567937

research-article2015

AORXXX10.1177/0003489414567937Annals of Otology, Rhinology & LaryngologySvider et al

Original Article

Craniofacial Surgery and Adverse Outcomes: An Inquiry Into Medical Negligence

Annals of Otology, Rhinology & Laryngology 1­–8 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0003489414567937 aor.sagepub.com

Peter F. Svider, MD1, Jean Anderson Eloy, MD, FACS2,3,4, Adam J. Folbe, MD1, Michael A. Carron, MD1, Giancarlo F. Zuliani, MD1, and Mahdi A. Shkoukani, MD1,5

Abstract Objective: This study aimed to evaluate factors contributing to medical negligence relevant to craniofacial surgery. Methods: Retrospective analysis of verdict and settlement reports on the Westlaw legal database for outcome, awards, physician defendants, and other specific factors raised in malpractice litigation. Results: Of 42 verdicts and settlement reports included, 52.4% were resolved with either an out-of-court settlement or plaintiff verdict, with aggregate payments totaling $50.1M (in 2013 dollars). Median settlements and jury-awarded damages were $988 000 and $555 000, respectively. Payments in pediatric cases ($1.2M) were significantly higher. Plastic surgeons, oral surgeons, and otolaryngologists were the most commonly named defendants. The most common alleged factors included intraoperative negligence (69.0%), permanent deficits (54.8%), requiring additional surgery (52.4%), missed/delayed diagnosis of a complication (42.9%), disfigurement/scarring (28.6%), postoperative negligence (28.6%), and inadequate informed consent (20.6% of surgical cases). Failure to diagnose a fracture (19.0%) and cleft-reparative procedures (14.3%) were the most frequently litigated entities. Conclusion: Medical negligence related to craniofacial surgery involves plaintiffs in a wide age range as well as physician defendants in numerous specialties, and proceedings resolved with settlement and plaintiff verdict involve substantial payments. Cases with death, allegedly permanent injuries, and pediatric plaintiffs had significantly higher payments. Keywords craniofacial, cleft palate, cleft lip, facial fracture, malpractice, negligence

Introduction After decades of rising litigation and concomitant increases in physician malpractice insurance premiums, claims related to medical negligence have started to decline.1,2 Nonetheless, costs associated with the malpractice “crisis” have been estimated to exceed tens of billions of dollars annually, and widely recognized sequelae such as the practice of defensive medicine continue to affect health care expenditures.3-9 A recent analysis estimated that the average physician spends nearly 5 years of his or her career involved with an unresolved malpractice claim.10 Consequently, evaluating factors raised in litigation and understanding the costs associated with specific injuries have been a topic of great interest to practitioners in multiple specialties. The authors have previously performed an analysis of legal proceedings relevant to facial plastic surgery using terms found on the American Academy of Facial Plastic and Reconstructive Surgery (AFFPRS) website.5 More than 85% of cases in the previous analysis involved rhinoplasty,

blepharoplasty, and rhytidectomy—procedures not typically considered to be in the realm of craniofacial 1

Department of Otolaryngology–Head and Neck Surgery, Wayne State University School of Medicine, Detroit, Michigan, USA 2 Department of Otolaryngology–Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, New Jersey, USA 3 Department of Neurological Surgery, Rutgers New Jersey Medical School, Newark, New Jersey, USA 4 Center for Skull Base and Pituitary Surgery, Neurological Institute of New Jersey, Rutgers New Jersey Medical School, Newark, New Jersey, USA 5 Division of Facial Plastic and Reconstructive Surgery/Craniofacial Surgery, Department of Otolaryngology–Head and Neck Surgery, Wayne State University School of Medicine, Detroit, Michigan, USA Corresponding Author: Jean Anderson Eloy, MD, FACS, Department of Otolaryngology–Head and Neck Surgery, Neurological Institute of New Jersey, Rutgers New Jersey Medical School, 90 Bergen Street, Suite 8100, Newark, NJ 07103, USA. Email: [email protected]

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surgery. Accordingly, in-depth discussion of results in that analysis was focused on those procedures. Furthermore, many cases specific to craniofacial surgery were not included in that analysis, as these terms were not highlighted on the AAFPRS website. The objectives of this article were to perform a focused analysis exploring factors in malpractice litigation relevant to craniofacial surgery using terms from the American Society of Craniofacial Surgery (ASCFS) and American Cleft Palate-Craniofacial Association (ACPA-CPF). The authors recognized a potential for overlap in a few cases; for example, there were 6 cases involving cleft palate/lip litigation included in the prior examination,5 although there was no discussion of factors specific to cleft cases, as this handful of trials was peripheral to that analysis as detailed above. In instances where there was overlap, we aimed to go into further detail regarding relevant cases, as craniofacial procedures were not the main focus in the prior analysis.

Methods and Materials All data were collected and analyzed in September and October 2013. The authors used the Westlaw legal database to examine litigation relevant to craniofacial surgery. Commercial vendors provide court records to Westlaw; whereas numerous jurisdictions contain attorney-reported reports, nearly all also contain confidential cases, labeled with terms such as confidential, anonymous, or Jane/John Doe.4,11 Westlaw is a widely used resource containing cases that progress to the point of inclusion in publicly available federal and state court records and has shown its value in prior malpractice analyses evaluating a multitude of topics in otolaryngology.4,5,11-21 Westlaw is a subscription-based resource (www.westlaw.com) that the authors logged onto via institutional access. The authors accessed online listings of fellowships from the ASCFS (http://ascfs.org/fellowships.cgi) and ACPACPF (http://www.acpa-cpf.org/education/fellowships/). The websites of all listed fellowships were evaluated, and terms describing procedures that fellows perform during their training were used for our Westlaw search. Using the advanced search function on Westlaw, jury verdicts and settlements were searched for using the term “medical malpractice” in combination with the following: “craniofacial” OR “facial deformities” OR “facial deformity” OR “skull abnormality” OR “skull deformity” OR “deformity of skull” OR “cleft palate” OR “cleft lip” OR “craniomaxillofacial” OR “monobloc” OR “lefort” OR “box osteotomy” OR “mandibular distraction” OR “palatal expansion” OR “orthognathic splint” OR “ptosis reconstruction” OR “canthopexy” OR “palatoplasty” OR “alveolar bone grafting” OR “ear reconstruction” OR “facial reanimation” OR “craniomaxillomandibular” OR “craniosynostosis” OR “microtia” OR “microsomia” OR

“crouzon” OR “apert” OR “treacher Collins” OR “robin sequence” OR “stickler syndrome” OR “van der woude” OR “plagiocephaly” OR “orthognathic surgery” OR “distraction osteogenesis” OR “facial trauma” OR “facial fracture” OR “le fort” OR “mandibular fracture” OR “mandible fracture” OR “fractured mandible” OR “maxillary fracture” OR “orbital fracture” OR “orbital blowout” OR “zygomaticomaxillary complex” OR “zygomatic arch” OR “smash fracture” OR “nasoorbitoethmoid”

This search yielded 122 initial jury verdicts and settlements, of which 80 were excluded for the following reasons: duplicate case entry (8), failure to diagnose craniofacial anomaly prenatally (7), failure to diagnose craniosynostosis after birth by pediatrician (3), not a craniofacial procedure (38), not medical malpractice (2), an obstetric issue during delivery (3), and not a surgical issue (19). From the remaining 42 jury verdict and settlement reports included in this analysis, the authors evaluated each individual record for outcome, awards, defendant specialty, patient demographics, and other alleged factors raised in litigation. All awards were adjusted for inflation using the Bureau of Labor Statistics Consumer Price Index Inflation Calculator (http:// www.bls.gov/data/inflation_calculator.htm).

Statistical Analysis As award totals in this analysis were not normally distributed, nonparametric statistical analysis with Mann-Whitney U tests was used for comparison of continuous variables as appropriate. Comparison of categorical variables was performed using Fisher exact test, with threshold for significance set at P < .05. SPSS version 20 (IBM, Chicago, Illinois, USA) was used for statistical calculations.

Results The 42 cases included in this analysis ranged from 1989 to 2013. Of the 42 cases included, 34 (81.0%) dealt with alleged perioperative negligence and 8 included plaintiffs pursuing litigation for failure to diagnose and operate for a surgical condition (19.0%). Of 40 cases reporting sex, women made up 60.0% of plaintiffs and men 40.0% of plaintiffs; no difference was noted in case outcome or median payments based on sex (P > .05). Of the 30 cases that reported age, the median age was 32.5 years (range, 8 months to 56 years); 10 cases with adult plaintiffs did not report specific ages, whereas 2 other cases simply reported that the plaintiff was a “minor.” Ten of 12 (83.3%) cases involving a minor were resolved with payment (either plaintiff verdict or settlement) compared to 18 of the 30 (60.0%) other cases, although this difference did not reach statistical significance (P = .22). Aggregate payments (adjusted for inflation to 2013 dollars) totaled $50.1M, including $31.6M from plaintiff

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Figure 1.  Overall outcomes and median payments (pie chart at inset), payment range in parentheses. Physician specialties named as defendants (bar chart); blue portion of bars represents cases resolved in the defendant’s favor, light red portion represents cases resolved with settlements, and dark red represents cases resolved with a plaintiff verdict. This figure is available in color online at http://aor.sagepub.com.

verdicts and $18.5M from out-of-court settlements. In cases resolved with payment, litigation involving a minor (< 18 years old) had a higher value (median, $1.2M) than cases not involving minors ($541 885) (P = .01). A plurality of cases included in this analysis was resolved in the defendant’s favor (Figure 1), with out-of-court settlements and plaintiff verdicts evenly comprising the remaining cases. No statistical difference in payment was noted upon comparison of settlements and plaintiff verdicts (P = .47). Plastic surgeons, oral surgeons, and otolaryngologists were the most commonly named defendant specialties, and outcome breakdown of cases organized by specialty is illustrated in Figure 1. The most common alleged factors raised in litigation included intraoperative negligence, sustaining permanent deficits, and requiring additional surgery as a result of negligence (Figure 2). Upon comparison of cases with and without specific factors raised, litigation involving allegations of permanent deficits and death as a result of negligence resulted in higher median payments (P < .05), whereas payments in cases where plaintiffs alleged that income and employment were affected trended higher, although this did not reach statistical significance (P = .08) (Table 1). Cleft lip/palate repairs were the most commonly litigated procedures included in our analysis (Tables 2 and

3), followed by ear reconstruction, Le Fort osteotomy, and mandible fracture repairs (3 cases each). Whereas each case had a unique set of factors, allegations of deficits in informed consent, requiring additional surgery, disfigurement, and sustaining permanent deficits were present in numerous cases resolved with a plaintiff verdict (Table 4). Information regarding average indemnities reported in other analyses of surgical procedures is illustrated in Table 5 for comparison.

Discussion The present analysis reveals that payments associated with craniofacial surgical malpractice are substantial, exceeding $50M (aggregate value) for the cases included in this analysis. In addition, the average jury award exceeded $500 000 and out-of-court settlements approached $1M (Figure 1). These figures say nothing about other costs associated with litigation, such as costs of legal representation, expert witness testimony, higher insurance premiums, and of course, indirect costs such as decreased health care access for patients and increases in defensive medicine practices.1,9,27-30 In addition to financial consequences, physicians also fear the effect of litigation on reputation, among both colleagues and patients.31,32

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Figure 2.  Most common alleged factors in litigation. Note that all values are expressed as percentage of total cases (42 cases) in this analysis except perceived deficits in informed consent and unnecessary/inappropriate surgery, which are percentages of the 34 operative cases. Addt’l, required additional surgery; con, informed consent; Delay, missed diagnosis or delay in diagnosis of complication or injury; Disf, disfigurement/scarring; Eye, vision sequelae (diplopia, blindness); Mal, malocclusion as a result of negligence; Numb, paresthesias; Op., intraoperative negligence; Perm, permanent deficits; post, postoperative negligence; Rad, radiologic study misinterpreted; Unn., unnecessary/inappropriate procedure; Work, employment/income affected.

Table 1.  Median Payments (in Thousands of Dollars) Organized by Presence of Frequently Alleged Factors. Factor Intraoperative negligence Permanent deficit Additional surgery required Missed/delayed Dxb Disfigurement/scarring Postoperative negligence Employment/incomec Radiologic misdiagnosis Informed consent Death

Factor Present

Factor Absent

P Value

  $912 $2100 $1210   $988 $1701   $850 $1946 $1399   $541 $1127

$709 $528 $542 $770 $708 $711 $555 $832 $912 $725

.97 .003a .38 .65 .40 .56 .08 .90 .72 .02a

a

Threshold for significance set at P < .05. Missed or delayed diagnosis of complication or injury. c Employment or income allegedly affected by negligence. b

Our analysis also highlights that litigation related to craniofacial surgical conditions affects practitioners in numerous specialties (Figure 1), as these conditions encompass both congenital and acquired/traumatic etiologies. Nonetheless, care of these patients is certainly an interdisciplinary venture, and not all causes of litigation may be

related to operative complications or a failure to diagnose an operative condition. For example, pediatricians play a critical role in identifying patients with congenital craniofacial anomalies and referring to appropriate specialists.33,34 Whereas the authors chose to perform a focused and succinct study of litigation specific to surgical management,

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Svider et al Table 2.  Litigated Craniofacial Procedures. No. of Cases

Procedure Cleft palate/lip repair Ear reconstruction Le Fort osteotomy (not for cleft repair) Mandible fracture repair Cancer resection Craniosynostosis repair Unspecified osteotomy/orthognathic procedure Bilateral sagittal split osteotomy Distraction osteogenesis (mandible) Nasal reconstruction Tracheotomy (cleft palate patient) Unspecified craniofacial procedure Failure to diagnose a surgical condition

6 3 3 3 2 2 2 1 1 1 1 6 8

further study into allegations of negligence against pediatricians and obstetricians for failure to recognize perinatal congenital anomalies may be of interest. Upon organization of cases by plaintiff age, cases involving minors were slightly more likely to be resolved with payment (83.3%) than those with adult plaintiffs (60.0%), although this difference did not reach statistical significance (P = .22). However, upon considering the size of these payments, litigation involving minors had awards more than double the size of those in cases involving adults (P = .01). These findings mirror results from a recently published analysis regarding malpractice risk among pediatricians,35 which found that indemnity payments among pediatricians are uncommon but large, specifically in cases with permanent patient injury. One key difference is that the aforementioned analysis of 1630 pediatricians was not focused on surgical negligence. Further evaluation of surgical malpractice litigation, as it relates to pediatric patients, may be of value to individuals in numerous specialties. Procedures involving cleft palate patients represent the most commonly reported entity in this analysis (Tables 2 and 3). It is perhaps surprising that 4 of these 7 cases involved adult litigants, even though patients typically undergo initial surgical intervention in childhood or even as early as infancy.36,37 However, upon further examination, all but 1 of these patients had a history of surgical intervention dating back to childhood. Nonetheless, the observed ages in Table 3 reinforce the point that adults undergoing intervention for congenital craniofacial anomalies are potentially as likely to pursue litigation should an adverse outcome occur. Several other important considerations were raised upon specific examination of cleft litigation. One of these is the presence of multiple cases reporting a persistent oronasal fistula, emphasizing the importance of including this potential complication in a comprehensive informed consent

process preoperatively. In addition, all surviving patients involved in Table 3 raised the fact that additional surgical intervention was required as a result of negligence. This further reinforces the point of not only including specific potential complications in an informed consent discussion but also including more general considerations, such as a potential need for additional surgery should expectations not be met.16 Alleged deficits in informed consent have been reported in a multitude of analyses, and it may not always relate to a physician simply omitting a specific complication, but rather, a patient not comprehending issues that were discussed. In addition to a comprehensive discussion of risks, alternatives, and benefits, physicians may potentially minimize liability by explicitly documenting this discussion in writing. Furthermore, communication may be enhanced by providing well-written patient education materials (PEMs). Care should be taken to ensure that any PEMs provided do not contain medical jargon and are written at an easily understandable level, as several analyses have noted that many PEMs may be written at too difficult a level for the average adult to comprehend.38-42 In addition to alleged deficits in informed consent, several other findings in this analysis are consistent with prior themes identified in the medicolegal literature. For example, 1 analysis of several hundred trials related to iatrogenic cranial nerve injuries noted a significant presence of informed consent allegations, delayed diagnoses of injury, requiring additional surgery as a result of complications, and alleging that surgical intervention was unnecessary,16 all factors identified in the present analysis (Figure 2). The presence of an increasing number of these 4 factors increased the likelihood of cases being resolved with a jury awarding damages in the prior analysis. Approximately one-fifth of litigation included in this analysis involved a failure to recognize facial fractures found on imaging studies (Figure 2), and plaintiffs in each of these cases pursued litigation, alleging a failure to pursue surgical intervention in a timely manner as a result. In all of these cases, radiologic diagnoses were either completely missed or results not communicated to the patient (2 cases). Radiologists were named as codefendants in several cases as a result (Figure 1). These findings emphasize the importance of looking at and interpreting imaging studies yourself as well as conferring with a radiologist; only 2 of these cases involved both the radiologist and another practitioner allegedly missing an injury. Although this is the first comprehensive analysis to examine litigation regarding craniofacial surgery, there are several limitations acknowledged by the authors. Jury verdict and settlement reports in the Westlaw database are comprehensive, and the level of detail found within these records is the main reason that this resource has been used in numerous other analyses. Nonetheless, there is some variation in detail within these records, and some jury

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Table 3.  Factors Alleged in Cleft Palate/Lip Litigation. A/S

$ (S/P)

Def

17/M 45/F M 40/F 1/M

$770 (P) $528 (P) $894 (S) $264 (S)

Unk PL Oral PL Unk

Lip Both Pal (B/L) Pal Pal (PR)

2/M

$1485 (S)

Oto

Pal/lip (PR)

38/M

PL

Condition

Procedure

Op/Post

UC

N/Y Y/N Y/N Y/N N/Y

Unspecified Palatoplasty a

Unspecified Unspecified & BMT Tracheotomy removal b

Pal/lip (VPI Hx)

IC Add

D

Comments

N Y N N N

N Y Y N N

N Y Y Y N

Y N N N Y

Postoperative narcotic overdose Oronasal fistula Removed 2 teeth without consent Infection of Silastic implants Tongue clot aspiration

Y/N

N

N

N

Y

Pneumomediastinum

Y/N

Y

Y

Y

N

“Outdated” procedure; “coerced” IC; fistula

Abbreviations: $ (S/P), awards (thousands of dollars), (settlement/plaintiff verdict); Add, required additional surgery; A/S, age/sex; B/L, bilateral; D, death; Def, defendant specialty; IC, informed consent; Op/Post, intraoperative negligence/postoperative negligence; Oral, oral surgery; Oto, otolaryngology; Pal, palate; PL, plastic surgery; PR, history of Pierre Robin syndrome; UC, unnecessary or inappropriate procedure; Unk, unknown specialty; Y/N, yes/no. a Maxillary Le Fort I osteotomy and grafting of bilateral alveolar clefts and bilateral mandibular sagittal osteotomy. b Pharyngoplasty, palatoplasty (including palate push-back procedure), and repair of oral-nasal fistula.

Table 4.  Cases Resolved With a Plaintiff Verdict. A/S 17/M F 7/F 30/F 56/F M 22/F 55/F 17/F F M

$Awd

Def

  $770  $2962   $931   $556   $125   $528  $2508   $290     $7   $158 $22 736

Unk PL Oph, PL PL Oto Oral PL Rad Oto ER, Rad PL

P/C Cleft repair Mandible Fx Congenital Nasal Le Fort/orb Fx Cleft repair Mandible Fx Mandible Fx Microtia Mandible Fx Unspecified

Op/Ftr

IC

Add

Disf

Per

Comments

Op Ftr Op Op Op Op Ftr Ftr Op Ftr Op

N NA N Y Y Y NA NA N NA Y

N N N Y Y Y N Y N Y Y

N Y N N N N Y N N N Y

N Y Y N N N Y N N N Y

Death (postop narcotic OD) Fail to Dx and treat Postoperative blindness Persistent bleeding Did not repair Le Fort Fx Did not obtain IC to remove tooth Fail to Dx and treat Missed Dx, pain, trismus Used bacitracin (pt was allergic) Fail to Dx and treat Scarring; CNVII paralysis

Abbreviations: Add, required additional surgery; A/S, age/sex; $Awd, award in thousands of dollars; CNVII, facial nerve; Congenital, unspecified congenital craniofacial anomaly; Def = defendant specialty; Disf, alleged disfigurement; Dx, diagnose; ER, emergency room physician; Fx, fracture; IC, alleged deficit in informed consent; NA, not applicable; Nasal, nasal trauma requiring extensive nasal reconstruction; Op/Ftr, operative negligence vs failure to recognize surgical condition; Oph, ophthalmologist; Oral, oral surgeon; Orb, orbital; Oto, otolaryngologist; P/C, procedure/condition; Per, permanent deficit; PL, plastic surgeon; pt, patient; Rad, radiologist; Unk, unknown specialty.

verdict and settlement reports are more comprehensive than others. Table 3 offers an illustrative example, in which specific cleft palate/lip reparative procedures were noted in only 4 of these cases. This relates to these jury verdict and settlement reports being compiled by nonmedical laypersons with an intention to disseminate information to legal professionals lacking a medical background. Consequently, areas in which medical terminology can be complicated (such as the numerous types of procedures available in cleft reconstruction) may often be simplified with terms such as cleft palate reconstruction or repair. Another potential criticism relates to the reliance on a single resource, Westlaw. In a prior medicolegal analysis of iatrogenic tracheal stenosis, the authors conducted searches using both Westlaw and the other widely used resource,

Lexis Nexis, and found that jury verdict and settlement reports attained were nearly identical.14 This is likely a result of these resources drawing from the same record pool. As a result, there is little to gain from conducting such an analysis using multiple resources, and Westlaw was chosen over Lexis Nexis for its ease of use. The authors acknowledge that analysis of potential cases in which litigants ultimately do not pursue litigation may be important, as an understanding of factors unique to these cases may yield valuable information. It is unfortunate that legal databases such as Westlaw are dependent on publicly available court records, of which these cases are obviously not a part. As jury verdict and settlement report patterns vary by jurisdiction and, furthermore, commercial vendor collection patterns vary by jurisdiction, there is no reliable

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Svider et al Table 5.  Comparison of Payments Among Prior Malpractice Analyses. Authors

Payment (in Thousands of Dollars, Mean/Median)

Procedure or Discipline 22

Paik et al Colaco et al23 Svider et al15 Svider et al5 Kim et al24 Jalian et al25 Singer et al26

$555,a $988,b $831c (median) $245,a $300b (median) $1200,a $900b (mean) $940a (mean) $352,a $577b (mean) $230c (mean) $380c (mean) $185c (mean)

Craniofacial surgery Cosmetic breast surgery Prostate surgery Otolaryngology Facial plastic surgery Cardiac catheterization Laser surgery Thyroidectomy

Boldface represents findings from the current study. a Plaintiff verdict awards. b Out-of-court settlement. c Payment (does not specify whether awarded damages or settlement).

way to determine the number of relevant cases that did not progress to inclusion in publicly available federal and state court records. Consequently, this resource is not ideal for estimating the overall prevalence of relevant litigation but is valuable in examining specific factors that do arise in litigation, and it has shown its unique value in numerous prior medicolegal analyses.4,5,11-17,19,20

Conclusion Medical negligence related to craniofacial surgery involves plaintiffs in a wide age range as well as physician defendants in numerous specialties, particularly plastic surgeons, oral surgeons, and otolaryngologists. Cleft palate/lip procedures and facial fracture injuries were the most commonly litigated procedures and conditions. Proceedings resolved with out-ofcourt settlement or plaintiff verdict involve substantial payments. Payments in cases with death, allegedly permanent injuries, and pediatric plaintiffs were significantly higher. Inclusion of specific factors as well as general considerations detailed in this analysis into a comprehensive informed consent process may be beneficial for both practitioners and patients, as improved communication may potentially minimize liability and possibly even improve patient safety. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.

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Craniofacial Surgery and Adverse Outcomes: An Inquiry Into Medical Negligence.

This study aimed to evaluate factors contributing to medical negligence relevant to craniofacial surgery...
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