Oral isotretinoin: 29 years of medical malpractice cases in the United States.

BACKGROUND: Reviews of malpractice claims in the United States show trends of increasing payments with statistically higher payouts for more debilitating and permanent injuries. OBJECTIVES: To examine lawsuits involving notable associated adverse reactions of isotretinoin. METHODS: Court records of US legal trials from 1985 to 2014 were obtained from a major computerized database: LexisNexis. Data were compiled on the demographics of the defendant and plaintiff, litigation over adverse drug reaction, legal allegations, verdicts, and ruling decisions. RESULTS: Seventy unique cases met inclusion criteria and were selected for review. Forty-four cases cited physicians, and 26 cited a pharmaceutical company. When data from physician and pharmaceutical company litigations were combined, individuals 17 years or younger were more likely to be granted litigation outcomes in their favor compared with adults (P = .0016). Cases alleging failure to monitor were associated with an outcome in favor of the plaintiff (P = .0379). LIMITATIONS: Cases settled or terminated before going to court could not be reviewed. CONCLUSIONS: Familiarity with malpractice trends through precedent-setting cases will increase physician awareness of common pitfalls, potentially mitigating litigation risk and improving patient care.

Necroptosis and Apoptosis Contribute to Cisplatin and Aminoglycoside Ototoxicity.

Ototoxic side effects of cisplatin and aminoglycosides have been extensively studied, but no therapy is available to date. Sensory hair cells, upon exposure to cisplatin or aminoglycosides, undergo apoptotic and necrotic cell death. Blocking these cell death pathways has therapeutic potential in theory, but incomplete protection and lack of therapeutic targets in the case of necrosis, has hampered the development of clinically applicable drugs. Over the past decade, a novel form of necrosis, termed necroptosis, was established as an alternative cell death pathway. Necroptosis is distinguished from passive necrotic cell death, in that it follows a cellular program, involving the receptor-interacting protein kinase (RIPK) 1 and RIPK3. In this study, we used pharmacological and genetic interventions in the mouse to test the relative contributions of necroptosis and caspase-8-mediated apoptosis toward cisplatin and aminoglycoside ototoxicity. We find that ex vivo, only apoptosis contributes to cisplatin and aminoglycoside ototoxicity, while in vivo, necroptosis as well as apoptosis are involved in both sexes. Inhibition of necroptosis and apoptosis using pharmacological compounds is thus a viable strategy to ameliorate aminoglycoside and cisplatin ototoxicity.SIGNIFICANCE STATEMENT The clinical application of cisplatin and aminoglycosides is limited due to ototoxic side effects. Here, using pharmaceutical and genetic intervention, we present evidence that two types of programmed cell death, apoptosis and necroptosis, contribute to aminoglycoside and cisplatin ototoxicity. Key molecular factors mediating necroptosis are well characterized and druggable, presenting new avenues for pharmaceutical intervention.

Dizziness, malpractice, and the otolaryngologist.

PURPOSE: To assess malpractice claims related to the management of dizziness in otolaryngology in order to improve care and minimize the risk of litigation. MATERIALS AND METHODS: This is a retrospective review of the LexisNexis "Jury Verdicts and Settlements" database. All lawsuits and out of court adjudications related to the management of dizziness by otolaryngologists were collected. Data including patient demographics, plaintiff allegation, procedure performed, and indemnities were analyzed. RESULTS: Of 21 cases meeting inclusion criteria, 17 were decided by a trial jury and four were resolved out of court. Jury verdicts favored the plaintiff 53% of the time and a payout was made in 57% of cases overall. Average payments were higher for jury verdicts in favor of the plaintiff ($1.8 million) as compared to out of court settlements ($545,000). Two-thirds of cases involved surgery, most commonly stapes surgery. Legal allegations, including physical injury, negligence, and lack of informed consent failed to predict the legal outcome. CONCLUSIONS: Appropriate examination, testing, and referrals within a timely manner are crucial in the management of dizzy patients to avoid misdiagnoses. It is imperative that patients undergoing ear surgery are appropriately counseled that dizziness is a potential complication. The analysis of malpractice literature is complementary to clinical studies, with the potential to educate practitioners, improve patient care, and mitigate risk.

Ceruminous adenocarcinoma: An analysis of the Surveillance Epidemiology and End Results (SEER) database.

OBJECTIVES: Ceruminous adenocarcinoma is a rare malignancy. However, due to the paucity of cases, this has been difficult to study. Using a population-based national database, patient demographics and survival trends were analyzed to further elucidate the management of this malignancy. METHODS: The SEER database was queried for patients diagnosed with ceruminous adenocarcinoma between 1973 and 2010. RESULTS: Twenty-two patients were identified in the database. The average age of diagnosis was between 60 and 64 years. All of the patients underwent surgical resection of the primary malignancy. Eight patients (36%) also had postoperative radiation. CONCLUSIONS: Ceruminous adenocarcinoma is uncommon but may not have as poor a prognosis as previously thought. Surgical resection alone appears to be a reasonable treatment option. Larger prospective studies are needed, but database analysis like this may provide clarity on the management of uncommon diseases.

Emergent treatment of button batteries in the esophagus: evolution of management and need for close second-look esophagoscopy.

OBJECTIVES: The evolving epidemiology of pediatric button battery ingestion is alarming. Currently, assessment of the degree of damage relies heavily on the initial esophagoscopy in a manner similar to the management of caustic ingestion. We have noted that use of this classic approach may delay the return to normal oral intake. Using several cases treated at our institution, we illustrate the value of "close second-look esophagoscopy" (CSLE) in expediting a return to normal oral intake after button battery ingestion. METHODS: We present a retrospective case series. RESULTS: Five patients (11 to 18 months of age) with button batteries trapped in the cervical esophagus were recently managed at our institution. The batteries were lodged in the esophagus for durations ranging from 6 hours to 4 months. Three cases of initial grade III circumferential necrotic injury were downgraded to grade IIa after a CSLE performed 2 to 4 days after removal, and their management was appropriately changed. CONCLUSIONS: The injury and healing of cases of button batteries in the proximal esophagus appear to be variable; caustic injury, electrical mucosal damage, and direct pressure are thought to be several contributory factors. Performing a CSLE within 2 to 4 days after battery removal may provide more useful prognostic information. In certain cases, downgrading of the injury may facilitate an earlier return to an oral diet, use of fewer diagnostic tests, and a shorter hospital stay. The utility and timing of imaging, management of diet and medications, and acceptable follow-up plans are discussed within the context of guiding future research.

Determining the Prognosis of Bell's Palsy Based on Severity at Presentation and Electroneuronography.

OBJECTIVE: To examine the demographics of Bell's palsy and determine how House-Brackmann (HB) grade at nadir and electroneuronography (ENoG) results correlate with HB grade after recovery and development of synkinesis. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary care military medical center. METHODS: Patients with acute Bell's palsy and adequate follow-up, defined as 6 months or return to HB grade I function, were included. Demographic information, HB scores at nadir and recovery, and ENoG results were collected. RESULTS: A total of 112 patient records were analyzed. Ages ranged from 8 to 87 years with peaks at 21 to 25 and 61 to 65 years. Among patients, 16.3% reached a nadir at HB II, 41.9% at HB III, 5.4% at HB IV, 16.3% at HB V, and 20.1% at HB VI. The overall recovery rate was 73.2% to HB I function, 17.0% to HB II, and 9.8% to HB III. The chance of recovery to HB I decreased as the severity of paralysis increased (rs = -1.0, P < .0001). Mean time to recovery to HB I was 6 weeks. Greater degeneration on ENoG suggested worse recovery (rs = 0.62, P = .01). Patients with HB V and VI were most likely to develop synkinesis. CONCLUSION: More severe paralysis increased the chance of recovery to HB II or III function. The granularity of this study provides prognostic insights that may inform the counseling of patients with Bell's palsy with respect to prognosis and recovery timeline.

COVID-19 Airway Management Isolation Chamber.

OBJECTIVE: During the coronavirus pandemic (COVID-19), health care workers are innovating patient care and safety measures. Unfortunately, many of these are not properly tested for efficacy. The objective of this study was to determine the efficacy of the novel COVID-19 Airway Management Isolation Chamber (CAMIC) to contain and evacuate particulate. STUDY DESIGN: Multi-institutional proof-of-concept study. SETTING: Two academic institutions: Walter Reed National Military Medical Center (WRNMMC) and Madigan Army Medical Center (MAMC). SUBJECTS AND METHODS: Smoke, saline nebulizer, and simulated working port models were developed to assess the efficacy of the CAMIC to contain and remove ultrafine particles. Particulate counts were collected at set time intervals inside and outside the system. RESULTS: With the CAMIC on, smoke particulate counts inside the chamber significantly decreased over time: r(18) = -0.88, P < .001, WRNMMC; r(18) = -0.91, P < .001, MAMC. Similarly, saline nebulizer particulate counts inside the chamber significantly decreased over time: r(23) = -0.82, P < .001, WRNMMC; r(23) = -0.70, P < .001, MAMC. In the working port model, particulate counts inside the chamber significantly decreased over time: r(23) = -0.95, P < .001, WRNMMC; r(23) = -0.85, P < .001, MAMC. No significant leak was detected in the smoke, saline nebulizer, or working port model when the CAMIC was turned on. CONCLUSIONS: The CAMIC system appears to provide a barrier that actively removes particles from within the chamber and limits egress. Further studies are necessary to determine clinical applicability. The CAMIC may serve as an adjunct to improve health care worker safety and patient outcomes.

Atresiaplasty in Congenital Aural Atresia: What the Facial Plastic Surgeon Needs to Know.

Patients with microtia and congenital aural atresia should have a comprehensive hearing assessment early in life. Options for hearing habilitation should be presented, and children with bilateral aural atresia should be fitted with a bone conducting hearing device to support normal speech and language development. If atresia surgery is pursued, the microtia surgeon must be aware of certain principles. This article presents recommendations on options for potentially improving hearing in children with congenital aural atresia: assessing surgical candidacy; chronology and timing of surgeries; functional importance of certain ear structures; and understanding the possible locations of an aberrant facial nerve to avoid injury in these patients.

Music Appreciation after Cochlear Implantation in Adult Patients: A Systematic Review.

Objective The cochlear implant (CI) improves quality of life for people who are severely and profoundly deafened, allowing implantees to perceive speech at levels similar to those of individuals with normal hearing. However, patients with CIs generally report a reduced appreciation of music after implantation. We aimed to systematically review the English-language literature for studies evaluating music enjoyment and perception among adult patients with CIs. Data Sources A systematic review of PubMed/MEDLINE, Scopus, Embase, and the Cochrane Library. Review Methods The PRISMA statement was utilized to identify English-language studies reporting music appreciation among adults with CIs. Two independent reviewers performed searches through May 2017. Included studies investigated parameters related to music enjoyment and music perception, including (1) pitch and timbre perception, (2) noise-canceling algorithms, and (3) the presence of dissonant chords, lyrics, or visual cues. Results A total of 508 articles were screened for relevance. Forty-one full-text articles were evaluated, and 18 met final inclusion criteria. Studies used heterogeneous methods of outcome measurement for identifying music appreciation. The outcome measures suggest that rhythm and lyrics are important components of enjoyment. Patients with CIs had difficulty with pitch and timbre perception. Conclusion The heterogeneous outcome measures identified in this systematic review suggest that rhythm and lyrics are important components of enjoyment, while patients with CIs had difficulty with pitch and timbre perception. Because there is no standardized reporting metric for music appreciation among adult patients with CIs, a standardized validated outcome-measuring tool is warranted.

Case Report: Facial Nerve Bifurcation Noted During Resection of Vestibular Schwannoma.

BACKGROUND AND IMPORTANCE: Resection of cerebellopontine angle tumors is challenging because the proximity of the facial nerve puts it at risk of inadvertent injury and subsequent dysfunction. It is critical to consider variations in anatomy and be aware of the potential deviations in the course of the nerve in order to avoid damage. CLINICAL PRESENTATION: We present a case of a facial nerve bifurcation identified during resection of a vestibular schwannoma. CONCLUSION: This is the only reported case of proximal facial nerve bifurcation. We review what is known about variations in proximal facial nerve anatomy, the rates of facial nerve injury after schwannoma resection, and the importance of neuromonitoring in identifying the nerve and predicting function postoperatively. Ultimately, understanding possible anatomic variations in the nerve is critical to minimize iatrogenic injury during surgery.

Medical Malpractice Implications of Clinical Practice Guidelines.

Clinical practice guidelines aim to improve medical care by clarifying and making useful recommendations to providers. Although providers should account for patients' unique characteristics when determining a treatment plan, it is generally perceived as good practice to follow guidelines when applicable. This is of interest in malpractice litigation, where it is essential to establish a standard of care to evaluate the performances of providers. Although the opinions of expert witnesses are used to determine standards of care, guidelines are expected to play a leading role. Guidelines alone should not establish a legal standard but may help inform this discussion in the courtroom. Therefore, it is incumbent that excellent, practical, and timely guidelines are continually created and updated in a transparent way. These guidelines must be very clear and underscore the various strengths of recommendation based on the quality of available evidence.

Use of Positive Airway Pressure Following Middle Ear Surgery: A Practice Survey of Otologists.

BACKGROUND: Positive airway pressure (PAP) devices are used as treatment for obstructive sleep apnea (OSA). PAP may increase middle ear pressure which is of interest to otologic surgeons. There is a lack of data to guide management of PAP therapy after middle ear surgery. OBJECTIVE: To elucidate how otologic surgeons manage PAP in their patients after ear surgery. STUDY DESIGN: A survey e-mailed to practicing members of the American Neurotology Society. RESULTS: Among 60 respondents, the most common recommendations to patients were to avoid PAP use for 1 week (40%), return to normal use immediately (23.3%), avoid PAP for 1 month (13.3%), or avoid PAP for 1 day (13.3%) after surgery. Twenty percent of providers reported that they change their advice on the basis of the PAP pressure settings (i.e., shorter hiatus for higher settings). Among respondents, 47% think that they have patients with middle ear issues because of PAP and 13% attributed surgical failures to PAP use. One-third of providers routinely pack the Eustachian tube during surgery. Providers who attributed a negative surgical outcome to PAP use were more likely to routinely pack/plug the Eustachian tube during otologic surgery (p = 0.001). CONCLUSION: Treatment recommendations regarding postoperative PAP treatment for obstructive sleep apnea vary greatly among practicing otologists. Providers who think that an adverse outcome was attributed to PAP use were more likely to prophylactically plug the Eustachian tube during surgery. Future research will provide additional information which will allow a better understanding of the effect of PAP on the middle ear, especially after otologic surgery.

Rhinology and medical malpractice: An update of the medicolegal landscape of the last ten years.

OBJECTIVES/HYPOTHESIS: Malpractice claims pertaining to rhinological procedures are a potentially important source of information that could be used to minimize the risk of future litigation and improve patient care. STUDY DESIGN: A retrospective review of a publicly available database containing jury verdicts and settlements. METHODS: The LexisNexis Jury Verdicts and Settlements database was reviewed for all lawsuits and out-of-court adjudications related to the practice of rhinology. Data including patient demographics, type of surgery performed, plaintiff allegation, nature of injury, outcomes, and indemnities were collected and analyzed. RESULTS: Of 85 cases meeting inclusion criteria, 42 were decided by a jury and 43 were adjudicated out of court. Endoscopic sinus surgery was the most commonly litigated surgery. The plaintiff was favored when the eye was injured (P = 0.0196), but the defendant was favored when neuropsychological injuries (P = 0.0137) or recurrent/worsened symptoms (P = 0.0050) were cited. No difference was found when death or skull base injuries occurred. When lack of informed consent was an allegation, the defendant was favored (P = 0.0001). A payout was made in two-thirds of cases overall, but the defendant was favored in two-thirds of cases decided by a jury. Payments were significant for both out-of-court settlements ($1.3 million) and jury verdicts ($2 million). CONCLUSIONS: Endoscopic sinus surgery remains the most commonly litigated rhinology procedure and has the potential to result in large payouts. Meticulous dissection, recognition of complications, and documentation of informed consent remain paramount for providing optimal patient care.

Updates in medical malpractice: an otology perspective.

PURPOSE OF REVIEW: Most surgeons at some point are involved in a medical malpractice case. There has been an increase in the number of manuscripts that analyse malpractice databases and insurance claims, as well as commentaries on the current medicolegal climate recently. This manuscript broadly reviews articles of interest to all providers and then focuses on malpractice in otology. RECENT FINDINGS: Medical malpractice articles (particularly topics related to otologic surgery published within the last 1-2 years) were searched. The growing body of literature can be divided into the themes of general negligence, mitigating injuries and the use of clinical practice guidelines in the courtroom as guidance for expert witnesses. SUMMARY: Recent findings suggest that the frequency of malpractice claims may be decreasing. Hearing loss and facial nerve injury are the most common injuries associated with otologic surgery. These injuries can be costly when negligence is found. Clinic practice guidelines are slowly being used as evidence in the courtroom and there are established guidelines that an expert witness must follow should a surgeon be called to give testimony.

Endoscopic management of esophageal discontinuity.

BACKGROUND: The management of esophageal discontinuity remains challenging and often involves complex reconstructive surgeries. METHODS AND RESULTS: We describe a unique and successful treatment of esophageal discontinuity using a modification of the natural orifice translumenal surgery (NOTES) approach in a patient presenting with long-standing esophageal discontinuity resulting from an iatrogenic esophageal injury. CONCLUSION: This case provided an opportunity to affirm the efficacy of endoscopy for treating esophageal discontinuities to minimize the degree of morbidity and mortality normally associated with the surgical treatment of this type of injury. Our case reveals a novel and possibly more direct means of evaluating and treating esophageal injuries in which the degree of discontinuity and/or stenosis initially remains unknown.

The effect of tonsillectomy alone in adult obstructive sleep apnea.

OBJECTIVE: The purpose of this study was to determine the effect of tonsillectomy as a single procedure in the treatment of adult obstructive sleep apnea (OSA). STUDY DESIGN: Prospective multi-institutional study evaluating adults with tonsillar hypertrophy scheduled to undergo tonsillectomy as an isolated surgery. SETTING: Tertiary care medical centers within the US Department of Defense. SUBJECTS AND METHODS: Adult subjects with tonsillar hypertrophy who were already scheduled for tonsillectomy were enrolled from October 2010 to July 2013. Subjects underwent physical examination, Epworth Sleepiness Scale, Berlin Questionnaire, and polysomnogram before surgery and after. Collected data included demographics, questionnaire scores, apnea-hypopnea index (AHI), and lowest saturation of oxygen. RESULTS: A total of 202 consecutive subjects undergoing tonsillectomy were enrolled. The final analysis included 19 subjects testing positive for OSA. The mean age was 27.9 years; mean body mass index, 29.6; median tonsil size, 3; and most frequent Friedman stage, 1. The AHI before surgery ranged from 5.4 to 56.4 events per hour. The mean AHI decreased from 18.0 to 3.2 events per hour after surgery, a reduction of 82%. The responder rate--with subjects achieving at least a 50% reduction of AHI to a value <15--was 94.7%. Following tonsillectomy, there were statistically significant reductions in median lowest saturation of oxygen level and Epworth Sleepiness Scale and Berlin scores. CONCLUSIONS: Adult tonsillectomy alone has beneficial effect in OSA management, particularly in young overweight men with large tonsils, moderate OSA, and low Friedman stage.

Medication associated with hearing loss: 25 years of medical malpractice cases in the United States.

OBJECTIVES: Many medications have the potential for ototoxicity. To potentiate management of this risk, this study examines malpractice litigation trends of lawsuits involving hearing loss associated with medication use. As experts in hearing loss, it may benefit otolaryngologists to be familiar with this information. STUDY DESIGN: Retrospective review. SETTING: All US civil trials. SUBJECTS AND METHODS: Court records of legal trials from 1987 to 2012 were obtained from 2 major computerized databases. Data were compiled on the demographics of the defendant and plaintiff, use of otolaryngologists as expert witnesses, medication used, legal allegations, verdicts, and judgments. RESULTS: Forty-six unique cases met inclusion criteria and were selected for review. Antibiotics (72%), specifically aminoglycosides (47%), were the most common medications cited as causing hearing loss. Eleven (22%) cases were resolved through a settlement before a verdict was reached. Verdicts in favor of the plaintiffs (37%) were awarded an average of $1,134,242. Pediatric patients were more likely to have outcomes in their favor (P = .03) compared to adults. Of the cases found in favor of the plaintiff, the most common reasons cited were inappropriate medication, dose, or duration (59%); failure to properly monitor (39%); and failure to choose a less toxic medication (18%). CONCLUSIONS: Physicians must be aware of the potential effects of the medications they prescribe. An understanding of potential drug interactions, proper monitoring, and appropriate substitution with less toxic medications are important to improve patient care. Analyzing litigation trends may be used to prevent future lawsuits and improve physician awareness.