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Legal Review and Commentary
Stent malfunction leads to $35,000 settlement with manufacturer, confidential settlement with hospital
By Blake J. Delaney, Esq., Buchanan Ingersoll & Rooney, Tampa, FL
News: During a routine visit to her primary care physician, a patient had abnormal EKG results and was sent to the emergency department. Interventional cardiologists admitted her and performed several procedures, one of which was a stent. At the time of the procedure, the physicians knew that there had been a malfunction in the materials used, but she was discharged with a normal EKG. Several months later, the woman suffered from a myocardial infarction and underwent bypass surgery. She subsequently brought suit against the manufacturer, hospital, and cardiologists. She successfully settled with the hospital and manufacturer; a defense verdict was rendered in favor of the cardiologists.
Background: In June 2000, a 59-year-old woman underwent an EKG in her primary care physician's office to evaluate a suspected heart-related problem. The results were abnormal and suggestive of a myocardial infarction, which is usually caused when an area of heart muscle dies or is permanently damaged because of an inadequate supply of oxygen to that area. She was sent to an emergency department, where an interventional cardiologist admitted her for telemetry to rule out myocardial infarction. The cardiologist's impression was that she had suffered a myocardial infarction four to five days earlier and was now experiencing recurrent chest pain.
Two days later, the cardiologist performed a cardiac catheterization via the right femoral arterial approach with selective coronary angiography. Single vessel coronary disease was disclosed. The cardiologist then recommended percutaneous transluminal coronary angioplasty (PTCA) and stenting of the left anterior descending artery (LAD). The patient consented, and a second interventional cardiologist performed the PTCA and stenting of the LAD using a guide wire catheter and stent provided by the hospital. When the second cardiologist withdrew the catheter at the end of the procedure, he noticed that the wire's distal tip had unraveled. Fluoroscopy revealed a portion of the guide wire had fractured and snagged a distal portion of the stent, causing the distal portion to become deformed.
After consultations, the first cardiologist performed a coronary angiogram, which revealed a patent proximal LAD with no compromise in the blood flow. It was determined that bypass surgery was not necessary, but the cardiologist decided to dilate the distal irregular portion of the stent with a balloon. Following the dilation, excellent angiographic results were obtained. The guide wire distributor's local representative recommended that the patient be placed on a specific anticoagulant for about six months to reduce the formation of blood clots in order to prevent any future heart attacks, strokes, or blockage of major veins and arteries. At discharge, the patient's EKG was normal.
Two months later, the patient was visiting in California and suffered a myocardial infarction and underwent emergency bypass surgery. The fractured wire and stent were not removed, as doctors felt such an attempt would be too dangerous.
The woman and her husband brought suit against the manufacturer of the stent and the distributor on a products liability theory. They also sued the hospital and the doctors; they claimed the cardiologists were negligent in performing the PTCA procedure, in re-ballooning the deformed stent, and in failing to obtain the plaintiff's informed consent for the procedures. During discovery, re-examination of the lead wire showed that the wire broke because it was overloaded in tension with stresses exceeding its material strength. The plaintiffs settled their products liability suit with the manufacturer and distribution for a total of $35,000. The plaintiffs also settled with the hospital for an undisclosed amount. The cardiologists, however, were granted a defense verdict. The jury found that there was no negligence on the part of the doctors and that the subsequent myocardial infarction could have been the result of natural restenosis.
What this means to you: This scenario underscores the importance of implementing appropriate policies and procedures regarding defective medical equipment. It is simply an inevitable fact that medical equipment occasionally will exhibit a defect or otherwise break down. Having and following appropriate policies, though, will minimize any disruption to a patient's care and, therefore, risk of liability, says Patricia S. Calhoun, JD, RN, of Buchanan Ingersoll in Tampa.
It appears in this case that the hospital did have a policy regarding defective equipment and, just as importantly, it appears that all health care providers involved were aware of the policy. When the interventional cardiologist noticed that the guide wire's tip had unraveled and that a portion of the wire had fractured and snagged the stent, he consulted with the other health care providers about the prudent course of action: The insertion of a balloon rather than bypass surgery. And based on the jury's ultimate finding of non-negligence on the part of the doctors, it appears the doctors' decision was medically reasonable. In fact, further evidence of the appropriateness of the physician's actions, Calhoun notes, is that the California providers, two months later, similarly concluded that no attempt should be made to remove the fractured wire and stent from the patient. Although the California physicians were acting in the context of emergency bypass surgery, their choice to not remove the fractured wire was certainly helpful to the original cardiologists' defense of the plaintiffs' claims.
But although the jury found that the cardiologists did not act negligently in their treatment of this patient, risk managers still can learn from the scenario. As an initial matter, Calhoun is struck by the fact that the guide wire manufacturer's representative recommended that the cardiologists administer a particular brand of anticoagulant to the patient. Although manufacturers often inform physicians of known complications associated with their products, it is ultimately the physician's job to determine what medicine to prescribe.
Moreover, after the physicians had discovered the fractured guide wire and determined that a coronary angiogram and balloon were advisable, Calhoun notes that they should have secured informed consent for the additional procedure from the patient's husband before proceeding. Even though most informed consent forms ostensibly cover "any additional emergency procedures necessary," these savings clauses generally are regarded as weak. In a case such as this one, where a slight delay in obtaining the husband's consent to the additional procedure would not have adversely affected the patient's care, further consent should have been obtained. Calhoun stresses that obtaining extra consent, even to intraoperative changes, can reduce a hospital's exposure and eliminate claims.
Of course, obtaining informed consent is not effective unless the risks and benefits of the procedure are clearly explained to the patient and documented in the patient's record. In a stent procedure, for example, the physician should tell the patients that tearing is possible. "Although obtaining informed consent is generally the realm of physicians, the hospital can ensure that the doctor has obtained the patient's informed consent by implementing a comprehensive informed consent policy," says Calhoun. The policy should include, for example, guidelines on when extra consent needs to be obtained.
Calhoun notes that the modern trend seems to be obtaining informed consent at the doctor's office, with the doctor then forwarding the signed form to the hospital prior to the surgery. This procedure eliminates the chance that nurses will be left to explain risks and benefits to patients, and it ensures that the physician has performed his duty in this regard. A physician-obtained consent is also likely to be more specific than the usually generic nurse-obtained informed consent.
Calhoun recognizes that if the cardiologists had obtained the additional informed consent from the patient's husband in this case, the only claim against the hospital would have been one for negligent credentialing relating to the doctors. A negligent credentialing claim is much easier to defend, especially when the underlying physicians are found to have acted non-negligently. In fact, given the jury's defense verdict as to the cardiologists in this case and that the plaintiffs' other claims were primarily against the catheter manufacturer, the hospital probably could have won this case had it not settled. Calhoun suspects, however, that the risk management team determined that incurring the cost of fighting the plaintiff, coupled with the risk (however minimal) of losing, was outweighed by the settlement offer.
"Whenever a facility learns of a situation like this, risk management should be involved as early as possible to facilitate communication with the patient and the patient's family," says Calhoun. "It is well documented that apologizing for a mistake — even if believed to not be the hospital's fault — and empathizing with the patient dramatically lowers the incidence of claims made against medical providers."