Medical malpractice claims may be asserted against any healthcare provider, including nurse practitioners as well as the practices that employ them. The insured in this case was a family nurse practitioner (FNP) who was employed by a weight loss clinic (“the clinic”). The FNP had been practicing for 10 years in the field of family practice and had been working at the clinic for several months at the time of the incident. The clinic was owned by a physician who also served as the medical director, but he was not involved in the care of patients or clinic procedures. The clinic’s weight loss program included prescribing phentermine, as well as behavioral modification and nutritional counseling. Phentermine is often the drug of choice due to its accessibility and cost-effectiveness as compared to the semaglutides, which may have health insurance coverage limitations.
Summary
This case involved a 40-year-old female patient who presented to the clinic for treatment related to a longstanding history of obesity. She expressed concerns about the health risks associated with obesity. The patient also expressed a desire to “lose a lot of weight quickly” for an upcoming wedding event in addition to her goal of long-term weight management. The NP’s initial assessment included a review of the patient’s medical history and current medications, as reported to her by the patient. The patient’s blood pressure was noted to be 184/124. The patient denied having a history of cardiac disease, hypertension, or being on antihypertensive medication. The patient informed the FNP that she had used phentermine in the past for weight loss and had positive results. The patient also reported that she smoked and frequently used energy drinks to control her appetite. Based upon the patient’s elevated blood pressure, the FNP informed the patient that she could not prescribe phentermine to her at this time. The patient was adamant in her desire to receive the phentermine and again informed the FNP that she did not have a history of hypertension. It was later discovered during litigation that the patient did have a history of hypertension and that she had stopped taking antihypertensive medication prescribed by her primary care provider (PCP) against medical advice.
The day following the initial clinic visit, the patient returned to the clinic requesting phentermine. She had not sought treatment for hypertension. The FNP was working at another clinic location that day, and there was no licensed provider on duty. The clinic had a sister operation located in a nearby city, and the providers rotated between the sites, often delegating clinic coverage to unlicensed medical assistants. The medical assistant (MA) on duty recorded a blood pressure reading of 146/86 and referred to the NP’s note from the previous day, interpreting it as a valid order allowing her to dispense the phentermine. One of the clinic’s criteria for prescribing phentermine was that the patient’s blood pressure needed to be below 150/90. She dispensed the phentermine, but did not provide the patient with information regarding dosage or side effects. The MA was newly hired and did not receive training regarding protocols for dispensing medications when there was no provider on-site. The patient did not return to the clinic, nor did she contact the FNP in follow-up after receiving the phentermine. Ten days after the patient received the phentermine, she was admitted to the hospital with aphasia and hemiplegia and was diagnosed with a severe right temporal lobe intracranial bleed (stroke). The attending neurosurgeon documented that the stroke was related to hypertension in the setting of phentermine use. The patient underwent a craniotomy with evacuation of the hemorrhage and a partial temporal lobectomy. There was an extensive rehabilitation period, and the patient was left with residual neurological injuries, including dysphagia, muscle weakness, gait disturbance, incontinence and cortical blindness. As a result of these injuries, the patient required lifelong care for herself, as well as assistance in caring for her two minor children.
Risk Management Comments
Six months after the patient (plaintiff) was discharged from rehabilitation treatment, she filed a lawsuit against the FNP, the medical director and the clinic. She asserted that the FNP failed to conduct a complete assessment, inappropriately prescribed phentermine and failed to conduct informed consent. The plaintiff further asserted that the medical director was negligent in allowing unlicensed staff members to dispense medications without proper oversight and for failing to ensure that there were updated policies in place to ensure proper supervision, staff training and delegation of duties. The clinic entity was held vicariously liable for the actions of the MAs and the FNP.
The plaintiff testified in her deposition that the FNP advised her to return to the clinic the day following the initial visit and that she would be able to receive the phentermine if her blood pressure was within acceptable limits. She denied being advised to seek additional medical treatment for hypertension and testified that the FNP did not inform her that she intended to re-evaluate her prior to agreeing to prescribe the phentermine. The plaintiff admitted that the FNP provided an informational brochure about phentermine, but she testified that she did not understand that phentermine could exacerbate hypertension which could then result in a stroke. Plaintiff stated that, had she been informed, she would not have taken the medication. The plaintiff stated that she was anxious to get started on the weight loss program, so did not ask any questions.
The plaintiff’s NP expert opined that that the FNP did not adhere to the standard of care, which required her to re-evaluate the patient before prescribing the phentermine to rule out hypertension and/or cardiovascular disease. The Food and Drug Administration (FDA) labeling indicated that cardiovascular disease was a contraindication for prescribing phentermine. The NP expert noted that the FNP inappropriately delegated duties to the unlicensed clinic staff. A physician specializing in obesity medicine, testified on the plaintiff’s behalf and criticized the medical director for failing to ensure proper oversight of the clinic and to develop and implement written protocols reflecting the standard of care. The plaintiff’s neurology expert opined with certainty that the phentermine was the direct and proximate cause of the stroke. The experts highlighted that they believed there was inappropriate delegation of duties to unlicensed staff and that these delegating practices were commonplace at the clinic. It was noted that, just prior to this incident, the medical director had been disciplined by the state medical board for this very thing but continued to operate this way.
The defense expert in neurology opined that the phentermine was likely a contributing factor to the patient’s stroke; however, he noted that the patient’s comorbidities, i.e., hypertension, obesity and smoking, also played a role. A causation defense was considered by the FNP’s defense attorney. However, the defense team believed that it would be difficult to contest the plaintiff’s neurosurgery expert who testified that the stroke was directly related to the use of phentermine. A pharmacology expert for the defense opined that the dosing, storage and logs related to phentermine dispensing were within the standard of care for a weight loss clinic. An NP expert for the defense was unable to support the care provided and opined that the FNP failed to adhere to the standard of care regarding prescribing medication, delegation of duties to unlicensed staff and documentation. The NP expert opined that the FNP should have reviewed the patient’s healthcare information record and/or requested clearance from the plaintiff’s PCP after identifying hypertension in the initial assessment.
The FNP testified in her deposition that she advised the patient to follow-up with her PCP or go to the emergency department for treatment of the hypertension and that she would re-evaluate her when her blood pressure was under control to determine if she was an acceptable candidate for phentermine use. The FNP did not document this conversation in the healthcare information record; rather the documentation stated: “the patient will return for a blood pressure recheck tomorrow and phentermine will be dispensed if her blood pressure is within the acceptable range”. The FNP admitted in her deposition that her documentation did not accurately reflect the discussion that she had with the patient. This discrepancy diminished the FNP’s credibility, resulting in a challenge to defend the care she provided. The FNP stated that she provided training to newly hired MAs regarding office practices. However, shortly after the incident, the MA informed the FNP that she had not received training regarding handling patient requests when there was no provider on site. She resigned shortly after the lawsuit was filed.
Resolution
In summary, the defense team identified the following weaknesses in this case:
- The FNP’s documentation conflicted with her deposition testimony.
- An audit trail of the electronic medical record, requested by the plaintiff, revealed that there were attempts to amend the documentation after the incident. The FNP denied tampering with the documentation. The clinic staff involved in this case were no longer employed at the clinic and could not be located for their testimony to either support or refute the FNP’s assertion.
- The FNP’s assessment was limited to what the patient self-reported with no attempt to review the prior healthcare information record. In this case, a review would have identified the patient’s history of untreated hypertension and nonadherence to taking prescribed antihypertensives.
- There was inadequate staff training regarding scope of practice and inappropriate delegation of duties to unlicensed staff members.
- Clinic policies did not reflect the practices in place at the time of the incident.
The case had the potential for a high jury verdict, given the permanent nature of the plaintiff’s neurological injuries and the potential for jury sympathy for the plaintiff and her minor children. The plaintiff testified that she could no longer care for her two minor children and was unable to work in her field as a medical technologist. Integral to the resolution plan of the defense was the fact that the defense experts were unable to support the care provided by the FNP. Based upon the above-referenced defense challenges and diminished potential for a successful defense jury verdict, a presuit settlement was negotiated on behalf of the insured FNP.
Total Incurred: More than $975,000.
Figures represent only the payments made on behalf of the insured FNP 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
- Conduct comprehensive assessments to determine if patients are appropriate candidates for a proposed treatment or medication based upon age, current health conditions and past medical history, among other criteria. Consider risk factors which may influence the treatment, and document the thought process.
- Remain current in knowledge of new and specialty medications, including but not limited to their pharmacology, side effects and drug-drug interactions; consult with a pharmacist as needed.
- Conduct informed consent discussions to ensure that patients understand the proposed medications and treatment plan. Informed consent should be conducted by NPs when prescribing controlled substances, drugs with “box warnings”, off-label medications or other medications which may have the potential for serious side effects. Document the informed consent discussion, including questions asked and answered, and the NP’s rationale for prescribing the medication.
- Document all patient communications contemporaneously, factually and comprehensively. Include details of the discussions and questions asked and answered. Objective and concise documentation is essential for both continuity of care, as well as for the defense of a potential malpractice claim.
- Provide patient education regarding the importance of adherence to the recommended treatment plan and track patient adherence relating to follow-up care and referrals. Document all clinical advice and efforts made to promote patient adherence.
- Assess the patient’s health literacy level to ensure that they have an adequate understanding about their role in the treatment plan. Consider using the “teach-back” method for communicating patient instructions about required tests or other elements of the treatment plan.
Risk Management Recommendations for Practice Owners
- Develop a standardized process for delegation of tasks to unlicensed staff members in compliance with state-specific scope of practice laws.
- Provide ongoing training for unlicensed staff members and specifically for new team members who may be unfamiliar with office procedures. Training should include information regarding scope of practice and proper documentation, including late entries. Instruct staff to refrain from altering the healthcare information record after an adverse event or upon learning that a claim has been filed. Conduct routine audits of the healthcare information record to ensure compliance.
- Comply with state/ federal laws and regulations, related to ownership and supervisory/collaborative relationships with physicians.
- Ensure that written and procedures for the practice are updated and reflect appropriate practices regarding staff training and supervision, documentation, delegation of duties and scope of practice.
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.
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