Source: http://archotol.jamanetwork.com/article.aspx?articleid=221757
Timestamp: 2014-10-30 15:56:44
Document Index: 658882945

Matched Legal Cases: ['art 1', 'art 2', 'ART 1', 'ART 2', 'art 2', 'art 1', 'art 1', 'art 2', 'arts 1', 'art 1', 'art 2']

JAMA Network | JAMA Otolaryngology–Head & Neck Surgery | Malpractice Litigation After Surgical Injury of the Spinal Accessory Nerve: An Evidence-Based Analysis
Malpractice Litigation After Surgical Injury of the Spinal Accessory Nerve: An Evidence-Based Analysis
Luc G. T. Morris, MD;
David J. S. Ziff, JD;
Arch Otolaryngol Head Neck Surg. 2008;134(1):102-107. doi:10.1001/archotol.134.1.102. Text Size: A A A
Strategies for optimal surgical care and litigation risk reduction are discussed.
The spinal accessory nerve, or cranial nerve XI, is at risk of injury in surgery involving the posterior triangle (level V), superior neck (level IIb), and the lateral skull base. Loss of accessory nerve function results in loss of innervation of the trapezius muscle and,
unintentional nerve injury is preventable.5 Also contributing to patient morbidity, surgeons generally do not recognize this injury promptly, jeopardizing surgical repair that might otherwise ameliorate some morbidity.6,7
It is, therefore, no surprise that inadvertent accessory nerve injury, usually preventable and potentially debilitating, is an important source of malpractice litigation. The contemporary medical malpractice debate has been suffused with rhetoric and competing claims, with tort reformists complaining of burdensome frivolous lawsuits and trial attorneys complaining of the prevalence of medical errors requiring legal redress.8,9 There is a distinct need for an evidence-based analysis of malpractice litigation,
of adverse events in the health care system.10
Unintentional injuries to the accessory nerve provide a useful case study in malpractice litigation. These are a homogeneous group of legal cases, in which injury of one nerve, during a series of similar surgical procedures, results in a group of patients with similar morbidity.
This study examined the background and outcomes of malpractice lawsuits alleging impaired spinal accessory nerve function after neck surgery, focusing on the closed cases of a liability insurance company and national civil court trials.
This was a retrospective review of medicolegal cases drawn from 2 sources: a private medical liability insurance company in New York State (part 1) and the public records of state and federal civil court trials (part 2). All closed cases between January 1, 1985, and January 1, 2007, were included. All awards were adjusted for inflation and are reported in current 2007 dollars. Intergroup comparisons used the 2-tailed t test, with an a priori level of significance of P = .05.
PART 1: NEW YORK STATE INSURANCE CASES
compensation, type of surgery, alleged injury, and case outcome. Cases discontinued or settled before jury selection were classified as discontinued or settled “before trial.”
PART 2: NATIONAL COURT TRIALS
was used to identify cases alleging iatrogenic injury to the spinal accessory nerve that proceeded to either federal or state civil trial in the United States. A plain-language search for “accessory nerve” in the “all verdicts/settlements” database was performed for the dates previously given. Information was collected concerning the defendant physician or hospital, date of surgery, date of trial, type of surgery, alleged injury, claims of negligence, jury verdict and award, and settlement details.
The WestLaw verdict reports are authored by jury verdict reporters who summarize case details based on court records and information submitted by trial attorneys. Accordingly, much more information about the legal proceedings was available for part 2 cases, compared with the insurance company records for part 1 cases. However, because there is no standard central information gathering system, not every trial in the United States is reflected in the WestLaw database.
Eight of the insurance cases reviewed in part 1 did reach the trial stage, and some of these cases may have been included in the part 2 WestLaw database. Because we sought to characterize each group of cases separately (and did not combine data from parts 1 and 2),
and because these cases contribute important information to each group independently, we did not exclude part 1 cases from inclusion in part 2.
Between 1985 and 2007, 41 closed New York State insurance cases were identified from the records of the Medical Liability Mutual Insurance Company of New York. The WestLaw database identified 81 additional civil trials.
Of 41 lawsuits, 40 involved excision of a neck mass and 1 involved a peripheral vascular procedure (axillary-subclavian bypass). There were 39 biopsies of cervical lymph nodes and 1 excision of a vascular malformation. All cases alleged shoulder weakness and surgical injury to the spinal accessory nerve.
Defendants included 24 general surgeons (59%), 5 otolaryngologists (12%), and 2 each of plastic surgeons, vascular surgeons, and general practitioners (5% each). One anesthesiologist (2%) was also sued,
as were 5 hospitals (12%).
All cases against the hospitals and the case against the anesthesiologist were discontinued before trial, leaving 34 cases against the physician performing the procedure. Of these 34 surgeon cases, only 8 (24%)
(Percentages do not total 100 because of rounding.) Of the 8 cases reaching trial, 6 were settled at trial and 2 jury verdicts were returned (both in favor of the defendant physicians) (Figure 1).
Place holder to copy figure label and captionFigure 1.Outcomes of 34 New York State insurance claims after alleged injury to the spinal accessory nerve;
28 (82%) cases compensated the plaintiff.Graphic Jump Location+View Large | Save Figure | Download Slide (.ppt)
If the 2 cases not involving cervical lymph node biopsy are excluded (1 was settled before trial and 1 was settled at trial),
5 settlements at trial (16%), 4 discontinuances (12%), and 2 defendant verdicts (6%). Therefore, 26 of 32 lymph node cases (81%), or 28 of 34 cases (82%), were ultimately compensated.
The mean indemnity award for cases settled before trial, adjusted for inflation, was $264 395 (range, $7150-$512 000) in 2007
Awards once the cases reached the trial stage were significantly higher (P = .01).
A total of 80 state court trials, from 21 states, and 1 federal court trial were identified. Of the 81 plaintiff patients, there were 79 adults and 2 children. Their mean age was 41.8 years, and there were 32 males and 49 females.
As was the case with the New York State cases, most cases were cervical lymph node biopsies (55 cases [68%]). Cases also included 6 sebaceous cysts (7%), 4 neck dissections (5%), and 2 each of face-lift,
and scar revision (1% each).
Defendant specialty was available for 68 cases. These included 36 general surgeons (53%), 17 otolaryngologists (25%), 4 plastic surgeons (6%), 4 general practitioners (6%), 2 each of orthopedic surgeons,
pediatric surgeons, and vascular surgeons (3% each), and 1 thoracic surgeon (1%) (Figure 2).
Place holder to copy figure label and captionFigure 2.Specialties of defendant surgeons represented in national court trials.Graphic Jump Location+View Large | Save Figure | Download Slide (.ppt)
Unfortunately, the Westlaw database did not formally record more detailed characteristics of the defendant surgeons, such as practice type (academic vs private), subspecialization (eg, head and neck surgery or endocrine surgery), or fellowship training, and this information was only available through secondary sources for a few of the cases.
Verdict reports included details of alleged negligence. Surgical misadventure or error was claimed in 79 (98%) cases. Lack of informed consent was claimed in 17 (21%) cases, although the details of any preoperative counseling, and documentation thereof, were not available.
cases. Only 1 case alleged nonindicated surgery.
Specific morbidity alleged by the patient included shoulder weakness (81 patients [100%]), chronic pain (30 patients [37%]), inability to work (20 patients [25%]), deformity (9 patients [11%]), numbness (4 patients [5%]), and depression (1 patient [1%]). Sixteen patients (20%) ultimately underwent nerve repair, in most cases by a neurosurgeon.
Of these 81 cases, 12 (15%) were settled during trial. A defendant verdict was returned in 37 cases (46%), and a plaintiff verdict was returned in 32 cases (40%) (percentages do not total 100 because of rounding) (Figure 3). Limited to the 55 cervical lymph node cases, 7 (13%) were settled, 25 (45%)
30 of 55 plaintiffs (55%) in lymph node court cases received monetary awards at trial.
Place holder to copy figure label and captionFigure 3.Outcomes of 81 national court trials; 44 (54%) cases eventuated in compensation for the plaintiff.Graphic Jump Location+View Large | Save Figure | Download Slide (.ppt)
When a settlement was reached, the mean initial demand by the plaintiff (as stated in the complaint) was $700 000. The mean inflation-adjusted settlement was $356 132 (range, $22 281-$622 988)
Jury awards were significantly higher than settlements (P = .003) (Figure 4).
Place holder to copy figure label and captionFigure 4.Mean inflation-adjusted monetary awards for cases settled before trial (New York State insurance cases),
at trial (national court cases), or by jury award (national court cases).Graphic Jump Location+View Large | Save Figure | Download Slide (.ppt)
Comparing the lymph node cases alleging lack of informed consent with those cases not alleging the same, there was no significant difference in monetary awards (P = .29). There was also no difference when comparing lymph node cases alleging failure to diagnose the injury postoperatively with cases that did not allege this (P = .94).
In essentially all verdict reports, the defendant surgeon argued that either nerve injury was a recognized complication of surgery or the shoulder weakness was caused by a separate process, such as trauma, infection, or cancer. Most defendants argued that it was not necessary to identify the nerve in the posterior triangle—the nerve was only identified in 1 case. In 9 cases, the nerve injury found on reexploration was reported: there were 7 nerve transections,
1 neuroma, and 1 case of intraneural fibrosis.
The highest jury verdict was an award for $700 000 in 1986
a believable basis for his contention that his self-image had been drastically affected, causing a severe depression.” This award included a $150 000 award to the patient's wife for loss of consortium.
The second highest jury verdict was an award for $1 million in 1998 ($1.25 million in 2007 dollars). This case involved a 57-year-old New Jersey warehouseman with medullary thyroid cancer. Following a total thyroidectomy, a right-sided radical neck dissection, sacrificing the sternocleidomastoid muscle, jugular vein, and accessory nerve,
was performed, although there was no clinical or radiographic evidence of neck metastases. The patient contended that the radical surgery was not indicated and that he had not been informed of any of the sequelae of radical neck dissection. The patient claimed he was unable to work, would be permanently unemployable, and had chronic pain as a result of the injury. The trial focused not only on the nonindicated surgery but also on the surgeon's lack of informed consent. The award included $430 000 for lost wages, $545 000 for pain and suffering, and $25 000 to the plaintiff's wife for loss of consortium.
loss of abduction, paresthesias, and adhesive capsulitis causing a frozen shoulder.11
Surgeons performing any manner of surgery in the posterior triangle of the neck should maintain a high suspicion for this clinical syndrome,
wallerian degeneration of the distal nerve segment will eventually make it unexcitable and scar tissue maturation will make nerve identification more difficult. By 18 to 24 months after injury, the denervated muscle will be replaced by fatty connective tissue, making any functional recovery impossible. Unfortunately, the average delay to referral for nerve repair is 14 months.12
The medical malpractice system has been described as “in crisis,”13 with litigation-driven increases in insurance premiums and an unknown percentage of baseless lawsuits. On the other hand, a landmark study of 30 000 patients by Localio et al14 revealed a 3.7%
up to 75%, are surgical and occur in the operating room.10
Until recently, discussion of surgical malpractice has been largely based on ex cathedra statements backed by little data. There is an emerging recognition among physicians that, distinct from the public policy debate on malpractice reform, there is a need for evidence-based analysis of malpractice claims from a medical perspective. Malpractice after surgical complications has been extensively analyzed in the areas of bile duct injury, facial nerve injury, and complications of thyroid and endoscopic sinus surgery.13,15- 17 The American Society of Anesthesiologists has been particularly active in review of closed medical liability cases.18- 20 These studies are necessary to understand the patterns of care resulting in medical errors and the nonmedical factors leading to successful litigation.
Prior analyses of litigation after surgery have focused on court trials, which do not capture the majority of cases—approximately 85%8—that never reach trial.
trials over 21 years in bile duct injury.16
Accessory nerve injuries are a homogeneous group of cases, well suited for medicolegal analysis, in that most patients undergo a similar procedure for a limited set of indications, experience injury to the same nerve, and subsequently develop symptoms that are relatively consistent from patient to patient. Most accessory nerve injuries in this study were the result of cervical lymph node biopsies—39
(95%) of the indemnity insurance cases and 55 (68%) of the court trials.
While most surgeons sued in this review were general surgeons and otolaryngologists, surgeons of any specialty who operate in the posterior triangle of the neck were at risk of litigation for this adverse outcome.
Although the Medical Liability Mutual Insurance Company of New York insurance cases reflect only New York State cases, they do help to describe the outcomes of claims not reaching the court system.
Nearly two-thirds (66%) of indemnity claims for cervical lymph node biopsies were settled before trial, and when combined with settlements at trial, most cases (81%) eventuated in an indemnity payment. Only 12% of cases were discontinued.
The WestLaw data reflect the quarter of accessory nerve cases that proceed to trial. Most cases (44 of 81 [54%]) favored the plaintiff with either a settlement or a plaintiff verdict.
While there are no similar surgical studies for comparison,
it becomes evident that injury of the accessory nerve carries a high liability risk, with an 81% overall compensation rate.
The study by Studdert et al8 classified the 1452 reviewed cases into 6 categories, based on an independent assessment of the probability a medical error occurred. Cases with less evidence for medical error tended to award compensation between 19% and 32% of the time, while cases with “moderate to strong”
evidence awarded compensation 72% of the time and cases with “virtually certain” evidence awarded compensation 84% of the time.8 Our study's outcomes are most consistent with the subgroup of cases deemed to have virtually certain evidence of medical error. Spinal accessory nerve injury is, thus, a significant source not only of litigation but of high-risk litigation, in which the surgeon has a low probability of prevailing.
Before surgery in or near the posterior triangle of the neck,
all patients should be informed of the risk of accessory nerve injury before informed consent is given. In this study, 21% of the claims reaching trial alleged lack of informed consent. The informed consent discussion should be carefully documented, because only one-third to one-half of patients retain information on surgical risk after considering the information and deciding to proceed.21,22
At surgery, if the posterior triangle is entered, the surgeon should anticipate the presence of the accessory nerve. Depending on the surgical field, the nerve may or may not be encountered: while the nerve would presumably be identified and preserved during a functional neck dissection inclusive of level V, it might not be encountered in many lymph node biopsies. However, even if the nerve is not encountered,
careful surgical techniques can minimize risk to the nerve. Use of blunt dissection and bipolar cautery may be appropriate. Preservation of the nerve requires not only anatomical integrity but functional integrity, which can be compromised if the nerve is stretched or devascularized or if nearby tissue is cauterized. Many patients with accessory nerve injury are found on reexploration to have an intact nerve with intraneural fibrosis.5
Unique to accessory nerve injury, 20% of patients in this study also sued for failure to diagnose the injury postoperatively. A high level of suspicion for nerve injury should be maintained after all neck surgery. Denial by the operating surgeon of possible injury delays appropriate treatment and may complicate the physician-patient relationship.
If a nerve injury is suspected, surgeons best reduce their liability exposure by making a timely diagnosis, taking responsibility for the injury, and referring the patient for physical therapy and possible repair by an experienced peripheral nerve surgeon. Honest and open communication with the patient after this complication is critical.
A medical malpractice claim requires proof of the 4 elements of negligence: (1) the physician had a duty to the patient, (2) the physician breached that duty, (3) the patient was harmed, and (4)
the breach was the legal cause of the harm.
Of these 4 elements, it is most difficult to determine whether the surgeon breached a duty to the patient. It is not sufficient to prove that the surgeon's action or inaction caused the injury, but that the surgeon acted negligently in doing so (ie, the action fell below the accepted standard of care). It is controversial whether attempted identification of the accessory nerve during surgery is within the standard of care in all posterior triangle neck surgery.
Nevertheless, in this study, the data show that the nerve was identified in only 1 of 55 court trials involving an injury after lymph node biopsy and that even in that case the jury returned a plaintiff verdict.
Even careful preservation of the nerve may not preclude the development of shoulder weakness. Of patients undergoing functional neck dissection inclusive of level V, 25% will develop clinical shoulder weakness and up to 85% will demonstrate electromyographic abnormalities.23 These symptoms are usually temporary, but may require as long as 18 months to fully resolve.24 Although injury may occur despite meticulous technique by an excellent surgeon, a surgeon who attempts to identify and preserve the nerve is likely less vulnerable to allegations of breach of duty.
Regardless of whether surgeons consider careful surgical technique and preservation of the nerve to be the standard of care, the legal system clearly treats it as such, awarding compensation in 82% of cases. Even in cases that settle and that, therefore, involve no legal determination that a duty was breached, settlement amounts undoubtedly reflect the likelihood that a jury would find such a breach.
Outcomes in malpractice claims do seem to correlate with the probability of error.8 Nevertheless,
37% of malpractice claims do not involve medical error and 28% of these claims will be compensated. Similar studies24- 26 have reported 16% to 59% rates of compensation in claims without merit.
There are believed to be many factors influencing the outcome of malpractice litigation, other than the medical facts of the case.
In this study, for example, neither the allegation of lack of informed consent nor the allegation of failure to diagnose the injury influenced outcome or award size. The severity of the disability, jurors' sympathy with the plaintiff, and sympathy with the defendant physician are critical factors in case outcome.27 The case description of the highest jury award in this series helps illustrate the importance of a sympathetic plaintiff who has experienced a demonstrable injury. Even cases not proceeding to jury trial will be influenced by the predicted response of a jury to the patient and the physician.
In conclusion, spinal accessory nerve injury may cause significant morbidity and is potentially preventable in most cases. The US legal system compensates malpractice claims against surgeons arising from accessory nerve injury at a rate of up to 82%, making it highly unlikely that a surgeon experiencing this complication will prevail in litigation.
and prompt diagnosis and referral in the event of an injury are crucial.
Correspondence: Luc G. T. Morris,
550 First Ave, NBV 5E5, New York, NY 10016 (luc.morris@med.nyu.edu).
Submitted for Publication: March 26,
2007; final revision received July 11, 2007; accepted July 29, 2007.
Author Contributions: Drs Morris and DeLacure and Mr Ziff had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design:
and material support: Morris, Ziff, and DeLacure.
Additional Contributions: Alvin Katz,
MD, of New York City, and James Robb, of Medical Liability Mutual Insurance Company, provided invaluable expertise in reviewing and interpreting malpractice claim outcomes; and Josephine Drew, Medical Liability Mutual Insurance Company, provided administrative assistance.
453- 455PubMed2 +Nason
241- 246PubMed Link to Article3 +Köybasioglu
73- 77PubMed Link to Article4 +King
35- 38PubMed5 +Chandawarkar
611- 619PubMed Link to Article6 +Osgaard
171- 175PubMed7 +Brown
654- 658PubMed Link to Article8 +Studdert
2024- 2033PubMed Link to Article9 +Baker
T The Medical Malpractice Myth. Chicago, IL University of Chicago Press2005;10 +Rogers
25- 33PubMed Link to Article11 +Wright
15- 20PubMed Link to Article12 +Donner
907- 911PubMed Link to Article13 +Lydiatt
50- 53PubMed Link to Article14 +Localio
245- 251PubMed Link to Article15 +Lynn-Macrae
1492- 1495PubMed Link to Article16 +Kern
217- 222PubMed Link to Article17 +Lydiatt
429- 431PubMed Link to Article18 +Peterson
33- 39PubMed Link to Article19 +Cheney
1081- 1086PubMed Link to Article20 +Bhananker
228- 234PubMed Link to Article21 +Hutson
160- 162PubMed22 +Hekkenberg
155- 159PubMed23 +Cappiello
259- 263PubMed Link to Article24 +Taragin
780- 784PubMed Link to Article25 +Sloan
997- 1039Link to Article26 +Brennan
1963- 1967PubMed Link to Article27 +Frangou
this.UserSessionItem = new UserSessionItem("oia5dawpmvxkb4p31axsephc", 0, 0);
doTracking(this.ActionType, value.toString(), "10/30/2014 11:56:44 AM", this.UserSessionItem, (window.location).toString());
Return to: Malpractice Litigation After Surgical Injury of the Spinal Accessory Nerve: An Evidence-Based Analysis
Morris LT, Ziff DS, DeLacure MD. Malpractice Litigation After Surgical Injury of the Spinal Accessory Nerve: An Evidence-Based Analysis. Arch Otolaryngol Head Neck Surg. 2008;134(1):102-107. doi:10.1001/archotol.134.1.102. Download citation file: RIS (Zotero)
Arch Otolaryngol Head Neck Surg. 2002;128(11):1243. doi:10.1001/archotol.128.11.1243. Impact of New Technologies in Medicine: Call for Papers for the 1999 Global Theme Issue
Arch Otolaryngol Head Neck Surg. 1999;125(1):11. doi:10.1001/archotol.125.1.11. Endoscopic Surgical Repair of Type 3 Laryngeal Clefts
JAMA Otolaryngol Head Neck Surg. Published online October 16, 2014.;():. doi:10.1001/jamaoto.2014.2421. A Model for Predicting Gastrostomy Tube Placement in Patients Undergoing Surgery for Upper Aerodigestive Tract Lesions
JAMA Otolaryngol Head Neck Surg. Published online October 09, 2014.;():. doi:10.1001/jamaoto.2014.2360. An In Situ, In Vivo Murine Model for the Study of Laryngotracheal Stenosis
Malpractice litigation after surgical injury of the spinal accessory nerve: an evidence-based analysis.
2008;134(1):102-7.
2013;92 Suppl 1():S33-72.