Law & Medicine

Question: A patient alleges that an ophthalmologist was negligent in performing blepharoplasty. The surgical site became infected and left the patient with a disfigured eye. An infectious disease specialist was to testify as plaintiff’s expert, but the defense, relying on a state statute, objected that the expert-to-be had no specialized training in ophthalmology.

Correct statements about expert medical testimony include the following, except:

A. The federal Rules of Evidence require that an expert possess the relevant knowledge, skill, education, training, or experience.

B. Only a few states have enacted statutes specifying that an expert must be in the same or similar specialty as the defendant.

C. Advocates contend that such statutes reduce frivolous lawsuits by limiting expert shopping and the use of “hired guns.”

D. It is the sitting judge, not the jury, who interprets the statute and decides whether a witness qualifies as an expert.

E. In some cases, a nondoctor such as a nurse or pharmacist may be allowed to offer expert testimony against a doctor.

Answer: B. Lay testimony is usually insufficient to define the standard of care in a claim of medical malpractice, and “the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony” (Craft v. Peebles, 893 P.2d 138 [Haw.1995]). Court rules of evidence dictate that the expert must possess the knowledge, skill, experience, training, or education for establishing that standard.

In coming to an opinion, the expert may rely on external evidence in the form of a book, treatise, or article; and although these sources represent hearsay evidence, they are admissible to enable the expert witness to form his/her opinion.

The facts of the multiple-choice question above are taken from a recent case (Edwards v. Sunrise Ophthalmology ASC, LLC, 134 So. 3d 1056 [Fla. 4th DCA 2013]), whose appeal is yet to be heard by the Florida Supreme Court. The plaintiff alleged that the surgical site was infected with nocardia during a lower-lid blepharoplasty, which caused her to undergo additional surgery with resulting disfigurement of the eye.

A lower court disqualified the plaintiff’s expert, an infectious disease specialist, based on a Florida statute stipulating that expert medical opinion can be offered only by one in the “same or similar specialty” (Section 766.102, Florida Statutes (2009)). In the words of the court, “Simply put, the infectious disease doctor is not an eye surgeon, nor is the ophthalmologist an infectious disease doctor.”

More than half of all the states have a medical-expert law, many with language comparable to the Florida statute. The idea behind such a statute, frequently enacted as part of a state’s tort reform, is to limit expert shopping and the use of hired guns and “junk science.”

Unsurprisingly, litigation abounds over the statutory language.

For example, a Maryland court ruled that a vascular surgeon was qualified to set the standard of care when an orthopedic surgeon’s alleged negligence caused a patient to lose a leg following knee surgery. The court found the two specialties to be “related,” because the orthopedic complication was vascular in origin.

In some jurisdictions without strict statutory requirements, doctors are more likely to be allowed to testify outside their specialty.

Instances of professionals of unlike specialties qualifying as experts include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores. Georgia requires only that an expert show significant familiarity with the area of practice in which the expert opinion is to be given. Still, in a sleep apnea case (Nathans v. Diamond, 654 S.E.2d 121 [Ga. 2007]), the court held that a pulmonologist was not qualified to testify on the standard of surgical care provided by an otolaryngologist.

Besides arguing over the statutory language, litigants have also raised questions of constitutionality. For example, Arizona’s statute ARS §12-2604 (A) requires a medical expert to be a specialist who is actively practicing or teaching in that area of medicine. The state court of appeals held that this violated the separation of powers doctrine (conflicting with Arizona Rule of Evidence 702), but the Supreme Court of Arizona subsequently reversed and reinstated the law (Seisinger v. Siebel, 203 P.3d 483 [Ariz. 2009]).

More recently, the same court upheld the constitutionality of the requirement that an expert share “the same specialty” as the treating physician, and disqualified an adult hematologist from serving as an expert because the defendant was a pediatric hematologist, not an adult hematologist (Baker v. University Physicians Healthcare, 296 P.3d 42 [Ariz. 2013]).

Another issue deals with the locality rule. In an Illinois case, the court accepted an out-of-state plaintiff expert based on his qualifications, competency, and familiarity with standards in the defendant’s community. The case dealt with the development of a rectovaginal fistula that complicated an episiotomy during delivery (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]).

The defense attempted to exclude the expert, alleging the lack of familiarity with the standards in the community (Rantoul, Ill.). However, the expert stated that he was familiar with the minimum standards of medical practice in relation to the diagnosis and treatment of rectovaginal fistulae, and those minimum standards were uniform throughout the country.

It is not necessary that the expert witness has the highest possible qualifications to testify about a particular matter. Still, in Domingo v. T.K. (289 F.3d 600 [9th Cir. 2002]), a federal court excluded the testimony of the plaintiff’s expert witness, because it lacked reliability. The plaintiff developed brain damage from fat embolism following hip surgery, and alleged that prolonged malleting of a hip prosthesis was the cause of the fat embolism syndrome (FES).

The court found that “there was no evidence of widespread acceptance of Dr. Harrington’s theory linking extended malleting to FES; indeed, no theory linking extensive malleting to FES had ever been published.” It also noted the lack of any objective source, peer review, clinical tests, establishment of an error rate or other evidence to show that Dr. Harrington followed a valid, scientific method in developing his theory.

Being disqualified as an expert is one thing, but a recent case goes further. In addition to dismissing an expert’s testimony, a state judge barred the expert from ever testifying in his courtroom after it was determined that the testimony was untruthful.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected]

Question: A patient alleges that an ophthalmologist was negligent in performing blepharoplasty. The surgical site became infected and left the patient with a disfigured eye. An infectious disease specialist was to testify as plaintiff’s expert, but the defense, relying on a state statute, objected that the expert-to-be had no specialized training in ophthalmology.

Correct statements about expert medical testimony include the following, except:

A. The federal Rules of Evidence require that an expert possess the relevant knowledge, skill, education, training, or experience.

B. Only a few states have enacted statutes specifying that an expert must be in the same or similar specialty as the defendant.

C. Advocates contend that such statutes reduce frivolous lawsuits by limiting expert shopping and the use of “hired guns.”

D. It is the sitting judge, not the jury, who interprets the statute and decides whether a witness qualifies as an expert.

E. In some cases, a nondoctor such as a nurse or pharmacist may be allowed to offer expert testimony against a doctor.

Answer: B. Lay testimony is usually insufficient to define the standard of care in a claim of medical malpractice, and “the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony” (Craft v. Peebles, 893 P.2d 138 [Haw.1995]). Court rules of evidence dictate that the expert must possess the knowledge, skill, experience, training, or education for establishing that standard.

In coming to an opinion, the expert may rely on external evidence in the form of a book, treatise, or article; and although these sources represent hearsay evidence, they are admissible to enable the expert witness to form his/her opinion.

The facts of the multiple-choice question above are taken from a recent case (Edwards v. Sunrise Ophthalmology ASC, LLC, 134 So. 3d 1056 [Fla. 4th DCA 2013]), whose appeal is yet to be heard by the Florida Supreme Court. The plaintiff alleged that the surgical site was infected with nocardia during a lower-lid blepharoplasty, which caused her to undergo additional surgery with resulting disfigurement of the eye.

A lower court disqualified the plaintiff’s expert, an infectious disease specialist, based on a Florida statute stipulating that expert medical opinion can be offered only by one in the “same or similar specialty” (Section 766.102, Florida Statutes (2009)). In the words of the court, “Simply put, the infectious disease doctor is not an eye surgeon, nor is the ophthalmologist an infectious disease doctor.”

More than half of all the states have a medical-expert law, many with language comparable to the Florida statute. The idea behind such a statute, frequently enacted as part of a state’s tort reform, is to limit expert shopping and the use of hired guns and “junk science.”

Unsurprisingly, litigation abounds over the statutory language.

For example, a Maryland court ruled that a vascular surgeon was qualified to set the standard of care when an orthopedic surgeon’s alleged negligence caused a patient to lose a leg following knee surgery. The court found the two specialties to be “related,” because the orthopedic complication was vascular in origin.

In some jurisdictions without strict statutory requirements, doctors are more likely to be allowed to testify outside their specialty.

Instances of professionals of unlike specialties qualifying as experts include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores. Georgia requires only that an expert show significant familiarity with the area of practice in which the expert opinion is to be given. Still, in a sleep apnea case (Nathans v. Diamond, 654 S.E.2d 121 [Ga. 2007]), the court held that a pulmonologist was not qualified to testify on the standard of surgical care provided by an otolaryngologist.

Besides arguing over the statutory language, litigants have also raised questions of constitutionality. For example, Arizona’s statute ARS §12-2604 (A) requires a medical expert to be a specialist who is actively practicing or teaching in that area of medicine. The state court of appeals held that this violated the separation of powers doctrine (conflicting with Arizona Rule of Evidence 702), but the Supreme Court of Arizona subsequently reversed and reinstated the law (Seisinger v. Siebel, 203 P.3d 483 [Ariz. 2009]).

More recently, the same court upheld the constitutionality of the requirement that an expert share “the same specialty” as the treating physician, and disqualified an adult hematologist from serving as an expert because the defendant was a pediatric hematologist, not an adult hematologist (Baker v. University Physicians Healthcare, 296 P.3d 42 [Ariz. 2013]).

Another issue deals with the locality rule. In an Illinois case, the court accepted an out-of-state plaintiff expert based on his qualifications, competency, and familiarity with standards in the defendant’s community. The case dealt with the development of a rectovaginal fistula that complicated an episiotomy during delivery (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]).

The defense attempted to exclude the expert, alleging the lack of familiarity with the standards in the community (Rantoul, Ill.). However, the expert stated that he was familiar with the minimum standards of medical practice in relation to the diagnosis and treatment of rectovaginal fistulae, and those minimum standards were uniform throughout the country.

It is not necessary that the expert witness has the highest possible qualifications to testify about a particular matter. Still, in Domingo v. T.K. (289 F.3d 600 [9th Cir. 2002]), a federal court excluded the testimony of the plaintiff’s expert witness, because it lacked reliability. The plaintiff developed brain damage from fat embolism following hip surgery, and alleged that prolonged malleting of a hip prosthesis was the cause of the fat embolism syndrome (FES).

The court found that “there was no evidence of widespread acceptance of Dr. Harrington’s theory linking extended malleting to FES; indeed, no theory linking extensive malleting to FES had ever been published.” It also noted the lack of any objective source, peer review, clinical tests, establishment of an error rate or other evidence to show that Dr. Harrington followed a valid, scientific method in developing his theory.

Being disqualified as an expert is one thing, but a recent case goes further. In addition to dismissing an expert’s testimony, a state judge barred the expert from ever testifying in his courtroom after it was determined that the testimony was untruthful.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected]

Question: A patient alleges that an ophthalmologist was negligent in performing blepharoplasty. The surgical site became infected and left the patient with a disfigured eye. An infectious disease specialist was to testify as plaintiff’s expert, but the defense, relying on a state statute, objected that the expert-to-be had no specialized training in ophthalmology.

Correct statements about expert medical testimony include the following, except:

A. The federal Rules of Evidence require that an expert possess the relevant knowledge, skill, education, training, or experience.

B. Only a few states have enacted statutes specifying that an expert must be in the same or similar specialty as the defendant.

C. Advocates contend that such statutes reduce frivolous lawsuits by limiting expert shopping and the use of “hired guns.”

D. It is the sitting judge, not the jury, who interprets the statute and decides whether a witness qualifies as an expert.

E. In some cases, a nondoctor such as a nurse or pharmacist may be allowed to offer expert testimony against a doctor.

Answer: B. Lay testimony is usually insufficient to define the standard of care in a claim of medical malpractice, and “the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony” (Craft v. Peebles, 893 P.2d 138 [Haw.1995]). Court rules of evidence dictate that the expert must possess the knowledge, skill, experience, training, or education for establishing that standard.

In coming to an opinion, the expert may rely on external evidence in the form of a book, treatise, or article; and although these sources represent hearsay evidence, they are admissible to enable the expert witness to form his/her opinion.

The facts of the multiple-choice question above are taken from a recent case (Edwards v. Sunrise Ophthalmology ASC, LLC, 134 So. 3d 1056 [Fla. 4th DCA 2013]), whose appeal is yet to be heard by the Florida Supreme Court. The plaintiff alleged that the surgical site was infected with nocardia during a lower-lid blepharoplasty, which caused her to undergo additional surgery with resulting disfigurement of the eye.

A lower court disqualified the plaintiff’s expert, an infectious disease specialist, based on a Florida statute stipulating that expert medical opinion can be offered only by one in the “same or similar specialty” (Section 766.102, Florida Statutes (2009)). In the words of the court, “Simply put, the infectious disease doctor is not an eye surgeon, nor is the ophthalmologist an infectious disease doctor.”

More than half of all the states have a medical-expert law, many with language comparable to the Florida statute. The idea behind such a statute, frequently enacted as part of a state’s tort reform, is to limit expert shopping and the use of hired guns and “junk science.”

Unsurprisingly, litigation abounds over the statutory language.

For example, a Maryland court ruled that a vascular surgeon was qualified to set the standard of care when an orthopedic surgeon’s alleged negligence caused a patient to lose a leg following knee surgery. The court found the two specialties to be “related,” because the orthopedic complication was vascular in origin.

In some jurisdictions without strict statutory requirements, doctors are more likely to be allowed to testify outside their specialty.

Instances of professionals of unlike specialties qualifying as experts include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores. Georgia requires only that an expert show significant familiarity with the area of practice in which the expert opinion is to be given. Still, in a sleep apnea case (Nathans v. Diamond, 654 S.E.2d 121 [Ga. 2007]), the court held that a pulmonologist was not qualified to testify on the standard of surgical care provided by an otolaryngologist.

Besides arguing over the statutory language, litigants have also raised questions of constitutionality. For example, Arizona’s statute ARS §12-2604 (A) requires a medical expert to be a specialist who is actively practicing or teaching in that area of medicine. The state court of appeals held that this violated the separation of powers doctrine (conflicting with Arizona Rule of Evidence 702), but the Supreme Court of Arizona subsequently reversed and reinstated the law (Seisinger v. Siebel, 203 P.3d 483 [Ariz. 2009]).

More recently, the same court upheld the constitutionality of the requirement that an expert share “the same specialty” as the treating physician, and disqualified an adult hematologist from serving as an expert because the defendant was a pediatric hematologist, not an adult hematologist (Baker v. University Physicians Healthcare, 296 P.3d 42 [Ariz. 2013]).

Another issue deals with the locality rule. In an Illinois case, the court accepted an out-of-state plaintiff expert based on his qualifications, competency, and familiarity with standards in the defendant’s community. The case dealt with the development of a rectovaginal fistula that complicated an episiotomy during delivery (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]).

The defense attempted to exclude the expert, alleging the lack of familiarity with the standards in the community (Rantoul, Ill.). However, the expert stated that he was familiar with the minimum standards of medical practice in relation to the diagnosis and treatment of rectovaginal fistulae, and those minimum standards were uniform throughout the country.

It is not necessary that the expert witness has the highest possible qualifications to testify about a particular matter. Still, in Domingo v. T.K. (289 F.3d 600 [9th Cir. 2002]), a federal court excluded the testimony of the plaintiff’s expert witness, because it lacked reliability. The plaintiff developed brain damage from fat embolism following hip surgery, and alleged that prolonged malleting of a hip prosthesis was the cause of the fat embolism syndrome (FES).

The court found that “there was no evidence of widespread acceptance of Dr. Harrington’s theory linking extended malleting to FES; indeed, no theory linking extensive malleting to FES had ever been published.” It also noted the lack of any objective source, peer review, clinical tests, establishment of an error rate or other evidence to show that Dr. Harrington followed a valid, scientific method in developing his theory.

Being disqualified as an expert is one thing, but a recent case goes further. In addition to dismissing an expert’s testimony, a state judge barred the expert from ever testifying in his courtroom after it was determined that the testimony was untruthful.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected]

Inadequate evaluation of a mole has costly consequences

A 53-year-old woman went to her physician for treatment of a mole on her upper right arm, which she stated had grown and changed color. The physician burned it off without conducting a biopsy or follow-up. Fifteen months later, the patient returned to her physician because the scar was raised with small bumps. He referred her to a surgeon, who diagnosed malignant melanoma (Clark’s level V), with a satellite lesion but negative lymph nodes. The patient underwent surgery and adjuvant interferon-alpha therapy, which caused significant adverse effects.

The patient now has anxiety related to fears of recurrence or death, and must undergo regular positron emission tomography and computed tomography scans to evaluate her for recurrence.

PLAINTIFF’S CLAIM The melanoma should have been diagnosed at the patient’s initial presentation. If it had been diagnosed at that time, the patient would have had an 85% to 90% chance of survival, but because it wasn’t, her survival rate dropped to 60%.

THE DEFENSE No information about the defense is available.

VERDICT $750,000 Virginia settlement.

COMMENT When there is any doubt—by patient or physician—cut it out and send it out (for biopsy).

A higher index of suspicion for PE could have been lifesaving

A 37-year-old morbidly obese man was recovering in a rehabilitation facility from spinal surgery performed 2 weeks earlier. On the day he was to be discharged, he was transported by ambulance to the emergency department (ED) complaining of “a syncopal episode” with weakness, lightheadedness, dizziness, and sweatiness. This was followed by a second episode with similar symptoms. The patient had no wheezes or rales and his heart rhythm was normal, with no murmurs or gallop. In the ED his pulse rose from 94 to 116 and his blood pressure (BP) rose from 106/82 to 145/102. An electrocardiogram (EKG) was abnormal.

The ED physician felt the likelihood of PE was low, despite the fact that the patient was obese and had recent back surgery and an abnormal EKG. The ED physician felt that the likelihood of pulmonary embolism (PE) was low; he suspected, instead, that it was “likely vagal syncope.” The patient returned to the rehab facility, stayed overnight, and was discharged the next day. Two days later, he became short of breath, passed out, and was taken by ambulance to the hospital, where resuscitation efforts were unsuccessful. Autopsy revealed the cause of death was pulmonary thromboemboli from deep vein thrombosis.

PLAINTIFF’S CLAIM The ED physician failed to rule out PE, which should have been considered because of the patient’s obesity, recent back surgery, immobilization, syncope, tachycardia, elevated BP, and abnormal EKG.

THE DEFENSE No information about the defense is available.

VERDICT $1.25 million Massachusetts settlement.

COMMENT Why the physician decided that this patient, who died of a PE, was at low risk for one is puzzling. I count at least 4 risk factors for PE: obesity, postoperative status, abnormal EKG, and tachycardia.

Inadequate evaluation of a mole has costly consequences

A 53-year-old woman went to her physician for treatment of a mole on her upper right arm, which she stated had grown and changed color. The physician burned it off without conducting a biopsy or follow-up. Fifteen months later, the patient returned to her physician because the scar was raised with small bumps. He referred her to a surgeon, who diagnosed malignant melanoma (Clark’s level V), with a satellite lesion but negative lymph nodes. The patient underwent surgery and adjuvant interferon-alpha therapy, which caused significant adverse effects.

The patient now has anxiety related to fears of recurrence or death, and must undergo regular positron emission tomography and computed tomography scans to evaluate her for recurrence.

PLAINTIFF’S CLAIM The melanoma should have been diagnosed at the patient’s initial presentation. If it had been diagnosed at that time, the patient would have had an 85% to 90% chance of survival, but because it wasn’t, her survival rate dropped to 60%.

THE DEFENSE No information about the defense is available.

VERDICT $750,000 Virginia settlement.

COMMENT When there is any doubt—by patient or physician—cut it out and send it out (for biopsy).

A higher index of suspicion for PE could have been lifesaving

A 37-year-old morbidly obese man was recovering in a rehabilitation facility from spinal surgery performed 2 weeks earlier. On the day he was to be discharged, he was transported by ambulance to the emergency department (ED) complaining of “a syncopal episode” with weakness, lightheadedness, dizziness, and sweatiness. This was followed by a second episode with similar symptoms. The patient had no wheezes or rales and his heart rhythm was normal, with no murmurs or gallop. In the ED his pulse rose from 94 to 116 and his blood pressure (BP) rose from 106/82 to 145/102. An electrocardiogram (EKG) was abnormal.

The ED physician felt the likelihood of PE was low, despite the fact that the patient was obese and had recent back surgery and an abnormal EKG. The ED physician felt that the likelihood of pulmonary embolism (PE) was low; he suspected, instead, that it was “likely vagal syncope.” The patient returned to the rehab facility, stayed overnight, and was discharged the next day. Two days later, he became short of breath, passed out, and was taken by ambulance to the hospital, where resuscitation efforts were unsuccessful. Autopsy revealed the cause of death was pulmonary thromboemboli from deep vein thrombosis.

PLAINTIFF’S CLAIM The ED physician failed to rule out PE, which should have been considered because of the patient’s obesity, recent back surgery, immobilization, syncope, tachycardia, elevated BP, and abnormal EKG.

THE DEFENSE No information about the defense is available.

VERDICT $1.25 million Massachusetts settlement.

COMMENT Why the physician decided that this patient, who died of a PE, was at low risk for one is puzzling. I count at least 4 risk factors for PE: obesity, postoperative status, abnormal EKG, and tachycardia.

Inadequate evaluation of a mole has costly consequences

A 53-year-old woman went to her physician for treatment of a mole on her upper right arm, which she stated had grown and changed color. The physician burned it off without conducting a biopsy or follow-up. Fifteen months later, the patient returned to her physician because the scar was raised with small bumps. He referred her to a surgeon, who diagnosed malignant melanoma (Clark’s level V), with a satellite lesion but negative lymph nodes. The patient underwent surgery and adjuvant interferon-alpha therapy, which caused significant adverse effects.

The patient now has anxiety related to fears of recurrence or death, and must undergo regular positron emission tomography and computed tomography scans to evaluate her for recurrence.

PLAINTIFF’S CLAIM The melanoma should have been diagnosed at the patient’s initial presentation. If it had been diagnosed at that time, the patient would have had an 85% to 90% chance of survival, but because it wasn’t, her survival rate dropped to 60%.

THE DEFENSE No information about the defense is available.

VERDICT $750,000 Virginia settlement.

COMMENT When there is any doubt—by patient or physician—cut it out and send it out (for biopsy).

A higher index of suspicion for PE could have been lifesaving

A 37-year-old morbidly obese man was recovering in a rehabilitation facility from spinal surgery performed 2 weeks earlier. On the day he was to be discharged, he was transported by ambulance to the emergency department (ED) complaining of “a syncopal episode” with weakness, lightheadedness, dizziness, and sweatiness. This was followed by a second episode with similar symptoms. The patient had no wheezes or rales and his heart rhythm was normal, with no murmurs or gallop. In the ED his pulse rose from 94 to 116 and his blood pressure (BP) rose from 106/82 to 145/102. An electrocardiogram (EKG) was abnormal.

The ED physician felt the likelihood of PE was low, despite the fact that the patient was obese and had recent back surgery and an abnormal EKG. The ED physician felt that the likelihood of pulmonary embolism (PE) was low; he suspected, instead, that it was “likely vagal syncope.” The patient returned to the rehab facility, stayed overnight, and was discharged the next day. Two days later, he became short of breath, passed out, and was taken by ambulance to the hospital, where resuscitation efforts were unsuccessful. Autopsy revealed the cause of death was pulmonary thromboemboli from deep vein thrombosis.

PLAINTIFF’S CLAIM The ED physician failed to rule out PE, which should have been considered because of the patient’s obesity, recent back surgery, immobilization, syncope, tachycardia, elevated BP, and abnormal EKG.

THE DEFENSE No information about the defense is available.

VERDICT $1.25 million Massachusetts settlement.

COMMENT Why the physician decided that this patient, who died of a PE, was at low risk for one is puzzling. I count at least 4 risk factors for PE: obesity, postoperative status, abnormal EKG, and tachycardia.

Stroke in a Young Man

A 26-year-old man presented to the ED with the chief complaint of mild right-sided weakness, paresthesias, and slurred speech. He stated the onset was sudden—approximately 30 minutes prior to arrival to the ED. The patient denied any previous similar symptoms and was otherwise in good health; he denied taking any medications. He drank alcohol socially, but denied smoking or illicit drug use.

On physical examination, his vital signs and oxygen saturation were normal. Pulmonary, cardiovascular, and abdominal examinations were also normal. The patient thought his speech was somewhat slurred, but the triage nurse and treating emergency physician (EP) had difficulty detecting any altered speech. He was noted to have mild (4+/5) right upper and lower extremity weakness; no facial droop was detected. The patient did have a mild pronator drift of the right upper extremity. Gait testing revealed a mild limp of the right lower extremity.

The EP consulted the hospitalist, and the patient was admitted to a monitored bed. The following morning, a brain magnetic resonance image revealed an ischemic stroke in the distribution of the left middle cerebral artery. The patient’s hospital course was uncomplicated, but at the time of discharge, he continued to have mild right-sided weakness and required the use of a cane.

The patient sued the hospital and the EP for negligence in failing to treat his condition in a timely manner and for not consulting a neurologist. The plaintiff’s attorneys argued the patient should have been given tissue plasminogen activator (tPA), which would have avoided the residual right-sided weakness. The defense denied negligence and argued the patient’s symptoms could have been due to several things for which tPA would have been an inappropriate treatment. A defense verdict was returned.

Discussion

Stroke in young patients is relatively rare. With “young” defined as aged 18 to 45 years, this population accounts for approximately 2% to 12% of cerebral infarcts.¹ In one nationwide US study of stroke in young adults, Ellis² found that 4.9% of individuals experiencing a stroke in 2007 were between ages 18 and 44 years. Among this group, 78% experienced an ischemic stroke; 11.2% experienced a subarachnoid hemorrhage (SAH); and 10.8% had an intracerebral hemorrhage.²

While the clinical presentation of stroke in young adults is similar to that of older patients, the etiologies and risk factors are very different. In older patients, atherosclerosis is the major cause of ischemic stroke. In studies of young adults with ischemic stroke, cardioembolism was found to be the leading cause. Under this category, a patent foramen ovale (PFO) was considered a common cause, followed by atrial fibrillation, bacterial endocarditis, rheumatic heart disease, and atrial myxoma. There is, however, increasing controversy over the role of PFO as an etiology of stroke. Many investigators think its role has been overstated and is probably more of an incidental finding than a causal relationship.³ Patients with a suspected cardioembolic etiology will usually require an echocardiogram (with saline contrast or a “bubble study” for suspected PFO), cardiac monitoring, and a possible Holter monitor at the time of discharge (to detect paroxysmal arrhythmias).

Following cardioembolic etiologies, arterial dissection is the next most common category.⁴ In one study of patients aged 31 to 45 years old, arterial dissection was the most common cause of ischemic stroke.⁴  Clinical features suggesting dissection include a history of head or neck trauma (even minor trauma), headache or neck pain, and local neurological findings (eg, cranial nerve palsy or Horner syndrome).³ Unfortunately, only about 25% of patients volunteer a history of recent neck trauma. If a cervical or vertebral artery dissection is suspected, contrast enhanced magnetic resonance angiography (MRA) is the most sensitive and specific test, followed by carotid ultrasound and CT angiography.³

Traditional risk factors for stroke include hypertension and diabetes mellitus (DM). This is not true for younger adults that experience an ischemic stroke. Cigarette smoking is a very important risk factor for cerebrovascular accident in young adults; in addition, the more one smokes, the greater the risk. Other risk factors in young adults include history of migraine headaches (especially migraine with aura), pregnancy and the postpartum period, and illicit drug use.³

The defense’s argument that there are many causes of stroke in young adults that would be inappropriate for treatment with tPA, such as a PFO, carotid dissection or bacterial endocarditis, is absolutely true. Young patients need to be aggressively worked up for the etiology of their stroke, and may require additional testing, such as an MRA, echocardiogram, or Holter monitoring to determine the underlying cause of their stroke.

Obstruction Following Gastric Bypass Surgery

A 47-year-old woman presented to the ED complaining of severe back and abdominal pain. Onset had been gradual and began approximately 4 hours prior to arrival. She described the pain as crampy and constant. The patient had vomited twice; she denied diarrhea and had a normal bowel movement the previous day. She denied any vaginal or urinary complaints. Her past medical history was significant for hypertension and status post gastric bypass surgery 6 months prior. She had lost 42 pounds to date. She denied smoking or alcohol use.

The patient’s vital signs on physical examination were: blood pressure, 154/92 mm Hg; pulse, 106 beats/minute; respiratory rate, 18 breaths/minute; and temperature, 99˚F. Oxygen saturation was 96% on room air. The patient’s lungs were clear to auscultation bilaterally. The heart was mildly tachycardic, with a regular rhythm and without murmurs, rubs, or gallops. The abdominal examination revealed diffuse tenderness and involuntary guarding. There was no distention or rebound. Bowel sounds were present but hypoactive. Examination of the back revealed bilateral paraspinal muscle tenderness without costovertebral angle tenderness.

The EP ordered a CBC, BMP, serum lipase, and a urinalysis. The patient was given an intravenous (IV) bolus of 250 cc normal saline in addition to IV morphine 4 mg and IV ondansetron 4 mg. Her white blood cell (WBC) count was slightly elevated at 12.2 g/dL, with a normal differential. The remainder of the laboratory studies were normal, except for a serum bicarbonate of 22 mmol/L.

The patient stated she felt somewhat improved, but continued to have abdominal and back pain. The EP admitted her to the hospital for observation and pain control. She died the following day from a bowel obstruction. The family sued the EP for negligence in failing to order appropriate testing and for not consulting with specialists to diagnose the bowel obstruction, which is a known complication of gastric bypass surgery. The jury returned a verdict of $2.4 million against the EP.

Discussion

The frequency of bariatric surgery in the United States continues to increase, primarily due to its success with regard to weight loss, but also because of its demonstrated improvement in hypertension, obstructive sleep apnea, hyperlipidemia, and type 2 DM.¹

Frequently, the term “gastric bypass surgery” is used interchangeably with bariatric surgery. However, the EP must realize these terms encompass multiple different operations. The four most common types of bariatric surgery in the United Stated are (1) adjustable gastric banding (AGB); (2) the Roux-en-Y gastric bypass (RYGB);  (3) biliopancreatic diversion with duodenal switch (BPD-DS); and (4) vertical sleeve gastrectomy (VSG).² (See the Table for a brief explanation of each type of procedure.)

Since each procedure has its own respective associated complications, it is important for the EP to know which the type of gastric bypass surgery the patient had. For example, leakage is much more frequent following RYGB than in gastric banding, while slippage and obstruction are the most common complications of gastric banding.^3,4 It is also very helpful to know the specific type of procedure when discussing the case with the surgical consultant.

Based on a recent review of over 800,000 bariatric surgery patients, seven serious common complications following the surgery were identified.³ These included bleeding, leakage, obstruction, stomal ulceration, pulmonary embolism and respiratory complications, blood sugar disturbances (usually hypoglycemia and/or metabolic acidosis), and nutritional disturbances. While not all-inclusive, this list represents the most common serious complications of gastric bypass surgery.

The complaint of abdominal pain in a patient that has undergone bariatric surgery should be taken very seriously. In addition to determining the specific procedure performed and date, the patient should be questioned about vomiting, bowel movements, and the presence of blood in stool or vomit. Depending upon the degree of pain present, the patient may need to be given IV opioid analgesia to facilitate a thorough abdominal examination. A rectal examination should be performed to identify occult gastrointestinal bleeding.

These patients require laboratory testing, including CBC, BMP, and other laboratory evaluation as indicated by the history and physical examination. Early consultation with the bariatric surgeon is recommended. Many, if not most, patients with abdominal pain and vomiting will require imaging, usually a CT scan with contrast of the abdomen and pelvis. Because of the difficulty in interpreting the CT scan results in these patients, the bariatric surgeon will often want to personally review the films rather than rely solely on the interpretation by radiology services.

Unfortunately, the EP in this case did not appreciate the seriousness of the situation. The presence of severe abdominal pain, tenderness, guarding, mild tachycardia with leukocytosis, and metabolic acidosis all pointed to a more serious etiology than muscle spasm. This patient required IV fluids, analgesia, and imaging, as well as consultation with the bariatric surgeon.

Stroke in a Young Man

A 26-year-old man presented to the ED with the chief complaint of mild right-sided weakness, paresthesias, and slurred speech. He stated the onset was sudden—approximately 30 minutes prior to arrival to the ED. The patient denied any previous similar symptoms and was otherwise in good health; he denied taking any medications. He drank alcohol socially, but denied smoking or illicit drug use.

On physical examination, his vital signs and oxygen saturation were normal. Pulmonary, cardiovascular, and abdominal examinations were also normal. The patient thought his speech was somewhat slurred, but the triage nurse and treating emergency physician (EP) had difficulty detecting any altered speech. He was noted to have mild (4+/5) right upper and lower extremity weakness; no facial droop was detected. The patient did have a mild pronator drift of the right upper extremity. Gait testing revealed a mild limp of the right lower extremity.

The EP consulted the hospitalist, and the patient was admitted to a monitored bed. The following morning, a brain magnetic resonance image revealed an ischemic stroke in the distribution of the left middle cerebral artery. The patient’s hospital course was uncomplicated, but at the time of discharge, he continued to have mild right-sided weakness and required the use of a cane.

The patient sued the hospital and the EP for negligence in failing to treat his condition in a timely manner and for not consulting a neurologist. The plaintiff’s attorneys argued the patient should have been given tissue plasminogen activator (tPA), which would have avoided the residual right-sided weakness. The defense denied negligence and argued the patient’s symptoms could have been due to several things for which tPA would have been an inappropriate treatment. A defense verdict was returned.

Discussion

Stroke in young patients is relatively rare. With “young” defined as aged 18 to 45 years, this population accounts for approximately 2% to 12% of cerebral infarcts.¹ In one nationwide US study of stroke in young adults, Ellis² found that 4.9% of individuals experiencing a stroke in 2007 were between ages 18 and 44 years. Among this group, 78% experienced an ischemic stroke; 11.2% experienced a subarachnoid hemorrhage (SAH); and 10.8% had an intracerebral hemorrhage.²

While the clinical presentation of stroke in young adults is similar to that of older patients, the etiologies and risk factors are very different. In older patients, atherosclerosis is the major cause of ischemic stroke. In studies of young adults with ischemic stroke, cardioembolism was found to be the leading cause. Under this category, a patent foramen ovale (PFO) was considered a common cause, followed by atrial fibrillation, bacterial endocarditis, rheumatic heart disease, and atrial myxoma. There is, however, increasing controversy over the role of PFO as an etiology of stroke. Many investigators think its role has been overstated and is probably more of an incidental finding than a causal relationship.³ Patients with a suspected cardioembolic etiology will usually require an echocardiogram (with saline contrast or a “bubble study” for suspected PFO), cardiac monitoring, and a possible Holter monitor at the time of discharge (to detect paroxysmal arrhythmias).

Following cardioembolic etiologies, arterial dissection is the next most common category.⁴ In one study of patients aged 31 to 45 years old, arterial dissection was the most common cause of ischemic stroke.⁴  Clinical features suggesting dissection include a history of head or neck trauma (even minor trauma), headache or neck pain, and local neurological findings (eg, cranial nerve palsy or Horner syndrome).³ Unfortunately, only about 25% of patients volunteer a history of recent neck trauma. If a cervical or vertebral artery dissection is suspected, contrast enhanced magnetic resonance angiography (MRA) is the most sensitive and specific test, followed by carotid ultrasound and CT angiography.³

Traditional risk factors for stroke include hypertension and diabetes mellitus (DM). This is not true for younger adults that experience an ischemic stroke. Cigarette smoking is a very important risk factor for cerebrovascular accident in young adults; in addition, the more one smokes, the greater the risk. Other risk factors in young adults include history of migraine headaches (especially migraine with aura), pregnancy and the postpartum period, and illicit drug use.³

The defense’s argument that there are many causes of stroke in young adults that would be inappropriate for treatment with tPA, such as a PFO, carotid dissection or bacterial endocarditis, is absolutely true. Young patients need to be aggressively worked up for the etiology of their stroke, and may require additional testing, such as an MRA, echocardiogram, or Holter monitoring to determine the underlying cause of their stroke.

Obstruction Following Gastric Bypass Surgery

A 47-year-old woman presented to the ED complaining of severe back and abdominal pain. Onset had been gradual and began approximately 4 hours prior to arrival. She described the pain as crampy and constant. The patient had vomited twice; she denied diarrhea and had a normal bowel movement the previous day. She denied any vaginal or urinary complaints. Her past medical history was significant for hypertension and status post gastric bypass surgery 6 months prior. She had lost 42 pounds to date. She denied smoking or alcohol use.

The patient’s vital signs on physical examination were: blood pressure, 154/92 mm Hg; pulse, 106 beats/minute; respiratory rate, 18 breaths/minute; and temperature, 99˚F. Oxygen saturation was 96% on room air. The patient’s lungs were clear to auscultation bilaterally. The heart was mildly tachycardic, with a regular rhythm and without murmurs, rubs, or gallops. The abdominal examination revealed diffuse tenderness and involuntary guarding. There was no distention or rebound. Bowel sounds were present but hypoactive. Examination of the back revealed bilateral paraspinal muscle tenderness without costovertebral angle tenderness.

The EP ordered a CBC, BMP, serum lipase, and a urinalysis. The patient was given an intravenous (IV) bolus of 250 cc normal saline in addition to IV morphine 4 mg and IV ondansetron 4 mg. Her white blood cell (WBC) count was slightly elevated at 12.2 g/dL, with a normal differential. The remainder of the laboratory studies were normal, except for a serum bicarbonate of 22 mmol/L.

The patient stated she felt somewhat improved, but continued to have abdominal and back pain. The EP admitted her to the hospital for observation and pain control. She died the following day from a bowel obstruction. The family sued the EP for negligence in failing to order appropriate testing and for not consulting with specialists to diagnose the bowel obstruction, which is a known complication of gastric bypass surgery. The jury returned a verdict of $2.4 million against the EP.

Discussion

The frequency of bariatric surgery in the United States continues to increase, primarily due to its success with regard to weight loss, but also because of its demonstrated improvement in hypertension, obstructive sleep apnea, hyperlipidemia, and type 2 DM.¹

Frequently, the term “gastric bypass surgery” is used interchangeably with bariatric surgery. However, the EP must realize these terms encompass multiple different operations. The four most common types of bariatric surgery in the United Stated are (1) adjustable gastric banding (AGB); (2) the Roux-en-Y gastric bypass (RYGB);  (3) biliopancreatic diversion with duodenal switch (BPD-DS); and (4) vertical sleeve gastrectomy (VSG).² (See the Table for a brief explanation of each type of procedure.)

Since each procedure has its own respective associated complications, it is important for the EP to know which the type of gastric bypass surgery the patient had. For example, leakage is much more frequent following RYGB than in gastric banding, while slippage and obstruction are the most common complications of gastric banding.^3,4 It is also very helpful to know the specific type of procedure when discussing the case with the surgical consultant.

Based on a recent review of over 800,000 bariatric surgery patients, seven serious common complications following the surgery were identified.³ These included bleeding, leakage, obstruction, stomal ulceration, pulmonary embolism and respiratory complications, blood sugar disturbances (usually hypoglycemia and/or metabolic acidosis), and nutritional disturbances. While not all-inclusive, this list represents the most common serious complications of gastric bypass surgery.

The complaint of abdominal pain in a patient that has undergone bariatric surgery should be taken very seriously. In addition to determining the specific procedure performed and date, the patient should be questioned about vomiting, bowel movements, and the presence of blood in stool or vomit. Depending upon the degree of pain present, the patient may need to be given IV opioid analgesia to facilitate a thorough abdominal examination. A rectal examination should be performed to identify occult gastrointestinal bleeding.

These patients require laboratory testing, including CBC, BMP, and other laboratory evaluation as indicated by the history and physical examination. Early consultation with the bariatric surgeon is recommended. Many, if not most, patients with abdominal pain and vomiting will require imaging, usually a CT scan with contrast of the abdomen and pelvis. Because of the difficulty in interpreting the CT scan results in these patients, the bariatric surgeon will often want to personally review the films rather than rely solely on the interpretation by radiology services.

Unfortunately, the EP in this case did not appreciate the seriousness of the situation. The presence of severe abdominal pain, tenderness, guarding, mild tachycardia with leukocytosis, and metabolic acidosis all pointed to a more serious etiology than muscle spasm. This patient required IV fluids, analgesia, and imaging, as well as consultation with the bariatric surgeon.

Stroke in a Young Man

A 26-year-old man presented to the ED with the chief complaint of mild right-sided weakness, paresthesias, and slurred speech. He stated the onset was sudden—approximately 30 minutes prior to arrival to the ED. The patient denied any previous similar symptoms and was otherwise in good health; he denied taking any medications. He drank alcohol socially, but denied smoking or illicit drug use.

On physical examination, his vital signs and oxygen saturation were normal. Pulmonary, cardiovascular, and abdominal examinations were also normal. The patient thought his speech was somewhat slurred, but the triage nurse and treating emergency physician (EP) had difficulty detecting any altered speech. He was noted to have mild (4+/5) right upper and lower extremity weakness; no facial droop was detected. The patient did have a mild pronator drift of the right upper extremity. Gait testing revealed a mild limp of the right lower extremity.

The EP consulted the hospitalist, and the patient was admitted to a monitored bed. The following morning, a brain magnetic resonance image revealed an ischemic stroke in the distribution of the left middle cerebral artery. The patient’s hospital course was uncomplicated, but at the time of discharge, he continued to have mild right-sided weakness and required the use of a cane.

The patient sued the hospital and the EP for negligence in failing to treat his condition in a timely manner and for not consulting a neurologist. The plaintiff’s attorneys argued the patient should have been given tissue plasminogen activator (tPA), which would have avoided the residual right-sided weakness. The defense denied negligence and argued the patient’s symptoms could have been due to several things for which tPA would have been an inappropriate treatment. A defense verdict was returned.

Discussion

Stroke in young patients is relatively rare. With “young” defined as aged 18 to 45 years, this population accounts for approximately 2% to 12% of cerebral infarcts.¹ In one nationwide US study of stroke in young adults, Ellis² found that 4.9% of individuals experiencing a stroke in 2007 were between ages 18 and 44 years. Among this group, 78% experienced an ischemic stroke; 11.2% experienced a subarachnoid hemorrhage (SAH); and 10.8% had an intracerebral hemorrhage.²

While the clinical presentation of stroke in young adults is similar to that of older patients, the etiologies and risk factors are very different. In older patients, atherosclerosis is the major cause of ischemic stroke. In studies of young adults with ischemic stroke, cardioembolism was found to be the leading cause. Under this category, a patent foramen ovale (PFO) was considered a common cause, followed by atrial fibrillation, bacterial endocarditis, rheumatic heart disease, and atrial myxoma. There is, however, increasing controversy over the role of PFO as an etiology of stroke. Many investigators think its role has been overstated and is probably more of an incidental finding than a causal relationship.³ Patients with a suspected cardioembolic etiology will usually require an echocardiogram (with saline contrast or a “bubble study” for suspected PFO), cardiac monitoring, and a possible Holter monitor at the time of discharge (to detect paroxysmal arrhythmias).

Following cardioembolic etiologies, arterial dissection is the next most common category.⁴ In one study of patients aged 31 to 45 years old, arterial dissection was the most common cause of ischemic stroke.⁴  Clinical features suggesting dissection include a history of head or neck trauma (even minor trauma), headache or neck pain, and local neurological findings (eg, cranial nerve palsy or Horner syndrome).³ Unfortunately, only about 25% of patients volunteer a history of recent neck trauma. If a cervical or vertebral artery dissection is suspected, contrast enhanced magnetic resonance angiography (MRA) is the most sensitive and specific test, followed by carotid ultrasound and CT angiography.³

Traditional risk factors for stroke include hypertension and diabetes mellitus (DM). This is not true for younger adults that experience an ischemic stroke. Cigarette smoking is a very important risk factor for cerebrovascular accident in young adults; in addition, the more one smokes, the greater the risk. Other risk factors in young adults include history of migraine headaches (especially migraine with aura), pregnancy and the postpartum period, and illicit drug use.³

The defense’s argument that there are many causes of stroke in young adults that would be inappropriate for treatment with tPA, such as a PFO, carotid dissection or bacterial endocarditis, is absolutely true. Young patients need to be aggressively worked up for the etiology of their stroke, and may require additional testing, such as an MRA, echocardiogram, or Holter monitoring to determine the underlying cause of their stroke.

Obstruction Following Gastric Bypass Surgery

A 47-year-old woman presented to the ED complaining of severe back and abdominal pain. Onset had been gradual and began approximately 4 hours prior to arrival. She described the pain as crampy and constant. The patient had vomited twice; she denied diarrhea and had a normal bowel movement the previous day. She denied any vaginal or urinary complaints. Her past medical history was significant for hypertension and status post gastric bypass surgery 6 months prior. She had lost 42 pounds to date. She denied smoking or alcohol use.

The patient’s vital signs on physical examination were: blood pressure, 154/92 mm Hg; pulse, 106 beats/minute; respiratory rate, 18 breaths/minute; and temperature, 99˚F. Oxygen saturation was 96% on room air. The patient’s lungs were clear to auscultation bilaterally. The heart was mildly tachycardic, with a regular rhythm and without murmurs, rubs, or gallops. The abdominal examination revealed diffuse tenderness and involuntary guarding. There was no distention or rebound. Bowel sounds were present but hypoactive. Examination of the back revealed bilateral paraspinal muscle tenderness without costovertebral angle tenderness.

The EP ordered a CBC, BMP, serum lipase, and a urinalysis. The patient was given an intravenous (IV) bolus of 250 cc normal saline in addition to IV morphine 4 mg and IV ondansetron 4 mg. Her white blood cell (WBC) count was slightly elevated at 12.2 g/dL, with a normal differential. The remainder of the laboratory studies were normal, except for a serum bicarbonate of 22 mmol/L.

The patient stated she felt somewhat improved, but continued to have abdominal and back pain. The EP admitted her to the hospital for observation and pain control. She died the following day from a bowel obstruction. The family sued the EP for negligence in failing to order appropriate testing and for not consulting with specialists to diagnose the bowel obstruction, which is a known complication of gastric bypass surgery. The jury returned a verdict of $2.4 million against the EP.

Discussion

The frequency of bariatric surgery in the United States continues to increase, primarily due to its success with regard to weight loss, but also because of its demonstrated improvement in hypertension, obstructive sleep apnea, hyperlipidemia, and type 2 DM.¹

Frequently, the term “gastric bypass surgery” is used interchangeably with bariatric surgery. However, the EP must realize these terms encompass multiple different operations. The four most common types of bariatric surgery in the United Stated are (1) adjustable gastric banding (AGB); (2) the Roux-en-Y gastric bypass (RYGB);  (3) biliopancreatic diversion with duodenal switch (BPD-DS); and (4) vertical sleeve gastrectomy (VSG).² (See the Table for a brief explanation of each type of procedure.)

Since each procedure has its own respective associated complications, it is important for the EP to know which the type of gastric bypass surgery the patient had. For example, leakage is much more frequent following RYGB than in gastric banding, while slippage and obstruction are the most common complications of gastric banding.^3,4 It is also very helpful to know the specific type of procedure when discussing the case with the surgical consultant.

Based on a recent review of over 800,000 bariatric surgery patients, seven serious common complications following the surgery were identified.³ These included bleeding, leakage, obstruction, stomal ulceration, pulmonary embolism and respiratory complications, blood sugar disturbances (usually hypoglycemia and/or metabolic acidosis), and nutritional disturbances. While not all-inclusive, this list represents the most common serious complications of gastric bypass surgery.

The complaint of abdominal pain in a patient that has undergone bariatric surgery should be taken very seriously. In addition to determining the specific procedure performed and date, the patient should be questioned about vomiting, bowel movements, and the presence of blood in stool or vomit. Depending upon the degree of pain present, the patient may need to be given IV opioid analgesia to facilitate a thorough abdominal examination. A rectal examination should be performed to identify occult gastrointestinal bleeding.

These patients require laboratory testing, including CBC, BMP, and other laboratory evaluation as indicated by the history and physical examination. Early consultation with the bariatric surgeon is recommended. Many, if not most, patients with abdominal pain and vomiting will require imaging, usually a CT scan with contrast of the abdomen and pelvis. Because of the difficulty in interpreting the CT scan results in these patients, the bariatric surgeon will often want to personally review the films rather than rely solely on the interpretation by radiology services.

Unfortunately, the EP in this case did not appreciate the seriousness of the situation. The presence of severe abdominal pain, tenderness, guarding, mild tachycardia with leukocytosis, and metabolic acidosis all pointed to a more serious etiology than muscle spasm. This patient required IV fluids, analgesia, and imaging, as well as consultation with the bariatric surgeon.

Question: Your office assistant misfiled a critical laboratory report showing dangerous hyperkalemia of 6.5 mEq/L. Unaware of the abnormality, you failed to notify the end-stage renal patient to return for treatment. In the meantime, the patient collapsed and died, and an autopsy revealed a fresh transmural myocardial infarct.

Which of the following statements is best?

A. You are negligent, because the standard of care is to promptly contact the patient.

B. Your office assistant is negligent, because she was the one who misfiled the report.

C. Liability rests with the laboratory, because it should have called the office immediately with the critical value.

D. Your lawyer will defend you on the legal theory that hyperkalemia was not the proximate cause of death.

E. All of the above.

Answer: E. In any negligence action, the plaintiff bears the burden of proof, on a balance of probabilities, that the defendant owes him/her a duty of care, the breach of which proximately caused the plaintiff’s injuries.

One begins with an inquiry into whether a duty exists and whether a breach has occurred. Generally, doctors owe a legal duty of due care to their patients arising out of the doctor-patient relationship. By “missing” the laboratory report, especially one of urgency, and not immediately notifying the patient, the doctor has likely breached his/her duty. Another way of putting it is to ask whether the conduct has fallen below what is ordinarily expected of a practitioner in a similar situation.

The doctor will likely blame the office assistant for misfiling the report, and the assistant is indeed liable, as he/she also owes a direct legal duty to the patient. However, such liability will then fall upon the doctor under “respondeat superior” or “let the master answer,” which is the legal doctrine underpinning vicarious liability. This is characteristically seen in an employer-employee situation, where liability is imputed to the employer despite the tortious act being committed only by the employee.

The idea behind this rule is to ensure that the employer, as supervisor, will enforce proper work conditions to avoid risk of harm. The employer also is better able to shoulder the cost of compensating the victim.

For vicarious liability to arise, the employee’s act must have occurred during and within the scope of employment, and the risk of harm must be foreseeable. Under the facts of this hypothetical scenario, it is easy to see that the doctor will be vicariously liable for the negligent act of the assistant.

The clinical laboratory also owes an independent duty to the patient, which includes, among other things, assuring the proper standards in specimen collection and test performance. The duty extends to timely and accurate reporting of the results, including calling the physician when there is a critically high or low value if that is the standard of care in the community, as it generally is.

Thus, the laboratory in this case will likely be named as a codefendant. This is called joint and several liability, where more than one defendant has concurrently or successively caused a plaintiff’s indivisible injury, and the latter can recover all damages from any of the wrongdoers irrespective of degree of fault, as long as causation is proven. However, the plaintiff is not entitled to double recovery, and a defendant can proceed against the other liable parties for contribution.

Proving existence and breach of duty are necessary but insufficient steps toward winning the lawsuit. The plaintiff must also establish causation, i.e., that the substandard care caused the injury.

Causation inquires into both cause-in-fact and cause-in-law, and the term “proximate cause” is used to cover both of these aspects of causation. Cause-in-fact is established with the “but for” test – whether it can be said that had it not been for the defendant’s actions, the plaintiff would not have suffered the injury.

In this scenario, the doctor’s attorney will argue that the cause of death, a myocardial infarct, was preexisting atherosclerotic heart disease, rather than hyperkalemia. Besides, the chronic renal patient typically adapts to hyperkalemia and can tolerate elevated levels better than nonrenal patients. Of course, the counterargument is that the patient’s cardiac injury was a likely consequence of hyperkalemia-induced ventricular arrhythmia.

The doctor, the nurse, and the laboratory will all be named as codefendants. However, the laboratory will attempt to escape liability by arguing that its negligence, if any, was superseded by the doctor’s own negligent failure to read the report. Cause-in-law analysis examines whether a new independent event has intervened between the negligent act and the outcome, which may have been aggravated by the new event.

It naturally raises the question whether the original wrongdoer – in this case, the laboratory – continues to be liable, or whether the chain of causation has been broken by the intervening cause (the doctor’s negligence).

In a federal case, the Florida District Court of Appeals found several doctors liable for missing the diagnosis of tuberculous meningitis (Hadley v. Terwilleger, 873 So.2d 378 (Fl. 2004)). The doctors had seen the patient at various times in a sequential manner. The court held that the plaintiff was entitled to concurring-cause, rather than superseding-cause, jury instructions. The purpose of such instruction was to negate the idea that a defendant is excused from the consequences of his or her negligence by reason of some other cause concurring in time and contributing to the same injury.

Overlooked, misfiled, or otherwise “missed” laboratory or x-ray reports are commonly encountered in medical practice, and may lead in some instances to serious patient injury. They are typically systems errors rather than the fault of any single individual, and like most medical errors, largely preventable.

Physicians and health care institutions should put in place tested protocols that protect patients from risk of harm, and, as the Institute of Medicine stated in its 2000 report, “To Err Is Human: Building a Safer Health System,” move away from “a culture of blame to a culture of safety.”

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at s[email protected].

Question: Your office assistant misfiled a critical laboratory report showing dangerous hyperkalemia of 6.5 mEq/L. Unaware of the abnormality, you failed to notify the end-stage renal patient to return for treatment. In the meantime, the patient collapsed and died, and an autopsy revealed a fresh transmural myocardial infarct.

Which of the following statements is best?

A. You are negligent, because the standard of care is to promptly contact the patient.

B. Your office assistant is negligent, because she was the one who misfiled the report.

C. Liability rests with the laboratory, because it should have called the office immediately with the critical value.

D. Your lawyer will defend you on the legal theory that hyperkalemia was not the proximate cause of death.

E. All of the above.

Answer: E. In any negligence action, the plaintiff bears the burden of proof, on a balance of probabilities, that the defendant owes him/her a duty of care, the breach of which proximately caused the plaintiff’s injuries.

One begins with an inquiry into whether a duty exists and whether a breach has occurred. Generally, doctors owe a legal duty of due care to their patients arising out of the doctor-patient relationship. By “missing” the laboratory report, especially one of urgency, and not immediately notifying the patient, the doctor has likely breached his/her duty. Another way of putting it is to ask whether the conduct has fallen below what is ordinarily expected of a practitioner in a similar situation.

The doctor will likely blame the office assistant for misfiling the report, and the assistant is indeed liable, as he/she also owes a direct legal duty to the patient. However, such liability will then fall upon the doctor under “respondeat superior” or “let the master answer,” which is the legal doctrine underpinning vicarious liability. This is characteristically seen in an employer-employee situation, where liability is imputed to the employer despite the tortious act being committed only by the employee.

The idea behind this rule is to ensure that the employer, as supervisor, will enforce proper work conditions to avoid risk of harm. The employer also is better able to shoulder the cost of compensating the victim.

For vicarious liability to arise, the employee’s act must have occurred during and within the scope of employment, and the risk of harm must be foreseeable. Under the facts of this hypothetical scenario, it is easy to see that the doctor will be vicariously liable for the negligent act of the assistant.

The clinical laboratory also owes an independent duty to the patient, which includes, among other things, assuring the proper standards in specimen collection and test performance. The duty extends to timely and accurate reporting of the results, including calling the physician when there is a critically high or low value if that is the standard of care in the community, as it generally is.

Thus, the laboratory in this case will likely be named as a codefendant. This is called joint and several liability, where more than one defendant has concurrently or successively caused a plaintiff’s indivisible injury, and the latter can recover all damages from any of the wrongdoers irrespective of degree of fault, as long as causation is proven. However, the plaintiff is not entitled to double recovery, and a defendant can proceed against the other liable parties for contribution.

Proving existence and breach of duty are necessary but insufficient steps toward winning the lawsuit. The plaintiff must also establish causation, i.e., that the substandard care caused the injury.

Causation inquires into both cause-in-fact and cause-in-law, and the term “proximate cause” is used to cover both of these aspects of causation. Cause-in-fact is established with the “but for” test – whether it can be said that had it not been for the defendant’s actions, the plaintiff would not have suffered the injury.

In this scenario, the doctor’s attorney will argue that the cause of death, a myocardial infarct, was preexisting atherosclerotic heart disease, rather than hyperkalemia. Besides, the chronic renal patient typically adapts to hyperkalemia and can tolerate elevated levels better than nonrenal patients. Of course, the counterargument is that the patient’s cardiac injury was a likely consequence of hyperkalemia-induced ventricular arrhythmia.

The doctor, the nurse, and the laboratory will all be named as codefendants. However, the laboratory will attempt to escape liability by arguing that its negligence, if any, was superseded by the doctor’s own negligent failure to read the report. Cause-in-law analysis examines whether a new independent event has intervened between the negligent act and the outcome, which may have been aggravated by the new event.

It naturally raises the question whether the original wrongdoer – in this case, the laboratory – continues to be liable, or whether the chain of causation has been broken by the intervening cause (the doctor’s negligence).

In a federal case, the Florida District Court of Appeals found several doctors liable for missing the diagnosis of tuberculous meningitis (Hadley v. Terwilleger, 873 So.2d 378 (Fl. 2004)). The doctors had seen the patient at various times in a sequential manner. The court held that the plaintiff was entitled to concurring-cause, rather than superseding-cause, jury instructions. The purpose of such instruction was to negate the idea that a defendant is excused from the consequences of his or her negligence by reason of some other cause concurring in time and contributing to the same injury.

Overlooked, misfiled, or otherwise “missed” laboratory or x-ray reports are commonly encountered in medical practice, and may lead in some instances to serious patient injury. They are typically systems errors rather than the fault of any single individual, and like most medical errors, largely preventable.

Physicians and health care institutions should put in place tested protocols that protect patients from risk of harm, and, as the Institute of Medicine stated in its 2000 report, “To Err Is Human: Building a Safer Health System,” move away from “a culture of blame to a culture of safety.”

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at s[email protected].

Question: Your office assistant misfiled a critical laboratory report showing dangerous hyperkalemia of 6.5 mEq/L. Unaware of the abnormality, you failed to notify the end-stage renal patient to return for treatment. In the meantime, the patient collapsed and died, and an autopsy revealed a fresh transmural myocardial infarct.

Which of the following statements is best?

A. You are negligent, because the standard of care is to promptly contact the patient.

B. Your office assistant is negligent, because she was the one who misfiled the report.

C. Liability rests with the laboratory, because it should have called the office immediately with the critical value.

D. Your lawyer will defend you on the legal theory that hyperkalemia was not the proximate cause of death.

E. All of the above.

Answer: E. In any negligence action, the plaintiff bears the burden of proof, on a balance of probabilities, that the defendant owes him/her a duty of care, the breach of which proximately caused the plaintiff’s injuries.

One begins with an inquiry into whether a duty exists and whether a breach has occurred. Generally, doctors owe a legal duty of due care to their patients arising out of the doctor-patient relationship. By “missing” the laboratory report, especially one of urgency, and not immediately notifying the patient, the doctor has likely breached his/her duty. Another way of putting it is to ask whether the conduct has fallen below what is ordinarily expected of a practitioner in a similar situation.

The doctor will likely blame the office assistant for misfiling the report, and the assistant is indeed liable, as he/she also owes a direct legal duty to the patient. However, such liability will then fall upon the doctor under “respondeat superior” or “let the master answer,” which is the legal doctrine underpinning vicarious liability. This is characteristically seen in an employer-employee situation, where liability is imputed to the employer despite the tortious act being committed only by the employee.

The idea behind this rule is to ensure that the employer, as supervisor, will enforce proper work conditions to avoid risk of harm. The employer also is better able to shoulder the cost of compensating the victim.

For vicarious liability to arise, the employee’s act must have occurred during and within the scope of employment, and the risk of harm must be foreseeable. Under the facts of this hypothetical scenario, it is easy to see that the doctor will be vicariously liable for the negligent act of the assistant.

The clinical laboratory also owes an independent duty to the patient, which includes, among other things, assuring the proper standards in specimen collection and test performance. The duty extends to timely and accurate reporting of the results, including calling the physician when there is a critically high or low value if that is the standard of care in the community, as it generally is.

Thus, the laboratory in this case will likely be named as a codefendant. This is called joint and several liability, where more than one defendant has concurrently or successively caused a plaintiff’s indivisible injury, and the latter can recover all damages from any of the wrongdoers irrespective of degree of fault, as long as causation is proven. However, the plaintiff is not entitled to double recovery, and a defendant can proceed against the other liable parties for contribution.

Proving existence and breach of duty are necessary but insufficient steps toward winning the lawsuit. The plaintiff must also establish causation, i.e., that the substandard care caused the injury.

Causation inquires into both cause-in-fact and cause-in-law, and the term “proximate cause” is used to cover both of these aspects of causation. Cause-in-fact is established with the “but for” test – whether it can be said that had it not been for the defendant’s actions, the plaintiff would not have suffered the injury.

In this scenario, the doctor’s attorney will argue that the cause of death, a myocardial infarct, was preexisting atherosclerotic heart disease, rather than hyperkalemia. Besides, the chronic renal patient typically adapts to hyperkalemia and can tolerate elevated levels better than nonrenal patients. Of course, the counterargument is that the patient’s cardiac injury was a likely consequence of hyperkalemia-induced ventricular arrhythmia.

The doctor, the nurse, and the laboratory will all be named as codefendants. However, the laboratory will attempt to escape liability by arguing that its negligence, if any, was superseded by the doctor’s own negligent failure to read the report. Cause-in-law analysis examines whether a new independent event has intervened between the negligent act and the outcome, which may have been aggravated by the new event.

It naturally raises the question whether the original wrongdoer – in this case, the laboratory – continues to be liable, or whether the chain of causation has been broken by the intervening cause (the doctor’s negligence).

In a federal case, the Florida District Court of Appeals found several doctors liable for missing the diagnosis of tuberculous meningitis (Hadley v. Terwilleger, 873 So.2d 378 (Fl. 2004)). The doctors had seen the patient at various times in a sequential manner. The court held that the plaintiff was entitled to concurring-cause, rather than superseding-cause, jury instructions. The purpose of such instruction was to negate the idea that a defendant is excused from the consequences of his or her negligence by reason of some other cause concurring in time and contributing to the same injury.

Overlooked, misfiled, or otherwise “missed” laboratory or x-ray reports are commonly encountered in medical practice, and may lead in some instances to serious patient injury. They are typically systems errors rather than the fault of any single individual, and like most medical errors, largely preventable.

Physicians and health care institutions should put in place tested protocols that protect patients from risk of harm, and, as the Institute of Medicine stated in its 2000 report, “To Err Is Human: Building a Safer Health System,” move away from “a culture of blame to a culture of safety.”

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at s[email protected].

Question: After statins had been in use for several years, data began to accumulate purporting to show that they increase the risk of diabetes. When Mrs. Smith learned that her recent diagnosis of diabetes might have something to do with the drug, she consulted a lawyer who began advertising for similar cases to consolidate them into a class action lawsuit. The legal theory (theories) seeking to prove product liability will be based on:

A. Contract law and breach of warranty.

B. Negligence in tort law.

C. Strict liability without requiring proof of fault.

D. A defective product that is unreasonably dangerous.

E. All of the above.

Answer:E. Should a prescription drug lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. The law of products liability governs this cause of action, wherein recovery is based on a number of legal theories, specifically negligence, breach of warranty, and strict liability. The latter is the most favored, as there is no need to prove fault or warranty. Products liability law also covers defective medical devices. The recent multimillion-dollar settlements and jury verdicts with Endo, Johnson & Johnson, Bard, and other manufacturers over their vaginal mesh devices are good examples.

In products liability, injured plaintiffs frequently claim a failure to warn of known risks, such as cardiovascular deaths caused by Vioxx, a nonsteroidal anti-inflammatory drug that was withdrawn in 2004. Merck, its manufacturer, has thus far won 11 and lost 3 of the cases that have gone to trial. Some of these judgments are under appeal; most notably, a Texas Court of Appeals recently reversed a $253 million award initially won by plaintiff Robert Ernst in the very first trial. However, the company has proposed $4.85 billion to settle tens of thousands of similar pending lawsuits. Other recent examples alleging failure to warn are heart attacks linked to the diabetes drug rosiglitazone and bladder cancer associated with the diabetes drug pioglitazone.

In 1963, the California Supreme Court bypassed the law of contracts and warranty in a seminal case of product-related injury, and introduced the notion of strict liability, which goes beyond simple negligence (Greenman v Yuba Power Products Inc., 377 P.2d 897 [Cal. 1963]). The strict liability approach centers on whether a product is defective and unreasonably dangerous, and it has now been adopted in virtually all jurisdictions.

The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Statins, which are powerful HMG-CoA reductase inhibitors widely used to treat hypercholesterolemia, are currently at the center of pharmaceutical products litigation.

Pfizer, the manufacturer of Lipitor (atorvastatin) has become the target of numerous lawsuits alleging that the drug causes diabetes. Lipitor is the best-selling prescription drug ever, with sales reaching $130 billion since it was approved in 1996. In the United States alone, more than 29 million people have been prescribed this medication. The drug is highly effective in lowering serum cholesterol and is proven to reduce cardiovascular deaths.

A meta-analysis in 2010 revealed an increased risk of diabetes in patients taking statins (Lancet 2010;375:735-42). Statin therapy was associated with a 9% increased risk for incident diabetes; it was calculated that treatment of 255 patients with statins for 4 years resulted in 1 extra case of diabetes. An earlier smaller study had rejected this conclusion, but other studies were in support.

In 2012, the Food and Drug Administration (FDA) required the revision of the package insert of Lipitor and other statins to warn that their use had been linked to a small increased risk of diabetes.

In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) and simvastatin (hazard ratio, 1.10). This population-based cohort study involved nondiabetic patients age 66 years or older who started statins between 1997 and 2010 (BMJ 2013;346:f2610).

These and other results, coupled with the FDA-mandated revised labeling, have spawned the filing of nearly 1,000 lawsuits by patients who developed diabetes while taking statins, especially postmenopausal women. The rapid increase in the number of lawsuits may be related to the recent decision of a federal judicial panel on multidistrict litigation to consolidate all Lipitor diabetes lawsuits into a single federal courtroom in Charleston, S.C., as a class-action suit. The first case has yet to go to trial, but is expected to do so in 2015.

Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.

However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:

1) Was there prior company knowledge of the risk and a failure to warn?

2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?

3) Is Lipitor a defective product, and is it unreasonably dangerous?

Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: After statins had been in use for several years, data began to accumulate purporting to show that they increase the risk of diabetes. When Mrs. Smith learned that her recent diagnosis of diabetes might have something to do with the drug, she consulted a lawyer who began advertising for similar cases to consolidate them into a class action lawsuit. The legal theory (theories) seeking to prove product liability will be based on:

A. Contract law and breach of warranty.

B. Negligence in tort law.

C. Strict liability without requiring proof of fault.

D. A defective product that is unreasonably dangerous.

E. All of the above.

Answer:E. Should a prescription drug lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. The law of products liability governs this cause of action, wherein recovery is based on a number of legal theories, specifically negligence, breach of warranty, and strict liability. The latter is the most favored, as there is no need to prove fault or warranty. Products liability law also covers defective medical devices. The recent multimillion-dollar settlements and jury verdicts with Endo, Johnson & Johnson, Bard, and other manufacturers over their vaginal mesh devices are good examples.

In products liability, injured plaintiffs frequently claim a failure to warn of known risks, such as cardiovascular deaths caused by Vioxx, a nonsteroidal anti-inflammatory drug that was withdrawn in 2004. Merck, its manufacturer, has thus far won 11 and lost 3 of the cases that have gone to trial. Some of these judgments are under appeal; most notably, a Texas Court of Appeals recently reversed a $253 million award initially won by plaintiff Robert Ernst in the very first trial. However, the company has proposed $4.85 billion to settle tens of thousands of similar pending lawsuits. Other recent examples alleging failure to warn are heart attacks linked to the diabetes drug rosiglitazone and bladder cancer associated with the diabetes drug pioglitazone.

In 1963, the California Supreme Court bypassed the law of contracts and warranty in a seminal case of product-related injury, and introduced the notion of strict liability, which goes beyond simple negligence (Greenman v Yuba Power Products Inc., 377 P.2d 897 [Cal. 1963]). The strict liability approach centers on whether a product is defective and unreasonably dangerous, and it has now been adopted in virtually all jurisdictions.

The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Statins, which are powerful HMG-CoA reductase inhibitors widely used to treat hypercholesterolemia, are currently at the center of pharmaceutical products litigation.

Pfizer, the manufacturer of Lipitor (atorvastatin) has become the target of numerous lawsuits alleging that the drug causes diabetes. Lipitor is the best-selling prescription drug ever, with sales reaching $130 billion since it was approved in 1996. In the United States alone, more than 29 million people have been prescribed this medication. The drug is highly effective in lowering serum cholesterol and is proven to reduce cardiovascular deaths.

A meta-analysis in 2010 revealed an increased risk of diabetes in patients taking statins (Lancet 2010;375:735-42). Statin therapy was associated with a 9% increased risk for incident diabetes; it was calculated that treatment of 255 patients with statins for 4 years resulted in 1 extra case of diabetes. An earlier smaller study had rejected this conclusion, but other studies were in support.

In 2012, the Food and Drug Administration (FDA) required the revision of the package insert of Lipitor and other statins to warn that their use had been linked to a small increased risk of diabetes.

In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) and simvastatin (hazard ratio, 1.10). This population-based cohort study involved nondiabetic patients age 66 years or older who started statins between 1997 and 2010 (BMJ 2013;346:f2610).

These and other results, coupled with the FDA-mandated revised labeling, have spawned the filing of nearly 1,000 lawsuits by patients who developed diabetes while taking statins, especially postmenopausal women. The rapid increase in the number of lawsuits may be related to the recent decision of a federal judicial panel on multidistrict litigation to consolidate all Lipitor diabetes lawsuits into a single federal courtroom in Charleston, S.C., as a class-action suit. The first case has yet to go to trial, but is expected to do so in 2015.

Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.

However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:

1) Was there prior company knowledge of the risk and a failure to warn?

2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?

3) Is Lipitor a defective product, and is it unreasonably dangerous?

Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: After statins had been in use for several years, data began to accumulate purporting to show that they increase the risk of diabetes. When Mrs. Smith learned that her recent diagnosis of diabetes might have something to do with the drug, she consulted a lawyer who began advertising for similar cases to consolidate them into a class action lawsuit. The legal theory (theories) seeking to prove product liability will be based on:

A. Contract law and breach of warranty.

B. Negligence in tort law.

C. Strict liability without requiring proof of fault.

D. A defective product that is unreasonably dangerous.

E. All of the above.

Answer:E. Should a prescription drug lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. The law of products liability governs this cause of action, wherein recovery is based on a number of legal theories, specifically negligence, breach of warranty, and strict liability. The latter is the most favored, as there is no need to prove fault or warranty. Products liability law also covers defective medical devices. The recent multimillion-dollar settlements and jury verdicts with Endo, Johnson & Johnson, Bard, and other manufacturers over their vaginal mesh devices are good examples.

In products liability, injured plaintiffs frequently claim a failure to warn of known risks, such as cardiovascular deaths caused by Vioxx, a nonsteroidal anti-inflammatory drug that was withdrawn in 2004. Merck, its manufacturer, has thus far won 11 and lost 3 of the cases that have gone to trial. Some of these judgments are under appeal; most notably, a Texas Court of Appeals recently reversed a $253 million award initially won by plaintiff Robert Ernst in the very first trial. However, the company has proposed $4.85 billion to settle tens of thousands of similar pending lawsuits. Other recent examples alleging failure to warn are heart attacks linked to the diabetes drug rosiglitazone and bladder cancer associated with the diabetes drug pioglitazone.

In 1963, the California Supreme Court bypassed the law of contracts and warranty in a seminal case of product-related injury, and introduced the notion of strict liability, which goes beyond simple negligence (Greenman v Yuba Power Products Inc., 377 P.2d 897 [Cal. 1963]). The strict liability approach centers on whether a product is defective and unreasonably dangerous, and it has now been adopted in virtually all jurisdictions.

The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Statins, which are powerful HMG-CoA reductase inhibitors widely used to treat hypercholesterolemia, are currently at the center of pharmaceutical products litigation.

Pfizer, the manufacturer of Lipitor (atorvastatin) has become the target of numerous lawsuits alleging that the drug causes diabetes. Lipitor is the best-selling prescription drug ever, with sales reaching $130 billion since it was approved in 1996. In the United States alone, more than 29 million people have been prescribed this medication. The drug is highly effective in lowering serum cholesterol and is proven to reduce cardiovascular deaths.

A meta-analysis in 2010 revealed an increased risk of diabetes in patients taking statins (Lancet 2010;375:735-42). Statin therapy was associated with a 9% increased risk for incident diabetes; it was calculated that treatment of 255 patients with statins for 4 years resulted in 1 extra case of diabetes. An earlier smaller study had rejected this conclusion, but other studies were in support.

In 2012, the Food and Drug Administration (FDA) required the revision of the package insert of Lipitor and other statins to warn that their use had been linked to a small increased risk of diabetes.

In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) and simvastatin (hazard ratio, 1.10). This population-based cohort study involved nondiabetic patients age 66 years or older who started statins between 1997 and 2010 (BMJ 2013;346:f2610).

These and other results, coupled with the FDA-mandated revised labeling, have spawned the filing of nearly 1,000 lawsuits by patients who developed diabetes while taking statins, especially postmenopausal women. The rapid increase in the number of lawsuits may be related to the recent decision of a federal judicial panel on multidistrict litigation to consolidate all Lipitor diabetes lawsuits into a single federal courtroom in Charleston, S.C., as a class-action suit. The first case has yet to go to trial, but is expected to do so in 2015.

Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.

However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:

1) Was there prior company knowledge of the risk and a failure to warn?

2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?

3) Is Lipitor a defective product, and is it unreasonably dangerous?

Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Failure to properly manage
 a patient’s hypertension


A 44-YEAR-OLD MAN WHO WEIGHED >450 POUNDS went to his internist for treatment of hypertension. At a work-related physical the previous day, his blood pressure had been 160/110 mm Hg. After examination, the internist wrote a 30-day prescription for amlodipine, 5 mg/d, with 3 refills. The patient saw the physician 2 weeks later but not again until 3 months later. At that visit, the internist prescribed amlodipine, 5 mg/d, for 90 days with 2 refills. The patient missed his next appointment, which was set for 4 months later, but when his medication was about to run out, he was able to get a prescription for 10 months’ worth of amlodipine by phone. The patient died 2 months before the prescription ran out.

PLAINTIFF’S CLAIM The physician failed to properly manage and monitor the patient’s hypertension. The dosage of amlodipine was insufficient.


THE DEFENSE The patient was noncompliant and failed to show for follow-up appointments. The dosage of amlodipine was sufficient. The cause of death was unknown because no autopsy was performed.


VERDICT $136,000 New Jersey verdict.

COMMENT If we accept a patient into our practice, we need to have reasonable policies for patients to show up for follow-up, and to consider having them find another physician if they do not.

Did the patient’s age discourage proper evaluation?

Be sure to document when you tell patients to “come back to see me right away if this happens again.” THREE MONTHS AFTER NOTICING BLOOD IN HER STOOL, a 19-year-old woman went to see her physician. Without ordering a flexible sigmoidoscopy or colonoscopy, the physician diagnosed a healing anal fissure. Approximately 4 years later, the patient developed bloody diarrhea and went to a gastroenterologist, who found a 2.6 cm lesion in her rectum during a flexible sigmoidoscopy. Biopsy confirmed a low-grade adenocarcinoma. Imaging studies revealed that the cancer had spread to her lungs and liver, and she was diagnosed with Stage IV rectal cancer. After 2 years of extensive treatment that included surgical resection, conventional and experimental chemotherapy, and radiation therapy, the patient died.

PLAINTIFF’S CLAIM If the physician had ordered endoscopy exams when the patient first presented for treatment, testing could have identified a polyp or early-stage cancer.

THE DEFENSE No information about the defense is available.


VERDICT $2.5 million Maryland verdict.

COMMENT Colon cancer in a 19-year-old is extraordinarily rare. I doubt that the patient didn’t experience any more rectal bleeding until 4 years after she first sought treatment. A lesson in this tragic case is to be sure to document when you tell patients to “come back to see me right away if this happens again.”

23-year-old dies when myocarditis is mistaken for bronchitis


A 23-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) with chest tightness, cough, and fever. After a chest x-ray, the ED physician diagnosed bronchitis and sent the patient home with prescriptions for hydrocodone/acetaminophen and antibiotics. He was found dead in his bed less than 24 hours later. An autopsy determined the cause of death was myocarditis.

PLAINTIFF’S CLAIM The physician didn’t perform an electrocardiogram (EKG), which is a routine evaluation for a patient with chest pain. The EKG would have detected myocarditis.

THE DEFENSE The patient was evaluated properly. An EKG was not necessary.

VERDICT $2.9 million Massachusetts verdict.

COMMENT I think the jury got this one wrong. I don’t think an EKG is necessary for every case of acute bronchitis. However, I do wonder if the chest x-ray showed a large heart shadow.

Failure to properly manage
 a patient’s hypertension


A 44-YEAR-OLD MAN WHO WEIGHED >450 POUNDS went to his internist for treatment of hypertension. At a work-related physical the previous day, his blood pressure had been 160/110 mm Hg. After examination, the internist wrote a 30-day prescription for amlodipine, 5 mg/d, with 3 refills. The patient saw the physician 2 weeks later but not again until 3 months later. At that visit, the internist prescribed amlodipine, 5 mg/d, for 90 days with 2 refills. The patient missed his next appointment, which was set for 4 months later, but when his medication was about to run out, he was able to get a prescription for 10 months’ worth of amlodipine by phone. The patient died 2 months before the prescription ran out.

PLAINTIFF’S CLAIM The physician failed to properly manage and monitor the patient’s hypertension. The dosage of amlodipine was insufficient.


THE DEFENSE The patient was noncompliant and failed to show for follow-up appointments. The dosage of amlodipine was sufficient. The cause of death was unknown because no autopsy was performed.


VERDICT $136,000 New Jersey verdict.

COMMENT If we accept a patient into our practice, we need to have reasonable policies for patients to show up for follow-up, and to consider having them find another physician if they do not.

Did the patient’s age discourage proper evaluation?

Be sure to document when you tell patients to “come back to see me right away if this happens again.” THREE MONTHS AFTER NOTICING BLOOD IN HER STOOL, a 19-year-old woman went to see her physician. Without ordering a flexible sigmoidoscopy or colonoscopy, the physician diagnosed a healing anal fissure. Approximately 4 years later, the patient developed bloody diarrhea and went to a gastroenterologist, who found a 2.6 cm lesion in her rectum during a flexible sigmoidoscopy. Biopsy confirmed a low-grade adenocarcinoma. Imaging studies revealed that the cancer had spread to her lungs and liver, and she was diagnosed with Stage IV rectal cancer. After 2 years of extensive treatment that included surgical resection, conventional and experimental chemotherapy, and radiation therapy, the patient died.

PLAINTIFF’S CLAIM If the physician had ordered endoscopy exams when the patient first presented for treatment, testing could have identified a polyp or early-stage cancer.

THE DEFENSE No information about the defense is available.


VERDICT $2.5 million Maryland verdict.

COMMENT Colon cancer in a 19-year-old is extraordinarily rare. I doubt that the patient didn’t experience any more rectal bleeding until 4 years after she first sought treatment. A lesson in this tragic case is to be sure to document when you tell patients to “come back to see me right away if this happens again.”

23-year-old dies when myocarditis is mistaken for bronchitis


A 23-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) with chest tightness, cough, and fever. After a chest x-ray, the ED physician diagnosed bronchitis and sent the patient home with prescriptions for hydrocodone/acetaminophen and antibiotics. He was found dead in his bed less than 24 hours later. An autopsy determined the cause of death was myocarditis.

PLAINTIFF’S CLAIM The physician didn’t perform an electrocardiogram (EKG), which is a routine evaluation for a patient with chest pain. The EKG would have detected myocarditis.

THE DEFENSE The patient was evaluated properly. An EKG was not necessary.

VERDICT $2.9 million Massachusetts verdict.

COMMENT I think the jury got this one wrong. I don’t think an EKG is necessary for every case of acute bronchitis. However, I do wonder if the chest x-ray showed a large heart shadow.

Failure to properly manage
 a patient’s hypertension


A 44-YEAR-OLD MAN WHO WEIGHED >450 POUNDS went to his internist for treatment of hypertension. At a work-related physical the previous day, his blood pressure had been 160/110 mm Hg. After examination, the internist wrote a 30-day prescription for amlodipine, 5 mg/d, with 3 refills. The patient saw the physician 2 weeks later but not again until 3 months later. At that visit, the internist prescribed amlodipine, 5 mg/d, for 90 days with 2 refills. The patient missed his next appointment, which was set for 4 months later, but when his medication was about to run out, he was able to get a prescription for 10 months’ worth of amlodipine by phone. The patient died 2 months before the prescription ran out.

PLAINTIFF’S CLAIM The physician failed to properly manage and monitor the patient’s hypertension. The dosage of amlodipine was insufficient.


THE DEFENSE The patient was noncompliant and failed to show for follow-up appointments. The dosage of amlodipine was sufficient. The cause of death was unknown because no autopsy was performed.


VERDICT $136,000 New Jersey verdict.

COMMENT If we accept a patient into our practice, we need to have reasonable policies for patients to show up for follow-up, and to consider having them find another physician if they do not.

Did the patient’s age discourage proper evaluation?

Be sure to document when you tell patients to “come back to see me right away if this happens again.” THREE MONTHS AFTER NOTICING BLOOD IN HER STOOL, a 19-year-old woman went to see her physician. Without ordering a flexible sigmoidoscopy or colonoscopy, the physician diagnosed a healing anal fissure. Approximately 4 years later, the patient developed bloody diarrhea and went to a gastroenterologist, who found a 2.6 cm lesion in her rectum during a flexible sigmoidoscopy. Biopsy confirmed a low-grade adenocarcinoma. Imaging studies revealed that the cancer had spread to her lungs and liver, and she was diagnosed with Stage IV rectal cancer. After 2 years of extensive treatment that included surgical resection, conventional and experimental chemotherapy, and radiation therapy, the patient died.

PLAINTIFF’S CLAIM If the physician had ordered endoscopy exams when the patient first presented for treatment, testing could have identified a polyp or early-stage cancer.

THE DEFENSE No information about the defense is available.


VERDICT $2.5 million Maryland verdict.

COMMENT Colon cancer in a 19-year-old is extraordinarily rare. I doubt that the patient didn’t experience any more rectal bleeding until 4 years after she first sought treatment. A lesson in this tragic case is to be sure to document when you tell patients to “come back to see me right away if this happens again.”

23-year-old dies when myocarditis is mistaken for bronchitis


A 23-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) with chest tightness, cough, and fever. After a chest x-ray, the ED physician diagnosed bronchitis and sent the patient home with prescriptions for hydrocodone/acetaminophen and antibiotics. He was found dead in his bed less than 24 hours later. An autopsy determined the cause of death was myocarditis.

PLAINTIFF’S CLAIM The physician didn’t perform an electrocardiogram (EKG), which is a routine evaluation for a patient with chest pain. The EKG would have detected myocarditis.

THE DEFENSE The patient was evaluated properly. An EKG was not necessary.

VERDICT $2.9 million Massachusetts verdict.

COMMENT I think the jury got this one wrong. I don’t think an EKG is necessary for every case of acute bronchitis. However, I do wonder if the chest x-ray showed a large heart shadow.