient’s symptoms continued to worsen and, on December 27, she underwent a second CT scan that identified an obstructed ureter. The gynecologist referred the patient to a urologist, who determined that the patient had sustained a significant ureter injury that required placement of a nephrostomy tube.

PATIENT'S CLAIM:

The gynecologist failed to identify the injury during surgery. The gynecologist was negligent in not consulting a urologist after results of the first CT scan.

PHYSICIAN'S DEFENSE:

Uterine injury is a known complication of the procedure. The gynecologist inspected adjacent organs during surgery but did not find an injury. Postoperative treatment was appropriate.

VERDICT:

The case was presented before a medical review board that concluded that there was no error after the first injury, there was no duty to trace the ureter, and a urology consult was not required after the first CT scan. A Louisiana defense verdict was returned.

Was FHR properly monitored?

After a failed nonstress test, a mother was admitted to triage for blood pressure monitoring. Fetal heart-rate (FHR) monitoring was discontinued at that time. Later that day, FHR monitoring was resumed, fetal distress was detected, and an emergency cesarean delivery was performed. Placental abruption resulted in hypoxia in the baby; she received a diagnosis of cerebral palsy.

PARENT'S CLAIM:

The pregnancy was at high risk because of the mother’s hypertension. The ObGyns misread the FHR at admission and discontinued FHR monitoring too early. If continuous FHR monitoring had occurred, fetal distress would have been detected earlier, resulting in a better outcome for the baby.

PHYSICIAN'S DEFENSE:

There were no signs of fetal distress when the FHR monitoring was discontinued. Placental abruption is an acute event that cannot be predicted.

VERDICT:

A Missouri defense verdict was returned.

Should the ObGyn have come to the hospital earlier?

At 39 weeks’ gestation, a mother arrived at the hospital for induction of labor. That evening, the ObGyn, who was not at the hospital, was notified that the mother had an elevated temperature and that the FHR indicated tachycardia. The ObGyn prescribed antibiotics, and the fever subsided. After an hour, the patient was fully dilated and started to push under a nurse’s supervision. Twenty minutes later, the ObGyn was notified that the fetus was experiencing variable decelerations. The ObGyn arrived in 30 minutes and ordered a cesarean delivery. The baby was born 24 minutes later.

The baby began to have seizures 10 hours after birth. He was transferred to another hospital and remained in the neonatal intensive care unit for 15 days. The child received a diagnosis of cerebral palsy.

PARENT'S CLAIM: 

The ObGyn was negligent in not coming to the hospital when the mother was feverish and the fetus tachycardic. The baby experienced an acute hypoxic ischemic injury; an earlier cesarean delivery would have avoided brain injury.

PHYSICIAN'S DEFENSE:

There was no negligence. The infant did not meet all the criteria for an acute hypoxic ischemic injury. Based on a computed tomography scan taken after the seizures began, the infant’s brain injury most likely occurred hours before birth.

VERDICT:

A Virginia defense verdict was returned.

Large scar after multiple procedures

A woman with a history of 3 cesarean deliveries, a tubal ligation reversal, and an abdominoplasty discussed treatment for a large uterine fibroid with her ObGyn. She wanted to avoid a large scar. The ObGyn informed the patient that a laparoscopic hysterectomy could not be promised until her pelvic area was inspected to see if minimally invasive surgery safely could be performed.

During surgery, the ObGyn discovered that pelvic adhesions had distorted the patient’s anatomy; he converted to laparotomy, which left a larger scar.

Two days after surgery, the patient was found to have a bowel injury and underwent additional surgery that included placement of surgical mesh, leaving an enlarged scar.

PATIENT'S CLAIM:

The ObGyn was negligent in injuring the patient’s bowel during hysterectomy and not detecting the injury intraoperatively. Her scars were larger because of the additional repair operation.

PHYSICIAN'S DEFENSE:

Bowel injury is a known complication of the procedure. Many bowel injuries are not detected intraoperatively. The ObGyn made every effort to prevent and check for injury during the procedure.

VERDICT:

An Illinois defense verdict was returned.

Uterus and bowel injured during D&C: $1.5M verdict

A 56-year-old woman underwent hysteroscopy and dilation and curettage (D&C). During the procedure, the gynecologist recognized that he had perforated the uterus and injured the bowel and called in a general surgeon to resect 5 cm of the bowel and repair the uterus.

PATIENT'S CLAIM:

The patient has a large abdominal scar and a chronically distended abdomen. She experienced a year of daily pain and suffering. The D&C was unnecessary and improperly performed: the standard of care is for the gynecologist to operate in a gentle manner; that did not occur.

PHYSICIAN'S DEFENSE:

The D&C was medically necessary. The gynecologist exercised the proper standard of care.

VERDICT:

A $1.5 million New Jersey verdict was returned. The jury found the D&C necessary, but determined that the gynecologist deviated from the accepted standard of care in his performance of the procedure.

Injured ureter allegedly not treated

On December 6, a 42-year-old woman underwent hysterectomy. Postoperatively, she reported increasing dysuria with pain and fever.

On December 13, a computed tomography (CT) scan suggested a partial ureter obstruction. Despite test results, the gynecologist elected to continue to monitor the patient.

The patient’s symptoms continued to worsen and, on December 27, she underwent a second CT scan that identified an obstructed ureter. The gynecologist referred the patient to a urologist, who determined that the patient had sustained a significant ureter injury that required placement of a nephrostomy tube.

PATIENT'S CLAIM:

The gynecologist failed to identify the injury during surgery. The gynecologist was negligent in not consulting a urologist after results of the first CT scan.

PHYSICIAN'S DEFENSE:

Uterine injury is a known complication of the procedure. The gynecologist inspected adjacent organs during surgery but did not find an injury. Postoperative treatment was appropriate.

VERDICT:

The case was presented before a medical review board that concluded that there was no error after the first injury, there was no duty to trace the ureter, and a urology consult was not required after the first CT scan. A Louisiana defense verdict was returned.

Was FHR properly monitored?

After a failed nonstress test, a mother was admitted to triage for blood pressure monitoring. Fetal heart-rate (FHR) monitoring was discontinued at that time. Later that day, FHR monitoring was resumed, fetal distress was detected, and an emergency cesarean delivery was performed. Placental abruption resulted in hypoxia in the baby; she received a diagnosis of cerebral palsy.

PARENT'S CLAIM:

The pregnancy was at high risk because of the mother’s hypertension. The ObGyns misread the FHR at admission and discontinued FHR monitoring too early. If continuous FHR monitoring had occurred, fetal distress would have been detected earlier, resulting in a better outcome for the baby.

PHYSICIAN'S DEFENSE:

There were no signs of fetal distress when the FHR monitoring was discontinued. Placental abruption is an acute event that cannot be predicted.

VERDICT:

A Missouri defense verdict was returned.

Should the ObGyn have come to the hospital earlier?

At 39 weeks’ gestation, a mother arrived at the hospital for induction of labor. That evening, the ObGyn, who was not at the hospital, was notified that the mother had an elevated temperature and that the FHR indicated tachycardia. The ObGyn prescribed antibiotics, and the fever subsided. After an hour, the patient was fully dilated and started to push under a nurse’s supervision. Twenty minutes later, the ObGyn was notified that the fetus was experiencing variable decelerations. The ObGyn arrived in 30 minutes and ordered a cesarean delivery. The baby was born 24 minutes later.

The baby began to have seizures 10 hours after birth. He was transferred to another hospital and remained in the neonatal intensive care unit for 15 days. The child received a diagnosis of cerebral palsy.

PARENT'S CLAIM: 

The ObGyn was negligent in not coming to the hospital when the mother was feverish and the fetus tachycardic. The baby experienced an acute hypoxic ischemic injury; an earlier cesarean delivery would have avoided brain injury.

PHYSICIAN'S DEFENSE:

There was no negligence. The infant did not meet all the criteria for an acute hypoxic ischemic injury. Based on a computed tomography scan taken after the seizures began, the infant’s brain injury most likely occurred hours before birth.

VERDICT:

A Virginia defense verdict was returned.

Large scar after multiple procedures

A woman with a history of 3 cesarean deliveries, a tubal ligation reversal, and an abdominoplasty discussed treatment for a large uterine fibroid with her ObGyn. She wanted to avoid a large scar. The ObGyn informed the patient that a laparoscopic hysterectomy could not be promised until her pelvic area was inspected to see if minimally invasive surgery safely could be performed.

During surgery, the ObGyn discovered that pelvic adhesions had distorted the patient’s anatomy; he converted to laparotomy, which left a larger scar.

Two days after surgery, the patient was found to have a bowel injury and underwent additional surgery that included placement of surgical mesh, leaving an enlarged scar.

PATIENT'S CLAIM:

The ObGyn was negligent in injuring the patient’s bowel during hysterectomy and not detecting the injury intraoperatively. Her scars were larger because of the additional repair operation.

PHYSICIAN'S DEFENSE:

Bowel injury is a known complication of the procedure. Many bowel injuries are not detected intraoperatively. The ObGyn made every effort to prevent and check for injury during the procedure.

VERDICT:

An Illinois defense verdict was returned.

Uterus and bowel injured during D&C: $1.5M verdict

A 56-year-old woman underwent hysteroscopy and dilation and curettage (D&C). During the procedure, the gynecologist recognized that he had perforated the uterus and injured the bowel and called in a general surgeon to resect 5 cm of the bowel and repair the uterus.

PATIENT'S CLAIM:

The patient has a large abdominal scar and a chronically distended abdomen. She experienced a year of daily pain and suffering. The D&C was unnecessary and improperly performed: the standard of care is for the gynecologist to operate in a gentle manner; that did not occur.

PHYSICIAN'S DEFENSE:

The D&C was medically necessary. The gynecologist exercised the proper standard of care.

VERDICT:

A $1.5 million New Jersey verdict was returned. The jury found the D&C necessary, but determined that the gynecologist deviated from the accepted standard of care in his performance of the procedure.

Injured ureter allegedly not treated

On December 6, a 42-year-old woman underwent hysterectomy. Postoperatively, she reported increasing dysuria with pain and fever.

On December 13, a computed tomography (CT) scan suggested a partial ureter obstruction. Despite test results, the gynecologist elected to continue to monitor the patient.

The patient’s symptoms continued to worsen and, on December 27, she underwent a second CT scan that identified an obstructed ureter. The gynecologist referred the patient to a urologist, who determined that the patient had sustained a significant ureter injury that required placement of a nephrostomy tube.

PATIENT'S CLAIM:

The gynecologist failed to identify the injury during surgery. The gynecologist was negligent in not consulting a urologist after results of the first CT scan.

PHYSICIAN'S DEFENSE:

Uterine injury is a known complication of the procedure. The gynecologist inspected adjacent organs during surgery but did not find an injury. Postoperative treatment was appropriate.

VERDICT:

The case was presented before a medical review board that concluded that there was no error after the first injury, there was no duty to trace the ureter, and a urology consult was not required after the first CT scan. A Louisiana defense verdict was returned.

Was FHR properly monitored?

After a failed nonstress test, a mother was admitted to triage for blood pressure monitoring. Fetal heart-rate (FHR) monitoring was discontinued at that time. Later that day, FHR monitoring was resumed, fetal distress was detected, and an emergency cesarean delivery was performed. Placental abruption resulted in hypoxia in the baby; she received a diagnosis of cerebral palsy.

PARENT'S CLAIM:

The pregnancy was at high risk because of the mother’s hypertension. The ObGyns misread the FHR at admission and discontinued FHR monitoring too early. If continuous FHR monitoring had occurred, fetal distress would have been detected earlier, resulting in a better outcome for the baby.

PHYSICIAN'S DEFENSE:

There were no signs of fetal distress when the FHR monitoring was discontinued. Placental abruption is an acute event that cannot be predicted.

VERDICT:

A Missouri defense verdict was returned.

Should the ObGyn have come to the hospital earlier?

At 39 weeks’ gestation, a mother arrived at the hospital for induction of labor. That evening, the ObGyn, who was not at the hospital, was notified that the mother had an elevated temperature and that the FHR indicated tachycardia. The ObGyn prescribed antibiotics, and the fever subsided. After an hour, the patient was fully dilated and started to push under a nurse’s supervision. Twenty minutes later, the ObGyn was notified that the fetus was experiencing variable decelerations. The ObGyn arrived in 30 minutes and ordered a cesarean delivery. The baby was born 24 minutes later.

The baby began to have seizures 10 hours after birth. He was transferred to another hospital and remained in the neonatal intensive care unit for 15 days. The child received a diagnosis of cerebral palsy.

PARENT'S CLAIM: 

The ObGyn was negligent in not coming to the hospital when the mother was feverish and the fetus tachycardic. The baby experienced an acute hypoxic ischemic injury; an earlier cesarean delivery would have avoided brain injury.

PHYSICIAN'S DEFENSE:

There was no negligence. The infant did not meet all the criteria for an acute hypoxic ischemic injury. Based on a computed tomography scan taken after the seizures began, the infant’s brain injury most likely occurred hours before birth.

VERDICT:

A Virginia defense verdict was returned.

During surgery, the ObGyn discovered that pelvic adhesions had distorted the patient’s anatomy; he converted to laparotomy, which left a larger scar. Two days after surgery, the patient was found to have a bowel injury and underwent additional surgery that included placement of surgical mesh, leaving an enlarged scar.

PATIENT'S CLAIM: The ObGyn was negligent in injuring the patient’s bowel during hysterectomy and not detecting the injury intraoperatively. Her scars were larger because of the additional repair operation.

PHYSICIAN'S DEFENSE: Bowel injury is a known complication of the procedure. Many bowel injuries are not detected intraoperatively. The ObGyn made every effort to prevent and check for injury during the procedure.

VERDICT: An Illinois defense verdict was returned.

Uterus and bowel injured during D&C: $1.5M verdict
A 56-year-old woman underwent hysteroscopy and dilation and curettage (D&C). During the procedure, the gynecologist recognized that he had perforated the uterus and injured the bowel and called in a general surgeon to resect 5 cm of the bowel and repair the uterus.

PATIENT'S CLAIM:The patient has a large abdominal scar and a chronically distended abdomen. She experienced a year of daily pain and suffering. The D&C was unnecessary and improperly performed: the standard of care is for the gynecologist to operate in a gentle manner; that did not occur.

PHYSICIAN'S DEFENSE:The D&C was medically necessary. The gynecologist exercised the proper standard of care.

VERDICT:A $1.5 million New Jersey verdict was returned. The jury found the D&C necessary, but determined that the gynecologist deviated from the accepted standard of care in his performance of the procedure.

Bowel perforation during myomectomy: $200,000 verdictA 44-year-old woman underwent hysteroscopic myomectomy. During the procedure the ObGyn realized that he had perforated the uterus. He switched to a laparoscopic procedure, found a 3-cm uterine tear, and converted to laparotomy to repair the injury. The postsurgical pathology report revealed multiple colon fragments.

Three days after surgery, the patient became ill and was found to have a bowel injury. She underwent bowel resection with colostomy and, a year later, colostomy reversal. She sustained abdominal scarring.

PATIENT'S CLAIM: The ObGyn was negligent in performing the myomectomy. He should have identified the bowel injury intraoperatively. When the pathology report indicated multiple colon fragments, he should have investigated rather than wait for the patient to develop symptoms.

PHYSICIAN'S DEFENSE: Uterine and colon injuries are known complications of the procedure and can occur within the standard of care. The ObGyn intraoperatively inspected the organs adjacent to the uterus but there was no evident injury. The patient’s postsurgical treatment was proper.

VERDICT: A $200,000 Illinois verdict was returned.

Injured ureter allegedly not treatedA 42-year-old woman underwent hysterectomy on December 6. Postoperatively, she reported increasing dysuria with pain and fever. On December 13, a computed tomography (CT) scan suggested a partial ureter obstruction. Despite test results, the gynecologist elected to continue to monitor the patient. The patient’s symptoms continued to worsen and, on December 27, she underwent a second CT scan that identified an obstructed ureter. The gynecologist referred the patient to a urologist, who determined that the patient had sustained a significant ureter injury that required placement of a nephrostomy tube.

PATIENT'S CLAIM: The gynecologist failed to identify the injury during surgery. The gynecologist was negligent in not consulting a urologist after results of the first CT scan.

PHYSICIAN'S DEFENSE: Uterine injury is a known complication of the procedure. The gynecologist inspected adjacent organs during surgery but did not find an injury. Postoperative treatment was appropriate.

VERDICT: The case was presented before a medical review board that concluded that there was no error after the first injury, there was no duty to trace the ureter, and a urology consult was not required after the first CT scan. A Louisiana defense verdict was returned.

During surgery, the ObGyn discovered that pelvic adhesions had distorted the patient’s anatomy; he converted to laparotomy, which left a larger scar. Two days after surgery, the patient was found to have a bowel injury and underwent additional surgery that included placement of surgical mesh, leaving an enlarged scar.

PATIENT'S CLAIM: The ObGyn was negligent in injuring the patient’s bowel during hysterectomy and not detecting the injury intraoperatively. Her scars were larger because of the additional repair operation.

PHYSICIAN'S DEFENSE: Bowel injury is a known complication of the procedure. Many bowel injuries are not detected intraoperatively. The ObGyn made every effort to prevent and check for injury during the procedure.

VERDICT: An Illinois defense verdict was returned.

Uterus and bowel injured during D&C: $1.5M verdict
A 56-year-old woman underwent hysteroscopy and dilation and curettage (D&C). During the procedure, the gynecologist recognized that he had perforated the uterus and injured the bowel and called in a general surgeon to resect 5 cm of the bowel and repair the uterus.

PATIENT'S CLAIM:The patient has a large abdominal scar and a chronically distended abdomen. She experienced a year of daily pain and suffering. The D&C was unnecessary and improperly performed: the standard of care is for the gynecologist to operate in a gentle manner; that did not occur.

PHYSICIAN'S DEFENSE:The D&C was medically necessary. The gynecologist exercised the proper standard of care.

VERDICT:A $1.5 million New Jersey verdict was returned. The jury found the D&C necessary, but determined that the gynecologist deviated from the accepted standard of care in his performance of the procedure.

Bowel perforation during myomectomy: $200,000 verdictA 44-year-old woman underwent hysteroscopic myomectomy. During the procedure the ObGyn realized that he had perforated the uterus. He switched to a laparoscopic procedure, found a 3-cm uterine tear, and converted to laparotomy to repair the injury. The postsurgical pathology report revealed multiple colon fragments.

Three days after surgery, the patient became ill and was found to have a bowel injury. She underwent bowel resection with colostomy and, a year later, colostomy reversal. She sustained abdominal scarring.

PATIENT'S CLAIM: The ObGyn was negligent in performing the myomectomy. He should have identified the bowel injury intraoperatively. When the pathology report indicated multiple colon fragments, he should have investigated rather than wait for the patient to develop symptoms.

PHYSICIAN'S DEFENSE: Uterine and colon injuries are known complications of the procedure and can occur within the standard of care. The ObGyn intraoperatively inspected the organs adjacent to the uterus but there was no evident injury. The patient’s postsurgical treatment was proper.

VERDICT: A $200,000 Illinois verdict was returned.

Injured ureter allegedly not treatedA 42-year-old woman underwent hysterectomy on December 6. Postoperatively, she reported increasing dysuria with pain and fever. On December 13, a computed tomography (CT) scan suggested a partial ureter obstruction. Despite test results, the gynecologist elected to continue to monitor the patient. The patient’s symptoms continued to worsen and, on December 27, she underwent a second CT scan that identified an obstructed ureter. The gynecologist referred the patient to a urologist, who determined that the patient had sustained a significant ureter injury that required placement of a nephrostomy tube.

PATIENT'S CLAIM: The gynecologist failed to identify the injury during surgery. The gynecologist was negligent in not consulting a urologist after results of the first CT scan.

PHYSICIAN'S DEFENSE: Uterine injury is a known complication of the procedure. The gynecologist inspected adjacent organs during surgery but did not find an injury. Postoperative treatment was appropriate.

VERDICT: The case was presented before a medical review board that concluded that there was no error after the first injury, there was no duty to trace the ureter, and a urology consult was not required after the first CT scan. A Louisiana defense verdict was returned.

During surgery, the ObGyn discovered that pelvic adhesions had distorted the patient’s anatomy; he converted to laparotomy, which left a larger scar. Two days after surgery, the patient was found to have a bowel injury and underwent additional surgery that included placement of surgical mesh, leaving an enlarged scar.

PATIENT'S CLAIM: The ObGyn was negligent in injuring the patient’s bowel during hysterectomy and not detecting the injury intraoperatively. Her scars were larger because of the additional repair operation.

PHYSICIAN'S DEFENSE: Bowel injury is a known complication of the procedure. Many bowel injuries are not detected intraoperatively. The ObGyn made every effort to prevent and check for injury during the procedure.

VERDICT: An Illinois defense verdict was returned.

Uterus and bowel injured during D&C: $1.5M verdict
A 56-year-old woman underwent hysteroscopy and dilation and curettage (D&C). During the procedure, the gynecologist recognized that he had perforated the uterus and injured the bowel and called in a general surgeon to resect 5 cm of the bowel and repair the uterus.

PATIENT'S CLAIM:The patient has a large abdominal scar and a chronically distended abdomen. She experienced a year of daily pain and suffering. The D&C was unnecessary and improperly performed: the standard of care is for the gynecologist to operate in a gentle manner; that did not occur.

PHYSICIAN'S DEFENSE:The D&C was medically necessary. The gynecologist exercised the proper standard of care.

VERDICT:A $1.5 million New Jersey verdict was returned. The jury found the D&C necessary, but determined that the gynecologist deviated from the accepted standard of care in his performance of the procedure.

Bowel perforation during myomectomy: $200,000 verdictA 44-year-old woman underwent hysteroscopic myomectomy. During the procedure the ObGyn realized that he had perforated the uterus. He switched to a laparoscopic procedure, found a 3-cm uterine tear, and converted to laparotomy to repair the injury. The postsurgical pathology report revealed multiple colon fragments.

Three days after surgery, the patient became ill and was found to have a bowel injury. She underwent bowel resection with colostomy and, a year later, colostomy reversal. She sustained abdominal scarring.

PATIENT'S CLAIM: The ObGyn was negligent in performing the myomectomy. He should have identified the bowel injury intraoperatively. When the pathology report indicated multiple colon fragments, he should have investigated rather than wait for the patient to develop symptoms.

PHYSICIAN'S DEFENSE: Uterine and colon injuries are known complications of the procedure and can occur within the standard of care. The ObGyn intraoperatively inspected the organs adjacent to the uterus but there was no evident injury. The patient’s postsurgical treatment was proper.

VERDICT: A $200,000 Illinois verdict was returned.

Injured ureter allegedly not treatedA 42-year-old woman underwent hysterectomy on December 6. Postoperatively, she reported increasing dysuria with pain and fever. On December 13, a computed tomography (CT) scan suggested a partial ureter obstruction. Despite test results, the gynecologist elected to continue to monitor the patient. The patient’s symptoms continued to worsen and, on December 27, she underwent a second CT scan that identified an obstructed ureter. The gynecologist referred the patient to a urologist, who determined that the patient had sustained a significant ureter injury that required placement of a nephrostomy tube.

PATIENT'S CLAIM: The gynecologist failed to identify the injury during surgery. The gynecologist was negligent in not consulting a urologist after results of the first CT scan.

PHYSICIAN'S DEFENSE: Uterine injury is a known complication of the procedure. The gynecologist inspected adjacent organs during surgery but did not find an injury. Postoperative treatment was appropriate.

VERDICT: The case was presented before a medical review board that concluded that there was no error after the first injury, there was no duty to trace the ureter, and a urology consult was not required after the first CT scan. A Louisiana defense verdict was returned.

PARENT'S CLAIM: The pregnancy was at high risk because of the mother’s hypertension. The ObGyns misread the FHR at triage and discontinued FHR monitoring too early. If continuous FHR monitoring had occurred, fetal distress would have been detected earlier, resulting in a better outcome for the baby.

PHYSICIAN'S DEFENSE: There were no signs of fetal distress when the FHR monitoring was discontinued. Placental abruption is an acute event that cannot be predicted.

VERDICT: A Missouri defense verdict was returned.

Should the ObGyn have come to the hospital earlier?At 39 weeks’ gestation, a mother presented to the hospital for induction of labor. A FHR monitor was immediately placed. That evening, the ObGyn, who was not at the hospital, was notified that the mother had an elevated temperature and that the fetus was experiencing tachycardia. The ObGyn prescribed antibiotics, and the fever subsided. After an hour, the patient was fully dilated and started to push under the nurse’s supervision. Twenty minutes later, the ObGyn was notified that the fetus was experiencing variable decelerations. The ObGyn arrived in 30 minutes and ordered cesarean delivery. The baby was born 24 minutes later.

Ten hours after birth, the baby began to have seizures. He was transferred to another hospital and remained in the neonatal intensive care unit for 15 days. The child received a diagnosis of cerebral palsy.

PARENT'S CLAIM: The ObGyn was negligent in not coming to the hospital when the mother was feverish and the baby tachycardic. The baby experienced an acute hypoxic ischemic injury; an earlier cesarean delivery would have avoided brain injury.

PHYSICIAN'S DEFENSE: There was no breach in the standard of care. The infant did not meet all the criteria for an acute hypoxic ischemic injury. Based on a computed tomography scan taken after seizures began, the infant’s brain injury most likely occurred hours before birth.

VERDICT: A Virginia defense verdict was returned.

These cases were selected by the editors of 
OBG Management from "Medical Malpractice Verdicts, Settlements, & Experts," with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts 
and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

PARENT'S CLAIM: The pregnancy was at high risk because of the mother’s hypertension. The ObGyns misread the FHR at triage and discontinued FHR monitoring too early. If continuous FHR monitoring had occurred, fetal distress would have been detected earlier, resulting in a better outcome for the baby.

PHYSICIAN'S DEFENSE: There were no signs of fetal distress when the FHR monitoring was discontinued. Placental abruption is an acute event that cannot be predicted.

VERDICT: A Missouri defense verdict was returned.

Should the ObGyn have come to the hospital earlier?At 39 weeks’ gestation, a mother presented to the hospital for induction of labor. A FHR monitor was immediately placed. That evening, the ObGyn, who was not at the hospital, was notified that the mother had an elevated temperature and that the fetus was experiencing tachycardia. The ObGyn prescribed antibiotics, and the fever subsided. After an hour, the patient was fully dilated and started to push under the nurse’s supervision. Twenty minutes later, the ObGyn was notified that the fetus was experiencing variable decelerations. The ObGyn arrived in 30 minutes and ordered cesarean delivery. The baby was born 24 minutes later.

Ten hours after birth, the baby began to have seizures. He was transferred to another hospital and remained in the neonatal intensive care unit for 15 days. The child received a diagnosis of cerebral palsy.

PARENT'S CLAIM: The ObGyn was negligent in not coming to the hospital when the mother was feverish and the baby tachycardic. The baby experienced an acute hypoxic ischemic injury; an earlier cesarean delivery would have avoided brain injury.

PHYSICIAN'S DEFENSE: There was no breach in the standard of care. The infant did not meet all the criteria for an acute hypoxic ischemic injury. Based on a computed tomography scan taken after seizures began, the infant’s brain injury most likely occurred hours before birth.

VERDICT: A Virginia defense verdict was returned.

These cases were selected by the editors of 
OBG Management from "Medical Malpractice Verdicts, Settlements, & Experts," with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts 
and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

PARENT'S CLAIM: The pregnancy was at high risk because of the mother’s hypertension. The ObGyns misread the FHR at triage and discontinued FHR monitoring too early. If continuous FHR monitoring had occurred, fetal distress would have been detected earlier, resulting in a better outcome for the baby.

PHYSICIAN'S DEFENSE: There were no signs of fetal distress when the FHR monitoring was discontinued. Placental abruption is an acute event that cannot be predicted.

VERDICT: A Missouri defense verdict was returned.

Should the ObGyn have come to the hospital earlier?At 39 weeks’ gestation, a mother presented to the hospital for induction of labor. A FHR monitor was immediately placed. That evening, the ObGyn, who was not at the hospital, was notified that the mother had an elevated temperature and that the fetus was experiencing tachycardia. The ObGyn prescribed antibiotics, and the fever subsided. After an hour, the patient was fully dilated and started to push under the nurse’s supervision. Twenty minutes later, the ObGyn was notified that the fetus was experiencing variable decelerations. The ObGyn arrived in 30 minutes and ordered cesarean delivery. The baby was born 24 minutes later.

Ten hours after birth, the baby began to have seizures. He was transferred to another hospital and remained in the neonatal intensive care unit for 15 days. The child received a diagnosis of cerebral palsy.

PARENT'S CLAIM: The ObGyn was negligent in not coming to the hospital when the mother was feverish and the baby tachycardic. The baby experienced an acute hypoxic ischemic injury; an earlier cesarean delivery would have avoided brain injury.

PHYSICIAN'S DEFENSE: There was no breach in the standard of care. The infant did not meet all the criteria for an acute hypoxic ischemic injury. Based on a computed tomography scan taken after seizures began, the infant’s brain injury most likely occurred hours before birth.

VERDICT: A Virginia defense verdict was returned.

These cases were selected by the editors of 
OBG Management from "Medical Malpractice Verdicts, Settlements, & Experts," with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts 
and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Failure to convert to laparotomy: $6.25M settlement

A 67-year-old woman with urinary incontinence underwent robot-assisted laparoscopic prolapse surgery and hysterectomy. Complications arose, including an injury to the transverse colon. Postoperatively, the patient developed sepsis and had multiple surgeries. At the time of trial, she used a colostomy bag and had a malabsorption syndrome that required frequent intravenous treatment for dehydration.

Patient's claim:

The gynecologist deviated from the standard of care by failing to convert from a laparoscopic procedure to an open procedure when complications developed.

Defendants' defense:

The procedure was properly performed.

Verdict:

A $6.25 million New Jersey settlement was reached, paid jointly by the gynecologist and the medical center.

Circumcision requires revision

A day after birth, a baby underwent circumcision performed by the mother’s ObGyn. Revision surgery was performed 2.5 years later. When the boy was age 7 years, urethral stricture developed and was treated.

Parents' claim:

Circumcision was improperly performed. Once the child was able to talk, he said that his penis constantly hurt. Pain was only relieved by revision surgery.

Physician's defense:

There was no negligence. Redundant foreskin is often left following a circumcision.

Verdict:

A Michigan defense verdict was returned.

Mother with CP has child with CP
A pregnant woman with cerebral palsy (CP) reported a prior preterm delivery at 24 weeks’ gestation to a high-risk prenatal clinic. At that time, she was offered synthetic progesterone (170HP) injections, but she declined because of the cost. She declined 170HP several times. Nine weeks after her initial visit, she declined 170HP despite ultrasonography (US) showing a shortened cervical length (25 mm) for the gestational age. In 2 weeks, when the cervical length measured 9 mm, she was hospitalized to rule out preterm labor but, before tests began, she left the hospital. Five days later, when her cervical length was 11 mm, she received the first 170HP injection. In the next month she received 4 injections, but she failed to show for the fifth injection and US. The next day, she went to the hospital with cramping. She was given steroids and medication to stop labor. US results indicated that the baby was in breech position. The mother consented to cesarean delivery, but the baby was born vaginally an hour later. The child has mild brain damage, CP, developmental delays, and learning disabilities.

Parents' claim: The mother should have been offered vaginal progesterone, which is cheaper. Given the high risk of preterm birth, steroids administered earlier would have improved fetal development. Cesarean delivery should have been performed.

Defendants' defense: Vaginal progesterone was not available at the time. Starting steroids earlier would not have improved fetal outcome. A cesarean delivery was not possible because the baby was in the birth canal.

Verdict: A $3,500,000 Michigan settlement was reached.

Fallopian tubes grow back, pregnancy

A couple decided they did not want more children and sought counseling from the woman’s ObGyn, who recommended laparoscopic tubal ligation. Several months after surgery, the patient became pregnant and gave birth to a son.

Parents' claim:

The additional child placed an economic hardship on the family, now raising 4 children. The youngest child has language delays and learning disabilities.

Physician's defense:

Regrowth of the fallopian tubes resulting in unwanted pregnancy is a known complication of tubal ligation.

Verdict:

A $397,000 Maryland verdict was returned, including funds for the cost of raising the fourth child and to cope with the child’s special needs.

Challenges in managing labor

At 37 weeks' gestation, a woman was hospitalized in labor. At 1:15 pm, she was dilated 3 cm. At 1:30 pm, she was dilated 4−5 cm with increasing contractions and a reassuring fetal heart rate (FHR). The ObGyn covering for the mother’s ObGyn ordered oxytocin augmentation, which started at 2:45 pm. Shortly thereafter, contractions became more frequent and uterine tachysystole was observed. At 4:12 pm, FHR showed multiple deep decelerations with slow recovery. The baseline dropped to a 90-bpm range and remained that way for 17 minutes. At that point, the ObGyn stopped oxytocin and administered terbutaline; the FHR returned to baseline.

After vaginal delivery, the baby’s Apgar scores were 8 and 9 at 1 and 5 minutes, respectively. Two days later, the baby had seizures and was transferred to the neonatal intensive care unit. An electroencephalogram confirmed seizure activity. Initial imaging results were normal. However, magnetic resonance imaging performed a week after delivery showed bilateral brain damage. The child has spastic displegia, is unable to ambulate, and is blind.

Parents' claim: A suit was filed against the hospital and both ObGyns. The hospital settled before trial. The case was discontinued against the primary ObGyn. The covering ObGyn allegedly made 4 departures from accepted medical practice that caused the child’s injury: ordering and administering oxytocin, failing to closely monitor the FHR, failing to timely administer terbutaline, and failing to timely respond to and correct tachysystole.

Physician's defense: The child’s injury occurred before or after labor. The pregnancy was complicated by multiple kidney infections. A week before delivery, US revealed a blood-flow abnormality. An intranatal hypoxic event did not cause the injury, proven by the fact that, after terbutaline was administered, the FHR promptly normalized.

Verdict: A $3 million New York settlement was reached with the hospital. A $134 million verdict was returned against the covering ObGyn.

Brachial plexus injury during delivery
At 37 weeks' gestation, a mother was admitted to the hospital for induction of labor. Increasing doses of oxytocin were administered. Near midnight, FHR monitoring indicated fetal distress. The ObGyn was called and he ordered cesarean delivery. Once he arrived and examined the mother, he found no fetal concerns and decided to proceed with the original birth plan. At 3:30 am, the patient was fully dilated and in active labor. The ObGyn used a vacuum extractor. Upon delivery of the baby’s head, the ObGyn encountered shoulder dystocia and called for assistance. The child was born with a near-total brachial plexus injury: avulsions of all 5 brachial plexus nerves with trauma to the cervical nerve roots at C5−C8 and T1. The child has undergone multiple nerve grafts and orthopedic operations.

Parents' claim: Fetal distress should have prompted the ObGyn to perform cesarean delivery. There was no reason to use vacuum extraction. Based on the severity of the outcome, the ObGyn must have applied excessive force and inappropriate traction during delivery maneuvers.

Physician's defense: The standard of care did not require a cesarean delivery. The vacuum extractor did not cause shoulder dystocia. The ObGyn did not apply excessive force or traction to complete the delivery. The extent of the outcome was partially due to a fetal anomaly and hypotonia.

Verdict: An Illinois defense verdict was returned.

HPV-positive pap tests results never reported
A single mother of 4 children underwent Papanicolaou (Pap) tests in 2004, 2005, and 2007 at a federally funded clinic. Each time, she tested positive for oncogenic human papillomaviruses. In 2011, the patient died of cervical cancer.

Estate's claim: The patient was never notified that the results of the 3 Pap tests were abnormal because all correspondence was sent to an outdated address although she had been treated at the same clinic for other issues during that period of time. Cervical dysplasia identified in 2004 progressed to cancer and metastasized, leading to her death 7 years later.

Defendants' defense: The case was settled during trial.

Verdict: A $4,950,000 Illinois settlement was reached.

Failure to convert to laparotomy: $6.25M settlement

A 67-year-old woman with urinary incontinence underwent robot-assisted laparoscopic prolapse surgery and hysterectomy. Complications arose, including an injury to the transverse colon. Postoperatively, the patient developed sepsis and had multiple surgeries. At the time of trial, she used a colostomy bag and had a malabsorption syndrome that required frequent intravenous treatment for dehydration.

Patient's claim:

The gynecologist deviated from the standard of care by failing to convert from a laparoscopic procedure to an open procedure when complications developed.

Defendants' defense:

The procedure was properly performed.

Verdict:

A $6.25 million New Jersey settlement was reached, paid jointly by the gynecologist and the medical center.

Circumcision requires revision

A day after birth, a baby underwent circumcision performed by the mother’s ObGyn. Revision surgery was performed 2.5 years later. When the boy was age 7 years, urethral stricture developed and was treated.

Parents' claim:

Circumcision was improperly performed. Once the child was able to talk, he said that his penis constantly hurt. Pain was only relieved by revision surgery.

Physician's defense:

There was no negligence. Redundant foreskin is often left following a circumcision.

Verdict:

A Michigan defense verdict was returned.

Mother with CP has child with CP
A pregnant woman with cerebral palsy (CP) reported a prior preterm delivery at 24 weeks’ gestation to a high-risk prenatal clinic. At that time, she was offered synthetic progesterone (170HP) injections, but she declined because of the cost. She declined 170HP several times. Nine weeks after her initial visit, she declined 170HP despite ultrasonography (US) showing a shortened cervical length (25 mm) for the gestational age. In 2 weeks, when the cervical length measured 9 mm, she was hospitalized to rule out preterm labor but, before tests began, she left the hospital. Five days later, when her cervical length was 11 mm, she received the first 170HP injection. In the next month she received 4 injections, but she failed to show for the fifth injection and US. The next day, she went to the hospital with cramping. She was given steroids and medication to stop labor. US results indicated that the baby was in breech position. The mother consented to cesarean delivery, but the baby was born vaginally an hour later. The child has mild brain damage, CP, developmental delays, and learning disabilities.

Parents' claim: The mother should have been offered vaginal progesterone, which is cheaper. Given the high risk of preterm birth, steroids administered earlier would have improved fetal development. Cesarean delivery should have been performed.

Defendants' defense: Vaginal progesterone was not available at the time. Starting steroids earlier would not have improved fetal outcome. A cesarean delivery was not possible because the baby was in the birth canal.

Verdict: A $3,500,000 Michigan settlement was reached.

Fallopian tubes grow back, pregnancy

A couple decided they did not want more children and sought counseling from the woman’s ObGyn, who recommended laparoscopic tubal ligation. Several months after surgery, the patient became pregnant and gave birth to a son.

Parents' claim:

The additional child placed an economic hardship on the family, now raising 4 children. The youngest child has language delays and learning disabilities.

Physician's defense:

Regrowth of the fallopian tubes resulting in unwanted pregnancy is a known complication of tubal ligation.

Verdict:

A $397,000 Maryland verdict was returned, including funds for the cost of raising the fourth child and to cope with the child’s special needs.

Challenges in managing labor

At 37 weeks' gestation, a woman was hospitalized in labor. At 1:15 pm, she was dilated 3 cm. At 1:30 pm, she was dilated 4−5 cm with increasing contractions and a reassuring fetal heart rate (FHR). The ObGyn covering for the mother’s ObGyn ordered oxytocin augmentation, which started at 2:45 pm. Shortly thereafter, contractions became more frequent and uterine tachysystole was observed. At 4:12 pm, FHR showed multiple deep decelerations with slow recovery. The baseline dropped to a 90-bpm range and remained that way for 17 minutes. At that point, the ObGyn stopped oxytocin and administered terbutaline; the FHR returned to baseline.

After vaginal delivery, the baby’s Apgar scores were 8 and 9 at 1 and 5 minutes, respectively. Two days later, the baby had seizures and was transferred to the neonatal intensive care unit. An electroencephalogram confirmed seizure activity. Initial imaging results were normal. However, magnetic resonance imaging performed a week after delivery showed bilateral brain damage. The child has spastic displegia, is unable to ambulate, and is blind.

Parents' claim: A suit was filed against the hospital and both ObGyns. The hospital settled before trial. The case was discontinued against the primary ObGyn. The covering ObGyn allegedly made 4 departures from accepted medical practice that caused the child’s injury: ordering and administering oxytocin, failing to closely monitor the FHR, failing to timely administer terbutaline, and failing to timely respond to and correct tachysystole.

Physician's defense: The child’s injury occurred before or after labor. The pregnancy was complicated by multiple kidney infections. A week before delivery, US revealed a blood-flow abnormality. An intranatal hypoxic event did not cause the injury, proven by the fact that, after terbutaline was administered, the FHR promptly normalized.

Verdict: A $3 million New York settlement was reached with the hospital. A $134 million verdict was returned against the covering ObGyn.

Brachial plexus injury during delivery
At 37 weeks' gestation, a mother was admitted to the hospital for induction of labor. Increasing doses of oxytocin were administered. Near midnight, FHR monitoring indicated fetal distress. The ObGyn was called and he ordered cesarean delivery. Once he arrived and examined the mother, he found no fetal concerns and decided to proceed with the original birth plan. At 3:30 am, the patient was fully dilated and in active labor. The ObGyn used a vacuum extractor. Upon delivery of the baby’s head, the ObGyn encountered shoulder dystocia and called for assistance. The child was born with a near-total brachial plexus injury: avulsions of all 5 brachial plexus nerves with trauma to the cervical nerve roots at C5−C8 and T1. The child has undergone multiple nerve grafts and orthopedic operations.

Parents' claim: Fetal distress should have prompted the ObGyn to perform cesarean delivery. There was no reason to use vacuum extraction. Based on the severity of the outcome, the ObGyn must have applied excessive force and inappropriate traction during delivery maneuvers.

Physician's defense: The standard of care did not require a cesarean delivery. The vacuum extractor did not cause shoulder dystocia. The ObGyn did not apply excessive force or traction to complete the delivery. The extent of the outcome was partially due to a fetal anomaly and hypotonia.

Verdict: An Illinois defense verdict was returned.

HPV-positive pap tests results never reported
A single mother of 4 children underwent Papanicolaou (Pap) tests in 2004, 2005, and 2007 at a federally funded clinic. Each time, she tested positive for oncogenic human papillomaviruses. In 2011, the patient died of cervical cancer.

Estate's claim: The patient was never notified that the results of the 3 Pap tests were abnormal because all correspondence was sent to an outdated address although she had been treated at the same clinic for other issues during that period of time. Cervical dysplasia identified in 2004 progressed to cancer and metastasized, leading to her death 7 years later.

Defendants' defense: The case was settled during trial.

Verdict: A $4,950,000 Illinois settlement was reached.

Failure to convert to laparotomy: $6.25M settlement

A 67-year-old woman with urinary incontinence underwent robot-assisted laparoscopic prolapse surgery and hysterectomy. Complications arose, including an injury to the transverse colon. Postoperatively, the patient developed sepsis and had multiple surgeries. At the time of trial, she used a colostomy bag and had a malabsorption syndrome that required frequent intravenous treatment for dehydration.

Patient's claim:

The gynecologist deviated from the standard of care by failing to convert from a laparoscopic procedure to an open procedure when complications developed.

Defendants' defense:

The procedure was properly performed.

Verdict:

A $6.25 million New Jersey settlement was reached, paid jointly by the gynecologist and the medical center.

Circumcision requires revision

A day after birth, a baby underwent circumcision performed by the mother’s ObGyn. Revision surgery was performed 2.5 years later. When the boy was age 7 years, urethral stricture developed and was treated.

Parents' claim:

Circumcision was improperly performed. Once the child was able to talk, he said that his penis constantly hurt. Pain was only relieved by revision surgery.

Physician's defense:

There was no negligence. Redundant foreskin is often left following a circumcision.

Verdict:

A Michigan defense verdict was returned.

Mother with CP has child with CP
A pregnant woman with cerebral palsy (CP) reported a prior preterm delivery at 24 weeks’ gestation to a high-risk prenatal clinic. At that time, she was offered synthetic progesterone (170HP) injections, but she declined because of the cost. She declined 170HP several times. Nine weeks after her initial visit, she declined 170HP despite ultrasonography (US) showing a shortened cervical length (25 mm) for the gestational age. In 2 weeks, when the cervical length measured 9 mm, she was hospitalized to rule out preterm labor but, before tests began, she left the hospital. Five days later, when her cervical length was 11 mm, she received the first 170HP injection. In the next month she received 4 injections, but she failed to show for the fifth injection and US. The next day, she went to the hospital with cramping. She was given steroids and medication to stop labor. US results indicated that the baby was in breech position. The mother consented to cesarean delivery, but the baby was born vaginally an hour later. The child has mild brain damage, CP, developmental delays, and learning disabilities.

Parents' claim: The mother should have been offered vaginal progesterone, which is cheaper. Given the high risk of preterm birth, steroids administered earlier would have improved fetal development. Cesarean delivery should have been performed.

Defendants' defense: Vaginal progesterone was not available at the time. Starting steroids earlier would not have improved fetal outcome. A cesarean delivery was not possible because the baby was in the birth canal.

Verdict: A $3,500,000 Michigan settlement was reached.

Fallopian tubes grow back, pregnancy

A couple decided they did not want more children and sought counseling from the woman’s ObGyn, who recommended laparoscopic tubal ligation. Several months after surgery, the patient became pregnant and gave birth to a son.

Parents' claim:

The additional child placed an economic hardship on the family, now raising 4 children. The youngest child has language delays and learning disabilities.

Physician's defense:

Regrowth of the fallopian tubes resulting in unwanted pregnancy is a known complication of tubal ligation.

Verdict:

A $397,000 Maryland verdict was returned, including funds for the cost of raising the fourth child and to cope with the child’s special needs.

Challenges in managing labor

At 37 weeks' gestation, a woman was hospitalized in labor. At 1:15 pm, she was dilated 3 cm. At 1:30 pm, she was dilated 4−5 cm with increasing contractions and a reassuring fetal heart rate (FHR). The ObGyn covering for the mother’s ObGyn ordered oxytocin augmentation, which started at 2:45 pm. Shortly thereafter, contractions became more frequent and uterine tachysystole was observed. At 4:12 pm, FHR showed multiple deep decelerations with slow recovery. The baseline dropped to a 90-bpm range and remained that way for 17 minutes. At that point, the ObGyn stopped oxytocin and administered terbutaline; the FHR returned to baseline.

After vaginal delivery, the baby’s Apgar scores were 8 and 9 at 1 and 5 minutes, respectively. Two days later, the baby had seizures and was transferred to the neonatal intensive care unit. An electroencephalogram confirmed seizure activity. Initial imaging results were normal. However, magnetic resonance imaging performed a week after delivery showed bilateral brain damage. The child has spastic displegia, is unable to ambulate, and is blind.

Parents' claim: A suit was filed against the hospital and both ObGyns. The hospital settled before trial. The case was discontinued against the primary ObGyn. The covering ObGyn allegedly made 4 departures from accepted medical practice that caused the child’s injury: ordering and administering oxytocin, failing to closely monitor the FHR, failing to timely administer terbutaline, and failing to timely respond to and correct tachysystole.

Physician's defense: The child’s injury occurred before or after labor. The pregnancy was complicated by multiple kidney infections. A week before delivery, US revealed a blood-flow abnormality. An intranatal hypoxic event did not cause the injury, proven by the fact that, after terbutaline was administered, the FHR promptly normalized.

Verdict: A $3 million New York settlement was reached with the hospital. A $134 million verdict was returned against the covering ObGyn.

Brachial plexus injury during delivery
At 37 weeks' gestation, a mother was admitted to the hospital for induction of labor. Increasing doses of oxytocin were administered. Near midnight, FHR monitoring indicated fetal distress. The ObGyn was called and he ordered cesarean delivery. Once he arrived and examined the mother, he found no fetal concerns and decided to proceed with the original birth plan. At 3:30 am, the patient was fully dilated and in active labor. The ObGyn used a vacuum extractor. Upon delivery of the baby’s head, the ObGyn encountered shoulder dystocia and called for assistance. The child was born with a near-total brachial plexus injury: avulsions of all 5 brachial plexus nerves with trauma to the cervical nerve roots at C5−C8 and T1. The child has undergone multiple nerve grafts and orthopedic operations.

Parents' claim: Fetal distress should have prompted the ObGyn to perform cesarean delivery. There was no reason to use vacuum extraction. Based on the severity of the outcome, the ObGyn must have applied excessive force and inappropriate traction during delivery maneuvers.

Physician's defense: The standard of care did not require a cesarean delivery. The vacuum extractor did not cause shoulder dystocia. The ObGyn did not apply excessive force or traction to complete the delivery. The extent of the outcome was partially due to a fetal anomaly and hypotonia.

Verdict: An Illinois defense verdict was returned.

HPV-positive pap tests results never reported
A single mother of 4 children underwent Papanicolaou (Pap) tests in 2004, 2005, and 2007 at a federally funded clinic. Each time, she tested positive for oncogenic human papillomaviruses. In 2011, the patient died of cervical cancer.

Estate's claim: The patient was never notified that the results of the 3 Pap tests were abnormal because all correspondence was sent to an outdated address although she had been treated at the same clinic for other issues during that period of time. Cervical dysplasia identified in 2004 progressed to cancer and metastasized, leading to her death 7 years later.

Defendants' defense: The case was settled during trial.

Verdict: A $4,950,000 Illinois settlement was reached.

CASE Surgeon accused of operating outside her scope of expertise

A 38-year-old woman (G2 P2002) presented to the emergency department (ED) with acute pelvic pain involving the right lower quadrant (RLQ). The patient had a history of stage IV endometriosis and chronic pelvic pain, primarily affecting the RLQ, that was treated by total laparoscopic hysterectomy with bilateral salpingo-oophorectomy 6 months earlier. Pertinent findings on physical examination included hypoactive bowel sounds and rebound tenderness. The ED physician ordered a computed tomography (CT) scan of the abdomen, which showed no evidence of ureteral injury or other abnormality. The gynecologist who performed the surgery 6 months ago evaluated the patient in the ED.

The gynecologist decided to perform operative laparoscopy because of the severity of the patient’s pain and duration of symptoms. Informed consent obtained in the ED before the patient received analgesics included a handwritten note that said “and other indicated procedures.” The patient signed the document prior to being taken to the operating room (OR). Time out occurred in the OR before anesthesia induction. The gynecologist proceeded with laparoscopic adhesiolysis with planned appendectomy, as she was trained. A normal appendix was noted and left intact. RLQ adhesions involving the colon and abdominal wall were treated with electrosurgical cautery. When the gynecologist found adhesions between the liver and diaphragm in the right upper quadrant (RUQ), she continued adhesiolysis. However, the diaphragm was inadvertently punctured.

As the gynecologist attempted to suture the defect laparoscopically, she encountered difficulty and converted to laparotomy. Adhesions were dense and initially precluded adequate closure of the diaphragmatic defect. The gynecologist persisted and ultimately the closure was adequate; laparotomy concluded. Postoperatively, the patient was given a diagnosis of atelectasis, primarily on the right side; a chest tube was placed by the general surgery team. The patient had an uneventful postoperative period and was discharged on postoperative day 5. One month later she returned to the ED with evidence of pneumonia; she was given a diagnosis of empyema, and antibiotics were administered. She responded well and was discharged after 6 days.

The patient filed a malpractice lawsuit against the gynecologist, the hospital, and associated practitioners. The suit made 3 negligence claims: 1) the surgery was improperly performed, as evidenced by the diaphragmatic perforation; 2) the gynecologist was not adequately trained for RUQ surgery, and 3) the hospital should not have permitted RUQ surgery to proceed. The liability claim cited the lack of qualification of a gynecologic surgeon to proceed with surgical intervention near the diaphragm and the associated consequences of practicing outside the scope of expertise.

Fitz-Hugh Curtis syndrome, a complication of pelvic inflammatory disease that may cause adhesions, was raised as the initial finding at the second surgical procedure and documented as such in the operative report. The plaintiff’s counsel questioned whether surgical correction of this syndrome was within the realm of a gynecologic surgeon. The plaintiff’s counsel argued that the laparoscopic surgical procedure involved bowel and liver; diaphragmatic adhesiolysis was not indicated, especially with normal abdominal CT scan results and the absence of RUQ symptoms. The claim specified that the surgery and care, as a consequence of the RUQ adhesiolysis, resulted in atelectasis, pneumonia, and empyema, with pain and suffering. The plaintiff sought unspecified monetary damages for these results.

What’s the verdict?

The case is in negotiation prior to trial.

Legal and medical considerations

“To err is not just human but intrinsically biological and no profession is exempt from fallibility.”¹

Error and liability

To err may be human, but human error is not necessarily the cause of every suboptimal medical outcome. In fact, the overall surgical complication rate has been reported at 3.4%.² Even when there is an error, it may not have been the kind of error that gives rise to medical malpractice liability. When it comes to surgical errors, the most common are those that actually relate to medications given at surgery that appear to be more common—one recent study found that 1 in 20 perioperative medication administrations resulted in a medication error or an adverse drug event.³

Medical error vs medical malpractice

The fact is that medical error and medical malpractice (or professional negligence) are not the same thing. It is critical to understand the difference.

Medical error is the third leading cause of death in the United States.⁴ It is defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim,”⁵ or, in the Canadian literature, “an act of omission or commission in planning or execution that contributes or could contribute to an unintended result.”⁶ The gamut of medical errors spans (among others) problems with technique, judgment, medication administration, diagnostic and surgical errors, and incomplete record keeping.⁵

Negligent error, on the other hand, is generally a subset of medical error recognized by the law. It is error that occurs because of carelessness. Technically, to give rise to liability for negligence (or malpractice) there must be duty, breach, causation, and injury. That is, the physician must owe a duty to the patient, the duty must have been breached, and that breach must have caused an injury.⁷

Usually the duty in medical practice is that the physician must have acted as a reasonable and prudent professional would have performed under the circumstances. For the most part, malpractice is a level of practice that the profession itself would not view as reasonable practice.⁸ Specialists usually are held to the higher standards of the specialty. It also can be negligent to undertake practice or a procedure for which the physician is not adequately trained, or for failing to refer the patient to another more qualified physician.

The duty in medicine usually arises from the physician-patient relationship (clearly present here). It is reasonably clear in this case that there was an injury, but, in fact, the question is whether the physician acted carelessly in a way that caused that injury. Our facts leave some ambiguity—unfortunately,a common problem in the real world.

It is possible that the gynecologist was negligent in puncturing the diaphragm. It may have been carelessness, for example, in the way the procedure was performed, or in the decision to proceed despite the difficulties encountered. It is also possible that the gynecologist was not appropriately trained and experienced in the surgery that was undertaken, in which case the decision to do the surgery (rather than to refer to another physician) could well have been negligent. In either of those cases, negligence liability (malpractice) is a possibility.

Proving negligence. It is the plaintiff (the patient) who must prove the elements of negligence (including causation).⁸ The plaintiff will have to demonstrate not only carelessness, but that carelessness is what caused the injuries for which she is seeking compensation. In this case, the injuries are the consequence of puncturing the diaphragm. The potential damages would be the money to cover the additional medical costs and other expenses, lost wages, and noneconomic damages such as pain and suffering.

The hospital’s role in negligence

The issue of informed consent is also raised in this case, with a handwritten note prior to surgery (but the focus of this article is on medical errors). In addition to the gynecologist, the hospital and other medical personnelwere sued. The hospital is responsible for the acts of its agents, notably its employees. Even if the physicians are not technically hospital employees, the hospital may in some cases be responsible. Among other things, the hospital likely has an obligation to prevent physicians from undertaking inappropriate procedures, including those for which the physician is not appropriately trained. If the gynecologist in this case did not have privileges to perform surgery in this category, the hospital may have an obligation to not schedule the surgery or to intraoperatively question her credentials for such a procedure. In any event, the hospital will have a major role in this case and its interests may, in some instances, be inconsistent with the interests of the physician.

Why settlement discussions?

The case description ends with a note that settlement discussions were underway. If the plaintiff must prove all of the elements of negligence, why have these discussions? First, such discussions are common in almost all negligence cases. This does not mean that the case actually will be settled by the insurance company representing the physician or hospital; many malpractice cases simply fade away because the patient drops the action. Second, there are ambiguities in the facts, and it is sometimes impossible to determine whether or not a jury would find negligence. The hospital may be inclined to settle if there is any realistic chance of a jury ruling against it. Paying a small settlement may be worth avoiding high legal expenses and the risk of an adverse outcome at trial.⁹

Reducing medical/surgical error through a team approach

Recognizing that “human performance can be affected by many factors that include circadian rhythms, state of mind, physical health, attitude, emotions, propensity for certain common mistakes and errors, and cognitive biases,”¹⁰ health care professionals have a commitment to reduce the errors in the interest of patient safety and best practice.

The surgical environment is an opportunity to provide a team approach to patient safety. Surgical risk is a reflection of operative performance, the main factor in the development of postoperative complications.¹¹ We wish to broaden the perspective that gynecologic surgeons, like all surgeons, must keep in mind a number of concerns that can be associated with problems related to surgical procedures, including¹²:

• visual perception difficulties
• stress
• loss of haptic perception (feedback using touch), as with robot-assisted procedures
• lack of situational awareness (a term we borrow from the aviation industry)
• long-term (and short-term) memory problems.

Analysis of surgical errors shows that they are related to, in order of frequency ¹:

• surgical technique
• judgment
• inattention to detail
• incomplete understanding of the problem or surgical situation.

Medical errors: Caring for the second victim (you)

Patrice M. Weiss, MD

We use the term “victim” to refer to the patient and her family following a medical error. The phrase “the second victim” was coined by Dr. Albert Wu in an article in the British Medical Journal¹ and describes how a clinician and team of health care professionals also can be affected by medical errors.

 

What signs and symptoms identify a second victim?Those suffering as a second victim may show signs of depression, loss of joy in work, and difficulty sleeping. They also may replay the events, question their own ability, and feel fearful about making another error. These reactions can lead to burnout—a serious issue that 46% of physicians report.²

As colleagues of those involved in a medical error, we should be cognizant of changes in behavior such as excessive irritability, showing up late for work, or agitation. It may be easier to recognize these symptoms in others rather than in ourselves because we often do not take time to examine how our experiences may affect us personally. Heightening awareness can help us recognize those suffering as second victims and identify the second victim symptoms in ourselves.
 

How can we help second victims?One challenge second victims face is not being allowed to discuss a medical error. Certainly, due to confidentiality requirements during professional liability cases, we should not talk freely about the event. However, silence creates a barrier that prevents a second victim from processing the incident.

Some hospitals offer forums to discuss medical errors, with the goal of preventing reoccurrence: morbidity and mortality conferences, morning report, Quality Assurance and Performance Improvement meetings, and root cause analyses. These forums often are not perceived by institutions’ employees in a positive way. Are they really meant to improve patient care or do they single out an individual or group in a “name/blame/shame game”? An intimidating process will only worsen a second victim’s symptoms. It is not necessary, however, to create a whole new process; it is possible to restructure, reframe, and change the culture of an existing practice.

Some institutions have developed a formalized program to help second victims. The University of Missouri has a “forYOU team,” an internal, rapid response group that provides emotional first aid to the entire team involved in a medical error case. These responders are not from human resources and do not need to be sought out; they are peers who have been educated about the struggles of the second victim. They will not discuss the case or how care was rendered; they naturally and instinctively provide emotional support to their colleagues.

At my institution, the Carilion Clinic at the Virginia Tech Carilion School of Medicine, “The Trust Program” encourages truth, respectfulness, understanding, support, and transparency. All health care clinicians receive basic training, but many have volunteered for additional instruction to become mentors because they have experienced second-victim symptoms themselves.

Clinicians want assistance when dealing with a medical error. One poll reports that 90% of physicians felt that health care organizations did not adequately help them cope with the stresses associated with a medical error.³ The goal is to have all institutions recognize that clinicians can be affected by a medical error and offer support.

To hear an expanded audiocast from Dr. Weiss on “the second victim” click here.

---

Dr. Weiss is Professor, Department of Obstetrics & Gynecology, Virginia Tech Carilion School of Medicine, and Chief Medical Officer and Executive Vice President, Carilion Clinic, Roanoke, Virginia.

The author reports no financial relationships relevant to this article.

 

---

References

1. Wu AW. Medical error: the second victim. BMJ. 2000;320(7237):726–727.
2. Peckham C. Medscape Physician Lifestyle Report 2015. Medscape website. http://www.medscape.com/features/slideshow/lifestyle/2015/public/overview#1. Published January 26, 2015. Accessed May 24, 2016.
3. White AA, Waterman AD, McCotter P, Boyle DJ, Gallagher TH. Supporting health care workers after medical error: considerations for health care leaders. JCOM. 2008;15(5):240–247.

“Inadequacy” with regard to surgical proceduresIndication for surgery is intrinsic to provision of appropriate care. Surgery inherently poses the possibility of unexpected problems. Adequate training and skill, therefore, must include the ability to deal with a range of problems that arise in the course of surgery. The spectrum related to inadequacy as related to surgical problems includes “failed surgery,” defined as “if despite the utmost care of everyone involved and with the responsible consideration of all knowledge, the designed aim is not achieved, surgery by itself has failed.”⁵ Of paramount importance is the surgeon’s knowledge of technology and the ability to troubleshoot, as well as the OR team’s responsibility for proper maintenance of equipment to ensure optimal functionality.¹

Aviation industry studies indicate that “high performing cockpit crews have been shown to devote one third of their communications to discuss threats and mistakes in their environment, while poor performing teams devoted much less, about 5%, of their time to such.”^1,13 A well-trained and well-motivated OR nursing team has been equated with reduction in operative time and rate of conversion to laparotomy.¹⁴ Outdated instruments may also contribute to surgical errors.¹

Moving the “learning curve” out of the OR and into the simulation lab remains valuable, which is also confirmed by the aviation industry.¹⁵ The significance of loss of haptic perception continues to be debated between laparoscopic (straight-stick) surgeons and those performing robotic approaches. Does haptic perception play a major role in surgical intervention? Most surgeons do not view loss of haptic perception, as with minimally invasive procedures, as a major impediment to successful surgery. From the legal perspective, loss of haptic perception has not been well addressed.

The American College of Obstetricians and Gynecologists has focused on patient safety in the surgical environment including concerns for wrong-patient surgery, wrong-side surgery, wrong-level surgery, and wrong-part surgery.¹⁶ The Joint Commission has identified factors that may enhance the risk of wrong-site surgery: multiple surgeons involved in the case, multiple procedures during a single surgical visit, unusual time pressures to start or complete the surgery, and unusual physical characteristics including morbid obesity or physical deformity.¹⁶

10 starting points for medical error preventionSo what are we to do? Consider:

Set the stage for best outcomesA true team approach is an excellent modus operandi before, during, and after surgery,setting the stage for best outcomes for patients.

“As human beings, surgeons will commit errors and for this reason they have to adopt and utilize stringent defense systems to minimize the incidence of these adverse events … Transparency is the first step on the way to a new safety culture with the acknowledgement of errors when they occur with adoption of systems destined to establish their cause and future prevention.”¹

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Surgeon accused of operating outside her scope of expertise

A 38-year-old woman (G2 P2002) presented to the emergency department (ED) with acute pelvic pain involving the right lower quadrant (RLQ). The patient had a history of stage IV endometriosis and chronic pelvic pain, primarily affecting the RLQ, that was treated by total laparoscopic hysterectomy with bilateral salpingo-oophorectomy 6 months earlier. Pertinent findings on physical examination included hypoactive bowel sounds and rebound tenderness. The ED physician ordered a computed tomography (CT) scan of the abdomen, which showed no evidence of ureteral injury or other abnormality. The gynecologist who performed the surgery 6 months ago evaluated the patient in the ED.

The gynecologist decided to perform operative laparoscopy because of the severity of the patient’s pain and duration of symptoms. Informed consent obtained in the ED before the patient received analgesics included a handwritten note that said “and other indicated procedures.” The patient signed the document prior to being taken to the operating room (OR). Time out occurred in the OR before anesthesia induction. The gynecologist proceeded with laparoscopic adhesiolysis with planned appendectomy, as she was trained. A normal appendix was noted and left intact. RLQ adhesions involving the colon and abdominal wall were treated with electrosurgical cautery. When the gynecologist found adhesions between the liver and diaphragm in the right upper quadrant (RUQ), she continued adhesiolysis. However, the diaphragm was inadvertently punctured.

As the gynecologist attempted to suture the defect laparoscopically, she encountered difficulty and converted to laparotomy. Adhesions were dense and initially precluded adequate closure of the diaphragmatic defect. The gynecologist persisted and ultimately the closure was adequate; laparotomy concluded. Postoperatively, the patient was given a diagnosis of atelectasis, primarily on the right side; a chest tube was placed by the general surgery team. The patient had an uneventful postoperative period and was discharged on postoperative day 5. One month later she returned to the ED with evidence of pneumonia; she was given a diagnosis of empyema, and antibiotics were administered. She responded well and was discharged after 6 days.

The patient filed a malpractice lawsuit against the gynecologist, the hospital, and associated practitioners. The suit made 3 negligence claims: 1) the surgery was improperly performed, as evidenced by the diaphragmatic perforation; 2) the gynecologist was not adequately trained for RUQ surgery, and 3) the hospital should not have permitted RUQ surgery to proceed. The liability claim cited the lack of qualification of a gynecologic surgeon to proceed with surgical intervention near the diaphragm and the associated consequences of practicing outside the scope of expertise.

Fitz-Hugh Curtis syndrome, a complication of pelvic inflammatory disease that may cause adhesions, was raised as the initial finding at the second surgical procedure and documented as such in the operative report. The plaintiff’s counsel questioned whether surgical correction of this syndrome was within the realm of a gynecologic surgeon. The plaintiff’s counsel argued that the laparoscopic surgical procedure involved bowel and liver; diaphragmatic adhesiolysis was not indicated, especially with normal abdominal CT scan results and the absence of RUQ symptoms. The claim specified that the surgery and care, as a consequence of the RUQ adhesiolysis, resulted in atelectasis, pneumonia, and empyema, with pain and suffering. The plaintiff sought unspecified monetary damages for these results.

What’s the verdict?

The case is in negotiation prior to trial.

Legal and medical considerations

“To err is not just human but intrinsically biological and no profession is exempt from fallibility.”¹

Error and liability

To err may be human, but human error is not necessarily the cause of every suboptimal medical outcome. In fact, the overall surgical complication rate has been reported at 3.4%.² Even when there is an error, it may not have been the kind of error that gives rise to medical malpractice liability. When it comes to surgical errors, the most common are those that actually relate to medications given at surgery that appear to be more common—one recent study found that 1 in 20 perioperative medication administrations resulted in a medication error or an adverse drug event.³

Medical error vs medical malpractice

The fact is that medical error and medical malpractice (or professional negligence) are not the same thing. It is critical to understand the difference.

Medical error is the third leading cause of death in the United States.⁴ It is defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim,”⁵ or, in the Canadian literature, “an act of omission or commission in planning or execution that contributes or could contribute to an unintended result.”⁶ The gamut of medical errors spans (among others) problems with technique, judgment, medication administration, diagnostic and surgical errors, and incomplete record keeping.⁵

Negligent error, on the other hand, is generally a subset of medical error recognized by the law. It is error that occurs because of carelessness. Technically, to give rise to liability for negligence (or malpractice) there must be duty, breach, causation, and injury. That is, the physician must owe a duty to the patient, the duty must have been breached, and that breach must have caused an injury.⁷

Usually the duty in medical practice is that the physician must have acted as a reasonable and prudent professional would have performed under the circumstances. For the most part, malpractice is a level of practice that the profession itself would not view as reasonable practice.⁸ Specialists usually are held to the higher standards of the specialty. It also can be negligent to undertake practice or a procedure for which the physician is not adequately trained, or for failing to refer the patient to another more qualified physician.

The duty in medicine usually arises from the physician-patient relationship (clearly present here). It is reasonably clear in this case that there was an injury, but, in fact, the question is whether the physician acted carelessly in a way that caused that injury. Our facts leave some ambiguity—unfortunately,a common problem in the real world.

It is possible that the gynecologist was negligent in puncturing the diaphragm. It may have been carelessness, for example, in the way the procedure was performed, or in the decision to proceed despite the difficulties encountered. It is also possible that the gynecologist was not appropriately trained and experienced in the surgery that was undertaken, in which case the decision to do the surgery (rather than to refer to another physician) could well have been negligent. In either of those cases, negligence liability (malpractice) is a possibility.

Proving negligence. It is the plaintiff (the patient) who must prove the elements of negligence (including causation).⁸ The plaintiff will have to demonstrate not only carelessness, but that carelessness is what caused the injuries for which she is seeking compensation. In this case, the injuries are the consequence of puncturing the diaphragm. The potential damages would be the money to cover the additional medical costs and other expenses, lost wages, and noneconomic damages such as pain and suffering.

The hospital’s role in negligence

The issue of informed consent is also raised in this case, with a handwritten note prior to surgery (but the focus of this article is on medical errors). In addition to the gynecologist, the hospital and other medical personnelwere sued. The hospital is responsible for the acts of its agents, notably its employees. Even if the physicians are not technically hospital employees, the hospital may in some cases be responsible. Among other things, the hospital likely has an obligation to prevent physicians from undertaking inappropriate procedures, including those for which the physician is not appropriately trained. If the gynecologist in this case did not have privileges to perform surgery in this category, the hospital may have an obligation to not schedule the surgery or to intraoperatively question her credentials for such a procedure. In any event, the hospital will have a major role in this case and its interests may, in some instances, be inconsistent with the interests of the physician.

Why settlement discussions?

The case description ends with a note that settlement discussions were underway. If the plaintiff must prove all of the elements of negligence, why have these discussions? First, such discussions are common in almost all negligence cases. This does not mean that the case actually will be settled by the insurance company representing the physician or hospital; many malpractice cases simply fade away because the patient drops the action. Second, there are ambiguities in the facts, and it is sometimes impossible to determine whether or not a jury would find negligence. The hospital may be inclined to settle if there is any realistic chance of a jury ruling against it. Paying a small settlement may be worth avoiding high legal expenses and the risk of an adverse outcome at trial.⁹

Reducing medical/surgical error through a team approach

Recognizing that “human performance can be affected by many factors that include circadian rhythms, state of mind, physical health, attitude, emotions, propensity for certain common mistakes and errors, and cognitive biases,”¹⁰ health care professionals have a commitment to reduce the errors in the interest of patient safety and best practice.

The surgical environment is an opportunity to provide a team approach to patient safety. Surgical risk is a reflection of operative performance, the main factor in the development of postoperative complications.¹¹ We wish to broaden the perspective that gynecologic surgeons, like all surgeons, must keep in mind a number of concerns that can be associated with problems related to surgical procedures, including¹²:

• visual perception difficulties
• stress
• loss of haptic perception (feedback using touch), as with robot-assisted procedures
• lack of situational awareness (a term we borrow from the aviation industry)
• long-term (and short-term) memory problems.

Analysis of surgical errors shows that they are related to, in order of frequency ¹:

• surgical technique
• judgment
• inattention to detail
• incomplete understanding of the problem or surgical situation.

Medical errors: Caring for the second victim (you)

Patrice M. Weiss, MD

We use the term “victim” to refer to the patient and her family following a medical error. The phrase “the second victim” was coined by Dr. Albert Wu in an article in the British Medical Journal¹ and describes how a clinician and team of health care professionals also can be affected by medical errors.

 

What signs and symptoms identify a second victim?Those suffering as a second victim may show signs of depression, loss of joy in work, and difficulty sleeping. They also may replay the events, question their own ability, and feel fearful about making another error. These reactions can lead to burnout—a serious issue that 46% of physicians report.²

As colleagues of those involved in a medical error, we should be cognizant of changes in behavior such as excessive irritability, showing up late for work, or agitation. It may be easier to recognize these symptoms in others rather than in ourselves because we often do not take time to examine how our experiences may affect us personally. Heightening awareness can help us recognize those suffering as second victims and identify the second victim symptoms in ourselves.
 

How can we help second victims?One challenge second victims face is not being allowed to discuss a medical error. Certainly, due to confidentiality requirements during professional liability cases, we should not talk freely about the event. However, silence creates a barrier that prevents a second victim from processing the incident.

Some hospitals offer forums to discuss medical errors, with the goal of preventing reoccurrence: morbidity and mortality conferences, morning report, Quality Assurance and Performance Improvement meetings, and root cause analyses. These forums often are not perceived by institutions’ employees in a positive way. Are they really meant to improve patient care or do they single out an individual or group in a “name/blame/shame game”? An intimidating process will only worsen a second victim’s symptoms. It is not necessary, however, to create a whole new process; it is possible to restructure, reframe, and change the culture of an existing practice.

Some institutions have developed a formalized program to help second victims. The University of Missouri has a “forYOU team,” an internal, rapid response group that provides emotional first aid to the entire team involved in a medical error case. These responders are not from human resources and do not need to be sought out; they are peers who have been educated about the struggles of the second victim. They will not discuss the case or how care was rendered; they naturally and instinctively provide emotional support to their colleagues.

At my institution, the Carilion Clinic at the Virginia Tech Carilion School of Medicine, “The Trust Program” encourages truth, respectfulness, understanding, support, and transparency. All health care clinicians receive basic training, but many have volunteered for additional instruction to become mentors because they have experienced second-victim symptoms themselves.

Clinicians want assistance when dealing with a medical error. One poll reports that 90% of physicians felt that health care organizations did not adequately help them cope with the stresses associated with a medical error.³ The goal is to have all institutions recognize that clinicians can be affected by a medical error and offer support.

To hear an expanded audiocast from Dr. Weiss on “the second victim” click here.

---

Dr. Weiss is Professor, Department of Obstetrics & Gynecology, Virginia Tech Carilion School of Medicine, and Chief Medical Officer and Executive Vice President, Carilion Clinic, Roanoke, Virginia.

The author reports no financial relationships relevant to this article.

 

---

References

1. Wu AW. Medical error: the second victim. BMJ. 2000;320(7237):726–727.
2. Peckham C. Medscape Physician Lifestyle Report 2015. Medscape website. http://www.medscape.com/features/slideshow/lifestyle/2015/public/overview#1. Published January 26, 2015. Accessed May 24, 2016.
3. White AA, Waterman AD, McCotter P, Boyle DJ, Gallagher TH. Supporting health care workers after medical error: considerations for health care leaders. JCOM. 2008;15(5):240–247.

“Inadequacy” with regard to surgical proceduresIndication for surgery is intrinsic to provision of appropriate care. Surgery inherently poses the possibility of unexpected problems. Adequate training and skill, therefore, must include the ability to deal with a range of problems that arise in the course of surgery. The spectrum related to inadequacy as related to surgical problems includes “failed surgery,” defined as “if despite the utmost care of everyone involved and with the responsible consideration of all knowledge, the designed aim is not achieved, surgery by itself has failed.”⁵ Of paramount importance is the surgeon’s knowledge of technology and the ability to troubleshoot, as well as the OR team’s responsibility for proper maintenance of equipment to ensure optimal functionality.¹

Aviation industry studies indicate that “high performing cockpit crews have been shown to devote one third of their communications to discuss threats and mistakes in their environment, while poor performing teams devoted much less, about 5%, of their time to such.”^1,13 A well-trained and well-motivated OR nursing team has been equated with reduction in operative time and rate of conversion to laparotomy.¹⁴ Outdated instruments may also contribute to surgical errors.¹

Moving the “learning curve” out of the OR and into the simulation lab remains valuable, which is also confirmed by the aviation industry.¹⁵ The significance of loss of haptic perception continues to be debated between laparoscopic (straight-stick) surgeons and those performing robotic approaches. Does haptic perception play a major role in surgical intervention? Most surgeons do not view loss of haptic perception, as with minimally invasive procedures, as a major impediment to successful surgery. From the legal perspective, loss of haptic perception has not been well addressed.

The American College of Obstetricians and Gynecologists has focused on patient safety in the surgical environment including concerns for wrong-patient surgery, wrong-side surgery, wrong-level surgery, and wrong-part surgery.¹⁶ The Joint Commission has identified factors that may enhance the risk of wrong-site surgery: multiple surgeons involved in the case, multiple procedures during a single surgical visit, unusual time pressures to start or complete the surgery, and unusual physical characteristics including morbid obesity or physical deformity.¹⁶

10 starting points for medical error preventionSo what are we to do? Consider:

Set the stage for best outcomesA true team approach is an excellent modus operandi before, during, and after surgery,setting the stage for best outcomes for patients.

“As human beings, surgeons will commit errors and for this reason they have to adopt and utilize stringent defense systems to minimize the incidence of these adverse events … Transparency is the first step on the way to a new safety culture with the acknowledgement of errors when they occur with adoption of systems destined to establish their cause and future prevention.”¹

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Surgeon accused of operating outside her scope of expertise

A 38-year-old woman (G2 P2002) presented to the emergency department (ED) with acute pelvic pain involving the right lower quadrant (RLQ). The patient had a history of stage IV endometriosis and chronic pelvic pain, primarily affecting the RLQ, that was treated by total laparoscopic hysterectomy with bilateral salpingo-oophorectomy 6 months earlier. Pertinent findings on physical examination included hypoactive bowel sounds and rebound tenderness. The ED physician ordered a computed tomography (CT) scan of the abdomen, which showed no evidence of ureteral injury or other abnormality. The gynecologist who performed the surgery 6 months ago evaluated the patient in the ED.

The gynecologist decided to perform operative laparoscopy because of the severity of the patient’s pain and duration of symptoms. Informed consent obtained in the ED before the patient received analgesics included a handwritten note that said “and other indicated procedures.” The patient signed the document prior to being taken to the operating room (OR). Time out occurred in the OR before anesthesia induction. The gynecologist proceeded with laparoscopic adhesiolysis with planned appendectomy, as she was trained. A normal appendix was noted and left intact. RLQ adhesions involving the colon and abdominal wall were treated with electrosurgical cautery. When the gynecologist found adhesions between the liver and diaphragm in the right upper quadrant (RUQ), she continued adhesiolysis. However, the diaphragm was inadvertently punctured.

As the gynecologist attempted to suture the defect laparoscopically, she encountered difficulty and converted to laparotomy. Adhesions were dense and initially precluded adequate closure of the diaphragmatic defect. The gynecologist persisted and ultimately the closure was adequate; laparotomy concluded. Postoperatively, the patient was given a diagnosis of atelectasis, primarily on the right side; a chest tube was placed by the general surgery team. The patient had an uneventful postoperative period and was discharged on postoperative day 5. One month later she returned to the ED with evidence of pneumonia; she was given a diagnosis of empyema, and antibiotics were administered. She responded well and was discharged after 6 days.

The patient filed a malpractice lawsuit against the gynecologist, the hospital, and associated practitioners. The suit made 3 negligence claims: 1) the surgery was improperly performed, as evidenced by the diaphragmatic perforation; 2) the gynecologist was not adequately trained for RUQ surgery, and 3) the hospital should not have permitted RUQ surgery to proceed. The liability claim cited the lack of qualification of a gynecologic surgeon to proceed with surgical intervention near the diaphragm and the associated consequences of practicing outside the scope of expertise.

Fitz-Hugh Curtis syndrome, a complication of pelvic inflammatory disease that may cause adhesions, was raised as the initial finding at the second surgical procedure and documented as such in the operative report. The plaintiff’s counsel questioned whether surgical correction of this syndrome was within the realm of a gynecologic surgeon. The plaintiff’s counsel argued that the laparoscopic surgical procedure involved bowel and liver; diaphragmatic adhesiolysis was not indicated, especially with normal abdominal CT scan results and the absence of RUQ symptoms. The claim specified that the surgery and care, as a consequence of the RUQ adhesiolysis, resulted in atelectasis, pneumonia, and empyema, with pain and suffering. The plaintiff sought unspecified monetary damages for these results.

What’s the verdict?

The case is in negotiation prior to trial.

Legal and medical considerations

“To err is not just human but intrinsically biological and no profession is exempt from fallibility.”¹

Error and liability

To err may be human, but human error is not necessarily the cause of every suboptimal medical outcome. In fact, the overall surgical complication rate has been reported at 3.4%.² Even when there is an error, it may not have been the kind of error that gives rise to medical malpractice liability. When it comes to surgical errors, the most common are those that actually relate to medications given at surgery that appear to be more common—one recent study found that 1 in 20 perioperative medication administrations resulted in a medication error or an adverse drug event.³

Medical error vs medical malpractice

The fact is that medical error and medical malpractice (or professional negligence) are not the same thing. It is critical to understand the difference.

Medical error is the third leading cause of death in the United States.⁴ It is defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim,”⁵ or, in the Canadian literature, “an act of omission or commission in planning or execution that contributes or could contribute to an unintended result.”⁶ The gamut of medical errors spans (among others) problems with technique, judgment, medication administration, diagnostic and surgical errors, and incomplete record keeping.⁵

Negligent error, on the other hand, is generally a subset of medical error recognized by the law. It is error that occurs because of carelessness. Technically, to give rise to liability for negligence (or malpractice) there must be duty, breach, causation, and injury. That is, the physician must owe a duty to the patient, the duty must have been breached, and that breach must have caused an injury.⁷

Usually the duty in medical practice is that the physician must have acted as a reasonable and prudent professional would have performed under the circumstances. For the most part, malpractice is a level of practice that the profession itself would not view as reasonable practice.⁸ Specialists usually are held to the higher standards of the specialty. It also can be negligent to undertake practice or a procedure for which the physician is not adequately trained, or for failing to refer the patient to another more qualified physician.

The duty in medicine usually arises from the physician-patient relationship (clearly present here). It is reasonably clear in this case that there was an injury, but, in fact, the question is whether the physician acted carelessly in a way that caused that injury. Our facts leave some ambiguity—unfortunately,a common problem in the real world.

It is possible that the gynecologist was negligent in puncturing the diaphragm. It may have been carelessness, for example, in the way the procedure was performed, or in the decision to proceed despite the difficulties encountered. It is also possible that the gynecologist was not appropriately trained and experienced in the surgery that was undertaken, in which case the decision to do the surgery (rather than to refer to another physician) could well have been negligent. In either of those cases, negligence liability (malpractice) is a possibility.

Proving negligence. It is the plaintiff (the patient) who must prove the elements of negligence (including causation).⁸ The plaintiff will have to demonstrate not only carelessness, but that carelessness is what caused the injuries for which she is seeking compensation. In this case, the injuries are the consequence of puncturing the diaphragm. The potential damages would be the money to cover the additional medical costs and other expenses, lost wages, and noneconomic damages such as pain and suffering.

The hospital’s role in negligence

The issue of informed consent is also raised in this case, with a handwritten note prior to surgery (but the focus of this article is on medical errors). In addition to the gynecologist, the hospital and other medical personnelwere sued. The hospital is responsible for the acts of its agents, notably its employees. Even if the physicians are not technically hospital employees, the hospital may in some cases be responsible. Among other things, the hospital likely has an obligation to prevent physicians from undertaking inappropriate procedures, including those for which the physician is not appropriately trained. If the gynecologist in this case did not have privileges to perform surgery in this category, the hospital may have an obligation to not schedule the surgery or to intraoperatively question her credentials for such a procedure. In any event, the hospital will have a major role in this case and its interests may, in some instances, be inconsistent with the interests of the physician.

Why settlement discussions?

The case description ends with a note that settlement discussions were underway. If the plaintiff must prove all of the elements of negligence, why have these discussions? First, such discussions are common in almost all negligence cases. This does not mean that the case actually will be settled by the insurance company representing the physician or hospital; many malpractice cases simply fade away because the patient drops the action. Second, there are ambiguities in the facts, and it is sometimes impossible to determine whether or not a jury would find negligence. The hospital may be inclined to settle if there is any realistic chance of a jury ruling against it. Paying a small settlement may be worth avoiding high legal expenses and the risk of an adverse outcome at trial.⁹

Reducing medical/surgical error through a team approach

Recognizing that “human performance can be affected by many factors that include circadian rhythms, state of mind, physical health, attitude, emotions, propensity for certain common mistakes and errors, and cognitive biases,”¹⁰ health care professionals have a commitment to reduce the errors in the interest of patient safety and best practice.

The surgical environment is an opportunity to provide a team approach to patient safety. Surgical risk is a reflection of operative performance, the main factor in the development of postoperative complications.¹¹ We wish to broaden the perspective that gynecologic surgeons, like all surgeons, must keep in mind a number of concerns that can be associated with problems related to surgical procedures, including¹²:

• visual perception difficulties
• stress
• loss of haptic perception (feedback using touch), as with robot-assisted procedures
• lack of situational awareness (a term we borrow from the aviation industry)
• long-term (and short-term) memory problems.

Analysis of surgical errors shows that they are related to, in order of frequency ¹:

• surgical technique
• judgment
• inattention to detail
• incomplete understanding of the problem or surgical situation.

Medical errors: Caring for the second victim (you)

Patrice M. Weiss, MD

We use the term “victim” to refer to the patient and her family following a medical error. The phrase “the second victim” was coined by Dr. Albert Wu in an article in the British Medical Journal¹ and describes how a clinician and team of health care professionals also can be affected by medical errors.

 

What signs and symptoms identify a second victim?Those suffering as a second victim may show signs of depression, loss of joy in work, and difficulty sleeping. They also may replay the events, question their own ability, and feel fearful about making another error. These reactions can lead to burnout—a serious issue that 46% of physicians report.²

As colleagues of those involved in a medical error, we should be cognizant of changes in behavior such as excessive irritability, showing up late for work, or agitation. It may be easier to recognize these symptoms in others rather than in ourselves because we often do not take time to examine how our experiences may affect us personally. Heightening awareness can help us recognize those suffering as second victims and identify the second victim symptoms in ourselves.
 

How can we help second victims?One challenge second victims face is not being allowed to discuss a medical error. Certainly, due to confidentiality requirements during professional liability cases, we should not talk freely about the event. However, silence creates a barrier that prevents a second victim from processing the incident.

Some hospitals offer forums to discuss medical errors, with the goal of preventing reoccurrence: morbidity and mortality conferences, morning report, Quality Assurance and Performance Improvement meetings, and root cause analyses. These forums often are not perceived by institutions’ employees in a positive way. Are they really meant to improve patient care or do they single out an individual or group in a “name/blame/shame game”? An intimidating process will only worsen a second victim’s symptoms. It is not necessary, however, to create a whole new process; it is possible to restructure, reframe, and change the culture of an existing practice.

Some institutions have developed a formalized program to help second victims. The University of Missouri has a “forYOU team,” an internal, rapid response group that provides emotional first aid to the entire team involved in a medical error case. These responders are not from human resources and do not need to be sought out; they are peers who have been educated about the struggles of the second victim. They will not discuss the case or how care was rendered; they naturally and instinctively provide emotional support to their colleagues.

At my institution, the Carilion Clinic at the Virginia Tech Carilion School of Medicine, “The Trust Program” encourages truth, respectfulness, understanding, support, and transparency. All health care clinicians receive basic training, but many have volunteered for additional instruction to become mentors because they have experienced second-victim symptoms themselves.

Clinicians want assistance when dealing with a medical error. One poll reports that 90% of physicians felt that health care organizations did not adequately help them cope with the stresses associated with a medical error.³ The goal is to have all institutions recognize that clinicians can be affected by a medical error and offer support.

To hear an expanded audiocast from Dr. Weiss on “the second victim” click here.

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Dr. Weiss is Professor, Department of Obstetrics & Gynecology, Virginia Tech Carilion School of Medicine, and Chief Medical Officer and Executive Vice President, Carilion Clinic, Roanoke, Virginia.

The author reports no financial relationships relevant to this article.

 

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References

1. Wu AW. Medical error: the second victim. BMJ. 2000;320(7237):726–727.
2. Peckham C. Medscape Physician Lifestyle Report 2015. Medscape website. http://www.medscape.com/features/slideshow/lifestyle/2015/public/overview#1. Published January 26, 2015. Accessed May 24, 2016.
3. White AA, Waterman AD, McCotter P, Boyle DJ, Gallagher TH. Supporting health care workers after medical error: considerations for health care leaders. JCOM. 2008;15(5):240–247.

“Inadequacy” with regard to surgical proceduresIndication for surgery is intrinsic to provision of appropriate care. Surgery inherently poses the possibility of unexpected problems. Adequate training and skill, therefore, must include the ability to deal with a range of problems that arise in the course of surgery. The spectrum related to inadequacy as related to surgical problems includes “failed surgery,” defined as “if despite the utmost care of everyone involved and with the responsible consideration of all knowledge, the designed aim is not achieved, surgery by itself has failed.”⁵ Of paramount importance is the surgeon’s knowledge of technology and the ability to troubleshoot, as well as the OR team’s responsibility for proper maintenance of equipment to ensure optimal functionality.¹

Aviation industry studies indicate that “high performing cockpit crews have been shown to devote one third of their communications to discuss threats and mistakes in their environment, while poor performing teams devoted much less, about 5%, of their time to such.”^1,13 A well-trained and well-motivated OR nursing team has been equated with reduction in operative time and rate of conversion to laparotomy.¹⁴ Outdated instruments may also contribute to surgical errors.¹

Moving the “learning curve” out of the OR and into the simulation lab remains valuable, which is also confirmed by the aviation industry.¹⁵ The significance of loss of haptic perception continues to be debated between laparoscopic (straight-stick) surgeons and those performing robotic approaches. Does haptic perception play a major role in surgical intervention? Most surgeons do not view loss of haptic perception, as with minimally invasive procedures, as a major impediment to successful surgery. From the legal perspective, loss of haptic perception has not been well addressed.

The American College of Obstetricians and Gynecologists has focused on patient safety in the surgical environment including concerns for wrong-patient surgery, wrong-side surgery, wrong-level surgery, and wrong-part surgery.¹⁶ The Joint Commission has identified factors that may enhance the risk of wrong-site surgery: multiple surgeons involved in the case, multiple procedures during a single surgical visit, unusual time pressures to start or complete the surgery, and unusual physical characteristics including morbid obesity or physical deformity.¹⁶

10 starting points for medical error preventionSo what are we to do? Consider:

Set the stage for best outcomesA true team approach is an excellent modus operandi before, during, and after surgery,setting the stage for best outcomes for patients.

“As human beings, surgeons will commit errors and for this reason they have to adopt and utilize stringent defense systems to minimize the incidence of these adverse events … Transparency is the first step on the way to a new safety culture with the acknowledgement of errors when they occur with adoption of systems destined to establish their cause and future prevention.”¹

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Dear Dr. Mossman,

All the psychiatrists at our clinic agree: It is hard to remember when our patients who take an antipsychotic are due for metabolic monitoring, and it’s even harder to get many of them to follow through with timely blood tests. For many, stopping their medication would be a bad idea. If we keep a patient on an antipsychotic and a metabolic problem results, how serious is our malpractice liability risk?

Submitted by “Dr. V”

Antipsychotics, the mainstay of treatment for schizophrenia,¹ put patients at risk of gaining weight and developing metabolic syndrome, including type 2 diabetes mellitus, hypertension, and dyslipidemia.² Second-generation antipsychotics are the biggest offenders, but taking a first-generation antipsychotic also can lead to these adverse effects.³

Most psychiatrists are aware of these risks and prefer that their patients do not experience them. However, many psychiatrists neglect proper monitoring or, like Dr. V, find it hard to ensure it happens and thus worry about clinical deterioration if patients stop taking an antipsychotic.⁴ If you are in the same situation as Dr. V, what medicolegal risks are you facing?

To answer this question, we will:

• review the clinical guidelines and standards for monitoring metabolic effects of antipsychotics
• examine how well (or poorly) physicians adhere to these standards
• discuss what “standard of care” means and how a practice guideline affects the standard effects
• propose how psychiatrists can do better at policing the metabolic effects of antipsychotics.

I’ll be watching you: Following guidelines
Several medical specialty societies have published guidelines for monitoring the metabolic effects of antipsychotics.^5-8 These guidelines instruct physicians to obtain a thorough personal and family history; consider metabolic risks when starting a medication; and monitor weight, waist circumference, blood pressure, glucose, hemoglobin A_1c, and lipids at various intervals. They also advise referral for management of detected metabolic problems.

Although the recommendations seem clear, many physicians don’t follow them. A 2012 meta-analysis of 48 studies, covering >200,000 antipsychotic-treated patients, showed that baseline measurements of cholesterol, glucose, and weight occurred in <50% of cases.⁹ A more recent review found that, among adults with a serious mental illness, the rate of lipid testing varied from 6% to 85% and for glucose monitoring, between 18% and 75%.¹⁰ In the first years after antipsychotic monitoring guidelines were established, they had only a modest impact on practice,^9,11 and some studies showed the guidelines made no difference at all.^12-14

Monitoring compliance varies with the type of insurance coverage patients have but remains suboptimal among the commercially insured,¹¹ Medicaid patients,^14-16 and veterans.^17,18 Studies on antipsychotic treatment in children, adolescents, patients with dementia, and patients with an intellectual disability show insufficient monitoring as well.^{9,14,17,19-21} The reasons for these gaps are manifold, but one commonly cited factor is uncertainty about whether the psychiatrist or primary care physician should handle monitoring.²²

Every claim you stake: The ‘standard of care’
In a medical malpractice case, the party claiming injury must show that the accused physician failed to follow “the generally recognized practices and procedures which would be exercised by ordinary competent practitioners in a defendant doctor’s field of medicine under the same or similar circumstances.”²³ In the studies mentioned above,^9-14 a large fraction of psychiatrists—many of whom, we can presume, are “competent practitioners”—don’t follow the antipsychotic monitoring guidelines in actual practice. Could failing to follow those guidelines still be the basis for a successful lawsuit?

The answer seems to be ‘yes.’ Published legal decisions describe malpractice lawsuits alleging physicians’ failure to follow antipsychotic guidelines,^24,25 and online advertisements show that attorneys believe such cases can generate a payout.^26,27 This may seem odd, given what studies say about psychiatrists’ monitoring practices. But determining the “standard of care” in a malpractice case is not an empirical question; it is a legal matter that is decided based on the testimony of expert witnesses.²⁸ Here, customary practice matters, but it’s not the whole story.

Although the standard of care against which courts measure a physician’s actions “is that of a reasonably prudent practitioner …, The degree of care actually practiced by members of the profession is only some evidence of what is reasonably prudent—it is not dispositive.”²⁹ To support their opinion concerning the standard of care, testifying medical witnesses sometimes use practice guidelines. In this case, an explanation of why a particular guideline was chosen is crucial.³⁰

Using guidelines to establish the standard is controversial. On one hand, using guidelines in malpractice litigation allows for some consistency about expectations of practitioners.^31,32 Although guidelines are not identical to evidenced-based medicine, they generally reflect an evidence-based expert consensus about sound medical practice. If a hospital uses a guideline to train its employees, the guideline provides the courts with clear information on what should have happened.^33,34 Laws in some states allow clinicians to invoke their adherence to a guideline in defense against malpractice claims.³⁵

On the other hand, critics contend that guidelines may not set an accurate standard for the quality of care, nor do they necessarily reflect a proper balance of the conflicting interests of patients and the health care system.³⁶ The American Psychiatric Association states that its practice guidelines “are not intended to serve or be construed as a ‘standard of medical care.’”³⁷

Conformity is not the only measure of prudent practice, and following guidelines does not immunize a clinician from lawsuit if a particular clinical situation demands a different course of action.³² Guidelines can be costly to implement,³⁶ compliance with guidelines generally is low,³⁵ and national guidelines do not necessarily improve the quality of care.³⁸ Last, relying on guidelines to determine the standard of care might stifle innovation or development of alternate approaches by silencing viewpoints.^39,40 Table 1^33-35,39,41 (page 60)summarizes variables that make a guideline more indicative of the standard of care.
 

Every step you take: Better monitoring
Medical professionals often are slow to update their practice to reflect new knowledge about optimal treatment. But practice guidelines influence the court’s views about the standard of care, and Dr. V’s question shows that he and his colleagues agree that metabolic status needs to be better monitored when patients take antipsychotic drugs. The following discussion and Table 2^42-45 offer suggestions for how psychiatrists and their practice settings could better accomplish this.

Electronic health records (EHRs). Monitor­ing health indices often is the largest hurdle that health care professionals face.⁴⁶ However, large health care systems with EHRs are in a good position to develop and implement automated computer routines that track which patients need monitoring and note due dates, abnormal results, and management interventions.⁴² Some studies suggest that monitoring rates in both inpatient⁴⁷ and outpatient⁴⁸ settings improve with built-in EHR reminders. However, if a system uses too many reminders, the resulting “alert fatigue” will limit their value.²² Providing individual feedback about monitoring practices may enhance physicians’ buy-in to reminder systems.⁴⁸
 

Integrated care systems can improve patient outcomes, particularly antipsychotic monitoring. Advantages include shared funding streams, a unified medical record, coordinated scheduling of psychiatric and primary care appointments, and addressing blood-draw refusals.⁴³ More frequent primary care visits make antipsychotic monitoring more likely.¹¹ Ultimately, integrated care could resolve problems related to determining which clinicians are responsible for monitoring and managing adverse metabolic effects.

Third-party payers. Managed care interventions also could improve monitoring rates.⁴⁴ Prior authorization often requires physicians to obtain appropriate lab work. Insurers might contact physicians with educational interventions, including free webinars, provider alerts, and letters about monitoring rates in their region. Some insurers also provide disease management programs for patients and their caregivers.

Individual and small group practices. Psychiatrists who practice outside a large health care system might designate 2 months each year as “physical health months.” In the “Let’s Get Physical” program,⁴⁵ physicians were given longer appointment times during these months to address metabolic monitoring, provide education about managing side effects of medication, and encourage better diets and exercise.

Overall, the best techniques might be those implicit to good doctoring: clear and open communication with patients, effective patient education, respect of informed consent, and thorough follow-up.⁴⁹

Dear Dr. Mossman,

All the psychiatrists at our clinic agree: It is hard to remember when our patients who take an antipsychotic are due for metabolic monitoring, and it’s even harder to get many of them to follow through with timely blood tests. For many, stopping their medication would be a bad idea. If we keep a patient on an antipsychotic and a metabolic problem results, how serious is our malpractice liability risk?

Submitted by “Dr. V”

Antipsychotics, the mainstay of treatment for schizophrenia,¹ put patients at risk of gaining weight and developing metabolic syndrome, including type 2 diabetes mellitus, hypertension, and dyslipidemia.² Second-generation antipsychotics are the biggest offenders, but taking a first-generation antipsychotic also can lead to these adverse effects.³

Most psychiatrists are aware of these risks and prefer that their patients do not experience them. However, many psychiatrists neglect proper monitoring or, like Dr. V, find it hard to ensure it happens and thus worry about clinical deterioration if patients stop taking an antipsychotic.⁴ If you are in the same situation as Dr. V, what medicolegal risks are you facing?

To answer this question, we will:

• review the clinical guidelines and standards for monitoring metabolic effects of antipsychotics
• examine how well (or poorly) physicians adhere to these standards
• discuss what “standard of care” means and how a practice guideline affects the standard effects
• propose how psychiatrists can do better at policing the metabolic effects of antipsychotics.

I’ll be watching you: Following guidelines
Several medical specialty societies have published guidelines for monitoring the metabolic effects of antipsychotics.^5-8 These guidelines instruct physicians to obtain a thorough personal and family history; consider metabolic risks when starting a medication; and monitor weight, waist circumference, blood pressure, glucose, hemoglobin A_1c, and lipids at various intervals. They also advise referral for management of detected metabolic problems.

Although the recommendations seem clear, many physicians don’t follow them. A 2012 meta-analysis of 48 studies, covering >200,000 antipsychotic-treated patients, showed that baseline measurements of cholesterol, glucose, and weight occurred in <50% of cases.⁹ A more recent review found that, among adults with a serious mental illness, the rate of lipid testing varied from 6% to 85% and for glucose monitoring, between 18% and 75%.¹⁰ In the first years after antipsychotic monitoring guidelines were established, they had only a modest impact on practice,^9,11 and some studies showed the guidelines made no difference at all.^12-14

Monitoring compliance varies with the type of insurance coverage patients have but remains suboptimal among the commercially insured,¹¹ Medicaid patients,^14-16 and veterans.^17,18 Studies on antipsychotic treatment in children, adolescents, patients with dementia, and patients with an intellectual disability show insufficient monitoring as well.^{9,14,17,19-21} The reasons for these gaps are manifold, but one commonly cited factor is uncertainty about whether the psychiatrist or primary care physician should handle monitoring.²²

Every claim you stake: The ‘standard of care’
In a medical malpractice case, the party claiming injury must show that the accused physician failed to follow “the generally recognized practices and procedures which would be exercised by ordinary competent practitioners in a defendant doctor’s field of medicine under the same or similar circumstances.”²³ In the studies mentioned above,^9-14 a large fraction of psychiatrists—many of whom, we can presume, are “competent practitioners”—don’t follow the antipsychotic monitoring guidelines in actual practice. Could failing to follow those guidelines still be the basis for a successful lawsuit?

The answer seems to be ‘yes.’ Published legal decisions describe malpractice lawsuits alleging physicians’ failure to follow antipsychotic guidelines,^24,25 and online advertisements show that attorneys believe such cases can generate a payout.^26,27 This may seem odd, given what studies say about psychiatrists’ monitoring practices. But determining the “standard of care” in a malpractice case is not an empirical question; it is a legal matter that is decided based on the testimony of expert witnesses.²⁸ Here, customary practice matters, but it’s not the whole story.

Although the standard of care against which courts measure a physician’s actions “is that of a reasonably prudent practitioner …, The degree of care actually practiced by members of the profession is only some evidence of what is reasonably prudent—it is not dispositive.”²⁹ To support their opinion concerning the standard of care, testifying medical witnesses sometimes use practice guidelines. In this case, an explanation of why a particular guideline was chosen is crucial.³⁰

Using guidelines to establish the standard is controversial. On one hand, using guidelines in malpractice litigation allows for some consistency about expectations of practitioners.^31,32 Although guidelines are not identical to evidenced-based medicine, they generally reflect an evidence-based expert consensus about sound medical practice. If a hospital uses a guideline to train its employees, the guideline provides the courts with clear information on what should have happened.^33,34 Laws in some states allow clinicians to invoke their adherence to a guideline in defense against malpractice claims.³⁵

On the other hand, critics contend that guidelines may not set an accurate standard for the quality of care, nor do they necessarily reflect a proper balance of the conflicting interests of patients and the health care system.³⁶ The American Psychiatric Association states that its practice guidelines “are not intended to serve or be construed as a ‘standard of medical care.’”³⁷

Conformity is not the only measure of prudent practice, and following guidelines does not immunize a clinician from lawsuit if a particular clinical situation demands a different course of action.³² Guidelines can be costly to implement,³⁶ compliance with guidelines generally is low,³⁵ and national guidelines do not necessarily improve the quality of care.³⁸ Last, relying on guidelines to determine the standard of care might stifle innovation or development of alternate approaches by silencing viewpoints.^39,40 Table 1^33-35,39,41 (page 60)summarizes variables that make a guideline more indicative of the standard of care.
 

Every step you take: Better monitoring
Medical professionals often are slow to update their practice to reflect new knowledge about optimal treatment. But practice guidelines influence the court’s views about the standard of care, and Dr. V’s question shows that he and his colleagues agree that metabolic status needs to be better monitored when patients take antipsychotic drugs. The following discussion and Table 2^42-45 offer suggestions for how psychiatrists and their practice settings could better accomplish this.

Electronic health records (EHRs). Monitor­ing health indices often is the largest hurdle that health care professionals face.⁴⁶ However, large health care systems with EHRs are in a good position to develop and implement automated computer routines that track which patients need monitoring and note due dates, abnormal results, and management interventions.⁴² Some studies suggest that monitoring rates in both inpatient⁴⁷ and outpatient⁴⁸ settings improve with built-in EHR reminders. However, if a system uses too many reminders, the resulting “alert fatigue” will limit their value.²² Providing individual feedback about monitoring practices may enhance physicians’ buy-in to reminder systems.⁴⁸
 

Integrated care systems can improve patient outcomes, particularly antipsychotic monitoring. Advantages include shared funding streams, a unified medical record, coordinated scheduling of psychiatric and primary care appointments, and addressing blood-draw refusals.⁴³ More frequent primary care visits make antipsychotic monitoring more likely.¹¹ Ultimately, integrated care could resolve problems related to determining which clinicians are responsible for monitoring and managing adverse metabolic effects.

Third-party payers. Managed care interventions also could improve monitoring rates.⁴⁴ Prior authorization often requires physicians to obtain appropriate lab work. Insurers might contact physicians with educational interventions, including free webinars, provider alerts, and letters about monitoring rates in their region. Some insurers also provide disease management programs for patients and their caregivers.

Individual and small group practices. Psychiatrists who practice outside a large health care system might designate 2 months each year as “physical health months.” In the “Let’s Get Physical” program,⁴⁵ physicians were given longer appointment times during these months to address metabolic monitoring, provide education about managing side effects of medication, and encourage better diets and exercise.

Overall, the best techniques might be those implicit to good doctoring: clear and open communication with patients, effective patient education, respect of informed consent, and thorough follow-up.⁴⁹

Dear Dr. Mossman,

All the psychiatrists at our clinic agree: It is hard to remember when our patients who take an antipsychotic are due for metabolic monitoring, and it’s even harder to get many of them to follow through with timely blood tests. For many, stopping their medication would be a bad idea. If we keep a patient on an antipsychotic and a metabolic problem results, how serious is our malpractice liability risk?

Submitted by “Dr. V”

Antipsychotics, the mainstay of treatment for schizophrenia,¹ put patients at risk of gaining weight and developing metabolic syndrome, including type 2 diabetes mellitus, hypertension, and dyslipidemia.² Second-generation antipsychotics are the biggest offenders, but taking a first-generation antipsychotic also can lead to these adverse effects.³

Most psychiatrists are aware of these risks and prefer that their patients do not experience them. However, many psychiatrists neglect proper monitoring or, like Dr. V, find it hard to ensure it happens and thus worry about clinical deterioration if patients stop taking an antipsychotic.⁴ If you are in the same situation as Dr. V, what medicolegal risks are you facing?

To answer this question, we will:

• review the clinical guidelines and standards for monitoring metabolic effects of antipsychotics
• examine how well (or poorly) physicians adhere to these standards
• discuss what “standard of care” means and how a practice guideline affects the standard effects
• propose how psychiatrists can do better at policing the metabolic effects of antipsychotics.

I’ll be watching you: Following guidelines
Several medical specialty societies have published guidelines for monitoring the metabolic effects of antipsychotics.^5-8 These guidelines instruct physicians to obtain a thorough personal and family history; consider metabolic risks when starting a medication; and monitor weight, waist circumference, blood pressure, glucose, hemoglobin A_1c, and lipids at various intervals. They also advise referral for management of detected metabolic problems.

Although the recommendations seem clear, many physicians don’t follow them. A 2012 meta-analysis of 48 studies, covering >200,000 antipsychotic-treated patients, showed that baseline measurements of cholesterol, glucose, and weight occurred in <50% of cases.⁹ A more recent review found that, among adults with a serious mental illness, the rate of lipid testing varied from 6% to 85% and for glucose monitoring, between 18% and 75%.¹⁰ In the first years after antipsychotic monitoring guidelines were established, they had only a modest impact on practice,^9,11 and some studies showed the guidelines made no difference at all.^12-14

Monitoring compliance varies with the type of insurance coverage patients have but remains suboptimal among the commercially insured,¹¹ Medicaid patients,^14-16 and veterans.^17,18 Studies on antipsychotic treatment in children, adolescents, patients with dementia, and patients with an intellectual disability show insufficient monitoring as well.^{9,14,17,19-21} The reasons for these gaps are manifold, but one commonly cited factor is uncertainty about whether the psychiatrist or primary care physician should handle monitoring.²²

Every claim you stake: The ‘standard of care’
In a medical malpractice case, the party claiming injury must show that the accused physician failed to follow “the generally recognized practices and procedures which would be exercised by ordinary competent practitioners in a defendant doctor’s field of medicine under the same or similar circumstances.”²³ In the studies mentioned above,^9-14 a large fraction of psychiatrists—many of whom, we can presume, are “competent practitioners”—don’t follow the antipsychotic monitoring guidelines in actual practice. Could failing to follow those guidelines still be the basis for a successful lawsuit?

The answer seems to be ‘yes.’ Published legal decisions describe malpractice lawsuits alleging physicians’ failure to follow antipsychotic guidelines,^24,25 and online advertisements show that attorneys believe such cases can generate a payout.^26,27 This may seem odd, given what studies say about psychiatrists’ monitoring practices. But determining the “standard of care” in a malpractice case is not an empirical question; it is a legal matter that is decided based on the testimony of expert witnesses.²⁸ Here, customary practice matters, but it’s not the whole story.

Although the standard of care against which courts measure a physician’s actions “is that of a reasonably prudent practitioner …, The degree of care actually practiced by members of the profession is only some evidence of what is reasonably prudent—it is not dispositive.”²⁹ To support their opinion concerning the standard of care, testifying medical witnesses sometimes use practice guidelines. In this case, an explanation of why a particular guideline was chosen is crucial.³⁰

Using guidelines to establish the standard is controversial. On one hand, using guidelines in malpractice litigation allows for some consistency about expectations of practitioners.^31,32 Although guidelines are not identical to evidenced-based medicine, they generally reflect an evidence-based expert consensus about sound medical practice. If a hospital uses a guideline to train its employees, the guideline provides the courts with clear information on what should have happened.^33,34 Laws in some states allow clinicians to invoke their adherence to a guideline in defense against malpractice claims.³⁵

On the other hand, critics contend that guidelines may not set an accurate standard for the quality of care, nor do they necessarily reflect a proper balance of the conflicting interests of patients and the health care system.³⁶ The American Psychiatric Association states that its practice guidelines “are not intended to serve or be construed as a ‘standard of medical care.’”³⁷

Conformity is not the only measure of prudent practice, and following guidelines does not immunize a clinician from lawsuit if a particular clinical situation demands a different course of action.³² Guidelines can be costly to implement,³⁶ compliance with guidelines generally is low,³⁵ and national guidelines do not necessarily improve the quality of care.³⁸ Last, relying on guidelines to determine the standard of care might stifle innovation or development of alternate approaches by silencing viewpoints.^39,40 Table 1^33-35,39,41 (page 60)summarizes variables that make a guideline more indicative of the standard of care.
 

Every step you take: Better monitoring
Medical professionals often are slow to update their practice to reflect new knowledge about optimal treatment. But practice guidelines influence the court’s views about the standard of care, and Dr. V’s question shows that he and his colleagues agree that metabolic status needs to be better monitored when patients take antipsychotic drugs. The following discussion and Table 2^42-45 offer suggestions for how psychiatrists and their practice settings could better accomplish this.

Electronic health records (EHRs). Monitor­ing health indices often is the largest hurdle that health care professionals face.⁴⁶ However, large health care systems with EHRs are in a good position to develop and implement automated computer routines that track which patients need monitoring and note due dates, abnormal results, and management interventions.⁴² Some studies suggest that monitoring rates in both inpatient⁴⁷ and outpatient⁴⁸ settings improve with built-in EHR reminders. However, if a system uses too many reminders, the resulting “alert fatigue” will limit their value.²² Providing individual feedback about monitoring practices may enhance physicians’ buy-in to reminder systems.⁴⁸
 

Integrated care systems can improve patient outcomes, particularly antipsychotic monitoring. Advantages include shared funding streams, a unified medical record, coordinated scheduling of psychiatric and primary care appointments, and addressing blood-draw refusals.⁴³ More frequent primary care visits make antipsychotic monitoring more likely.¹¹ Ultimately, integrated care could resolve problems related to determining which clinicians are responsible for monitoring and managing adverse metabolic effects.

Third-party payers. Managed care interventions also could improve monitoring rates.⁴⁴ Prior authorization often requires physicians to obtain appropriate lab work. Insurers might contact physicians with educational interventions, including free webinars, provider alerts, and letters about monitoring rates in their region. Some insurers also provide disease management programs for patients and their caregivers.

Individual and small group practices. Psychiatrists who practice outside a large health care system might designate 2 months each year as “physical health months.” In the “Let’s Get Physical” program,⁴⁵ physicians were given longer appointment times during these months to address metabolic monitoring, provide education about managing side effects of medication, and encourage better diets and exercise.

Overall, the best techniques might be those implicit to good doctoring: clear and open communication with patients, effective patient education, respect of informed consent, and thorough follow-up.⁴⁹

Dear Dr. Hospitalist:

I am a seasoned hospitalist at a large academic medical center in the Northeast and have recently become more bothered by how our group is being coerced to aggressively bill for our services. It seems the current reimbursement environment has pushed some of our leaders to demand more aggressive billing from our hospitalists. How should I respond?

Sincerely,

A Seasoned Hospitalist

Dr. Hospitalist responds:

As another “seasoned” hospitalist, I, too, have seen the wide pendulum swing from when internist inpatient billing was an afterthought and done by others to the current system of billing classes, RVU enticement, and reminders of how to construct the note. Enter the electronic health record, and now instead of clinical notes being used as a form of communication among clinicians, it does seem today to be created more for billing purposes.

How did we get here?

Physicians have to accept some of the blame. I can recall when I was an orderly at our local hospital in the mid 1970s and some physician “rounds” consisted of standing in a patient’s doorway and calling out, “How are you doing today, Mrs. Smith?” I must admit to having no idea how these docs were billing, but I do know that Medicare allowed for twice-daily billing for hospital visits back then. I also recall some of the paltry progress notes that consisted of one-liners like “pt doing well today.”

Like most corrective actions, the response has overshot the intended mark and made the daily progress note more ritualistic than informative. When the first attempts by the American Medical Association and the Centers for Medicare & Medicaid Services were released in the early 1990s, I’m sure most docs had no idea it would morph into its current level of significance for reimbursement—and that one day docs would be asked to implement, keep up with changes and modifications (think ICD-10), and use daily. Don’t get me wrong: I, like most hospitalists, recognize the clinical utility of a concise and well-written note. But when an otherwise complete H&P gets down-coded from a level 99223 to a 99221 because I leave off the family history of a 95-year-old man, of course I believe something is wrong with the system.

Also, human nature being what it is, I have always felt that if you incentivize people to increase production of an item, whether it’s a widget or an RVU, you will have some who will learn to game the system, consciously or subconsciously. With healthcare spending in the U.S. approaching 20% of gross domestic product, we as physicians should not be placed in positions of increased financial gain at the expense of our country’s economic health and viability. After all, we’re citizens first and physicians second.

You should recognize the need for proper coding and billing as inherent to the hospital’s financial viability, and if done correctly, it should not create an ethical or legal conflict for you. In the vast majority of cases, a well-written note can be properly billed and coded without creating angst.

Good luck! TH

Dear Dr. Hospitalist:

I am a seasoned hospitalist at a large academic medical center in the Northeast and have recently become more bothered by how our group is being coerced to aggressively bill for our services. It seems the current reimbursement environment has pushed some of our leaders to demand more aggressive billing from our hospitalists. How should I respond?

Sincerely,

A Seasoned Hospitalist

Dr. Hospitalist responds:

As another “seasoned” hospitalist, I, too, have seen the wide pendulum swing from when internist inpatient billing was an afterthought and done by others to the current system of billing classes, RVU enticement, and reminders of how to construct the note. Enter the electronic health record, and now instead of clinical notes being used as a form of communication among clinicians, it does seem today to be created more for billing purposes.

How did we get here?

Physicians have to accept some of the blame. I can recall when I was an orderly at our local hospital in the mid 1970s and some physician “rounds” consisted of standing in a patient’s doorway and calling out, “How are you doing today, Mrs. Smith?” I must admit to having no idea how these docs were billing, but I do know that Medicare allowed for twice-daily billing for hospital visits back then. I also recall some of the paltry progress notes that consisted of one-liners like “pt doing well today.”

Like most corrective actions, the response has overshot the intended mark and made the daily progress note more ritualistic than informative. When the first attempts by the American Medical Association and the Centers for Medicare & Medicaid Services were released in the early 1990s, I’m sure most docs had no idea it would morph into its current level of significance for reimbursement—and that one day docs would be asked to implement, keep up with changes and modifications (think ICD-10), and use daily. Don’t get me wrong: I, like most hospitalists, recognize the clinical utility of a concise and well-written note. But when an otherwise complete H&P gets down-coded from a level 99223 to a 99221 because I leave off the family history of a 95-year-old man, of course I believe something is wrong with the system.

Also, human nature being what it is, I have always felt that if you incentivize people to increase production of an item, whether it’s a widget or an RVU, you will have some who will learn to game the system, consciously or subconsciously. With healthcare spending in the U.S. approaching 20% of gross domestic product, we as physicians should not be placed in positions of increased financial gain at the expense of our country’s economic health and viability. After all, we’re citizens first and physicians second.

You should recognize the need for proper coding and billing as inherent to the hospital’s financial viability, and if done correctly, it should not create an ethical or legal conflict for you. In the vast majority of cases, a well-written note can be properly billed and coded without creating angst.

Good luck! TH

Dear Dr. Hospitalist:

I am a seasoned hospitalist at a large academic medical center in the Northeast and have recently become more bothered by how our group is being coerced to aggressively bill for our services. It seems the current reimbursement environment has pushed some of our leaders to demand more aggressive billing from our hospitalists. How should I respond?

Sincerely,

A Seasoned Hospitalist

Dr. Hospitalist responds:

As another “seasoned” hospitalist, I, too, have seen the wide pendulum swing from when internist inpatient billing was an afterthought and done by others to the current system of billing classes, RVU enticement, and reminders of how to construct the note. Enter the electronic health record, and now instead of clinical notes being used as a form of communication among clinicians, it does seem today to be created more for billing purposes.

How did we get here?

Physicians have to accept some of the blame. I can recall when I was an orderly at our local hospital in the mid 1970s and some physician “rounds” consisted of standing in a patient’s doorway and calling out, “How are you doing today, Mrs. Smith?” I must admit to having no idea how these docs were billing, but I do know that Medicare allowed for twice-daily billing for hospital visits back then. I also recall some of the paltry progress notes that consisted of one-liners like “pt doing well today.”

Like most corrective actions, the response has overshot the intended mark and made the daily progress note more ritualistic than informative. When the first attempts by the American Medical Association and the Centers for Medicare & Medicaid Services were released in the early 1990s, I’m sure most docs had no idea it would morph into its current level of significance for reimbursement—and that one day docs would be asked to implement, keep up with changes and modifications (think ICD-10), and use daily. Don’t get me wrong: I, like most hospitalists, recognize the clinical utility of a concise and well-written note. But when an otherwise complete H&P gets down-coded from a level 99223 to a 99221 because I leave off the family history of a 95-year-old man, of course I believe something is wrong with the system.

Also, human nature being what it is, I have always felt that if you incentivize people to increase production of an item, whether it’s a widget or an RVU, you will have some who will learn to game the system, consciously or subconsciously. With healthcare spending in the U.S. approaching 20% of gross domestic product, we as physicians should not be placed in positions of increased financial gain at the expense of our country’s economic health and viability. After all, we’re citizens first and physicians second.

You should recognize the need for proper coding and billing as inherent to the hospital’s financial viability, and if done correctly, it should not create an ethical or legal conflict for you. In the vast majority of cases, a well-written note can be properly billed and coded without creating angst.

Good luck! TH

Too Much Medication, Too Little Monitoring

A 58-year-old man presented to the ED via emergency medical services (EMS) for evaluation of severe low-back pain. The patient said the pain started abruptly, approximately 1 hour earlier when he was picking up a 50-lb television set. He stated that the pain was so severe that he was unable to move and was forced to lie down on the floor. Although the patient noted that he had a history of a “bad back,” he said he never required surgery and never experienced an episode this severe. The patient denied any radiation of pain or lower extremity numbness or weakness. He denied any chest pain or abdominal pain. His medical history was significant for obstructive sleep apnea and hypertension for which he was taking hydrochlorothiazide. Regarding his social history, he denied any tobacco or alcohol use.

Upon presentation, the patient was found to be in extreme discomfort, rating his pain as an “11” on a scale of 0 to 10. His vital signs were heart rate (HR), 110 beats/minute; blood pressure (BP), 154/91 mm Hg; respiratory rate, 20 breaths/minute; and temperature, 98.6°F. Oxygen (O₂) saturation was 98% on room air.

When the emergency physician (EP) entered the examination room, the patient was in bed, resting on his side and moaning from the pain. The head, eyes, ears, nose, and throat, cardiac, and lung examinations were all normal. The patient’s abdomen was soft and nontender and without guarding, rebound, or palpable mass. When the EP examined the patient’s back, there was no midline tenderness over the thoracic and lumbar spine. The patient did, however, exhibit bilateral paraspinal lumbar muscle tenderness to palpation and muscle spasm. After much prompting, he demonstrated 5/5 motor strength in his lower extremities bilaterally. The dorsalis pedis and posterior tibial pulses were 2+ and symmetrical.

To treat the patient’s severe pain, the EP had a saline lock placed and ordered intravenous (IV) hydromorphone 1 mg, ondansetron 4 mg, and diazepam 5 mg. No laboratory or imaging studies were ordered. Ninety minutes after receiving the analgesics, the patient continued to complain of severe pain without any improvement, and the EP ordered another two rounds of IV hydromorphone 1 mg and diazepam 5 mg. The EP did not return to check up on the patient, but rather relied solely on updates from the patient’s nurse.

Despite the additional doses of hydromorphone and diazepam, the patient continued to complain of severe pain, and the EP ordered IV hydromorphone 2 mg and diazepam 10 mg. Shortly after the patient received this third round of analgesics, his wife arrived at the ED asking to see her husband. When she entered his room, the patient was unresponsive. A code was called and the patient was found to be in asystole. Despite aggressive resuscitative efforts that included intubation, cardiopulmonary resuscitation, and advanced cardiac life support medications, the patient did not recover.

The patient’s wife sued the EP, the ED nurse, and the hospital for failure to appropriately monitor her husband while he received multiple doses of analgesic and sedative agents. The plaintiff argued that the patient’s death was caused by a cardiac arrest occurring secondary to a respiratory arrest, and that the respiratory arrest was secondary to the medications he was given in the ED. The defendants denied the allegations. A $2 million settlement was reached prior to trial.

Discussion

This was clearly a preventable death. Emergency physicians treat pain daily and should be knowledgeable about and experienced in managing acute pain. When evaluating and treating a patient’s pain, the EP must select the appropriate medication. Though we often talk about a tiered approach to pain in the ED, most of us would agree that opioids, usually via IV, are the first choice for managing severe pain.

In addition to prescribing the appropriate analgesics, the EP must identify which patients are at risk of opioid complications. This patient was at risk for opioid-induced respiratory depression based on his age (ie, >55 years old) and history of obstructive sleep apnea. These two risk factors, along with pre-existing chronic obstructive pulmonary disease, anatomic oral or airway abnormalities, and comorbidities (eg, renal or hepatic impairment), place patients at high risk for opioid-associated complications.¹ Patients with any of these conditions must be closely monitored and, based on their response to the prescribed analgesia, the EP may need to decrease the analgesic dosage and increase dosage intervals. In addition to close monitoring, reversal agents such as naloxone should be readily available in case of respiratory depression.

The problem in this case was not the selection of hydromorphone as the initial analgesic agent. Hydromorphone is frequently used safely in the ED to treat severe pain associated with conditions such as sickle cell vaso-occlusive pain crisis, renal colic, and long-bone fracture. Issues arise when hydromorphone is combined with a benzodiazepine (in this case, diazepam), which by itself causes sedation and anxiolysis. Central nervous system (CNS) depression may be additive and occur when benzodiazepines are used concomitantly with drugs that also cause CNS depression (eg, opioids).¹ This combination can lead to excessive sedation, resulting in partial airway obstruction and hypoxia.¹ For example, in an investigation by Bailey et al,² in human volunteers, neither hypoxemia nor apnea was evident after administration of .05 mg/kg of IV midazolam. In patients who received 2 mcg/kg of IV fentanyl alone, hypoxemia occurred in 50%, but apnea did not occur in any of the patients studied. However, when the same doses of these drugs were administered together, 92% of participants exhibited hypoxemia and 50% became apneic.²

When a combination of an opioid and benzodiazepine are given over frequent intervals, the clinician crosses over from treating pain to performing procedural sedation and analgesia—whether he intended to or not. As such, the patient in this case required proper monitoring, including cardiac monitoring and pulse oximetry; he also should have been placed on supplemental O₂. Ideally, the patient would have benefited from end-tidal carbon dioxide (ETCO₂), monitoring, if available. This is a noninvasive measurement of the partial pressure of CO₂ in exhaled breath. Hypoventilation from respiratory depression results in an increase in ETCO₂, and hyperventilation results in a decreased ETCO₂. While pulse oximetry is excellent at monitoring O₂ saturation, it is ineffective in the early detection of respiratory depression, hypoventilation, and apnea. The hypercarbia precedes the hypoxemia—by as much as 60 seconds (range 5-240 seconds), according to a study by Deitch et al.³

Finally, rather than relying solely on the reports from the nurse, the EP should have personally reassessed the patient at some point. Nursing updates are extremely helpful, but when ordering repeated doses of IV opioids and benzodiazepines, the EP should personally reassess the patient.
 

Hot Red Knee

 64-year-old man presented to the ED with a chief complaint of right knee pain, which he stated began approximately 2 days earlier. He denied any injury or trauma or a recent history of fever, chills, or other joint complaints. He described the pain as constant, worse with weight bearing, and becoming progressively more painful. The patient had a history of gout; however, previous attacks had only affected his great toes and elbows. His medical history was also significant for hypertension, for which he was taking lisinopril and hydrochlorothiazide. He admitted to moderate alcohol consumption but denied tobacco use.

On physical examination, the patient appeared uncomfortable due to the knee pain. All of his vital signs were normal. A focused examination of the affected knee revealed a small effusion, diffuse tenderness to palpation, mild erythema, and slight increased warmth. The patient exhibited pain with flexion and extension of the right knee. The right ankle examination and right dorsalis pedis pulse and posterior tibial pulse were all normal. No laboratory or imaging studies were obtained.

Based on the patient’s history and physical examination, the EP believed the patient’s symptoms were due to an episode of gout. He prescribed oral colchicine, allopurinol, and acetaminophen/hydrocodone; he also advised the patient to apply warm compresses to the affected area and limit his activity. He discharged the patient home with instructions to follow up with his primary care physician.

Two days after discharge, the patient returned to the same ED via EMS. On this presentation, he was febrile, with a temperature of 102.6^oF; a HR of 120 beats/minute; and a BP of 92/50 mm Hg. He also had altered mental status. The patient’s right knee appeared more swollen, and he would not flex it due to the severe pain. The EP was concerned for sepsis, and ordered blood cultures, a complete blood count, basic metabolic profile, and lactic acid evaluation. The patient was administered 2 L normal saline IV and broad-spectrum antibiotics. Despite the addition of vasopressors, he continued to deteriorate; he ultimately went into cardiac arrest and died.

The patient’s family sued the EP from the initial ED visit for failure to diagnose the right knee pain and swelling as septic arthritis (SA). The plaintiff’s attorney argued that this failure to diagnosis directly caused the patient’s sepsis and death. The EP argued that the patient’s history and physical examination were consistent with an acute gout attack, that there was no evidence of infection in the right knee, and that this was not the cause of the patient’s death. At trial, the jury returned a verdict in favor of the defense.

Discussion

Gout is caused by the precipitation of uric acid crystals into a joint. Attacks are usually monoarticular as opposed to polyarticular. The presence of hyperuricemia is variable; some patients have high serum uric acid levels and never experience gout, while other patients have normal serum uric acid levels and experience gout attacks. The condition is more common in men than in women. There are multiple risk factors for the development of gout, including obesity, hypertension, chronic kidney disease, regular excessive consumption of alcohol, taking diuretics, and consuming foods high in fructose corn syrup.¹ The joints most often affected are the great toe and knee. Patients with gout typically complain of pain, swelling, redness, and increased warmth in the affected area.

Unfortunately, the clinical presentation of an acute gout attack and SA are indistinguishable.² Risk factors for SA include IV drug abuse, diabetes mellitus, having a prosthetic joint, immunosuppression, and human immunodeficiency virus infection. The only reliable way to distinguish between gout and SA requires arthrocentesis with microscopic examination of the synovial fluid for bacteria, crystals, white blood cell (WBC) count, and culture.²

It is critical not to miss SA because it is associated with significant morbidity and a mortality rate of 11%.² To further complicate the diagnosis, some patients can experience SA in the setting of an acute gout attack. In a study of all joint aspirations with crystals (both uric acid and calcium pyrophosphate), there was a 5.2% incidence of concomitant infection.² Similarly, in patients with confirmed SA, crystals were present 21% of the time.²

A gram stain of the synovial fluid is highly specific, but only positive in 59% of cases of SA. Therefore, a negative gram stain does not exclude the diagnosis. Similarly, the presence of crystals does not exclude a coexisting joint infection. If there is high clinical suspicion for SA or an elevated synovial WBC, the patient should be presumed to have SA and treated as such until cultures prove otherwise.

It is unclear if this patient had SA. However, an EP is taking a risk in diagnosing an acute gout attack based solely on a patient’s history and physical examination. The EP should always be mindful that gout and SA can present with the identical signs and symptoms, and can present concomitantly.

Too Much Medication, Too Little Monitoring

A 58-year-old man presented to the ED via emergency medical services (EMS) for evaluation of severe low-back pain. The patient said the pain started abruptly, approximately 1 hour earlier when he was picking up a 50-lb television set. He stated that the pain was so severe that he was unable to move and was forced to lie down on the floor. Although the patient noted that he had a history of a “bad back,” he said he never required surgery and never experienced an episode this severe. The patient denied any radiation of pain or lower extremity numbness or weakness. He denied any chest pain or abdominal pain. His medical history was significant for obstructive sleep apnea and hypertension for which he was taking hydrochlorothiazide. Regarding his social history, he denied any tobacco or alcohol use.

Upon presentation, the patient was found to be in extreme discomfort, rating his pain as an “11” on a scale of 0 to 10. His vital signs were heart rate (HR), 110 beats/minute; blood pressure (BP), 154/91 mm Hg; respiratory rate, 20 breaths/minute; and temperature, 98.6°F. Oxygen (O₂) saturation was 98% on room air.

When the emergency physician (EP) entered the examination room, the patient was in bed, resting on his side and moaning from the pain. The head, eyes, ears, nose, and throat, cardiac, and lung examinations were all normal. The patient’s abdomen was soft and nontender and without guarding, rebound, or palpable mass. When the EP examined the patient’s back, there was no midline tenderness over the thoracic and lumbar spine. The patient did, however, exhibit bilateral paraspinal lumbar muscle tenderness to palpation and muscle spasm. After much prompting, he demonstrated 5/5 motor strength in his lower extremities bilaterally. The dorsalis pedis and posterior tibial pulses were 2+ and symmetrical.

To treat the patient’s severe pain, the EP had a saline lock placed and ordered intravenous (IV) hydromorphone 1 mg, ondansetron 4 mg, and diazepam 5 mg. No laboratory or imaging studies were ordered. Ninety minutes after receiving the analgesics, the patient continued to complain of severe pain without any improvement, and the EP ordered another two rounds of IV hydromorphone 1 mg and diazepam 5 mg. The EP did not return to check up on the patient, but rather relied solely on updates from the patient’s nurse.

Despite the additional doses of hydromorphone and diazepam, the patient continued to complain of severe pain, and the EP ordered IV hydromorphone 2 mg and diazepam 10 mg. Shortly after the patient received this third round of analgesics, his wife arrived at the ED asking to see her husband. When she entered his room, the patient was unresponsive. A code was called and the patient was found to be in asystole. Despite aggressive resuscitative efforts that included intubation, cardiopulmonary resuscitation, and advanced cardiac life support medications, the patient did not recover.

The patient’s wife sued the EP, the ED nurse, and the hospital for failure to appropriately monitor her husband while he received multiple doses of analgesic and sedative agents. The plaintiff argued that the patient’s death was caused by a cardiac arrest occurring secondary to a respiratory arrest, and that the respiratory arrest was secondary to the medications he was given in the ED. The defendants denied the allegations. A $2 million settlement was reached prior to trial.

Discussion

This was clearly a preventable death. Emergency physicians treat pain daily and should be knowledgeable about and experienced in managing acute pain. When evaluating and treating a patient’s pain, the EP must select the appropriate medication. Though we often talk about a tiered approach to pain in the ED, most of us would agree that opioids, usually via IV, are the first choice for managing severe pain.

In addition to prescribing the appropriate analgesics, the EP must identify which patients are at risk of opioid complications. This patient was at risk for opioid-induced respiratory depression based on his age (ie, >55 years old) and history of obstructive sleep apnea. These two risk factors, along with pre-existing chronic obstructive pulmonary disease, anatomic oral or airway abnormalities, and comorbidities (eg, renal or hepatic impairment), place patients at high risk for opioid-associated complications.¹ Patients with any of these conditions must be closely monitored and, based on their response to the prescribed analgesia, the EP may need to decrease the analgesic dosage and increase dosage intervals. In addition to close monitoring, reversal agents such as naloxone should be readily available in case of respiratory depression.

The problem in this case was not the selection of hydromorphone as the initial analgesic agent. Hydromorphone is frequently used safely in the ED to treat severe pain associated with conditions such as sickle cell vaso-occlusive pain crisis, renal colic, and long-bone fracture. Issues arise when hydromorphone is combined with a benzodiazepine (in this case, diazepam), which by itself causes sedation and anxiolysis. Central nervous system (CNS) depression may be additive and occur when benzodiazepines are used concomitantly with drugs that also cause CNS depression (eg, opioids).¹ This combination can lead to excessive sedation, resulting in partial airway obstruction and hypoxia.¹ For example, in an investigation by Bailey et al,² in human volunteers, neither hypoxemia nor apnea was evident after administration of .05 mg/kg of IV midazolam. In patients who received 2 mcg/kg of IV fentanyl alone, hypoxemia occurred in 50%, but apnea did not occur in any of the patients studied. However, when the same doses of these drugs were administered together, 92% of participants exhibited hypoxemia and 50% became apneic.²

When a combination of an opioid and benzodiazepine are given over frequent intervals, the clinician crosses over from treating pain to performing procedural sedation and analgesia—whether he intended to or not. As such, the patient in this case required proper monitoring, including cardiac monitoring and pulse oximetry; he also should have been placed on supplemental O₂. Ideally, the patient would have benefited from end-tidal carbon dioxide (ETCO₂), monitoring, if available. This is a noninvasive measurement of the partial pressure of CO₂ in exhaled breath. Hypoventilation from respiratory depression results in an increase in ETCO₂, and hyperventilation results in a decreased ETCO₂. While pulse oximetry is excellent at monitoring O₂ saturation, it is ineffective in the early detection of respiratory depression, hypoventilation, and apnea. The hypercarbia precedes the hypoxemia—by as much as 60 seconds (range 5-240 seconds), according to a study by Deitch et al.³

Finally, rather than relying solely on the reports from the nurse, the EP should have personally reassessed the patient at some point. Nursing updates are extremely helpful, but when ordering repeated doses of IV opioids and benzodiazepines, the EP should personally reassess the patient.
 

Hot Red Knee

 64-year-old man presented to the ED with a chief complaint of right knee pain, which he stated began approximately 2 days earlier. He denied any injury or trauma or a recent history of fever, chills, or other joint complaints. He described the pain as constant, worse with weight bearing, and becoming progressively more painful. The patient had a history of gout; however, previous attacks had only affected his great toes and elbows. His medical history was also significant for hypertension, for which he was taking lisinopril and hydrochlorothiazide. He admitted to moderate alcohol consumption but denied tobacco use.

On physical examination, the patient appeared uncomfortable due to the knee pain. All of his vital signs were normal. A focused examination of the affected knee revealed a small effusion, diffuse tenderness to palpation, mild erythema, and slight increased warmth. The patient exhibited pain with flexion and extension of the right knee. The right ankle examination and right dorsalis pedis pulse and posterior tibial pulse were all normal. No laboratory or imaging studies were obtained.

Based on the patient’s history and physical examination, the EP believed the patient’s symptoms were due to an episode of gout. He prescribed oral colchicine, allopurinol, and acetaminophen/hydrocodone; he also advised the patient to apply warm compresses to the affected area and limit his activity. He discharged the patient home with instructions to follow up with his primary care physician.

Two days after discharge, the patient returned to the same ED via EMS. On this presentation, he was febrile, with a temperature of 102.6^oF; a HR of 120 beats/minute; and a BP of 92/50 mm Hg. He also had altered mental status. The patient’s right knee appeared more swollen, and he would not flex it due to the severe pain. The EP was concerned for sepsis, and ordered blood cultures, a complete blood count, basic metabolic profile, and lactic acid evaluation. The patient was administered 2 L normal saline IV and broad-spectrum antibiotics. Despite the addition of vasopressors, he continued to deteriorate; he ultimately went into cardiac arrest and died.

The patient’s family sued the EP from the initial ED visit for failure to diagnose the right knee pain and swelling as septic arthritis (SA). The plaintiff’s attorney argued that this failure to diagnosis directly caused the patient’s sepsis and death. The EP argued that the patient’s history and physical examination were consistent with an acute gout attack, that there was no evidence of infection in the right knee, and that this was not the cause of the patient’s death. At trial, the jury returned a verdict in favor of the defense.

Discussion

Gout is caused by the precipitation of uric acid crystals into a joint. Attacks are usually monoarticular as opposed to polyarticular. The presence of hyperuricemia is variable; some patients have high serum uric acid levels and never experience gout, while other patients have normal serum uric acid levels and experience gout attacks. The condition is more common in men than in women. There are multiple risk factors for the development of gout, including obesity, hypertension, chronic kidney disease, regular excessive consumption of alcohol, taking diuretics, and consuming foods high in fructose corn syrup.¹ The joints most often affected are the great toe and knee. Patients with gout typically complain of pain, swelling, redness, and increased warmth in the affected area.

Unfortunately, the clinical presentation of an acute gout attack and SA are indistinguishable.² Risk factors for SA include IV drug abuse, diabetes mellitus, having a prosthetic joint, immunosuppression, and human immunodeficiency virus infection. The only reliable way to distinguish between gout and SA requires arthrocentesis with microscopic examination of the synovial fluid for bacteria, crystals, white blood cell (WBC) count, and culture.²

It is critical not to miss SA because it is associated with significant morbidity and a mortality rate of 11%.² To further complicate the diagnosis, some patients can experience SA in the setting of an acute gout attack. In a study of all joint aspirations with crystals (both uric acid and calcium pyrophosphate), there was a 5.2% incidence of concomitant infection.² Similarly, in patients with confirmed SA, crystals were present 21% of the time.²

A gram stain of the synovial fluid is highly specific, but only positive in 59% of cases of SA. Therefore, a negative gram stain does not exclude the diagnosis. Similarly, the presence of crystals does not exclude a coexisting joint infection. If there is high clinical suspicion for SA or an elevated synovial WBC, the patient should be presumed to have SA and treated as such until cultures prove otherwise.

It is unclear if this patient had SA. However, an EP is taking a risk in diagnosing an acute gout attack based solely on a patient’s history and physical examination. The EP should always be mindful that gout and SA can present with the identical signs and symptoms, and can present concomitantly.

Too Much Medication, Too Little Monitoring

A 58-year-old man presented to the ED via emergency medical services (EMS) for evaluation of severe low-back pain. The patient said the pain started abruptly, approximately 1 hour earlier when he was picking up a 50-lb television set. He stated that the pain was so severe that he was unable to move and was forced to lie down on the floor. Although the patient noted that he had a history of a “bad back,” he said he never required surgery and never experienced an episode this severe. The patient denied any radiation of pain or lower extremity numbness or weakness. He denied any chest pain or abdominal pain. His medical history was significant for obstructive sleep apnea and hypertension for which he was taking hydrochlorothiazide. Regarding his social history, he denied any tobacco or alcohol use.

Upon presentation, the patient was found to be in extreme discomfort, rating his pain as an “11” on a scale of 0 to 10. His vital signs were heart rate (HR), 110 beats/minute; blood pressure (BP), 154/91 mm Hg; respiratory rate, 20 breaths/minute; and temperature, 98.6°F. Oxygen (O₂) saturation was 98% on room air.

When the emergency physician (EP) entered the examination room, the patient was in bed, resting on his side and moaning from the pain. The head, eyes, ears, nose, and throat, cardiac, and lung examinations were all normal. The patient’s abdomen was soft and nontender and without guarding, rebound, or palpable mass. When the EP examined the patient’s back, there was no midline tenderness over the thoracic and lumbar spine. The patient did, however, exhibit bilateral paraspinal lumbar muscle tenderness to palpation and muscle spasm. After much prompting, he demonstrated 5/5 motor strength in his lower extremities bilaterally. The dorsalis pedis and posterior tibial pulses were 2+ and symmetrical.

To treat the patient’s severe pain, the EP had a saline lock placed and ordered intravenous (IV) hydromorphone 1 mg, ondansetron 4 mg, and diazepam 5 mg. No laboratory or imaging studies were ordered. Ninety minutes after receiving the analgesics, the patient continued to complain of severe pain without any improvement, and the EP ordered another two rounds of IV hydromorphone 1 mg and diazepam 5 mg. The EP did not return to check up on the patient, but rather relied solely on updates from the patient’s nurse.

Despite the additional doses of hydromorphone and diazepam, the patient continued to complain of severe pain, and the EP ordered IV hydromorphone 2 mg and diazepam 10 mg. Shortly after the patient received this third round of analgesics, his wife arrived at the ED asking to see her husband. When she entered his room, the patient was unresponsive. A code was called and the patient was found to be in asystole. Despite aggressive resuscitative efforts that included intubation, cardiopulmonary resuscitation, and advanced cardiac life support medications, the patient did not recover.

The patient’s wife sued the EP, the ED nurse, and the hospital for failure to appropriately monitor her husband while he received multiple doses of analgesic and sedative agents. The plaintiff argued that the patient’s death was caused by a cardiac arrest occurring secondary to a respiratory arrest, and that the respiratory arrest was secondary to the medications he was given in the ED. The defendants denied the allegations. A $2 million settlement was reached prior to trial.

Discussion

This was clearly a preventable death. Emergency physicians treat pain daily and should be knowledgeable about and experienced in managing acute pain. When evaluating and treating a patient’s pain, the EP must select the appropriate medication. Though we often talk about a tiered approach to pain in the ED, most of us would agree that opioids, usually via IV, are the first choice for managing severe pain.

In addition to prescribing the appropriate analgesics, the EP must identify which patients are at risk of opioid complications. This patient was at risk for opioid-induced respiratory depression based on his age (ie, >55 years old) and history of obstructive sleep apnea. These two risk factors, along with pre-existing chronic obstructive pulmonary disease, anatomic oral or airway abnormalities, and comorbidities (eg, renal or hepatic impairment), place patients at high risk for opioid-associated complications.¹ Patients with any of these conditions must be closely monitored and, based on their response to the prescribed analgesia, the EP may need to decrease the analgesic dosage and increase dosage intervals. In addition to close monitoring, reversal agents such as naloxone should be readily available in case of respiratory depression.

The problem in this case was not the selection of hydromorphone as the initial analgesic agent. Hydromorphone is frequently used safely in the ED to treat severe pain associated with conditions such as sickle cell vaso-occlusive pain crisis, renal colic, and long-bone fracture. Issues arise when hydromorphone is combined with a benzodiazepine (in this case, diazepam), which by itself causes sedation and anxiolysis. Central nervous system (CNS) depression may be additive and occur when benzodiazepines are used concomitantly with drugs that also cause CNS depression (eg, opioids).¹ This combination can lead to excessive sedation, resulting in partial airway obstruction and hypoxia.¹ For example, in an investigation by Bailey et al,² in human volunteers, neither hypoxemia nor apnea was evident after administration of .05 mg/kg of IV midazolam. In patients who received 2 mcg/kg of IV fentanyl alone, hypoxemia occurred in 50%, but apnea did not occur in any of the patients studied. However, when the same doses of these drugs were administered together, 92% of participants exhibited hypoxemia and 50% became apneic.²

When a combination of an opioid and benzodiazepine are given over frequent intervals, the clinician crosses over from treating pain to performing procedural sedation and analgesia—whether he intended to or not. As such, the patient in this case required proper monitoring, including cardiac monitoring and pulse oximetry; he also should have been placed on supplemental O₂. Ideally, the patient would have benefited from end-tidal carbon dioxide (ETCO₂), monitoring, if available. This is a noninvasive measurement of the partial pressure of CO₂ in exhaled breath. Hypoventilation from respiratory depression results in an increase in ETCO₂, and hyperventilation results in a decreased ETCO₂. While pulse oximetry is excellent at monitoring O₂ saturation, it is ineffective in the early detection of respiratory depression, hypoventilation, and apnea. The hypercarbia precedes the hypoxemia—by as much as 60 seconds (range 5-240 seconds), according to a study by Deitch et al.³

Finally, rather than relying solely on the reports from the nurse, the EP should have personally reassessed the patient at some point. Nursing updates are extremely helpful, but when ordering repeated doses of IV opioids and benzodiazepines, the EP should personally reassess the patient.
 

Hot Red Knee

 64-year-old man presented to the ED with a chief complaint of right knee pain, which he stated began approximately 2 days earlier. He denied any injury or trauma or a recent history of fever, chills, or other joint complaints. He described the pain as constant, worse with weight bearing, and becoming progressively more painful. The patient had a history of gout; however, previous attacks had only affected his great toes and elbows. His medical history was also significant for hypertension, for which he was taking lisinopril and hydrochlorothiazide. He admitted to moderate alcohol consumption but denied tobacco use.

On physical examination, the patient appeared uncomfortable due to the knee pain. All of his vital signs were normal. A focused examination of the affected knee revealed a small effusion, diffuse tenderness to palpation, mild erythema, and slight increased warmth. The patient exhibited pain with flexion and extension of the right knee. The right ankle examination and right dorsalis pedis pulse and posterior tibial pulse were all normal. No laboratory or imaging studies were obtained.

Based on the patient’s history and physical examination, the EP believed the patient’s symptoms were due to an episode of gout. He prescribed oral colchicine, allopurinol, and acetaminophen/hydrocodone; he also advised the patient to apply warm compresses to the affected area and limit his activity. He discharged the patient home with instructions to follow up with his primary care physician.

Two days after discharge, the patient returned to the same ED via EMS. On this presentation, he was febrile, with a temperature of 102.6^oF; a HR of 120 beats/minute; and a BP of 92/50 mm Hg. He also had altered mental status. The patient’s right knee appeared more swollen, and he would not flex it due to the severe pain. The EP was concerned for sepsis, and ordered blood cultures, a complete blood count, basic metabolic profile, and lactic acid evaluation. The patient was administered 2 L normal saline IV and broad-spectrum antibiotics. Despite the addition of vasopressors, he continued to deteriorate; he ultimately went into cardiac arrest and died.

The patient’s family sued the EP from the initial ED visit for failure to diagnose the right knee pain and swelling as septic arthritis (SA). The plaintiff’s attorney argued that this failure to diagnosis directly caused the patient’s sepsis and death. The EP argued that the patient’s history and physical examination were consistent with an acute gout attack, that there was no evidence of infection in the right knee, and that this was not the cause of the patient’s death. At trial, the jury returned a verdict in favor of the defense.

Discussion

Gout is caused by the precipitation of uric acid crystals into a joint. Attacks are usually monoarticular as opposed to polyarticular. The presence of hyperuricemia is variable; some patients have high serum uric acid levels and never experience gout, while other patients have normal serum uric acid levels and experience gout attacks. The condition is more common in men than in women. There are multiple risk factors for the development of gout, including obesity, hypertension, chronic kidney disease, regular excessive consumption of alcohol, taking diuretics, and consuming foods high in fructose corn syrup.¹ The joints most often affected are the great toe and knee. Patients with gout typically complain of pain, swelling, redness, and increased warmth in the affected area.

Unfortunately, the clinical presentation of an acute gout attack and SA are indistinguishable.² Risk factors for SA include IV drug abuse, diabetes mellitus, having a prosthetic joint, immunosuppression, and human immunodeficiency virus infection. The only reliable way to distinguish between gout and SA requires arthrocentesis with microscopic examination of the synovial fluid for bacteria, crystals, white blood cell (WBC) count, and culture.²

It is critical not to miss SA because it is associated with significant morbidity and a mortality rate of 11%.² To further complicate the diagnosis, some patients can experience SA in the setting of an acute gout attack. In a study of all joint aspirations with crystals (both uric acid and calcium pyrophosphate), there was a 5.2% incidence of concomitant infection.² Similarly, in patients with confirmed SA, crystals were present 21% of the time.²

A gram stain of the synovial fluid is highly specific, but only positive in 59% of cases of SA. Therefore, a negative gram stain does not exclude the diagnosis. Similarly, the presence of crystals does not exclude a coexisting joint infection. If there is high clinical suspicion for SA or an elevated synovial WBC, the patient should be presumed to have SA and treated as such until cultures prove otherwise.

It is unclear if this patient had SA. However, an EP is taking a risk in diagnosing an acute gout attack based solely on a patient’s history and physical examination. The EP should always be mindful that gout and SA can present with the identical signs and symptoms, and can present concomitantly.