Litigations following spinal neurosurgery in France: "out-of-court system," therapeutic hazard, and welfare state.

OBJECTIVE: Spinal surgeries carry risks of malpractice litigation due to the random nature of their functional results, which may not meet patient expectations, and the hazards associated with these complex procedures. Claims are frequent and costly. In France, since 2002, a new law, the Patients' Rights Law of March 4, 2002, has created an alternative, out-of-court scheme, which established a simplified, rapid, free-of-charge procedure (Commission for Conciliation and Compensation [CCI]). Moreover, this law has optimized the compensation provided to patients for therapeutic hazards by use of a national solidarity fund. The authors analyzed the consequences of this alternative route in the case of claims against private neurosurgeons in France. METHODS: From the data bank of the insurer Mutuelle d'Assurances du Corps de Santé Français (MACSF), the main insurance company for private neurosurgeons in France, the authors retrospectively analyzed 193 files covering the period 2015-2019. These computerized files comprised the anonymized medical records of the patients, the reports of the independent experts, and the final judgments of the CCI and the entities supporting the compensation, if any. RESULTS: During the 5-year study period (2015-2019), the insurance company recorded 494 complaints involving private neurosurgeons for spinal surgery procedures, of which 126 (25.5%) were in civil court, 123 (24.9%) were under amicable procedure, and 245 (49.6%) were in the out-of-court scheme administered by the CCI. Out of these 245 cases, only 193 were closed due to delays. The conclusions of the commission were rejection/incompetence decisions in 47.2% of the cases, therapeutic hazards in 21.2%, nosocomial infections in 17.6%, and practitioner fault in 13.5%. National solidarity compensated for 48 complaints (24.8%). The final decision of the CCI is not always consistent with the conclusions of the experts mandated by it, illustrating the difficulty in defining the concept of hazards. The authors found that the therapeutic hazards retained and compensated by the national solidarity included decompensated spondylotic myelopathies (15% of the 40 cases) and cauda equina syndromes (30%). As allowed by law, 11.5% of the patients who were not satisfied triggered a classical procedure in a court. CONCLUSIONS: In the French out-of-court system, trial decisions resulting in rulings of proven medical malpractice are rare, but patients can start a new procedure in the classical courts. The therapeutic hazard remains a subtle definition, which may be problematic and require further discussion between experts and magistrates. In spite of the imperfections, this out-of-court system proposes a major evolution to move patients and medical providers from legal battles to reconciliations.

Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practice-a qualitative study.

BACKGROUND: The judicialization of medicine can lead to professional disenchantment and defensive attitudes among surgeons. Some quantitative studies have investigated this topic in spine surgery, but none has provided direct thematic feedback from physicians. This qualitative study aimed to identify the impact of this phenomenon in the practice of spine neurosurgeons. METHODS: We proposed a qualitative study using grounded theory approach. Twenty-three purposively selected private neurosurgeons participated. Inclusion took place until data saturation was reached. Data were collected through individual interviews and analyzed thematically and independently by three researchers (an anthropologist, a psychiatrist, and a neurosurgeon). RESULTS: Data analysis identified five superordinate themes that were based on items that recurred in interviews: (1) private practice of spinal surgery (high-risk surgery based on frequent functional symptoms, in an unfavorable medicolegal context); (2) societal transformation of the doctor-patient relationship (new societal demands, impact of the internet and social network); (3) judicialization of spine surgery (surgeons' feelings about the frequency and motivation of the complaints they receive, and their own management of them); (4) coping strategies (identification and solutions for "at risk" situations and patients); and (5) professional disenchantment (impact of these events on surgeons' daily practice and career planning). Selected quotes of interviews were reported to support these findings. CONCLUSIONS: Our study highlights several elements that can alter the quality of care in a context of societal change and the judicialization of medicine. The alteration of the doctor-patient relationship and the permanent pressure of a possible complaint encourage surgeons to adopt defensive attitudes in order to minimize the risks of litigation and increased insurance premiums. These phenomena can affect the quality of care and the privacy of physicians to the extent that they may consider changing or interrupting their careers earlier.

Improved Outcomes and Therapy Longevity after Salvage Using a Novel Spinal Cord Stimulation System for Chronic Pain: Multicenter, Observational, European Case Series.

Spinal cord stimulation (SCS) is proven to effectively relieve chronic neuropathic pain. However, some implanted patients may face loss of efficacy (LoE) over time, and conversion to more recent devices may rescue SCS therapy. Recent SCS systems offer novel stimulation capabilities, such as temporal modulation and spatial neural targeting, and can be used to replace previous neurostimulators without changing existing leads. Our multicenter, observational, consecutive case series investigated real-world clinical outcomes in previously implanted SCS patients who were converted to a new implantable pulse generator. Data from 58 patients in seven European centers were analyzed (total follow-up 7.0 years, including 1.4 years after conversion). In the Rescue (LoE) subgroup (n = 51), the responder rate was 58.5% at the last follow-up, and overall pain scores (numerical rating scale) had decreased from 7.3 ± 1.7 with the previous SCS system to 3.5 ± 2.5 (p < 0.0001). Patients who converted for improved battery longevity (n = 7) had their pain scores sustained below 3/10 with their new neurostimulator. Waveform preferences were diverse and patient dependent (34.4% standard rate; 44.8% sub-perception modalities; 20.7% combination therapy). Our results suggest that patients who experience LoE over time may benefit from upgrading to a more versatile SCS system.

Spine Surgery Infection, Litigation, and Financial Compensation: Analysis of 98 Claims Involving French Spine Surgeons Between 2015 and 2019.

OBJECTIVE: Since 2002, France has adopted the Patients' Rights Law, an alternative malpractice scheme creating a faster, less expensive out-of-court settlement ensuring compensation even in the absence of fault. We aimed to describe the implications of this system by analyzing 5 years of claims for infections related to spinal surgeries collected by the main insurer of French spine surgeons. METHODS: We retrospectively analyzed 98 anonymized malpractice claims from 2015 to 2019 (20% of overall claims), including anonymized medical records of the patients, reports of the independent experts, final judgments, and entities supporting the compensation if any. RESULTS: Claims included 8 deaths and 17 newly acquired neurological sequelae. The conclusions identified 22 faulty cases. The most frequent fault was a delay in diagnosis (10 cases), followed by inadequate surgical management (6 cases), inadequate antibiotic therapy (5 cases), and inadequate follow-up (1 case). Among the 67 cases (68.4%) proved not to be at fault, 10 were covered by the national solidarity fund because of their severity, and the remaining 57 were covered by hospitals. CONCLUSIONS: Since the 2002 Patients' Rights Law, patients with postoperative infections have always received compensation. The out-of-court settlement offers the patients incurring morbidities the assurance of faster compensation. Although certainly subject to selection criteria, this procedure is free and does not necessitate the presence of a lawyer. The analysis of expert reports and the resulting court decisions imply prevention, anticipation, and collaboration of all health care providers and open an opportunity to improve their practices to limit these crucial followings.

Management of symptomatic postoperative epidural hematoma in spine surgery: Medicolegal implications.

INTRODUCTION: Spine surgery is one of the specialties with the highest medicolegal risk, with a legal action initiated every 17 months per practitioner. One of the most dreaded complications is an epidural hematoma with postoperative deficit. The treatment of this complication is still being debated. We therefore conducted a retrospective study of the database of a medical liability insurer to assess perioperative factors determining the liability of the surgeon or paramedical team during an expert review in the event of a postoperative symptomatic epidural hematoma. HYPOTHESIS: To identify the factors determining the liability of the medical team in the event of a postoperative symptomatic epidural hematoma. MATERIALS AND METHODS: We retrospectively analyzed the largest French register of medicolegal expert reviews between 2011 and 2018. We identified 68 cases by entering the following keywords in this database: "spine surgery," "complications," and "epidural hematoma." After a thorough review of each case, only 14 were deemed to be truly relevant to our study. We collected for each patient the perioperative data, complications (including neurologic deficits) and their clinical course. RESULTS: Only one surgeon was accused and found liable for failing to perform a surgical revision within a reasonable timeframe (time to revision of 11 days). In 2 cases, the liability of a nurse working in the surgical department was called into question for failing to contact the surgeon upon the onset of symptoms. In the other cases (11 patients, 79%), the occurrence of a symptomatic epidural hematoma was considered a no-fault medical accident that was not caused by the surgeon. The presence of a drain did not have any medicolegal impact in the cases reviewed. CONCLUSION: The key element in medicolegal decisions is the reaction time of the healthcare teams, in particular the time between the onset of symptoms and surgical revision. According to these expert reviews, the placement of a drain was not taken into consideration during the medicolegal assessment of a postoperative symptomatic epidural hematoma. LEVEL OF EVIDENCE: II; retrospective prognostic study, investigation of patient characteristics and their impact on functional outcome.

Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience.

Given the differing mechanisms thought to underlie therapeutic sub- and supra-perception-based neurostimulative modalities, Spinal Cord Stimulation (SCS) systems designed for combined delivery of these approaches may help improve analgesic outcomes and quality of life, and reduce treatment failures. This multicenter, observational case-series evaluated 188 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of sub-perception and supra-perception stimulation programming (i.e., combination therapy) at 16 in Europe. Following implantation, patients were provided with an array of advanced supra-perception programs (e.g., paresthesia-based SCS using multiple independent current sources), and a custom set of sub-perception programs optimized with specific waveforms and/or field shapes. A mean overall pain score of 7.9 ± 1.7 (Standard Deviation (SD)) was reported pre-trial (Baseline). Overall pain was reduced by 4.4 ± 2.8 points (NRS) at 3-months (n = 117) and at 12 months post-implant (n = 90), respectively (p < 0.0001). Substantial quality-of-life (EQ-5D-5L) improvement as assessed at last follow-up was also observed (n = 60). These results suggest that an implanted SCS device capable of combination therapy, while also enabled with patient-specific waveform optimization and stimulation field targeting capabilities, can enable highly effective pain relief and improve quality of life in patients suffering with chronic pain.

Management of Incidental Durotomy: Results from a Nationwide Survey Conducted by the French Society of Spine Surgery.

OBJECTIVE: To obtain real-life data on the most common practices used for management of incidental durotomy (ID) in France. METHODS: Data were collected from spinal surgeons using a practice-based online questionnaire. The survey comprised 31 questions on the current management of ID in France. The primary outcome was the identification of areas of consensus and uncertainty on ID follow-up. RESULTS: A total of 217 surgeons (mainly orthopaedic surgeons and neurosurgeons) completed the questionnaire and were included in the analysis. There was a consensus on ID repair with 94.5% of the surgeons considering that an ID should always be repaired, if repairable, and 97.2% performing a repair if an ID occurred. The most popular techniques were simple suture or locked continuous suture (48.3% vs. 57.8% of surgeons). Nonrepairable IDs were more likely to be treated with surgical sealants than with an endogenous graft (84.9% vs. 75.5%). Almost two thirds of surgeons (71.6%) who adapted their standard postoperative protocol after an ID recommended bed rest in the supine position. Among these, 48.8% recommended 24 hours of bed rest, while 53.5% recommended 48 hours of bed rest. The surgeons considered that the main risk factors for ID were revision surgery (98.6%), patient's age (46.8%), surgeon's exhaustion (46.3%), and patient's weight (21.3%). CONCLUSIONS: This nationwide survey reflects the lack of a standardized management protocol for ID. Practices among surgeons remain very heterogeneous. Further consensus studies are required to develop a standard management protocol for ID.

The role of the temporal pole in auditory processing.

Experiments in animals have shown that the temporal pole and the amygdala are involved in auditory processing. Comparable data are scarce in humans. It is only known that after temporal lobectomy, hearing may be impaired and dichotic listening scores reduced on the ear contralateral to the operated temporal lobe. Middle-latency auditory evoked potentials (MLAEPs) and late auditory evoked potentials (LAEPs) have been recorded in 14 patients before and after temporal lobectomy for the treatment of drug-resistant temporal lobe epilepsy. The Na and Pa components of MLAEPs were significantly delayed and the Pa component amplitude reduced before and after surgery as compared to a group of 21 healthy subjects. Data in pre- and postoperative period were not statistically different. N100 and P200 component of LAEPs were similarly altered. It is concluded that in humans the amygdala and probably the temporal pole may be involved in the process of auditory activation-inhibition. The possible role of auditory processing impairment in cognitive deficits in TLE patients can also be questioned.