David M. Lang, JD, PA-C

A 54-year-old woman with chronic renal disease was diagnosed with gout and prescribed allopurinol. Two days later, she was evaluated by her nephrologist, whom she informed about her new medication.

Subsequently, the patient developed fever and rash. Laboratory analysis indicated elevated transaminase levels and eosinophilia. She was admitted to the hospital.

During her stay, an infectious disease consultation was obtained, and the allopurinol was discontinued. When the patient’s condition improved, she was discharged.

Following discharge, the patient resumed taking allopurinol, and her rash returned. Eleven days later, she returned to the hospital, where she was diagnosed with toxic epidermal necrolysis. She was found to have a desquamating rash covering 62% of her body. The patient was transferred to a burn center but eventually succumbed to multi-organ failure.

The patient’s estate filed a medical malpractice lawsuit against the nephrologist alleging negligence—specifically, failure to diagnose toxic epidermal necrolysis and failure to review her medications more carefully.

Continue for the outcome >>

OUTCOME
A $5.1 million verdict was returned against the nephrologist.

COMMENT
Many medications cause rash and are subsequently withdrawn; in a few cases, the effects are life threatening. Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) are relatively uncommon but potentially fatal examples.

From the limited facts presented, we know that a 54-year-old woman with established renal disease of unknown magnitude was prescribed allopurinol for gout and consulted the nephrologist two days later. It is unclear if the patient had the rash during the first visit with her nephrologist. But we do know that she was eventually admitted and maintained on allopurinol while she had the rash, pending infectious disease consultation. At some point, the allopurinol was apparently stopped and the rash improved. After discharge, the patient resumed taking allopurinol. The rash not only returned but also worsened, necessitating her readmission to a burn center.

TEN, like SJS, is often induced by certain medications, including sulfonamides, macrolides, penicillins, and quinolones. Allopur­inol, phenobarbital, phenytoin, carbamazepine, valproic acid, and lamotrigine are frequently implicated as well.

TEN is rare but serious. The initial presentation may be subtle, with influenza-like symptoms such as malaise, fever, cough, rhinitis, headache, and arthralgia—and the most discriminating sign: rash.

The rash begins as a poorly defined, erythematous macular rash with purpuric centers. The lesions predominate on the torso and face, sparing the scalp. Mucosal membranes are involved in more than 90% of cases.¹ Pain at the site of the skin lesions is often the predominate symptom and is often out of proportion to physical findings. Over a period of hours to days, the rash coalesces to form flaccid blisters and sheetlike epidermal detachment.² In established cases, patients will nearly universally demonstrate Nikolsky’s sign: Mild frictional contact with the skin results in epithelial desquamation and immediate blistering.

Management involves immediate withdrawal of the offending agent and hospitalization for aggressive management. The mortality rate is high (30% to 60%³) and generally attributed to sepsis or multi-organ failure.

As clinicians, we are sometimes hesitant to label a rash allergic—thereby forever disqualifying an entire class of useful agents from that patient. However, in this case, the fact that the rash occurred simultaneously with a constellation of signs and symptoms perhaps made the rash appear to be part of an infectious process and not a drug-induced reaction. That is the challenge with TEN and SJS: The symptoms are subtle, flu-like, and confounding.

Here, the nephrologist apparently did not take action to stop the allopurinol after the patient first developed the rash. The jury was persuaded that a reasonably prudent clinician would have recognized the clinical presentation and stopped the allopurinol—and certainly not restarted it following discharge (especially after the allopurinol was stopped in the hospital and the rash began to improve).

This case brings to mind two physicians from my training who made an impression. The first was a second-year internal medicine resident. I remember quietly remarking to another student during rounds, “He is really good.” Overhearing, an attending physician answered, “He is really good because in his workup he always considers a presentation as a function of an underlying process, and walks through each of those processes in formulating his differential.”

“Walking through” various disease categories forces the clinician to consider them all: infectious, autoimmune, neoplastic, environmental/toxic, vascular, traumatic, metabolic, inflammatory. In challenging cases, I’ve found it helpful to step backward into those broad basic categories of disease and reconsider the clinical picture.

Here, doing so may have allowed the clinician to reconsider inflammatory and autoimmune processes and revisit the possibility of iatrogenic toxic/environmental causes (ie, the allopurinol). Perhaps the outcome of this case would have been different.

The second physician was a nephrology fellow, who left me with this piece of wisdom: “When in doubt, blame the drug.” Since nephrologists are expert drug-blamers, I suspect the early stages of this unfortunate case presented a clinical challenge.

IN SUM 
Before you “missile lock” onto a diagnosis, take a mental step back to consider broad categories of disease. —DML

REFERENCES
1. Letko E, Papaliodis DN, Papaliodis GN, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: a review of the literature. Ann Allergy Asthma Immunol. 2005;94(4):419-436.
2. Cohen V, Jellinek SP, Schwartz RA, et al. Toxic epidermal necrolysis.  Medscape; 2013. emedicine.medscape.com/article/229698-overview. Accessed September 16, 2015.
3. Schulz JT, Sheridan RL, Ryan CM, et al. A 10-year experience with toxic epidermal necrolysis. J Burn Care Rehabil. 2000;21(3): 199-204.

A 54-year-old woman with chronic renal disease was diagnosed with gout and prescribed allopurinol. Two days later, she was evaluated by her nephrologist, whom she informed about her new medication.

Subsequently, the patient developed fever and rash. Laboratory analysis indicated elevated transaminase levels and eosinophilia. She was admitted to the hospital.

During her stay, an infectious disease consultation was obtained, and the allopurinol was discontinued. When the patient’s condition improved, she was discharged.

Following discharge, the patient resumed taking allopurinol, and her rash returned. Eleven days later, she returned to the hospital, where she was diagnosed with toxic epidermal necrolysis. She was found to have a desquamating rash covering 62% of her body. The patient was transferred to a burn center but eventually succumbed to multi-organ failure.

The patient’s estate filed a medical malpractice lawsuit against the nephrologist alleging negligence—specifically, failure to diagnose toxic epidermal necrolysis and failure to review her medications more carefully.

Continue for the outcome >>

OUTCOME
A $5.1 million verdict was returned against the nephrologist.

COMMENT
Many medications cause rash and are subsequently withdrawn; in a few cases, the effects are life threatening. Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) are relatively uncommon but potentially fatal examples.

From the limited facts presented, we know that a 54-year-old woman with established renal disease of unknown magnitude was prescribed allopurinol for gout and consulted the nephrologist two days later. It is unclear if the patient had the rash during the first visit with her nephrologist. But we do know that she was eventually admitted and maintained on allopurinol while she had the rash, pending infectious disease consultation. At some point, the allopurinol was apparently stopped and the rash improved. After discharge, the patient resumed taking allopurinol. The rash not only returned but also worsened, necessitating her readmission to a burn center.

TEN, like SJS, is often induced by certain medications, including sulfonamides, macrolides, penicillins, and quinolones. Allopur­inol, phenobarbital, phenytoin, carbamazepine, valproic acid, and lamotrigine are frequently implicated as well.

TEN is rare but serious. The initial presentation may be subtle, with influenza-like symptoms such as malaise, fever, cough, rhinitis, headache, and arthralgia—and the most discriminating sign: rash.

The rash begins as a poorly defined, erythematous macular rash with purpuric centers. The lesions predominate on the torso and face, sparing the scalp. Mucosal membranes are involved in more than 90% of cases.¹ Pain at the site of the skin lesions is often the predominate symptom and is often out of proportion to physical findings. Over a period of hours to days, the rash coalesces to form flaccid blisters and sheetlike epidermal detachment.² In established cases, patients will nearly universally demonstrate Nikolsky’s sign: Mild frictional contact with the skin results in epithelial desquamation and immediate blistering.

Management involves immediate withdrawal of the offending agent and hospitalization for aggressive management. The mortality rate is high (30% to 60%³) and generally attributed to sepsis or multi-organ failure.

As clinicians, we are sometimes hesitant to label a rash allergic—thereby forever disqualifying an entire class of useful agents from that patient. However, in this case, the fact that the rash occurred simultaneously with a constellation of signs and symptoms perhaps made the rash appear to be part of an infectious process and not a drug-induced reaction. That is the challenge with TEN and SJS: The symptoms are subtle, flu-like, and confounding.

Here, the nephrologist apparently did not take action to stop the allopurinol after the patient first developed the rash. The jury was persuaded that a reasonably prudent clinician would have recognized the clinical presentation and stopped the allopurinol—and certainly not restarted it following discharge (especially after the allopurinol was stopped in the hospital and the rash began to improve).

This case brings to mind two physicians from my training who made an impression. The first was a second-year internal medicine resident. I remember quietly remarking to another student during rounds, “He is really good.” Overhearing, an attending physician answered, “He is really good because in his workup he always considers a presentation as a function of an underlying process, and walks through each of those processes in formulating his differential.”

“Walking through” various disease categories forces the clinician to consider them all: infectious, autoimmune, neoplastic, environmental/toxic, vascular, traumatic, metabolic, inflammatory. In challenging cases, I’ve found it helpful to step backward into those broad basic categories of disease and reconsider the clinical picture.

Here, doing so may have allowed the clinician to reconsider inflammatory and autoimmune processes and revisit the possibility of iatrogenic toxic/environmental causes (ie, the allopurinol). Perhaps the outcome of this case would have been different.

The second physician was a nephrology fellow, who left me with this piece of wisdom: “When in doubt, blame the drug.” Since nephrologists are expert drug-blamers, I suspect the early stages of this unfortunate case presented a clinical challenge.

IN SUM 
Before you “missile lock” onto a diagnosis, take a mental step back to consider broad categories of disease. —DML

REFERENCES
1. Letko E, Papaliodis DN, Papaliodis GN, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: a review of the literature. Ann Allergy Asthma Immunol. 2005;94(4):419-436.
2. Cohen V, Jellinek SP, Schwartz RA, et al. Toxic epidermal necrolysis.  Medscape; 2013. emedicine.medscape.com/article/229698-overview. Accessed September 16, 2015.
3. Schulz JT, Sheridan RL, Ryan CM, et al. A 10-year experience with toxic epidermal necrolysis. J Burn Care Rehabil. 2000;21(3): 199-204.

A 54-year-old woman with chronic renal disease was diagnosed with gout and prescribed allopurinol. Two days later, she was evaluated by her nephrologist, whom she informed about her new medication.

Subsequently, the patient developed fever and rash. Laboratory analysis indicated elevated transaminase levels and eosinophilia. She was admitted to the hospital.

During her stay, an infectious disease consultation was obtained, and the allopurinol was discontinued. When the patient’s condition improved, she was discharged.

Following discharge, the patient resumed taking allopurinol, and her rash returned. Eleven days later, she returned to the hospital, where she was diagnosed with toxic epidermal necrolysis. She was found to have a desquamating rash covering 62% of her body. The patient was transferred to a burn center but eventually succumbed to multi-organ failure.

The patient’s estate filed a medical malpractice lawsuit against the nephrologist alleging negligence—specifically, failure to diagnose toxic epidermal necrolysis and failure to review her medications more carefully.

Continue for the outcome >>

OUTCOME
A $5.1 million verdict was returned against the nephrologist.

COMMENT
Many medications cause rash and are subsequently withdrawn; in a few cases, the effects are life threatening. Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) are relatively uncommon but potentially fatal examples.

From the limited facts presented, we know that a 54-year-old woman with established renal disease of unknown magnitude was prescribed allopurinol for gout and consulted the nephrologist two days later. It is unclear if the patient had the rash during the first visit with her nephrologist. But we do know that she was eventually admitted and maintained on allopurinol while she had the rash, pending infectious disease consultation. At some point, the allopurinol was apparently stopped and the rash improved. After discharge, the patient resumed taking allopurinol. The rash not only returned but also worsened, necessitating her readmission to a burn center.

TEN, like SJS, is often induced by certain medications, including sulfonamides, macrolides, penicillins, and quinolones. Allopur­inol, phenobarbital, phenytoin, carbamazepine, valproic acid, and lamotrigine are frequently implicated as well.

TEN is rare but serious. The initial presentation may be subtle, with influenza-like symptoms such as malaise, fever, cough, rhinitis, headache, and arthralgia—and the most discriminating sign: rash.

The rash begins as a poorly defined, erythematous macular rash with purpuric centers. The lesions predominate on the torso and face, sparing the scalp. Mucosal membranes are involved in more than 90% of cases.¹ Pain at the site of the skin lesions is often the predominate symptom and is often out of proportion to physical findings. Over a period of hours to days, the rash coalesces to form flaccid blisters and sheetlike epidermal detachment.² In established cases, patients will nearly universally demonstrate Nikolsky’s sign: Mild frictional contact with the skin results in epithelial desquamation and immediate blistering.

Management involves immediate withdrawal of the offending agent and hospitalization for aggressive management. The mortality rate is high (30% to 60%³) and generally attributed to sepsis or multi-organ failure.

As clinicians, we are sometimes hesitant to label a rash allergic—thereby forever disqualifying an entire class of useful agents from that patient. However, in this case, the fact that the rash occurred simultaneously with a constellation of signs and symptoms perhaps made the rash appear to be part of an infectious process and not a drug-induced reaction. That is the challenge with TEN and SJS: The symptoms are subtle, flu-like, and confounding.

Here, the nephrologist apparently did not take action to stop the allopurinol after the patient first developed the rash. The jury was persuaded that a reasonably prudent clinician would have recognized the clinical presentation and stopped the allopurinol—and certainly not restarted it following discharge (especially after the allopurinol was stopped in the hospital and the rash began to improve).

This case brings to mind two physicians from my training who made an impression. The first was a second-year internal medicine resident. I remember quietly remarking to another student during rounds, “He is really good.” Overhearing, an attending physician answered, “He is really good because in his workup he always considers a presentation as a function of an underlying process, and walks through each of those processes in formulating his differential.”

“Walking through” various disease categories forces the clinician to consider them all: infectious, autoimmune, neoplastic, environmental/toxic, vascular, traumatic, metabolic, inflammatory. In challenging cases, I’ve found it helpful to step backward into those broad basic categories of disease and reconsider the clinical picture.

Here, doing so may have allowed the clinician to reconsider inflammatory and autoimmune processes and revisit the possibility of iatrogenic toxic/environmental causes (ie, the allopurinol). Perhaps the outcome of this case would have been different.

The second physician was a nephrology fellow, who left me with this piece of wisdom: “When in doubt, blame the drug.” Since nephrologists are expert drug-blamers, I suspect the early stages of this unfortunate case presented a clinical challenge.

IN SUM 
Before you “missile lock” onto a diagnosis, take a mental step back to consider broad categories of disease. —DML

REFERENCES
1. Letko E, Papaliodis DN, Papaliodis GN, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: a review of the literature. Ann Allergy Asthma Immunol. 2005;94(4):419-436.
2. Cohen V, Jellinek SP, Schwartz RA, et al. Toxic epidermal necrolysis.  Medscape; 2013. emedicine.medscape.com/article/229698-overview. Accessed September 16, 2015.
3. Schulz JT, Sheridan RL, Ryan CM, et al. A 10-year experience with toxic epidermal necrolysis. J Burn Care Rehabil. 2000;21(3): 199-204.

A 3-month-old boy was diagnosed with severe respiratory syncytial virus infection at a North Carolina hospital in 2009. The infant was intubated, and a transfer to another hospital that had a pediatric ICU was ordered. The second hospital’s emergency transport service facilitated the transfer.

The ambulance was staffed by an EMT-paramedic and a transport registered nurse, both certified in Pediatric Advanced Life Support (PALS). During transport, the infant was intubated and medically paralyzed with vecuronium. About 10 minutes prior to arrival, the infant’s condition worsened, and he experienced cardiac arrest. Chest compressions and heart medications were provided.

Upon arrival at the second hospital, the infant was resuscitated. An emergency department physician, Dr S., ordered reintubation, and the infant again experienced cardiac arrest. For the next 10 minutes, Dr S. ordered chest compressions and heart medication; he eventually reintubated the infant, at which point cardiac arrest ceased with a spontaneous heartbeat.

After transfer to the pediatric ICU, the infant was diagnosed with permanent hypoxic ischemic brain injury caused by the cardiac episodes and low oxygen intake. At the time of trial, the child could not walk, talk, or hear very well and was fed via feeding tube. His vision and cognitive function were also impaired.

The plaintiff claimed that the intubation tube should have been adjusted or removed and re-inserted in the ambulance, but that did not happen. At trial, they called as an adverse witness the EMT-paramedic who had been in the ambulance with the plaintiff.

Continue for the outcome >>

OUTCOME  
During the plaintiff’s presentation of evidence, the hospital agreed to a settlement of $13 million. The trial against Dr S. continued but ended in a mistrial. The plaintiffs were expected to re-try the claims against him.

COMMENT  
This is a bad-airway case. Many medical malpractice cases are bad-airways cases: They are easy to bring and easy for jurors to understand, since hypoxic/anoxic injury is evident and plainly correlated with the airway missteps. These cases are also easy to prove, since the plaintiff can always hire an expert to testify that a reasonably prudent clinician would have been able to properly secure and monitor the airway—and the patient “would be standing here today,” unscathed.

Of course, securing an airway is not a “given” and can be challenging. Factor in variables such as anatomy, age, body habitus, intoxication, combativeness, medical comorbidities, and a full stomach, and the risk swells. If your employment requires that you manage airways, you are practicing in a high-legal-risk environment.

Make sure your skills are up to par. Practice often. Have a plan, a backup plan, and rescue backup plan. Have working suction ready. Check your equipment regularly. Run practice codes—particularly if your practice does not manage cardiorespiratory emergencies often. Does your staff know how to open the crash cart? Are the meds expired? Is the oxygen cylinder empty? Are roles clearly defined? As clinicians, we sit through our share of useless meetings (discussing things like who left what in the break room fridge). We should find time to drill on cardiorespiratory emergencies, because there is no time to “reacquaint oneself” on the fly.

In the case report, we are told that the patient was monitored by O₂ saturation (SaO₂) and end tidal CO₂ (ETCO₂). The plaintiff alleges that the transport team (EMT-paramedic and RN) failed to address tube placement and rather focused their efforts on chest compressions and medications. As we know, most cases of pediatric cardiac arrest are not primarily cardiac but instead follow primary progressive respiratory failure. Despite the emphasis on “airway, breathing, circulation” covered by PALS, the airway appears to have been missed and tube placement unquestioned after the child began to decompensate. Tube placement wasn’t reconsidered until 10 minutes after arrival at the second hospital, when the patient was reintubated and ventilatory status improved.

Airway cases—this one included—are “high damages” cases. A high damages case is one in which the injury is clear and expenses and costs to care for the patient are clear and immense. Such cases can be difficult to defend, because the enormity of the plaintiff’s plight (the limitations, years of required rehabilitation, hospitalization, PT, OT, nutritional care, etc) can overwhelm the jury, who may infer negligence based on the plaintiff’s condition. While jurors are required to consider damages only after negligence has been proven, lay jurors are human and many find it difficult to parse liability from damages. This is particularly true in airway cases involving a young, now-debilitated patient and an expert witness claiming an error that was preventable.

In this case, the plaintiff’s attorney made an unusual move, by calling as a “hostile witness” the paramedic who treated the 3-month-old boy. The paramedic would generally be called by the defense and later cross-examined by the plaintiff. Instead, the plaintiff chose to examine him first. Under evidence rules in most states (including North Carolina,¹ where this case was heard), an adverse (or hostile) witness can be called by the opposing party.

Why is this important? Because during direct examination, you cannot lead the witness; during cross-examination, you can. Leading questions (if done correctly) generally produce the most effective and damaging moments during a trial. In this case, the plaintiffs were able to immediately examine one of the defendant’s principal actors using leading questions. Shortly thereafter, when the plaintiff was directly examining his own paramedic expert witnesses, the defense relented and settled for $13 million, with further recovery against the emergency physician still available.

Interestingly, the attorney suing the medical personnel in this case was none other than John Edwards. Yes, that John Edwards—the former vice presidential candidate famous for his $500 haircuts, campaign finance tribulations, and ethical lapses. He originally became famous (and rich) suing clinicians. After his political fall from grace, he is back in business suing clinicians—and for him, business is good.

IN SUM
This case was unfortunate. Always use care in securing the airway, particularly during patient movement. Once it is established, monitor the airway using SaO₂, ETCO₂, and keen observation. Airways are not in the “set it and forget it” camp. An airway must be maintained, safeguarded, and protected. Be prepared to act quickly should the airway become dislodged, migrate, or otherwise fail. —DML

REFERENCE
1. North Carolina Rules of Evidence Rule 611 (1983, c. 701, s. 1.).

A 3-month-old boy was diagnosed with severe respiratory syncytial virus infection at a North Carolina hospital in 2009. The infant was intubated, and a transfer to another hospital that had a pediatric ICU was ordered. The second hospital’s emergency transport service facilitated the transfer.

The ambulance was staffed by an EMT-paramedic and a transport registered nurse, both certified in Pediatric Advanced Life Support (PALS). During transport, the infant was intubated and medically paralyzed with vecuronium. About 10 minutes prior to arrival, the infant’s condition worsened, and he experienced cardiac arrest. Chest compressions and heart medications were provided.

Upon arrival at the second hospital, the infant was resuscitated. An emergency department physician, Dr S., ordered reintubation, and the infant again experienced cardiac arrest. For the next 10 minutes, Dr S. ordered chest compressions and heart medication; he eventually reintubated the infant, at which point cardiac arrest ceased with a spontaneous heartbeat.

After transfer to the pediatric ICU, the infant was diagnosed with permanent hypoxic ischemic brain injury caused by the cardiac episodes and low oxygen intake. At the time of trial, the child could not walk, talk, or hear very well and was fed via feeding tube. His vision and cognitive function were also impaired.

The plaintiff claimed that the intubation tube should have been adjusted or removed and re-inserted in the ambulance, but that did not happen. At trial, they called as an adverse witness the EMT-paramedic who had been in the ambulance with the plaintiff.

Continue for the outcome >>

OUTCOME  
During the plaintiff’s presentation of evidence, the hospital agreed to a settlement of $13 million. The trial against Dr S. continued but ended in a mistrial. The plaintiffs were expected to re-try the claims against him.

COMMENT  
This is a bad-airway case. Many medical malpractice cases are bad-airways cases: They are easy to bring and easy for jurors to understand, since hypoxic/anoxic injury is evident and plainly correlated with the airway missteps. These cases are also easy to prove, since the plaintiff can always hire an expert to testify that a reasonably prudent clinician would have been able to properly secure and monitor the airway—and the patient “would be standing here today,” unscathed.

Of course, securing an airway is not a “given” and can be challenging. Factor in variables such as anatomy, age, body habitus, intoxication, combativeness, medical comorbidities, and a full stomach, and the risk swells. If your employment requires that you manage airways, you are practicing in a high-legal-risk environment.

Make sure your skills are up to par. Practice often. Have a plan, a backup plan, and rescue backup plan. Have working suction ready. Check your equipment regularly. Run practice codes—particularly if your practice does not manage cardiorespiratory emergencies often. Does your staff know how to open the crash cart? Are the meds expired? Is the oxygen cylinder empty? Are roles clearly defined? As clinicians, we sit through our share of useless meetings (discussing things like who left what in the break room fridge). We should find time to drill on cardiorespiratory emergencies, because there is no time to “reacquaint oneself” on the fly.

In the case report, we are told that the patient was monitored by O₂ saturation (SaO₂) and end tidal CO₂ (ETCO₂). The plaintiff alleges that the transport team (EMT-paramedic and RN) failed to address tube placement and rather focused their efforts on chest compressions and medications. As we know, most cases of pediatric cardiac arrest are not primarily cardiac but instead follow primary progressive respiratory failure. Despite the emphasis on “airway, breathing, circulation” covered by PALS, the airway appears to have been missed and tube placement unquestioned after the child began to decompensate. Tube placement wasn’t reconsidered until 10 minutes after arrival at the second hospital, when the patient was reintubated and ventilatory status improved.

Airway cases—this one included—are “high damages” cases. A high damages case is one in which the injury is clear and expenses and costs to care for the patient are clear and immense. Such cases can be difficult to defend, because the enormity of the plaintiff’s plight (the limitations, years of required rehabilitation, hospitalization, PT, OT, nutritional care, etc) can overwhelm the jury, who may infer negligence based on the plaintiff’s condition. While jurors are required to consider damages only after negligence has been proven, lay jurors are human and many find it difficult to parse liability from damages. This is particularly true in airway cases involving a young, now-debilitated patient and an expert witness claiming an error that was preventable.

In this case, the plaintiff’s attorney made an unusual move, by calling as a “hostile witness” the paramedic who treated the 3-month-old boy. The paramedic would generally be called by the defense and later cross-examined by the plaintiff. Instead, the plaintiff chose to examine him first. Under evidence rules in most states (including North Carolina,¹ where this case was heard), an adverse (or hostile) witness can be called by the opposing party.

Why is this important? Because during direct examination, you cannot lead the witness; during cross-examination, you can. Leading questions (if done correctly) generally produce the most effective and damaging moments during a trial. In this case, the plaintiffs were able to immediately examine one of the defendant’s principal actors using leading questions. Shortly thereafter, when the plaintiff was directly examining his own paramedic expert witnesses, the defense relented and settled for $13 million, with further recovery against the emergency physician still available.

Interestingly, the attorney suing the medical personnel in this case was none other than John Edwards. Yes, that John Edwards—the former vice presidential candidate famous for his $500 haircuts, campaign finance tribulations, and ethical lapses. He originally became famous (and rich) suing clinicians. After his political fall from grace, he is back in business suing clinicians—and for him, business is good.

IN SUM
This case was unfortunate. Always use care in securing the airway, particularly during patient movement. Once it is established, monitor the airway using SaO₂, ETCO₂, and keen observation. Airways are not in the “set it and forget it” camp. An airway must be maintained, safeguarded, and protected. Be prepared to act quickly should the airway become dislodged, migrate, or otherwise fail. —DML

REFERENCE
1. North Carolina Rules of Evidence Rule 611 (1983, c. 701, s. 1.).

A 3-month-old boy was diagnosed with severe respiratory syncytial virus infection at a North Carolina hospital in 2009. The infant was intubated, and a transfer to another hospital that had a pediatric ICU was ordered. The second hospital’s emergency transport service facilitated the transfer.

The ambulance was staffed by an EMT-paramedic and a transport registered nurse, both certified in Pediatric Advanced Life Support (PALS). During transport, the infant was intubated and medically paralyzed with vecuronium. About 10 minutes prior to arrival, the infant’s condition worsened, and he experienced cardiac arrest. Chest compressions and heart medications were provided.

Upon arrival at the second hospital, the infant was resuscitated. An emergency department physician, Dr S., ordered reintubation, and the infant again experienced cardiac arrest. For the next 10 minutes, Dr S. ordered chest compressions and heart medication; he eventually reintubated the infant, at which point cardiac arrest ceased with a spontaneous heartbeat.

After transfer to the pediatric ICU, the infant was diagnosed with permanent hypoxic ischemic brain injury caused by the cardiac episodes and low oxygen intake. At the time of trial, the child could not walk, talk, or hear very well and was fed via feeding tube. His vision and cognitive function were also impaired.

The plaintiff claimed that the intubation tube should have been adjusted or removed and re-inserted in the ambulance, but that did not happen. At trial, they called as an adverse witness the EMT-paramedic who had been in the ambulance with the plaintiff.

Continue for the outcome >>

OUTCOME  
During the plaintiff’s presentation of evidence, the hospital agreed to a settlement of $13 million. The trial against Dr S. continued but ended in a mistrial. The plaintiffs were expected to re-try the claims against him.

COMMENT  
This is a bad-airway case. Many medical malpractice cases are bad-airways cases: They are easy to bring and easy for jurors to understand, since hypoxic/anoxic injury is evident and plainly correlated with the airway missteps. These cases are also easy to prove, since the plaintiff can always hire an expert to testify that a reasonably prudent clinician would have been able to properly secure and monitor the airway—and the patient “would be standing here today,” unscathed.

Of course, securing an airway is not a “given” and can be challenging. Factor in variables such as anatomy, age, body habitus, intoxication, combativeness, medical comorbidities, and a full stomach, and the risk swells. If your employment requires that you manage airways, you are practicing in a high-legal-risk environment.

Make sure your skills are up to par. Practice often. Have a plan, a backup plan, and rescue backup plan. Have working suction ready. Check your equipment regularly. Run practice codes—particularly if your practice does not manage cardiorespiratory emergencies often. Does your staff know how to open the crash cart? Are the meds expired? Is the oxygen cylinder empty? Are roles clearly defined? As clinicians, we sit through our share of useless meetings (discussing things like who left what in the break room fridge). We should find time to drill on cardiorespiratory emergencies, because there is no time to “reacquaint oneself” on the fly.

In the case report, we are told that the patient was monitored by O₂ saturation (SaO₂) and end tidal CO₂ (ETCO₂). The plaintiff alleges that the transport team (EMT-paramedic and RN) failed to address tube placement and rather focused their efforts on chest compressions and medications. As we know, most cases of pediatric cardiac arrest are not primarily cardiac but instead follow primary progressive respiratory failure. Despite the emphasis on “airway, breathing, circulation” covered by PALS, the airway appears to have been missed and tube placement unquestioned after the child began to decompensate. Tube placement wasn’t reconsidered until 10 minutes after arrival at the second hospital, when the patient was reintubated and ventilatory status improved.

Airway cases—this one included—are “high damages” cases. A high damages case is one in which the injury is clear and expenses and costs to care for the patient are clear and immense. Such cases can be difficult to defend, because the enormity of the plaintiff’s plight (the limitations, years of required rehabilitation, hospitalization, PT, OT, nutritional care, etc) can overwhelm the jury, who may infer negligence based on the plaintiff’s condition. While jurors are required to consider damages only after negligence has been proven, lay jurors are human and many find it difficult to parse liability from damages. This is particularly true in airway cases involving a young, now-debilitated patient and an expert witness claiming an error that was preventable.

In this case, the plaintiff’s attorney made an unusual move, by calling as a “hostile witness” the paramedic who treated the 3-month-old boy. The paramedic would generally be called by the defense and later cross-examined by the plaintiff. Instead, the plaintiff chose to examine him first. Under evidence rules in most states (including North Carolina,¹ where this case was heard), an adverse (or hostile) witness can be called by the opposing party.

Why is this important? Because during direct examination, you cannot lead the witness; during cross-examination, you can. Leading questions (if done correctly) generally produce the most effective and damaging moments during a trial. In this case, the plaintiffs were able to immediately examine one of the defendant’s principal actors using leading questions. Shortly thereafter, when the plaintiff was directly examining his own paramedic expert witnesses, the defense relented and settled for $13 million, with further recovery against the emergency physician still available.

Interestingly, the attorney suing the medical personnel in this case was none other than John Edwards. Yes, that John Edwards—the former vice presidential candidate famous for his $500 haircuts, campaign finance tribulations, and ethical lapses. He originally became famous (and rich) suing clinicians. After his political fall from grace, he is back in business suing clinicians—and for him, business is good.

IN SUM
This case was unfortunate. Always use care in securing the airway, particularly during patient movement. Once it is established, monitor the airway using SaO₂, ETCO₂, and keen observation. Airways are not in the “set it and forget it” camp. An airway must be maintained, safeguarded, and protected. Be prepared to act quickly should the airway become dislodged, migrate, or otherwise fail. —DML

REFERENCE
1. North Carolina Rules of Evidence Rule 611 (1983, c. 701, s. 1.).

In March 2009, a 63-year-old man was diagnosed with stage IV gastric carcinoma with metastasis to the liver. His treating oncologist gave him a prognosis of about 10 months’ life expectancy with chemotherapy. The patient’s family searched for alternative treatment options and found a natural alternative treatment center claiming the ability to cure the patient.

The patient and his family decided to defer chemotherapy, and he was admitted to the alternative treatment center for three to four weeks of inpatient care. The treatment consisted of “colonic hydrotherapy,” supplements designed to cleanse the body, and a diet restricted to seed milk, vegetable juice, and spinach soup. 

After six days, the patient developed severe diarrhea, confusion, and profound weakness. He was taken to a local hospital and admitted with a diagnosis of acute renal failure. Dialysis attempts were unsuccessful, and the man died of respiratory distress secondary to acute renal failure a week later.

The plaintiff claimed that the treatment provided by the defendants was contraindicated and caused acute renal failure, noting that the patient’s kidney function had been relatively normal when he entered the treatment facility. The plaintiff claimed that defendant Dr N., a chiropractor, never reviewed any of the decedent’s medical records, did not discuss the proposed treatment plan with his treating physicians, and failed to properly monitor the patient’s condition, notice his deterioration, and provide timely transfer to a hospital.

The defendant claimed that the treatment given had no adverse effects on the decedent and that the acute renal failure was due to hepatorenal syndrome due to his advanced metastatic liver cancer.

What was the outcome? >>

OUTCOME 
A $2.5 million verdict was returned. An appeal was pending.

COMMENT 
This is a case against a chiropractor, so why discuss it in a journal dedicated to NP and PA practice? Because it involves scope of practice, alternative medicine, the safety of “natural” treatments, and the ethical and legal problems of making unsupportable promises to patients.

Know your scope of practice, and don’t overextend. Clinicians trained as specialists (eg, in pediatrics, midwifery, or anesthesia) should use caution departing from that area. Those trained as “generalists” need to be careful as well; even if you were trained in a family practice program, if you are a PA who  has worked in dermatology for the past 10 years, think twice about giving treatment or advice to your friend with a neurologic complaint. In the event of a lawsuit, the plaintiff will spend a great deal of time building your resume as an expert in your discipline, only to attack you as inexperienced and unqualified in the case in which you extended yourself.

Here a chiropractor, without ever examining the patient, directed the treatment of a very sick man in an area in which he was not qualified. While chiropractors may claim the ability to treat outside their traditional scope, the jury’s verdict in this case proves that they were not persuaded he was right to do so. The chiropractor, Dr N., eventually lost his license, based in part on the false promises he made about his ability to cure patients of “any and all diseases, including cancer, by restoring the body to its natural state ….” This opportunistic preying upon the most ill and vulnerable in our society likely irked the jurors, who returned a substantial award, considering that the patient’s short life expectancy was uncontested.

Handle alternative medicine with particular care, because an alternative treatment may not qualify as “medicine” at all. If we define medicine as the application of scientific principles to health care, an alternative that is unproven, unstudied, and unknown does not qualify. Rather, it is guesswork—with potentially devastating consequences.

In this case, through his company, the chiropractor based his treatment plan on guesswork that colonic hydrotherapy and severe dietary restrictions would help a patient with stage IV metastatic gastric carcinoma. He was wrong, and the jury concluded that these alternatives injured the patient and hastened his death.

Certainly, Western medicine has been rightly and fairly criticized for failing to promote wellness through a healthy lifestyle, including diet, exercise, safety, emotional well-being, and stress management. However, when venturing from generally accepted health promotion strategies to a specific recommendation that an alternative agent “is good for” a specific problem, be careful. You may believe lavender oil is an effective antibiotic—but can you prove it?

If you choose lavender oil over a demonstrably effective antibiotic to treat pneumonia, and the patient deteriorates, you will be held accountable. The plaintiff will demand answers, and the jury will await your explanation. Reliance on vague concepts, not generally accepted in the literature (eg, “energy management,” detoxifying, unblocking “clogged” nervous systems), will be ridiculed by the plaintiff’s experts, and you will be skewered on cross-examination. It is not enough to personally “believe” in the alternative; you must be able to support your treatment decisions through the best evidence possible.

To be fair, this cuts both ways: Some Western medical practices are based on anecdotal evidence with minimal scientific support.  There was a time when a corneal abrasion was patched, a fractured clavicle was stabilized with a figure-of-eight dressing, and narcotics were withheld from a suffering patient with acute abdomen because it would “mask signs.” Our “Western” system is not immune from the impact of poor research, group-think, dogmas leading to inappropriate practice, and other sources of logical fallacy.

As NPs and PAs, we will be held to a scientific evidentiary standard. The standard of care will be based upon the care a reasonably prudent clinician would deliver in a similar situation. At trial, you will be confronted with a PA or NP on the stand testifying against you regarding what is reasonably prudent, acceptable care. Make sure your actions are scientifically defensible.

Interestingly, the standard for admitting a scientific opinion as expert testimony has changed. In 1923, Frye v United States¹ established that, for an expert opinion to be admissible, the testimony had to be based on what is “generally accepted in the scientific community.” In 1993, the Supreme Court case Daubert v Merrell Dow Pharmaceuticals² determined that the opinion need not be “generally accepted” but must be based on scientific method and must be relevant to the case; the judge serves as a “gatekeeper” to be sure the opinions flow from “scientific knowledge.”

Medical malpractice cases are based on state law. Some follow Frye, some Daubert. The latter is a more relaxed standard, but even in states following Daubert, an expert witness who purports to testify on an alternative treatment must follow the scientific method. For example, the webpage of the defendant chiropractor’s institute (still in business) currently claims that “Heart/Brain Entrainment Therapy balances frequencies of organs/glands/tissues. Everything in the universe resonates at a particular frequency—light, sound, and every cell, organ, gland, and tissue in you.”³

So, whatever Heart/Brain Entrainment Therapy is, for that theory to be admissible in a Frye jurisdiction it would likely have to be “generally accepted” in the medical community. To be admissible in a Daubert jurisdiction, proponents of the testimony would have to show evidence of a scientific methodology supporting the theory before the jury could hear any testimony about it. In either case, strategically, the defense attorney would likely file a motion to block either certain parts of the testimony or the testimony entirely.

IN SUM
Jurors expect sound scientific methodology supporting medical decisions; use care when selecting treatment for patients. Robustly adopt health promotion and general wellness strategies. However, if you use alternatives directed toward a specific therapy solving a specific problem, use them cautiously and with an awareness that the indication for the therapy should be scientifically defensible. —DML 

REFERENCES
1. Frye v United States, 293 F. 1013 (D.C. Cir. 1923).
2. Daubert v Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993).
3. Total Health Institute. Bioelectrical Energy, Quantum Frequency Resonance. www.totalhealthinstitute.com/about. Accessed July 14, 2015.

In March 2009, a 63-year-old man was diagnosed with stage IV gastric carcinoma with metastasis to the liver. His treating oncologist gave him a prognosis of about 10 months’ life expectancy with chemotherapy. The patient’s family searched for alternative treatment options and found a natural alternative treatment center claiming the ability to cure the patient.

The patient and his family decided to defer chemotherapy, and he was admitted to the alternative treatment center for three to four weeks of inpatient care. The treatment consisted of “colonic hydrotherapy,” supplements designed to cleanse the body, and a diet restricted to seed milk, vegetable juice, and spinach soup. 

After six days, the patient developed severe diarrhea, confusion, and profound weakness. He was taken to a local hospital and admitted with a diagnosis of acute renal failure. Dialysis attempts were unsuccessful, and the man died of respiratory distress secondary to acute renal failure a week later.

The plaintiff claimed that the treatment provided by the defendants was contraindicated and caused acute renal failure, noting that the patient’s kidney function had been relatively normal when he entered the treatment facility. The plaintiff claimed that defendant Dr N., a chiropractor, never reviewed any of the decedent’s medical records, did not discuss the proposed treatment plan with his treating physicians, and failed to properly monitor the patient’s condition, notice his deterioration, and provide timely transfer to a hospital.

The defendant claimed that the treatment given had no adverse effects on the decedent and that the acute renal failure was due to hepatorenal syndrome due to his advanced metastatic liver cancer.

What was the outcome? >>

OUTCOME 
A $2.5 million verdict was returned. An appeal was pending.

COMMENT 
This is a case against a chiropractor, so why discuss it in a journal dedicated to NP and PA practice? Because it involves scope of practice, alternative medicine, the safety of “natural” treatments, and the ethical and legal problems of making unsupportable promises to patients.

Know your scope of practice, and don’t overextend. Clinicians trained as specialists (eg, in pediatrics, midwifery, or anesthesia) should use caution departing from that area. Those trained as “generalists” need to be careful as well; even if you were trained in a family practice program, if you are a PA who  has worked in dermatology for the past 10 years, think twice about giving treatment or advice to your friend with a neurologic complaint. In the event of a lawsuit, the plaintiff will spend a great deal of time building your resume as an expert in your discipline, only to attack you as inexperienced and unqualified in the case in which you extended yourself.

Here a chiropractor, without ever examining the patient, directed the treatment of a very sick man in an area in which he was not qualified. While chiropractors may claim the ability to treat outside their traditional scope, the jury’s verdict in this case proves that they were not persuaded he was right to do so. The chiropractor, Dr N., eventually lost his license, based in part on the false promises he made about his ability to cure patients of “any and all diseases, including cancer, by restoring the body to its natural state ….” This opportunistic preying upon the most ill and vulnerable in our society likely irked the jurors, who returned a substantial award, considering that the patient’s short life expectancy was uncontested.

Handle alternative medicine with particular care, because an alternative treatment may not qualify as “medicine” at all. If we define medicine as the application of scientific principles to health care, an alternative that is unproven, unstudied, and unknown does not qualify. Rather, it is guesswork—with potentially devastating consequences.

In this case, through his company, the chiropractor based his treatment plan on guesswork that colonic hydrotherapy and severe dietary restrictions would help a patient with stage IV metastatic gastric carcinoma. He was wrong, and the jury concluded that these alternatives injured the patient and hastened his death.

Certainly, Western medicine has been rightly and fairly criticized for failing to promote wellness through a healthy lifestyle, including diet, exercise, safety, emotional well-being, and stress management. However, when venturing from generally accepted health promotion strategies to a specific recommendation that an alternative agent “is good for” a specific problem, be careful. You may believe lavender oil is an effective antibiotic—but can you prove it?

If you choose lavender oil over a demonstrably effective antibiotic to treat pneumonia, and the patient deteriorates, you will be held accountable. The plaintiff will demand answers, and the jury will await your explanation. Reliance on vague concepts, not generally accepted in the literature (eg, “energy management,” detoxifying, unblocking “clogged” nervous systems), will be ridiculed by the plaintiff’s experts, and you will be skewered on cross-examination. It is not enough to personally “believe” in the alternative; you must be able to support your treatment decisions through the best evidence possible.

To be fair, this cuts both ways: Some Western medical practices are based on anecdotal evidence with minimal scientific support.  There was a time when a corneal abrasion was patched, a fractured clavicle was stabilized with a figure-of-eight dressing, and narcotics were withheld from a suffering patient with acute abdomen because it would “mask signs.” Our “Western” system is not immune from the impact of poor research, group-think, dogmas leading to inappropriate practice, and other sources of logical fallacy.

As NPs and PAs, we will be held to a scientific evidentiary standard. The standard of care will be based upon the care a reasonably prudent clinician would deliver in a similar situation. At trial, you will be confronted with a PA or NP on the stand testifying against you regarding what is reasonably prudent, acceptable care. Make sure your actions are scientifically defensible.

Interestingly, the standard for admitting a scientific opinion as expert testimony has changed. In 1923, Frye v United States¹ established that, for an expert opinion to be admissible, the testimony had to be based on what is “generally accepted in the scientific community.” In 1993, the Supreme Court case Daubert v Merrell Dow Pharmaceuticals² determined that the opinion need not be “generally accepted” but must be based on scientific method and must be relevant to the case; the judge serves as a “gatekeeper” to be sure the opinions flow from “scientific knowledge.”

Medical malpractice cases are based on state law. Some follow Frye, some Daubert. The latter is a more relaxed standard, but even in states following Daubert, an expert witness who purports to testify on an alternative treatment must follow the scientific method. For example, the webpage of the defendant chiropractor’s institute (still in business) currently claims that “Heart/Brain Entrainment Therapy balances frequencies of organs/glands/tissues. Everything in the universe resonates at a particular frequency—light, sound, and every cell, organ, gland, and tissue in you.”³

So, whatever Heart/Brain Entrainment Therapy is, for that theory to be admissible in a Frye jurisdiction it would likely have to be “generally accepted” in the medical community. To be admissible in a Daubert jurisdiction, proponents of the testimony would have to show evidence of a scientific methodology supporting the theory before the jury could hear any testimony about it. In either case, strategically, the defense attorney would likely file a motion to block either certain parts of the testimony or the testimony entirely.

IN SUM
Jurors expect sound scientific methodology supporting medical decisions; use care when selecting treatment for patients. Robustly adopt health promotion and general wellness strategies. However, if you use alternatives directed toward a specific therapy solving a specific problem, use them cautiously and with an awareness that the indication for the therapy should be scientifically defensible. —DML 

REFERENCES
1. Frye v United States, 293 F. 1013 (D.C. Cir. 1923).
2. Daubert v Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993).
3. Total Health Institute. Bioelectrical Energy, Quantum Frequency Resonance. www.totalhealthinstitute.com/about. Accessed July 14, 2015.

In March 2009, a 63-year-old man was diagnosed with stage IV gastric carcinoma with metastasis to the liver. His treating oncologist gave him a prognosis of about 10 months’ life expectancy with chemotherapy. The patient’s family searched for alternative treatment options and found a natural alternative treatment center claiming the ability to cure the patient.

The patient and his family decided to defer chemotherapy, and he was admitted to the alternative treatment center for three to four weeks of inpatient care. The treatment consisted of “colonic hydrotherapy,” supplements designed to cleanse the body, and a diet restricted to seed milk, vegetable juice, and spinach soup. 

After six days, the patient developed severe diarrhea, confusion, and profound weakness. He was taken to a local hospital and admitted with a diagnosis of acute renal failure. Dialysis attempts were unsuccessful, and the man died of respiratory distress secondary to acute renal failure a week later.

The plaintiff claimed that the treatment provided by the defendants was contraindicated and caused acute renal failure, noting that the patient’s kidney function had been relatively normal when he entered the treatment facility. The plaintiff claimed that defendant Dr N., a chiropractor, never reviewed any of the decedent’s medical records, did not discuss the proposed treatment plan with his treating physicians, and failed to properly monitor the patient’s condition, notice his deterioration, and provide timely transfer to a hospital.

The defendant claimed that the treatment given had no adverse effects on the decedent and that the acute renal failure was due to hepatorenal syndrome due to his advanced metastatic liver cancer.

What was the outcome? >>

OUTCOME 
A $2.5 million verdict was returned. An appeal was pending.

COMMENT 
This is a case against a chiropractor, so why discuss it in a journal dedicated to NP and PA practice? Because it involves scope of practice, alternative medicine, the safety of “natural” treatments, and the ethical and legal problems of making unsupportable promises to patients.

Know your scope of practice, and don’t overextend. Clinicians trained as specialists (eg, in pediatrics, midwifery, or anesthesia) should use caution departing from that area. Those trained as “generalists” need to be careful as well; even if you were trained in a family practice program, if you are a PA who  has worked in dermatology for the past 10 years, think twice about giving treatment or advice to your friend with a neurologic complaint. In the event of a lawsuit, the plaintiff will spend a great deal of time building your resume as an expert in your discipline, only to attack you as inexperienced and unqualified in the case in which you extended yourself.

Here a chiropractor, without ever examining the patient, directed the treatment of a very sick man in an area in which he was not qualified. While chiropractors may claim the ability to treat outside their traditional scope, the jury’s verdict in this case proves that they were not persuaded he was right to do so. The chiropractor, Dr N., eventually lost his license, based in part on the false promises he made about his ability to cure patients of “any and all diseases, including cancer, by restoring the body to its natural state ….” This opportunistic preying upon the most ill and vulnerable in our society likely irked the jurors, who returned a substantial award, considering that the patient’s short life expectancy was uncontested.

Handle alternative medicine with particular care, because an alternative treatment may not qualify as “medicine” at all. If we define medicine as the application of scientific principles to health care, an alternative that is unproven, unstudied, and unknown does not qualify. Rather, it is guesswork—with potentially devastating consequences.

In this case, through his company, the chiropractor based his treatment plan on guesswork that colonic hydrotherapy and severe dietary restrictions would help a patient with stage IV metastatic gastric carcinoma. He was wrong, and the jury concluded that these alternatives injured the patient and hastened his death.

Certainly, Western medicine has been rightly and fairly criticized for failing to promote wellness through a healthy lifestyle, including diet, exercise, safety, emotional well-being, and stress management. However, when venturing from generally accepted health promotion strategies to a specific recommendation that an alternative agent “is good for” a specific problem, be careful. You may believe lavender oil is an effective antibiotic—but can you prove it?

If you choose lavender oil over a demonstrably effective antibiotic to treat pneumonia, and the patient deteriorates, you will be held accountable. The plaintiff will demand answers, and the jury will await your explanation. Reliance on vague concepts, not generally accepted in the literature (eg, “energy management,” detoxifying, unblocking “clogged” nervous systems), will be ridiculed by the plaintiff’s experts, and you will be skewered on cross-examination. It is not enough to personally “believe” in the alternative; you must be able to support your treatment decisions through the best evidence possible.

To be fair, this cuts both ways: Some Western medical practices are based on anecdotal evidence with minimal scientific support.  There was a time when a corneal abrasion was patched, a fractured clavicle was stabilized with a figure-of-eight dressing, and narcotics were withheld from a suffering patient with acute abdomen because it would “mask signs.” Our “Western” system is not immune from the impact of poor research, group-think, dogmas leading to inappropriate practice, and other sources of logical fallacy.

As NPs and PAs, we will be held to a scientific evidentiary standard. The standard of care will be based upon the care a reasonably prudent clinician would deliver in a similar situation. At trial, you will be confronted with a PA or NP on the stand testifying against you regarding what is reasonably prudent, acceptable care. Make sure your actions are scientifically defensible.

Interestingly, the standard for admitting a scientific opinion as expert testimony has changed. In 1923, Frye v United States¹ established that, for an expert opinion to be admissible, the testimony had to be based on what is “generally accepted in the scientific community.” In 1993, the Supreme Court case Daubert v Merrell Dow Pharmaceuticals² determined that the opinion need not be “generally accepted” but must be based on scientific method and must be relevant to the case; the judge serves as a “gatekeeper” to be sure the opinions flow from “scientific knowledge.”

Medical malpractice cases are based on state law. Some follow Frye, some Daubert. The latter is a more relaxed standard, but even in states following Daubert, an expert witness who purports to testify on an alternative treatment must follow the scientific method. For example, the webpage of the defendant chiropractor’s institute (still in business) currently claims that “Heart/Brain Entrainment Therapy balances frequencies of organs/glands/tissues. Everything in the universe resonates at a particular frequency—light, sound, and every cell, organ, gland, and tissue in you.”³

So, whatever Heart/Brain Entrainment Therapy is, for that theory to be admissible in a Frye jurisdiction it would likely have to be “generally accepted” in the medical community. To be admissible in a Daubert jurisdiction, proponents of the testimony would have to show evidence of a scientific methodology supporting the theory before the jury could hear any testimony about it. In either case, strategically, the defense attorney would likely file a motion to block either certain parts of the testimony or the testimony entirely.

IN SUM
Jurors expect sound scientific methodology supporting medical decisions; use care when selecting treatment for patients. Robustly adopt health promotion and general wellness strategies. However, if you use alternatives directed toward a specific therapy solving a specific problem, use them cautiously and with an awareness that the indication for the therapy should be scientifically defensible. —DML 

REFERENCES
1. Frye v United States, 293 F. 1013 (D.C. Cir. 1923).
2. Daubert v Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993).
3. Total Health Institute. Bioelectrical Energy, Quantum Frequency Resonance. www.totalhealthinstitute.com/about. Accessed July 14, 2015.

In October 2010, a 33-year-old woman with type 1 diabetes presented to a medical center in Cook County, Illinois, with shortness of breath. She was diagnosed with excessive fluid around her lungs, for which she received treatment. When her pain persisted, she was placed on hydromorphone. A long-­acting form of insulin was also  prescribed.

Two days later, the woman experienced respiratory arrest­—presumed to be a reaction to the medication. She was resuscitated and remained in the ICU. Although she was not eating food by mouth, no order for a diet change was received or documented. She continued to be administered insulin and went into a diabetic coma, dying about a week after admission.

The plaintiff claimed that the internal medicine physician employed by the hospital failed to review the decedent’s medical chart and discuss the decedent’s risk for low blood sugar levels with the attending physician. The defendants argued that the decedent was receiving regular dialysis due to end-stage renal failure and had a short life expectancy.

What was the outcome? >>

OUTCOME 
A $2 million settlement was reached.

COMMENT 
This patient’s admission to the ICU and continued monitoring were obviously stressful and ensured that her serum glucose would be high. Systems should have been in place to prevent a fatal outcome—yet the system failed in this case.

The clinicians failed to recognize the need for closer monitoring and management in a sick, acutely stressed patient. The internist did not revisit the prescribed diet and did not appreciate the impact an acute illness can have on glycemic control—and thus did not order closer serum glucose monitoring.

Because diabetes is common, jurors expect competent management; as a result, this case was likely difficult to defend. The case report tells us that the defense did not challenge a breach of the standard of care (liability) but instead focused on the ultimate impact of the mistake, given the patient’s end-stage renal failure and short life expectancy (damages).

The $2 million settlement is relatively restrained, given the patient’s young age and the location of the case. This suggests the defense had some success arguing that the patient, at baseline, was gravely ill with a diminished lifespan.

As clinicians, we would all agree that an acutely stressed, hospitalized diabetic patient should be managed closely. But how often do we see diabetic patients in an ambulatory setting who are moderately stressed, ill, vomiting, and not eating? How often do we consider the possibility that these patients could slip out of control if not monitored more closely?

While we can’t revamp our diabetic patients’ regimens for every cold, we can encourage them to develop a “sick day” plan and remind them to be vigilant about managing their diabetes during illness. Consider the “sick day” advice given to patients by the Joslin Diabetes Center:
• Always take your diabetes medication. If you have difficulty keeping the medicine down due to vomiting, call your clinician.
• Check your blood glucose level at least 4 times a day. If you are too sick to test it yourself, have someone else do it. Record your levels in case you need to contact your clinician.
• Check for ketones if your blood glucose is 250 or higher. Again, write down your levels for reference.
• Stick to your normal meal plan, if possible.
• Drink lots of sugar-free liquids to prevent dehydration.¹

Patients are also advised to contact their health care provider if they have any of the following symptoms: a fever of more than 100.5°F; vomiting or diarrhea of more than two hours’ duration; blood glucose levels higher than 250 mg after two checks, or levels that do not decrease after extra insulin is taken; and moderate or large ketones.¹

The instruction to call the office for any fever higher than 100.5°F may seem abundantly cautious. But the discussion that ensues would serve as an opportunity to reinforce the need for closer monitoring—perhaps preventing a patient with a modest illness from spiraling out of glycemic control. —DML

REFERENCE 
1. Joslin Diabetes Center. Sick Days. www.joslin.org/info/Sick_Days.html. Accessed June 10, 2015.

In October 2010, a 33-year-old woman with type 1 diabetes presented to a medical center in Cook County, Illinois, with shortness of breath. She was diagnosed with excessive fluid around her lungs, for which she received treatment. When her pain persisted, she was placed on hydromorphone. A long-­acting form of insulin was also  prescribed.

Two days later, the woman experienced respiratory arrest­—presumed to be a reaction to the medication. She was resuscitated and remained in the ICU. Although she was not eating food by mouth, no order for a diet change was received or documented. She continued to be administered insulin and went into a diabetic coma, dying about a week after admission.

The plaintiff claimed that the internal medicine physician employed by the hospital failed to review the decedent’s medical chart and discuss the decedent’s risk for low blood sugar levels with the attending physician. The defendants argued that the decedent was receiving regular dialysis due to end-stage renal failure and had a short life expectancy.

What was the outcome? >>

OUTCOME 
A $2 million settlement was reached.

COMMENT 
This patient’s admission to the ICU and continued monitoring were obviously stressful and ensured that her serum glucose would be high. Systems should have been in place to prevent a fatal outcome—yet the system failed in this case.

The clinicians failed to recognize the need for closer monitoring and management in a sick, acutely stressed patient. The internist did not revisit the prescribed diet and did not appreciate the impact an acute illness can have on glycemic control—and thus did not order closer serum glucose monitoring.

Because diabetes is common, jurors expect competent management; as a result, this case was likely difficult to defend. The case report tells us that the defense did not challenge a breach of the standard of care (liability) but instead focused on the ultimate impact of the mistake, given the patient’s end-stage renal failure and short life expectancy (damages).

The $2 million settlement is relatively restrained, given the patient’s young age and the location of the case. This suggests the defense had some success arguing that the patient, at baseline, was gravely ill with a diminished lifespan.

As clinicians, we would all agree that an acutely stressed, hospitalized diabetic patient should be managed closely. But how often do we see diabetic patients in an ambulatory setting who are moderately stressed, ill, vomiting, and not eating? How often do we consider the possibility that these patients could slip out of control if not monitored more closely?

While we can’t revamp our diabetic patients’ regimens for every cold, we can encourage them to develop a “sick day” plan and remind them to be vigilant about managing their diabetes during illness. Consider the “sick day” advice given to patients by the Joslin Diabetes Center:
• Always take your diabetes medication. If you have difficulty keeping the medicine down due to vomiting, call your clinician.
• Check your blood glucose level at least 4 times a day. If you are too sick to test it yourself, have someone else do it. Record your levels in case you need to contact your clinician.
• Check for ketones if your blood glucose is 250 or higher. Again, write down your levels for reference.
• Stick to your normal meal plan, if possible.
• Drink lots of sugar-free liquids to prevent dehydration.¹

Patients are also advised to contact their health care provider if they have any of the following symptoms: a fever of more than 100.5°F; vomiting or diarrhea of more than two hours’ duration; blood glucose levels higher than 250 mg after two checks, or levels that do not decrease after extra insulin is taken; and moderate or large ketones.¹

The instruction to call the office for any fever higher than 100.5°F may seem abundantly cautious. But the discussion that ensues would serve as an opportunity to reinforce the need for closer monitoring—perhaps preventing a patient with a modest illness from spiraling out of glycemic control. —DML

REFERENCE 
1. Joslin Diabetes Center. Sick Days. www.joslin.org/info/Sick_Days.html. Accessed June 10, 2015.

In October 2010, a 33-year-old woman with type 1 diabetes presented to a medical center in Cook County, Illinois, with shortness of breath. She was diagnosed with excessive fluid around her lungs, for which she received treatment. When her pain persisted, she was placed on hydromorphone. A long-­acting form of insulin was also  prescribed.

Two days later, the woman experienced respiratory arrest­—presumed to be a reaction to the medication. She was resuscitated and remained in the ICU. Although she was not eating food by mouth, no order for a diet change was received or documented. She continued to be administered insulin and went into a diabetic coma, dying about a week after admission.

The plaintiff claimed that the internal medicine physician employed by the hospital failed to review the decedent’s medical chart and discuss the decedent’s risk for low blood sugar levels with the attending physician. The defendants argued that the decedent was receiving regular dialysis due to end-stage renal failure and had a short life expectancy.

What was the outcome? >>

OUTCOME 
A $2 million settlement was reached.

COMMENT 
This patient’s admission to the ICU and continued monitoring were obviously stressful and ensured that her serum glucose would be high. Systems should have been in place to prevent a fatal outcome—yet the system failed in this case.

The clinicians failed to recognize the need for closer monitoring and management in a sick, acutely stressed patient. The internist did not revisit the prescribed diet and did not appreciate the impact an acute illness can have on glycemic control—and thus did not order closer serum glucose monitoring.

Because diabetes is common, jurors expect competent management; as a result, this case was likely difficult to defend. The case report tells us that the defense did not challenge a breach of the standard of care (liability) but instead focused on the ultimate impact of the mistake, given the patient’s end-stage renal failure and short life expectancy (damages).

The $2 million settlement is relatively restrained, given the patient’s young age and the location of the case. This suggests the defense had some success arguing that the patient, at baseline, was gravely ill with a diminished lifespan.

As clinicians, we would all agree that an acutely stressed, hospitalized diabetic patient should be managed closely. But how often do we see diabetic patients in an ambulatory setting who are moderately stressed, ill, vomiting, and not eating? How often do we consider the possibility that these patients could slip out of control if not monitored more closely?

While we can’t revamp our diabetic patients’ regimens for every cold, we can encourage them to develop a “sick day” plan and remind them to be vigilant about managing their diabetes during illness. Consider the “sick day” advice given to patients by the Joslin Diabetes Center:
• Always take your diabetes medication. If you have difficulty keeping the medicine down due to vomiting, call your clinician.
• Check your blood glucose level at least 4 times a day. If you are too sick to test it yourself, have someone else do it. Record your levels in case you need to contact your clinician.
• Check for ketones if your blood glucose is 250 or higher. Again, write down your levels for reference.
• Stick to your normal meal plan, if possible.
• Drink lots of sugar-free liquids to prevent dehydration.¹

Patients are also advised to contact their health care provider if they have any of the following symptoms: a fever of more than 100.5°F; vomiting or diarrhea of more than two hours’ duration; blood glucose levels higher than 250 mg after two checks, or levels that do not decrease after extra insulin is taken; and moderate or large ketones.¹

The instruction to call the office for any fever higher than 100.5°F may seem abundantly cautious. But the discussion that ensues would serve as an opportunity to reinforce the need for closer monitoring—perhaps preventing a patient with a modest illness from spiraling out of glycemic control. —DML

REFERENCE 
1. Joslin Diabetes Center. Sick Days. www.joslin.org/info/Sick_Days.html. Accessed June 10, 2015.

At a New Jersey hospital, a pregnant woman underwent an ultrasound examination with results suggesting a possible fetal abnormality. In response, DNA testing of the patient and her husband was ordered to investigate for a suspected hormonal disorder. But the wrong test was ordered, and the results of that test were negative.

A baby girl was born with congenital adrenal hyperplasia, a condition causing ambiguous genitalia due to exposure to high concentrations of androgens in utero. She underwent genital reconstructive surgery at age 4 months and is expected to require additional surgery, lifelong hormone replacement therapy, and lifelong monitoring.

The parents claimed that they would have elected to terminate the pregnancy if they had been properly informed of the child’s condition.

What was the outcome? >>

OUTCOME
A jury returned a ruling of 75% liability to the hospital and 25% liability to a hospital lab technician. The verdict was for $1 million, comprising $625,000 for the child and $375,000 for her parents.

COMMENT
The controversial legal theory of recovery in this case is known as “wrongful life” or “wrongful birth.” To prevail on these tort actions, one must prove that the defendant’s negligence led to the birth of an infant following a pregnancy that would have been terminated, had the parents been given all the prenatal screening information required by the standard of care.

The goal of any prenatal screening program should be to provide parents with information that is adequate, accurate, and timely. In this case, after the suspicious sonographic findings were encountered, the wrong test was ordered and the diagnosis was missed. Each practice providing prenatal screening should have a checklist to confirm that the correct test was ordered, completed, and documented—not to mention discussed with the patient in a timely manner.

In this case, the clinician ordered the wrong test, which left the patient with inadequate information. From the facts given, it is unclear if the ordering clinician became aware of this fact and what information, if any, the patient was given regarding the error. Importantly, information must also be given in a timely manner, leaving the patient adequate time to make an informed decision regarding termination—before fetal viability. But how is viability defined?

Although a detailed discussion of the constitutional principles of fetal viability is beyond the scope of this commentary, three US Supreme Court cases paved the way for successful wrongful life/wrongful birth actions. In Griswold v Connecticut (1965), the court held that decisions regarding birth control were protected by the right to privacy. In Roe v Wade (1973), the court held that a constitutionally protected right to privacy exists with regard to pregnancy terminations until the point of “viability,” originally defined as between 24 and 28 gestational weeks. Planned Parenthood v Casey (1991) held that advances in neonatal care required a revised definition of viability to a point “somewhat earlier,” without establishing a specific bright-line rule for viability.

To complicate matters, in recent years, at least 14 states (Alabama, Arizona, Arkansas, Georgia, Idaho, Indiana, Kansas, Louisiana, Mississippi, Nebraska, North Carolina, North Dakota, Oklahoma, and Texas) have redefined viability and passed laws banning therapeutic abortion beyond week 20 (although some of these bans have been judicially blocked). In states with this type of legislation, whether a clinician could be held legally responsible for failing to provide information necessary to permit an informed decision prior to the 20-week mark is unclear.

Questions as to whether these state laws were in conflict with Roe v Wade led to a constitutional challenge. In 2013, the US Court of Appeals for the Ninth Circuit (the highest level before the Supreme Court) ruled that a 20-week cutoff was unconstitutional because it violated the “viability rule” established by Roe and Casey. The Supreme Court declined to review that decision.¹

Damage awards in wrongful life/wrongful birth cases are often substantial. The verdict in this case was relatively restrained.

Without doubt, this is a sensitive issue, and respect for our fellow clinicians’ opinions is warranted. However, from a liability standpoint, the safest course of action is to provide patients with all the necessary information—including prenatal testing results—as soon as possible, ­allowing them to make an informed decision before viability (however that is defined in your state). —DML

REFERENCE
1. Isaacson v. Horne, 716 F.3d 1213, 1225 (9th Cir. 2013), cert denied, 134 S. Ct. 905 (2014).

At a New Jersey hospital, a pregnant woman underwent an ultrasound examination with results suggesting a possible fetal abnormality. In response, DNA testing of the patient and her husband was ordered to investigate for a suspected hormonal disorder. But the wrong test was ordered, and the results of that test were negative.

A baby girl was born with congenital adrenal hyperplasia, a condition causing ambiguous genitalia due to exposure to high concentrations of androgens in utero. She underwent genital reconstructive surgery at age 4 months and is expected to require additional surgery, lifelong hormone replacement therapy, and lifelong monitoring.

The parents claimed that they would have elected to terminate the pregnancy if they had been properly informed of the child’s condition.

What was the outcome? >>

OUTCOME
A jury returned a ruling of 75% liability to the hospital and 25% liability to a hospital lab technician. The verdict was for $1 million, comprising $625,000 for the child and $375,000 for her parents.

COMMENT
The controversial legal theory of recovery in this case is known as “wrongful life” or “wrongful birth.” To prevail on these tort actions, one must prove that the defendant’s negligence led to the birth of an infant following a pregnancy that would have been terminated, had the parents been given all the prenatal screening information required by the standard of care.

The goal of any prenatal screening program should be to provide parents with information that is adequate, accurate, and timely. In this case, after the suspicious sonographic findings were encountered, the wrong test was ordered and the diagnosis was missed. Each practice providing prenatal screening should have a checklist to confirm that the correct test was ordered, completed, and documented—not to mention discussed with the patient in a timely manner.

In this case, the clinician ordered the wrong test, which left the patient with inadequate information. From the facts given, it is unclear if the ordering clinician became aware of this fact and what information, if any, the patient was given regarding the error. Importantly, information must also be given in a timely manner, leaving the patient adequate time to make an informed decision regarding termination—before fetal viability. But how is viability defined?

Although a detailed discussion of the constitutional principles of fetal viability is beyond the scope of this commentary, three US Supreme Court cases paved the way for successful wrongful life/wrongful birth actions. In Griswold v Connecticut (1965), the court held that decisions regarding birth control were protected by the right to privacy. In Roe v Wade (1973), the court held that a constitutionally protected right to privacy exists with regard to pregnancy terminations until the point of “viability,” originally defined as between 24 and 28 gestational weeks. Planned Parenthood v Casey (1991) held that advances in neonatal care required a revised definition of viability to a point “somewhat earlier,” without establishing a specific bright-line rule for viability.

To complicate matters, in recent years, at least 14 states (Alabama, Arizona, Arkansas, Georgia, Idaho, Indiana, Kansas, Louisiana, Mississippi, Nebraska, North Carolina, North Dakota, Oklahoma, and Texas) have redefined viability and passed laws banning therapeutic abortion beyond week 20 (although some of these bans have been judicially blocked). In states with this type of legislation, whether a clinician could be held legally responsible for failing to provide information necessary to permit an informed decision prior to the 20-week mark is unclear.

Questions as to whether these state laws were in conflict with Roe v Wade led to a constitutional challenge. In 2013, the US Court of Appeals for the Ninth Circuit (the highest level before the Supreme Court) ruled that a 20-week cutoff was unconstitutional because it violated the “viability rule” established by Roe and Casey. The Supreme Court declined to review that decision.¹

Damage awards in wrongful life/wrongful birth cases are often substantial. The verdict in this case was relatively restrained.

Without doubt, this is a sensitive issue, and respect for our fellow clinicians’ opinions is warranted. However, from a liability standpoint, the safest course of action is to provide patients with all the necessary information—including prenatal testing results—as soon as possible, ­allowing them to make an informed decision before viability (however that is defined in your state). —DML

REFERENCE
1. Isaacson v. Horne, 716 F.3d 1213, 1225 (9th Cir. 2013), cert denied, 134 S. Ct. 905 (2014).

At a New Jersey hospital, a pregnant woman underwent an ultrasound examination with results suggesting a possible fetal abnormality. In response, DNA testing of the patient and her husband was ordered to investigate for a suspected hormonal disorder. But the wrong test was ordered, and the results of that test were negative.

A baby girl was born with congenital adrenal hyperplasia, a condition causing ambiguous genitalia due to exposure to high concentrations of androgens in utero. She underwent genital reconstructive surgery at age 4 months and is expected to require additional surgery, lifelong hormone replacement therapy, and lifelong monitoring.

The parents claimed that they would have elected to terminate the pregnancy if they had been properly informed of the child’s condition.

What was the outcome? >>

OUTCOME
A jury returned a ruling of 75% liability to the hospital and 25% liability to a hospital lab technician. The verdict was for $1 million, comprising $625,000 for the child and $375,000 for her parents.

COMMENT
The controversial legal theory of recovery in this case is known as “wrongful life” or “wrongful birth.” To prevail on these tort actions, one must prove that the defendant’s negligence led to the birth of an infant following a pregnancy that would have been terminated, had the parents been given all the prenatal screening information required by the standard of care.

The goal of any prenatal screening program should be to provide parents with information that is adequate, accurate, and timely. In this case, after the suspicious sonographic findings were encountered, the wrong test was ordered and the diagnosis was missed. Each practice providing prenatal screening should have a checklist to confirm that the correct test was ordered, completed, and documented—not to mention discussed with the patient in a timely manner.

In this case, the clinician ordered the wrong test, which left the patient with inadequate information. From the facts given, it is unclear if the ordering clinician became aware of this fact and what information, if any, the patient was given regarding the error. Importantly, information must also be given in a timely manner, leaving the patient adequate time to make an informed decision regarding termination—before fetal viability. But how is viability defined?

Although a detailed discussion of the constitutional principles of fetal viability is beyond the scope of this commentary, three US Supreme Court cases paved the way for successful wrongful life/wrongful birth actions. In Griswold v Connecticut (1965), the court held that decisions regarding birth control were protected by the right to privacy. In Roe v Wade (1973), the court held that a constitutionally protected right to privacy exists with regard to pregnancy terminations until the point of “viability,” originally defined as between 24 and 28 gestational weeks. Planned Parenthood v Casey (1991) held that advances in neonatal care required a revised definition of viability to a point “somewhat earlier,” without establishing a specific bright-line rule for viability.

To complicate matters, in recent years, at least 14 states (Alabama, Arizona, Arkansas, Georgia, Idaho, Indiana, Kansas, Louisiana, Mississippi, Nebraska, North Carolina, North Dakota, Oklahoma, and Texas) have redefined viability and passed laws banning therapeutic abortion beyond week 20 (although some of these bans have been judicially blocked). In states with this type of legislation, whether a clinician could be held legally responsible for failing to provide information necessary to permit an informed decision prior to the 20-week mark is unclear.

Questions as to whether these state laws were in conflict with Roe v Wade led to a constitutional challenge. In 2013, the US Court of Appeals for the Ninth Circuit (the highest level before the Supreme Court) ruled that a 20-week cutoff was unconstitutional because it violated the “viability rule” established by Roe and Casey. The Supreme Court declined to review that decision.¹

Damage awards in wrongful life/wrongful birth cases are often substantial. The verdict in this case was relatively restrained.

Without doubt, this is a sensitive issue, and respect for our fellow clinicians’ opinions is warranted. However, from a liability standpoint, the safest course of action is to provide patients with all the necessary information—including prenatal testing results—as soon as possible, ­allowing them to make an informed decision before viability (however that is defined in your state). —DML

REFERENCE
1. Isaacson v. Horne, 716 F.3d 1213, 1225 (9th Cir. 2013), cert denied, 134 S. Ct. 905 (2014).

In January 2009, an Alabama woman with multiple sclerosis visited Dr T., the defendant ob-gyn, for severe pelvic pain. Dr T. made a diagnosis of a fibroid uterus and ovarian cysts. The patient underwent a transvaginal hysterectomy, but her pain persisted after the surgery.

After being discharged, she discovered a long strip of packing protruding from her vagina, which Dr T. instructed her to extract herself. After doing so, however, the patient continued to have pain, bleeding, and a foul–smelling vaginal discharge. Dr T. diagnosed urinary tract infection and bacterial vaginosis. Antibiotics and pain medication were prescribed, but the patient’s pelvic pain persisted.

In April 2009, Dr T. ordered CT to rule out an abscess or a foreign body. A gauze surgical sponge, left at the conclusion of the patient’s hysterectomy, was detected. Surgery was performed to remove the sponge.

The plaintiff alleged negligence in the sponge’s retention, maintaining that not only was a second surgery required, but that her multiple sclerosis was exacerbated as a result of the entire situation.

The defendant claimed that tests had been performed to investigate the possibility of a foreign body, and that as soon as the surgical sponge was detected, it was removed.

What was the outcome? >>

OUTCOME
According to a published report, a defense verdict was returned.

COMMENT
The defense verdict here is surprising. In most cases in which surgical instruments are left in patients, plaintiffs prevail by using a legal doctrine known as res ipsa loquitur—a Latin legal term of art meaning “the thing speaks for itself.” This is generally requested as a jury charge, wherein the plaintiff asks the judge to explain to the jury that they may find negligence from a certain unusual fact that cannot have occurred without negligence (eg, a sponge left in a patient after surgery).

The history of res ipsa loquitur dates back to 1863 in the case of Byrne v Boadle, in which a barrel of flour rolled from a second-story window and struck a pedestrian below, causing serious injury. The defendants’ claim was that the plaintiff (who had no recollection of the event) was unable to show evidence of negligence. The court created the doctrine, holding that the fact of the accident itself provided ample evidence of negligence, excusing the plaintiff from the burden of proving that negligent acts (eg, inadequate harnessing of the barrels) led to the accident.

Why is this important? The concept of res ipsa loquitur is commonly invoked in medical malpractice actions. It generally requires three elements: the plaintiff suffers an unusual injury, the plaintiff was under the exclusive control of the medical defendants, and the plaintiff did not contribute to the injury.

In a leading malpractice case, Ybarra v Spangard (1944), a plaintiff awoke after undergoing an appendectomy with difficulty moving his arm as a result of reflex sympathetic dystrophy. The plaintiff alleged negligence stemming from the intraoperative positioning of his body, but he could not show the specifics of positioning during surgery. The court held that the patient’s body was under the exclusive control of the team of medical professionals, and that negligence could be inferred because loss of an arm’s function following an appendectomy is unusual and cannot occur without some negligent action involved.

When successfully used in malpractice cases, res ipsa loquitur relieves the plaintiff of the need to prove by a preponderance of the evidence the actions that led to the breach of the standard of care. In order to prevail, she must show the injury, the defendants’ exclusive control, and no contribution on her part. Practically, this permits the case to withstand defense motions for summary judgment and to be brought before a jury with scant to no evidence on the purported negligent act itself—merely the unusual injury and the defendants’ exclusive control.

Traditional application of the doctrine was limited to cases in which negligence was obvious to a layperson: for example, instruments left in patients or amputation of the wrong leg—the thing that “speaks for itself.” Newer evolution of the doctrine is problematic when extended to cases in which expert testimony should be required to demonstrate the standard of care and the defendant’s breach of it. When courts are willing to extend the doctrine, the plaintiff is awarded the presumption of negligence, which the defendant(s) must now come forward to rebut. For example, in a 2010 case in Illinois, a jury returned a $3.6 million verdict following the death of a 2-year-old who had had a seizure. The child’s seizure was reportedly controlled, but he was allegedly hypoventilated while undergoing CT and unfortunately died. The plaintiff was permitted to invoke the doctrine of res ipsa loquitur and was allowed the presumption that medical negligence was responsible for the outcome.

Unlike the surgical sponge left in a patient, matters of central nervous system status, monitoring during CT, airway and ventilation status, hypoxemia, and postictal states are not within the experience of the typical juror. The negligent “thing” is not a sponge that “speaks for itself,” but a course of actions that requires expert testimony precisely because it does not “speak for itself.” In cases in which an injury is ­beyond the average juror’s realm of experience, courts should require the plaintiff to prove her case. The doctrine should not “evolve” to excuse a plaintiff from the burden of producing evidence and persuading a jury. This forms the foundation of our civil law system. —DML

In January 2009, an Alabama woman with multiple sclerosis visited Dr T., the defendant ob-gyn, for severe pelvic pain. Dr T. made a diagnosis of a fibroid uterus and ovarian cysts. The patient underwent a transvaginal hysterectomy, but her pain persisted after the surgery.

After being discharged, she discovered a long strip of packing protruding from her vagina, which Dr T. instructed her to extract herself. After doing so, however, the patient continued to have pain, bleeding, and a foul–smelling vaginal discharge. Dr T. diagnosed urinary tract infection and bacterial vaginosis. Antibiotics and pain medication were prescribed, but the patient’s pelvic pain persisted.

In April 2009, Dr T. ordered CT to rule out an abscess or a foreign body. A gauze surgical sponge, left at the conclusion of the patient’s hysterectomy, was detected. Surgery was performed to remove the sponge.

The plaintiff alleged negligence in the sponge’s retention, maintaining that not only was a second surgery required, but that her multiple sclerosis was exacerbated as a result of the entire situation.

The defendant claimed that tests had been performed to investigate the possibility of a foreign body, and that as soon as the surgical sponge was detected, it was removed.

What was the outcome? >>

OUTCOME
According to a published report, a defense verdict was returned.

COMMENT
The defense verdict here is surprising. In most cases in which surgical instruments are left in patients, plaintiffs prevail by using a legal doctrine known as res ipsa loquitur—a Latin legal term of art meaning “the thing speaks for itself.” This is generally requested as a jury charge, wherein the plaintiff asks the judge to explain to the jury that they may find negligence from a certain unusual fact that cannot have occurred without negligence (eg, a sponge left in a patient after surgery).

The history of res ipsa loquitur dates back to 1863 in the case of Byrne v Boadle, in which a barrel of flour rolled from a second-story window and struck a pedestrian below, causing serious injury. The defendants’ claim was that the plaintiff (who had no recollection of the event) was unable to show evidence of negligence. The court created the doctrine, holding that the fact of the accident itself provided ample evidence of negligence, excusing the plaintiff from the burden of proving that negligent acts (eg, inadequate harnessing of the barrels) led to the accident.

Why is this important? The concept of res ipsa loquitur is commonly invoked in medical malpractice actions. It generally requires three elements: the plaintiff suffers an unusual injury, the plaintiff was under the exclusive control of the medical defendants, and the plaintiff did not contribute to the injury.

In a leading malpractice case, Ybarra v Spangard (1944), a plaintiff awoke after undergoing an appendectomy with difficulty moving his arm as a result of reflex sympathetic dystrophy. The plaintiff alleged negligence stemming from the intraoperative positioning of his body, but he could not show the specifics of positioning during surgery. The court held that the patient’s body was under the exclusive control of the team of medical professionals, and that negligence could be inferred because loss of an arm’s function following an appendectomy is unusual and cannot occur without some negligent action involved.

When successfully used in malpractice cases, res ipsa loquitur relieves the plaintiff of the need to prove by a preponderance of the evidence the actions that led to the breach of the standard of care. In order to prevail, she must show the injury, the defendants’ exclusive control, and no contribution on her part. Practically, this permits the case to withstand defense motions for summary judgment and to be brought before a jury with scant to no evidence on the purported negligent act itself—merely the unusual injury and the defendants’ exclusive control.

Traditional application of the doctrine was limited to cases in which negligence was obvious to a layperson: for example, instruments left in patients or amputation of the wrong leg—the thing that “speaks for itself.” Newer evolution of the doctrine is problematic when extended to cases in which expert testimony should be required to demonstrate the standard of care and the defendant’s breach of it. When courts are willing to extend the doctrine, the plaintiff is awarded the presumption of negligence, which the defendant(s) must now come forward to rebut. For example, in a 2010 case in Illinois, a jury returned a $3.6 million verdict following the death of a 2-year-old who had had a seizure. The child’s seizure was reportedly controlled, but he was allegedly hypoventilated while undergoing CT and unfortunately died. The plaintiff was permitted to invoke the doctrine of res ipsa loquitur and was allowed the presumption that medical negligence was responsible for the outcome.

Unlike the surgical sponge left in a patient, matters of central nervous system status, monitoring during CT, airway and ventilation status, hypoxemia, and postictal states are not within the experience of the typical juror. The negligent “thing” is not a sponge that “speaks for itself,” but a course of actions that requires expert testimony precisely because it does not “speak for itself.” In cases in which an injury is ­beyond the average juror’s realm of experience, courts should require the plaintiff to prove her case. The doctrine should not “evolve” to excuse a plaintiff from the burden of producing evidence and persuading a jury. This forms the foundation of our civil law system. —DML

In January 2009, an Alabama woman with multiple sclerosis visited Dr T., the defendant ob-gyn, for severe pelvic pain. Dr T. made a diagnosis of a fibroid uterus and ovarian cysts. The patient underwent a transvaginal hysterectomy, but her pain persisted after the surgery.

After being discharged, she discovered a long strip of packing protruding from her vagina, which Dr T. instructed her to extract herself. After doing so, however, the patient continued to have pain, bleeding, and a foul–smelling vaginal discharge. Dr T. diagnosed urinary tract infection and bacterial vaginosis. Antibiotics and pain medication were prescribed, but the patient’s pelvic pain persisted.

In April 2009, Dr T. ordered CT to rule out an abscess or a foreign body. A gauze surgical sponge, left at the conclusion of the patient’s hysterectomy, was detected. Surgery was performed to remove the sponge.

The plaintiff alleged negligence in the sponge’s retention, maintaining that not only was a second surgery required, but that her multiple sclerosis was exacerbated as a result of the entire situation.

The defendant claimed that tests had been performed to investigate the possibility of a foreign body, and that as soon as the surgical sponge was detected, it was removed.

What was the outcome? >>

OUTCOME
According to a published report, a defense verdict was returned.

COMMENT
The defense verdict here is surprising. In most cases in which surgical instruments are left in patients, plaintiffs prevail by using a legal doctrine known as res ipsa loquitur—a Latin legal term of art meaning “the thing speaks for itself.” This is generally requested as a jury charge, wherein the plaintiff asks the judge to explain to the jury that they may find negligence from a certain unusual fact that cannot have occurred without negligence (eg, a sponge left in a patient after surgery).

The history of res ipsa loquitur dates back to 1863 in the case of Byrne v Boadle, in which a barrel of flour rolled from a second-story window and struck a pedestrian below, causing serious injury. The defendants’ claim was that the plaintiff (who had no recollection of the event) was unable to show evidence of negligence. The court created the doctrine, holding that the fact of the accident itself provided ample evidence of negligence, excusing the plaintiff from the burden of proving that negligent acts (eg, inadequate harnessing of the barrels) led to the accident.

Why is this important? The concept of res ipsa loquitur is commonly invoked in medical malpractice actions. It generally requires three elements: the plaintiff suffers an unusual injury, the plaintiff was under the exclusive control of the medical defendants, and the plaintiff did not contribute to the injury.

In a leading malpractice case, Ybarra v Spangard (1944), a plaintiff awoke after undergoing an appendectomy with difficulty moving his arm as a result of reflex sympathetic dystrophy. The plaintiff alleged negligence stemming from the intraoperative positioning of his body, but he could not show the specifics of positioning during surgery. The court held that the patient’s body was under the exclusive control of the team of medical professionals, and that negligence could be inferred because loss of an arm’s function following an appendectomy is unusual and cannot occur without some negligent action involved.

When successfully used in malpractice cases, res ipsa loquitur relieves the plaintiff of the need to prove by a preponderance of the evidence the actions that led to the breach of the standard of care. In order to prevail, she must show the injury, the defendants’ exclusive control, and no contribution on her part. Practically, this permits the case to withstand defense motions for summary judgment and to be brought before a jury with scant to no evidence on the purported negligent act itself—merely the unusual injury and the defendants’ exclusive control.

Traditional application of the doctrine was limited to cases in which negligence was obvious to a layperson: for example, instruments left in patients or amputation of the wrong leg—the thing that “speaks for itself.” Newer evolution of the doctrine is problematic when extended to cases in which expert testimony should be required to demonstrate the standard of care and the defendant’s breach of it. When courts are willing to extend the doctrine, the plaintiff is awarded the presumption of negligence, which the defendant(s) must now come forward to rebut. For example, in a 2010 case in Illinois, a jury returned a $3.6 million verdict following the death of a 2-year-old who had had a seizure. The child’s seizure was reportedly controlled, but he was allegedly hypoventilated while undergoing CT and unfortunately died. The plaintiff was permitted to invoke the doctrine of res ipsa loquitur and was allowed the presumption that medical negligence was responsible for the outcome.

Unlike the surgical sponge left in a patient, matters of central nervous system status, monitoring during CT, airway and ventilation status, hypoxemia, and postictal states are not within the experience of the typical juror. The negligent “thing” is not a sponge that “speaks for itself,” but a course of actions that requires expert testimony precisely because it does not “speak for itself.” In cases in which an injury is ­beyond the average juror’s realm of experience, courts should require the plaintiff to prove her case. The doctrine should not “evolve” to excuse a plaintiff from the burden of producing evidence and persuading a jury. This forms the foundation of our civil law system. —DML

A 28-year-old man presented to a Maryland hospital emergency department (ED) with a two-day history of low-grade fever, nonproductive cough, and dizziness. He was also tachycardic and significantly hypoxic. After an hour’s wait, the patient saw an emergency physician, who noted complaints of weakness, shortness of breath, and lightheadedness. The differential diagnosis included pneumonia, congestive heart failure, and pulmonary embolism (PE).

After an ECG, chest x-ray, and blood work, the emergency physician diagnosed pneumonia and renal insufficiency. The patient was admitted but within eight hours of arrival at the ED was transferred to another hospital. The admitting physician at the second hospital did not evaluate the patient on admission.

Almost five hours later, the patient got out of bed and collapsed in the presence of his wife. A code was called, but the man never regained consciousness and was pronounced dead about 90 minutes later. An autopsy confirmed a PE as the cause of death.

Plaintiff for the decedent alleged negligence in the clinicians’ failure to diagnose and treat the PE. The plaintiff claimed that with proper treatment, the patient would have ­survived.

The defendants argued that there was no negligence involved and that heparin therapy would not have prevented the patient’s death.

What was the outcome? >>

OUTCOME
According to a published account, a $6.1 million verdict was returned.

COMMENT
This is a substantial verdict, reflecting the jury’s revulsion at the loss of a 28-year-old patient. His initial presentation of low-grade fever, nonproductive cough, and dizziness with tachycardia and hypoxia could be consistent with either pneumonia or PE. The facts as presented render the chest x-ray findings and the magnitude of hypoxia unclear. We also are not told whether any specific risk factors existed to make PE more likely, nor whether there was evidence of deep vein thrombosis (DVT) during presentation or at autopsy.

Diagnosing PE can be difficult. However, jurors confronted with a case involving a fatal PE may be led to believe that the diagnosis is straightforward and should never be missed. Plaintiff’s counsel will argue that the patient “would be standing here today” in a fully functional status if the diagnosis had been made.

Here, presumptively, the chest films and chest auscultation were suggestive of pneumonia and led the clinician, who actively considered PE, to ultimately exclude the possibility. It is not clear why the patient was transferred and not formally evaluated upon arrival at the second hospital, but the facts indicate that the patient was “significantly hypoxic.” This should have entailed close monitoring by the receiving clinician, irrespective of the diagnosis.

The pathophysiology of PE is straightforward—but the presentation is often variable and nonspecific and the diagnosis tricky. Thus, for the clinician confronted with a hypoxic patient, it is important to consider this diagnosis early and thoroughly. Evaluate for risk factors: hypercoagulability, as in cases of malignancy, estrogen use, pregnancy, antiphospholipid syndrome (Hughes syndrome), or genomic mutations (eg, factor V Leiden mutation, prothrombin mutation, factor VIII mutations, protein C and protein S deficiency); venous stasis; and vascular endothelial damage, as possibly occasioned by hypertension or atherosclerotic disease.

In addition, it is important to confirm the presence or absence of a DVT. Follow evidence-based rules, such as the Wells score, to guide decision making. In Wells scoring, points are assigned for each of seven criteria, allowing the patient to be categorized by high, moderate, or low probability for PE. The Wells scoring criteria comprise
• Suspected DVT (3 points)
• PE the most likely diagnosis, or equally likely as a second diagnosis (3 points)
• Tachycardia (heart rate > 100 beats/min; 1.5 points)
• Immobilization for at least three days or surgery within the previous four weeks (1.5 points)
• History of DVT or PE (1.5 points)
• Hemoptysis (1 point)
• Malignancy with treatment within previous six months (1 point)

Patients with a total score exceeding 6 points are considered high-probability for PE and should undergo multidetector CT. Those with a score of 2 to 6 have moderate probability and should undergo high-sensitivity d-dimer testing; negative d-dimer results exclude PE and positive results warrant multidetector CT and lower-extremity ultrasound. In low-probability patients (Wells score below 2) with negative d-dimer results, PE is excluded; if d-dimer results are positive, multidetector CT should be ordered.

IN SUM
Extensive discussion of clinical predictive rules, diagnostic modalities, and treatment is beyond the scope of this comment. But clinicians should apply evidence-based decision-making rules to establish a diagnosis. And it should be apparent that hypoxic patients warrant close monitoring—particularly when a change of provider, service, or institution occurs. —DML

A 28-year-old man presented to a Maryland hospital emergency department (ED) with a two-day history of low-grade fever, nonproductive cough, and dizziness. He was also tachycardic and significantly hypoxic. After an hour’s wait, the patient saw an emergency physician, who noted complaints of weakness, shortness of breath, and lightheadedness. The differential diagnosis included pneumonia, congestive heart failure, and pulmonary embolism (PE).

After an ECG, chest x-ray, and blood work, the emergency physician diagnosed pneumonia and renal insufficiency. The patient was admitted but within eight hours of arrival at the ED was transferred to another hospital. The admitting physician at the second hospital did not evaluate the patient on admission.

Almost five hours later, the patient got out of bed and collapsed in the presence of his wife. A code was called, but the man never regained consciousness and was pronounced dead about 90 minutes later. An autopsy confirmed a PE as the cause of death.

Plaintiff for the decedent alleged negligence in the clinicians’ failure to diagnose and treat the PE. The plaintiff claimed that with proper treatment, the patient would have ­survived.

The defendants argued that there was no negligence involved and that heparin therapy would not have prevented the patient’s death.

What was the outcome? >>

OUTCOME
According to a published account, a $6.1 million verdict was returned.

COMMENT
This is a substantial verdict, reflecting the jury’s revulsion at the loss of a 28-year-old patient. His initial presentation of low-grade fever, nonproductive cough, and dizziness with tachycardia and hypoxia could be consistent with either pneumonia or PE. The facts as presented render the chest x-ray findings and the magnitude of hypoxia unclear. We also are not told whether any specific risk factors existed to make PE more likely, nor whether there was evidence of deep vein thrombosis (DVT) during presentation or at autopsy.

Diagnosing PE can be difficult. However, jurors confronted with a case involving a fatal PE may be led to believe that the diagnosis is straightforward and should never be missed. Plaintiff’s counsel will argue that the patient “would be standing here today” in a fully functional status if the diagnosis had been made.

Here, presumptively, the chest films and chest auscultation were suggestive of pneumonia and led the clinician, who actively considered PE, to ultimately exclude the possibility. It is not clear why the patient was transferred and not formally evaluated upon arrival at the second hospital, but the facts indicate that the patient was “significantly hypoxic.” This should have entailed close monitoring by the receiving clinician, irrespective of the diagnosis.

The pathophysiology of PE is straightforward—but the presentation is often variable and nonspecific and the diagnosis tricky. Thus, for the clinician confronted with a hypoxic patient, it is important to consider this diagnosis early and thoroughly. Evaluate for risk factors: hypercoagulability, as in cases of malignancy, estrogen use, pregnancy, antiphospholipid syndrome (Hughes syndrome), or genomic mutations (eg, factor V Leiden mutation, prothrombin mutation, factor VIII mutations, protein C and protein S deficiency); venous stasis; and vascular endothelial damage, as possibly occasioned by hypertension or atherosclerotic disease.

In addition, it is important to confirm the presence or absence of a DVT. Follow evidence-based rules, such as the Wells score, to guide decision making. In Wells scoring, points are assigned for each of seven criteria, allowing the patient to be categorized by high, moderate, or low probability for PE. The Wells scoring criteria comprise
• Suspected DVT (3 points)
• PE the most likely diagnosis, or equally likely as a second diagnosis (3 points)
• Tachycardia (heart rate > 100 beats/min; 1.5 points)
• Immobilization for at least three days or surgery within the previous four weeks (1.5 points)
• History of DVT or PE (1.5 points)
• Hemoptysis (1 point)
• Malignancy with treatment within previous six months (1 point)

Patients with a total score exceeding 6 points are considered high-probability for PE and should undergo multidetector CT. Those with a score of 2 to 6 have moderate probability and should undergo high-sensitivity d-dimer testing; negative d-dimer results exclude PE and positive results warrant multidetector CT and lower-extremity ultrasound. In low-probability patients (Wells score below 2) with negative d-dimer results, PE is excluded; if d-dimer results are positive, multidetector CT should be ordered.

IN SUM
Extensive discussion of clinical predictive rules, diagnostic modalities, and treatment is beyond the scope of this comment. But clinicians should apply evidence-based decision-making rules to establish a diagnosis. And it should be apparent that hypoxic patients warrant close monitoring—particularly when a change of provider, service, or institution occurs. —DML

A 28-year-old man presented to a Maryland hospital emergency department (ED) with a two-day history of low-grade fever, nonproductive cough, and dizziness. He was also tachycardic and significantly hypoxic. After an hour’s wait, the patient saw an emergency physician, who noted complaints of weakness, shortness of breath, and lightheadedness. The differential diagnosis included pneumonia, congestive heart failure, and pulmonary embolism (PE).

After an ECG, chest x-ray, and blood work, the emergency physician diagnosed pneumonia and renal insufficiency. The patient was admitted but within eight hours of arrival at the ED was transferred to another hospital. The admitting physician at the second hospital did not evaluate the patient on admission.

Almost five hours later, the patient got out of bed and collapsed in the presence of his wife. A code was called, but the man never regained consciousness and was pronounced dead about 90 minutes later. An autopsy confirmed a PE as the cause of death.

Plaintiff for the decedent alleged negligence in the clinicians’ failure to diagnose and treat the PE. The plaintiff claimed that with proper treatment, the patient would have ­survived.

The defendants argued that there was no negligence involved and that heparin therapy would not have prevented the patient’s death.

What was the outcome? >>

OUTCOME
According to a published account, a $6.1 million verdict was returned.

COMMENT
This is a substantial verdict, reflecting the jury’s revulsion at the loss of a 28-year-old patient. His initial presentation of low-grade fever, nonproductive cough, and dizziness with tachycardia and hypoxia could be consistent with either pneumonia or PE. The facts as presented render the chest x-ray findings and the magnitude of hypoxia unclear. We also are not told whether any specific risk factors existed to make PE more likely, nor whether there was evidence of deep vein thrombosis (DVT) during presentation or at autopsy.

Diagnosing PE can be difficult. However, jurors confronted with a case involving a fatal PE may be led to believe that the diagnosis is straightforward and should never be missed. Plaintiff’s counsel will argue that the patient “would be standing here today” in a fully functional status if the diagnosis had been made.

Here, presumptively, the chest films and chest auscultation were suggestive of pneumonia and led the clinician, who actively considered PE, to ultimately exclude the possibility. It is not clear why the patient was transferred and not formally evaluated upon arrival at the second hospital, but the facts indicate that the patient was “significantly hypoxic.” This should have entailed close monitoring by the receiving clinician, irrespective of the diagnosis.

The pathophysiology of PE is straightforward—but the presentation is often variable and nonspecific and the diagnosis tricky. Thus, for the clinician confronted with a hypoxic patient, it is important to consider this diagnosis early and thoroughly. Evaluate for risk factors: hypercoagulability, as in cases of malignancy, estrogen use, pregnancy, antiphospholipid syndrome (Hughes syndrome), or genomic mutations (eg, factor V Leiden mutation, prothrombin mutation, factor VIII mutations, protein C and protein S deficiency); venous stasis; and vascular endothelial damage, as possibly occasioned by hypertension or atherosclerotic disease.

In addition, it is important to confirm the presence or absence of a DVT. Follow evidence-based rules, such as the Wells score, to guide decision making. In Wells scoring, points are assigned for each of seven criteria, allowing the patient to be categorized by high, moderate, or low probability for PE. The Wells scoring criteria comprise
• Suspected DVT (3 points)
• PE the most likely diagnosis, or equally likely as a second diagnosis (3 points)
• Tachycardia (heart rate > 100 beats/min; 1.5 points)
• Immobilization for at least three days or surgery within the previous four weeks (1.5 points)
• History of DVT or PE (1.5 points)
• Hemoptysis (1 point)
• Malignancy with treatment within previous six months (1 point)

Patients with a total score exceeding 6 points are considered high-probability for PE and should undergo multidetector CT. Those with a score of 2 to 6 have moderate probability and should undergo high-sensitivity d-dimer testing; negative d-dimer results exclude PE and positive results warrant multidetector CT and lower-extremity ultrasound. In low-probability patients (Wells score below 2) with negative d-dimer results, PE is excluded; if d-dimer results are positive, multidetector CT should be ordered.

IN SUM
Extensive discussion of clinical predictive rules, diagnostic modalities, and treatment is beyond the scope of this comment. But clinicians should apply evidence-based decision-making rules to establish a diagnosis. And it should be apparent that hypoxic patients warrant close monitoring—particularly when a change of provider, service, or institution occurs. —DML

A 17-year-old girl with diminished appetite, abdominal pain, and vomiting presented to a pediatrics clinic in New York, where she was examined by an NP. She was found to have hematuria as well, and the NP diagnosed viral gastroenteritis.

Eight days later, the patient returned to the clinic with worsening pain. The pediatrician who examined her had her transported to a hospital, where a ruptured appendix was diagnosed. The patient underwent immediate surgery, which included resection of portions of her colon and intestines.

Despite a good recovery, the patient claimed that she suffers residual gastrointestinal dysfunction. She further claimed that the NP should have diagnosed appendicitis during her initial visit, which would have allowed for less invasive treatment.

Initially, the plaintiff brought suit against the clinic and several employees, but not the NP. She later moved to add the NP, but that motion was denied due to the statute of limitations. The clinic then impleaded the NP, arguing that it was her negligence in failing to diagnose the appendicitis.

The matter proceeded to trial against the NP and the clinic. The defendants claimed that the plaintiff’s symptoms did not suggest appendicitis at the time of the NP’s examination.

OUTCOME
A defense verdict was returned.

Continue for David M. Lang's comments >>

COMMENT
I used to tell students, “There are only two things in medicine that you need to know well: the common and the dangerous. For everything else, there is time.” I realize now that I sound like that guy from the Dos Equis commercial.

Consider this, however: If we don’t remember the difference between polymyositis and polymyalgia rheumatica, who cares? In such cases, we have time for review—and the patient will be better served by a clinician who has the intellectual curiosity to review conditions that he or she hasn’t seen in a while.

But the diseases that are both common and dangerous require our full proficiency. Basic competence requires us to be well versed in common diseases. And dangerous conditions, even if relatively rare, must be recognized and managed immediately. Entities that are common and dangerous—such as appendicitis—should enter our thoughts often.

In this case, we have a 17-year-old girl presenting to an outpatient clinic setting with abdominal pain, vomiting, and anorexia. Unfortunately, we are not given some important historical information, including duration and location of the pain and the presence or absence of pain migration. Physical exam findings are not described.

The trouble with appendicitis is that there is no single sign or symptom that can effectively diagnose it or exclude it from the differential. When evaluating a patient in a setting in which real-time laboratory testing is not generally ordered, clinicians must distinguish between self-limiting and dangerous abdominal pain. Where does that leave us in this case? Abdominal pain and vomiting are common, and ill patients frequently report anorexia.

Other clinical features associated with appendicitis may be more helpful. For example, pain migration has been described as “the most discriminating feature of the patient’s history,”¹ with a sensitivity and specificity of approximately 80%.² When present, psoas sign is fairly specific (0.95) but not sensitive (0.16).³

When evaluating patients in an outpatient setting, we have a snapshot of a disease process—a still frame of a movie. We are told what happened up to that point (with varying degrees of accuracy). But like the patient, we don’t know what will happen after he or she leaves the office: The still frame is gone, but the movie continues.

It can be helpful to inform patients of the concerning diagnoses in your differential and alert them to patterns of clinical progression that warrant return or immediate emergency department evaluation. Calling the patient to see how he or she is doing can be very useful for clinicians and generally highly valued and appreciated by patients. Here, if gastroenteritis were suspected, a phone call after a few hours of antiemetic and rehydration therapy may have been helpful to determine if the patient’s symptoms had improved. This, of course, would not be conclusive—but at least it would give the clinician additional information and the patient additional comfort.

In this case, the jury was persuaded that the NP provided good treatment and acted within the standard of care. Diagnosing appendicitis can be tricky, even under the best circumstances. The NP’s defense was probably aided by good documentation showing that appendicitis seemed less likely at the time of her evaluation. Ultimately, she performed well enough that her care withstood scrutiny from the plaintiff, the plaintiff’s expert witness, and eventually, her own practice.

This case was interesting from a legal perspective in that the plaintiff originally failed to file suit against the NP—probably resorting to liability under the theory of respondeat superior (generally, employer liability for employee actions). While the plaintiff was unsuccessful in adding the NP later, due to the statute of limitations, the NP was brought into the case by her own practice, through a procedure known as impleader. An impleader action is brought by a co-defendant. Under typical impleader rules, the defendant becomes a “third-party plaintiff” and brings suit against a “third-party defendant” (in this case, the practice and the NP, respectively).

IN SUM
Always keep important diagnoses in mind, and document well. Anticipate a changing clinical course, and instruct patients on how to respond to potential changes. In certain cases, we are well served to pick up the phone, check on the patient, and make the presentation less of a static picture and more of a dynamic movie. —DML

REFERENCES
1. Craig S, Brenner BE. Appendicitis (updated October 26, 2012). Medscape Reference. http://emedicine.medscape.com/article/773895-overview. Accessed January 16, 2015.
2. Yeh B. Evidence-based emergency medicine/rational clinical examination abstract: does this adult patient have appendicitis? Ann Emerg Med. 2008;52(3):301-303.
3. Wagner J, McKinney WP, Carpenter JL. Does this patient have appendicitis? JAMA. 1996;276(19):1589-1594.

A 17-year-old girl with diminished appetite, abdominal pain, and vomiting presented to a pediatrics clinic in New York, where she was examined by an NP. She was found to have hematuria as well, and the NP diagnosed viral gastroenteritis.

Eight days later, the patient returned to the clinic with worsening pain. The pediatrician who examined her had her transported to a hospital, where a ruptured appendix was diagnosed. The patient underwent immediate surgery, which included resection of portions of her colon and intestines.

Despite a good recovery, the patient claimed that she suffers residual gastrointestinal dysfunction. She further claimed that the NP should have diagnosed appendicitis during her initial visit, which would have allowed for less invasive treatment.

Initially, the plaintiff brought suit against the clinic and several employees, but not the NP. She later moved to add the NP, but that motion was denied due to the statute of limitations. The clinic then impleaded the NP, arguing that it was her negligence in failing to diagnose the appendicitis.

The matter proceeded to trial against the NP and the clinic. The defendants claimed that the plaintiff’s symptoms did not suggest appendicitis at the time of the NP’s examination.

OUTCOME
A defense verdict was returned.

Continue for David M. Lang's comments >>

COMMENT
I used to tell students, “There are only two things in medicine that you need to know well: the common and the dangerous. For everything else, there is time.” I realize now that I sound like that guy from the Dos Equis commercial.

Consider this, however: If we don’t remember the difference between polymyositis and polymyalgia rheumatica, who cares? In such cases, we have time for review—and the patient will be better served by a clinician who has the intellectual curiosity to review conditions that he or she hasn’t seen in a while.

But the diseases that are both common and dangerous require our full proficiency. Basic competence requires us to be well versed in common diseases. And dangerous conditions, even if relatively rare, must be recognized and managed immediately. Entities that are common and dangerous—such as appendicitis—should enter our thoughts often.

In this case, we have a 17-year-old girl presenting to an outpatient clinic setting with abdominal pain, vomiting, and anorexia. Unfortunately, we are not given some important historical information, including duration and location of the pain and the presence or absence of pain migration. Physical exam findings are not described.

The trouble with appendicitis is that there is no single sign or symptom that can effectively diagnose it or exclude it from the differential. When evaluating a patient in a setting in which real-time laboratory testing is not generally ordered, clinicians must distinguish between self-limiting and dangerous abdominal pain. Where does that leave us in this case? Abdominal pain and vomiting are common, and ill patients frequently report anorexia.

Other clinical features associated with appendicitis may be more helpful. For example, pain migration has been described as “the most discriminating feature of the patient’s history,”¹ with a sensitivity and specificity of approximately 80%.² When present, psoas sign is fairly specific (0.95) but not sensitive (0.16).³

When evaluating patients in an outpatient setting, we have a snapshot of a disease process—a still frame of a movie. We are told what happened up to that point (with varying degrees of accuracy). But like the patient, we don’t know what will happen after he or she leaves the office: The still frame is gone, but the movie continues.

It can be helpful to inform patients of the concerning diagnoses in your differential and alert them to patterns of clinical progression that warrant return or immediate emergency department evaluation. Calling the patient to see how he or she is doing can be very useful for clinicians and generally highly valued and appreciated by patients. Here, if gastroenteritis were suspected, a phone call after a few hours of antiemetic and rehydration therapy may have been helpful to determine if the patient’s symptoms had improved. This, of course, would not be conclusive—but at least it would give the clinician additional information and the patient additional comfort.

In this case, the jury was persuaded that the NP provided good treatment and acted within the standard of care. Diagnosing appendicitis can be tricky, even under the best circumstances. The NP’s defense was probably aided by good documentation showing that appendicitis seemed less likely at the time of her evaluation. Ultimately, she performed well enough that her care withstood scrutiny from the plaintiff, the plaintiff’s expert witness, and eventually, her own practice.

This case was interesting from a legal perspective in that the plaintiff originally failed to file suit against the NP—probably resorting to liability under the theory of respondeat superior (generally, employer liability for employee actions). While the plaintiff was unsuccessful in adding the NP later, due to the statute of limitations, the NP was brought into the case by her own practice, through a procedure known as impleader. An impleader action is brought by a co-defendant. Under typical impleader rules, the defendant becomes a “third-party plaintiff” and brings suit against a “third-party defendant” (in this case, the practice and the NP, respectively).

IN SUM
Always keep important diagnoses in mind, and document well. Anticipate a changing clinical course, and instruct patients on how to respond to potential changes. In certain cases, we are well served to pick up the phone, check on the patient, and make the presentation less of a static picture and more of a dynamic movie. —DML

REFERENCES
1. Craig S, Brenner BE. Appendicitis (updated October 26, 2012). Medscape Reference. http://emedicine.medscape.com/article/773895-overview. Accessed January 16, 2015.
2. Yeh B. Evidence-based emergency medicine/rational clinical examination abstract: does this adult patient have appendicitis? Ann Emerg Med. 2008;52(3):301-303.
3. Wagner J, McKinney WP, Carpenter JL. Does this patient have appendicitis? JAMA. 1996;276(19):1589-1594.

A 17-year-old girl with diminished appetite, abdominal pain, and vomiting presented to a pediatrics clinic in New York, where she was examined by an NP. She was found to have hematuria as well, and the NP diagnosed viral gastroenteritis.

Eight days later, the patient returned to the clinic with worsening pain. The pediatrician who examined her had her transported to a hospital, where a ruptured appendix was diagnosed. The patient underwent immediate surgery, which included resection of portions of her colon and intestines.

Despite a good recovery, the patient claimed that she suffers residual gastrointestinal dysfunction. She further claimed that the NP should have diagnosed appendicitis during her initial visit, which would have allowed for less invasive treatment.

Initially, the plaintiff brought suit against the clinic and several employees, but not the NP. She later moved to add the NP, but that motion was denied due to the statute of limitations. The clinic then impleaded the NP, arguing that it was her negligence in failing to diagnose the appendicitis.

The matter proceeded to trial against the NP and the clinic. The defendants claimed that the plaintiff’s symptoms did not suggest appendicitis at the time of the NP’s examination.

OUTCOME
A defense verdict was returned.

Continue for David M. Lang's comments >>

COMMENT
I used to tell students, “There are only two things in medicine that you need to know well: the common and the dangerous. For everything else, there is time.” I realize now that I sound like that guy from the Dos Equis commercial.

Consider this, however: If we don’t remember the difference between polymyositis and polymyalgia rheumatica, who cares? In such cases, we have time for review—and the patient will be better served by a clinician who has the intellectual curiosity to review conditions that he or she hasn’t seen in a while.

But the diseases that are both common and dangerous require our full proficiency. Basic competence requires us to be well versed in common diseases. And dangerous conditions, even if relatively rare, must be recognized and managed immediately. Entities that are common and dangerous—such as appendicitis—should enter our thoughts often.

In this case, we have a 17-year-old girl presenting to an outpatient clinic setting with abdominal pain, vomiting, and anorexia. Unfortunately, we are not given some important historical information, including duration and location of the pain and the presence or absence of pain migration. Physical exam findings are not described.

The trouble with appendicitis is that there is no single sign or symptom that can effectively diagnose it or exclude it from the differential. When evaluating a patient in a setting in which real-time laboratory testing is not generally ordered, clinicians must distinguish between self-limiting and dangerous abdominal pain. Where does that leave us in this case? Abdominal pain and vomiting are common, and ill patients frequently report anorexia.

Other clinical features associated with appendicitis may be more helpful. For example, pain migration has been described as “the most discriminating feature of the patient’s history,”¹ with a sensitivity and specificity of approximately 80%.² When present, psoas sign is fairly specific (0.95) but not sensitive (0.16).³

When evaluating patients in an outpatient setting, we have a snapshot of a disease process—a still frame of a movie. We are told what happened up to that point (with varying degrees of accuracy). But like the patient, we don’t know what will happen after he or she leaves the office: The still frame is gone, but the movie continues.

It can be helpful to inform patients of the concerning diagnoses in your differential and alert them to patterns of clinical progression that warrant return or immediate emergency department evaluation. Calling the patient to see how he or she is doing can be very useful for clinicians and generally highly valued and appreciated by patients. Here, if gastroenteritis were suspected, a phone call after a few hours of antiemetic and rehydration therapy may have been helpful to determine if the patient’s symptoms had improved. This, of course, would not be conclusive—but at least it would give the clinician additional information and the patient additional comfort.

In this case, the jury was persuaded that the NP provided good treatment and acted within the standard of care. Diagnosing appendicitis can be tricky, even under the best circumstances. The NP’s defense was probably aided by good documentation showing that appendicitis seemed less likely at the time of her evaluation. Ultimately, she performed well enough that her care withstood scrutiny from the plaintiff, the plaintiff’s expert witness, and eventually, her own practice.

This case was interesting from a legal perspective in that the plaintiff originally failed to file suit against the NP—probably resorting to liability under the theory of respondeat superior (generally, employer liability for employee actions). While the plaintiff was unsuccessful in adding the NP later, due to the statute of limitations, the NP was brought into the case by her own practice, through a procedure known as impleader. An impleader action is brought by a co-defendant. Under typical impleader rules, the defendant becomes a “third-party plaintiff” and brings suit against a “third-party defendant” (in this case, the practice and the NP, respectively).

IN SUM
Always keep important diagnoses in mind, and document well. Anticipate a changing clinical course, and instruct patients on how to respond to potential changes. In certain cases, we are well served to pick up the phone, check on the patient, and make the presentation less of a static picture and more of a dynamic movie. —DML

REFERENCES
1. Craig S, Brenner BE. Appendicitis (updated October 26, 2012). Medscape Reference. http://emedicine.medscape.com/article/773895-overview. Accessed January 16, 2015.
2. Yeh B. Evidence-based emergency medicine/rational clinical examination abstract: does this adult patient have appendicitis? Ann Emerg Med. 2008;52(3):301-303.
3. Wagner J, McKinney WP, Carpenter JL. Does this patient have appendicitis? JAMA. 1996;276(19):1589-1594.

A 57-year-old woman sustained an injury to her left shoulder during a fall down stairs. She presented to the emergency department, where a physician ordered x-rays that a radiologist interpreted as depicting a simple fracture.

The patient claimed that the radiologist misread the x-rays and that the emergency medicine (EM) physician failed to realize her pain was out of proportion to a fracture. She said the EM physician should have ordered additional tests and sought a radiologic consult. The patient contended that she had actually dislocated her shoulder and that the delay in treatment caused her condition to worsen, leaving her unable to use her left hand.

In addition to the radiologist and the EM physician, two nurses were named as defendants. The plaintiff maintained that they had failed to notify the physician when her condition deteriorated.

OUTCOME
A $2.75 million settlement was reached. The hospital, the EM physician, and the nurses were responsible for $1.5 million and the radiologist, $1.25 million.

Continue for David M. Lang's comments >>

COMMENT
Although complex regional pain syndrome (CRPS, formerly known as reflex sympathetic dystrophy) is not specifically mentioned in this case synopsis, the size of the settlement suggests that it was likely claimed as the resulting injury. CRPS is frequently a source of litigation.

Relatively minor trauma can lead to CRPS; why only certain patients subsequently develop the syndrome, however, is a mystery. What is certain is that CRPS is recognized as one of the most painful conditions known to humankind. Once it develops, the syndrome can result in constant, debilitating pain, the loss of a limb, and near-total decay of a patient’s quality of life.

Plaintiffs’ attorneys are quick to claim negligence and substantial damages for these patients, with their sad, compelling stories. Because the underlying pathophysiology of CRPS is unclear, liability is often hotly debated, with cases difficult to defend.

Malpractice cases generally involve two elements: liability (the presence and magnitude of the error) and damages (the severity of the injury and impact on life). CRPS cases are often considered “damages” cases, because while liability may be uncertain, the patient’s damages are very clear. An understandingly sympathetic jury panel sees the unfortunate patient’s red, swollen, misshapen limb, hears the story of the patient’s ever-present, exquisite pain, and (based largely on human emotion) infers negligence based on the magnitude of the patient’s suffering.

In this case, the patient sustained a shoulder injury in a fall that was initially treated as a fracture (presumptively proximal) but later determined to be a dislocation. Management of the injury was not described, but we can assume that if a fracture was diagnosed, the shoulder joint was immobilized. The plaintiff did not claim that there were any diminished neurovascular findings at the time of injury. We are not told whether follow-up was arranged for the patient, what the final, full diagnosis was (eg, fracture/anterior dislocation of the proximal humerus), or when/if the shoulder was actively reduced.

Under these circumstances, what could a bedside clinician have done differently? The most prominent element is the report of “pain out of proportion to the diagnosis.” When confronted with pain that seems out of proportion to a limb injury, stop and review the case. Be sure to consider occult or evolving neurovascular injury (eg, compartment syndrome, brachial plexus injury). Seek consultation and a second opinion in cases involving pain that seems intractable and out of proportion.

One quick word about pain and drug-seeking behavior. Many of us are all too familiar with patients who overstate their symptoms to obtain narcotic pain medications. Will you encounter drug seekers who embellish their level of pain to obtain narcotics? You know the answer to that question.

But it is necessary to take an injured patient’s claim of pain as stated. Don’t view yourself as “wrong” or “fooled” if patients misstate their level of pain and you respond accordingly. In many cases, there is no way to differentiate between genuine manifestations of pain and gamesmanship. To attempt to do so is dangerous because it may lead you to dismiss a patient with genuine pain for fear of being “fooled.” Don’t. Few situations will irritate a jury more than a patient with genuine pathology who is wrongly considered a “drug seeker.” Take patients at face value and act appropriately if substance misuse is later discovered.

In this case, recognition of ­out-of-control pain may have resulted in an orthopedic consultation. At minimum, that would demonstrate that the patient’s pain was taken seriously and the clinicians acted with due concern for her.  —DML

A 57-year-old woman sustained an injury to her left shoulder during a fall down stairs. She presented to the emergency department, where a physician ordered x-rays that a radiologist interpreted as depicting a simple fracture.

The patient claimed that the radiologist misread the x-rays and that the emergency medicine (EM) physician failed to realize her pain was out of proportion to a fracture. She said the EM physician should have ordered additional tests and sought a radiologic consult. The patient contended that she had actually dislocated her shoulder and that the delay in treatment caused her condition to worsen, leaving her unable to use her left hand.

In addition to the radiologist and the EM physician, two nurses were named as defendants. The plaintiff maintained that they had failed to notify the physician when her condition deteriorated.

OUTCOME
A $2.75 million settlement was reached. The hospital, the EM physician, and the nurses were responsible for $1.5 million and the radiologist, $1.25 million.

Continue for David M. Lang's comments >>

COMMENT
Although complex regional pain syndrome (CRPS, formerly known as reflex sympathetic dystrophy) is not specifically mentioned in this case synopsis, the size of the settlement suggests that it was likely claimed as the resulting injury. CRPS is frequently a source of litigation.

Relatively minor trauma can lead to CRPS; why only certain patients subsequently develop the syndrome, however, is a mystery. What is certain is that CRPS is recognized as one of the most painful conditions known to humankind. Once it develops, the syndrome can result in constant, debilitating pain, the loss of a limb, and near-total decay of a patient’s quality of life.

Plaintiffs’ attorneys are quick to claim negligence and substantial damages for these patients, with their sad, compelling stories. Because the underlying pathophysiology of CRPS is unclear, liability is often hotly debated, with cases difficult to defend.

Malpractice cases generally involve two elements: liability (the presence and magnitude of the error) and damages (the severity of the injury and impact on life). CRPS cases are often considered “damages” cases, because while liability may be uncertain, the patient’s damages are very clear. An understandingly sympathetic jury panel sees the unfortunate patient’s red, swollen, misshapen limb, hears the story of the patient’s ever-present, exquisite pain, and (based largely on human emotion) infers negligence based on the magnitude of the patient’s suffering.

In this case, the patient sustained a shoulder injury in a fall that was initially treated as a fracture (presumptively proximal) but later determined to be a dislocation. Management of the injury was not described, but we can assume that if a fracture was diagnosed, the shoulder joint was immobilized. The plaintiff did not claim that there were any diminished neurovascular findings at the time of injury. We are not told whether follow-up was arranged for the patient, what the final, full diagnosis was (eg, fracture/anterior dislocation of the proximal humerus), or when/if the shoulder was actively reduced.

Under these circumstances, what could a bedside clinician have done differently? The most prominent element is the report of “pain out of proportion to the diagnosis.” When confronted with pain that seems out of proportion to a limb injury, stop and review the case. Be sure to consider occult or evolving neurovascular injury (eg, compartment syndrome, brachial plexus injury). Seek consultation and a second opinion in cases involving pain that seems intractable and out of proportion.

One quick word about pain and drug-seeking behavior. Many of us are all too familiar with patients who overstate their symptoms to obtain narcotic pain medications. Will you encounter drug seekers who embellish their level of pain to obtain narcotics? You know the answer to that question.

But it is necessary to take an injured patient’s claim of pain as stated. Don’t view yourself as “wrong” or “fooled” if patients misstate their level of pain and you respond accordingly. In many cases, there is no way to differentiate between genuine manifestations of pain and gamesmanship. To attempt to do so is dangerous because it may lead you to dismiss a patient with genuine pain for fear of being “fooled.” Don’t. Few situations will irritate a jury more than a patient with genuine pathology who is wrongly considered a “drug seeker.” Take patients at face value and act appropriately if substance misuse is later discovered.

In this case, recognition of ­out-of-control pain may have resulted in an orthopedic consultation. At minimum, that would demonstrate that the patient’s pain was taken seriously and the clinicians acted with due concern for her.  —DML

A 57-year-old woman sustained an injury to her left shoulder during a fall down stairs. She presented to the emergency department, where a physician ordered x-rays that a radiologist interpreted as depicting a simple fracture.

The patient claimed that the radiologist misread the x-rays and that the emergency medicine (EM) physician failed to realize her pain was out of proportion to a fracture. She said the EM physician should have ordered additional tests and sought a radiologic consult. The patient contended that she had actually dislocated her shoulder and that the delay in treatment caused her condition to worsen, leaving her unable to use her left hand.

In addition to the radiologist and the EM physician, two nurses were named as defendants. The plaintiff maintained that they had failed to notify the physician when her condition deteriorated.

OUTCOME
A $2.75 million settlement was reached. The hospital, the EM physician, and the nurses were responsible for $1.5 million and the radiologist, $1.25 million.

Continue for David M. Lang's comments >>

COMMENT
Although complex regional pain syndrome (CRPS, formerly known as reflex sympathetic dystrophy) is not specifically mentioned in this case synopsis, the size of the settlement suggests that it was likely claimed as the resulting injury. CRPS is frequently a source of litigation.

Relatively minor trauma can lead to CRPS; why only certain patients subsequently develop the syndrome, however, is a mystery. What is certain is that CRPS is recognized as one of the most painful conditions known to humankind. Once it develops, the syndrome can result in constant, debilitating pain, the loss of a limb, and near-total decay of a patient’s quality of life.

Plaintiffs’ attorneys are quick to claim negligence and substantial damages for these patients, with their sad, compelling stories. Because the underlying pathophysiology of CRPS is unclear, liability is often hotly debated, with cases difficult to defend.

Malpractice cases generally involve two elements: liability (the presence and magnitude of the error) and damages (the severity of the injury and impact on life). CRPS cases are often considered “damages” cases, because while liability may be uncertain, the patient’s damages are very clear. An understandingly sympathetic jury panel sees the unfortunate patient’s red, swollen, misshapen limb, hears the story of the patient’s ever-present, exquisite pain, and (based largely on human emotion) infers negligence based on the magnitude of the patient’s suffering.

In this case, the patient sustained a shoulder injury in a fall that was initially treated as a fracture (presumptively proximal) but later determined to be a dislocation. Management of the injury was not described, but we can assume that if a fracture was diagnosed, the shoulder joint was immobilized. The plaintiff did not claim that there were any diminished neurovascular findings at the time of injury. We are not told whether follow-up was arranged for the patient, what the final, full diagnosis was (eg, fracture/anterior dislocation of the proximal humerus), or when/if the shoulder was actively reduced.

Under these circumstances, what could a bedside clinician have done differently? The most prominent element is the report of “pain out of proportion to the diagnosis.” When confronted with pain that seems out of proportion to a limb injury, stop and review the case. Be sure to consider occult or evolving neurovascular injury (eg, compartment syndrome, brachial plexus injury). Seek consultation and a second opinion in cases involving pain that seems intractable and out of proportion.

One quick word about pain and drug-seeking behavior. Many of us are all too familiar with patients who overstate their symptoms to obtain narcotic pain medications. Will you encounter drug seekers who embellish their level of pain to obtain narcotics? You know the answer to that question.

But it is necessary to take an injured patient’s claim of pain as stated. Don’t view yourself as “wrong” or “fooled” if patients misstate their level of pain and you respond accordingly. In many cases, there is no way to differentiate between genuine manifestations of pain and gamesmanship. To attempt to do so is dangerous because it may lead you to dismiss a patient with genuine pain for fear of being “fooled.” Don’t. Few situations will irritate a jury more than a patient with genuine pathology who is wrongly considered a “drug seeker.” Take patients at face value and act appropriately if substance misuse is later discovered.

In this case, recognition of ­out-of-control pain may have resulted in an orthopedic consultation. At minimum, that would demonstrate that the patient’s pain was taken seriously and the clinicians acted with due concern for her.  —DML

A 17-year-old girl underwent a routine tonsillectomy without complications at a surgical center. Following the procedure, she was taken to the recovery room and administered fentanyl for pain. 

The recovery room nurse assigned to monitor the patient spent 20 minutes treating another patient and then went on break, signing out to a second recovery room nurse. On receiving the sign­out, the second recovery room nurse discovered that the patient was in respiratory distress and began resuscitation efforts. The patient was resuscitated but died 15 days later.

The plaintiff claimed that the girl was left unmonitored by nurses assigned to the unit and that the monitoring equipment was not used, not set properly, or muted.
During her deposition, the second recovery room nurse admitted under oath that the first recovery room nurse falsified the patient’s chart; the first nurse claimed that she had assessed the patient during an important time period when she had not.  

Continue for the outcome and commentary >>

OUTCOME
The case was settled for $6 million: $1 million against the surgical center’s primary policy and $5 million against its excess policy.

COMMENT
Cases such as this one are unfortunate and avoidable—and tragically, too common. On any medical malpractice lawyer’s desk is a teetering stack of potential cases; much of that stack involves narcotics. This case raises two important areas to discuss: the dangers of parenteral narcotics and the perils of falsifying medical records.

First, when parenteral narcotics are given, proper monitoring safeguards must be in place. Malpractice cases frequently involve a scenario in which patients are given parenteral narcotics and left alone, out of sight, and unmonitored. This simply can’t be done. Close supervision and monitoring—with both equipment and eyes—are required to safeguard your patients and avoid malpractice risk. 

Other malpractice scenarios involve the ambulatory patient who is given parenteral narcotics in a clinic setting and discharged after a 10-minute “observation” period—a period during which peak drug effect is probably not realized. The patient is unsafely discharged before that peak is reached and suffers potentially fatal adverse effects. Even when direct fatal effects are not realized, the patient is discharged with impaired motor coordination and cognitive judgment, placing the patient at risk in his/her surroundings.

If a clinician commits to giving parenteral narcotics, he or she commits to providing “real-time” monitoring until the narcotic effects have safely diminished and the patient’s condition is thoroughly documented in the record. Generally speaking, the patient must be reasonably clear of the effects of narcotics before discharge. (Remember the special case of naloxone, administered for opiate excesses, in which naloxone is metabolized before the opiate; the patient can relapse into a coma/apnea if the naloxone fully metabolizes before the opiate.)

Here, this young woman was probably opiate naïve. While the amount she was given was certain, her response to the drug was not. She was left alone for at least 20 minutes and did not have a functioning SaO₂ monitor. Close monitoring of this patient was required but not provided.

As a result of this case, the surgical center changed several policies: Nurses must be on a one-to-one ratio with patients who have received narcotics during anesthesia. Furthermore, nurses must have line-of-sight to see patients at all times and, importantly, may not mute monitors (eg, oximetry monitors). 

The second salient point of this case is never, ever alter or falsify patient records! It will be discovered, and your credibility will be irretrievably damaged. Plaintiff lawyers live for this, and yet clinicians continue to do it. Don’t.

When altered medical records are discovered, the plaintiff’s theory of the case will be “cover up,” and jurors will be invited to punish the clinician for it. The jurors will do so. 

Also problematic is an otherwise defensible case that becomes much more difficult to defend because a clinician has altered the records. Remember, the plaintiff must prove all aspects of negligence, including causation and damages. In some cases, the clinician knows an obvious mistake was made but does not know that the eventual damages may be minimal or attributable to another cause. By altering the medical record, the clinician may enhance the damages value of a case by introducing a punitive element. Altering records may result in a lawsuit being filed when it otherwise wouldn’t have, or maintained when it would have been dropped before trial. In sum, don’t create a case against yourself by altering the medical records. 

Here, the falsification of records came to light during the deposition of the second nurse—who, being under oath, probably had little choice but to testify that the first nurse falsified the records. No doubt, this falsification made a bad case worse and gave the plaintiff leverage in securing more favorable settlement terms. 

You can’t make it right by rewriting history, but you can make it right by showing concern for the patient in your actions following a problem. You can also make it right by troubleshooting problems in a closed-door, formal peer review conference. Peer review conferences are designed for full and frank communication between clinicians and staff to solve problems, and as such they are protected from plaintiff disclosure.

This is an unfortunate case and a tragic loss of life. As clinicians, we must respect the potential life-ending power of parenteral narcotics. —DML

A 17-year-old girl underwent a routine tonsillectomy without complications at a surgical center. Following the procedure, she was taken to the recovery room and administered fentanyl for pain. 

The recovery room nurse assigned to monitor the patient spent 20 minutes treating another patient and then went on break, signing out to a second recovery room nurse. On receiving the sign­out, the second recovery room nurse discovered that the patient was in respiratory distress and began resuscitation efforts. The patient was resuscitated but died 15 days later.

The plaintiff claimed that the girl was left unmonitored by nurses assigned to the unit and that the monitoring equipment was not used, not set properly, or muted.
During her deposition, the second recovery room nurse admitted under oath that the first recovery room nurse falsified the patient’s chart; the first nurse claimed that she had assessed the patient during an important time period when she had not.  

Continue for the outcome and commentary >>

OUTCOME
The case was settled for $6 million: $1 million against the surgical center’s primary policy and $5 million against its excess policy.

COMMENT
Cases such as this one are unfortunate and avoidable—and tragically, too common. On any medical malpractice lawyer’s desk is a teetering stack of potential cases; much of that stack involves narcotics. This case raises two important areas to discuss: the dangers of parenteral narcotics and the perils of falsifying medical records.

First, when parenteral narcotics are given, proper monitoring safeguards must be in place. Malpractice cases frequently involve a scenario in which patients are given parenteral narcotics and left alone, out of sight, and unmonitored. This simply can’t be done. Close supervision and monitoring—with both equipment and eyes—are required to safeguard your patients and avoid malpractice risk. 

Other malpractice scenarios involve the ambulatory patient who is given parenteral narcotics in a clinic setting and discharged after a 10-minute “observation” period—a period during which peak drug effect is probably not realized. The patient is unsafely discharged before that peak is reached and suffers potentially fatal adverse effects. Even when direct fatal effects are not realized, the patient is discharged with impaired motor coordination and cognitive judgment, placing the patient at risk in his/her surroundings.

If a clinician commits to giving parenteral narcotics, he or she commits to providing “real-time” monitoring until the narcotic effects have safely diminished and the patient’s condition is thoroughly documented in the record. Generally speaking, the patient must be reasonably clear of the effects of narcotics before discharge. (Remember the special case of naloxone, administered for opiate excesses, in which naloxone is metabolized before the opiate; the patient can relapse into a coma/apnea if the naloxone fully metabolizes before the opiate.)

Here, this young woman was probably opiate naïve. While the amount she was given was certain, her response to the drug was not. She was left alone for at least 20 minutes and did not have a functioning SaO₂ monitor. Close monitoring of this patient was required but not provided.

As a result of this case, the surgical center changed several policies: Nurses must be on a one-to-one ratio with patients who have received narcotics during anesthesia. Furthermore, nurses must have line-of-sight to see patients at all times and, importantly, may not mute monitors (eg, oximetry monitors). 

The second salient point of this case is never, ever alter or falsify patient records! It will be discovered, and your credibility will be irretrievably damaged. Plaintiff lawyers live for this, and yet clinicians continue to do it. Don’t.

When altered medical records are discovered, the plaintiff’s theory of the case will be “cover up,” and jurors will be invited to punish the clinician for it. The jurors will do so. 

Also problematic is an otherwise defensible case that becomes much more difficult to defend because a clinician has altered the records. Remember, the plaintiff must prove all aspects of negligence, including causation and damages. In some cases, the clinician knows an obvious mistake was made but does not know that the eventual damages may be minimal or attributable to another cause. By altering the medical record, the clinician may enhance the damages value of a case by introducing a punitive element. Altering records may result in a lawsuit being filed when it otherwise wouldn’t have, or maintained when it would have been dropped before trial. In sum, don’t create a case against yourself by altering the medical records. 

Here, the falsification of records came to light during the deposition of the second nurse—who, being under oath, probably had little choice but to testify that the first nurse falsified the records. No doubt, this falsification made a bad case worse and gave the plaintiff leverage in securing more favorable settlement terms. 

You can’t make it right by rewriting history, but you can make it right by showing concern for the patient in your actions following a problem. You can also make it right by troubleshooting problems in a closed-door, formal peer review conference. Peer review conferences are designed for full and frank communication between clinicians and staff to solve problems, and as such they are protected from plaintiff disclosure.

This is an unfortunate case and a tragic loss of life. As clinicians, we must respect the potential life-ending power of parenteral narcotics. —DML

A 17-year-old girl underwent a routine tonsillectomy without complications at a surgical center. Following the procedure, she was taken to the recovery room and administered fentanyl for pain. 

The recovery room nurse assigned to monitor the patient spent 20 minutes treating another patient and then went on break, signing out to a second recovery room nurse. On receiving the sign­out, the second recovery room nurse discovered that the patient was in respiratory distress and began resuscitation efforts. The patient was resuscitated but died 15 days later.

The plaintiff claimed that the girl was left unmonitored by nurses assigned to the unit and that the monitoring equipment was not used, not set properly, or muted.
During her deposition, the second recovery room nurse admitted under oath that the first recovery room nurse falsified the patient’s chart; the first nurse claimed that she had assessed the patient during an important time period when she had not.  

Continue for the outcome and commentary >>

OUTCOME
The case was settled for $6 million: $1 million against the surgical center’s primary policy and $5 million against its excess policy.

COMMENT
Cases such as this one are unfortunate and avoidable—and tragically, too common. On any medical malpractice lawyer’s desk is a teetering stack of potential cases; much of that stack involves narcotics. This case raises two important areas to discuss: the dangers of parenteral narcotics and the perils of falsifying medical records.

First, when parenteral narcotics are given, proper monitoring safeguards must be in place. Malpractice cases frequently involve a scenario in which patients are given parenteral narcotics and left alone, out of sight, and unmonitored. This simply can’t be done. Close supervision and monitoring—with both equipment and eyes—are required to safeguard your patients and avoid malpractice risk. 

Other malpractice scenarios involve the ambulatory patient who is given parenteral narcotics in a clinic setting and discharged after a 10-minute “observation” period—a period during which peak drug effect is probably not realized. The patient is unsafely discharged before that peak is reached and suffers potentially fatal adverse effects. Even when direct fatal effects are not realized, the patient is discharged with impaired motor coordination and cognitive judgment, placing the patient at risk in his/her surroundings.

If a clinician commits to giving parenteral narcotics, he or she commits to providing “real-time” monitoring until the narcotic effects have safely diminished and the patient’s condition is thoroughly documented in the record. Generally speaking, the patient must be reasonably clear of the effects of narcotics before discharge. (Remember the special case of naloxone, administered for opiate excesses, in which naloxone is metabolized before the opiate; the patient can relapse into a coma/apnea if the naloxone fully metabolizes before the opiate.)

Here, this young woman was probably opiate naïve. While the amount she was given was certain, her response to the drug was not. She was left alone for at least 20 minutes and did not have a functioning SaO₂ monitor. Close monitoring of this patient was required but not provided.

As a result of this case, the surgical center changed several policies: Nurses must be on a one-to-one ratio with patients who have received narcotics during anesthesia. Furthermore, nurses must have line-of-sight to see patients at all times and, importantly, may not mute monitors (eg, oximetry monitors). 

The second salient point of this case is never, ever alter or falsify patient records! It will be discovered, and your credibility will be irretrievably damaged. Plaintiff lawyers live for this, and yet clinicians continue to do it. Don’t.

When altered medical records are discovered, the plaintiff’s theory of the case will be “cover up,” and jurors will be invited to punish the clinician for it. The jurors will do so. 

Also problematic is an otherwise defensible case that becomes much more difficult to defend because a clinician has altered the records. Remember, the plaintiff must prove all aspects of negligence, including causation and damages. In some cases, the clinician knows an obvious mistake was made but does not know that the eventual damages may be minimal or attributable to another cause. By altering the medical record, the clinician may enhance the damages value of a case by introducing a punitive element. Altering records may result in a lawsuit being filed when it otherwise wouldn’t have, or maintained when it would have been dropped before trial. In sum, don’t create a case against yourself by altering the medical records. 

Here, the falsification of records came to light during the deposition of the second nurse—who, being under oath, probably had little choice but to testify that the first nurse falsified the records. No doubt, this falsification made a bad case worse and gave the plaintiff leverage in securing more favorable settlement terms. 

You can’t make it right by rewriting history, but you can make it right by showing concern for the patient in your actions following a problem. You can also make it right by troubleshooting problems in a closed-door, formal peer review conference. Peer review conferences are designed for full and frank communication between clinicians and staff to solve problems, and as such they are protected from plaintiff disclosure.

This is an unfortunate case and a tragic loss of life. As clinicians, we must respect the potential life-ending power of parenteral narcotics. —DML