Undiluted Acetic Acid Used for Surgery on Vulvar Lesion

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

Undiluted Acetic Acid Used for Surgery on Vulvar Lesion
The patient, a 42-year-old Ohio woman, was scheduled for a

gynecologic surgical procedure. The surgery was to be performed in the hospital by a general practice obstetrician/gynecologist for treatment of low-grade squamous intraepithelial lesions (ie, vulvar intraepithelial neoplasm [VIN] with moderate dysplasia). The planned procedure was a wide local excision of the vulvar lesions, to be performed under general anesthesia.

The procedure typically includes application of a diluted acetic acid wash to the vulvar area to delineate the borders of the dysplastic areas. Instead of the diluted solution, however, a highly concentrated acetic acid, trichloroacetic acid (TCA), was used.

The patient sustained a severe chemical burn of the vulva, which took several months to heal. She was left with permanent scarring of the vulvar area and extreme tenderness at the vaginal opening, which is atrophic and severely reddened and discolored. The patient has a band of thick scar tissue at the posterior fourchette, and she also sustained burning and severe scarring of the perineum that extends to the anal area, including a 2-mm plaque layer.

The plaintiff claimed that her injuries limited her to extremely painful sexual intercourse (if any), as well as discomfort at all times. Only a complicated set of additional surgical procedures could be recommended to attempt to alleviate her condition and allow relatively pain-free intercourse.

OUTCOME
A $600,000 settlement was reached in direct negotiations with the risk management department of the hospital in question.

COMMENT
This case settled before trial after direct negotiations with the hospital’s risk management department, which is unusual; cases are typically turned over to trial counsel after a case is initiated.

Jurors take a harsh view of such mix-ups, expecting simple safety precautions, like clear labeling, to prevent devastating outcomes.

The negotiated settlement is rather low, given the patient’s pain and demonstrable losses. Ohio has a damages cap on noneconomic damages (eg, pain and suffering, vs economic damages, such as loss of income). Ohio also has a cap on punitive damages—which is double the cap on compensatory damages. In a different jurisdiction without these caps, the defendant hospital’s exposure to larger damages would have been greater.

Clinicians must take an active role to prevent such outcomes. Any substance used in a clinical setting should be clearly labeled. Items not suitable for direct patient use (eg, undiluted acetic acid) should never be brought into the examining room or the operating room. Clinicians should actively monitor support personnel to detect practices that could result in an accident.

Our role as clinicians is to protect the patient: That includes monitoring our practice environment for patterns that could result in accidents (eg, slip and fall), errors (medication administered to the incorrect patient), or unclear accountability (lab values not reviewed in a timely manner). Stay vigilant and work within your team practice environment to spot and correct problems before those problems ripen into errors that may injure patients and land clinicians in court. —DML

Excessive Epinephrine Injection Causes Cardiac Arrest
An Idaho woman, age 39, was to undergo an arthroscopic shoulder procedure in February 2007 at a specialty hospital. Prior to surgery, the patient was mistakenly given an injection of 9 cc epinephrine at a concentration of 1:1,000 instead of the ordered presurgical injection—a diluted concentration of epinephrine 1:200,000, combined with bupivacaine. The patient went into full cardiac arrest and was subsequently diagnosed with a mild brain injury resulting from the lengthy code conducted at the hospital.

The plaintiff claimed that the hospital’s use of 30-mL multidose vials of concentrated epinephrine 1:1,000 in the operating room heightened the risk for medication error. The plaintiff also claimed that the circulating nurse failed to properly label the syringe containing the medication and that the circulating nurse failed to properly run a time-out procedure prior to the medication error.

The defendant claimed that the presence of multidose vials of concentrated epinephrine in the operating room was proper and that the syringe used to inject the plaintiff was properly labeled. The defendant also claimed that a time-out had been properly conducted prior to the medication error.

OUTCOME
According to a published account, a $760,000 verdict was returned. The plaintiff had settled the claim against the orthopedic group prior to trial for a confidential amount and had entered into a high-low agreement with the hospital ($750,000/$500,000) minutes before the verdict was returned.

COMMENT
As in the previous case, this action involves the unintended use of a substance (epinephrine 1:1,000) that bears some similarity to the correct substance (bupivacaine with epinephrine 1:200,000). There was disagreement as to whether the syringe was properly labeled.

Here, the case was settled against the orthopedic surgeon. The hospital has vicarious liability for the circulating nurse as an employee of the hospital. The plaintiff alleged that the use of the multidose vial was risky, and that the nurse did not perform an adequate time-out procedure before the error. This procedure is designed to give nurses protected time, free from other distractions, within which to manage and administer medications. The concept of protected time seeks to minimize errors of medication administration by giving nurses dedicated time to concentrate only on medications without the usual distractions from clinicians, other patients, telephone calls, pages, and the like. This is important, because a clinician’s prescribing or ordering error is often detected (by pharmacists or nurses, respectively). Generally, when a nurse administers a medication, there is no automatic “second pair of eyes” to review his or her action.

In this instance, however, the opposite situation existed: The nurse prepared the medication, and the physician administered it. The plaintiff’s contention was that the nurse mislabeled the medication, and the plaintiff was able to prevail at trial on this theory.

Interestingly, the plaintiff likely took the opposite position with the physician to obtain settlement before trial—that is, that the nurse correctly labeled the syringe, but it was inappropriately administered by the physician. After settling with the physician, the plaintiff was free to change the theory of the case—placing blame with the nurse and hospital. At trial, with an injured plaintiff and no clinician to blame, the jury found the plaintiff’s position credible and found the nurse responsible.

If there was no indication for 9 mL of epinephrine 1:1,000 to be placed on a tray next to bupivacaine with epinephrine 1:200,000, the jury would believe the medication was mislabeled. While epinephrine is often used to increase visualization during arthroscopic surgery, it is typically added to the irrigation solution (eg, 1 mL epinephrine 1:1,000 added to 3,000 mL of irrigation fluid). From the facts given, it is unclear whether the undiluted epinephrine 1:1,000 was kept within the surgeon’s reach. If so, this was a dangerous practice pattern that could have been recognized and the outcome prevented.

Confusion can lead to use of an incorrect concentration of the correct medication. This is particularly true with epinephrine—a substance with a built-in, tenfold fatal error potential. Epinephrine 1:1,000 (generally used for subcutaneous administration) can have disastrous consequences when given in place of epinephrine 1:10,000 (generally administered by IV). Several fatal and near-fatal cases have been reported involving this error. Epinephrine 1:1,000 in 30-mL vials has been specified for its overdose potential. Consider replacing these vials with 1-mL ampoules, and if this is not feasible, consider applying a warning label: “not for IV use without appropriate dilution.”

In cases in which similar medications are used in close proximity, consider applying a use-based label in addition to that showing dosing/concentration. For example, try labeling the syringe of epinephrine 1:1,000 “for subcutaneous/endotracheal use only” versus epinephrine 1:10,000, “for intravenous use.”

In whatever setting you practice, do your part to ensure that staff is specifically alerted to the hazard of potentially fatal epinephrine concentration errors. A life saved by preventing an error is a life saved.   —DML

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

Undiluted Acetic Acid Used for Surgery on Vulvar Lesion
The patient, a 42-year-old Ohio woman, was scheduled for a

gynecologic surgical procedure. The surgery was to be performed in the hospital by a general practice obstetrician/gynecologist for treatment of low-grade squamous intraepithelial lesions (ie, vulvar intraepithelial neoplasm [VIN] with moderate dysplasia). The planned procedure was a wide local excision of the vulvar lesions, to be performed under general anesthesia.

The procedure typically includes application of a diluted acetic acid wash to the vulvar area to delineate the borders of the dysplastic areas. Instead of the diluted solution, however, a highly concentrated acetic acid, trichloroacetic acid (TCA), was used.

The patient sustained a severe chemical burn of the vulva, which took several months to heal. She was left with permanent scarring of the vulvar area and extreme tenderness at the vaginal opening, which is atrophic and severely reddened and discolored. The patient has a band of thick scar tissue at the posterior fourchette, and she also sustained burning and severe scarring of the perineum that extends to the anal area, including a 2-mm plaque layer.

The plaintiff claimed that her injuries limited her to extremely painful sexual intercourse (if any), as well as discomfort at all times. Only a complicated set of additional surgical procedures could be recommended to attempt to alleviate her condition and allow relatively pain-free intercourse.

OUTCOME
A $600,000 settlement was reached in direct negotiations with the risk management department of the hospital in question.

COMMENT
This case settled before trial after direct negotiations with the hospital’s risk management department, which is unusual; cases are typically turned over to trial counsel after a case is initiated.

Jurors take a harsh view of such mix-ups, expecting simple safety precautions, like clear labeling, to prevent devastating outcomes.

The negotiated settlement is rather low, given the patient’s pain and demonstrable losses. Ohio has a damages cap on noneconomic damages (eg, pain and suffering, vs economic damages, such as loss of income). Ohio also has a cap on punitive damages—which is double the cap on compensatory damages. In a different jurisdiction without these caps, the defendant hospital’s exposure to larger damages would have been greater.

Clinicians must take an active role to prevent such outcomes. Any substance used in a clinical setting should be clearly labeled. Items not suitable for direct patient use (eg, undiluted acetic acid) should never be brought into the examining room or the operating room. Clinicians should actively monitor support personnel to detect practices that could result in an accident.

Our role as clinicians is to protect the patient: That includes monitoring our practice environment for patterns that could result in accidents (eg, slip and fall), errors (medication administered to the incorrect patient), or unclear accountability (lab values not reviewed in a timely manner). Stay vigilant and work within your team practice environment to spot and correct problems before those problems ripen into errors that may injure patients and land clinicians in court. —DML

Excessive Epinephrine Injection Causes Cardiac Arrest
An Idaho woman, age 39, was to undergo an arthroscopic shoulder procedure in February 2007 at a specialty hospital. Prior to surgery, the patient was mistakenly given an injection of 9 cc epinephrine at a concentration of 1:1,000 instead of the ordered presurgical injection—a diluted concentration of epinephrine 1:200,000, combined with bupivacaine. The patient went into full cardiac arrest and was subsequently diagnosed with a mild brain injury resulting from the lengthy code conducted at the hospital.

The plaintiff claimed that the hospital’s use of 30-mL multidose vials of concentrated epinephrine 1:1,000 in the operating room heightened the risk for medication error. The plaintiff also claimed that the circulating nurse failed to properly label the syringe containing the medication and that the circulating nurse failed to properly run a time-out procedure prior to the medication error.

The defendant claimed that the presence of multidose vials of concentrated epinephrine in the operating room was proper and that the syringe used to inject the plaintiff was properly labeled. The defendant also claimed that a time-out had been properly conducted prior to the medication error.

OUTCOME
According to a published account, a $760,000 verdict was returned. The plaintiff had settled the claim against the orthopedic group prior to trial for a confidential amount and had entered into a high-low agreement with the hospital ($750,000/$500,000) minutes before the verdict was returned.

COMMENT
As in the previous case, this action involves the unintended use of a substance (epinephrine 1:1,000) that bears some similarity to the correct substance (bupivacaine with epinephrine 1:200,000). There was disagreement as to whether the syringe was properly labeled.

Here, the case was settled against the orthopedic surgeon. The hospital has vicarious liability for the circulating nurse as an employee of the hospital. The plaintiff alleged that the use of the multidose vial was risky, and that the nurse did not perform an adequate time-out procedure before the error. This procedure is designed to give nurses protected time, free from other distractions, within which to manage and administer medications. The concept of protected time seeks to minimize errors of medication administration by giving nurses dedicated time to concentrate only on medications without the usual distractions from clinicians, other patients, telephone calls, pages, and the like. This is important, because a clinician’s prescribing or ordering error is often detected (by pharmacists or nurses, respectively). Generally, when a nurse administers a medication, there is no automatic “second pair of eyes” to review his or her action.

In this instance, however, the opposite situation existed: The nurse prepared the medication, and the physician administered it. The plaintiff’s contention was that the nurse mislabeled the medication, and the plaintiff was able to prevail at trial on this theory.

Interestingly, the plaintiff likely took the opposite position with the physician to obtain settlement before trial—that is, that the nurse correctly labeled the syringe, but it was inappropriately administered by the physician. After settling with the physician, the plaintiff was free to change the theory of the case—placing blame with the nurse and hospital. At trial, with an injured plaintiff and no clinician to blame, the jury found the plaintiff’s position credible and found the nurse responsible.

If there was no indication for 9 mL of epinephrine 1:1,000 to be placed on a tray next to bupivacaine with epinephrine 1:200,000, the jury would believe the medication was mislabeled. While epinephrine is often used to increase visualization during arthroscopic surgery, it is typically added to the irrigation solution (eg, 1 mL epinephrine 1:1,000 added to 3,000 mL of irrigation fluid). From the facts given, it is unclear whether the undiluted epinephrine 1:1,000 was kept within the surgeon’s reach. If so, this was a dangerous practice pattern that could have been recognized and the outcome prevented.

Confusion can lead to use of an incorrect concentration of the correct medication. This is particularly true with epinephrine—a substance with a built-in, tenfold fatal error potential. Epinephrine 1:1,000 (generally used for subcutaneous administration) can have disastrous consequences when given in place of epinephrine 1:10,000 (generally administered by IV). Several fatal and near-fatal cases have been reported involving this error. Epinephrine 1:1,000 in 30-mL vials has been specified for its overdose potential. Consider replacing these vials with 1-mL ampoules, and if this is not feasible, consider applying a warning label: “not for IV use without appropriate dilution.”

In cases in which similar medications are used in close proximity, consider applying a use-based label in addition to that showing dosing/concentration. For example, try labeling the syringe of epinephrine 1:1,000 “for subcutaneous/endotracheal use only” versus epinephrine 1:10,000, “for intravenous use.”

In whatever setting you practice, do your part to ensure that staff is specifically alerted to the hazard of potentially fatal epinephrine concentration errors. A life saved by preventing an error is a life saved.   —DML

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

Undiluted Acetic Acid Used for Surgery on Vulvar Lesion
The patient, a 42-year-old Ohio woman, was scheduled for a

gynecologic surgical procedure. The surgery was to be performed in the hospital by a general practice obstetrician/gynecologist for treatment of low-grade squamous intraepithelial lesions (ie, vulvar intraepithelial neoplasm [VIN] with moderate dysplasia). The planned procedure was a wide local excision of the vulvar lesions, to be performed under general anesthesia.

The procedure typically includes application of a diluted acetic acid wash to the vulvar area to delineate the borders of the dysplastic areas. Instead of the diluted solution, however, a highly concentrated acetic acid, trichloroacetic acid (TCA), was used.

The patient sustained a severe chemical burn of the vulva, which took several months to heal. She was left with permanent scarring of the vulvar area and extreme tenderness at the vaginal opening, which is atrophic and severely reddened and discolored. The patient has a band of thick scar tissue at the posterior fourchette, and she also sustained burning and severe scarring of the perineum that extends to the anal area, including a 2-mm plaque layer.

The plaintiff claimed that her injuries limited her to extremely painful sexual intercourse (if any), as well as discomfort at all times. Only a complicated set of additional surgical procedures could be recommended to attempt to alleviate her condition and allow relatively pain-free intercourse.

OUTCOME
A $600,000 settlement was reached in direct negotiations with the risk management department of the hospital in question.

COMMENT
This case settled before trial after direct negotiations with the hospital’s risk management department, which is unusual; cases are typically turned over to trial counsel after a case is initiated.

Jurors take a harsh view of such mix-ups, expecting simple safety precautions, like clear labeling, to prevent devastating outcomes.

The negotiated settlement is rather low, given the patient’s pain and demonstrable losses. Ohio has a damages cap on noneconomic damages (eg, pain and suffering, vs economic damages, such as loss of income). Ohio also has a cap on punitive damages—which is double the cap on compensatory damages. In a different jurisdiction without these caps, the defendant hospital’s exposure to larger damages would have been greater.

Clinicians must take an active role to prevent such outcomes. Any substance used in a clinical setting should be clearly labeled. Items not suitable for direct patient use (eg, undiluted acetic acid) should never be brought into the examining room or the operating room. Clinicians should actively monitor support personnel to detect practices that could result in an accident.

Our role as clinicians is to protect the patient: That includes monitoring our practice environment for patterns that could result in accidents (eg, slip and fall), errors (medication administered to the incorrect patient), or unclear accountability (lab values not reviewed in a timely manner). Stay vigilant and work within your team practice environment to spot and correct problems before those problems ripen into errors that may injure patients and land clinicians in court. —DML

Excessive Epinephrine Injection Causes Cardiac Arrest
An Idaho woman, age 39, was to undergo an arthroscopic shoulder procedure in February 2007 at a specialty hospital. Prior to surgery, the patient was mistakenly given an injection of 9 cc epinephrine at a concentration of 1:1,000 instead of the ordered presurgical injection—a diluted concentration of epinephrine 1:200,000, combined with bupivacaine. The patient went into full cardiac arrest and was subsequently diagnosed with a mild brain injury resulting from the lengthy code conducted at the hospital.

The plaintiff claimed that the hospital’s use of 30-mL multidose vials of concentrated epinephrine 1:1,000 in the operating room heightened the risk for medication error. The plaintiff also claimed that the circulating nurse failed to properly label the syringe containing the medication and that the circulating nurse failed to properly run a time-out procedure prior to the medication error.

The defendant claimed that the presence of multidose vials of concentrated epinephrine in the operating room was proper and that the syringe used to inject the plaintiff was properly labeled. The defendant also claimed that a time-out had been properly conducted prior to the medication error.

OUTCOME
According to a published account, a $760,000 verdict was returned. The plaintiff had settled the claim against the orthopedic group prior to trial for a confidential amount and had entered into a high-low agreement with the hospital ($750,000/$500,000) minutes before the verdict was returned.

COMMENT
As in the previous case, this action involves the unintended use of a substance (epinephrine 1:1,000) that bears some similarity to the correct substance (bupivacaine with epinephrine 1:200,000). There was disagreement as to whether the syringe was properly labeled.

Here, the case was settled against the orthopedic surgeon. The hospital has vicarious liability for the circulating nurse as an employee of the hospital. The plaintiff alleged that the use of the multidose vial was risky, and that the nurse did not perform an adequate time-out procedure before the error. This procedure is designed to give nurses protected time, free from other distractions, within which to manage and administer medications. The concept of protected time seeks to minimize errors of medication administration by giving nurses dedicated time to concentrate only on medications without the usual distractions from clinicians, other patients, telephone calls, pages, and the like. This is important, because a clinician’s prescribing or ordering error is often detected (by pharmacists or nurses, respectively). Generally, when a nurse administers a medication, there is no automatic “second pair of eyes” to review his or her action.

In this instance, however, the opposite situation existed: The nurse prepared the medication, and the physician administered it. The plaintiff’s contention was that the nurse mislabeled the medication, and the plaintiff was able to prevail at trial on this theory.

Interestingly, the plaintiff likely took the opposite position with the physician to obtain settlement before trial—that is, that the nurse correctly labeled the syringe, but it was inappropriately administered by the physician. After settling with the physician, the plaintiff was free to change the theory of the case—placing blame with the nurse and hospital. At trial, with an injured plaintiff and no clinician to blame, the jury found the plaintiff’s position credible and found the nurse responsible.

If there was no indication for 9 mL of epinephrine 1:1,000 to be placed on a tray next to bupivacaine with epinephrine 1:200,000, the jury would believe the medication was mislabeled. While epinephrine is often used to increase visualization during arthroscopic surgery, it is typically added to the irrigation solution (eg, 1 mL epinephrine 1:1,000 added to 3,000 mL of irrigation fluid). From the facts given, it is unclear whether the undiluted epinephrine 1:1,000 was kept within the surgeon’s reach. If so, this was a dangerous practice pattern that could have been recognized and the outcome prevented.

Confusion can lead to use of an incorrect concentration of the correct medication. This is particularly true with epinephrine—a substance with a built-in, tenfold fatal error potential. Epinephrine 1:1,000 (generally used for subcutaneous administration) can have disastrous consequences when given in place of epinephrine 1:10,000 (generally administered by IV). Several fatal and near-fatal cases have been reported involving this error. Epinephrine 1:1,000 in 30-mL vials has been specified for its overdose potential. Consider replacing these vials with 1-mL ampoules, and if this is not feasible, consider applying a warning label: “not for IV use without appropriate dilution.”

In cases in which similar medications are used in close proximity, consider applying a use-based label in addition to that showing dosing/concentration. For example, try labeling the syringe of epinephrine 1:1,000 “for subcutaneous/endotracheal use only” versus epinephrine 1:10,000, “for intravenous use.”

In whatever setting you practice, do your part to ensure that staff is specifically alerted to the hazard of potentially fatal epinephrine concentration errors. A life saved by preventing an error is a life saved.   —DML