Nurse Practitioner and Medical Malpractice

Case Study with Risk Management Strategies
Presented by NSO and CNA
 
Case Study: Alleged inappropriate clinical management of a home infusion company resulting in patient injury

Medical malpractice claims can be brought against any healthcare provider, including nurse practitioners (NPs), as well as the healthcare entities they own. In this case, the insured NP owned and operated a home infusion company (“the company”) At the time of the alleged incident, the company had been in operation for approximately one year. The NP had over ten years of clinical experience in family medicine. Infusion services were administered by three registered nurses (RNs) engaged as independent contractors. The RN involved in this incident had been working at the company since its inception and this was her first job as a licensed RN. The company also retained a physician specializing in obstetrics as its medical director, primarily to fulfill state supervisory requirements. This physician did not have any direct involvement in the clinical care related to the incident.
 

Summary

A 50-year-old male patient contacted the company to schedule an infusion for the treatment of fatigue and a hangover. An unlicensed medical assistant completed the company’s “pre-assessment” template during the initial phone intake documenting basic demographic information, type of infusion requested and a Covid vaccination history. The NP reviewed the information, approved the infusion treatment via an electronic signature, per her usual practice, and entered an order for the infusion based on the patient’s complaints. The NP did not routinely perform a patient history and physical neither in person nor via telehealth, but delegated this task to the RNs. Once the NP’s approval was entered into the electronic scheduling system, an RN would be assigned to the case. The RN would then contact the patient directly to schedule an appointment time.
 
Following the initial phone intake, the patient was scheduled for a home infusion appointment the next day. The assigned RN presented to the patient’s home and completed an assessment form, documenting vital signs and the patient’s stated reason for the infusion. The patient reported that he had recently undergone gastric bypass surgery and was experiencing chronic fatigue since the surgery. He also complained of a headache with a pain level of 7, which he attributed to excessive alcohol consumption the previous night. The patient disclosed that he had a history of bipolar depression, noting that his symptoms had worsened since the surgery and that he was self-medicating by consuming excessive amounts of alcohol. Although he was under the care of a psychiatrist and a bariatric surgeon, there was no indication that these symptoms had been reported to his treating providers. The RN documented that the patient appeared pale and malnourished. His vital signs were as follows: temperature 97.2°F, heart rate 70 bpm, respiratory rate 18 breaths per minute, blood pressure 105/70 mmHg, and oxygen saturation 98%.
 
The RN explained the procedure to the patient, discussed the risks and benefits and had the patient sign a consent form. However, due to a subsequent computer system failure, the informed consent documentation could not be retrieved. The RN then proceeded with the intravenous (IV) hydration administration. The infusion consisted of one liter of lactated ringer’s (LR) solution, supplemented with 2 mL of B-complex vitamins and 3 mL of glutathione. These additives were manually injected into the IV bag by the RN. A pressure infusion bag was applied to expedite the infusion rate. The company did not provide IV pumps for controlled administration.
 
Shortly after the infusion was completed, the patient exhibited seizure activity. The RN immediately contacted emergency services (911) and monitored the patient for eight minutes when the emergency medical technicians (EMTs) arrived. The RN informed the EMTs that the seizure lasted approximately 30 seconds followed by a post ictal state. Immediately upon arrival, the EMTs noted that the patient was unresponsive, with labored breathing and copious secretions. They repositioned the patient into a side-lying position, suctioned him and applied oxygen. Vital signs at that time were heart rate of 118 bpm, blood pressure of 140/80 mmHg, oxygen saturation of 80%, and blood glucose level of 140 mg/dL. The patient was transported to the hospital where he was diagnosed with an anoxic brain injury. Diagnostic imaging studies revealed that the underlying cause was an air embolism that occurred during the IV infusion. The patient had an extended rehabilitation, and was discharged with permanent neurological deficits in areas of attention, memory and processing speed.
 

Risk Management Comments

Approximately six months after the patient was discharged from rehabilitation, a lawsuit was filed naming the NP, as the owner of the home infusion company, the treating RN and the medical director.

The following assertions were made against the NP:
 

• Noncompliance with state licensure requirements for home infusion services---operating without the mandatory licensure designation as a licensed residential service agency.
• Inadequate staff orientation and training.
• Failure to establish a patient-provider relationship and to conduct a patient history and physical.
• Failure to provide appropriate infusion pumps thereby compromising patient safety.
• Failure to establish clinical protocols for IV infusion preparation, administration, and documentation.
• Lack of backup for electronic medical records, resulting in the loss of critical documentation.
• False advertising, suggesting a level of clinical oversight not upheld in practice and use of superlatives and promises made regarding the curative aspects of the treatments offered.
• Vicarious liability for the inappropriate actions of the RN.

 
Assertions against the RN included the following, among others:
 

• Failure to communicate with the patient’s treating providers to determine whether IV infusion therapy was clinically appropriate.
• Improper IV infusion techniques i.e.use of a pressure bag without safeguards.
• Inadequate nursing care in response to a medical complication--failing to secure the patient’s airway and ensure adequate oxygenation while awaiting emergency medical services.
• Failure to document medication preparation/administration information including time, concentrations, additives as well as nursing actions taken during the post infusion complication.

The plaintiff asserted that the medical director failed to provide administrative oversight and supervision and lacked the appropriate clinical expertise to serve in this role.
 
The defense team concluded that there was professional liability exposure due to significant deviations from accepted clinical standards and the overall lack of structured clinical oversight. Expert witnesses specializing in IV infusion therapy were critical of the NP citing the absence of formal policies, inadequate staff training for a newly licensed RN, and insufficient supervision of clinical operations. Although not directly linked to the cause of the air embolism, defense experts expressed concern about whether the patient was a candidate for the IV infusion and were critical of the NP’s failure to conduct a comprehensive patient history and assessment prior to approving the treatment.
 
The NP admitted in her deposition that the medical director’s oversight was insufficient and that the expertise of an obstetrician was not aligned with the scope of services provided by the home infusion company, rendering him an inappropriate choice for supervision in this context. The plaintiff was able to establish that the  limited engagement of the medical director was a contributing factor to the system failures and a breach of the standard of care.
 

Resolution

The case had the potential for an exorbitant jury verdict, given the permanent nature of the plaintiff’s neurological injuries and the potential for jury sympathy for the plaintiff, his wife and three minor children. The plaintiff testified that he could no longer enjoy family activities and was unable to work in his field of accounting. Integral to the resolution plan of the defense was the fact that the defense experts were unable to support the care provided by the NP. Based upon the above-referenced defense challenges and diminished potential for a successful defense jury verdict, a settlement was negotiated in mediation on behalf of the NP.
 
Total Incurred: More than $950,000
Figures represent only the outcome for the insured NP and the company 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 Practitioner Business Owners 

• Ensure competency of employed and contracted clinical staff and provide ongoing education regarding IV infusion procedures, equipment and emergency care in the event of a complication. Consider a preceptor program in which newly hired RNs can shadow experienced staff members prior to providing independent home infusions.
• Establish a provider-patient relationship and conduct a screening assessment on all patients to determine if they are appropriate candidates based upon age, current health conditions, medications, and past medical history, among other criteria. IV therapy requires a good faith exam by a licensed provider. Standing orders do not meet these requirements.
• Discuss the proposed treatment plan, risks, benefits and alternatives with patients to ensure their understanding  and document the informed consent discussion in the healthcare information record.

• Develop and implement documentation policies and provide employed/contracted clinical staff with ongoing education/oversight to ensure compliance.  IV infusion services should be documented contemporaneously, factually and comprehensively and include information about the solutions, additives, flow rate and patient response, among other clinical information. Objective and concise documentation is essential for the defense of a potential malpractice claim. Often, a comprehensive healthcare information record is the best legal defense.
• Adhere to national guidelines and state-specific laws/regulations including but not limited to supervision, hiring, collaborative agreements with physicians, scope of practice and delegation of clinical tasks and procedures.
• Comply with state pharmacy board and federal FDA regulations regarding compounding IV solutions. The addition of any drug, vitamin, mineral, amino acid or other substance to an IV bag is considered compounding.
• Adhere to state-specific “Corporate Practice of Medicine” doctrines which dictate whether or not an infusion company can be non-physician owned.
• Ensure that the appropriate equipment is available for safe medication administration including but not limited to infusion pumps with safety features for control and accuracy. Sequester equipment involved in an adverse event or resulting in patient injury.
• Consult with legal counsel in your state regarding the process for operating/owning an IV hydration business.
• Ensure all website content and marketing materials accurately reflect the services offered. Avoid using superlatives or making promises about outcomes. All messaging should be clear, factual, and aligned with the actual capabilities and scope of services provided.

 
_Disclaimers

_{The information, examples and suggestions presented in this material have been developed from sources believed to be reliable as of the date they are cited, but they should not be construed as legal or other professional advice. CNA, Aon, Affinity Insurance Services, Inc., NSO, or HPSO accepts no responsibility for the accuracy or completeness of this material and recommends the consultation with competent legal counsel and/or other professional advisors before applying this material in any particular factual situations. This material is for illustrative purposes and is not intended to constitute a 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.  Certain coverages may be provided by a surplus lines insurer. Surplus lines insurers do not generally participate in state guaranty funds, and insureds are therefore not protected by such funds.  The claims examples are hypothetical situations based on actual matters.  Settlement amounts are approximations. Certain facts and identifying characteristics were changed to protect confidentiality and privacy. Any references to non-CNA, non-Aon, AIS, NSO, and HPSO websites are provided solely for convenience, and CNA, Aon, AIS, NSO and HPSO disclaim any responsibility with respect to such websites. “CNA” is a registered trademark of CNA Financial Corporation. Certain CNA Financial Corporation subsidiaries use the “CNA” trademark in connection with insurance underwriting and claims activities. This material is not for further distribution without the express consent of CNA. Copyright © 2026 CNA. All rights reserved.}

 

_{Nurses Service Organization is a registered trade name of Affinity Insurance Services, Inc., a licensed producer in all states (TX 13695); (AR 100106022); in CA, MN, AIS Affinity Insurance Agency, Inc. (CA 0795465); in OK, AIS Affinity Insurance Services, Inc.; in CA, Aon Affinity Insurance Services, Inc., (CA 0G94493), Aon Direct Insurance Administrators and Berkely Insurance Agency and in NY, AIS Affinity Insurance Agency.}

<sub>This publication is intended to inform Affinity Insurance Services, Inc., customers of potential liability in their practice. This information is provided for general informational purposes only and is not intended to provide individualized guidance. All descriptions, summaries or highlights of coverage are for general informational purposes only and do not amend, alter or modify the actual terms or conditions of any insurance policy. Coverage is governed only by the terms and conditions of the relevant policy. Any references to non-Aon, AIS, NSO, HPSO websites are provided solely for convenience, and Aon, AIS, NSO and HPSO disclaims any responsibility with respect to such websites. This information is not intended to offer legal advice or to establish appropriate or acceptable standards of professional conduct. Readers should consult with a lawyer if they have specific concerns. Neither Affinity Insurance Services, Inc., NSO, nor CNA assumes any liability for how this information is applied in practice or for the accuracy of this information.

Nurses Service Organization is a registered trade name of Affinity Insurance Services, Inc., a licensed producer in all states (TX 13695); (AR 100106022); in CA, MN, AIS Affinity Insurance Agency, Inc. (CA 0795465); in OK, AIS Affinity Insurance Services, Inc.; in CA, Aon Affinity Insurance Services, Inc., (CA 0G94493), Aon Direct Insurance Administrators and Berkely Insurance Agency and in NY, AIS Affinity Insurance Agency.</sub>