Pain Management Closed Claims Study
The Doctors Company reviewed medical malpractice claims that closed between 2008 and 2018 and involved pain management physicians as the primary specialty responsible in the claim. That criteria identified 273 claims and lawsuits. The overarching goal of this study was to provide data and analysis of closed claims, which in turn promotes open discussions with peers and organizations for ways to improve patient safety within the pain management environment and beyond.
Though COVID-19 is known for respiratory symptoms, it is also affiliated with chronic pain, including widespread hyperalgesia. Moreover, COVID-19 exacerbates existing risks for patients with chronic pain—and creates new risks. Since hazards for patients increase liability for physicians, both benefit when pain management specialists adapt care to pandemic circumstances.
The following risks to patient safety and provider liability are exacerbated by COVID-19:
- Some pain management therapies increase infection risks.
- Many opioids suppress immune response. If prescribing an opioid, consider one with minimal immunosuppressive effects, such as buprenorphine.
- Steroids used in interventional pain procedures may also cause immune suppression. Use the lowest possible dose of steroids, and ensure patients are informed of their increased infection risk.
- Some COVID-19 therapies increase risks for interventional pain procedures.
- Christopher J. Malinky, MD, of Colorado Springs Interventional Pain Management, highlights the risks presented by use of anticoagulants for COVID-19 patients months down the line. Citing lack of long-term data regarding the effects of stopping a blood thinner for someone who has had COVID-19 and/or vasculitis, he says, “At this point, I would recommend continuing blood thinner and not doing any elective procedures on those COVID-19 patients who are on blood thinners, at least for the first few months.”
- Delayed care increases a variety of risks.
- Dr. Malinky points out that performing in-office procedures for acute and/or chronic pain may keep patients out of urgent care clinics or emergency departments. Providing access to some in-office procedures can help physicians balance infection risks against the risks of delayed care, which include:
- Patients may have experienced deconditioning through lack of access to physical therapy or nonadherence to regular exercise programs, whether stemming from lifestyle changes during stay-at-home orders, clinic infection-control measures, or financial changes.
- Some patients may have had interventional pain procedures delayed, and are managing their pain with medicines, which may include narcotics—perhaps originally intended for short-term use.
- Fewer opportunities for social or recreational interactions may lead to across-the-board heightened risk for patients suffering from mental health concerns, including addiction disorders.
- Use of opioids carries increased risk from adverse drug effects—and COVID-19.
- Patient isolation during the pandemic exacerbates opioid risk. Physicians should focus on best prescribing practices: Screen patients for red flags. Always check the prescription drug monitoring program, and develop an opioid prescription exit strategy. For opioid use continuing beyond two weeks, conduct a full physical examination and assess the treatment plan, including the potential for procedural intervention and/or referral.
- Since opioids are also cough suppressants, they may mask or delay early COVID-19 symptoms. “I think among pain physicians that prescribe narcotics,” Dr. Malinky says, “there is concern that when people are on narcotics and stable, they can contract COVID-19 without knowing it. Their respiratory drive and ability to oxygenate would be affected.”
- Being limited to telehealth increases risks of diagnostic errors and/or inadequate treatment.
- During the pandemic, many patients are opting for telehealth, but various kinds of chronic pain conditions are diagnosed using in-person musculoskeletal and/or neurological exams. When physical access to a patient is limited, get the best history
- A “physical examination” can be conducted via telehealth through problem-focused exams that the patient can perform and the physician can observe. If possible, physicians should adjust history and physician examination protocols, and utilize diagnostic imaging and lab tests. However, physicians should use their “sixth sense” if they think the patient needs to be seen in person.
This was a cross-sectional analysis of The Doctors Company’s data using the CRICO Comprehensive Risk Intelligence Tool (CRIT).
The analysis was descriptive for the characteristics of claims based on closed claim years from 2008 to 2018 in which pain management was listed as the primary responsible specialty. Variables examined included the type of patient (inpatient, ambulatory), severity, major injury, location, procedure, case type, indemnity paid, expenses paid, and contributing factors.
Chi-square was used to examine differences between the groups of claims with indemnity payments and those with no indemnity payments, in particular the contributing factors involved with the claims.
Chronic pain is considered pain that persists for more than three months. In the United States, one out of every five Americans experiences chronic pain that is unrelated to cancer pain. Chronic pain can extend beyond the pain itself, often encompassing fatigue, anxiety, and sleep deprivation. The cost of pain extends into the overall economy, with the loss of productivity estimated to be around $300 billion, and with other factors like medical costs and disability programs, the annual costs are upwards of $600 billion. Add in issues related to the ongoing opioid crisis, and we quickly realize that by understanding chronic pain management, we can improve medical care, patients’ quality of life, and society overall.
Given the complexity of chronic pain, it is essential that patients receive expert medical management from their healthcare providers. Pain management physicians have advanced training in the evaluation, diagnosis, and treatment of various types of pain. These specialists may treat both acute and chronic pain, and they can coordinate the care of patients, as many people require multiple therapies for their pain. Treatments used by pain management physicians include medications, nerve blocks, epidural steroid injections, spinal cord stimulations, joint injections, and others.
Major Injuries
In exploring the major injuries involved with pain management claims, the top three injuries were adverse medication reaction (16 percent), puncture/perforation (11 percent) and nerve damage (11 percent). The most common body parts/systems affected were found to be the central nervous system (23 percent), lumbar spine (10 percent), cervical spine (8 percent), and thoracic spine (5 percent).
Top Major Injuries in Claims Involving Pain Management Physicians 2008–2018
Over the study period, some differences were found in evaluating patient injuries. While the injuries of adverse medication reaction and death remained steady, the other major injuries demonstrated increases over the studied years. Emotional distress and infections showed slight increases as the years proceeded. However, nerve damage and punctures/perforations rose at a steeper rate, with puncture/perforation having the most pronounced rise in major injuries.
Major Injuries in Pain Management Claims 2008—2018
Emotional
Infection
Nerve Damage
Puncture-Perf.
Treatment Location
The treatment location involved in pain management claims was found to be primarily the ambulatory setting (89 percent). That said, locations varied, and they included:
Location of Pain Management Claims 2008–2018
Claim Severity
The severity of injury was assessed using the National Association of Insurance Commissioners (NAIC) severity scale (0–9), with an added severity of B to indicate a high-severity injury involving a viable pregnancy that resulted in the infant’s death. The majority of the pain management physicians’ claim sample was made up of medium-severity ratings (n =143; 53 percent). Included in the thirty-eight percent high-severity category (n = 103) were fifty-one deaths (49.5 percent of the high-severity category).
Severity Among Claims for Pain Management
Physicians 2008—2018
Assessing the severity of the claims over this study period, the low-severity category was found to remain steady. There was a noted decrease in medium-severity claims, from 56 percent in the first half of the period studied (2008 to 2013) to 48 percent during the second half of the period studied (2014 to 2018). This drop was manifested in the expanded percentage of high-severity claims during the 2014 to 2018 period, 41 percent of the claims, compared to 35 percent during the interval from 2008 to 2013, including a rise in deaths from 16 percent to 21 percent during 2014 to 2018.
Comparison of Severity of Two Periods for Pain Management Physicians
2008-2013
2014-2018
Procedures
Procedures in each claim are coded by the clinical analysts if the procedure contributed to the malpractice claim. Sixty-three percent of the claims reviewed had a procedure included, which indicated the procedure was integral in the claim being filed.
By far, the most common procedures performed by pain management physicians whose claims were included in our study involved the spinal cord area. The injection of an anesthetic for analgesia was the most frequent, followed by injection of a steroid, then the placement of a spinal neurostimulator into the spinal column. Injection of anesthetic into a peripheral nerve for analgesia was the second most typical procedure group seen. Injection into a sympathetic nerve for analgesia, implantable infusion pump, and the injection of a steroid or other prophylactic substance each comprised five percent of the procedures performed.
Procedures Involved in Malpractice Claims Alleged Against Pain Management Physicians 2008–2018
Top Factors Contributing to Patient Claims
Before recommending any patient safety measures, it is essential to examine areas for mitigation. Our analysis includes a review of physician experts’ review of medical records, depositions, interviews, and other documents to determine what could be done differently to avert patient harm.
During the analysis of each claim, a structured taxonomy is used. This taxonomy provides various levels to examine the data, and with the contributing factors, there are three levels: category (broad), subcategory (more specific), and detail (specific). In the review of these claims, broad categories of contributing factors were defined first.
Technical skill was the most prominent contributing factor, found in 54 percent of the claims, followed by clinical judgment (41 percent); behavior-related and communication factors contributed to 31 percent of claims. Documentation as a contributing factor was observed in 22 percent of the claims, administration in 11 percent, and clinical systems in 7 percent.
Further drilling into the subcategory level was accomplished, revealing that technical performance was the leading factor in the studied pain management claims, found in 49 percent of these claims. This factor was followed closely by patient factors, appearing in 48 percent of these claims. Tied for third place, appearing in 23 percent of pain management claims, were the factors communication between the provider and the patient/family and the selection/management of therapy. Clinical judgment factors were found in 21 percent of these claims, and insufficient or lack of documentation factors were noted in 18 percent of these claims.
A closer analysis of an event is required to better understand and identify any effective changes that could be implemented. With any procedure or treatment, there are possible known complications, and (hypothetically) pre-procedure, all patients are informed of these potential complications. However, injuries may still occur, and this would be considered a possible technical problem. Yet, these complications can often lead to claims being filed and, in this study, this occurred 44 percent of the time. Further, 10 percent of the claims revealed patient concerns that the choice of invasive procedure was not the correct one. Additionally, another 10 percent of claims involved patients who were dissatisfied with the care their pain management physician was providing to them.
Top Contributing Factors Among Pain Management Physicians 2008–2018
When considering whether the contributing factors may have changed over the years of the study, the overall categories were examined. Differences were noted in the clinical judgment, documentation, and technical skill categories, so the next level of analysis was completed on the subcategory level.
The clinical judgment category has seven subcategories: patient assessment, selection/management of therapy, patient monitoring, failure to obtain consult/referral, failure to ensure patient safety, conditions affecting the caregiver, and other. Each of these areas were evaluated. Two categories showed steady increases over the duration of this study: patient assessment and the selection/management of therapy.
The documentation category included three subcategories: mechanics, insufficient/lack of documentation, and content decisions. Insufficient/lack of documentation showed an increase in the number of claims over the years. The other two categories remained relatively the same.
The technical skill category includes four subcategories: improper use of equipment, medical error, retained foreign body, and technical skill. Assessment of each subcategory was completed, with technical skill demonstrating an increase over the study period. The other categories remained stable. Technical skill showed the strongest increase of all the combined subcategories over the years.
Informed consent crosses over contributing factor categories, with communication and documentation features. The influence of informed consent in malpractice claims, or poor outcomes overall, should not be underestimated. For example, despite being a low (7 percent) contributing factor for improper performance, insufficient consent between the physician and the patient or family remains a top contributing factor in pain management claims. An effective informed consent discussion requires an open dialogue that sets realistic expectations regarding outcomes and affords the patient an opportunity to ask questions and voice concerns. It benefits the patient and can mitigate the risk of a malpractice claim.
Contributing Factor Change in Pain Management 2008—2018
Patient Assesment Issues
Insufficient/Lack of Documentation
Selection/Management of Therapy
Technical Performance
Claim Types
The top four types of claims for pain management physicians composed sixty-eight percent of the studied claims, with the most prominent type being improper performance of treatment/procedure (n = 112). Improper medication regimen management appeared in 13 percent (n = 36) of the claims, improper management of treatment course appeared in nine percent of claims (n = 25), and diagnosis-related allegations appeared in six percent (n = 16) of the claims.
Case Types of Pain Management Physicians 2008–2018
How the case types may have changed over the study period was explored. The proportion of diagnosis-related claims did not change during the study period. Improper medication management claims increased slightly. Importantly, both improper performance of treatment/procedure and improper management of treatment case types increased over the study period.
Indemnity and Expense
Overall, there has been a steady rise in closed pain management claims over the study period. There were 275 total coded claims from 2008 to 2018, with an increasing pace from a low of 14 cases in 2008 to an average of 30.5 cases per year in 2017 and 2018:
Frequency of Claims Among Pain Management Physicians 2008—2018
Thirty-six percent of the claims had a paid indemnity (n = 99 claims), with an average indemnity paid of $312,944 (median $34,330). The overall mean expense paid was $102,760 (median $240,000). Over the study period, there has been a slight increase in the number of paid indemnities in the CRICO database.
Pain Management Claims with Paid Indemnities 2008—2018
The most common case type among the paid indemnities was improper performance of treatment/procedure (44 percent), followed by improper medication regimen management (14 percent) and improper management of treatment course (8 percent), which mirrors the overall case types. Sixty-five percent of the claims with paid indemnities had procedures that were considered directly related to the malpractice claim. The most common procedures involved injections of agents into the spinal canal (56 percent), with a distant second being the insertion of a spinal neurostimulator (9 percent).
When comparing the subcategories of contributing factors of paid indemnities to claims overall, differences did emerge. All claims in the study and those claims with a paid indemnity had technical performance as the top factor (49 percent for all, and 48 percent for indemnity). However, for claims with indemnity, the selection and management of therapy was the second highest subcategory of contributing factors at 44 percent, rather than patient factors. Selection and management of therapy was only 23 percent of the overall claims group, so it is evident that with indemnity, this contributing factor is a more salient subcategory. Additionally, clinical judgment and insufficient documentation had higher percentages in indemnities (39 percent and 25 percent, respectively), compared with their representation in the overall claims group (21 percent and 18 percent). Patient factors had less of an influence, with a drop from 48 percent overall to 14 percent within the indemnity claims group.
As the information was drilled down to the most specific contributing factors, potential differences between the specific contributing factors in claims that had a paid indemnity and specific contributing factors in claims that did not have a paid indemnity were examined. If a factor met the assumptions for the chi-square for independence statistical test, then this test was applied to assess if there was a relationship between the contributing factor and paid indemnity.
Six contributing factors met the criteria for the chi-square for independence statistical test, and four were statistically significant, indicating a relationship between a specific contributing factor and a paid indemnity. Those contributing factors included the selection and management of surgical/invasive procedures, the selection and management of medication, the failure or delay in ordering a diagnostic test, and communication between providers regarding the patient’s condition. The most common test not ordered or delayed was the urine drug test while the pain management physician was prescribing opioids, followed by a CT scan prior to placement of a spinal neurostimulator.
There were no relationships found between paid indemnity and technical performance, known complication, or failure and delay in obtaining a consult. Other contributing factors, such as the selection and management of therapy for surgical/invasive procedures, showed a stronger tendency to result in a paid indemnity.
|
Contributing Factors Involved in Pain Management Claims Overall |
Indemnity Paid |
No Indemnity Paid |
|
Technical performance—possible technical problem, known complication |
40% |
45% |
|
Selection/management of therapy—surgical/invasive procedures# |
20% |
3% |
|
Selection/management of therapy—medication, other# |
19% |
3% |
|
Communication between providers regarding patient’s condition# |
14% |
2% |
|
Failure/delay in obtaining consult/referral |
8% |
5% |
|
Patient assessment—failure/delay in ordering diagnostic test ** |
13% |
4% |
Significant at *p < .05; **p < .01; #p < .001
Top Pain Management Case Type: Improper Performance of Treatment/Procedure
The major case type found among the studied claims was the improper performance of treatment or procedure (40 percent). As such, a better understanding of this case type is crucial. Additional analysis was conducted.
The claimants affected mostly experienced a medium-severity injury (64 percent), followed by high-severity injury (33 percent), then a few low-severity injuries (3 percent). Thirty-two percent (32 percent) of the final diagnoses in the improper performance of treatment/procedure case type entailed a nervous system / central nervous system complication. Seventeen percent of the claims were punctures or lacerations during a procedure, and 7 percent included a hematoma complicating a procedure.
The procedures involved in the improper performance of treatment/procedure case type were placed into broad ICD9 categories. Seventy-two percent of the claims comprised injections into the spinal canal or placement of a spinal neurostimulator. Twelve percent involved injection into the peripheral nerve or implantation of neurostimulator leads. Six percent entailed the injection of a steroid, and 5 percent included injections into a sympathetic nerve.
An overwhelming percentage of the subcategory contributing factors with improper performance of treatment/procedure involved technical performance factors (86 percent), followed by insufficient or lack of documentation (22 percent), communication between the patient/family and the provider (19 percent), patient assessment issues (16 percent), selection and management (16 percent), and patient behavior factors (15 percent).
Improper performance is a subset of the larger pain management contributing factor. There is relatively no difference in the detail level contributing factor percentage and the percentage of the overall pain management contributing factors.
However, the variances begin to emerge with other detail-level contributing factors. For example, in the improper performance of treatment/procedure sample, 11 percent of the claims had the detail-level contributing factor of selection/management of surgical/invasive procedures, but when placed in the larger pool of the entire pain management sample, that percentage of improper performance of treatment/procedure case types was found in 44 percent of the sample. There was a difference of 33 percent in this contributing factor. Where a surgical or invasive procedure was involved, the increase seen would be reasonable within the context of the larger sample, since the case type itself involves a procedure/treatment that is often invasive in nature.
Wider variances are seen in issues related to informed consent, both in communication (83 percent) and documentation (55 percent), poor technique/other (47 percent), and insufficient documentation in the review of/participation in care (52 percent). These larger variances are important to investigate more closely to determine if they denote meaning based on the case type.
|
Contributing Factor (CF) |
% of CF of Improper Performance |
% of all of Pain Management CF |
|
Technical performance—possible technical problem, known complication |
79% |
74% |
|
Selection/management therapy—surgical/invasive procedures |
11% |
44% |
|
Insufficient/lack of documentation—informed consent |
10% |
65% |
|
Patient factors—seeking other providers due to dissatisfaction with care |
9% |
37% |
|
Inadequate informed consent for procedures—surgical/invasive |
7% |
90% |
|
Poor rapport (includes unsympathetic response to patient) |
7% |
36% |
|
Technical performance—poor technique, other |
7% |
54% |
|
Patient assessment—failure/delay in ordering diagnostic test |
6% |
35% |
|
Insufficient/lack of documentation—review of/participation in care |
6% |
58% |
Additional analysis was completed by examining those claims of improper performance of treatment or procedure claims to compare those claims that had a paid indemnity and claims that did not. Thirty-nine percent of these claims settled, which was slightly higher than the 36 percent for the overall pain management claims. Additionally, the average paid indemnity was higher at $312,944 per claim.
Comparing the groups, differences did exist between them. The group that had no indemnity paid had slightly more female patients in their group. Their severity levels included some low-severity claims, more medium-severity claims (74 percent compared to 50 percent), and had an overall older average age.
|
Indemnity Paid n = 44 |
Percentage Indemnity |
No Indemnity Paid n = 68 |
Percentage No Indemnity |
|
|
Males |
19 |
43% |
22 |
32% |
|
Females |
25 |
57% |
46 |
68% |
|
Severity |
||||
|
Low |
0 |
3% |
||
|
Males |
N/A |
1 |
||
|
Females |
N/A |
2 |
||
|
Average age |
N/A |
61.3 years |
||
|
Medium |
50% |
74% |
||
|
Males |
8 |
18% |
15 |
22% |
|
Females |
14 |
32% |
35 |
51% |
|
Average age |
48.4 years |
53.6 years |
||
|
High |
50% |
22% |
||
|
Males |
11 |
25% |
6 |
9% |
|
Females |
11 |
25% |
9 |
13% |
|
Average age |
54.9 years |
57.6 years |
||
|
Overall average age |
51.8 years |
65.1 years |
The contributing factors were investigated, comparing claims that ended in a paid indemnity with those did not following an allegation of improper performance of treatment or procedure. The table below displays the contributing factors examined by a chi-test of independence to examine if there was a relationship between the contributing factor and indemnity.
|
Contributing Factors Improper Performance of Treatment or Procedure |
Indemnity Paid |
No Indemnity Paid |
|
Technical performance—possible technical problem, known complication |
75% |
81% |
|
Selection/management of therapy—surgical/invasive procedures* |
18% |
6% |
|
Insufficient/lack of documentation-informed consent |
14% |
7% |
Significant at *p < .001
There were no significant differences between the groups with claims involving technical performance, known complication (p = .49), or insufficient/lack of documentation-informed consent (p = .28). There was a significant difference found with the selection and management of surgical/invasive procedures and paid indemnity (p < .001).
Case Examples
While there was no significant association between misidentifying an anatomical structure and indemnity payment, opportunities to learn to avoid these errors in the future are important. Below is a case in point.
A patient was referred to a pain management physician for an epidural steroid injection to treat radicular lumbosacral pain. The risks and benefits for the epidural steroid injection were reviewed, including the possibility of hematoma and/or an ischemic injury from an embolism due to the steroid medication.
At the start of the procedure, the pain management physician identified and marked the L4-L5 location in the patient’s lower lumbar area. The medical record read that after 5 cc of local anesthetic were injected into the patient’s skin, the 17-guage Touhy 1.5-inch needle was inserted into the epidural interspace. The interspace location was verified using the loss-of-resistance technique, and the steroid medication was administered. While the physician was inserting the needle, the patient complained of sudden, severe pain into the left leg; however, the sensation was short-lived, and it ended abruptly.
Post-procedure, the patient complained about his foot feeling numb and an inability to move his left foot. The pain management physician attributed this symptom to leakage of local anesthetic and had the patient stay in the office. After three hours without change, an MRI and physical therapy were ordered for the following day. Despite the physical therapy, the patient continued to have foot drop and loss of motor function in his lower extremity. One year later, he still required assistance when walking and continually developed significant ulcers on his foot and ankle due to the deformity of the foot.
The physician expert reviewers were critical. The post-procedural MRI showed an injury to the spinal cord, indicating that there was a high probability that the injection had been given into the subdural space, and the needle had injured the L4-L5 dorsal root. Furthermore, the patient had a lumbar spine abnormality, which could not be appreciated by the pain management physician because of an inadequate assessment and review of the patient’s prior diagnostic imaging. The expert reviewers went on to say that nonguided epidural injections have a greater rate of inaccurate placement. The pain physician’s consent documentation needed improvement by addressing more of the known risks of the procedure. The post-procedure management of the patient was further criticized, even though everyone acknowledged it likely would not have changed the outcome.
While non-image-guided spinal injections have largely been eliminated through advocacy and education by various professional societies, this case is an important reminder of what can go wrong without image guidance.
Takeaway Lesson
The most common case type in this study involved improper performance of treatment or procedure. To decrease the chance for poor outcomes, the best practices would include:
- Having an informed consent for the procedure.
- Reviewing all of the patient’s medications prior to the procedure.
- Completing a time-out checklist.
- Assuring a separate provider for anesthesia administration.
- Using ultrasound or fluoroscopy guidance.
- Providing x-ray (C-arm) protective equipment for the patient and staff.
The contributing factor of the selection of surgical and/or invasive procedure was statistically significant in its relationship to indemnity payments. One example, involving improper selection of a cervical epidural steroid injection (CESI) (among other factors), is described below.
A patient in his forties presented to a pain management specialist with a history of pain radiating into his bilateral shoulder and scapula areas. His sensory and motor function was intact without radiculopathy. Past conservative treatments had provided no relief. The imaging studies showed severe degenerative disc disease, spondylosis, and stenosis in C5-C6, C6-C7.
After several meetings with the pain management specialist, the patient agreed to have a CESI done at an ambulatory surgery center. The patient arrived at the ambulatory surgery center for the procedure and signed the informed consent that listed the risk of possible nerve damage.
A nurse anesthetist (CRNA) administered a general anesthetic to the patient despite the pain management physician’s request for monitored anesthesia care (MAC). The pain management physician proceeded to perform a CESI to C6-C7 under fluoroscopy guidance. The procedure note indicated “no complications,” and there was no documentation regarding any post-procedure pain.
The next day, the patient called the pain management physician complaining of feeling “pins and needles” in his shoulders and fingers, along with overall weakness. By the time the patient arrived in the office later that day, his left arm was numb, his hand was swollen, he was unable to move his left hand or fingers, and he continued with pain in his shoulder and shoulder blades.
The patient was referred to the emergency department (ED) for a stat MRI. The MRI showed intrinsic signal alteration around left hemicord C5 and altered attenuation consistent with edema below this level. The patient was admitted to intensive care (ICU), where the patient remained for the next four days. A neurologist provided the ICU care, and the patient was started on IV Decadron. The patient’s discharge diagnosis was epidural hemorrhage of cervical spine, cord edema, and spinal hemorrhage from a spinal cord punctate injury. The patient now has left-hand paralysis and a later diagnosis of complex regional pain syndrome.
Plaintiff and some defense experts were critical of the pain management physician’s treatment plan to do a CESI, since the patient did not have radiculopathy but rather axial neck pain. Other experts noted that CESI are acceptable in the treatment of axial neck pain.
The main issue in the case was poor communication between the pain management physician and the CRNA, given the CRNA’s choice to use general anesthesia for this procedure. This decision did not follow the American Society of Anesthesiologists (ASA) standard on sedation for interventional pain procedures. The procedure should have been aborted once the pain management physician discovered that the patient was under a general anesthetic.
The fluoroscopy images were of poor quality, which could have been a contributing factor to the patient’s injury. The pain management physician was likely unaware of anatomical markers prior to the injection, as air was identified on subsequent MRIs. A wet tap alone does not provide verification of the epidural space, given the possibility of decreased fluid in the cervical region.
The deviation from standards of practice in this case began with the improper choice of anesthesia technique.
Takeaway Lesson
CESI should never be done under deep sedation or general anesthesia. While rare, a complication of placing a needle too far into the spinal cord may occur. The pain management physician needs the patient alert enough to respond to the pain so the needle can be retracted, leading to complications that would be transient, rather than a patient who is too sleepy, unable to report the pain, and then left with permanent paralysis. Pain management physicians need to communicate to patients and their families why general or deep sedation cannot be used with this procedure.
The contributing factor of lack of communication between the provider and patient regarding informed consent for surgical and/or invasive procedure is examined in the case example below.
A patient in her late sixties presented to a pain management physician with pain in her cervical and lumbar regions. She was treated with multiple CESI and lumbar epidural steroid injections.
A few days after a recommended medial branch nerve block, the pain management physician did a radiofrequency ablation of a medial branch nerve, and the patient had another ablation two weeks later. At a follow-up appointment, the patient reported that the pain had been reduced 50 percent.
Two months later, the pain management physician recommended a trial lead implantation of a spinal cord stimulator. The patient agreed, and the patient had excellent coverage during the trial of neuromodulation. The recommendation was to proceed forward with the permanent implant.
The pain management physician reviewed the procedure with the patient. The leads were placed, under fluoroscopy, to upper portions of C2 and C3, with anchoring sleeves slipped over the leads and attached with sutures.
Two months post-procedure, the patient returned to the pain management physician’s office complaining of a headache and some lumbar pain. This pain continued, and the patient sought a neurology consult. The impression was spinal cord stimulator migration, occipital neuralgia, and cervical degenerative disc disease.
The headaches continued. The pain management physician did a series of occipital nerve blocks. Five months after the procedure to implant the permanent stimulator, another provider removed a scalp mass that was discovered to be an anchor from the stimulator leads.
The expert physician reviewers noted that it was not below the standard of care to leave the anchor in after the implant. However, it was below the standard of care not to inform the patient that there were anchors left in place. Additionally, one expert physician reviewer opined that the pain the patient was experiencing was not from the anchor, but it was related to occipital neuralgia. The lack of communication regarding the anchor led to a small settlement.
The main issues in this case involved a poor informed consent process and the lack of communication with the patient.
Takeaway Lesson
The importance of informed consent cannot be overlooked. Health literacy is an important factor to consider. Some patients may feel embarrassed to ask for clarification regarding medical complexities or items included on the informed consent form. Use common words and avoid medical jargon. Ask the patient to tell you what you just explained to them, and to repeat back their treatment and discharge instructions. In this study, the lack of communication regarding surgical consent occurred more frequently among paid indemnity claims.
While most medical malpractice claims against pain management physicians tended to involve improper performance of treatment or procedure, there were other case types. One of those case types included choosing multiple medications and delivery methods for treatment of chronic pain.
An elderly female patient was seen in a pain management center for chronic pain due to compression fractures of her spinal vertebrae. The patient was not a spinal surgical candidate because of multiple co-morbidities, including diabetes, so the pain management physician recommended the placement of an intrathecal pain pump.
When the patient arrived at the ambulatory surgery center, her preoperative blood glucose was 65 (low), and she had an elevated respiratory rate of 32. The patient was given an IV infusion of dextrose 50 percent in water, and surgery proceeded forward.
Post-procedure, the morphine dosage to be delivered by the pain pump was calculated by the pain management physician, and the pump was programmed to deliver 7.5 mg per day. Ten minutes later, the pain management physician also ordered the patient a Dilaudid PCA pump for additional pain management, since the patient was already being admitted for 23 hours of observation and placed on telemetry.
At 6 PM that evening, the nurse assessed the patient as being lethargic with depressed respirations; her blood glucose was charted as 56 (low), and she was also hypothermic (95.1°F). There was no documentation of any physician being called regarding these abnormal findings. Later when the nurse completed the dressing change, the patient did not even wake up during this activity. Four hours into the admission, the patient’s oxygen saturation was 88 percent (low), and the nurse placed the patient on oxygen via nasal cannula.
Around 7 AM, the patient complained of nausea with some emesis; the pain management physician was notified, and a chest x-ray was ordered. The x-ray indicated pneumonia. It was decided to have the patient remain in hospital until the nausea and vomiting could be resolved. The patient used the Dilaudid PCA pump twice.
Around 1 PM, the patient’s oxygen saturation dropped to 80 percent. The nurses described the patient as lethargic with decreased respirations, and the house physician was called to attend to the patient. The patient was found to have thick brown secretions in her mouth. Dextrose 50 percent in water infusion was given with no improvement; the patient was administered Narcan with an immediate wake-up. An arterial blood gas study indicated respiratory acidosis, necessitating the patient’s transfer to ICU.
In the ICU, the patient was given a second dose of Narcan, and the pain management physician was contacted regarding how to decrease the intrathecal pain pump dosage, which required equipment not readily available at the hospital. The pain management physician confirmed that the Dilaudid PCA pump had been discontinued. At some point that day, the pain management physician was able to decrease the pump’s delivery dosage to .63 mg per day from 0.710 mg per day. Subsequently, the patient required intubation and was placed on a ventilator. The diagnosis was acute respiratory failure and vomit pneumonitis.
The patient remained semi-comatose in the ICU for the next several days, where she later arrested and was unable to be revived.
The defense experts were puzzled as to why the pain management physician’s treatment plan supported the use of an implanted pain pump and a Dilaudid PCA pump at the same time. The experts had concerns about the procedure going forward despite the patient’s low glucose and rapid respirations prior to the procedure, given her multiple co-morbidities. They went on to criticize the pain management physician’s communication with and accessibility to the hospital’s care team.
The main issues involved in this case were the poor clinical decision making on the part of the pain management physician, as well as poor communication within the healthcare team.
Takeaway Lesson
Having a documented plan of care establishes the treatment goals and discharge plan for the entire healthcare team. The plan of care can be reviewed and updated throughout the time in the hospital. The patient and their family should be educated on the plan of care. Additionally, the rationale for procedures should be documented. For example, in this claim, the choice of medications and the decision to proceed in light of labs and vital signs were unknown to the team members.
Risk Mitigation Strategies
- Include documentation about the procedure, including any abnormalities, difficulties, and/or complaints of the patient.
- Any inconsistency regarding a patient’s drug screen requires justification and possible action. Pain management providers cannot ignore alcohol, marijuana, and/or other substances identified in the drug screen.
- A significant factor was the lack of communication between providers regarding the patient’s condition. Several claims involved patients who were on anticoagulants, and the management of these medications pre- or post-procedure/s were not well-established between providers. Other claims contained problems with physicians not getting the previous physician’s medical records or assuring the patient was not obtaining narcotics from other physicians. This finding emphasizes the necessity of reviewing all medications with the patient at every visit and prior to any procedure. The use of a pre-procedure checklist can ensure that medications are consistently reviewed, along with other items. Such standardization assists in decreasing errors.
- Opioids for chronic pain have a low rate of efficacy and a high risk for addiction and withdrawal. The Centers for Disease Control and Prevention (CDC) recommends that alternative treatments be attempted and other options used prior to starting long-term opioids.
- Pain management physicians following best practices use a multimodal approach as well as a multidisciplinary approach for patients with chronic pain and underlying pain conditions. Best practices emphasize safe opioid management and implementing approaches that lessen opioid exposure. These multidisciplinary approaches may include medications, interventional approaches, restorative therapies, behavioral health interventions, and other approaches. Communication and collaboration are central to patient-centered care when diagnosing and planning a treatment strategy, regardless of the management approach.
- When considering patient assessment, patient care, and patient evaluation in pain management, consider the mnemonic of HAMSTER: History, Assessment, Mechanism of pain, Social and Psychological issues, Treatment, Education, and Re-assessment.
- Pain management physicians cannot ignore a patient’s alcohol intake when prescribing opioids.
- As with all specialties where patients have chronic illness and see their physicians/providers over a long period of time, boundaries are essential. When these boundaries between pain management physicians and their patients become blurred, allegations of abandonment and/or a board of medicine or other regulatory agency action may be made against a physician’s license.
- Pharmacists are important partners for pain management physicians and patients. Consulting with them can be very beneficial.
- Consider coprescribing naloxone to high-risk patients (sleep apnea, obesity, personality disorders). This action is especially important during influenza season and during the recent COVID-19 outbreak.
Limitations
This study is not representative of all pain management physicians and their practices. This study relied on closed medical malpractice claims from one large national malpractice carrier. The study does not account for other malpractice claims in the United States. Additionally, all injured patients do not seek legal action.
Conclusion
With over 100 million Americans experiencing chronic pain, pain management physicians are a vital part of the healthcare team. The ability to learn from past experiences, such as closed malpractice claims, about how to improve safety is vital. This study may provide some helpful guidance.
Further Reading
Singh VM. Patient-centered care is key to best practices in pain management. U.S. Department of Health and Human Services. Published May 10, 2019. Accessed January 7, 2021. https://www.hhs.gov/blog/2019/05/10/patient-centered-care-is-key-to-best-practices-in-pain-management.html
Acknowledgments
The Doctors Company extends its sincere gratitude to Dr. Sean Li for his insightful review of this study. Dr. Li is an interventional pain physician and the regional medical director at Premier Pain Centers in Newark, NJ. He is also the vice president of the NJ Society of Interventional Pain Physicians (NJSIPP) and an executive board member of the American Society of Pain and Neuroscience (ASPN).
The Doctors Company would also like to recognize Christopher Malinky, MD, for his contributions on current risks faced by pain management specialists. Dr. Malinky is the Chief Medical Officer at Interventional Pain Management in Colorado Springs . He is originally from Columbus, Ohio. He completed his medical degree from the Medical University of Ohio in 2002. Dr. Malinky completed a four-year anesthesiology residency and a subsequent pain medicine fellowship at Rush University Center in Chicago.
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.
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