Medical malpractice after artificial urinary sphincter implantation
Imran Khawaja1
, Zachary Boston1
, Hassan Choudhry1
, Meher Pandher1
, Aleksandar Popovic1
, Kunj Jain1
, Rhea Prabu2, Amjad Alwaal1
Contributions: (I) Conception and design: I Khawaja, M Pandher, R Prabu; (II) Administrative support: A Alwaal; (III) Provision of study materials or patients: M Pandher, A Alwaal; (IV) Collection and assembly of data: Z Boston, H Choudhry, M Pandher, A Popovic, R Prabu; (V) Data analysis and interpretation: I Khawaja, Z Boston, H Choudhry, A Popovic, K Jain; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.
Background: Artificial urinary sphincter (AUS) remains the gold standard of urinary incontinence management for moderate and severe cases. However, risks such as erosion, infection, and mechanical failure are present when using these sphincters. Therefore, it is essential to explore this aspect of AUS in order to deliver more effective patient care. This analysis offers the first investigation into medical malpractice cases pertaining to AUS placement.
Methods: The LexisNexis+ and Westlaw databases were used to access all federal and state cases, jury verdicts, and settlements. The LexisNexis+ and Westlaw databases were queried for the term “artificial urinary sphincter” or “artificial urethral sphincter” between the years 1990 and 2024. Cases selected for patients suing a urologist or medical system after implantation of an AUS. Common reasons for exclusion included the plaintiff suing a urologist who performed prostate surgery requiring eventual placement of AUS.
Results: Investigation of the LexisNexis+ database yielded 103 cases. The Westlaw database offered 41 cases. After exclusion criteria, 24 cases were included from the LexisNexis+ database and 3 cases from Westlaw; 14 cases were ruled in favor of the defendant; 4 cases were ruled in favor of the plaintiff with awards ranging from $46,400–$980,000; 4 cases were settled with payouts ranging from $70,000–$4,500,000. The most common cause for litigation included damage to a device, which was a precipitating issue in 46% of cases. Failure of technique of AUS placement was alleged in 33% of cases. The region of the United States with the most cases was the South with 58% of cases. Precipitating issues that resulted in outcomes in favor of the plaintiff were diverse and included failure of informed consent, failure of technique, infection, pain, and damage to the device.
Conclusions: Urologic surgeons placing artificial urethral sphincters face the risk of medical malpractice litigation.
Keywords: Jurisprudence; malpractice; urinary sphincter; artificial
Submitted Jun 10, 2025. Accepted for publication Sep 21, 2025. Published online Nov 30, 2025.
doi: 10.21037/tau-2025-408
Highlight box
Key findings
• Twenty-seven malpractice cases related to artificial urinary sphincter (AUS) implantation were identified from 1990–2024 using LexisNexis+ (n=24) and Westlaw (n=3).
• Most common cause of litigation was damage to the device (46%), followed by failure of surgical technique (33%) and infection (17%).
• Geographically, 58% of cases originated in the Southern United States.
• Of the 22 cases with recorded outcomes, 14/22 (63.6%) favored the defendant, 4/22 (18.2%) favored the plaintiff, and 4/22 (18.2%) were settled.
What is known and what is new?
• Urologists face measurable malpractice risk, particularly with prosthetic and reconstructive procedures. Prior literature evaluated litigation for general stress urinary incontinence and urethral reconstruction.
• This study is the first to specifically characterize malpractice claims tied to AUS implantation, highlighting recurrent issues such as catheter-related device damage and incomplete explanation.
What is the implication, and what should change now?
• Emphasize standardized Foley catheter protocols and targeted staff training for patients with AUS.
• Strengthen informed consent documentation and surgical training to reduce technique-related litigation risk.
• Future case-control work comparing litigation vs. non-litigation AUS cases could identify modifiable risk factors.
Introduction
Artificial urinary sphincters (AUS) are a gold standard in medical care for patients with moderate and severe stress urinary incontinence (SUI) (1). Although SUI is a non-life threatening, this is a condition which can severely impact a patient’s quality of life with drastic psychosocial implications. While patients with moderate SUI may undergo trials of pelvic floor exercises and pelvic floor physical therapy, AUS is an option for refractory cases (2). AUS are typically comprised of a pump to control the device, an inflatable cuff, and a pressure regulating balloon. By restricting the outflow of urine from the urethra, it has been particularly helpful in SUI for patients who have undergone treatment for prostate cancer with prostatectomy (3). However, overall continence rates have been documented between 61–100% following placement of AUS with complications including infection, erosion, mechanical dysfunction, among others (3).
Medical malpractice represents a societal effort to prevent negligence in patient care. Although litigation can be pursued in any fashion, to successfully claim malpractice a defendant must classically illustrate four tenants: a physician needed to act, the physician did not meet that expectation, there was a patient who suffered, and the patient suffered because of the physician failing to act in the required role. Malpractice has come to recent attention starting in the 1970s and since then, there have been waves of increased litigation and premiums among physicians seeking coverage against liability. While there is inherent risk for litigation while practicing medicine, this is particularly relevant for urologists offering care as previous reports have demonstrated that urologists will typically experience at least one malpractice claim during their career (4). While previous reports have characterized malpractice litigation for interventions, such as urethroplasty, none have investigated claims regarding treatment with AUS (5). This analysis offers a novel analysis as the first to describe legal processes following treatment with AUS. We believe that similar to other medical procedures, there are potentially numerous cases of malpractice litigation against physicians implementing artificial urethral sphincters. We present this article in accordance with the STROBE reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-408/rc).
Methods
The LexisNexis+ and Westlaw databases were used to access all federal and state cases as well as jury verdicts and settlements. The LexisNexis+ and Westlaw databases were queried for the term “artificial urinary sphincter” or “artificial urethral sphincter” between the years 1990 and 2024 to account for recent cases over a sufficient period of time. One author manually reviewed all cases to find cases involving a patient suing the urologist or medical system after implantation of an AUS. Cases that did not sue the urologist in question and cases not directly pertaining to the consequences of an AUS were ruled out. Common reasons for exclusion included the plaintiff suing a urologist who performed prostate surgery requiring eventual placement of AUS. These methods were implemented to maintain consistency and minimize bias during data collection.
Cases were divided into reasons the plaintiff sued the defendant: failure of surgical technique of AUS placement, damage to the device, pain, infection, or erectile dysfunction. Variables included but not limited to court verdict, monetary award, allegation, and precipitating issue were recorded. The court verdict and monetary award were recognized as the main outcomes. Given that each filed case on record was separate, no major confounding variables were present. Missing data was indicated as such in data tables and were therefore not included in processed results (total percentages and averages).
Statistical analysis
Statistical analyses were performed using Microsoft Excel and SPSS statistics software to calculate percentages, averages, and ranges from the quantitative variables that were analyzed. In particular, frequency counts and percentages were used for regional stratification, precipitating cause, and case verdict (categorical variables). Continuous variables such as monetary award amounts were summarized through ranges and mean values. Analyses were conducted accordingly to adjust for sample size and missing data.
Results
Investigation of the LexisNexis+ database yielded 103 cases. The Westlaw database offered 41 cases. After exclusion criteria, 24 cases were included from the LexisNexis+ database and 3 cases from Westlaw (Table 1); 2 of these cases did not record the court verdict, and 5 cases did not include the monetary award; 14 cases were ruled in favor of the defendant; 4 cases were ruled in favor of the plaintiff with awards ranging from $46,400–$980,000; 4 cases were settled with payouts ranging from $70,000–$4,500,000; 2 cases did not have records available regarding outcomes. The most common cause for litigation included damage to a device, which was a precipitating issue in 46% of cases. However, 5 of the 11 cases involving damage to a device were related to damage due to foley catheter placement. Failure of technique of AUS placement was alleged in 33% of cases. Infection was alleged in 17% of cases. The region of the United States with the most cases was the South with 58% of cases. Of the 4 cases ruled in favor of the plaintiff, 50% were in the South and 50% were in the Midwest. Precipitating issues which resulted in outcomes in favor of the plaintiff were diverse and included failure of informed consent, failure of technique, infection, pain, and damage to the device.
Table 1
| Case | Year | State | Allegation | Precipitating issue | Case summary | Verdict | Award |
|---|---|---|---|---|---|---|---|
| P v. G | 1990 | FL | AUS complications after urethral foley insertion | Damage to device | Patient had to undergo several surgeries after AUS was damaged during foley insertion | Settled | $215,000 |
| R v. SHMA | 1994 | NY | Mishandling of removal of AUS | Erectile dysfunction, pain, infection | AUS failed and required removal. During removal, a portion of plastic from device remained in body forming an abscess. Abscess had to heal through secondary intention. Patient citing impotence and severe pain after AUS removal and subsequent abscess formation | Settled | $4,500,000 |
| D v. SIMO | 1996 | MI | AUS improperly implanted | Failure of informed consent, failure of technique | During AUS implantation, the bladder and urethra were punctured resulting in ongoing incontinence. Plaintiff argues physician also failed to get proper informed consent | Plaintiff | $150,000 |
| P v. F | 1998 | WA | Erectile dysfunction after AUS | Failure of informed consent, erectile dysfunction | Plaintiff complained of erectile dysfunction after AUS, and says risks and benefits of AUS implantation were not properly discussed with him | Defendant | $0 |
| A v. G | 2000 | TX | Infection after not all parts of AUS were explanted | Infection | Patient had infection after AUS implantation requiring explanation. During explanation, the entire device was not removed. This led to future infection of leftover parts of the device over the next 6 months |
Plaintiff | $46,400 |
| D v. P | 2001 | MN | Improper explant of AUS | Failure of technique | Plaintiff alleged defendant was negligent while explanting AUS requiring multiple further surgeries | Defendant | $0 |
| K v. WHH | 2003 | FL | AUS complications after urethral foley insertion | Damage to device | Foley catheter was passed while AUS was inflated and activated. This led to urethral erosion and AUS needed to be explanted. This led to subsequent urinary incontinence | Defendant | $0 |
| A v. K | 2004 | NC | Unhappy with AUS | Pain | Plaintiff alleged that he was not given alternative treatments for incontinence after prostate surgery, and he is unhappy with results after AUS implantation | Settled | $70,000 |
| J v. LRMC | 2006 | FL | AUS complications after urethral foley insertion | Damage to device | AUS damaged when inserting foley catheter and resulted in permanent incontinence | Plaintiff | $980,000 |
| H v. AMS | 2008 | MD | AUS malfunction with urethral erosion requiring explanation | Pain, damage to device | AUS failed to function 2 months after insertion with evidence of urethral erosion leading to explanation. This led to patient experiencing significant pain, embarrassment and discomfort | Defendant | – |
| S v. D | 2009 | TX | AUS complications after urethral foley insertion | Damage to device | AUS was damaged when inserting foley catheter | Defendant | $0 |
| T v. PIC | 2009 | WI | Failure to recognize presence of AUS | Damage to device | Failure to recognize presence of AUS | Settled | $150,000 |
| P v. MS | 2010 | TX | AUS complications after urethral foley insertion | Damage to device | Patient presented ED staff with implant card stating he had AUS in place. Despite this, ED staff did not deactivate AUS before inserting foley catheter | – | – |
| K v. KMS | 2010 | TX | AUS complications after urethral foley insertion | Damage to device | Urethral injury from foley catheter insertion in patient with history of AUS insertion | Defendant | $0 |
| S v. SAH | 2011 | OK | Paralysis due to AUS insertion | Infection, failure of technique | Plaintiff alleges lower half of body was paralyzed due to AUS insertion. Repeated catheter attempts after insertion resulted in urethral damage and infections, requiring removal | Defendant | $0 |
| A v. UTM | 2011 | OH | AUS caused short-term and long-term unpleasant complications | Pain, failure of technique | Plaintiff is upset over inability to enjoy retirement due to urinary concerns. He had AUS inserted and immediately after had severe post operative pain and a scrotal rash. Patient continued to have leakage and was unable to maneuver pump properly. Plaintiff said this has affected his marriage and worsened his every day quality of life significantly | Plaintiff | $295,000 |
| M v. U | 2012 | DC | Damage to urethra and AUS during hospitalization for knee surgery | Damage to device | Damage required removal of AUS and further reconstructive surgery | Defendant | $0 |
| C v. S | 2013 | NY | AUS was too easily and inadvertently activated | Failure of technique | Patient had AUS re-implant after original one was damaged in automobile accident. Plaintiff felt new AUS was too easily activated | Defendant | – |
| L v. M | 2015 | GA | Improper placement of reservoir | Failure of technique | Thrombosis of iliofemoral vein and laceration of external iliac vein due to improper placement of AUS reservoir | Defendant | $0 |
| T v. S | 2018 | NY | Improper functioning of AUS | Damage to device | AUS was ineffective and second surgery was performed to replace AUS | Defendant | – |
| T v. Z | 2019 | NY | Patient claimed to have damage to the urethra after AUS implantation | Failure of technique | Patient had AUS implanted and then re-implanted by urologist that he believes was done improperly. Plaintiff argues he had damage to his urethra after AUS insertion, and physician also failed to obtain proper informed consent | Defendant | $0 |
| M v. M | 2021 | MD | Defendant failed to check urinalysis prior to AUS re-implantation | Infection | Plaintiff had AUS re-implanted with urologist who did not check urinalysis prior to implantation. After AUS implantation, plaintiff became septic with urinary tract infection. Plaintiff also suffered urethral erosion requiring a third re-implantation of AUS. Defendant argued patient did not display any signs of urinary tract infection and urinalysis is not necessary prior to AUS implantation | Defendant | $0 |
| M v. BSC | 2023 | WA | Faulty AUS device | Damage to device | Faulty device inserted with sustained urinary leakage requiring second surgery to replace it | – | – |
| D v. S | 2024 | VA | Unsuccessful placement of AUS | Failure of technique | Plaintiff argues AUS was the improper procedure done for his urinary incontinence | Defendant | 0 |
AUS, artificial urinary sphincter; ED, emergency department.
Discussion
Severe male urinary incontinence that fails to respond to conservative management can be treated with slings, bulking agents, adjustable continence devices, or AUS. According to Frazier et al. (2), artificial urethral sphincter placement is the gold standard for the treatment of moderate-to-severe stress incontinence. AUS placement has shown to have improved both short-term and long-term incontinence, as well as improve the overall quality of life in patients. However, as with any urologic procedure, patients should be aware that some risks and complications may result. Malpractice litigation involving urologic procedures is typically due to negligence in preoperative care, negligence in surgical performance, or negligence in postoperative care (6). In a study conducted by Lynch et al. (6), the judicial outcomes of malpractice claims related to urinary incontinence management were analyzed. Of the 79 cases reviewed, 22.2% ruled in favor of the plaintiff, 70.4% ruled in favor of the defense, and 7.4% were settled. Of the cases that were decided in favor of the plaintiff, 26.7% of cases alleged negligence in preoperative care, 27.6% of cases alleged negligence in surgical performance, and 23.1% alleged negligence in postoperative care. The average indemnity payments for negligence in preoperative care, negligence in surgical performance, and negligence in postoperative care were $1,253,644, $1,254,491, and $2,239,198, respectively. This previous study is related to our findings that postoperative damage to the device, postoperative infection, preoperative failure of informed consent, and failure in surgical technique were the precipitating issues leading to medical malpractice litigation in AUS implantation. While there have been previous studies that analyze medical malpractice regarding stress incontinence management, our study is the first to analyze lawsuit data specific to AUS implantation. Our results show that such cases exist and that urologists remain at significant risk of encountering malpractice litigation when treating urinary incontinence with AUS.
Urethral catheters are a common medical device used to monitor urine output in patients requiring hospitalization (7). While their usage is common, the improper insertion or removal of a urethral catheter can lead to various complications. Catheter-associated urinary tract infections, damage to surrounding structures, and device malfunction are all possible outcomes of improper catheter placement. Our findings demonstrate that damage and complications due to catheter placement were the most common causes of medical malpractice litigation in patients with AUS implants. Of the analyzed cases that alleged damage to the device, 5 of the 11 cases (45%) were related to damage due to catheter placement, and three of these cases resulted in a settlement or plaintiff award ranging from $150,000 to $980,000. In Jacobs v. Leesburg Regional Medical Center, a patient alleged their AUS was damaged during Foley catheter placement, resulting in permanent incontinence, and the jury awarded $980,000 in damages. These findings are consistent with Awad et al. (7), who conducted a study in which 29 medical malpractice cases related to urethral catheter placement were analyzed. Fourteen of the cases (48%) claimed trauma/improper insertion as the alleged breach of standard of care. Of these 14 cases, 4 resulted in favor of the plaintiff, with awards ranging from $25,000 to $84,128.95. Our results, along with the results of Awad et al., highlight the importance of adequate urethral catheter placement and removal training for the hospital staff. A robust universal training protocol that includes an emphasis on technique and collecting a thorough urologic history from patients who require catheter placement/removal, will likely reduce the frequency of catheter-related damage to AUS devices. Additionally, patients should be educated on the importance of wearing a bracelet that alerts healthcare providers that they have an AUS device. This subtle action has a significant impact on legal events that healthcare entities encounter.
With any urologic surgical procedure, urologists can encounter complications that arise in the intraoperative setting. Our findings show that failure of technique in AUS placement was also a common cause of AUS malpractice litigation, accounting for 33% of cases. Two of the eight cases involving failure of technique allegations ruled in favor of the plaintiff. Interestingly, our findings show that 6 cases that alleged failure of technique occurred after the year 2011, compared to only two cases from 1990 to 2010. In Aubrey v. University of Toledo Medical Center, the plaintiff alleged negligent AUS implantation caused severe postoperative pain, persistent leakage, and inability to use the pump, leading to a $295,000 verdict in his favor. In Dickerson v. SIMO, the plaintiff alleged negligent AUS implantation with bladder and urethral injury leading to persistent incontinence, resulting in a $150,000 verdict in his favor. These two cases complemented the findings presented by Lynch et al., which showed that urethral and bladder injury were among the most common complications in cases that alleged negligence in surgical performance. Of the 42 cases that claimed negligence in surgical performance, eight of the cases resulted directly in bladder injury, while six resulted in urethral injury. In reviewing litigation cases involving penile prosthetics, similar causes of malpractice were noted. In a study conducted by Sunaryo et al. (8), 48.8% of penile prosthetic cases reviewed faced allegations of error in surgical decision making. These errors most related to improper device placement or sizing errors. Furthermore, non-device related complications in the reviewed cases were related to damage to surrounding structures (i.e., bowel and vasculature). Although damage to surrounding anatomical structures is an inherent risk in many urologic procedures, it is imperative that the training urologists receive in AUS placement emphasizes techniques to reduce surgical error. This data suggests that urologic related prosthetic surgeries may ultimately prompt similar causes of legal action (8).
Additionally, clinical volume may have an effect on medical malpractice risk. In a study conducted by Schaffer et al. (9), medical malpractice claims and their relationship to procedural patient encounters were analyzed. Findings showed that annual risk of malpractice claims increased linearly by 0.373% (P<0.0001) as clinical volume increased. However, as clinical volume increased, the rate of malpractice claims per 1,000 patient encounters ultimately decreased (9). While it is unknown if these same trends are reflected in our dataset, it is reasonable to assume that there are likely similarities within clinical volume of AUS placement. Further investigation on the relationship between AUS implantation volume and malpractice claims may highlight current trends within the medical malpractice environment.
Postoperative device infection is a complication that has driven significant changes in the field of prosthetic urology (1). Innovations involving antibiotic-coated artificial urethral sphincters have been introduced in recent years to mitigate perioperative and postoperative infection rates (2). Although device infection prevention has been a point of emphasis, our findings demonstrate that infection following AUS device implantation remains a common cause of medical malpractice litigation. Of the cases analyzed in this study, 17% had alleged postoperative infection after the AUS implantation between the years of 1994 to 2021. In Allen v. Giannakis, the plaintiff alleged that incomplete AUS explanation led to recurrent infection, and the jury awarded $46,400 in damages. Device infection can be a devastating outcome of AUS implantation. With the potential to burden a patient’s quality of life and finances, device infection is a complication that urologists must continue to reduce. Per our knowledge, there remains no conclusive evidence that antibiotic-coated devices are significantly altering postoperative infection rates when compared to uncoated devices (10). Infection risk still remains to be an area of legal pursuit. In the 2021 case of M v. M, the defendant alleged malpractice after the patient became septic following an AUS device re-implant. Because the frequency of AUS device-related infection lawsuits has remained consistent in frequency since 1994, urologists must continue to adhere to the preoperative, perioperative, and postoperative protocols in place to prevent infection risk. Further studies analyzing the frequency of medical malpractice litigation alleging device infection before and after antibiotic-coated devices were introduced into the market can provide insight into the effectiveness of these devices.
While medical malpractice litigation has affected urologists on a national scale, the malpractice environment is largely established at the state level. Each state has its own set of legislation that governs the legal issues that may arise between patients and physicians. In fact, states have the freedom to enact tort law reforms that protect physicians and lower malpractice liability risk (11). Chen et al. conducted a study that analyzed the impact that the different law environments in each state affect overall orthopedic surgical outcomes. This study showed that in states with an increased number of tort reforms, orthopedic surgeons were more willing to operate on patients who were considered higher risk. The increase in overall surgical rate consequently led to an increase in mortality rates. Interestingly, this study showed that the surgery rate increased the most with an increasing number of tort reforms in southern states, particularly. In our findings, 14 of the 24 analyzed cases originated in southern states. Additionally, 50% of cases that resulted in a verdict in favor of the plaintiff were from the South. While the specific tort reforms that were in place during the trial of each case are unknown, the study provided by Chen et al. may provide an explanation for the increased number of medical malpractice litigation in southern states. In states where the liability risk was lower, urologists may have been more willing to operate on a more vulnerable or high-risk subset of patients. This may have resulted in more complications and increased opportunities to take legal action against urologists. Further studies would be needed to analyze each individual state tort reforms to determine the precise impact that a legal environment has on surgery rates.
Despite the comprehensive medicolegal analysis the Westlaw and LexisNexis+ databases provide, our study had some limitations. The analyzed data did not provide any specific demographic information regarding the level of training or case volume of each urologist undergoing malpractice litigation. It is important to note that these databases utilized do not capture every case filed against a urologist. Rather it only captures the cases that progressed to legal proceedings, and does not include many of the cases may have ended in settlement or did progress to a formal lawsuit. This likely impacts our ability to have a comprehensive understanding of the legal landscape related to AUS implantation malpractice. These variables may provide insight into the possible relationship between experience levels and risk of medical malpractice. Additionally, the specific tort laws enacted by each state during time of litigation were not included in the databases. Understanding the tort laws that compromised the legal environment during each case could provide further explanation for the geographic trends our findings and previous studies have shown. Interestingly, there have been no cases that ruled in the favor of the plaintiff since 2011. While the exact reasoning for this trend is unknown, it would be beneficial to perform a deeper analysis on what specific factors within contemporary urology have mitigated litigation events. This may be explained by many facilities’ enhancement of the informed consent process that has been integrated within various electronic medical record (EMR) systems, or more definitive standard of care guidelines that are upheld within legal proceedings. Regardless, the further investigation as to why many lawsuits against urologist are unsuccessful should be done. Finally, the Westlaw and LexisNexis+ databases do not include cases that have been settled outside of the court system, so the data presented is not a comprehensive review of the instances a urologist has been sued after AUS implantation.
Future extensions of this project could include performing a case-control study that compares these litigation cases of AUS to its non-litigation cases, and analyze differences such as surgeon experience, incidence, patient comorbidities, and identification of risk factors. This approach would help increase generalizability of our findings and ultimately support the development of targeted interventions to reduce the risk of malpractice in the clinical setting.
Conclusions
Medical malpractice allegations are a risk that urologists may encounter after placement of AUS. This analysis identified that allegations were most common in Southern states. The most common allegation in this analysis pertained to the damage to device. However, in the majority of allegations, the outcome favored the defendant.
Acknowledgments
We would like to thank Rutgers New Jersey Medical School and its Division of Urology for their continued support of our clinical research. This study was presented as a podium presentation at the 2025 American Urological Association Annual Meeting in Las Vegas, NV.
Footnote
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-408/rc
Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-408/prf
Funding: None.
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-408/coif). The authors have no conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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