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Two Fundoplications Lead to Nerve Damage

Cases reprinted with permission from Medical Malpractice Verdicts, Settlements and Experts, Lewis Laska, Editor, (800) 298-6288.

Two Fundoplications Lead to Nerve Damage
A 13-year-old girl underwent surgery for intractable gastroesophageal reflux disease (GERD) in March 1999. The procedure involved the creation of a Nissen fundoplication, which was intended to tighten the esophagus’s lower sphincter. The surgery was performed by pediatrician Dr. S. with assistance from gastroenterologist Dr. N. at a major medical center.

The fundoplication subsequently unraveled, so in December 2000, the physicians recreated it. The patient subsequently developed gastroparesis.

The plaintiff claimed that improper performance of the fundoplications was to blame for the gastroparesis. She subsequently underwent seven surgeries, including the implantation of a pacemaker to control her gastrointestinal functions. The plaintiff also argued that her GERD had not resolved, which impaired her respiration and caused her to require continuous use of supplemental oxygen. The plaintiff also now receives nutrition by tube.

The matter proceeded to trial against both doctors and the medical center. The gastroenterologist, however, was dismissed when evidence showed that the pediatrician, Dr. S., was the primary performer of the fundoplications.

The plaintiff claimed that the failure of the initial fundoplication was due to the use of 3-0 absorbable sutures, when 2-0 nonabsorbable sutures should have been used. The plaintiff claimed that the nonabsorbable sutures were stronger. The plaintiff claimed that during the second fundoplication, a suture was improperly applied, damaging a portion of the vagus nerve. The plaintiff claimed that Dr. S. failed to identify and protect the nerve.

The defendants claimed that while 2-0 sutures are typically used in fundoplications, the 3-0 sutures were acceptable, and that identification and preservation of the vagus nerve was not required. The defendant also maintained that the vagus nerve was not damaged, but that the gastroparesis was due to an unrelated abnormality of the plaintiff’s metabolic process.

OUTCOME
According to a published account, a jury found Dr. S. negligent and awarded $60 million. An appeal was expected.

COMMENT
Medical malpractice awards can be astronomical, particularly when complications so substantially degrade a young patient’s quality of life. That said, damage to the vagus nerve is an accepted risk of a Nissen fundoplication. So how is it that a known risk of a surgery can result in the largest verdict awarded in New York in 2011?

Most lay jurors would recognize that the essential goal of a Nissen fundoplication for GERD is to improve symptoms by making structural changes to the lower esophagus and stomach. Jurors would believe it clearly foreseeable that the surgery would “fall apart” over time and regard the use of smaller dissolvable sutures as obvious error. In fact, the surgeon’s own expert acknowledged that fundoplications are typically secured with 2-0 nonabsorbable sutures and the defendant surgeon utilized 3-0 absorbable sutures. In the eyes of most jurors, this would have essentially served as an admission of liability.

Once the jurors were convinced of “shoddy workmanship” in the first surgery, they would have little trouble finding that the surgeon damaged the vagus nerve in the second. The surgeon defended on the grounds that the standard of care did not require the vagus nerve to be identified and preserved. This argument may have inflamed the jury, who will regard failure to look out for the nerve as wantonly reckless.

Further, the defendant’s claim that the patient’s gastroparesis was due to an “unrelated abnormality of her metabolic process” likely raised the ire of the jurors, who may have considered such an argument an unbelievable attempt to skirt responsibility for the outcome.

The jury may have been incensed that the surgeon chose the wrong size suture, used the wrong material, didn’t even bother to look for important nerves, and then sought to “blame the patient” for the subsequent surgeries, her need for continuous supplemental oxygen, and need for tube feeding.

As a matter of legal strategy, the surgeon’s attorneys should have considered a bifurcated trial (one in which the liability and damages are separated into, essentially, two mini-trials). This is sometimes done in medical malpractice cases because jurors can become overwhelmed with sympathy at the plaintiff’s plight, and then be unable to fairly judge whether or not the clinician made a mistake in the first place.

Second, defense counsel should have considered admitting liability in the first surgery. Why do this? By admitting liability for the first surgery, the defense should have been able to block damaging evidence of the first surgery (suture size and absorbability) from being presented in a trial dealing with the second surgery.

 

 

Why is this fair? Because the ultimate issue in this case was whether or not the vagus nerve was injured in the second surgery—not whether better material could have been chosen for the first. By contesting liability for the first surgery, defense counsel permitted the jurors to hear prejudicial evidence of arguably “shoddy workmanship,” which was irrelevant in determining whether or not the vagus nerve was injured during the second surgery.

What lessons can be learned from this substantial verdict? All aspects of a surgical technique should be supported by the standard of care. Where there are choices in operative or procedural technique, ensure that the chosen technique has a foundation in defensible evidence-based medicine. Jurors will expect clinicians to identify and preserve sensitive structures. While inadvertent damage to nearby structures may be a risk inherent in certain procedures, jurors expect the utmost care in protecting those structures.

Candidly, jurors will likely find the clinician responsible for an intra-operative iatrogenic injury. The consent form disclosing “known risks” is necessary, but at time of trial, it will not be an impenetrable shield. Proceed carefully and thoughtfully, with support from evidence-based literature whenever possible. —DML

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With commentary by Clinician Reviews editorial board member Julia Pallentino, MSN, JD, ARNP, and David M. Lang, JD, PA-C

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Clinician Reviews - 22(8)
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14-15
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malpractice, gastroesophageal reflux disease, GERD, Nissen fundoplication, gastroparesis, nonabsorbable sutures, esophagus, lower sphincter, surgerymalpractice, gastroesophageal reflux disease, GERD, Nissen fundoplication, gastroparesis, nonabsorbable sutures, esophagus, lower sphincter, surgery
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With commentary by Clinician Reviews editorial board member Julia Pallentino, MSN, JD, ARNP, and David M. Lang, JD, PA-C

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With commentary by Clinician Reviews editorial board member Julia Pallentino, MSN, JD, ARNP, and David M. Lang, JD, PA-C

Cases reprinted with permission from Medical Malpractice Verdicts, Settlements and Experts, Lewis Laska, Editor, (800) 298-6288.

Two Fundoplications Lead to Nerve Damage
A 13-year-old girl underwent surgery for intractable gastroesophageal reflux disease (GERD) in March 1999. The procedure involved the creation of a Nissen fundoplication, which was intended to tighten the esophagus’s lower sphincter. The surgery was performed by pediatrician Dr. S. with assistance from gastroenterologist Dr. N. at a major medical center.

The fundoplication subsequently unraveled, so in December 2000, the physicians recreated it. The patient subsequently developed gastroparesis.

The plaintiff claimed that improper performance of the fundoplications was to blame for the gastroparesis. She subsequently underwent seven surgeries, including the implantation of a pacemaker to control her gastrointestinal functions. The plaintiff also argued that her GERD had not resolved, which impaired her respiration and caused her to require continuous use of supplemental oxygen. The plaintiff also now receives nutrition by tube.

The matter proceeded to trial against both doctors and the medical center. The gastroenterologist, however, was dismissed when evidence showed that the pediatrician, Dr. S., was the primary performer of the fundoplications.

The plaintiff claimed that the failure of the initial fundoplication was due to the use of 3-0 absorbable sutures, when 2-0 nonabsorbable sutures should have been used. The plaintiff claimed that the nonabsorbable sutures were stronger. The plaintiff claimed that during the second fundoplication, a suture was improperly applied, damaging a portion of the vagus nerve. The plaintiff claimed that Dr. S. failed to identify and protect the nerve.

The defendants claimed that while 2-0 sutures are typically used in fundoplications, the 3-0 sutures were acceptable, and that identification and preservation of the vagus nerve was not required. The defendant also maintained that the vagus nerve was not damaged, but that the gastroparesis was due to an unrelated abnormality of the plaintiff’s metabolic process.

OUTCOME
According to a published account, a jury found Dr. S. negligent and awarded $60 million. An appeal was expected.

COMMENT
Medical malpractice awards can be astronomical, particularly when complications so substantially degrade a young patient’s quality of life. That said, damage to the vagus nerve is an accepted risk of a Nissen fundoplication. So how is it that a known risk of a surgery can result in the largest verdict awarded in New York in 2011?

Most lay jurors would recognize that the essential goal of a Nissen fundoplication for GERD is to improve symptoms by making structural changes to the lower esophagus and stomach. Jurors would believe it clearly foreseeable that the surgery would “fall apart” over time and regard the use of smaller dissolvable sutures as obvious error. In fact, the surgeon’s own expert acknowledged that fundoplications are typically secured with 2-0 nonabsorbable sutures and the defendant surgeon utilized 3-0 absorbable sutures. In the eyes of most jurors, this would have essentially served as an admission of liability.

Once the jurors were convinced of “shoddy workmanship” in the first surgery, they would have little trouble finding that the surgeon damaged the vagus nerve in the second. The surgeon defended on the grounds that the standard of care did not require the vagus nerve to be identified and preserved. This argument may have inflamed the jury, who will regard failure to look out for the nerve as wantonly reckless.

Further, the defendant’s claim that the patient’s gastroparesis was due to an “unrelated abnormality of her metabolic process” likely raised the ire of the jurors, who may have considered such an argument an unbelievable attempt to skirt responsibility for the outcome.

The jury may have been incensed that the surgeon chose the wrong size suture, used the wrong material, didn’t even bother to look for important nerves, and then sought to “blame the patient” for the subsequent surgeries, her need for continuous supplemental oxygen, and need for tube feeding.

As a matter of legal strategy, the surgeon’s attorneys should have considered a bifurcated trial (one in which the liability and damages are separated into, essentially, two mini-trials). This is sometimes done in medical malpractice cases because jurors can become overwhelmed with sympathy at the plaintiff’s plight, and then be unable to fairly judge whether or not the clinician made a mistake in the first place.

Second, defense counsel should have considered admitting liability in the first surgery. Why do this? By admitting liability for the first surgery, the defense should have been able to block damaging evidence of the first surgery (suture size and absorbability) from being presented in a trial dealing with the second surgery.

 

 

Why is this fair? Because the ultimate issue in this case was whether or not the vagus nerve was injured in the second surgery—not whether better material could have been chosen for the first. By contesting liability for the first surgery, defense counsel permitted the jurors to hear prejudicial evidence of arguably “shoddy workmanship,” which was irrelevant in determining whether or not the vagus nerve was injured during the second surgery.

What lessons can be learned from this substantial verdict? All aspects of a surgical technique should be supported by the standard of care. Where there are choices in operative or procedural technique, ensure that the chosen technique has a foundation in defensible evidence-based medicine. Jurors will expect clinicians to identify and preserve sensitive structures. While inadvertent damage to nearby structures may be a risk inherent in certain procedures, jurors expect the utmost care in protecting those structures.

Candidly, jurors will likely find the clinician responsible for an intra-operative iatrogenic injury. The consent form disclosing “known risks” is necessary, but at time of trial, it will not be an impenetrable shield. Proceed carefully and thoughtfully, with support from evidence-based literature whenever possible. —DML

Cases reprinted with permission from Medical Malpractice Verdicts, Settlements and Experts, Lewis Laska, Editor, (800) 298-6288.

Two Fundoplications Lead to Nerve Damage
A 13-year-old girl underwent surgery for intractable gastroesophageal reflux disease (GERD) in March 1999. The procedure involved the creation of a Nissen fundoplication, which was intended to tighten the esophagus’s lower sphincter. The surgery was performed by pediatrician Dr. S. with assistance from gastroenterologist Dr. N. at a major medical center.

The fundoplication subsequently unraveled, so in December 2000, the physicians recreated it. The patient subsequently developed gastroparesis.

The plaintiff claimed that improper performance of the fundoplications was to blame for the gastroparesis. She subsequently underwent seven surgeries, including the implantation of a pacemaker to control her gastrointestinal functions. The plaintiff also argued that her GERD had not resolved, which impaired her respiration and caused her to require continuous use of supplemental oxygen. The plaintiff also now receives nutrition by tube.

The matter proceeded to trial against both doctors and the medical center. The gastroenterologist, however, was dismissed when evidence showed that the pediatrician, Dr. S., was the primary performer of the fundoplications.

The plaintiff claimed that the failure of the initial fundoplication was due to the use of 3-0 absorbable sutures, when 2-0 nonabsorbable sutures should have been used. The plaintiff claimed that the nonabsorbable sutures were stronger. The plaintiff claimed that during the second fundoplication, a suture was improperly applied, damaging a portion of the vagus nerve. The plaintiff claimed that Dr. S. failed to identify and protect the nerve.

The defendants claimed that while 2-0 sutures are typically used in fundoplications, the 3-0 sutures were acceptable, and that identification and preservation of the vagus nerve was not required. The defendant also maintained that the vagus nerve was not damaged, but that the gastroparesis was due to an unrelated abnormality of the plaintiff’s metabolic process.

OUTCOME
According to a published account, a jury found Dr. S. negligent and awarded $60 million. An appeal was expected.

COMMENT
Medical malpractice awards can be astronomical, particularly when complications so substantially degrade a young patient’s quality of life. That said, damage to the vagus nerve is an accepted risk of a Nissen fundoplication. So how is it that a known risk of a surgery can result in the largest verdict awarded in New York in 2011?

Most lay jurors would recognize that the essential goal of a Nissen fundoplication for GERD is to improve symptoms by making structural changes to the lower esophagus and stomach. Jurors would believe it clearly foreseeable that the surgery would “fall apart” over time and regard the use of smaller dissolvable sutures as obvious error. In fact, the surgeon’s own expert acknowledged that fundoplications are typically secured with 2-0 nonabsorbable sutures and the defendant surgeon utilized 3-0 absorbable sutures. In the eyes of most jurors, this would have essentially served as an admission of liability.

Once the jurors were convinced of “shoddy workmanship” in the first surgery, they would have little trouble finding that the surgeon damaged the vagus nerve in the second. The surgeon defended on the grounds that the standard of care did not require the vagus nerve to be identified and preserved. This argument may have inflamed the jury, who will regard failure to look out for the nerve as wantonly reckless.

Further, the defendant’s claim that the patient’s gastroparesis was due to an “unrelated abnormality of her metabolic process” likely raised the ire of the jurors, who may have considered such an argument an unbelievable attempt to skirt responsibility for the outcome.

The jury may have been incensed that the surgeon chose the wrong size suture, used the wrong material, didn’t even bother to look for important nerves, and then sought to “blame the patient” for the subsequent surgeries, her need for continuous supplemental oxygen, and need for tube feeding.

As a matter of legal strategy, the surgeon’s attorneys should have considered a bifurcated trial (one in which the liability and damages are separated into, essentially, two mini-trials). This is sometimes done in medical malpractice cases because jurors can become overwhelmed with sympathy at the plaintiff’s plight, and then be unable to fairly judge whether or not the clinician made a mistake in the first place.

Second, defense counsel should have considered admitting liability in the first surgery. Why do this? By admitting liability for the first surgery, the defense should have been able to block damaging evidence of the first surgery (suture size and absorbability) from being presented in a trial dealing with the second surgery.

 

 

Why is this fair? Because the ultimate issue in this case was whether or not the vagus nerve was injured in the second surgery—not whether better material could have been chosen for the first. By contesting liability for the first surgery, defense counsel permitted the jurors to hear prejudicial evidence of arguably “shoddy workmanship,” which was irrelevant in determining whether or not the vagus nerve was injured during the second surgery.

What lessons can be learned from this substantial verdict? All aspects of a surgical technique should be supported by the standard of care. Where there are choices in operative or procedural technique, ensure that the chosen technique has a foundation in defensible evidence-based medicine. Jurors will expect clinicians to identify and preserve sensitive structures. While inadvertent damage to nearby structures may be a risk inherent in certain procedures, jurors expect the utmost care in protecting those structures.

Candidly, jurors will likely find the clinician responsible for an intra-operative iatrogenic injury. The consent form disclosing “known risks” is necessary, but at time of trial, it will not be an impenetrable shield. Proceed carefully and thoughtfully, with support from evidence-based literature whenever possible. —DML

Issue
Clinician Reviews - 22(8)
Issue
Clinician Reviews - 22(8)
Page Number
14-15
Page Number
14-15
Publications
Publications
Topics
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Two Fundoplications Lead to Nerve Damage
Display Headline
Two Fundoplications Lead to Nerve Damage
Legacy Keywords
malpractice, gastroesophageal reflux disease, GERD, Nissen fundoplication, gastroparesis, nonabsorbable sutures, esophagus, lower sphincter, surgerymalpractice, gastroesophageal reflux disease, GERD, Nissen fundoplication, gastroparesis, nonabsorbable sutures, esophagus, lower sphincter, surgery
Legacy Keywords
malpractice, gastroesophageal reflux disease, GERD, Nissen fundoplication, gastroparesis, nonabsorbable sutures, esophagus, lower sphincter, surgerymalpractice, gastroesophageal reflux disease, GERD, Nissen fundoplication, gastroparesis, nonabsorbable sutures, esophagus, lower sphincter, surgery
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