Nurse Practitioner Medical Malpractice Case Study with Risk Management Strategies
Presented by NSO and CNA
Medical malpractice claims may be asserted against any healthcare provider, including nurse practitioners (NPs) as well as the practices that they own. The insured in this case was a nurse practitioner who was the owner and sole employee of a medispa. A collaborating physician specializing in plastic surgery, the medical director of the spa, was also involved in the case.
Summary
This case involves a 60-year-old female patient who presented to the insured NP’s medispa for a facial rejuvenation treatment. The patient initially requested threading to reduce the appearance of a “double chin.” However, the NP suggested radiofrequency (RF) microneedling as a treatment option, as he believed this treatment would provide a better cosmetic result. RF microneedling is a cosmetic procedure which utilizes small needles and the application of heat generated from radiofrequency waves to trigger the production of elastin and collagen, thereby rejuvenating and toning the facial skin.
The NP had been practicing in aesthetics and owned the medispa for 5 years at the time of this case. Prior to transitioning to a career in cosmetic nursing, he worked in an acute care hospital setting for 10 years. RF microneedling was a new treatment option that he had begun offering. The NP purchased a RF microneedling machine and completed an eight-hour certification class taught by the medical device distributor. The training included a review of the settings that were recommended by the device manufacturer - ranging from a level 3 for acne treatment to a level 12 for submental fat reduction. The NP had successfully treated four other patients with RF microneedling using a lower setting of 3 for acne prior to treating this patient.
Before initiating the treatment, the NP obtained a patient history, conducted a medication review, and discussed the pre-treatment requirements. Based upon this assessment, he determined that the patient was an appropriate candidate for the procedure. The client had discontinued anticoagulant medications and avoided sun exposure, as these were the requirements for the injectable treatments that she was originally planning to undergo. The same preparations were required for the RF microneedling procedure. The NP conducted an informed consent discussion, advising the patient about the potential risks of the procedure, including pain at the time of needle injection, skin discoloration and temporary swelling. The patient stated that she understood the risks, agreed to the treatment, and signed the consent form which listed the above-mentioned risks. The risk of burns was neither discussed nor included on the consent form. The NP was not aware of the manufacturer’s warnings regarding the risk of burns when using a setting over 9 and had not received this information in the training session.
The NP initiated the procedure utilizing a setting of 12 as indicated for submental fat reduction on the manufacturer’s instructions. Rather than performing a spot test to see if the patient could tolerate this setting, the NP completed the treatment at this setting on the right side of the patient’s face. Upon completing the right side of the patient’s face, he observed significant redness and believed that this was normal because he was informed in the training that skin irritation/redness were common reactions. However, the amount or nature of expected redness was not discussed in the class, and, since the NP had only performed this procedure a few times, he had no reference point to gauge a normal reaction versus a complication. As he was transitioning to the opposite side of the patient’s face, the NP observed that the needles were clogging with what appeared to be dermal tissue. He immediately discontinued the procedure and noted significant irritation, redness and swelling on both sides of the patient’s face where he had inserted the needles. Over the course of the following week, the patient developed bilateral full thickness burns requiring medical care.
The NP conducted an immediate investigation, which included a review of his technique with the collaborating physician/medical director and a retraining session with the certification instructor, both of whom confirmed that the technique utilized on this patient was appropriate. The NP then sent the machine to the distributor so that the manufacturer could perform testing to rule out defects as the cause of the patient’s burns. The NP was informed by the manufacturer that the machine was functioning properly. Of note, when the machine was returned to the NP, he noticed that the recommended setting for submental facial treatments were changed from 12 to 9 in the owner’s manual. When he asked the distributor about this change, he was told it was changed by the manufacturer as a precautionary measure.
The patient subsequently developed a wound infection requiring an inpatient hospital admission for intravenous antibiotics and wound debridement. As a result of the burn injury and resultant scarring, the patient reported difficulty eating and sleeping for several months and that she could no longer work in her field as a make-up artist. The NP continued to treat and advocate for the patient for a one-year period following the incident, providing wound care, dressing changes and home consultations free of charge. In addition, the collaborating physician/medical director coordinated a plastic surgery referral for the patient. However, the NP did not report this incident as a claim or potential claim to their professional liability insurer and did not seek advice of counsel.
Risk Management Comments
Fortunately, the patient fully recovered from the infection. However, she was left with permanent residual scarring despite undergoing several plastic surgery procedures. In an effort to be transparent and advocate for the patient, the NP shared all of the investigative documentation with the patient, including the incident report and the correspondence from the manufacturer, without first consulting with an attorney. Unfortunately, the patient shared all of this volunteered information with her attorney and used it to substantiate a professional liability claim against the NP.
One month after the patient discontinued treatment with the NP, a medical malpractice claim was filed by the patient’s attorney asserting the following:
- Failure to appropriately screen and prepare the patient prior to the treatment;
- Failure to abort the treatment immediately upon noticing a complication;
- Failure to adhere to the standard of care in performing RF microneedling.
- Failure to have proper policies in place regarding treatments and handling complications.
Defense experts included an NP specializing in the field of aesthetics and a plastic surgeon. Both experts refuted the patient allegations regarding the pre-treatment care and opined that the NP appropriately conducted a screening assessment, and that the patient was an appropriate candidate for RF microneedling. The experts agreed that the NP aborted the procedure within a reasonable time frame upon noticing the complication and provided excellent post-incident care.
However, the defense experts were critical that the NP’s informed consent discussion did not include the risk for burns, as the manufacturer’s instructions (both before and after the settings were altered) contained a warning statement that “any setting at 9 or above increases a risk of skin burns.” The plastic surgery expert opined that the NP did not adhere to the standard of care because he failed to use clinical judgement and critical thinking to identify that a setting of “12” was too high. The NP expert was unable to support the care and opined that the NP should not have relied solely on the manufacturer’s instruction sheet. Instead, the NP should have started the treatment at a lower setting to ascertain how the patient’s skin would respond. Both experts were experienced in the use of RF microneedling and concurred that the setting of 12 was too high for facial use.
Resolution
The case had the potential for a high jury verdict, given the visual nature of the injury and the potential for jury sympathy. Integral to the resolution plan of the defense was the fact that the defense experts were unable to support the care provided.
Based upon the above-referenced defense challenges and diminished potential for a successful defense verdict, a presuit settlement was negotiated in mediation on behalf of the insured NP and the medispa. There was a consensus amongst the defense team that the NP’s vigilant post-incident care and commitment to the patient contributed to an early resolution of this claim, helped to avoid a lengthy litigation process and likely mitigated the potential severity of the settlement.
It is not known if the patient filed a direct claim against the manufacturer, but the defense team decided not to pursue a third-party claim against the manufacturer, as they were located outside of the U.S. which would entail significant legal expenses and a lengthy litigation process.
Total Incurred: More than
$175,000.
(Figures represent only the payments made on behalf of the insured NP and the medispa and do not include any payments that may have been made by or on behalf of other involved providers or companies.)
Risk Management Recommendations for Nurse Practitioners
- Engage in ongoing education regarding new procedures and equipment. Read the manuals and instructions. Consider shadowing experienced providers when offering a new procedure. Training and certification classes offered by device manufacturers may be limited in clinical content regarding identification and treatment of complications and adverse outcomes.
- Establish a provider-patient relationship and conduct a screening assessment on all patients to determine if they are an appropriate candidate based upon age, current health conditions and medications, past medical history, among other criteria.
- Discuss the proposed treatment plan and reasonable expectations for outcomes with patients, in order to ensure their understanding of the proposed treatment and their responsibilities.
- Document the treatment rationale contemporaneously, factually and comprehensively and include details regarding patient screening. Objective and concise documentation is essential for both continuity of care, as well as for the defense of a potential malpractice claim. Often, a comprehensive healthcare information record is the best legal defense.
- Consider risk factors which may influence the treatment choice and document the informed consent discussion.
- Provide follow-up care and referrals, as needed, for patients who experience adverse outcomes/complications.
Risk Management Recommendations for Nurse Practitioner Business Owners
- Comply with state/ federal laws and regulations, related to ownership, prescribing and supervisory/collaborative agreements with physicians.
- Adhere to state-specific “Corporate Practice of Medicine” doctrines which dictate whether or not a medispa can be non-physician owned.
- Ensure the quality of products/equipment purchased for patient use. Sequester equipment involved in an adverse event or resulting in patient injury.
- Consult with legal counsel regarding the process for sequestering medical devices/equipment involved in cases in which there were complications. Also seek advice regarding what information/documentation should be shared with patients who have experienced an adverse outcome.
- Develop policies that address the process for handling adverse outcomes, patient complaints and outpatient emergencies.
- Refrain from copying or distributing incident reports to anyone other than your legal counsel or professional liability insurance carrier, and never place an incident report in the patient healthcare information record.
- Establish a formal process for disclosure of incidents, adverse outcomes and unexpected occurrences to patients.
References
Disclaimers
These case scenarios are illustrations of actual claims that were managed by the CNA insurance companies. However, every claim arises out of its own unique set of facts which must be considered within the context of applicable state and federal laws and regulations, as well as the specific terms, conditions and exclusions of each insurance policy, their forms, and optional coverages. The information contained herein is not intended to establish any standard of care, serve as professional advice or address the circumstances of any specific entity. These statements do not constitute a risk management directive from CNA. This material is for illustrative purposes and is not intended to constitute a contract. No organization or individual should act upon this information without appropriate professional advice, including advice of legal counsel, given after a thorough examination of the individual situation, encompassing a review of relevant facts, laws and regulations. CNA assumes no responsibility for the consequences of the use or nonuse of this information.
One or more of the CNA companies provide the products and/or services described. The information is intended to present a general overview for illustrative purposes only. It is not intended to constitute a binding contract. Please remember that only the relevant insurance policy can provide the actual terms, coverages, amounts, conditions and exclusions for an insured. All products and services may not be available in all states and may be subject to change without notice. “CNA” is a registered trademark of CNA Financial Corporation. Certain CNA Financial Corporation subsidiaries use the “CNA” service mark in connection with insurance underwriting and claims activities. Copyright © 2024 CNA. All rights reserved.