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Lack of Informed Consent Leads to Pacemaker for Young Woman, $4 Million Settlement | Deltona Malpractice Attorney

Lack of Informed Consent Leads to Pacemaker for Young Woman, $4 Million Settlement

When a patient consents to having a surgical procedure done by a physician, he or she does so with the understanding that they will be consulted on important issues related to their care and treatment related to the procedure. A patient wants to know who is performing the surgery as well as all the risks involved. In short, a patient wants to be part of the process.

That didn’t happen for this young woman in her 30s who was seeking surgical treatment for a rapid heart rhythm. Her goal was to stop taking the medication required for this condition so that she could have another child.

Her goal was not achieved after an unknown surgeon performed the surgery without her consent and a new heart condition was discovered. During an ablation procedure, she developed a complete heart block, resulting in placement of a permanent pacemaker and continuation of medications.

The woman, married with three children, wanted to conceive another child. She sought medical advice and treatment in order to safely stop the beta-blockers she was taking for her condition.

For the past 20 years, the woman had had recurrent supraventricular tachycardia (SVT) or rapid heart rhythm with symptoms including excessive sweating, shortness of breath, and mild lightheadedness. The frequency and duration of these symptoms had been increasing, resulting in several visits to the emergency department over the past few years.

To treat her SVT, she had been taking several medications with varying degrees of success in tolerating their side effects. Her family history included both parents with myocardial infarctions or heart attacks and a brother who had a cardiac attack at age 55.

Her doctor referred her to a cardiologist who was board-certified in internal medicine, electrophysiology and cardiology, with extensive experience performing radiofrequency catheter ablations.

After an EKG revealed both a normal ejection fraction and LV function, the cardiologist suggested the patient undergo an electrophysiology study (EPS), followed by a radio-frequency ablation procedure. During that appointment, the cardiologist reviewed with the patient the risks and benefits of the EPS and ablation, providing written literature for both.

The patient signed a consent form for both the EPS study and procedure, which included the following language on risks: “…other complications…damage to heart’s normal conduction system requiring a permanent pacemaker.” The surgery was set for a few weeks later.

Just days before the surgery, the cardiologist found he had a conflict with his schedule and arranged for one of his associates, a physician unknown to the patient and not board-certified, to step in. The patient’s medical record has no documentation to show this was ever explained to her.

The associate cardiologist performed the EPS, which resulted in the expected typical AV node re-entrant tachycardia (AVNRT). The patient then was noted to have sinus tachycardia (HR 120), which was felt to be inappropriate sinus tachycardia or IST. The patient had a history of such episodes with palpitations independent of SVT.

The IST condition requires ongoing treatment with beta blockers, even with an ablation procedure, which meant the woman’s goal of getting off medication would not be realized. Prior to initiating the radio-frequency ablation, the cardiologist contacted the original cardiologist and explained both the AVNRT, as well as the IST. He was instructed to proceed with the ablation.

During the ablation procedure, a junctional rhythm developed and within one second of seeing the heart block, the cardiologist terminated the radio-frequency energy. Heart block is a problem that occurs with the heart’s electrical system, which controls the rate and rhythm of heartbeats.

The patient was observed overnight in the ICU, but a complete heart block persisted, which required the implantation of a permanent pacemaker. Two weeks after the procedure, she was again placed on beta-blockers for the IST condition.

The patient sued both cardiologists, alleging failure to obtain adequate informed consent and improper performance of the radio-frequency ablation procedure, resulting in complete heart block that required placement of a permanent pacemaker, chronic shoulder and arm discomfort, continued symptoms and an ongoing need for medication.

This case went to a jury, which found against both defendants and the case was settled for more than $4 million against the two cardiologists during the appeal. The following factors lead to this successful settlement:

Informed consent was limited to one conversation and a form, weeks before the operation. Proper informed consent means that patients are active decision-makers in their own care. A thorough informed consent helps to set expectations, and a single conversation is not enough. The goal is to ensure that the patient understands the planned procedure, including the risks of doing it and not doing it, as well as alternative treatments.

Two decisions were made without the patient’s consent:

  1. Transferring the procedure to a different, less experienced surgeon who was not board certified; and
  2. Continuing with the ablation after the IST was discovered meant the operation would no longer give the patient the ability to quit medications — her main treatment goal. When one part of a procedure reveals something that changes the risk-benefit scenario of moving forward, doctors must include the patient in the decision. It may even mean stopping and allowing any sedation to wear off and then apprising the patient of the situation. That’s what should have been done this case.

The jury sided with evidence that complication rates are lowered by a doctor’s experience and skill.

For more on medical safety issues, see the library of articles by Daytona Beach medical malpractice attorney.


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