Stroke Misdiagnosis Leads to Locked-in Syndrome

Stroke Misdiagnosis Leads to Locked-in Syndrome 2017-09-21T16:32:29+00:00

Below are excerpts from the Court’s verdict in Farley v. United States, a case this firm tried in 2014. Attorneys Jamal Alsaffar & Tom Jacob tried the case to verdict, and were able to secure a $21.5m verdict for the family. We have excerpted the portions of the opinion that deal with stroke standard of care and treatment.

MEMORANDUM AND ORDER

In October of 2010, Michael Farley experienced symptoms including the loss of his peripheral vision and a painful headache. A veteran of the United States Navy, Mr. Farley sought treatment at the Veterans Administration Medical Center in Manchester, New Hampshire (“Manchester VA”). There, Mr.
Farley was examined and given a series of tests, and he learned that he had suffered a stroke.

It is a basic principle of medicine that a patient who has suffered a stroke is generally at an elevated risk of suffering a second stroke. Therefore, doctors who are treating stroke patients must be cognizant of this risk, and they must take steps to prevent a second stroke from occurring. As such, the established standard of care requires that a stroke patient undergo a thorough diagnostic evaluation to determine the cause of his stroke, and it requires that the patient be prescribed certain medication to treat the underlying condition that caused the stroke to occur.

Unfortunately, Mr. Farley’s doctors at the Manchester VA did not adhere to this standard of care. They failed to provide him with an adequate diagnostic evaluation, and as a result, they carelessly prescribed him the wrong medication. In the words of one of the expert witnesses, Mr. Farley was “medically abandoned” by his doctors.

Approximately six weeks after his initial visit to the Manchester VA, Mr. Farley suffered a second stroke. This second stroke was massive, and it left Mr. Farley with “locked-in” syndrome, meaning that he remains fully conscious, but has no voluntary muscle movement other than the very limited ability to move his eyes and his head.

Now, Mr. Farley’s wife, Jeanice Farley, has brought suit on his behalf under the Federal Tort Claims Act (“FTCA”), 28 U.S.C. §§ 2671 et al. The court held a four-day bench trial from October 21 to October 24, 2014. After considering the trial testimony and the record evidence, it is the finding of this court that two of Mr. Farley’s doctors at the Manchester VA committed medical malpractice and are legally responsible for failing to prevent Mr. Farley’s second stroke from occurring. This memorandum and order will more fully set forth the court’s findings of fact and rulings of law. See Fed. R. Civ. P. 52(a).

II. General Stroke Principles

Broadly speaking, there are two types of stroke. An “ischemic,” or “dry” stroke occurs when the arteries leading to the brain become narrowed or blocked, resulting in reduced blood flow. A “hemorrhagic,” or “wet” stroke occurs when a blood vessel in the brain leaks or ruptures. In this case, the parties agree that Mr. Farley’s first stroke was an ischemic stroke.

With rare exceptions, ischemic strokes can be further categorized as either “thrombotic” strokes, or “embolic” strokes. In this case, while the parties agree that Mr. Farley suffered an ischemic stroke, there is disagreement over whether the stroke was thrombotic or embolic. A thrombotic stroke occurs when a blood clot forms in the arteries that supply blood to the brain. Most commonly, these blood clots result from deposits of a substance known as atherosclerotic plaque, which can accumulate in the arteries.

The plaque deposits can break away and travel through the blood stream to the brain, where they can cause a stroke. Approximately 80% of ischemic strokes are thrombotic in nature. An embolic stroke occurs when the blood clot responsible for causing the stroke forms in another part of the body, and sweeps through the bloodstream, ultimately making its way to the brain and causing a blockage. Approximately 20% of ischemic strokes are embolic in nature and the vast majority of embolic strokes involve “cardioembolic” blood clots, or blood clots that form in the heart.

The evidence established that there are five potential causes of a cardioembolic blood clot: a tumor in the heart known as a myxoma; an infection of the heart valve called endocarditis; a hole in one of the walls of the heart; a disorder known as atrial fibrillation; and the development of a blood clot in the left ventricle attributable to an irregular heartbeat. The parties appeared to agree that Mr. Farley did not have myxoma, endocarditis, or a hole in the wall of his heart. And, as will be discussed below, the weight of the evidence established that Mr. Farley did not suffer from atrial fibrillation. Thus, the vast majority of the trial testimonyrelevant to cardioembolic blood clots focused on whether Mr. Farley had developed a clot in his left ventricle.

Dr. Charash, the Farleys’ expert cardiologist, explained the process through which blood clots may form in a patient’s left ventricle. Dr. Charash explained that, in a normally functioning heart, blood flows in a smooth, laminar fashion as the heart contracts in an efficient and symmetrical fashion.
Dr. Charash drew an analogy to rushing water, explaining that “[i]f you take a river or rapids and throw a plastic cup in, it’s going to go flying down the river. The chance of it just sticking on the side in the rapids is very low because the momentum of the fluid drives it downstream.”

Dr. Charash testified that certain abnormalities in a patient’s heart may allow blood clots to form. This is particularly true, Dr. Charash explained, when the patient’s heart is beating in an asymmetrical fashion. An example of such asymmetry, Dr. Charash testified, would be if certain walls of the patient’s heart were contracting faster or slower than other walls. Dr. Charash and other experts described this condition as a “segmental wall motion abnormality.”
This distinction between symmetrical and asymmetrical weakening of the heart is important. Symmetrical weakening, Dr. Charash testified, refers to a uniform weakening of the heart.

A patient will be said to be suffering from symmetrical weakening when his heart is pumping blood with diminished efficiency, but when the mechanics of the heartbeat are otherwise normal. Dr. Charash explained that this global weakening might occur, for example, as a result of prolonged alcohol abuse, chronic high blood pressure, or a viral disease.

Asymmetrical weakening, on the other hand, refers to a scenario where a patient’s heart exhibits signs of weakening in some areas but not others. Dr. Charash testified that symmetrically weakened hearts are less likely to produce blood clots, while asymmetrically weakened hearts are at much higher risk. Dr. Charash explained as follows:

The global [weakening] group, even though [the heart is] weakened, has symmetric contraction, and that somewhat lessens the risk of forming a blood clot
. . . . [A] segmental wall motion abnormality [] is the one that carries the greatest risk of clot formation.

In a symmetrically weakened heart, Dr. Charash explained, the blood continues to move in a smooth and uniform fashion. In an asymmetrically weakened heart, however, the blood has an opportunity to form eddies or pools because the heart is not expanding and contracting in a uniform fashion. This disrupts the flow of blood and can lead to areas of stagnation where blood clots are likely to form. Dr. Charash again invoked thesame rushing water analogy, explaining that “a blood clot will typically form on a wall of the heart because that’s where the most stagnant flow is, just like in a rapids. The speed is quickest in the center, where on the side it’s slower.”

The evidence established that a cardioembolic blood clot that forms in a patient’s left ventricle is likely to be ejected from the heart into the blood stream. Once in the blood stream, the clot can travel anywhere in the body, but may make its way to the brain and cause a stroke.

III. The Standard of Care

The standard of care applicable to the treatment of ischemic stroke patients is well-settled.

A. SECONDARY STROKE PREVENTION

The evidence conclusively established that patients who have suffered a stroke are at elevated risk of having another stroke, and that the standard of care calls on a doctor treating a stroke patient to take steps to reduce this risk. This process is generally referred to as “secondary stroke prevention.” Counsel for the Farleys used a demonstrative exhibit that set forth five “rules” for doctors in the capacity of treating stroke patients. The first of these rules stated that a doctor should try to prevent a second stroke in a patient who presents with a stroke. Over the course of the trial, every single expert witness stated that he agreed with this rule.

B. THE DIAGNOSTIC PROCESS

Often, as here, the first physician to encounter a patient following a stroke is an emergency room doctor. To successfully engage in secondary stroke prevention, the emergency room doctor must orchestrate a diagnostic process (often referred to by the expert witnesses as a diagnostic “workup”) to identify the cause of the patient’s stroke. The standard of care calls on the doctor to utilize a series of tests and to involve a series of specialists in this process.
As an initial matter, the doctor should order a computed tomography scan (“CT scan”) to obtain imaging of the patient’s brain. This imaging will allow the doctor to assess whether a stroke has occurred and whether the stroke was ischemic or hemorrhagic. It will also allow the doctor to identify the severity of the stroke, as well as the location of the stroke within the brain. Finally, a CT scan may allow the doctor to identify the approximate period of time that the stroke took place.

The standard of care also calls on the doctor to order an imaging study known as a computed tomography angiogram (“CTA”). A CTA is a scan designed to evaluate the arteries in a patient’s head and neck to look for the presence of atherosclerotic plaque. The presence of atherosclerotic plaque may be an indication to the doctor that the patient has suffered a thrombotic stroke.

The doctor should also order a series of tests to assess the patient’s heart. An abnormally functioning heart may be an indication to the doctor that the patient has suffered an embolic stroke resulting from a cardioembolic blood clot. The first of these tests is known as electrocardiogram (“EKG”). An EKG measures the electrical impulses in the heart and can detect the occurrence of a recent heart attack or other anomaly.
The second test of the heart is known as an echocardiogram.

Two types of echocardiograms were discussed at trial: a transthoracic echocardiogram (“TTE”), and a transesophageal echocardiogram (“TEE”). The TEE and the TTE are both echocardiograms, and they share similar acronyms, but they are significantly different tests. A TEE is an invasive procedure that involves sedating the patient and using a probe, inserted orally and into the esophagus, to view the heart from the interior of the chest cavity. Because a TEE views the heart from the rear, it tends to produce superior imaging of the posterior portions of the heart. A TTE, on the other hand, is an echocardiogram that uses technology similar to an ultrasound, and is administered by holding a transducer above the patient’s chest, which produces a visual image of the heart. Unlike the TEE, the TTE views the heart from the front, and therefore tends to produce superior imaging of the anterior portions of the heart. The parties dispute whether the TEE or the TTE is the superior test, but the evidence clearly established that the standard of care calls on doctors to order at least one of these echocardiograms promptly following the patient’s first stroke.

Next, the standard of care calls on the doctor to assess the patient for atrial fibrillation, which, as noted previously, is a disorder that can lead to blood clots forming in a patient’s heart. Atrial fibrillation occurs when electrical signals to the heart are disrupted, causing the upper chambers of the heart to quiver, instead of beating normally and rhythmically. This can result in decreased circulatory efficiency and may put the patient at risk of a cardioembolic blood clot.

To test patients for atrial fibrillation, doctors often prescribe the use of a device known as a Holter monitor. A Holter monitor is a portable heart monitoring device that a patient may wear continuously for extended periods of time. The use of a Holter monitor over a period of several days (or even several weeks) is important. There was much discussion at trial about the difficulty of diagnosing atrial fibrillation. The evidence established that this difficulty stems from the fact that atrial fibrillation is often episodic, meaning that a patient may exhibit symptoms at one point in time, but not another. One of the Farleys’ expert witnesses, Dr. Rutledge, drew an analogy to a set of railroad tracks. Dr. Rutledge testified that simply because a passerby does not happen to see a train at one point in time does not mean that a train did not pass by previously, or that one would not pass by in the future. Thus, the extended use of the Holter monitor increases the likelihood that it will detect evidence of atrial fibrillation.

Finally, the standard of care calls on an emergency room doctor treating a stroke patient to engage the services of both a cardiologist and a neurologist to assess the patient. These specialists bring to bear particularized knowledge of the brain and the cardiovascular system to ensure that the patient receives an accurate diagnosis of the cause of his stroke, and to ensure that he receives appropriate preventative treatment. Separately, the emergency room doctor should take steps to ensure that the patient’s primary care provider (“PCP”) is made aware of the stroke and is integrated into the patient’s treatment.

The involvement of a cardiologist, a neurologist, and the PCP is relevant to a concept known as “continuity of care.” The treatment of stroke patients generally requires a team approach, involving the emergency room physicians who initially treat the patient, a cardiologist, a neurologist, and the patient’s PCP. There was widespread agreement among the expert witnesses that the involvement of all of these doctors increases the likelihood that the patient will be treated properly, that a single physician will coordinate his care, and that, consequently, the patient will have a better outcome.

Because the stroke diagnostic process involves the administration of multiple tests, and the involvement of multiple doctors, the standard of care generally calls for stroke patients to be admitted to the hospital. Multiple expert witnesses testified that doing so serves to facilitate the information-gathering process by ensuring that test results are gathered efficiently, and that experts are promptly engaged and consulted.

In sum, when a patient presents to the emergency room after suffering an ischemic stroke, the standard of care calls on the treating physician to promptly order the following tests (in no particular order): a CT scan, a CTA, an EKG, and an echocardiogram (whether a TTE or a TEE). The doctor should also consider the use of a Holter monitor to test the patient for atrial fibrillation. In addition, the doctor should promptly engage the services of a cardiologist and a neurologist to evaluate the patient, and the doctor should contact the patient’s PCP to make him aware of the stroke and to ensure the continuity of the patient’s care. To facilitate this diagnostic process, the doctor should have the patient admitted to the hospital.

C. TREATMENT

In most cases of ischemic stroke, the treating physician will be able to determine the cause of the patient’s stroke by using the diagnostic process outlined above. As noted, except in rare cases, the stroke will either have been a thrombotic stroke resulting from atherosclerotic plaque in the arteries leading to the brain, or an embolic stroke resulting from a blood clot that formed in the patient’s heart and swept through the bloodstream to the brain. The thoroughness and accuracy of the diagnostic process is critical, because a physician’s prescribed course of treatment for secondary stroke prevention will differ significantly based on the cause of the patient’s first stroke.

Two drugs, Aspirin and Coumadin, are commonly used in secondary stroke prevention. Aspirin belongs to a class of drugs known as antiplatelet agents. Aspirin works to “thin” the blood by preventing blood platelets from binding to one another. As a general matter, Aspirin is considered to be effective as a means of preventing blood clots from forming in the arterial circulation. Thus, if a patient is deemed to be at risk of a thrombotic stroke (meaning a stroke resulting from atherosclerotic plaque in the arteries), the patient may be prescribed Aspirin.

Coumadin belongs to a class of drugs known as anticoagulants. Coumadin prevents clotting proteins in the blood from binding together. As a very general matter, Coumadin is considered to be effective at preventing blood clots from forming in the heart in certain circumstances. Thus, a patient deemed to be at risk of a cardioembolic stroke may be prescribed Coumadin, depending on the situation and a long list of patient- specific risk factors.

Although Coumadin and Aspirin are both used in secondary stroke prevention, they function differently and are intended to treat different causes of stroke. Thus, the decision to treat a patient with Aspirin versus Coumadin is an important one.

Several of the Farleys’ expert witnesses offered helpful and persuasive testimony about the science underlying the formation of blood clots in the arteries and in the heart, and about how Aspirin or Coumadin can alleviate these problems.

Dr. Stein testified that when an individual has atherosclerotic plaque in the arteries leading to the brain, it raises the potential for blood clot formation. Dr. Stein explained that a small piece of the plaque may become slightly detached, causing blood platelets to flock to this area in order to seal the newly-formed opening. These platelets can bind together and form a blood clot, which may then break away and travel through the bloodstream to the brain.

Dr. Stein explained that Aspirin is generally the accepted treatment for patients who have suffered strokes resulting from atherosclerotic plaque. Aspirin works to “thin” the blood by preventing blood platelets from binding to one another, and thus it prevents clots from forming in areas where a piece of atherosclerotic plaque has broken away.

Coumadin is intended to serve a very different function. There was widespread agreement among the expert witnesses that Coumadin is ineffective at preventing strokes caused by atherosclerotic plaque. Rather, Coumadin is intended to treat blood clots that can form inside the heart in certain circumstances. Several of the Farleys’ expert witnesses explained how Coumadin can remedy this situation.

Above, the court outlined the process through which asymmetrical weakening of a patient’s heart can prompt the formation of blood clots in areas of slow or stagnant blood flow. Dr. Charash explained that Coumadin prevents blood clots from forming by suppressing the “chemical chain reaction” that occurs in these areas.
Dr. Stein added further detail by explaining the chemical processes through which pooled or stagnant blood will prompt the formation of blood clots. Dr. Stein testified regarding the role of clotting proteins. These proteins serve a vital function. For example, when an individual suffers a cut to the skin, clotting proteins serve to seal the cut, preventing further blood loss and infection. However, Dr. Stein explained that clotting proteins can also bind together and cause a blood clot in areas where there is stagnation or pooling of blood.

Dr. Frey offered similar testimony. He testified regarding the presence of 13 types of protein molecules in the blood that interact to form what he described as a “spiderweb net” in areas where blood flow has slowed. Dr. Frey explained that this spiderweb will often form the basis of a blood clot.
Drs. Charash, Stein, and Frey offered persuasive testimony that Coumadin is highly effective in blocking the chemical process that causes the clotting proteins to bind together.

Thus, Coumadin is the preferred drug to treat patients who have a blood clot in the heart, or who are at risk of forming a clot in the heart, because Coumadin will dissolve existing clots and prevent new ones from forming.

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