Thrombolysis (Tissue Plasminogen Activator-tPA) in Stroke A Medical-Legal Perspective

[CAL/AAEM News Service]

Dear Colleagues,

Here is an article from the Legal Medicine Perspectives, November/December 2006 Vol. 15,
No. 6. This is a publication of the American College of Legal Medicine, an excellent
organization of which I am a member. I encourage others to consider joining at
www.aclm.org. This article describes the legal issues currently surrounding the use or
non-use of thrombolytics in the ED setting. It creates quite a conundrum.

Steven C.Gabaeff, M.D.
President CalAAEM

Note: I have included the article in the body of the email and I have attached a Word
version if the formatting is problematic.

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Thrombolysis (Tissue Plasminogen Activator-tPA) in Stroke A Medical-Legal Perspective

Introduction

This issue’s Colleagues’ Corner examines the medical-legal quagmire that exists when
physicians are faced with the decision to use thrombolytics in the treatment of acute
strokes. This article is an edited version of the recently published article in Stroke on
the subject by Michael I. Weintraub, MD, FACP, FAAN. As. Dr. Weintraub makes clear
despite the success of the 1995 National Institutes of Neurological Disorders and Stroke
(NINDS) study using IV recombinant tissue plasminogen activator (tPA) within 3 hours in
acute stroke and its subsequent FDA approval, there has been a reluctance to use tPA
because of safety and efficacy issues with high incidence of intracerebral hemorrhage,
and protocol violations. This article and the cases will illustrate the increased number
of malpractice lawsuits generated by the controversy over the “standard of care” and
educate clinicians regarding several specific issues surrounding tPA and how to avoid the
legal pitfalls. Overall, his extensive review has led Dr. Weintraub to conclude that
neurologists, emergency room physicians and hospitals are at increased liability risk if
they use or do not use tPA. Detailed documentation, informed consent or timely transfer
should reduce threat of legal action. This article is likely to generate opinions pro and
con. Accordingly, the editors of LMP encourage the Fellows and Members of the ACLM to
file their concurring and dissenting opinions on LEGALMEDNET so that we may all benefit
from our collective knowledge. 

Article

Acute ischemic stroke is a leading cause of death and disability in the United States.
One-third of patients who experience stroke die within 1year. It has been estimated that
~600 000 new cases occur yearly. In1995, 624 patients were randomized in the National
Institute of Neurological Diseases in Stroke (NINDS) study demonstrating that intravenous
recombinant tissue plasminogen activator (rtPA, alteplase) produced clinical and
statistical benefit over placebo for patients treated within 3 hours of evaluation.
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERSAND STROKE, TISSUE PLASMINOGEN ACTIVATOR FOR
ACUTE ISCHEMIC STROKE 333 N ENGL J MED. 1581-1587 (1995). The benefits also appear to be
long lasting at 3 months and 1 year as well as cost-effective, thus generating a great
deal of enthusiasm. Specifically, it was stated that if the guidelines for eligible
persons were followed within a 3-hour time period then there was at least 30% more likely
to have minimal or no disability at 3 months and a 3-month mortality of 17%. There was a
6.4% risk of intracerebral hemorrhage. Id.; NINDS tPA Stroke Study Group, Intracerebral
Hemorrhage after Intravenous tPA Therapy for ischemic Stroke28 Stroke 2109-2118 (1997).
On the basis of these results, alteplase (rtPA) was approved in the United States for use
within 3 hours of onset of symptoms. However, closer scrutiny of this study raised
methodologic concerns that there was an imbalance in stroke severity scores between
groups from 90 to 180 minutes. Specifically, the placebo-treated group had more severe
strokes than the tPA-treatment groups, and thus the results favored the mild stroke
groups. HOFFMAN J. IV T-PA INTERVENTIONALTHERAPY FOR ACUTE STROKE PATIENTS: NEGATIVE
POSITION. Stroke Interventionalist .2002; 11:6-10; SOLOMON R, HOFFMAN J. TPA FOR ACUTE
ISCHEMIC STROKE: THESTANDARD OF CARE? ACEP NEWS. 2001; MAY; LENZER J. ALTEPLASE FOR
STROKE: MONEY AND OPTIMISTIC CLAIMS BUTTRESS THE “BRAIN ATTACK” CAMPAIGN. BMJ.2002;
324:723–726. Others felt that chance could explain the benefits. A prior European
multicentered trial (ECASS I) of 620 patients used a maximum interval from onset to
treatment of 1.1 mg/kg with 6-hour window. HACKE W ET AL. INTRAVENOUS THROMBOLYSIS WITH
RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR FOR ACUTE HEMISPHERIC STROKE. THE EUROPEAN
COOPERATIVEACUTE STROKE STUDY (ECASS). JAMA. 1995; 274:1017–1025. This was a higher dose
than used in the NINDS trial and resulted in a negative study with no difference between
treatment and placebo groups. A high degree of protocol violations were also noted.
Mortality was increased33% as well as increased intracerebral cerebral hemorrhage in the
treatment group of 40%. A follow-up study ECASS II of 800 patients was subsequently
designed with a lower dose of alteplase (0.9 mg/kg) which was identical to NINDS criteria
given IV within 6 hours of onset. HACKE W ET AL. RANDOMIZED, DOUBLE-BLIND,
PLACEBO-CONTROLLED TRIAL OF THROMBOLYTICTHERAPY WITH INTRAVENOUS ALTEPLASE IN ACUTE
ISCHEMIC STROKE (ECASS II). SECONDEUROPEAN-AUSTRALASIAN ACUTE STROKE STUDY INVESTIGATORS.
LANCET.1998; 352:1245–1251. Stricter criteria were followed as well as CT eligibility and
blood pressure control parameters. The results indicated that mortality was not increased
and supported the use of dose of 0.9mg/kg within 3 hours of stroke onset. However, there
was a 2-to-5-fold increase in symptomatic intracerebral hemorrhage.

The Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke
(ATLANTIS) study, a phase 3, placebo-controlled trial of 547 patients, used a protocol
similar to NINDS trial using tPA in a 3-to-5-hour window. Treatment with tPA basically
was ineffective. CLARK WM, WISSMAN S, ALBERS GW, JHAMANDAS JH, MADDEN KP, HAMILTON S.
RECOMBINANT TISSUE-TYPE PLASMINOGEN ACTIVATOR (ALTEPLASE) FOR ISCHEMIC STROKE 3 TO5 HOURS
AFTER SYMPTOMS ONSET. THE ATLANTIS STUDY: A RANDOMIZED, CONTROLLED TRIAL. ALTEPLASE
THROMBOLYSIS FOR ACUTE NON-INTERVENTIONAL THERAPY IN ISCHEMIC STROKE. JAMA. 1999; 282:
2019–2026. However, a Cochrane review using meta-analysis of various types of
thrombolysis, including tPA, urokinase, streptokinase, etc, concluded that this therapy
was effective. Some critics would argue that the conclusions of the Cochrane review are
not always considered valid. BJORDAL JM, BOGEN B, LOPES-MARTINS RA, KLOVNING A. CAN
COCHRANE REVIEW IN CONTROVERSIAL AREAS BE BIASED? PHOTOMED LASER SURG. 2005; 23: 453–458.
REANALYSIS OF THE ORIGINAL NINDS TRIAL CONFIRMED BENEFIT. KWIATKOWSKI T ET AL. NIH STROKE
RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR STROKE STUDY GROUP. THE IMPACT OF IMBALANCES IN
BASELINE STROKE SEVERITY ON OUTCOME IN THE NATIONAL INSTITUTE OF NEUROLOGICAL
DISORDERSAND STROKE RECOMBINANT TISSUE PLASMA ACTIVATOR STROKE STUDY. ANN EMERG MED.
2005; 45:377–384.

A disturbing community study from the Cleveland area’s experience revealed that 2% of
admitted patients with acute ischemic stroke received intravenous tPA. There was a 50%
incidence of protocol deviation from national treatment guidelines. In-hospital mortality
was higher among treated patients (16%) compared with placebo (5%) and there was a 16%
rate of intracerebral hemorrhage with a 55% mortality in this group. These findings
significantly differed from the NINDS trial. KATZAN IL ET AL. USE OF TISSUE-TYPE
PLASMINOGEN ACTIVATOR FOR ACUTE ISCHEMIC STROKE: THE CLEVELAND AREA EXPERIENCE. JAMA.
2000; 283: 1151–1158.

In August 2000, the American Heart Association upgraded its recommendation of tPA for
stroke from optional (Class IIB) to definitely recommended (Class I) despite safety and
efficacy concerns from the treatment. Several national groups made position articles
contrary to the above. Of note, all four major emergency medicine organizations in North
America, i.e. the American College of Emergency Physicians (ACEP), the American Academy
of Emergency Medicine (AAEM), the Society for Academic Emergency Medicine (SAEM), and the
Canadian Association of Emergency Physicians (CAEP) have explicitly refused to endorse
tPA as standard of care in their position papers. These organizations represent over
40,000 emergency physicians who are at the forefront of care and this fact cannot be
ignored by the AHA/ASA and needs to be addressed. Further, the Canadian Association of
Emergency Physicians (CAEP) has stated that “further evidence is necessary to support the
wide-spread application of stroke thrombolysis outside of research settings.” CAEP
COMMITTEE ON THROMBOLYTIC THERAPY FOR ACUTE ISCHEMIC STROKE. POSITION STATEMENT ON
THROMBOLYTIC THERAPY FOR ACUTE ISCHEMIC STROKE. CANADIAN ASSOCIATION OF EMERGENCY
PHYSICIANS. CJEM 2001; 3:8 –12. AVAILABLE AT:
WWW.CAEP.CA/002.POLICIES/00202.GUIDELINES/THROMBOLYTIC.HTM . Also, the American Academy
of Emergency Medicine reached a similar conclusion and has stated that: “objective
evidence regarding the efficacy, safety, and applicability of tPA for acute ischemic
stroke is insufficient to warrant its classification as standard of care.” AAEM WORK
GROUP ONTHROMBOLYTIC THERAPY IN STROKE. POSITION STATEMENT OF THE AMERICAN ACADEMYOF
EMERGENCY MEDICINE ON THE USE OF INTRAVENOUS THERAPY IN THE TREATMENT OFSTROKE. AVAILABLE
AT: WWW.AAEM.ORG/POSITIONSTATEMENTS/THROMBOLYTICTHERAPY.HTML . Critics of the AHA’s
approval based only on 1 NINDS study led to further investigation demonstrating that in
the minutes of AHA Board of Directors meeting of October 18, 1991, Genentech contributed
$2.5 million to build the Dallas headquarters of AHA, and subsequent contributions to AHA
have totaled $11 million. LENZER J. ALTEPLASE FOR STROKE: MONEY AND OPTIMISTIC CLAIMS
BUTTRESS THE “BRAIN ATTACK”CAMPAIGN. BMJ. 2002; 324:723–726. A panel of nine was
responsible for the guidelines and 1 investigator noted that six out of eight panelists
who supported alteplase for stroke as a Class I recommendation had ties to the
manufacturer. The specific decision, however, to approve could have been reflective of
scientific analysis of the data rather than the alleged taint of financial conflict. Two
panelists who supported the upgraded classification had no ties to the manufacturer and
one physician dissented from the recommendations.

Currently, there is a major disconnect between advocates who believe the AHA position has
sufficient data to justify Class I position contrasted by critics who do not believe tPA
should represent the standard of care in acute ischemic stroke. Though industry
participation was acknowledged in the NINDS study, the AHA has never acknowledged any
conflict of interest of its panelists and continues to hold financial “disclosures"
secret. The implication of financial taint as well as refusal to release the NINDS raw
data under the Freedom of Information Act to the British Medical Journal has only fueled
this controversy. Further, there has been growing skepticism regarding industry-sponsored
studies and this has been recently addressed in editorials in Neurology as well as JAMA.
CHADWICK D, PRIVATERA M: HOW SKEPTICAL SHOULD WE BE ABOUT INDUSTRY-SPONSORED STUDIES?
NEUROLOGY 2006; 67: 378-379; FONTANAROSA PB, FLANAGIN A, DEANGELIS CD: REPORTING
CONFLICTS OF INTEREST, FINANCIAL ASPECTS OF RESEARCH AND ROLE OF SPONSORS IN FUNDED
STUDIES. JAMA 2005; 294: 110-111; DAVIDOFF F, DEANGELIS CD, DRAZEN JM, ET AL.
SPONSORSHIP, AUTHORSHIP AND ACCOUNTABILITY.JAMA 2001; 286: 1232-1234; DEANGELIS CD,
FONTANAROSA PB. UNREPORTED FINANCIAL DISCLOSURES IN A STUDY OF MIGRAINE AND
CARDIOVASCULAR DISEASE.JAMA 2006; 296:653-654.

Current Catalyst

Despite the debate regarding efficacy and safety of tPA in acute ischemic stroke, there
has been significant pressure exerted on physicians and hospitals to expand its use. In
2000, the Brain Attack Coalition (BAC) proposed numerous specific criteria for developing
academic primary stroke centers so that a standardized treatment would prevail which
would facilitate early treatment. None of the 11 BAC recommendations was associated with
the reduction of in hospital mortality or an increased frequency of discharge to home.
ALBERTS MJ ET AL.RECOMMENDATIONS FOR THE ESTABLISHMENT OF PRIMARY STROKE CENTERS. BRAIN
ATTACK COALITION. JAMA. 2000;283:3102–3109; DOUGLAS VC, TONG DC,GILLUM LA, ZHAO S, BRASS
LM, DOSTAL J, JOHNSTON SL. DO THE BRAIN ATTACK COALITION’S CRITERIA FOR STROKE CENTERS
IMPROVE CARE FOR ISCHEMIC STROKE? NEUROLOGY. 2005; 64:422– 427.

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) began
certifying primary stroke centers in 2005 using guidelines based on the American Stroke
Association and BAC. JOINT COMMISSIONON ACCREDITATION OF HEALTHCARE ORGANIZATIONS.
PRIMARY STROKE CENTERS.JULY 13, 2004. AVAILABLE AT: 
WWW.JCAHO.ORG/DSCC/PSC/INDEX.HTM  . Several states’ health departments (New York,
California, North Carolina) have been active in trying to create community stroke
centers. New York State has compelled emergency medical services to divert appropriate
stroke patients past a closer hospital to a state designated stroke center within 2
hours. CAMILO O, GOLDSTEIN LB. STATEWIDE ASSESSMENT OF HOSPITAL BASED STROKE PREVENTION
AND TREATMENT SERVICES IN NORTH CAROLINA. STROKE.2003; 34: 2945–2950; CALIFORNIA ACUTE
STROKE PILOT REGISTRY (CASPR) INV. PRIORITIZING INTERVENTIONS TO IMPROVE RATES OF
THROMBOLYSIS FOR ISCHEMIC STROKE. NEUROLOGY. 2005; 64:654–659.

Medicare has now created a new DRG 559 code for “acute ischemic stroke with use of
thrombolytic agent” which pays about $6,000 more than the previous DRG 014. TONG D.
STROKE CERTIFICATION AND YOU: WHAT DOES THE FUTURE HOLD? PRACTICAL NEUROLOGY. 2005;
21–23.

Current Standard of Care

It is clear that currently there is no universal standard of care. SOLOMONR, HOFFMAN J.
TPA FOR ACUTE ISCHEMIC STROKE: THE STANDARD OF CARE? ACEP NEWS. 2001; MAY. Less than 2%
of community hospitals use tPA. The anticipation that this number will increase is
attributable to the direction of Board of Health, JCAHO and Medicare. It is also clear
that there are strong advocates and critics as well as cautious, concerned clinicians and
the practicing physician and patient are in the middle of a quagmire. CAPLAN LR.
THROMBOLYSIS 2004: THE GOOD, THE BAD AND THE UGLY. REV NEUROL DIS. 2004; 1:16 –26; CAPLAN
LR. EVIDENCE-BASED MEDICINE: CONCERNS OF A CLINICAL NEUROLOGIST. J NEUROL NEUROSURG
PYSCH. 2001; 71:569 –576; CAPLAN LR. TREATMENT OF ACUTE STROKE. STILL STRUGGLING.
JAMA.2004; 292: 1883–1885.

What is the correct decision? This is currently not known from the literature, yet this
has not stopped the generation of civil (medical malpractice) lawsuits for both the use
and nonuse of tPA. MCINTYRE K MEDICOLEGAL IMPLICATIONS OF THE CONSENSUS CONFERENCE:
CHEST. 2001; 119:337S–343S; PHYSICIANS RECIPROCAL INSURERS. DOCUMENTATION OF MEDICAL
REASONING/JUDGEMENT. ALERT: 2006; 1. There has been a shift in court thinking to accept
“community care” rather than standard of care (nationwide). Thus, if neighboring
hospitals are designated stroke centers, individuals may be held to an elevated
criterion.

Definitions

“Malpractice” is defined as any medical treatment that fails to conform to the standard
of care within the profession and that proximately results in injury to the patient.
Plaintiffs have the burden of proving their case by a preponderance of the credible
evidence (51%). They must show that there was a departure from standard and accepted
medical practice and that this departure caused or was a substantial contributing factor
causing the alleged injuries. Current tort law requires a physician-expert statement of
deviation and negligence in order to initiate a lawsuit. In many states, any licensed
physician can testify as an expert. Expert witness testimony is often indispensable in
medical malpractice outcomes with opinions offered on behalf of both plaintiffs and
defendants. Guidelines exist as to the qualifications in many specialty organizations.

In the United States, physicians and hospitals are involved in lawsuits whether they use
or do not use tPA. Although all medical malpractice claims measure a physician’s actions
against a standard of care, how does one address this issue in controversial and evolving
standards of care? 

“Maloccurence” is defined as a negative outcome based on the natural history of the
condition. There is often a fine line between negligent medicine and poor quality of care
or inherent risks of disease. Persuaded by partisan expert witnesses, the jury often
cannot tell the difference between medical malpractice and maloccurence, standard of care
and evolving standard of care. These issues are of paramount importance because there is
a major thrust by national organizations to expand the number of stroke centers in the
United States. It is clear that physicians in hospitals are faced with increased
malpractice risk in dealing with stroke and thrombolysis.

Elements of a Malpractice Claim

Currently, there is a marked increase in the number of lawsuits regarding stroke and tPA.
PHYSICIANS RECIPROCAL INSURERS. DOCUMENTATION OF MEDICALREASONING/ JUDGEMENT. ALERT:
2006; 1. Physicians are currently being sued if they treat or do not treat with tPA. This
topic is somewhat complex but usually revolves around several issues relating to
documentation, informed consent, etc. Inherent in this is the fact that there are
protocol deviations noted with absence of National Institutes of Health Stroke Scale
(NIHSS) in 84%, and a recent retrospective analysis study revealed that one major
protocol deviation in 67% and 97% had combined major and minor protocol deviations. When
protocol deviations arise, there is increased mortality and morbidity. DENG YZ ET AL. IV
TISSUE PLASMINOGEN ACTIVATOR USE IN ACUTE STROKE. EXPERIENCE FROM A STATEWIDE REGISTRY.
NEUROLOGY. 2006; 16:306 –312; BRAVATA DM, KIM N, CONCATO J, KRUMHOLZ HM, BRASS LM.
THROMBOLYSIS FOR ACUTE STROKE IN ROUTINE CLINICAL PRACTICE. ARCH INT MED. 2002; 162:
1994–2001.

The Locality Rule, which calls for physicians to be judged according to the standards of
practice in their communities, has been in decline because of the explosion of
information on the Internet, etc. The current burgeoning of local stroke centers in the
community has now produced a change from “nationwide standard of care” to “standard of
community care.”

“Competence (testamentary capacity)” is the threshold element of informed consent because
only a competent person can give valid consent to treatment or treatment refusal.
Physicians are obligated and must make an assessment of the individual's capacity or lack
of capacity before accepting a patient’s consent or refusal as being informed. Thorv. The
Superior Court of Solano County, 855 P 2d. 375, 381 (Cal.1993). Under emergency
situations where the patients lack testamentary capacity, the physician should turn to a
family member for consent if time and circumstances permit. It is noteworthy that a
recent study found a substantial percentage of patients who received tPA for stroke had
no consent documented. Surrogates often provided consent (63%) despite patients having
capacity. Additionally, patients with diminished capacity sometimes provided their own
consent. In one study 16%, of stroke patients treated with tPA had no documented informed
consent. ROSENBAUM JR, BRAVATA DM, CONCATO J, BRASS LM, KIM N, FRIED TR. INFORMEDCONSENT
FOR THROMBOLYTIC THERAPY FOR PATIENTS WITH ACUTE ISCHEMIC STROKE TREATED IN ROUTINE
CLINICAL PRACTICE. STROKE. 2004; 35:353–355.

“Informed consent” refers to the legal principle that patients have the right to make an
informed judgment as to their care after receiving the pertinent facts regarding a
proposed treatment option rather than the appropriateness of the treatment. Informed
consent should include statements regarding the condition being treated with its
associated morbidity and mortality and if a specific treatment is being offered, describe
state of current knowledge, i.e., accepted standard of care or controversial therapy as
well as risks associated, and specifically describe hemorrhage into the brain, spinal
cord and death. Because of the critical 3-hour time window, physicians must offer a
timely transfer and this must be documented to both the patient and/or family
(surrogate).Failure to do so may result in liability.

Documentation

This issue is critical to the success or failure of a lawsuit. Despite all allegations,
legible documentation remains the key factor that leads to success or failure of a claim
in a significant number of cases. Because the time of the trial is often years later, an
accurate memory for the events can be reflected only by the records. Physicians need to
adopt good habits of documentation to be aware of their obligations. A number of
malpractice cases have been reported to a large malpractice insurer and were found to be
“difficult to defend, not because of the medical care, but because the physicians did not
document their thought processes in the medical records.” PHYSICIANS RECIPROCAL INSURERS.
DOCUMENTATIONOF MEDICAL REASONING/ JUDGEMENT. ALERT: 2006; 1. An Alert bulletin was sent
out urging physicians to document the reasons for their decisions, particularly when
there are multiple acceptable therapies to treat a patient’s condition. Id. Specifically,
legible records should reflect the time of onset, the time of workup completion, the
diagnosis and differential diagnosis as well as the proposed treatments. Specifically,
the use of tPA or lack of tPA should be described in the chart. Thus, good clinical care
is not sufficient if the medical record does not adequately document that care. The
records should reflect the diagnosis and proposed treatment and the bases for them, etc.
In the absence of documentation, the litigation may come down to the word of the injured
patient or his family versus the memory and reputation of the physician defendant. Poor
medical records can suggest negligence to the jury. WEINTRAUB MI. DOCUMENTATION AND
INFORMED CONSENT. NEUROLOGIC CLINICS OF NORTH AMERICA. IN: WEINTRAUB MI, ED. MEDICAL AND
LEGAL ASPECTS OF NEUROLOGY. PHILADELPHIA, PA: W.B. SAUNDERS; 1999, 371–381.

Methodology

A legal search of Jury Verdict Reporter (JVR) in Lexis and Westlaw regarding thrombolysis
(tPA) and malpractice produced various case reports related to the heart, peripheral
arterial and venous disease and stroke. The following cases were selected to illustrate
and represent the types of malpractice lawsuits generated that should be of concern to
neurologists, emergency room physicians and hospitals. It does not represent a selection
bias and I hereby affirm that I personally do not know or have any relationship with any
of the individual parties or their attorneys.

As will be noted, these vignettes are inconsistent in detail from venue to venue and were
submitted not by physicians but by the involved successful attorney to JVR which may also
have edited the vignette. Hospital records, deposition or trial testimony transcripts
were not personally reviewed for more detailed clinical information. However, the Courts
and Arbitration panels in each of these cited cases accepted the alleged damages as
representing “stroke.”

A. Failure to Use tPA. Absence of a Specific Hospital Protocol

Reed v. Grandbury Hospital, 117 S.W.3d 404 (Tex. App. Ft. Worth2003)

Plaintiff experienced stroke-like symptoms and was taken to a local hospital 10 minutes
away. His wife (nurse) wanted tPA to be used but Emergency Room physician (defendant) did
not choose this option and wife transferred him to local Fort Worth Hospital for specific
tPA treatment. He arrived outside the 3-hour window and did not receive treatment. The
original defendant hospital did have tPA available and had a written protocol for
administering only to cardiac patients. The Trial Court determined that both of the
Plaintiffs’ experts were not qualified to opine on the standard of care for the hospital
defendant with respect to tPA protocols. Id. at 408. As a result, the Court granted a no
evidence summary judgment for the defendants with respect to the hospital's negligence.
Id. at 408. Despite plaintiff’s expert, the Court stated that there was no showing that a
common or universal standard of care for administering tPA to stroke patients applied to
both physicians and hospitals or even to all physicians. The case was appealed and the
Court of Appeals affirmed the Trial Court’s decision.

B. Failure to Offer tPA or Promptly Transfer to Another Hospital

Mei v. Kaiser Permanente South San Francisco Medical Center

In 2001, 45-year-old woman (plaintiff) experienced a stroke while driving. An ambulance
took her to local hospital (defendant). The Emergency Room doctor diagnosed her with
“depression and stress" for her symptoms of aphasia, inability to walk and facial
weakness. A neurologist did not see her for a total of 6 hours. An arbitrator found
negligence.

Lane v. TH Allied Services IC

In 1996, plaintiff experienced a stroke after an endoscopy procedure at Boone City
Hospital (defendants). An emergency CAT scan was ordered and performed revealing findings
compatible with ischemic stroke. The attending physician recommended transfer to the
Intensive Care Unit (ICU) and emergency treatment with tPA. However, the orders for
transfer and administration of treatment of tPA were not carried out. A Neurology
consultation was called to determine whether anything else could be done after 3 hours.
She then started tPA 6 and a half hour after the onset of symptoms. There was no benefit
and the patient had residual dysphasia and hemiparesis. There was a plaintiff’s
settlement of $500,000.

Herbert Paige and Annette Paige vs. HCA Health Service of Florida, Inc. d/b/a Blake
Medical Center: Robert C Gessner MD, and Steven A Norris, M.D. Manatee County (Fl),
Circuit Court. Case No 2000 CA-1895.

Plaintiff experienced an ischemic stroke in February 1998 and was brought to Blake
Medical Center (defendant) where he was evaluated by Emergency Room physician
(defendant). The on-call neurologist (defendant) examined the patient and spoke with
patient and physician on regarding treatment options and they decided on heparin. A
second neurological opinion was sought and it was later determined that plaintiff was a
candidate for tPA treatment. Defendant neurologist stated that this was untrue because
symptoms were improving. Because of residual damages, the patient and his wife filed a
lawsuit against defendant medical center and all involved physicians for failure to
recommend tPA. A settlement of $50,000 was reached with defendant hospital. The claims
against defendant Emergency Room physician were dismissed before trial. A defense verdict
was returned for defendant neurologist.

C. Stroke Misdiagnosis as Vertigo and Loss of Chance

Fernandez v. University of Pennsylvania. MOORE’S MONTHLY MEDICAL LEGAL REPORT NO 2,
OCTOBER 2003.

Fifty-seven year-old male (plaintiff) with prior history of stroke complained of sudden
headache, blurred vision, dizziness and weakness. He went to the local hospital
(defendant) Emergency Room where Emergency Room physician (defendant) diagnosed vertigo
and sent him home. He was on clopidogrel (Plavix) for prior stroke prophylaxis. He
returned several times to the Emergency Room and ultimately was admitted with stroke
symptoms of slurred speech, incontinence, right facial numbness and inability to walk. A
lawsuit ensued for failure to diagnose stroke and loss of opportunity to give tPA,
because it was alleged that this intervention could have significantly improved outcome.
Verdict: $5 million to plaintiff.

D. Complications of Therapy/Failure of Informed Consent

Brooks v. SSM HealthCare and Fernando DeCastro, MD 73 S.W.3d686 (Mo. Ct. App. 2002).

The plaintiff brought actions against the doctor and hospital for negligently
administering tPA, which rendered the patient quadriplegic secondary to cervical epidural
hematoma. She required two surgeries and was left with permanent incontinence of
bowel/bladder, flaccid quadriplegia and wobbly head. A jury awards plaintiff $315,000 but
defendant requested a new trial, which was granted by the Trial Courts, a decision that
was reviewed by the Court of Appeals. While defendant cardiologist was using the drug for
a cardiac condition, he did not specifically mention bleeding and also used higher
amounts of tPA. Defendant cardiologist contested the plaintiff’s neurology expert’s
qualifications in his rendering of the opinion because he did not have knowledge of tPA
as it applied to the heart rather than the brain. The Court of Appeals reversed the Trial
Court’s decision to grant a new trial and reinstated the jury verdict.

E. Hemorrhagic Stroke After tPA/Informed Consent

Wilma Harris and Phillip Harris vs. Oak Valley Hospital District, Mohammed S. Al-Husan
MD, Stanislaus County (CA) Superior Court, Case # 387697.

Plaintiff was a 65 year-old female who presented to the Emergency Room with stroke-like
symptoms and hypertension. A CAT scan revealed an ischemic stroke and tPA was started.
She subsequently developed an intracerebral hemorrhage producing permanent damages of
dysphasia and walking difficulties and started a malpractice suit alleging that the tPA
should not have been given and that her blood pressure was not adequately controlled and
that her symptoms were rapidly resolving before the inappropriate administration of tPA.
The defense argued that the patient and family received appropriate informed consent and
that her blood pressure was in the appropriate range and under good control. A defense
verdict was reached.

Expert Witness Testimony

The following 2 cases illustrate the influence of expert witness testimony in failure to
offer tPA or transfer to local stroke center.

Ensink v. Mecosta County General Hospital, 687 N.W.2d 143 (Mich.Ct. App. 2004).

The patient was brought to local hospital with sudden paralysis. Stroke work-up was
concluded 2 hours after onset but tPA was not given and residual damages occurred
generating a lawsuit for allegations of loss of chance, failure to transfer and failure
to treat. Dr. S. Levine, a stroke neurologist expert for plaintiff, admitted that he
could not say how much the patient’s condition would have been expected to improve in
this last available hour of window but that “it was more likely than not that there would
be “some improvement.” He also acknowledged that there was a “20% spontaneous improvement
without tPA.” The Trial Court approved summary judgment for the defense but the patient
appealed. The Court of Appeals felt that plaintiff neurological expert's testimony was
“speculative” and that the patient could not show that opportunity to achieve better
results exceeded 50% had tPA been given by ER within 3 hours. The decision was affirmed.

Woodcock v. Caragher, MD, 849 N.E.2d 1258 (Mass. 2006) 

The patient (plaintiff) was brought to Emergency Room of Addison Gilbert Hospital
(defendant) after experiencing a “severe stroke.” Dr. Caragher (defendant) decided not to
treat with tPA or transfer to another hospital. The patient had acute breast cancer with
lymph node metastases, a falling hematocrit and was receiving chemotherapy. The
defendant's expert witness, Dr. Fred Hochberg, a well-known neuro-oncologist at
Massachusetts General Hospital, stated that he was familiar with an NINDS study published
in December 1995. He stated that there were no patients with breast cancer in the NINDS
study. He also stated that no patients in the NINDS study had cancer. He never reviewed
the CD-Rom disk of the study, which led to the defendant’s verdict, based on his
testimony. The plaintiffs appealed, stating that defendant neurological expert gave
“false and misleading testimony” and provided an affidavit from Dr. John Marler, the NIH
coordinator for the NINDS study, which indicated that 59 of the 624 patients in the study
responded affirmatively to a question on the baseline history form about malignancy.
Another affidavit by Dr. Barbara Tilley, the lead Biostatistician for the study,
confirmed that 59 patients responded positively to the questionnaire relating to
diagnosis of malignancy. In Dr. Hochberg’s deposition on 01/23/04, he strenuously
defended his trial testimony. He also stated that he spoke personally with Dr. Tilley 2
weeks before the trial and she said that the patient would not be a candidate for tPA. He
also testified that he spoke with a secretary of Dr. Marler who suggested that he call
Dr. Tilley. He made the calls from his office at Massachusetts General Hospital.
Telephone records were ultimately retrieved showing a 30-second call to Dr Tilley’s
office in Charleston, South Carolina on November 17, 2003 (first day of trial) and a
6-minute telephone call to Dr. Marler’s office in Bethesda, Maryland. Dr. Tilley
reiterated that she never spoke with him and that she was in San Francisco attending a
meeting of the American Public Health Association at that time.

The Court found that Dr. Hochberg’s testimony was not credible and that he perpetrated a
“fraud on the Court.” He intentionally and deliberately misled the Court and the jury and
was responsible for a second trial. The Court ordered a new trial and ordered Dr.
Hochberg to pay reasonable Court costs as well as attorney costs totaling $20,305 in
sanctions for deceiving jurors as an expert in a malpractice case. Id. at1265 n.13. On
review, the Supreme Judicial Court of Massachusetts reversed the Trial Court’s order for
a new trial and its sanctions against Dr. Hochberg. Id. at 1271. Though the Supreme
Judicial Court found that Dr. Hochberg’s testimony was misleading, it was not found to
constitute a fraud on the Court or to be completely false. Id. at 1266-1268. Further, the
Court found that the disclosure for 59 patients with a history of cancer in the NINDS
study did not constitute new evidence warranting a new trial. The Court considered that
such evidence could have been obtained by the plaintiffs at trial and was thus not newly
discovered. Id. at 1268-1269. As Dr. Hochberg’s sanctions were contingent on the Court's
order for a new trial, these sanctions were vacated. Id. at 1271.

Comments

Neurologists and emergency room physicians stand at the forefront of stroke management
and are at increased liability risk if they use or do not use tPA. Regardless of one’s
personal view regarding the efficacy and safety of tPA, it is essential to discuss and
document with patient and family (surrogate) all treatment options. By maintaining
legible, detailed and timely documentation as to time of onset, examination findings and
informed consent why patients should or should not receive tPA should substantially
reduce the threat of legal action. If patient or family wish to receive tPA and physician
disagrees with this approach, then a second opinion with another stroke physician is
necessary or alternatively offering a timely transfer to a nearby stroke facility may
also avoid litigation. However, this issue will not disappear as long as there is
controversy regarding standard of care. The current guidelines are outdated and do not
even include the benefit of MRI and diffusion-weighted imaging as well as the increased
mortality associated with older age and large infarcts, etc. CAPLAN, L.R. TREATMENT OF
ACUTE STROKE. STILL STRUGGLING. JAMA. 2004; 292: 1883–1885. Therapeutic decisions for
treatment of acute stroke need to be current and precise, yet the current FDA guidelines
which physicians are using are too imprecise and controversial. Currently, tPA is not
used universally and thus it is not a standard of care across the United States but
rather is becoming a local community healthcare standard. However, the public’s demand
for acute treatment and high expectations only fuels this controversy. We need to
reestablish trust and confidence in our professional societies which can only occur with
a definitive new trial and updated protocol. Because the Class I status for ischemic
stroke treatment with tPA is controversial, a moratorium on this designation may be
warranted. Such an action may serve to reduce the amount of litigation over this issue
pending the resolution of the proper standard of care.



Cyrus Shahpar & Brian Potts 
Managing Editors, CAL/AAEM News Service
University of California, Irvine

The CAL/AAEM Archives are available at: http://maillists.uci.edu/mailman/public/calaaem/



 
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