Medical Malpractice and Trigeminal Neuralgia: An Analysis of 49 Cases

Background Our study aims to ll the vacancy of litigation studies related to trigeminal neuralgia management, and to give healthcare providers the necessary information needed to better understand the potential litigious outcomes that often follow certain treatment methods. queried the Westlaw Edge legal database to identify litigation cases related to the management of trigeminal neuralgia for the using the following search criteria: (trigeminal & (tic & douloureux) and & Key the following: were in of and in of using t-test or were chi-square or exact


Abstract Background
Our study aims to ll the vacancy of litigation studies related to trigeminal neuralgia management, and to give healthcare providers the necessary information needed to better understand the potential litigious outcomes that often follow certain treatment methods.

Methods
We queried the Westlaw Edge legal database to identify litigation cases related to the management of trigeminal neuralgia for the years 1985-2019 using the following search criteria: (trigeminal & neuralgia), (tic & douloureux) and (microvascular & decompression). Key variables extracted included the following: plaintiff medical complaints, trial outcome, payout, and demographic characteristics. Continuous variables were compared between cases in favor of defendant and cases in favor of plaintiff using t-test or Wilcoxon rank sum test. Categorical variables were compared using chi-square or Fischer's exact test.
Results 49 cases met the inclusion criteria -for those cases surgical complication (42.9%) and failure to diagnose (32.7%) were cited as the most common alleged reasons for ling a malpractice claim. Cranial nerve de cits (34.7%) and loss of consortium (12.2%) were the most frequent post-operative complaints.
Verdicts ruled in favor of the defendant in 61.2% of cases, and for the plaintiff in 26.5% of cases with a mean payout of $1,982,428.46. Dental specialists were included in the most cases, 63.3%, and the average payout was $415,908, while Neurosurgical specialists were involved in 20.4% of cases with an average payout of $618,775. Cases where the verdict was in favor of the plaintiff were more likely to be older than cases with a verdict in favor of the defendant (p=0.03).

Conclusions
Over one-half of the cases resulted in a defendant's verdict with surgical complications cited as the most common reason for litigation. Dentistry and neurosurgery were listed as the most common individual physician specialties for defendants, also contributing to the largest average payouts based on specialty (for specialties > 1 occurrence). Cranial nerve de cits and loss of consortium were the most common plaintiff post-operative complaints. A key implication of this study is the need for more extensive discussions between physician and patient regarding informed consent, especially when neurosurgical interventions are required.

Background
Patient litigation remains an ongoing concern for many licensed medical practitioners. Medical malpractice lawsuits have been a common occurrence in the United States since 1960. [1] Due to the consequential nature of neurosurgical procedures, physicians within the specialty face a high risk of malpractice lawsuits. The malpractice risk for general surgeons and neurosurgeons is especially high, being around 65% and 95% respectively. [2] Although there are relatively high occurrences of litigation within surgery, research detailing the weight of these effects for different specialties and diagnoses remains relatively scarce. Of these, procedures involving head and neck surgeries have been studied for medical litigation. To our knowledge, examination of malpractice due to the surgical treatment of trigeminal neuralgia has not yet been conducted.
Trigeminal neuralgia (TN) is a chronic pain condition presenting in the trigeminal nerve distribution which often occurs when the nerve is compressed by a blood vessel or tumor. The typical presentation may include recurrent paroxysms of unilateral, severe shooting, and burning pain which can be triggered by gentle touching of the face, chewing, or while brushing teeth. [4] Causes for these presentations may be due to aging, effects of stroke-like symptoms, or damage to the myelin nerve sheath. Dental ailments and surgical procedures can also mimic TN. In order to treat the commonly chronic, and very severe, pain that can occur from TN, a series of medical treatments are usually initially applied. Primarily these treatments include sodium channel blockers (e.g. carbamazepine and oxcarbazepine). [5] If combination medical treatments are unhelpful, procedures such as microvascular decompression or stereotactic radiosurgery may be employed. Other surgical treatment methods can be undertaken depending on the cause of the TN.
There have been case reports of patients with atypical presentations of trigeminal neuralgia in whom a diagnosis was missed. [4] There have also been presented cases of patients in whom a trigeminal neuropathy was uncovered after a dental procedure. [6] Such cases have also been reported in the media after patients decided to le a lawsuit. [7,8] However, to our knowledge to date, no study has comprehensively examined lawsuits led by patients with respect to the surgical management of trigeminal neuralgia. Our study aims to ll the vacancy of litigation studies related to TN management, and to give physicians and other healthcare providers the necessary information needed to better understand the potential litigious outcomes that often follow certain treatment methods.

Data Source
For the current study, we queried the Westlaw Edge (Thomson Reuters) online legal database with the aim of identifying public litigation cases related to the management of trigeminal neuralgia for the years 1985-2019. [9] The database Westlaw Edge serves as a comprehensive national repository for legal cases from all court levels across the United States of America. Cases presented in Westlaw are screened for accuracy by attorneys. [10,11] Cohort Cases documented as Jury Verdicts and Settlements from all Federal and State level courts were searched. Legal cases were included in the study provided that they were related to one individual patient, and the allegation was directly related to engagement with medical staff who diagnosed or managed trigeminal neuralgia. In order to obtain the most comprehensive number of cases from the database, the following search criteria was used: (trigeminal & neuralgia), (tic & douloureux) and (microvascular & decompression). The "&" function ensures that the retrieved results include all the search terms.

Outcomes and Covariates of Interest
Trigeminal neuralgia data was extracted from the Westlaw database. The variables extracted included the following: plaintiff and defendant background, trial year, litigation category, plaintiff medical complaints, trial outcome, and payout if applicable. Demographic characteristics of patient age and sex were also recorded. These characteristics were then compared based on verdict in favor of the defendant (physician) and cases with a verdict in favor of the plaintiff.

Statistical Analysis
Continuous variables were summarized using means and standard deviations and compared between cases in favor of defendant and cases in favor of plaintiff using t-test or Wilcoxon rank sum test. Categorical variables were summarized using frequencies and proportions and compared between the two groups using chi-square or Fischer's exact test. Table 1 here 132 cases relating to trigeminal neuralgia and medical malpractice occurring from 1985 to 2019 were obtained from the primary search. Of those, 83 cases were excluded from the study due to litigation focused on a motor vehicle accident, insu cient information about the case, or the presence of duplicate cases. After screening, there were a total of 49 cases eligible for inclusion in this analysis.

Demographics
Of the total 49 cases, 13 (26.5%) were male, 35 (71.4%) were female, and 1 (2.0%) was of unknown sex ( Table 1). The average age of those who led a claim was 48.1 years (range 22 to 78 years old).

Geographic Distribution
Cases involving trigeminal neuralgia were declared across 17 states in the United States. Notably, New York (n=11; 22.4%) had the greatest number of cases, with California and Pennsylvania following with 7 (14.3%) cases each (Table 1).

Reasons for Litigation
Occurrence of a surgical complication (n=21; 42.9%) was cited as the most common alleged reason for ling a malpractice claim. The second most common reason was failure to diagnose (n=16; 32.7%).

Plaintiff Complaints or Outcomes involved in Claim
For pre-operative symptoms, including symptoms reported by patients who never underwent a procedure, cranial nerve de cits (n=10; 20.4%) and nancial loss (n=2; 4.1%) were the most frequent complaints (Table 1 and Figure 1). Other complaints included loss of consortium, facial paralysis, speech impairment, quadriplegia, and headache or chronic headache each represented in 1 (2%) case.

Legal Jurisdiction, Verdict, and Payments
Information on case outcome was available for 46 of the cases included in this study. A verdict was reached at the state level for all of these cases. Verdicts ruled in favor of the defendant in 30 (61.2%) of cases, and for the plaintiff in 13 (26.5%). A settlement was reached in 3 (6.1%) cases. The payout range for all verdicts ranged from $55,000 -7,978,185. The mean payout for verdicts in favor of the plaintiff was $1,982,428.46, which was greater than the $660,724.67 mean for settlements. When considering payouts based on specialty, the largest amount was in a single case involving Anesthesiology, where the payout was $7,978,185 ( Table 2). The next highest average payout was $1,030,898 over 9 cases against a hospital, medical center, or healthcare system group. Dental specialists were included in the most cases, 31 (63.3%), and the average payout was $415,908. Neurosurgical specialists were involved in 10 (20.4%) cases which were found to have an average payout of $618,775. We also compared characteristics between cases which had a verdict in favor of the defendant (n=30) and those in favor of plaintiff (n=13). Cases where the verdict was in favor of the plaintiff were more likely to be older (55.6 ± 12.9 vs 42.9 ± 12.5, p=0.03). Other factors found to be different but not approaching statistical signi cance included defendant's position where cases in favor of the plaintiff were more likely to involve physicians (53.8%, n=7 vs 30%, n=9, p=0.137); type of lawsuit where cases in favor of plaintiff were more likely to be malpractice lawsuits (66.7%, n=8 vs 36.7%, n=11, p=0.078). Finally, cases with verdict in favor of plaintiff, compared to those with verdict in favor of defendant, were more likely to involve a litigation of failure to treat and informed consent failure (failure to treat: 23.1%, n=3 vs 6.7%, n=6; informed consent failure: 23.1%, n=3 vs 3.3%, n=1; overall p=0.093). In this study, the most common reasons for litigation were surgical complications (n=21; 42.9%) and failure to diagnose (n=16; 32.7%) (see Table 1 and Figure 1). These ndings are consistent with a previous study of medical malpractice in neurosurgery that found procedural error (45.5%) and failure to diagnose (41.4%) as the top cited reasons for litigation.
[13] Cranial nerve de cits (n=17; 34.7%) and loss of consortium (n=6; 12.2%) were the most numerous post-operative complaints (Figure 1). Cranial nerve de cits can not only result in additional complaints of vision impairment or loss, facial paralysis, deafness, and other de cits, but they can also exacerbate symptoms of trigeminal neuralgia, providing a potential correlation between the high frequencies of surgical complication as a reason for litigation and cranial nerve de cits as a post-operative complaint.
Although trigeminal neuralgia is most commonly initially treated nonoperatively with an anticonvulsant medication such as carbamazepine, the etiology of the disease (e.g. MS, blood vessel or tumor compression, facial trauma) and severity of pain may necessitate surgical intervention. Microvascular decompression has been found to sustain pain relief in 73% of patients over 5 years. [5] As with many invasive surgical procedures, this treatment approach does not come without risks such as aseptic meningitis, sensory loss, and hearing loss. [5] The two defendant specialties most commonly cited in claims were Dentistry (n=31; 63.3%) and Neurosurgery (n=10; 20.4%) ( Table 1). The vast majority of claims studied were led against defendants involved in dentistry. This is likely because trigeminal neuralgia commonly presents with gum and tooth pain with chewing, and dentists are the specialists frequently consulted rst, contributing to their large representation in legal claims. [15] This might also explain why a large majority of cases resulted in a favorable verdict for the defendant in these cases (n=30; 61.2%) ( Table 1). The condition may have been pre-existing and simply manifested after a visit to the defendant, also potentially refuting plaintiff claims of surgical complications.
The highest average payout based on defendant specialty was for Anesthesiology at $7,978,185. However, there was only a single case involving this specialty. Neurosurgery presented as the specialty with the highest average payout (for specialties with N > 1) at $618,775. Neurosurgeons are responsible for the surgical, and often stereotactic, treatment of trigeminal neuralgia, such as percutaneous procedures on the Gasserian ganglion, gamma knife surgery, and microvascular decompression, thus it logically follows that this specialty is one of the most commonly represented specialties in lawsuits and payouts pertaining to trigeminal neuralgia. [16] Our nding that cases with physicians as defendants were more likely to result in a verdict in favor of the plaintiff has previously been demonstrated by Shantharam et al., who investigated factors associated with outcomes of malpractice litigation among patients with spinal epidural abscess and found a similar association. [17] The same study found that a delay in treatment was associated with a verdict more likely in favor of the plaintiff. [17] Finally, our nding that informed consent failure was associated often with a verdict in favor of the defense warrants a speci c discussion. A study by Cassileth et al. showed that among patients who were tested on their recall of the details of the informed consent 24 hours after it was obtained, only 60% remembered the purpose of the treatment and only half of the patients could list one potential complication.
[18] This underscores the need for clear and explicit consent for the surgical or radiosurgical treatment of trigeminal neuralgia. Patients a icted with this condition are often desperate for a solution due to the extreme pain. The potential risks of intervention need to be clearly expressed and all questions answered in full. It is wise to have family members involved with the discussion of the risks, and also a thorough discussion of all the treatment options that are available, including continued non-procedural or medical management.
One limitation in our analysis is that only 47 cases met the inclusion criteria. Though multiple search terms, such as "Trigeminal Neuralgia", "Tic Douloureux", and "Microvascular Decompression" were used to lter cases, many cases were excluded as they included duplicates or non-medical related primary incidents. Additionally, the Westlaw database excludes cases mediated outside of the court system and only includes cases reported at the discretion of state courts.
Another limitation to the database is that the trial data documented in Westlaw is recorded by nonmedical professionals, which leads to less medically relevant information regarding the interventional procedures performed by the defendants. Such information could potentially provide context to the postoperative complaints and trial outcomes if include

Conclusions
Our study presents a 34-year analysis of trigeminal neuralgia-related medical malpractice suits in the United States. Over one-half of the cases resulted in a defendant's verdict with surgical complications cited as the most common reason for litigation. Dentistry and neurosurgery were listed as the most common individual physician specialties for defendants, also contributing to the largest average payouts based on specialty (for specialties > 1 occurrence). Cranial nerve de cits, loss of consortium, nancial loss, and death were the most common plaintiff complaints.

Declarations
Ethics Approval and consent to participate Not applicable Consent for publication Not applicable

Availability of data and materials
The data that support the ndings of this study are available from Westlaw Edge database, but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors under reasonable request and with permission of Thomson Reuters.

Competing interests
The authors declare that they have no competing interests.