Allegation
Improper use of hydralazine and failure to properly monitor the patient in an ALLHAT study led to DVT, PE, and death.
Case Details
The patient, a 62 YOM (5’11”, 241 lbs.), contacted the hospital to ask about participating in their ALLHAT study (Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial) after seeing the study advertised nationally. The purpose of the ALLHAT study was to determine if the combined incidence of fatal coronary heart disease and nonfatal MI differed with diuretics (chlorthalidone), or with one of three double-blinded, first-line antihypertensive agents: amlodipine, lisinopril, or doxazosin.
To qualify for the study, patients had to be more than 55 years old, have a history of HTN, and at least one other condition that increased cardiovascular disease risk. The therapeutic goal of the study was to achieve blood pressure control of <140/90, on the lowest possible front-line drug dosage. If patients could not achieve BP control on dose three of the first-line drug, the physician had discretion to add an open-label choice from the second-line of drugs (reserpine, clonidine, and atenolol), and/or the third-line drug (hydralazine).
Patients were to be seen every three months for one year, and then every four months thereafter. Initial labs were obtained, with potassium and creatinine measured twice the first year and annually for two years. Potassium, glucose, creatinine, serum triglycerides, and an ECG would be obtained every two years. At the hospital, a registered nurse served as the clinical research coordinator with a cardiologist as principal investigator. Cardiology fellows served as co-investigators.
The patient, a physician himself, was accepted into the study. He had a history of HTN, pneumonia, and esophagitis, and a long-term history of smoking. His initial BP was 150/102. His only medication was Calan. His ECG and labs were normal except for cholesterol 210 (0-200) and LDL 142 (0-130). The defendant cardiologist discussed the consent form including risks and side effects, and started the patient on amlodipine 2.5 mg.
The next month, the patient’s BP was 140/94. The defendant cardiologist increased the amlodipine to 5 mg. The patient entered the cholesterol-lowering arm of the ALLHAT study and started pravastatin.
At his six-month visit, the patient’s BP was 121/94. The defendant cardiologist increased the amlodipine to 10 mg and maintained this dose throughout the patient’s participation in the study. The patient was to have his PCP monitor his CPK and LFT. On his next visit, the patient’s labs were normal; his BP was 118/92 and his weight was 249 lbs. The defendant cardiologist stressed diet and exercise to achieve weight loss.
Six months later, the patient’s BP was 116/92 and his weight was 256 lbs. The defendant cardiologist added hydralazine 25 mg BID and again encouraged diet and exercise. The patient, who wasn’t always following the guidelines for office visits, follow-up, and labs, was to return in six weeks for a BP check. On his return visit, his BP was 110/76 and his meds were continued.
The following year, the patient’s BP was well-controlled and he expressed no complaints. The third year into the study, his BP was 128/100, and his weight 256 lbs. The next month, the patient’s BP was 120/88; his meds were continued, and he was to follow-up with his PCP for labs, including a lipid profile. The next month, his BP was 120/92 and he voiced no complaints. Hydralazine was increased to 50 mg BID. This was the last time the insured cardiologist saw the patient.
Six months later, the patient had lost weight. He weighed 225 lbs. and his BP was 112/74. The cardiology fellow noted the patient’s well-controlled HTN and weight loss. He ordered the patient to continue all meds. At his next visit four months later, the patient’s BP was 118/82 and his weight was 228 lbs. Labs were again normal.
In another four months, the patient obtained labs privately, including Hgb 7.6 (14-18), Hct 22 (42-52), Cr 5.8 (0.3-1.3), and BUN 68 (7-20). He showed the labs to another MD while socializing. She noted markedly abnormal labs, and said hydralazine could cause lupus-like effects. The patient was evaluated at a university medical center where he complained of eight to 10 months of increasing fatigue, five months intermittent nausea, and three months resting SOB on moderate exertion. At this point, the patient had been taking hydralazine three years. Labs drawn were consistent with lupus. Assessment was probable hydralazine-induced systemic lupus erythematosus.
The patient was told to stop taking hydralazine, and to inform the ALLHAT study RN of an adverse effect. The patient was told lupus should respond to discontinuation of the hydralazine, and if it did not resolve quickly, steroids would be started. The patient declined recommendation for admission. The next day, the patient advised the nurse he had stopped the hydralazine due to increasing tiredness, SOB, and abnormal labs. He sent her a copy of the labs. Five days later, the patient collapsed at home. EMS intubated the patient and administered CPR. Upon arrival at the hospital, the patient was asystole and could not be resuscitated.
The autopsy revealed that the cause of death was PE due to drug-induced lupus and end-stage, rapidly progressing glomerulonephritis. After the patient’s death, it was discovered the MD who was listed as his PCP had never been his physician, but rather was someone he had worked with several years prior.
A suit was subsequently filed alleging that improper use of hydralazine and failure to properly monitor the patient in an ALLHAT study led to DVT, PE, and death.
Resolution
At trial, judgment was granted in favor of the defendant on the first day as the plaintiff’s expert was not board certified in internal medicine and/or cardiology and therefore could not provide standard of care testimony against the defendant cardiologist.
---
If you have questions on this topic, please email RiskAdvisor@ProAssurance.com or call 844-223-9648.
