Malpractice defense: tPA Administration Leads to Brain Hemorrhage

In addition to my consulting work and writing the Health Business Blog, I’m chairman of the board of Advanced Practice Strategies, a medical risk management firm that provides litigation support for malpractice defense and an eLearning curriculum focused on enhancing patient safety. Here’s the Advanced Practice Strategies case of the month.

For previous examples see Fetal assessment and response Stroke after lung surgery and Coronary artery disease vs. medication administration.

Illustrated Verdict by APS
Every month APS’s Demonstrative Evidence Group shares case examples from our archives to show how a visual strategy can support the defense effort. We hope that it is of value in your practice as you develop your defense strategies on behalf of health care providers. Please feel free to forward it to colleagues or clients.

About Us
APS is a leading provider of demonstrative evidence for the defense of medical malpractice claims. Our team of medical illustrators consults with defense teams to educate the lay jury audience about the complexities of medical care. We do this by developing a visual strategy with expert witnesses including high-quality case-specific medical illustrations, x-ray enhancements, and multimedia presentations. To learn more, e-mail us or call 877.APS.4500.

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I.V. Library
Click to view other editions:
Fetal Assessment / Response
Stroke After Lung Surgery
Shoulder Dystocia
Spleen Injury and Bleed
Cardiac Artery Disease
Gastric Bypass
tPA Infusion

Judgment for the Defense
tPA Administration Leads to Brain Hemorrhage

Wrongful death from the administration of tPA (Tissue Plasminogen Activator) which led to a fatal brain hemorrhage.

The patient, an 80-year-old woman with severe peripheral vascular disease and impending gangrene in her right leg, was seen by the defendant, a vascular surgeon. She had previously undergone a femoral-tibial bypass in her right leg and had no pulse in her right foot.  Her left leg had already been amputated above the knee after a failed bypass and she was now facing the possibility of losing her right leg.  As a result, she wanted aggressive therapy to save her right leg and was admitted to the hospital for thrombolytic therapy and surgery to revise the graft.

Two days later, an angiogram of the patient’s right leg showed blood clots blocking the distal vessels as well as the bypass graft.  She received intra-arterial thrombolysis to break down the blood clots, after which she suffered a stroke and became nonresponsive. The patient was given a brain CT scan, which showed a large intracerebral hemorrhage and she died within a few days.

Thrombolysis is a common treatment of peripheral vascular disease, either on its own or as a precursor to surgery. The most serious potential side effect is bleeding in various body parts, including the arterial puncture site or in the brain. To minimize this risk, the treatment is not generally administered to patients with a history of intracranial hemorrhage, uncontrolled hypertension, recent stroke, or a bleeding disorder.  However, the patient presented with none of these risk factors.

The defendant testified that he discussed the potential, inherent complications of tPA therapy with the patient, including the possibility of a fatal hemorrhage. The patient, informed of these risks, opted for this aggressive treatment in an effort to save her right leg, rather than undergo an amputation because it would have led to a significant decrease in her functionality and independence.

APS worked with the attorneys and experts to develop a visual strategy that would help explain to the jury in detail how peripheral artery disease presents itself and the issues of treatment:

We began by demonstrating the normal anatomy of the leg and foot.

We also used a posterior view of the normal vasculature to provide a greater understanding of the circulatory anatomy of the arteries and the branches that supply the foot.

We then created illustrations to show, comparatively, the effects of peripheral artery disease in the leg, with cross sections of the vessels and the occlusions that can cut off blood flow.

Next, we showed the patient’s anatomy with a functional femoral-tibial bypass and compared it to a blocked bypass.  This helped demonstrate the severity of blockage in her leg and the lack of blood flow to her foot that resulted.

A visual was also created to show how a clot within a severely diseased leg can lead to gangrene, posing a fatal threat to the patient.   This demonstrated that immediate action was warranted to clear the vessels of the clot.

To help the jury visualize what the defendant was trying to achieve by opening up the blood flow through the graft, we illustrated the tPA infusion (thrombolysis). The pre- and post-treatment films showed the tPA infusion was successful in this regard.

Lastly, we created timelines to help give the jury a better understanding of the patient’s history and the treatment she received while in the hospital.

This combination of illustrations helped the defense successfully explain that:

  • The patient had a very serious condition and needed immediate action to save her limb and her life;
  • The tPA infusion is a commonly accepted therapy to clear clots in vessels; and
  • While the clotting abnormalities induced by the treatment resulted in an unusually large and ultimately fatal hemorrhage, this is an inherent complication. The risk was fully explained to the patient prior to the treatment and she had given her informed consent.

The jury found in favor of the defense.

“APS was very helpful in taking the complex medical issues in the case and simplifying them with the medical visuals.   The timelines that were created were used in the opening and closing statements and I believe they helped solidify the jury’s understanding of the case as a whole.”
— Attorney Dennis R. Anti, Partner, Morrison Mahoney LLP., Springfield MA

August 24, 2009

5 thoughts on “Malpractice defense: tPA Administration Leads to Brain Hemorrhage”

  1. These cases can be won and we did win on the defense side in this instance. We work only on defense cases, supporting the legal team representing physicians. Overall national statistics suggest that defense wins in 70+% of cases, though our win rate is, in the mid 90s. This tPA case is a good example of the effectiveness of an approach—which we endorse—in which the focus is on education of the jury by 1) demonstrating that the standard of care was followed, 2) teaching the medicine, and 3) using strong visual storytelling to make the argument real. Jurors take their responsibility very seriously, particularly in the medical malpractice arena and our experience is that they often get it right; especially when they understand the medicine. Ironically, the tPA issue can show up on both sides of the liability argument. One of our clients responded to the article by saying that they were defending a physician who was accused of injuring a patient by failing to administer tPA, leading brain bleed.

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