Nonphysician operators (NPOs) using laser and energy-based devices are accounting for an increasing share of malpractice lawsuits in dermatology, and when they use these devices in a dermatologic practice or a dermatologist-owned medical spa, the dermatologist can be on the hook for liability. Dermatologists can protect themselves by understanding malpractice trends and taking preventive steps, such as making sure NPOs have appropriate training and using a rigorous informed consent process, according to a dermatology resident and a dermatologist who have researched recent trends in dermatology lawsuits.
"It's really important that physicians recognize their responsibility when delegating procedures to nonphysician operators and the physician's role in supervision of these procedures," Scott Stratman, MD, MPH, a dermatology resident at the Icahn School of Medicine at Mount Sinai, New York City, told this news organization. He led a study recently published in the Journal of the American Academy of Dermatology, which found that the majority (52%) of malpractice cases for cutaneous energy-based device procedures in the LexisNexis database from 1985 to September 2023 involved NPOs. The study did not break the data down between different types of NPOs.
Trends in Dermatology Malpractice
This follows a similar trend reported in a 2014 study led by Mathew Avram, MD, JD, director of the MGH Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston. The study analyzed liability claims related to cutaneous laser surgery performed by nonphysicians from January 1999 to December 2012.
"With nonphysician litigation data, we saw trend lines beginning in 2008 where the proportion of cases began to increase," Avram said at the American Society for Laser Medicine and Surgery (ASLMS) meeting on April 12, 2024. "Over a period of 2008-2012, it went from 36% of cases to about 78%," he said.
About a quarter (23.4%) of those were in medical offices; 76.6% were in nontraditional settings such as medical spas, he added. The proportion of NPOs was similar in a 2022 study that looked at causes of litigation in cutaneous laser surgery from 2012 to 2020, Avram said. Again, neither study broke down cases involving NPOs by specific type, but the 2014 study reported that 64% of cases by NPOs occurred outside of a traditional medical setting.
"So it seems that the location and potentially the supervision are issues that are important to patient safety," Avram said at the meeting. While state laws regarding laser delegation vary widely, "depending on where you practice, it's incumbent upon you to know that."
Avram and colleagues were also the authors of a study published in June in Dermatologic Surgery that looked at the reasons behind ligations involving dermatologists in a retrospective analysis of 48 state and federal cases between 2011 and 2022. The majority of cases — 54.2% — were for unexpected harm, followed by wrong or delayed diagnoses, which accounted for a third of litigations.
Stratman's study found that laser hair removal was the most common procedure for malpractice claims in dermatology among cutaneous energy-based device procedures. Complications from energy-based devices included burns, scarring, and pigmentation changes.
The growth of malpractice suits involving NPOs could be because NPOs are performing a greater proportion of dermatologic procedures, "particularly those practicing without direct supervision, such as in the context of a medical spa," Stratman said in the interview. "Again, this highlights a physician's responsibility in delegating these kinds of procedures to NPOs."
Training Is a Must — But Not Standardized
Comprehensive training for physicians, staff, NPOs, and physicians "is all necessary and paramount in order to diminish adverse outcomes and legal risk, and then, of course, all these practitioners, be it staff or [NPOs], and, of course, physicians, are all held to the same standard of care," Stratman said.
However, he added, "There is really no standardized training to operate these devices. That being said, it's really important to know that both providers and facility owners have a significant obligation to their patients to make sure that their staff in their centers are appropriately trained."
Training not only involves protocols and procedures but also how to handle patient interactions, Stratman said.
The legal concept of respondeat superior applies when nonphysicians participate in a patient's care, Avram said at the ASLMS meeting. The physician is held liable for a nonphysician's "negligence provided he or she is an employee receiving a salary [and] benefits and is performing within the scope of his or her duty," regardless of whether the physician saw the patient or not at that visit, he said. Again, supervision of nonphysician laser procedures varies from state to state, he added.
"So the take-home point is to provide excellent training and appropriate supervision, and if you're the owner of that practice, you are liable in the event of negligence even though you never were part of the treatment," Avram said.
Ins and Outs of Informed Consent
When a patient outcome is less than desirable, or at least less than what the patient expected, a transparent and thorough informed consent process can protect the practice and physician, Avram said at the meeting.
"Malpractice and consent have nothing to do with each other," he said. "Consent is getting permission to do a procedure. It's needed actually for any medical intervention that you perform. What you need to do is to provide information to enable the patient or guardian or to choose knowledgeably among reasonable medical alternatives. This places the patient in control of the course of their medical treatment."
The information conveyed to the patient should include the diagnosis, the medical causes, the nature and purpose of the treatment, and the risks and alternatives of procedure, "particularly if they're high risk," Avram said.
"Failure to obtain informed consent constitutes a civil battery, and the physician is liable for civil damages," he said. "The patient need only show that he or she was not informed of the medical nature of the medical touching; physical injury is not necessary," Avram said.
A battery could occur if a procedure extends beyond the scope or area of treatment the patient agreed to — for example, extending a liposuction to an area that wasn't originally targeted, or extending a laser procedure to an area of the body as a presumed favor to the patient. "It does not require a standard of care or an expert witness," Avram said. "One only needs to show nonconsensual touching."
Informed consents should include plain language, he said. "The whole idea is the patient understands what the risks and benefits are," Avram said. "You don't need to use medical jargon." As an example, he suggested using the term "blisters" instead of "bullae." If the treatment involves an off-label procedure, include that too, he said.
He also advised avoiding blanket authorizations. "Courts disfavor them," he noted. "They need more specificity. So those are not valid."
Stratman added that providers should think about the setting in which they obtain informed consent. "It's really important that providers are consenting their patients in private and quiet places, free from distractions, that they accommodate patients who might have disabilities or limitations in English proficiency, using a teach-back method to help patients understand or demonstrate their understanding of the procedure in order to gauge comprehension," he said.
Both Avram and Stratman pointed out that another strategy to prevent malpractice is to build trusting patient-provider relationships. "The patient-provider relationship is paramount not only to the success of the procedure but to the clinical visit as a whole," Stratman said.
That's a two-way street, he added. Patients should be able to trust that their provider provides them with the best treatment based on their own history, and providers should also be able to trust that patients are providing them with an accurate history, asking relevant questions, or expressing any level of apprehension about the procedure or visit. "The patient-provider relationship is everything," Stratman said.
Stratman and Avram had no relevant disclosures.
Richard Mark Kirkner is a medical journalist based in the Philadelphia area.
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