The Stroke Litigation Guide

A stroke is characterized by sudden loss of blood circulation to an area of the brain, resulting in a corresponding loss of neurologic function. Strokes are classified as either ischemic or hemorrhagic. Acute ischemic stroke refers to a stroke caused by thrombosis or embolism (blood clot) and is more common than hemorrhagic stroke (vessel rupture). Hemorrhagic stroke, however, is associated with higher mortality rates than ischemic stroke. It is important to differentiate the type of strokes in terms of acute treatment of such vascular disorders.

No matter the type of stroke, once it occurs, brain cells begin to die and brain damage occurs at a rapid rate. When brain cells die during a stroke, the sensory and motor abilities controlled by that area of the brain are lost and are (almost) never fully recovered. These abilities include speech, movement, memory, and other cognitive functions. How a stroke patient is affected depends on where the stroke occurs in the large distribution vessels in the brain and how much brain tissue is affected by the lack of oxygen delivery.

Given these considerations, litigating a case involving a stroke can be difficult because of the different elements that come into play. There can be a claim based on:

At The Expert Institute, we have provided experts for stroke, and stroke-related issues, to attorneys in hundreds of cases. While no two cases are the same, we’ve discovered some commonalities and trends that repeatedly occur. With that in mind, we put together this stroke litigation guide, to provide some insight and knowledge into what elements we found to be most common, and what experts were used most often in these cases.

Scientific Underpinnings of Stroke

On the cellular level, the oxygen-starved neuron becomes depleted of energy and the intrinsic systems at the single cell level begin to fail. It is believed that several intracellular signaling mechanisms result in the release of a number of neurotransmitters (signaling molecules). These activate various degradative enzymes, leading to the destruction of the cell membrane and other essential neuronal structures.

This lack of oxygen also directly results in dysfunction of the cerebral vasculature. A breakdown of the blood-brain barrier occurs within four to six hours after the initial insult. Following the barrier’s breakdown, proteins and water flood into the space surrounding individual brain cells. This leads to vasogenic edema, also known as brain swelling. Vasogenic edema produces greater levels of brain swelling and mass effect that peaks at three to five days and resolves over several weeks.

A major worry of clinicians is the possible transformation of a stroke from ischemic to a hemorrhagic. This conversion represents the conversion of a bland infarction into an area of massive hemorrhage, which has a significantly higher mortality rate. Proposed mechanisms for hemorrhagic transformation include reperfusion (reintroduction of oxygen) to previously injured tissue. This occurs either from surgical correction of an occluded vessel, or collateral blood supply to the oxygen-starved territory. With the disruption of the blood-brain barrier, red blood cells leak from the weakened capillary bed producing a slow hemorrhage that may evolve to a full-blown hematoma.

Prognosis

The prognosis 3 after an acute ischemic stroke varies greatly, depending on the stroke severity and on the patient’s premorbid condition, age, and post-stroke complications.

Stroke rehabilitation is a combined and coordinated use of medical, social, educational, and vocational measures to retrain a person who has suffered a stroke to his/her maximal physical, psychological, social, and vocational potential, consistent with physiologic and environmental limitations.

Evidence from clinical trials supports the premise that early initiation of therapy favorably influences recovery from stroke. When the initiation of therapy is delayed, patients may, in the interim, develop avoidable secondary complications, such as contractures and deconditioning. In addition, many studies show that stroke rehabilitation can improve functional ability even in patients who are elderly or medically ill, and who have severe neurologic and functional deficits.

Significant improvement in extremity function is seen only in the first three months post-stroke. If no return of motor function is noted after more than six months, the prognosis for useful function is likely unfavorable. If no return of voluntary motor function is noted after more than one week, it is unlikely that full use of the affected extremities will return.

Most patients with stroke who undergo rehabilitation have many other associated medical conditions that require professional attention. These problems might be preexisting medical illnesses that necessitate ongoing care (eg, hypertension, diabetes mellitus), secondary post-stroke complications (eg, deep venous thrombosis, pneumonia), or acute post-stroke exacerbations of preexisting chronic diseases (such as angina in a patient with ischemic heart disease).

Management of these conditions can constitute major portions of the rehabilitation effort. Some patients may be more disabled by certain associated comorbid diseases than by the stroke itself. The occurrence of these associated conditions has several implications for management of stroke cases during and after rehabilitation. Essentially, these problems can detract from the benefits of rehabilitation. Some medical problems, such as heart disease, have been found to affect the course and outcome of rehabilitation adversely following a stroke. Intercurrent medical complications can limit the patient’s ability to participate in therapeutic exercise programs, inhibit functional skill performance, and reduce the likelihood of achieving favorable outcomes from rehabilitation.

Issues surrounding treatment

Stroke affects some 750,000 persons yearly in the United States and is the leading cause of serious, long-term disability. Annually over 150,000 deaths are attributed to stroke and approximately 4 million Americans live with the associated complications. In 1998, the annual national cost was in excess of $60 billion, with an average direct cost per case of approximately $59,000.2 The devastating impact of stroke, along with rising expectations for correct diagnosis and treatment, creates fertile ground for malpractice claims. Stroke-associated civil suits generally fall into two areas—informed consent and failure to diagnose, as illustrated by a discussion of treatment issues.

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Tissue plasminogen activator (tPA) has been shown to be effective in reducing the morbidity rate in strokes by approximately 30% when given according to a strict protocol. Efficacy of tPA gradually diminishes over time, approaching that of a placebo at 180 minutes after onset of stroke symptoms. Symptomatic cerebral hemorrhage occurred in approximately 6% of cases, and the rate increased with treatment beyond 180 minutes. tPA use is ordinarily reserved for moderately severe deficits that are not improving while under observation in the emergency department.

Patients with acute stroke may not be able to fully participate in the informed consent process. This can be because of lethargy, impaired communication, impaired recall, or lack of cognitive appreciation of benefits and risks inherent in the use of tPA. Some would consider the risks of systemic or cerebral hemorrhage potentially excessive. As a general protection for both patients and physicians, good informed consent is essential. If the patient is unable to give consent, then the consent should be obtained from a close family member, if possible. While written consent is not required ordinarily, the chart should document the discussion and the family member who was present.

Appropriate elements to discuss would include the potential benefits of using tPA, along with its risks including asymptomatic or symptomatic cerebral hemorrhage, bleeding in other organs, and the possibility of death. Factors raising or lowering the risk or benefit in that patient (eg, recent surgery or other invasive procedures) should be mentioned.

Given widespread efforts to educate physicians and lay communities regarding acute stroke, asserting that tPA is now the standard of care in the appropriate setting would be easy. This puts great burden on the hospital, the ED staff, and consulting neurologists to provide appropriate care or rapid transfer to another facility. As such, an effort is now in place across the United States to certify hospitals as primary stroke centers that meet basic standards of stroke care. These include the availability of CT scanning, neurological evaluations, and timely handling of acute stroke patients.3 Many hospitals have developed a “Code Stroke” approach in this fashion with standardized protocols that allow for rapid implementation of stroke evaluation and care. This typically includes being seen as soon as possible by the appropriate personnel, having the correct diagnostic tests performed, and being administered tPA anywhere from an hour to three hours after the onset of stroke-like symptoms (see chart below). In addition, certain core indicators of quality are being developed to track quality in stroke care.

If a physician elects not to use tPA, the reasons should be documented clearly. Given the potential for long-term disability, refusal of tPA by patients with acute stroke or by their families is somewhat unusual, although not unheard of.

Neurologists may feel pressured to use tPA by the family, by the emergency staff, or by their own desire to reduce disability. A definite onset time is critical; in its absence, the last known neurologically normal period must be used. For example, if the attack begins during sleep, onset must be dated from the night before, unless the patient got up during the night with no deficit. While full consideration of risks and benefits occasionally may mandate using tPA outside the original strict criteria, deviations should be discussed clearly with the patient and/or family and the discussion documented in the chart.

Failure by the hospital to provide essential facilities (24-hour CT technician availability, streamlined care paths in the ED) may create liability for the hospital and/or emergency physicians. In the best interest of patient care and malpractice avoidance, the neurologist should collaborate actively with both emergency staff and hospital administration to guarantee appropriate care or transfer of patients who potentially meet tPA criteria.

Whether tPA should be given by a neurologist or an emergency physician is an evolving issue, with strong partisans espousing each viewpoint. The standard of care continues to evolve and varies with locality. Implicit in the therapeutic potential of tPA is the failure to diagnose acute stroke. It carries liability risk but only if the patient met strict criteria for tPA at the time of assessment. If additional new therapies broaden the therapeutic window, liability risk for failure to diagnose will broaden correspondingly.

Types of Experts Needed

Neurology

Neurology is a medical specialty dealing with disorders of the nervous system. To be specific, neurology deals with the diagnosis and treatment of all categories of disease involving the central and peripheral nervous system; or equivalently, the autonomic nervous systems and the somatic nervous systems, including their coverings, blood vessels, and all effector tissue, such as muscle. A stroke fellowship is frequently attained and is an essential part of training for neurologists interested in gaining expertise in the diagnosis and management of complex problems involving the cerebrovascular system.

Emergency Medicine

In the case of acute stroke, it is the ER physician’s responsibility to coordinate the collaborative effort amongst many physicians for the benefit of the patient. Also, in most cases, the first physician that the patient encounter is in the ER. That physician has the responsibility of gauging the severity of the patient’s stroke and how to proceed from there.

Radiology

Radiology is a medical specialty that employs the use of imaging to both diagnose and treat disease visualized within the human body. Radiologists use an array of imaging technologies (such as X-ray radiography, ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI)) to diagnose or treat diseases such as stroke. Interventional radiology is the performance of (usually minimally invasive) medical procedures with the guidance of imaging technologies to remove clots or clip aneurysms stopping ischemic and hemorrhagic strokes before major damage occurs.

Neurosurgery

Neurosurgery is the medical specialty concerned with the prevention, diagnosis, treatment, and rehabilitation of disorders which affect any portion of the nervous system including the brain, spinal cord, peripheral nerves, and extra-cranial cerebrovascular system. Occasionally, neurosurgeons may be called in to assist in a stroke case that may necessitate surgical intervention. An example would be clipping a hemorrhagic bleed via endovascular therapy or open craniotomy.

Physical Medicine and Rehabilitation

Physical medicine and rehabilitation (PM&R), psychiatrist or rehabilitation medicine, is a branch of medicine that aims to enhance and restore functional ability and quality of life to those with physical impairments or disabilities. A physician having completed training in this field is referred to as a psychiatrist or rehabilitation medicine specialist. Psychiatrists specialize in restoring optimal function to people with injuries to the muscles, bones, tissues, and nervous system (such as stroke patients).

Consultations in Stroke Diagnosis and Treatment

An experienced professional who is sufficiently familiar with stroke or a stroke team should be available within fifteen minutes of the patient’s arrival in the ED. Often, occupational therapy, physical therapy, speech therapy, and physical medicine and rehabilitation experts are consulted within the first day of hospitalization. Consultation of cardiology and vascular surgery or neurosurgery may be warranted based on the results of carotid duplex scanning, neuroimaging, transthoracic and transesophageal echocardiography, and clinical course. During hospitalization, additional useful consultations include the following: