Legal Review & Commentary: Malfunctioning defibrillator results in $5.3M award
Legal Review & Commentary
Malfunctioning defibrillator results in $5.3M award
News: A woman suffered cardiac arrest while at home. Hospital paramedics arrived, but attempts to resuscitate her with a Lifepak 11 monitor and defibrillator failed. Forty minutes later, the woman was pronounced dead. The decedent's estate sued the hospital and was awarded $5.3 million in damages.
Background: A 39-year-old woman employed as a security guard at a high school suffered cardiac arrest while at her home. Paramedics from a local hospital arrived within eight minutes of the call to 911 but were unable to find a pulse on the woman. The woman had no respirations and had a Glasgow Coma Scale score of 3. Attempts by the paramedics to resuscitate her with a Lifepak 11 monitor and defibrillator failed. Twenty minutes after the paramedics arrived at the woman's home, she was transported to the hospital, where she was pronounced dead.
Her husband brought suit against the hospital on behalf of the woman's estate. He claimed that the paramedics declared that the defibrillator was "not working" immediately after they placed the leads on his wife. According to the complaint filed, the Lifepak 11 had not administered a shock to the woman because of improper battery maintenance. While no malfunction was specifically noted by the hospital, the machine was removed from service after the call and left with an outside on-site service technician for complaints of "intermittent operation." The repairman testified, based on his records, that the machine was functional but that it had expired battery packs. Plaintiff's counsel also went on to point out the fact that electrocardiogram strips from the machine were missing. These strips would have been kept by the hospital for patients who had ventricular fibrillation and were shocked. The plaintiff further contended that even if the strips were not printed at the scene, they could have been printed at a later date from the machine's memory.
The paramedics' supervisor testified that a controversy had existed regarding whether the woman had actually been shocked by the Lifepak 11. Despite that, the machine had a limited memory and had been put back into service a few days later with no EKG strips being printed. The plaintiff claimed that this amounted to spoliation of evidence, because the defendant knew that the machine had never turned or had failed to render a shock. Based on the fact that only the battery pack for the machine's monitor was tested daily, the plaintiff's expert testified that the hospital had inadequate battery maintenance standards. He went on to opine that the hospital's failure to have an inventory system for batteries and a policy requiring the paramedics to keep spare batteries at all times violated industry standards regarding required paramedic equipment.
The defense relied on the fact that it had successfully shocked her twice, intubated her, injected her with medications, and given her cardiopulmonary respiration. The defense conceded that the machine had malfunctioned but that the malfunction occurred late in the rescue effort and only affected the monitor screen and not the treatment of the patient. Once the malfunction was realized, the woman was transferred to the ED, because the paramedics realized there was no other means by which to attempt resuscitation once all measures had been taken. Lending credibility to the defense was the argument that, had the machine malfunctioned, the paramedics would have utilized one of the other machines contained in the other emergency vehicles that arrived soon thereafter, including two other ambulances and at least two fire department vehicles.
The plaintiff's surgery expert testified that the woman would have had a 40% chance of survival if the shocks had been properly administered. Defense experts countered stating that at the time paramedics arrived, the woman had been in cardiac arrest for 10 minutes, making her chances of successful defibrillation and recovery slim. Along with the time frames, the defense introduced evidence of the woman's numerous medical conditions, including insulin-dependent diabetes, uncontrolled hypertension, high cholesterol, smoking, and morbid obesity.
The plaintiff introduced evidence that the woman earned an annual salary of $30,000, and that, based on a life expectancy of 60, her past and future lost earnings, health insurance benefits for her family of eight children, and household services totaled $1.3 million. The jury found the hospital negligent and awarded $5,322,000.
What this means to you: The narrative would indicate that the patient's death would most likely have been the outcome even if the equipment had functioned properly. The paramedic squad did attempt resuscitation prior to the mechanical malfunction without success. The facts presented, if accurate, would have precluded a successful outcome. Even if they did manage to restore cardiac function, the time that had elapsed from the onset of the event to the initiation of transport would have doomed this patient to an anoxic vegetative state.
It appears that the EMS team did all that was possible to effect resuscitation in the home and was unsuccessful. While there was an admission that the defibrillator had indeed failed, the failure was said to have occurred after several successful attempts to shock the patient. There also was evidence that backup equipment was available at the time, so the conjecture is that resuscitation was not possible and the ultimate malfunction by the defibrillator in use did not contribute to that failure and could have been readily overcome by the use of an available substitute.
The apparent issue was the failure of the defibrillator to provide adequate "shock intensity" given the use of expired battery packs. Generally, portable defibrillator units utilize rechargeable batteries, which have a diminishing ability to retain a charge as they age. The expiration date does not necessarily mean that the defibrillator will not operate, but rather that consecutive shocks would prematurely discharge the batteries and/or ultimately cause failure. The expiration date is the manufacturer's safeguard statement to the user that the battery unit is not reliable after that date and should be replaced. Unfortunately, the data stored in the machine's memory were not accessed in a timely fashion and were lost, so proof positive was not available to support the contentions that the woman had already received two shock attempts that had failed.
Now, on top of a failure to properly monitor and replace the batteries is the added failure to maintain the integrity of the effort by failing to follow manufacturer's directions for timely retrieval of data stored in the unit's electronic memory. Had the strips been printed simultaneously with each shock attempt, as recommended in the unit's instruction manual, there would have been proof positive that the unit had delivered sufficient energy to affect resuscitation or that it had not and required substitution.
All of this speaks to staff training and equipment maintenance. It is essential that all equipment be utilized and maintained as recommended by the manufacturer, including policy development, training records, and service logs. Electrical and mechanical equipment by nature is subject to wear and potential failure. Preventive maintenance programs must be utilized and maintained in order to track required service and repairs. Such critical equipment as a defibrillator should have a daily inspection program and maintenance log.
Batteries, in particular, have expiration dates that need to be recorded and inspected. If a battery-powered unit is used more frequently than one would normally expect, the factory-estimated life of the battery may, in fact, be compromised, and the expiration date may need to be adjusted to assure that it still can maintain a charge.
In this case, the jury heard that essential equipment had failed not because of malfunction but because of user negligence. While there was no evidence that the battery life failure had actually contributed to the woman's death, juries are not trained medical professionals. They cannot separate the outcome from appropriate causation factors, such as the extended period of cardiac failure, her various comorbid conditions, and the generally anticipated success of a resuscitation effort in such patients.
The verdict amount also would speak to the fact that the jury was angry that the hospital, through what they had determined to be negligence, had allowed this to happen. Her comorbid conditions and their effect on her life expectancy were not given due consideration, nor was her income level reflective in the $5 million-plus award.
Mediation is a controlled session designed to bring the parties together on a common ground instead of a volatile court room situation where six or more individuals must come to a consensus over two opposing parties. This certainly would be a case where risk management would dictate that the hospital consider mediation. The battery expiration alone was enough to establish liability. The effort should have focused on controlling the damages.
It would have been far easier and less costly to mitigate a more reasonable settlement in the interest of both the plaintiff and the defendant. Had a mediation been attempted, such issues as the patient's state of health, the realistic outcome of prolonged anoxia, and the fact that this family needed an immediate infusion of cash would have played more favorably in the final amount. The results would still have been tragic, but the monetary losses to the hospital not as damaging.
Reference
Case No. 23407/03, Supreme Court, 11th Judicial District, Queens (NY) County.
News: A woman suffered cardiac arrest while at home. Hospital paramedics arrived, but attempts to resuscitate her with a Lifepak 11 monitor and defibrillator failed. Forty minutes later, the woman was pronounced dead. The decedent's estate sued the hospital and was awarded $5.3 million in damages.Subscribe Now for Access
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