Practice of Medicine
Medication Risk/Benefit Analysis
November 26, 2013
This case involved the death of a 64 y/o old married male secondary to a massive intracranial hemorrhage following a cardiac catheterization performed by our insured cardiologist.
The plaintiff patient had a history of cerebral hemorrhage and DVT. As a result of the stroke, his vision was affected but he did not suffer from mobility problems. Three years later, the patient suffered a heart attack and was referred to our insured cardiology practice. At that time physicians inserted a pacemaker. The patient continued to be followed by cardiologists in this group.
Two years later while on a camping trip, the patient suffered another heart attack. He was admitted to the care of the same cardiologists. One of the group's cardiologists performed a cardiac catheterization on the patient. On the previous day, and at the time of admission, that cardiologist's On-Call partner wrote a progress note stating that the patient was to receive no Integrilin® based on his history. The On-Call partner testified that his note was in no way meant to preclude the use of Integrilin. He meant it as an "advisory" in the event the patient needed catheterization. Our treating cardiologist does not recall seeing this progress note prior to the catheterization. Prior to cardiac catheterization, he gave the patient Lovenox® and Plavix® even though the record clearly stated that no TPA or other thrombolytic agents were to be used due to the patient's predisposition to intracranial bleed. The cardiologist performed an angioplasty, and observed the area of chronic occlusion. He thought the patient would benefit from opening the occluded coronary vessels, and therefore administered Heparin and Integrilin. Heparin was administered at 70 units/kilogram of body weight. When the cardiologist determined that he would be unable to open the occluded artery, he terminated the procedure. He discontinued the Integrilin at the conclusion of the procedure. Later that evening when the cardiologist made rounds, he learned that the patient had suffered a massive intracranial bleed, was in a comatose state, was not expected to survive, and would not benefit from neurosurgery according to neurology and neurosurgery consults. At the family's request, orders were written for "Do Not Resuscitate"; the patient was not intubated nor placed on a ventilator. He died two days later.
At the post death conference, the patient's wife asked the cardiologist why he did not review the chart, and why he gave her husband blood thinners. The cardiologist's response was that no one told him and that he was sorry.
The plaintiff alleged negligence in the administration of the anticoagulant, Heparin, and the platelet inhibitor, Integrilin to the patient during cardiac catheterization, resulting in intracranial hemorrhage and death.
The key issue in this case was our treating cardiologist's failure to review the medical record and to communicate with his partner concerning the patient's sensitivity to Integrilin and other blood thinners. We attempted to mount a defense based upon a theory of "benefit greater than the risk". Defense experts opined that the use of Integrilin on this patient outweighed the risks of hemorrhagic stroke. However, they agreed that substantial defense obstacles included:
- The PDR and package inserts contradicted the cardiologist's decision and treatment plan.
- While the information concerning the use of Integrilin in patients with prior history of stroke may have been somewhat outdated when compared with newer studies, most likely the cause of the patient's stroke was the administration of Heparin.
- There was a question as to whether the intervention to open the patient's right coronary artery blockage, present for years, should have been attempted.
- The patient had not had an MRI or MRA to evaluate his neurological status prior to administering the Integrilin.
- Our insured was poorly prepared for the post death conference with family, making statements which may have implied negligence.
The case was mediated and a compromise settlement of disputed liability was achieved for a moderate amount. There was no determination made of deviation from the Standard of Care.
Risk Management Commentary & Advice
Some lessons to be learned from this classic case scenario are that physicians should implement a standardized approach to "hand off" communications, including allowing an opportunity for the receiving physician to ask and respond to questions. The receiving physician should build in time to conduct a complete review of the patient's history.
In addition, physicians should be well-prepared for family conferences dealing with adverse outcomes. MagMutual Risk Management Consultants can be a resource for physicians who find themselves in this position.
® Integrilin is a registered trademark of Millennium Pharmaceuticals. ® Plavix is a registered trademark of Bristol Myers Squibb/Sanofi Pharmaceuticals Partnership. ® Lovenox is a registered trademark of Sanofi-aventis U.S. LLC. Integrilin is a registered trademark of Millennium Pharmaceuticals. ® Plavix is a registered trademark of Bristol Myers Squibb/Sanofi Pharmaceuticals Partnership. ® Lovenox is a registered trademark of Sanofi-aventis U.S. LLC. Integrilin is a registered trademark of Millennium Pharmaceuticals. ® Plavix is a registered trademark of Bristol Myers Squibb/Sanofi Pharmaceuticals Partnership. ® Lovenox is a registered trademark of Sanofi-aventis U.S. LLC.
The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.