Cleft Lip and Cleft Palate Surgery: Malpractice Litigation Outcomes

The Cleft Palate Craniofacial Journal 54(1) pp. 75 79 January 2017 Ó Copyright 2017 American Cleft Palate Craniofacial Association ORIGINAL ARTICLE Cleft Lip and Cleft Palate Surgery: Malpractice Litigation Outcomes Grant A. Justin, B.S., Scott E. Brietzke, M.D., M.P.H. Objective: This study examined malpractice claims related to cleft lip and cleft palate surgery to identify common allegations and injuries and reviewed financial outcomes. Design: The WestlawNext legal database was analyzed for all malpractice lawsuits and settlements related to the surgical repair of cleft lip and palate. Main Outcomes Measures: Inclusion criteria included patients undergoing surgical repair of a primary cleft lip or palate or revision for complications of previous surgery. Data evaluated included patient demographics, type of operation performed, plaintiff allegation, nature of injury, and litigation outcomes. Results: A total of 36 cases were identified, with 12 unique cases from 1981 to 2006 meeting the inclusion criteria. Six cases (50%) were decided by a jury and six by settlement. Five cases involved complications related to the specific surgery, and the other seven were associated with any surgery and perioperative care of children and adults. Cleft palate repair (50%) was the most frequently litigated surgery. Postoperative negligent was the most common allegation (42%) and resulted in a payout in each case (mean ¼ $3,126,032). Death (42%) and brain injury (25%) were the most frequent injuries reported. Financial awards were made in nine cases (after adjusting for inflation, mean ¼ $2,470,552, range ¼ $0 to $7,704,585). The awards were significantly larger for brain injury than other outcomes ($4,675,395 versus $1,368,131 after adjusting for inflation, P ¼.0101). Conclusion: Malpractice litigation regarding cleft lip and palate surgery is uncommon. However, significant financial awards involving perioperative brain injury have been reported. KEY WORDS: brain injury, cleft lip, cleft palate, litigation, malpractice, negligent postoperative Medical malpractice litigation has existed in the United States since the 1840s (Mohr, 2000). It persists today as a costly compensatory mechanism. However, during the past decade, state tort reform laws have led to a decline in the number of paid claims and the rate of claims made (Paik et al., 2013; Mello et al., 2014). In addition, malpractice insurance costs have been stable for the past 20 years (Mello et al., 2014). Surgeons generally have the highest rates of malpractice suits and the highest number of suits resulting in paid claims, with an 88% chance of a first claim by the age of 45 years (Jena et al., 2011). Thus, during the past 15 years, multiple medico-legal databases have been analyzed to better understand the predictive factors and actual costs of litigation. Mr. Justin is medical student, Uniformed Services University of the Health Sciences, Bethesda, Maryland. Dr. Brietzke is Program Director, Department of Otolaryngology Head and Neck Surgery, Walter Reed National Military Medical Center, Bethesda, Maryland. Presented at the American Academy of Otolaryngology Head and Neck Surgery Foundation 2015 Annual Meeting, Dallas, Texas. Submitted October 2015; Accepted November 2015. Address correspondence to: Mr. Grant A. Justin, Uniformed Services University of the Health Sciences, Bethesda, MD 20814. E- mail grant.justin@usuhs.edu. DOI: 10.1597/15-285 Complications from cleft lip and cleft palate surgeries occur infrequently. Mortality related to cleft palate surgery is as low as 0.01%, with 3% of patients having airway failure, and hemorrhage, infection, or wound disruption occurring in less than 1% (Nguyen et al., 2014). As such, cleft palate and cleft lip surgical litigation has been rarely described in the medical literature. Previous studies have looked at selected cases involving litigation related to cleft lip and cleft palate repair (Svider et al., 2013b; Svider et al., 2015), but did not include an exhaustive database search to identify the larger number of the cases found in this study. The goal of this study was to educate the cleft lip and palate surgeon regarding the medical litigation related to cleft lip and cleft palate surgery, the associated allegations and injuries resulting in litigation, and significant financial outcomes. MATERIALS AND METHODS This study was exempt from a review from the institutional review board at our institution because it included only previously existing, deidentified data. A search of the WestlawNext legal database was completed in December 2014. The WestlawNext legal database is a collection of jury verdicts deemed important by commercial 75

76 Cleft Palate Craniofacial Journal, January 2017, Vol. 54 No. 1 vendors for future court precedence or case contents. It contains cases that are publicly available in federal and state court records. Multiple malpractice litigation retrospective case reviews in plastic surgery (Svider et al., 2013b; Paik et al., 2014a, 2014b; Svider et al., 2014a; Svider et al., 2015) and otolaryngology (Morris et al., 2008; Nash et al., 2011; Blake et al., 2013; Eloy et al., 2013a, 2013b; Hong et al., 2013; Kovalerchik et al., 2013; Reilly et al., 2013; Ruhl et al., 2013; Svider et al., 2013a, 2013b, 2013c, 2013d, 2013e; Hong et al., 2014; Khan et al., 2014; Svider et al., 2014a, 2014b; Farida et al., in press) have been completed using the WestlawNext database, demonstrating its significance and reliability in malpractice analysis. The WestlawNext database was queried with the following search terms: medical malpractice AND cleft lip OR cleft palate OR cleft palate repair OR cleft lip repair OR cleft lip surgery OR cleft palate surgery OR palatoplasty OR nasoalveolar molding OR cleft lip revision OR alveolar bone graft OR pharyngeal flap OR sphincter pharyngoplasty. Inclusion criteria included patients undergoing surgical repair of a primary cleft lip or palate defect or revisions of prior surgery. The following data were collected: age, sex, state of case, decision for plaintiff or defendant, jury or settlement, type of surgery, allegations, injury, and payment or settlement. All awards were adjusted for inflation using the Bureau of Labor and Statistics Inflation Calculator (http://www.bls.gov/data/ inflation_calculator.htm). Quantitative analysis consisted of primarily descriptive statistics. Limited hypothesis testing was performed using an unpaired, two-tailed Student s t test. Significant differences were defined as a P value less than.05. RESULTS Database Search Results and Case Demographics A total of 36 cases containing jury verdicts and settlements were found on the initial database search. After applying the inclusion criteria, 12 unique cases were identified. A total of 24 cases were excluded because the basis for the lawsuit was not directly related to surgery. These lawsuits were based on failure to diagnose cleft lip and cleft palate birth defects leading to wrongful birth (8), pharmaceuticals as cause of cleft lip and cleft palate (8), negligent surgery or for non cleft lip or cleft palate surgery (4), chemical exposure at work leading to birth defect (1), disability discrimination (1), failure to assess infant apnea monitor (1), and failure to diagnose pregnancy (1). Inclusive dates ranged from 1981 to 2006 and originated in nine different states (Table 1). Ten cases included male patients, and two cases involved female patients. The mean patient age at the time of injury was 11.22 years (median ¼ 17 months old, range ¼ 1 month old to 45 years old), with six cases involving pediatric patients (mean age ¼ 10 months old), three adults (mean age ¼ 32 years old), two adults of unknown age, and one adult aged older than 40 years. Six cases (50%) were decided by juries, with three (50%) of these favoring the defendant and three the plaintiff. The remaining six cases were settled out of court. Only five cases entailed complications related to the specific surgery, whereas the other seven involved perioperative care of children and adults. Surgical Procedure(s) Performed The most common operations were to repair the cleft palate (75%): unspecified cleft palate repair (six cases, 50%), with four (66%) favoring the plaintiff and two (33%) being favorable to the defendant, and palatoplasty (three cases, 25%), with two favoring the plaintiff and one being favorable to the defendant (Table 1). Lip revision (two cases, 17%) was the next most frequent surgical procedure, with one case favoring the plaintiff and one favoring the defendant. The remaining procedures included frenulectomy, cleft lip repair, silastic implants, and maxillary Le Fort I, with all resulting in a favorable decision for the plaintiff. Plaintiff Allegations Many cases included more than one allegation (Table 2). Negligent postoperative was the most common plaintiff allegation occurring in five different cases (42%) that were all favorable to the plaintiff (Table 1). Two of these cases resulted in death, two resulted in brain injury, and one led to compartment syndrome. An analysis of litigation outcomes based on allegation did not result in any significant findings. Patient Injuries Death (42%) was the most frequent injury occurring in five cases, with three favoring the plaintiff and two favoring the defendant (Table 1). Brain injury (25%) occurred in three unfavorable cases for the defendant. Extraction of teeth, facial injury, infection, and compartment syndrome were each involved in an unfavorable case to the physician, whereas causing a permanent anterior fistula led to a favorable decision. Financial Payout The mean payout before adjusting for inflation was $1,472,722, and after adjusting for inflation was $2,470,552. Financial awards were significantly larger for brain injury than other outcomes ($4,675,395 versus $1,368,131 after adjusting for inflation, P ¼.0101) (Table 3). A comparison of the mean payment based on jury decision versus settlement, negligent postoperative

Justin and Brietzke, CLEFT LIP AND CLEFT PALATE SURGERY: MALPRACTICE OUTCOMES 77 TABLE 1 Case Demographics and Data Age/Sex* Year of Trial State Type of Surgery Jury Decision Jury Versus Set Allegation Injury Payout $US Payout $US, Inflation Adjusted Unk/M 2002 CA Maxillary Lefort 1 Pl Jury Neg, LIC, Bat Extraction of two 400,000 528,749 front teeth.40 years/m 2006 VA Lip revision, palatoplasty Def Jury BSC, LIC Permanent anterior 0 0 fistula Unk/M 1998 PA CPR Def Jury BSC, Negpre Death 0 0 17 months/m 2000 CA CPR Set Neg, Negpos, BSC Death 199,500 275,505 1 year/m 2000 IL CPR Def Jury Negpre Death 0 0 10 months/m 1994 NY CPR Set Negop Mild brain injury 350,000 561,617 1 year/m 1993 TX Palatoplasty with Set Negpos Mild brain injury 3,500,000 5,759,982 frenulectomy 45 years/f 1995 WA Sialastic implants and Set LIC Facial injury, 600,000 936,240 cleft lip revision infection of implants 8 months/m 2000 TX Palatoplasty Set Negpos Compartment 825,000 1,139,309 syndrome 17 years/m 1991 MO CLR Pl Jury Negpos Death 430,000 750,779 1 month/f 1997 NY CPR Set Negpos Moderate brain 5,200,000 7,704,585 injury 34 years/m 1981 NC CPR Pl Jury Negop Death 1,750,000 4,578,204 * Unk ¼ unknown; M ¼ male; F ¼ female; CA ¼ California; VA ¼ Virginia; PA ¼ Pennsylvania; IL ¼ Illinois; NY ¼ New York; TX ¼ Texas; WA ¼ Washington; MO ¼ Missouri; NC ¼ North Carolina; CPR ¼ cleft palate repair unspecified; CLR ¼ cleft lip repair; Pl ¼ plaintiff; Def ¼ defendant; Neg ¼ Negligence; LIC ¼ lack of informed consent; Bat ¼ battery; BSC ¼ breach of standard of care; Negpre ¼ negligent preoperative; Negop ¼ negligent interoperative; Negpos ¼ negligent postoperative. versus other allegations, and death versus other injuries was not found to be statistically significant. DISCUSSION Although the rates of medical litigation and the number of paid claims have begun to decline (Paik et al., 2013; Mello et al., 2014), a review of medical litigation can still improve physician education, understanding of litigation causes, and associated allegations and injuries. A recent study reviewing the Kid s Inpatient Database of approximately 14,000 pediatric patients undergoing cleft palate repair in the United States found a mortality rate of 0.01% (Nguyen et al., 2014). About 3% of patients had complications with airways, with respiratory failure being the most common (2%). Infections, hemorrhage, or wound disruption combined occurred in less than 1% of cases (Nguyen et al., 2014). In addition, two studies (Svider et al., TABLE 2 Litigation Outcomes by Allegation* Plaintiff Allegation Cases With Litigation Outcome Favoring Plaintiff Cases With Litigation Outcome Favoring Defendant Negligent postoperative 5 0 Lack of informed consent 2 1 Negligence 2 0 Negligent interoperative 2 0 Negligent preoperative 0 2 Breach of standard of care 1 2 Battery 1 0 * The sum is greater than 12 cases because many cases had more than one plaintiff allegation. 2013b; Svider et al., 2015) discussed cleft lip and palate repair litigation using the WestlawNext database, but neither included all of the cases discussed in this paper. Reviewing these 12 cases led to multiple interesting and important observations, especially with regard to certain factors leading to patient injury and subsequent litigation. Negligent Postoperative Supervision The most common allegation in this study was postoperative negligent, leading to five unfavorable decisions. In addition, besides the cases involving brain injury, postoperative negligent led to the highest mean payment by any factor. In one case, a surgeon operating on a 17-month-old boy for an elective surgery for cleft palate failed to monitor the patient. After his operation, multiple nurses noticed that the patient had a blood clot in his mouth but failed to notify the physician. The patient aspirated on his clot and died. In a different case, an 8-month-old had a successful palatoplasty, but he suffered nerve damage and compartment syndrome requiring fasciotomies from IV infiltration despite hospital protocol that the nurses TABLE 3 Mean Payment by Various s Present (US$)* Absent (US$)* P Value Jury decision 1,952,577 2,729,539.1608 Negligent postoperative 3,126,032 1,651,202.1036 Death 1,868,163 2,771,747.2792 Brain injury 4,675,395 1,368,131.0101 * After adjusting for inflation. Prior to adjusting for inflation.

78 Cleft Palate Craniofacial Journal, January 2017, Vol. 54 No. 1 inspect the IV site. The nurses even falsely documented that they had checked the site. These cases demonstrate the importance of communication between nurses and physicians. In addition, it is critical that physicians complete their own postoperative physical exam to ensure that these types of errors resulting in severe injuries do not occur. In another case involving postoperative negligence, a 17-year-old boy died of an overdose of painkillers after he had an unspecified cleft lip repair. He was maintained on life support for nine months but eventually died. Although rare, serious complications especially involving the cardiopulmonary system can occur from perioperative opioid use both in IV patient-controlled analgesia and non-patient-controlled analgesia continuous infusions (Nelson et al., 2010). Brain Injury Two cases involving negligent postoperative also led to brain injury. After an elective palatoplasty and frenulectomy with nasal packing, a 6- month-old boy suffered permanent brain damage when he developed respiratory distress and arrest overnight. In another case, a 1-year-old girl who had undergone surgery for an unspecified cleft palate repair was not properly supervised by her physician, went into cardiac arrest 40 hours after surgery, and suffered brain injury. In addition, there was one case involving negligent during surgery in which a 10-month-old undergoing an unspecified cleft palate surgery suffered respiratory distress due to airway blockage, leading to mild brain injury. Brain injury led to the highest mean payout of $4,675,395 versus $1,368,131 after adjusting for inflation (P ¼.0101) (Table 3). Two of the brain injury cases occurred as a result of respiratory depression. Respiratory depression is a common complication of cleft lip and cleft palate surgery. Intraoperative airway complications can occur as often as 8.7% of the time for cleft palate repairs and 7.4% of the time postoperatively (Kulkarni et al., 2013). Some of the risk factors associated with respiratory depression in cleft lip and palate repair include wide cleft palate (Takemura et al., 2002), a syndromic cleft associated with hypoplasia or mandible, aspiration of secretions or blood (Kulkarni et al., 2013), evidence of a common cold (Takemura et al., 2002), and prehospital obstructive sleep apnea (Smith et al., 2013). Death Death was the most common injury, occurring in 5 of 12 cases. In two cases discussed in the previous section on perioperative negligent, a 17-year-old boy overdosed on painkillers and a 17-month-old boy aspirated on a blood clot. Both of these cases led to unfavorable decisions, with the former resulting in a jury decision for the plaintiff and the latter a settlement. Another case involved the death of a 34-year-old man after he was deprived of oxygen for 17 minutes during the repair of his cleft palate, leading to a settlement. In addition, two cases involving death were favorable to the defendant. The first involved a male of unknown age who died after cleft palate repair. The physician was accused of breach of standard of care and failure to perform a preoperative workup, leading to subsequent unspecified problems. The second case involved an 11- month-old boy who died of cardiac arrest after discharge home from surgery for cleft palate repair. The physician was accused of inadequate preoperative workup but won the case. Overall, the causes of death of this heterogeneous mix of patients involved a wide range of causes. It is interesting that both of the cases involving preoperative workup were favorable to the defendant. Regardless, it is important to ensure that patients are adequately evaluated before surgery. Especially because cleft lip and cleft palate are associated with about 200 different syndromes, including DiGeorge, VACTERL, CHARGE, and velocardiofacial syndromes and their serious comorbidities. As previously discussed in other sections, many of the deaths that resulted in a payout were a result of poor communication between nurses and physicians and improper postoperative observation and examination. There were multiple limitations to this study. This is a review of a large legal database, and only one database was analyzed. As such, it is not inclusive of all litigation on cleft lip and cleft palate repair. The legal database only includes those cases deemed important for future precedence or the nature of the case by commercial vendors. In addition, this study is limited because it is retrospective. The cases that were used were frequently incomplete in the amount of information provided, making analyses of some cases difficult. CONCLUSION Malpractice litigation regarding cleft lip and palate surgery is uncommon, but most cases favor the plaintiff, and there have been large rewards. Only five cases were actually a result of injuries incurred during an operation, whereas seven cases were a result of failure in perioperative care. Postoperative negligent and brain injury were the most common allegation and injury, respectively, for which large financial awards were made in each case. Each cleft lip and palate surgeon should consider these data and how they could potentially improve the quality of their practice in their individual systems. Acknowledgments. The authors would like to thank F. Cartwright Weiland, J.D., for accessing the WestlawNext database and providing the

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