Failure to diagnose heart disease and improper prescribing of sildenafil
Presentation
On January 1, a 56-year-old man came to the emergency department (ED) for suspicion of congestive heart failure (CHF). The patient had a history of hypertension and smoked one pack of cigarettes a day. His blood pressure was 148/88 mm Hg.
The patient was admitted to the hospital, where his care was followed by an internal medicine (IM) physician. The patient reported he began taking anti-hypertensive medication two months before, but he stopped taking it after one month because he ran out of medication. He did not obtain a refill.
Physician action
On January 2, Cardiologist A examined the patient. He documented his impression as CHF, atherosclerotic heart disease, hypertension, edema, obesity, and tobacco abuse. EKG abnormalities suggested possible underlying coronary artery disease. He recommended further work up once myocardial infarction (MI) had been ruled out, with possible cardiac catheterization and coronary angiography. Cardiologist A also planned to continue the patient with diuretics and ACE inhibitor. She explained her impression and recommendations to the patient.
On January 3, the patient’s chest x-ray showed improvement, and he was discharged by the IM physician. He noted the patient’s CHF as “resolved.” The patient’s discharge instructions were to follow a low sodium, low cholesterol diet and to follow up in one week. There was also a plan to perform an outpatient cardiac catheterization to rule out coronary artery disease as the cause of dilated cardiomyopathy. Medications at discharge were lisinopril, coenzyme Q10, aspirin, furosemide, and potassium chloride.
On January 9, the patient returned to the IM physician. His edema was improved, and he asked for a sildenafil prescription. The physician provided a prescription of 50 mg sildenafil and instructed the patient to follow up with the cardiologist in a week to 10 days.
In late February, the patient was hospitalized, initially against his wishes, for cellulitis of the left leg and wound on the left big toe. The admitting physician listed additional diagnoses of hypertension, CHF, and dilated cardiomyopathy. The toe was amputated, and the patient was discharged two days later with oral antibiotics; instructions for hyperbaric oxygen treatment; referral to an infectious disease physician; and monitoring by a home health nurse.
On March 22, the patient experienced tachycardia during a hyperbaric treatment. In the ED, the patient denied shortness of breath, chest pain, or dizziness. His blood pressure was 114/69 mm Hg (it was documented as 168/86 mm Hg at the hyperbaric oxygen clinic).
Cardiologist B saw the patient in the ED and diagnosed sinus tachycardia likely reactive to bacteremia secondary to osteomyelitis. While various tests and labs were pending, the patient signed out of the ED against medical advice. An appointment was scheduled for March 30 with Cardiologist A.
Before leaving the ED, the patient signed a form acknowledging the cardiology appointment and that he was to fill his prescriptions and take his medication as directed. Medications included a new prescription for metoprolol. The patient returned for hyperbaric treatments, but after missing several appointments, the patient stopped treatment. He also did not keep his cardiology appointment.
The patient returned to see the IM physician three times before the end of the calendar year. At each appointment, he reported taking his medications sporadically. The physician noted the patient’s CHF as “compensated.”
At the last appointment of the year in September, the IM physician documented diagnoses of cardiomyopathy, hypertension, and erectile dysfunction. He indicated the need for a nuclear stress test but wanted to wait until December to schedule it. The patient requested samples of sildenafil. Sildenafil was inconsistently listed as one of the patient’s medications in the record, including different dosages. The physician provided him 50 mg samples.
On April 17 of the next year, the patient saw Cardiologist A on recommendation from the IM physician for a workup of his heart. Cardiologist A documented that the patient did not have chest pains or CHF. His lungs were clear and blood pressure was 150/90 mmHg. Cardiologist A recommended an echocardiogram and stress test, but the patient refused. The cardiologist also wrote the patient a prescription for sildenafil at 100 mg.
Later that day, the patient died during a sexual encounter with his wife. According to the autopsy, the patient’s cause of death was hypertensive and atherosclerotic cardiovascular disease. Lab testing confirmed that there was sildenafil in his system; there was no ethanol, methanol, acetone, or isopropanol in the patient’s system.
Allegations
The patient’s family filed a lawsuit against Cardiologist A and the IM physician. The allegations were:
- failure to diagnose heart disease;
- failure to manage CHF and hypertension; and
- improperly prescribing sildenafil.
Legal implications
The consultants who reviewed this case agreed that the patient’s noncompliance was an important factor in this case. One consultant felt the standard of care was not met due to the physicians repeated failure to work up the patient’s dilatory cardiomyopathy and tachycardia. There were also criticisms about prescribing sildenafil; failing to document their reasoning for doing so; and failing to educate the patient on the medication’s risks.
Another consultant shared the consensus position of the American College of Cardiology and the American Heart Association that sildenafil is safe for men with stable coronary artery disease not taking nitrates. This consultant also emphasized that the autopsy reflected 80% occlusion of the right and anterior descending coronary arteries, suggesting the patient died as a result of ventricular arrhythmia.
A third consultant pointed out that the patient’s heart weighed 1025 grams, about three times the normal size, according to the autopsy report. He felt that prescribing sildenafil was contraindicated for this patient, but that the medication was only a contributing factor to his death. Based on the autopsy report, he felt the proximate cause of death was severe heart disease.
While critical of the physicians for failing to manage the patient’s hypertension; diagnose heart disease; and communicate the importance of treatment and testing, experts for the plaintiff also called the patient negligent due to his noncompliance.
They highlighted several instances where the patient failed to take medications, fill prescriptions, follow advice to eat sensibly and quit smoking, maintain appointments, and undergo testing that could have helped him prolong his life.
Disposition
This case was settled on behalf of Cardiologist A and the IM physician.
Risk management considerations
New medications or samples provided to a patient should be documented in the patient’s medical record. Documentation of new medications or samples would include, but may not be limited to, name of medication, dosage, frequency, route, any specific instructions, and discussion of potential side effects or adverse interactions. Additionally, documentation should include the rationale and decision-making involved to determine the treatment plan.
Medications should be reviewed and reconciled at each patient follow-up appointment to monitor compliance; identify any new medications or treatments since the previous appointment; and the patient’s response to the medication treatment plan.
Any form of patient education including discussion or written materials such as handouts or pamphlets should be documented in the patient’s medical record. This makes it evident that the patient was provided adequate information to make informed decisions regarding his or her medical care.
Documentation of patient noncompliance is crucial. Documentation should include noncompliance with medications and recommended treatment plans. Furthermore, documentation should also include when a patient refuses diagnostic testing, laboratory testing, or a procedure. Include reasoning for recommending the testing or procedure; the discussion with the patient of risks, benefits, and alternatives; and the patient’s reasoning for refusing the testing or procedure. This documentation makes it evident that the patient was informed and adequately educated regarding his/her medical condition and refused to follow recommendations.