Nurse Practitioner Case Study: Failure to warn patient of dangers of testosterone treatment

This case study involves a Family Nurse Practitioner (FNP) who owned an adult wellness clinic, which specialized in hormone replacement for both male and female patients, as well as weight management. The FNP employed the collaborating physician, an OB/GYN, front office staff and two licensed practical nurses.

On January 23, a patient sought treatment with our insured FNP for bioidentical hormone replacement therapy.  The patient was referred by his wife, who was also a patient of our insured’s practice.
 
The FNP noted that the “Patient was a healthy, 57-year-old male in no acute distress, 6’0”, 255 pounds (BMI 34.6), and had a negative surgical and medical history.  He is a truck driver and appears to be in good health.  He reports no history of illness.  He denies any past medical history.  Patient denies any chest pain, shortness of breath or swelling to his lower extremities. His current medications include atorvastatin 80 mg, once a day as well as a baby aspirin”.
 
During the initial assessment, the FNP documented the following:
  • Complaints of fatigue and decreased energy level, not as much stamina;
  • Denies depression but reports some decrease in interests;
  • Weight gain around abdomen with difficulty losing weight;
  • Decrease in strength and muscle tone;
  • Loss of interest in sex;
  • Difficulty maintaining an erection and difficulty achieving an orgasm; and
  • Is most interested in improving sexual symptoms.
  • When questioned about prior testosterone usage or levels, he stated “My doctor has said they were normal, but they seem low for me.  I feel like I used to have a very high testosterone level”. 
 
The FNP documented that the benefits and risks of hormone therapy via pellet insertion were discussed and included the following:
  • The benefits of testosterone are that it may improve HDL, bone density, muscle mass and strength, red blood cell production, sex drive and lower LDL.
  • The risks of testosterone therapy may include elevated blood pressure, increased or exacerbated heart or liver problems, worsened sleep apnea, acne or other skin reactions, stimulation of noncancerous growth of the prostate (benign prostatic hyperplasia), growth of existing prostate cancer, enlargement of breasts, limitation on sperm production or causing testicles to shrink and stimulating too much red blood cell production, which contributes to the increased risk of forming a blood clot.
 
Patient verbalized understanding and stated that he wanted to proceed with therapy.  A lab work request for testosterone level was given. The patient signed a “Pellet Insertion Consent” form the same day. This consent form states that “I have been told that I am to have one to two pellets inserted under my skin to achieve a steady delivery of natural testosterone hormone into my blood system…”  The consent form also states that “I understand that these pellets are 100% natural without additives and match my estradiol and testosterone exactly.  These pellets slowly dissolve within 4-6 months.  I will receive an amount that has been adjusted for my age, weight and testosterone level.” The patient also was given a “Patient Education Information on Hormone Replacement” pamphlet and signed the “Informed Consent for Hormone Replacement Therapy”.  However, the patient information pamphlet, hormone replacement consent and pellet insertion consent form were intended for female patients, not male patients.  
 
The FNP stated that he had been using the same pamphlet and consent forms for several years for all of his hormone replacement patients. He testified that he had never read the pamphlet and consent forms and was unaware that the forms were gender-specific.         
 
The FNP received the patient’s lab work. His total testosterone level was 609 (reference range 250-1100ng/dL) and his free testosterone level was 88.9 (reference range 35-155pg/mL). The FNP wrote “not optimal” at the side of these results on the lab report.  On the same day, the collaborating physician prescribed 10, 200mg fused testosterone pellets.
 
The insured obtained the patient’s lab results from his primary care provider from March of the prior year.  These results indicated that the patient had a PSA, hematocrit and platelet count that were all within normal limits.  While the FNP requested the testosterone level, including the other lab results from the primary care provider, it was not received. The missing testosterone result went unnoticed by both the FNP and the staff.   
 
The patient returned on February 5, and the office note stated the following:
“Patient here for pellet insertion. Tolerated procedure well. No complaints or concerns noted.  Patient understands that pellets are fused and will be broke down slowly.  Effect typically takes a few weeks to begin to feel.  Discharge instructions given.  Return to office in 2 weeks for recheck and 6 weeks for lab re-draw.”
 
A procedural note for male testosterone pellet insertion from this date stated that our insured inserted 10, 200mg testosterone pellets in the patient’s right upper buttock.  The listed indications for the procedure were low levels of testosterone, hypotestosteronism, decreased energy, decreased short-term memory, weight gain, loss of muscle mass, decreased libido, decreased morning erections, loss of interest in sex and problems maintaining erections.
 
Two weeks later, the patient returned to the FNP office for a follow up visit. The patient relayed that he was concerned about his 7-pound weight gain over the past two weeks and continued to have difficulty keeping an erection.  The FNP prescribed tadalafil 5mg, once a day for his erectile dysfunction. The patient was instructed to keep his follow up lab work appointment in four weeks. 
 
The patient expired March 7. According to the death certificate, the patient sustained a sudden cardiac arrest.  No autopsy was performed. The patient went to the bathroom after sex with his wife. His wife heard him fall to the floor, and when she went to check on him, she found him pulseless and started CPR.  When the Emergency Medical Services (EMS) arrived, they began advanced life support measures and transported the patient to the local emergency department. Unfortunately, resuscitation efforts were unsuccessful. 
 
Risk Management Comments
A year after the patient’s death, the family (plaintiff) filed a lawsuit naming our insured FNP and the collaborating physician individually, as well as the wellness clinic. The allegations included:
  • Knowingly and intentionally prescribing large doses of testosterone to a 57-year-old man who had a demonstrably normal level of testosterone;
  • Failure to recommend alternative and safer means of addressing the patient’s complaints of weight gain and loss of sexual vigor;
  • Knowingly and intentionally making a false diagnosis of low testosterone when the patient’s testosterone level was normal;
  • Failure to advise the patient of the risks of testosterone therapy in older men, including heart attack and stroke;
  • Knowingly and intentionally misleading the patient by advising that testosterone therapy provides any benefit on men who already have normal levels of testosterone;
  • Failure to consult with collaborating physician on the appropriateness of prescribing tadalafil;
  • Failure to provide appropriate clinical supervision to ancillary medical staff; and
  • Failure to obtain a thorough history on the patient by obtaining a detailed family and personal medical history as well as most recent pertinent lab work.
 
During a review of the patient’s records, defense experts found that the FNP and the collaborating physician did not breach the standard of care when the patient was administered 2,000 mgs of testosterone via 10 pellets.  The experts explained that a patient’s symptoms may be due to a decrease in testosterone even if the patient’s testosterone level is within the lab reference range. The experts opined that testosterone can act as a cardiac protector and there is no causation between testosterone and an increased risk of cardiovascular events.
 
Additionally, the experts opined that if the testosterone therapy led to the cardiac issues, that process would take years to develop and not one month (which was the approximate period of time that elapsed between when the patient received the pellets and his death). The experts noted that the patient had risk factors for a heart attack, including the following:
  • Obesity, BMI of 30 or greater
  • Hypercholesterolemia
  • Extensive family history of cardiac disease (paternal father, paternal grandfather and older brother died of sudden cardiac arrest in their early 60’s, information available in primary care provider’s patient healthcare information records)
  • Questionable prior syncope episodes (information available in primary care provider’s patient healthcare information records)
 
However, the experts also acknowledged that our insured’s documentation, especially with respect to the information pamphlet, the hormone replacement consent form and the pellet insertion consent form, could have been better.  The “Patient Education Information”, “Informed Consent for Hormone Replacement Therapy” and “Pellet Insertion Consent” forms that the patient signed were intended for women. The “Pellet Insertion Consent” form that was signed indicated that the number of pellets that were to be inserted was “one to two,” but ten pellets were inserted.
 
The experts further opined that they would have started the testosterone at a lower dose than 2,000 mgs and increased the dosage, as needed, to achieve a positive response.  
 
The FNP did not have professional liability insurance coverage for the business or for any of the employees of the wellness clinic.  Since the plaintiff filed a lawsuit against the FNP and the collaborating physician individually, as well as the wellness clinic, the only coverage afforded to the FNP was for the claims against him individually.  Exacerbating the facts of the claim, the collaborative agreement with the physician had expired three years before the patient’s treatment.
 
The plaintiff refused to dismiss the business or the collaborating physician from the lawsuit. These concerns, coupled with the fact that there was no autopsy, made the likelihood of a defense verdict less than 50%.
The court ordered mediation, and our insured agreed that if the claim could be settled for a reasonable amount, we should do so.
 
Resolution
The court-ordered mediation was successful, but, unfortunately, the FNP was responsible for paying any settlements made on behalf of the business and the collaborating physician since they were not covered under his individual liability insurance policy.
 
Indemnity and legal fees totaled more than $600,000
(Monetary amounts represent the payments made solely on behalf of the insured, the treating FNP.)
 
Risk Management Recommendations for Treating Nurse Practitioners:
  • Follow documentation standards established by professional organizations.
  • Document all patient-related discussions, consultations, clinical information and actions taken, including any treatment orders provided and ensure that the documentation is timely.
  • Document all clinical decision making procedures, especially if the treatment plan differs from the typical plan of care.
  • Understand, maintain, and implement the scope and standard of care that applies to the relevant setting, including determining whether the patient’s clinical symptoms can be appropriately and safely managed.
  • Complete documentation in a timely manner. If an addendum to the patient healthcare information record is needed, avoid documenting in a manner that is self-serving and state information factually.
  • Obtain, review and consider pertinent patient and family medical history. A comprehensive and accurate history should be obtained prior to providing a patient with treatment or medications.
  • Remain current regarding clinical practice, medications, biologics and equipment related to the diagnosis and treatment of illnesses and conditions encountered in one’s specialty
  • Prescribe medication in compliance with state nurse practice act, state prescriptive authority, authority for nurse practitioners and employer policies and protocols.
  • Educate and document patients regarding their responsibilities for adhering to medication and treatment regimens, including lifestyle modifications as well as the risk of noncompliance.
  • Identify and address concerns or questions regarding patient care treatments and ensure that any concerns are resolved prior to discharge.
  • Engage in timely and proactive discussions with the collaborating physician and other members of the care team to ensure that the team is educated about the patient’s treatment plan.
  • Report thoroughly and in a timely manner any changes in the patient’s condition and/or response to treatment and documentation such interactions, as well as any modifications or changes to the treatment plan in the patient’s healthcare information record.
 

Risk Management Recommendations for Nurse Practitioner Business Owners:

  • Know and understand state medical malpractice laws as they pertain to potential professional liability exposures. Review the state practice act, speak with representatives of professional associations, and discuss potential liability risks with a broker or the insurer.
  • Assess business operations and obtain the appropriate professional and general liability insurance. If questions arise about the coverage, contact your insurance broker and/or professional liability insurer.
  • Periodically review and update, as needed, all collaborating agreements. Collaborative agreement files should include:
    • Current professional licensure and certifications;
    • Privileging for or assignment of clinical services, consistent with the scope of licensure and/or certification;
    • Training and experience;
    • Education; and
    • Certificate of insurance
  • Continuously update employee and independent contractor’s employment files. These updates include:
    • Current professional licensure/certification;
    • Position-specific skills certifications (e.g., CPR, ACLS)
    • Professional liability claims history, if applicable, including a list of both pending and closed claims;
  • Establish a ‘tickler system’ to track due dates for appraisals and licensure recertification.
 

Disclaimer
The information, examples and suggestions presented in this material have been developed from sources believed to be reliable, but they should not be construed as legal or other professional advice. CNA 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. Please note that Internet hyperlinks cited herein are active as of the date of publication, but may be subject to change or discontinuation. 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. Use of the term “partnership” and/or “partner” should not be construed to represent a legally binding partnership. 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. Copyright © 2021 CNA. All rights reserved.


This publication is intended to inform Affinity Insurance Services, Inc., customers of potential liability in their practice. It reflects general principles only. It 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. This publication is published by Affinity Insurance Services, Inc., with headquarters at 1100 Virginia Drive, Suite 250, Fort Washington, PA 19034-3278. Phone: (215) 773-4600. All world rights reserved. Reproduction without permission is prohibited.


Nurses Service Organization is a registered trade name of Affinity Insurance Services, Inc. (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.


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