Allegations of Failure to Obtain Informed Consent in Otolaryngology: Evidenced-Based Recommendations for Sinus Surgeons

Abstract

Background

Informed consent requires preoperative discussion of surgical risks, complications, and alternative treatment options. Allegations of incomplete informed consent are common in the field of otolaryngology.

Objectives

Analyze outcomes and case variables in cases of alleged informed consent failure involving otolaryngologists.

Methods

A legal research database containing state and federal case records from across the United States was retrospectively reviewed for malpractice claims involving informed consent and otolaryngology.

Results

Among the 128 informed consent cases identified, 72.6% resulted in favorable verdicts for otolaryngologists. Functional endoscopic sinus surgery (FESS) was the most common source of informed consent litigation in the field of otolaryngology, with an incidence four-fold higher than the next most litigated procedure of uvulopalatopharyngoplasty (21.9% vs 5.4%). The top four factors cited in FESS-related cases were CSF leak (10), inadequate discussion of alternative therapies (4), diplopia (3), and meningitis (3). Cases resulting in a transient injury were significantly less likely to result in a payment from a plaintiff verdict or settlement (9.1%) as compared to payment-rates among cases involving permanent complications (34.6%) (p = 0.005).

Conclusions

Failure to obtain informed consent is an important factor in medical malpractice litigation. This report identifies specific, actionable recommendations aimed at protecting sinus surgeons from liability and ensuring that patients are better informed.

Keywords

medical malpractice otolaryngology informed consent: functional endoscopic sinus surgery westlaw

Get full access to this article

View all access options for this article.

References

Baker

. Informed consent: obligation or opportunity [comment]? J Health Hospital Law. 1993;26:214–215.

Spatz

Krumholz

Moulton

. The new era of informed consent: getting to a reasonable-patient standard through shared decision making. JAMA. 2016 May 17;315(19):2063–2064. doi: 10.1001/jama.2016.3070

Naunheim

Randolph

Shin

. Evidence-based medicine in otolaryngology part XII: assessing patient preferences. Otolaryngol–Head Neck Surg. 2021;164(3):473–481. doi:10.1177/0194599820950723

Main

McNair

Blazeby

. Informed consent and the reasonable-patient standard. JAMA. 2016;316(9):992–993. doi:10.1001/jama.2016.10555

Burns

Keogh

Timon

. Informed consent: a patients’ perspective. J Laryngol Otol. 2005;119(1):19–22. doi:10.1258/0022215053222860

Hall

Prochazka

Fink

. Informed consent for clinical treatment. CMAJ. 2012 Mar 20;184(5):533–540. doi: 10.1503/cmaj.112120. Epub 2012 Mar 5. PMID: 22392947; PMCID: PMC3307558.

Seabury

Chandra

Lakdawalla

Jena

. On average, physicians spend nearly 11% of their 40-year careers with an open, unresolved malpractice claim. Health Aff (Millwood). 2013;32:111–119.

Annas

. Doctors, patients, and lawyers—two centuries of health law. N Engl J Med. 2012;367:445–450.

Mehlman

. The shame of medical malpractice. J Leg Med. 2006;27:17–32.

10.

Svider

Keeley

Zumba

Mauro

Setzen

Eloy

. From the operating room to the courtroom: a comprehensive characterization of litigation related to facial plastic surgery procedures. Laryngoscope. 2013;123:1849–1853.

11.

General Accounting Office. Medical Liability: Impact on Hospital and Physician Costs Extends Beyond Insurance. General Accounting Office; 1995.

12.

Anderson

Hussey

Frogner

Waters

. Health spending in the United States and the rest of the industrialized world. Health Aff (Millwood). 2005;24:903–914.

13.

Brooks

Menachemi

Hughes

Clawson

. Impact of the medical professional liability insurance crisis on access to care in Florida. Arch Intern Med. 2004;164:2217–2222.

14.

Mello

Kachalia

Goodell

. Medical malpractice—April 2011 update. Synth Proj Res Synth Rep. 2011;21(suppl 1):72097.

15.

Studdert

Mello

Brennan

. Medical malpractice. N Engl J Med. 2004;350:283–292.

16.

Studdert

Mello

Gawande

, et al. Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med. 2006;354(19):2024–2033.

17.

Moffett

Moore

. The standard of care: legal history and definitions: the bad and good news. West J Emerg Med. 2011;12:109–112.

18.

Nash

Leach

Poetker

. Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011;144:10–15.

19.

Reilly

Horn

Sewell

. Hearing loss resulting in malpractice litigation: what physicians need to know. Laryngoscope. 2013;123:112–117.

20.

Kovalerchik

Mady

Svider

, et al. Physician accountability in iatrogenic cerebrospinal fluid leak litigation [published online March 27, 2013]. Int Forum Allergy Rhinol. 2013;3(9), 722–725. doi: 10.1002/alr.21169

21.

Jena

Seabury

Lakdawalla

Chandra

. Malpractice risk according to physician specialty. N Engl J Med. 2011;365(7):629–636.

22.

Studdert

Bismark

Mello

Singh

Spittal

. Prevalence and characteristics of physicians prone to malpractice claims. N Engl J Med. 2016;374(4):354–362.

23.

Svider

Kovalerchik

Mauro

Baredes

Eloy

. Legal liability in iatrogenic orbital injury. Laryngoscope. 2013;123:2099–2103.

24.

Svider

Sunaryo

Keeley

Kovalerchik

Mauro

Eloy

. Characterizing liability for cranial nerve injuries: a detailed analysis of 209 malpractice trials. Laryngoscope. 2013;123:1156–1162.

25.

Ong

Kelly

Castillo

Carr

Sherris

. Characterization of medical malpractice litigation after rhinoplasty in the United States. Aesthet Surg J. 2021;41(10):1132–1138. doi:10.1093/asj/sjaa380

26.

Fink

Prochazka

Henderson

, et al. Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial. Ann Surg. 2010;252(1):27–36.

27.

Lynn-Macrae

Emani

Kern

Conley

. Medicolegal analysis of injury during endoscopic sinus surgery. Laryngoscope. 2004;114:1492–1495.

28.

Wolf

Malekzadeh

Berry

O'Malley

Jr . Informed consent in functional endoscopic sinus surgery. Laryngoscope. 2002;112(5):774–778.

29.

Mady

Choudhry

Svider

, et al. The importance of informed consent and its role in the outcome of surgical liability cases. Otolaryngol–Head Neck Surg. 2013;149(2_suppl):P152–P153. doi:10.1177/0194599813496044a34

30.

Svider

Husain

Kovalerchik

, et al. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Am J Otolaryngol. 2013;34(6):699–705. doi:10.1016/j.amjoto.2012.12.005

31.

Bowden

Church

Chiu

Vaughan

. Informed consent in functional endoscopic sinus surgery: the patient’s perspective. Otolaryngol Head Neck Surg. 2004;131(1):126–132. doi:10.1016/j.otohns.2004.02.027

32.

Magliulo

Romeo

Gioacchini

Pasquini

. Risks and medico-legal aspects of endoscopic sinus surgery: a review. Eur Arch Otorhinolaryngol. 2014;271(8):2103–2117. doi:10.1007/s00405-013-2652-4

33.

Hosemann

Draf

. Danger points, complications and medico-legal aspects in endoscopic sinus surgery. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2013;12:Doc06. Published 2013 Dec 13. doi:10.3205/cto000098

34.

Collins

. Going Solo: Otolaryngologists Share the Benefits and Challenges of Private Practice. ENTtoday. 2021. Available at: https://www.enttoday.org/article/going-solo-otolaryngologists-share-the-benefits-and-challenges-of-private-practice/#:∼:text = As%20two%2Dthirds%20of%20residents,’t%20attract%20young%20doctors.%E2%80%9D.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.02 MB