Medication Error Lawsuit Resulting in Death of Woman Settles for $1.25 Million

2011 Medical Malpractice Trial Report

Death of 76-year-old woman from preventable medication error—30 times dose of Lepirudin

The plaintiff’s decedent was a 76-year-old woman who died on 11/24/10 from a hemorrhage. Her death occurred following a preventable medication error involving the drug Lepirudin. The patient was given over 30 times too much medication which resulted in uncontrollable internal bleeding and her subsequent death.

Her past medical history included cirrhosis with well preserved hepatocellular synthetic function. She also had Type 2 diabetes, hypertension and hypercholesterolemia, and a history of splenectomy for treatment of severe thrombocytopenia.

See other medication error lawsuit reports:
$2 Million Settlement for Insulin Dosing Error Death

$1.75 Million Settlement in Heparin Medication Mixup Death

In August, 2010, she suffered a fall which led to a right humeral fracture. Her fracture was to be managed conservatively. Following this injury, she remained hospitalized at various facilities due to anemia, acute renal failure, urinary tract infections, and an upper extremity blood clot. In November 2010, she was found to be suffering from Heparin induced thrombocytopenia (HIT). It was noted that in light of her HIT, immediate anticoagulation was necessary, and that Lepirudin would be administered. The order was for 0.1 mg/kg/hr in a premixed continuous infusion. It was to be titrated to a PTT level of 50-70. If the PTT was greater than 2.5 times the baseline, then the infusion was to be held for two hours and reinstituted at 50% of the original infusion dose. The PTT was then to be checked in 4 more hours. If the PTT was less than 1.5 times the baseline, that the infusion rate was to be increased by 20% and the PTT was to be rechecked. If in 4 hours the PTT was still subtherapeutic, the infusion was to be increased by another 20%. The maximum dose to be administered was 16.5 mg/hr.

Lepirudin was started at 9:13 p.m. on 11/20/10. The initial dose was 7.2 mg/hr based on the patient’s weight of 72 kg. Over the next several days, the Lepirudin dose was altered in accordance with the physician’s order as mentioned previously. At 6:00 a.m. on 11/23/10, the Lepirudin was running at a rate of 0.5 mg/hr. At some point in the morning, the nurse who reported understanding the intended dosing, made an error in entering the information into the IV pump. A PTT level checked at 12:00 p.m. was refused and was noted to be a compromised sample. The sample was not repeated by the nurse or by any other provider at the time of the rejection.

At 3:25 p.m., due to miscommunication between nurses and doctors, the order for Lepirudin was adjusted to run at the maximum dose of 16.5 mg/hr overnight on 11/23/10, and then was to be readjusted based on the diluted thrombin time dosing guidelines.

The Lepirudin continued to infuse at the maximum dose over the course of that day. The patient developed shoulder pain with movement, as well as hypotension and decreased responsiveness. The Lepirudin was held as her hematocrit (HCT) was checked. She was found to be profoundly anemic and was transfused. She was transferred to the Medical Intensive Care Unit (MICU), where it was noted that she might have received too much Lepirudin over the course of the day. There is no reversal agent for Lepirudin, and the only available treatment was discontinuation of the drug, which had been discontinued already. She continued to suffer from profound anemia and began oozing from all IV sites. She passed away the following day from a hemorrhage.

The hospital prepared a Preventability Determination Narrative regarding the care received and noted that the nurse’s note from the 11/22/10 night shift revealed the Lepirudin dose of 0.5 mg/hr. It was initially thought that there had been a misunderstanding of the dosage instructions at the time of the handoff from the night nurse to the day nurse. Upon further discussion and interviews with the involved staff, it was determined that the day nurse understood the intended dosing but made an error when entering the dose into the IV pump.

The Root Cause Analysis revealed that documentation and communication of the dosing of medication varied from the standard system of mg/kg/hr. The standard, pharmacy approved dosing guideline for Lepirudin was followed until early in the morning of 11/23/10. Further, the blood specimen for the PTT taken at noon on 11/23/10 was rejected as a “compromised sample,” and was not redrawn for some nine hours. It appears that the “compromised specimen” was instead just a sample with no obtainable clot. It was noted that the excessive medication dose was preventable and was a result of a failure of systems within the hospital’s control.

The plaintiff alleged that the doctors and nurses violated the standard of care when they gave the patient an improper dose of medication, and failed to appreciate or correct the error. As a direct result of the deviations from the accepted standard of care, the patient suffered an excessive overdose of Lepirudin, directly leading to hemorrhage and death.

The defendants contended there was a “systems error” more than a failure of any one individual. The defendants further contended that the patient was in dire medical condition to begin with and may well not have survived the admission even if there had been no medication error. Further, the defendants contended that the hemorrhage and death may have been due to an underlying bleeding disorder unrelated to the medication overdose.

The case was settled a month after the lawsuit was filed for $1,250,000.

Lubin & Meyer attorneys represented the plaintiff in this medication error lawsuit.

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