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The Importance of Informed Consent & its Role in the Outcome of Surgical Liability Cases

Leila J. Mady, PhD1 · Amad Choudhry1 · Peter F. Svider, MD2 · Asad Choudhry1 · Michael Setzen, MD, FACS3 · Soly Baredes, MD, FACS1 · Jean Anderson Eloy, MD, FACS1,4,5

[1] Department of Otolaryngology—Head and Neck Surgery, Rutgers New Jersey Medical School (NJMS), Newark, NJ · [2] Department of Otolaryngology—Head and Neck Surgery, Wayne State University School of Medicine, Detroit, MI · [3] Rhinology Section, North Shore University Hospital, Manhasset, NY · [4] Center for Skull Base and Pituitary Surgery, Neurological Institute of New Jersey, Rutgers NJMS, Newark, NJ · [5]

Department of Neurological Surgery, Rutgers NJMS, Newark, NJ

ABSTRACT Objective: Previous analyses have noted perceived deficits in informed consent (IC) in many otolaryngology malpractice lawsuits. However, no comprehensive analysis of IC in malpractice litigation across surgical specialties exists. Our objectives were to 1) examine IC in litigation across surgical specialties and 2) characterize factors in determining legal responsibility. Data Sources: Westlaw database. Methods: Using the Westlaw Database, 694 jury verdicts and settlement reports since 2010 involving defendants practicing general surgery, neurosurgery, ophthalmology, orthopedic surgery, otolaryngology, plastic surgery, and urology were examined for outcome, awards, procedure types, and alleged deficits in IC. Results: Of 694 cases, 67.0% of decisions favored physicians, 25.5% resulted in damages awarded, and 7.5% in out-of-court settlements. Although perceived IC deficits did not increase the likelihood of jury awards, a high number of cases (24%) identified IC as a factor. Plastic surgery (45.1%), ophthalmology (39.6%), and otolaryngology (27.8%) litigations were among the highest to identify IC deficits. Many cases in plastic surgery and ophthalmology with alleged deficits in IC involved elective procedures. In contrast, otolaryngology had a lower proportion of elective procedures in cases with alleged deficits in IC. Conclusion: Although perceived deficits in IC do not necessarily increase the likelihood of a negative outcome, it may play an important role in the initiation of malpractice litigation across surgical specialties. While otolaryngology had a relatively high rate of litigation involving IC deficits, it had a lower proportion of elective procedures in comparison to other surgical specialties in this analysis, suggesting elective interventions influence legal responsibility in a specialty-specific manner.

INTRODUCTION Malpractice litigation is among the primary factors involved in the dramatic rise of healthcare costs

and the resulting financial crisis affecting America’s healthcare industry. Litigation exerts its influence directly through costs such as legal defense payment, jury damages awarded, and out of court settlements (1). The often-substantial monetary awards given to plaintiffs in malpractice cases have forced nearly all physicians in America to have malpractice insurance. The cost of an average policy typically averages to $25,000 a year and certain surgical sub-specialties (particularly obstetrics/gynecology and neurosurgery) peaking at $100,000. Given this ever-increasing threat of litigation, studies have also shown an increase in the practice of defensive medicine, through which ancillary tests and treatments are acquired in order to protect the physician from perceived liability (2). Recent studies have shown the indirect and direct costs of medical malpractice litigation to total $55.6 billion annually equivalent to 2.4% of total healthcare spending (3).

An often-cited factor in pursuit of malpractice litigation by patients is negligence, by the physician,

of the patient’s right to informed consent (4-6). Informed consent, which aims to protect the autonomous choice of the patient, is traditionally defined in terms of two components: the disclosure of information on a procedure, leading to the patient's comprehension of this information; and authorization by the patient to proceed with treatment (7). Disclosure includes information on the nature of a procedure, potential risks and benefits, and alternative treatments. Numerous studies and the opinion of legal experts have shown negligence in securing proper informed consent to fuel malpractice suits. Several studies have shown defects in informed consent to be responsible for outcomes of cases in favor of the plaintiff in specialties such as plastic surgery, dermatology and dentistry (8-9). Informed consent is of particular importance in procedure-heavy, high-risk specialties, particularly surgical sub-specialties, where complications can manifest acutely and the patient is much more likely to understand whether such risks were explained in the recent time period preceding the procedure (10).

There has been no analysis performed on the role of perceived or actual negligence of informed

consent in outcomes of lawsuits in surgical sub-specialty fields. The primary objective of this analysis was to comprehensively examine malpractice litigation in multiple surgical subspecialties where informed consent was brought up as an issue to determine if it played an important factor in determining legal responsibility. Such information is critical in elucidating precautions that should be taken to limit liability and augment patient safety, particularly in high-risk specialties.

METHODS Used as a primary source by legal professionals, the Westlaw legal database (Thomson Reuters, New York, NY) is available by subscription to

the public and compiles information regarding legal cases, jury verdicts and summaries, and trial court documents. As such, the database contains no protected patient information and does not necessitate institutional review board (IRB) review. Westlaw accumulates cases from all publically available state and federal court records, which are obtained from commercial vendors that vary by jurisdiction. Due to the variety of commercial vendors, the comprehensiveness and details regarding compiled case information varies within the database. Jurisdictions predominantly acquire case jury verdict and settlement reports via mandated submissions from legal professionals, though a small proportion of records are attained through voluntary submissions by attorneys (8-10). To protect identifying information, legal parties involved in cases submitted by way of involuntary submissions are frequently categorized as “anonymous” or “confidential.” Though publically available records may not be available for litigation settled out of court, the Westlaw database amasses substantial case records and is an extensive resource for case law regarding medical malpractice (8-15).

A search of federal and state court records was performed by 2 authors (A.C, L.J.M) for jury verdict and settlement reports related to

medical malpractice and selected surgical specialties including general surgery, neurosurgery, ophthalmology, orthopedic surgery, otolaryngology, plastic surgery, and urology. Specific search-terms included medical malpractice, urology, urologist, neurosurgery, neurosurgeon, otolaryngology, otolaryngologist, ear nose throat, ophthalmology, ophthalmologist, plastic surgery, plastic surgeon, general surgery, general surgeon, orthopedic surgery, orthopedic surgeon, orthopaedic surgery, and orthopaedic surgeon. Queries were not limited by state but were restricted to dates ranging January 2010 to December 2012 for respective surgical specialties.

The search yielded 753 results that were independently reviewed for applicability and completeness. Of the 753 initial results, 59 cases

were deemed as duplicate or non-relevant and thereby excluded. The remaining 694 jury verdict and settlement reports were included for analysis and examined for year of action, geographic location of action, procedure performed, allegations of injury, cause of litigation, verdict, and indemnity payments. Emergent procedures in which delaying immediate surgical intervention could adversely affect patient outcome were classified as non-elective. Surgical emergencies for each specialty included: vascular compromise, ischemic bowel, acute/perforated appendicitis, peritonitis, trauma-related surgery (general surgery); intracranial hemorrhage, increased intracranial hemorrhage (neurosurgery); pediatric blindness, increased intracranial hemorrhage (ophthalmology); vascular compromise (orthopedic surgery); compromised airway, ear infection, acute infection (otolaryngology); inadequate tissue coverage (plastic surgery); testicular torsion, septic shock (urology).

All data was collected in December 2012. Nonparametric statistical analysis was conducted using Fisher’s exact test for comparison of

categorical data and Mann-Whitney U test was used for evaluation of continuous variables (InStat; GraphPad Software, Inc, La Jolla, CA). Statistical significance was set at p < 0.05.

References 1. Seabury, S., et al., Defense costs of medical malpractice claims. N Engl J Med, 2012. 366(14): p. 1354-6. 2. Studdert, D.M., et al., Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA, 2005. 293(21): p. 2609-17. 3. Mello, M.M., et al., National costs of the medical liability system. Health Aff (Millwood), 2010. 29(9): p. 1569-77. 4. Bismark, M.M., et al. Legal disputes over informed consent for cosmetic procedures: a descriptive study of negligence claims and complaints in Australia. J Plast Reconstr Aesthet Surg, 2012. 65(11): 1506-12. 5. Gogos, A.J., et al., When informed consent goes poorly: a descriptive study of medical negligence claims and patient complaints. Med J Aust, 2011. 195(6): p. 340-4. 6. Berlin, L., Malpractice issues in radiology. Informed consent. AJR Am J Roentgenol, 1997. 169(1): p. 15-8. 7. Heywood, R., A. Macaskill, and K. Williams, Informed consent in hospital practice: health professionals' perspectives and legal reflections. Med Law Rev, 2010. 18(2): p. 152-84. 8. Lopez-Nicolas, M., et al., Informed consent in dental malpractice claims. A retrospective study. Int Dent J, 2007. 57(3): p. 168-72. 9. Goldberg, D.J., Legal issues in dermatology: informed consent, complications and medical malpractice. Semin Cutan Med Surg, 2007. 26(1): p. 2-5. 10. DeVille, K., D. Goldberg, and G. Hassler, Malpractice risk according to physician specialty. N Engl J Med, 2011. 365(20): p. 1939; author reply 1940.

RESULTS

Jean Anderson Eloy, MD, FACS Associate Professor and Vice Chairman

Director, Rhinology and Sinus Surgery Co-Director, Endoscopic Skull Base Surgery Program

Department of Otolaryngology – Head and Neck Surgery Rutgers New Jersey Medical School

90 Bergen Street., Suite 8100 Newark, NJ 07103

jean.anderson.eloy@gmail.com

Figure 1. Search methodology for specialty specific malpractice jury verdicts using the Westlaw database (Thomson Reuters, New York, NY). Search conducted in December 2012.

Figure 2. Frequency of cases by the year of jury verdict or settlement within each surgical specialty.

Figure 3A. Geographic distribution by state of all surgical specialty malpractice cases. Figure 3B. Geographic distribution by state of otolaryngology specific malpractice cases.

Figure 5A. Disposition of malpractice cases by surgical specialty. Figure 5B. Specialty specific proportion of cases claiming alleged deficits in informed consent.

Figure 4A. Disposition of overall surgical specialty malpractice cases.

Figure 4B. Proportion of overall cases claiming alleged deficits in informed consent.

Figure 6. Specialty specific disposition of cases claiming alleged deficits in informed consent. Comparison of categorical data was conducted using Fisher’s exact test with statistical significance p <0.05.