Increased Risk of Litigation Associated With Laser Surgery by Nonphysician Operators

Importance  Controversy exists regarding the role of nonphysicians performing laser surgery and the increased risk of injury associated with this practice.

Objective  To identify the incidence of medical professional liability claims stemming from cutaneous laser surgery performed by nonphysician operators (NPOs).

Design, Setting, and Participants  Search of an online national database of public legal documents involving laser surgery by NPOs.

Exposure  Laser surgery by nonphysicians.

Main Outcomes and Measures  Frequency and nature of cases, including year of litigation, certification of provider and operator, type of procedure performed, clinical setting of injury, and cause of legal action.

Results  From January 1999, to December 2012, we identified 175 cases related to injury secondary to cutaneous laser surgery. Of these, 75 (42.9%) were cases involving an NPO. From 2008 to 2011, the percentage of cases with NPOs increased from 36.3% to 77.8%. Laser hair removal was the most commonly performed procedure. Despite the fact that approximately only one-third of laser hair removal procedures are performed by NPOs, 75.5% of hair removal lawsuits from 2004 to 2012 were performed by NPOs. From 2008 to 2012, this number increased to 85.7%. Most cases (64.0%) by NPOs were performed outside of a traditional medical setting.

Conclusions and Relevance  Claims related to cutaneous laser surgery by NPOs, particularly outside of a traditional medical setting, are increasing. Physicians and other laser operators should be aware of their state laws, especially in regard to physician supervision of NPOs.

Cutaneous laser surgery remains one of the most popular elective procedures performed in the United States. Among dermatologic surgeons alone in 2011, more than 1.6 million laser treatments were performed.¹ Many more procedures were performed by physicians in other specialties and by nonphysician operators (NPOs). As the numbers of these procedures increase, a concomitant growth has occurred in laser injury–related litigation.² The practice of delegation to NPOs has accompanied the burgeoning trend toward greater availability of laser surgery and is hypothesized to be in part responsible for the increase in injury and litigation.³ Moreover, the past decade saw the massive expansion of the so-called medical spas, nonmedical facilities offering aesthetic and cosmetic procedures.⁴ Many of these facilities are owned by or retained by physicians; however, most of the procedures are performed by NPOs of varying certifications as permitted by state regulation. The degree of supervision varies among states, and often the physician supervisor is not required to be on the premises at the time of rendering of services.⁵

Many physicians are increasingly using physician extenders (PEs) within their practice to meet rising demand and falling reimbursements. Among dermatologists, almost 30% reported using a PE within their practice, a 40% increase over the preceding 5 years.⁶ Although no data have emerged regarding increased litigation associated with this practice, legal precedence and numerous investigations are clear on liability.⁷ When a physician delegates duties to a PE, responsibility and liability remain squarely on the supervising physician provided that the services rendered fall within the scope of duty of the PE. This holds true for physician supervision of NPOs in the setting of cutaneous laser surgery.²

Despite these trends and clear inconsistencies in state regulations, no study to date has quantified the effect of these practices on medical professional liability claims with regard to cutaneous laser surgery. The objective of this study was to expand on previously published findings in an effort to identify high-risk practices that result in litigation. In addition, the study examines the incidence of litigation related to the performance of laser surgery by NPOs.

We searched the legal research resource WestlawNext (http://westlaw.com) using various keywords as previously reported.² This database is a primary source used by attorneys to gather legal information and is available by subscription to the public. Documents within this database are in the public record. The study was exempt from review, as determined by the institutional review board at Massachusetts General Hospital. An updated search yielded one additional case, bringing the total number of claims concerning injury resulting from cutaneous laser surgery to 175. Of these 175 cases, 75 of the procedures were performed by NPOs. For this study, an NPO is defined as a non-MD, non-DO provider. Because of the nature of the documents within the database, it is difficult to ascertain the exact certification of the NPOs. In an effort to be accurate, various allied health professionals comprised the NPO category. This included operators described as a registered nurse or a nurse practitioner, as well as terms such as technician, aesthetician, assistant, and intern. In addition to previously acquired data, the setting where services were rendered was recorded.

Of 175 cases identified, the first occurrence of an NPO was in 1999. From January 1999, to December 2012, a total of 75 cases with NPOs were identified. This represents 42.9% of the total cases during the same time frame. Stratification of laser operator by year of litigation revealed a striking trend. From 2004 to 2012, a trend was observed toward an increased proportion of lawsuits stemming from cutaneous laser surgery performed by NPOs. This trend is most notable from 2008 to 2011, our most recent data, during which time the percentage of cases involving an NPO increased from 36.3% to 77.8%. Of the 2 cases in 2012, both were performed by an NPO. These results are summarized in the Figure.

In line with our previously published data,² the most commonly performed procedure (n = 40) from 2004 to 2012 that resulted in injury and litigation by an NPO involved laser hair removal. Rejuvenation, composed mainly of intense pulsed light treatments, was the second most commonly litigated procedure (n = 7). Among the NPO cases, a notable trend is evident: when expressing the number of NPO cases as a percentage of the total number of cases for the same procedure, 75.5% of laser hair removal lawsuits from 2004 to 2012 were performed by an NPO. This number is even more dramatic in the years 2008 to 2012, when 85.7% of all laser hair removal lawsuits were performed by an NPO. From 2010 to 2012, a total of 90.0% (18 of 20) of laser hair removal cases were performed by an NPO. The remainder of the litigated procedures by NPOs and the proportion of total cases are given in Table 1.

From 1999 to 2012, a total of 64.0% (n = 48) of the NPO cases arose in a nonmedical practice setting. These include medical spas and other nonmedical facilities offering cosmetic services (eg, salons, spas, etc). In 2008 to 2011, NPO procedures performed in medical spas represented almost 80% of lawsuits. Of the 2 cases in 2012, one was performed in a medical spa setting and the other in a physician office. When looking at the type of procedure performed in this setting, most of these cases were laser hair removal procedures. From 2008 to 2012, a total of 68.6% (n = 24) of laser hair removal litigation cases involved an NPO in a medical spa setting. These results are summarized in Table 2.

Not surprisingly, the injuries sustained following laser surgery by NPOs and the causes of action in these cases mirror those previously reported by our group.² However, the specific allegations in these cases offer insight into various liabilities imposed on physician supervisors.

It is necessary to first examine the 2 different forms of liability (direct and vicarious) that a physician could face arising from allegedly improper laser treatment. A physician is directly liable for any negligence that can be attributed to an individual capacity (ie, the personal failure to perform his or her duties at the requisite standard of care). A physician’s duties often extend beyond the laser procedure; for instance, a physician may be directly liable for any negligent hiring, supervision, or training and so forth.

Conversely, a physician is vicariously liable for the negligence of his or her employees. A physician’s vicarious liability is rooted in the doctrine of respondeat superior (Latin for “let the master answer”). This common law doctrine is often used to hold the employer responsible for the actions of his or her employees if and when the employee is acting within the scope of his or her employment. The rationale underpinning the application of vicarious liability to an employer is 2-fold. First, an employer has the ability and duty to control his or her employees. Second, presumably an employee is performing duties that will result in a benefit to the employer and in so doing is acting under the direction or authority of the employer. Therefore, in a medical malpractice context, a physician can be vicariously liable for the negligence of his or her subordinates, including nurses, NPOs, and other staff.

Almost all of the malpractice cases arising from the negligence of NPOs are coupled with vicarious liability claims against the employer, often a medical spa but at times a physician owner. Notably, 25 of 58 cases (43.1%) with NPOs from 2004 to 2012 represented instances in which no direct physician supervisor was identified. In these cases, the facility was often named as the defendant. As for a physician’s direct liability in NPO cases, by far the most common specific allegation (n = 27) was failure to supervise the delegate. Failure to supervise represents the physician’s failure to properly oversee the procedure. Failure to train and hire appropriate staff was the second most common specific allegation (n = 23). In addition to these allegations, negligent entrustment (n = 2) was alleged against the physician employers in their individual capacity. Negligent entrustment arises when one party (the entrustor) is held liable for providing another individual (the entrustee) with a potentially dangerous instrument. In this context, a physician can be held liable for providing an NPO with a laser if this instrument is used for a procedure that results in injury to a patient. The physician liability is predicated on the fact that a reasonable person in like circumstances would not have entrusted the NPO with the equipment. A summary of specific allegations (where available) relating to injury sustained as a result of laser surgery by NPOs from 1999 to 2012 includes the following: failure to properly hire, train, or supervise staff (n = 27); failure to properly perform treatment or operate a laser (n = 23); failure to conduct a test spot (n = 10); lack of a license to perform a procedure (n = 6); failure to recognize or treat an injury (n = 5); and negligent entrustment (n = 2). As can be seen from the foregoing definitions, a physician’s direct liability is predicated on his or her negligence, not the negligence of his or her employee or agent.

Physician delegation of laser surgery has grown significantly during the past decade. In addition, nonphysician-supervised NPO laser surgery is being performed legally in many states at nonmedical facilities. Data on the safety of NPO performance of cutaneous laser surgery are lacking in the medical literature. Most important, a clear trend demonstrates a dramatic increase in the number of lawsuits associated with NPO performance of laser surgery. The NPOs comprise a vast diversity of operators, including nurse practitioners, registered nurses, medical assistants, electrologists, and aestheticians, among others. In 2011, the latest year with a presumed complete data set, 77.8% of the cases involved an NPO. In addition, of the cases with NPOs, almost two-thirds occurred outside of a traditional medical practice. From an examination of the specific allegations available in this study, the following 2 themes emerged: (1) both vicarious and direct liability of the supervising physician and (2) the prevalence of nonmedical personnel failing to perform procedures commensurate with the standard of care, including recognizing and treating complications.

We propose that the overall trend in increased litigation for laser surgery is in part explained by greater numbers of NPOs performing these procedures, in particular those practicing without direct supervision in the medical spas. This is the first study to date to offer such quantitative evidence. Of the procedures performed, laser hair removal accounted for most of these cases. Indeed, laser hair removal is the most frequently performed laser procedure in the United States.⁸ However, if one takes into account the number of procedures performed by operators (physician vs NPO), the data become even more compelling. Only one-third of laser hair removal procedures in 2012 were performed by an NPO; the remaining two-thirds were performed by physicians.⁸ Despite the fact that physicians perform most laser hair removal, 85.7% of laser hair removal lawsuits in our study from 2008 to 2012 are cases involving an NPO. In 2011, a remarkable 90.9%% (10 of 11) of laser hair removal litigation was against NPOs. One way to interpret these data is that some increased inherent risk of injury exists with an NPO.

The inconsistency and ambiguity of the state laws exemplify the lack of uniformity of the practice of delegation. For example, in Maine only a physician may operate a laser for hair removal. At the other end of the spectrum, Nevada as of June 2011 had no regulations regarding the use of a laser. In addition to the ability to delegate these procedures is the degree of supervision required. Some state statutes are explicit in stating the need for a written protocol, the requirement to appropriately train and document the training of personnel, and the necessity for adequate supervision. Many physicians “lend” their medical license to these facilities without meeting the legal requirements for supervision. In line with this, California recently passed a bill (California Assembly Bill 1548, Chapter 140) that increases penalties for illegally owning and operating a medical spa, with fines up to $50 000 and a maximum of 2 to 5 years in state prison. The lack of overarching federal law makes it difficult to uniformly require qualifications of personnel allowed to render laser treatments. Despite appropriate certification, regulations regarding appropriate training are ambiguous and are subject to interpretation. Because laws and regulations are constantly evolving, it is imperative for physicians who use PEs to be up to date. Current guidelines can be found at state medical board and state legislature websites.

In the correct setting, with close on-site supervision and appropriate training, the use of NPOs can prove to be a fruitful, productive, and safe environment for patients. Perhaps a larger issue is the role of NPOs, as well as physicians without adequate training, in the operation of a laser. Technology related to laser surgery has evolved rapidly since the description of selective photothermolysis by Anderson and Parrish⁹ in 1983. Despite the propagation of nonmedical facilities performing these procedures, the tremendous amount of physics and medicine related to cutaneous surgery should not be overlooked. The American Society for Dermatologic Surgery Association position promulgates the use of energy devices capable of altering or damaging living tissue to physicians who are “trained appropriately in the physics, safety, and surgical techniques involved in the use of energy devices capable of damaging living tissue prior to performing procedures using such devices.”¹⁰ Moreover, in the setting of delegation, a physician “should be fully qualified by residency training and preceptorship or appropriate course work prior to delegating procedures to licensed allied health professionals and should directly supervise the procedures. The supervising physician shall be physically present on-site, immediately available, and able to respond promptly to any question or problem that may occur while the procedure is being performed.”¹⁰ Finally, the position statement underscores the need for “appropriate documented training in the physics, safety, and surgical techniques of each system. The licensed allied health professional should also be appropriately trained by the delegating physician in cutaneous medicine, the indications for such surgical procedures, and the pre- and post-operative care involved in treatment.”¹⁰

Several limitations are inherent in conducting research using a legal database. First, although it is a massive data bank, only one legal database was searched. Cases within the database are those in which some form of legal action was taken and exclude complaints handled outside of the judicial system (ie, third-party arbitration through a malpractice carrier). This is likely to have excluded many frivolous claims with little merit. Second, the query was a retrospective review and was limited by the search terms selected; it is likely that some decisions exist that did not contain the searched terms. Third, these legal pleadings are layman documents (ie, not medical records), and the veracity of the facts was assumed to be true. Furthermore, layman terms may have eluded a database search for the purposes of this study. Fourth, because of the limited number of cases with NPOs for certain procedures, it is difficult to interpret the trends for less commonly performed surgery. Nonetheless, the actual data likely understate the true incidence of NPO laser complications. Generally, plaintiffs’ attorneys do not pursue litigation against uninsured operators. Unlike physicians, NPOs (especially in a nonmedical office setting) are less likely to possess liability insurance that can satisfy a potential malpractice or other legal judgment.

A dramatic increase in litigation has been filed against NPOs performing cutaneous laser procedures in medical and nonmedical office settings. This has important implications for the safety of patients undergoing these procedures. When a physician delegates duties to a PE, responsibility and liability remain squarely on the supervising physician provided that the services rendered fall within the scope of duty of the PE. This holds true for physicians supervising NPOs in the setting of cutaneous laser surgery. Given the increase in NPO laser surgery procedures and a parallel trend in greater frequency of lawsuits, further studies are needed to examine this troubling trend in laser safety.

Accepted for Publication: July 21, 2013.

Corresponding Author: H. Ray Jalian, MD, Division of Dermatology, University of California, Los Angeles, 2020 Santa Monica Blvd, Ste 570, Santa Monica, CA 90404 (hjalian@partners.org).

Published Online: October 16, 2013. doi:10.1001/jamadermatol.2013.7117.

Author Contributions: Dr H. R. Jalian had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: H. R. Jalian, Avram.

Acquisition of data: H. R. Jalian, C. A. Jalian.

Analysis and interpretation of data: All authors.

Drafting of the manuscript: All authors.

Conflict of Interest Disclosures: Dr Avram serves as a member of the medical advisory board for Zeltiq Aesthetics, Inc, and of the scientific advisory board for Cytrellis Biosystems, Inc. He has served as a consultant for Unilever, Zeltiq Aesthetics, Inc, and Allergan within the past 12 months. No other disclosures were reported.