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Stroke Treatment Legal Issues Christopher H. Howard, J.D. Albert C. Weihl, M.D. Wailea Marriott December 5, 2007.

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Presentation on theme: "Stroke Treatment Legal Issues Christopher H. Howard, J.D. Albert C. Weihl, M.D. Wailea Marriott December 5, 2007."— Presentation transcript:

1 Stroke Treatment Legal Issues Christopher H. Howard, J.D. Albert C. Weihl, M.D. Wailea Marriott December 5, 2007

2 Objectives Cover medical issues related to diagnosis and treatment of stroke in the ED Cover medical issues related to diagnosis and treatment of stroke in the ED Cover the legal implications of those issues Cover the legal implications of those issuesAnd…. Ruin your morning Ruin your morning

3 Issues Diagnosis Diagnosis Treatment--Thrombolysis Treatment--Thrombolysis Yes or no (AHA Class I, 8/2000) Yes or no (AHA Class I, 8/2000) Protocols Protocols Informed consent Informed consent Back-up–Neurology/Neurosurgery Back-up–Neurology/Neurosurgery Transfer Transfer

4 A Little Legal Overview Lawsuits require Lawsuits require A breach of the standard of care A breach of the standard of care That is the proximate cause of That is the proximate cause of Injury or damages Injury or damages Strokes have great potential for high damages Strokes have great potential for high damages The higher the damage potential, the higher the incentive for patients, family (and attorneys) to bring a case The higher the damage potential, the higher the incentive for patients, family (and attorneys) to bring a case

5 Case 1 TC Michigan TC Michigan 70 yr old man collapsed on court while refereeing a basketball game 70 yr old man collapsed on court while refereeing a basketball game Time of event known to 0.1 sec Time of event known to 0.1 sec Immediate R hemiparesis/aphasia Immediate R hemiparesis/aphasia Transferred to hospital via EMS Transferred to hospital via EMS Arrived within less than 40 min of event Arrived within less than 40 min of event Found to have R hemiparesis (dominant) and aphasia Found to have R hemiparesis (dominant) and aphasia

6 Case 1 CT scan and TPA available CT scan and TPA available Protocol for MI, not stroke Protocol for MI, not stroke MD had used TPA many times for MI MD had used TPA many times for MI tPA had been used (by other MDs) at hospital for stroke tPA had been used (by other MDs) at hospital for stroke Family present Family present CT scan performed within 90 min of event CT scan performed within 90 min of event Patient admitted to hospital Patient admitted to hospital Hemiparesis/aphasia persisted Hemiparesis/aphasia persisted Confined to institution Confined to institution

7 Case 1 Family filed suit Family filed suit Issues Issues Lack of treatment or offer of treatment Lack of treatment or offer of treatment Lack of information about options Lack of information about options OPINIONS OPINIONS Met standard? Met standard? Did not meet standard? Did not meet standard?

8 Case 1 Outcome Outcome Verdict--Emergency MD failed to meet standard of care for failing to discuss options with family Verdict--Emergency MD failed to meet standard of care for failing to discuss options with family No $$$ awarded because Michigan rule of >50% likelihood of improvement required for damage award No $$$ awarded because Michigan rule of >50% likelihood of improvement required for damage award

9 Case 1 “The question in this case is that the physicians actively or passively made a unilateral decision not to offer an FDA approved on-label drug that is the only drug that has any proven benefit, regardless of whether it's a massive benefit or a minor benefit or whether there's ups and downs or pluses or minuses, which there are; there is no question about that. There is some controversy about this drug. But it is not within the standard of care for a physician to simply say it's my opinion, although I'm not telling you about my opinion, that I'm not even going to mention this.” “The Food and Drug Administration of the United States says this is a proven effective on label nonexperimental drug. The physician may disagree with that, and he should tell the family: "This is what's available. I don't think you should get it." And if the family says "Fine, we don't want it," fine. Nobody did any of that. That is the issue in this case. But it didn't happen, and that's really the issue. And it goes far beyond whether it's tPA for MI or stroke or anything else. Patients deserve the right to be told what their options are. And we have passed the '60s and '70s. Marcus Welby is no longer our family doctor, and this is not how practice is done in the United States, by the standard of care. Doctors do not have that right. And I think that's fairly well known by most practicing physicians.”

10 Case 1 Discussion Discussion

11 Case 1 Legal Legal What impact age of patient? What impact age of patient? Any different standard of care? Any different standard of care? Different risks Different risks Juries treat geriatric cases differently Juries treat geriatric cases differently Counter-intuitive impact on “damages” Counter-intuitive impact on “damages”

12 Case 2 Reed v. Granbury (TX--date unknown) Reed v. Granbury (TX--date unknown) Stroke sx--taken to hospital 10 min away Stroke sx--taken to hospital 10 min away Protocol for tPA (available) for MI only Protocol for tPA (available) for MI only Wife (nurse) wished tPA rx Wife (nurse) wished tPA rx MD refused MD refused Wife initiated transfer to 2 nd hospital Wife initiated transfer to 2 nd hospital Arrived > 3 hr from onset--no rx Arrived > 3 hr from onset--no rx

13 Case 2 Suit re: failure to treat with tPA Suit re: failure to treat with tPA Summary judgment for defendants Summary judgment for defendants “No showing that a common or universal standard of care for administering tPA to stroke patients applied to both MDs and hospitals” “No showing that a common or universal standard of care for administering tPA to stroke patients applied to both MDs and hospitals” Appealed Appealed Affirmed above decision Affirmed above decision Discussion Discussion

14 Case 2 Legal: Legal: Depends upon individual state standards Depends upon individual state standards Some states would only require an expert to say it was reasonable and prudent Some states would only require an expert to say it was reasonable and prudent Then case would proceed to trial Then case would proceed to trial There may also be a “judgment call” defense or a “schools of thought” defense if multiple options There may also be a “judgment call” defense or a “schools of thought” defense if multiple options (documentation of consideration is helpful and informed consent to course of Tx still probably necessary)

15 Case 3 Fernandez vs U Penn (PA ? date) Fernandez vs U Penn (PA ? date) Sudden H/A, dizziness, weakness Sudden H/A, dizziness, weakness Dx--“vertigo” Dx--“vertigo” Discharged Discharged Admitted with slurred speech, inability to walk Admitted with slurred speech, inability to walk Dx--Stroke Dx--Stroke

16 Case 3 Suit for failure to diagnose stroke and loss of opportunity to give tPA Suit for failure to diagnose stroke and loss of opportunity to give tPA Loss of chance in PA/NJ Loss of chance in PA/NJ Verdict $5M Verdict $5M Discussion Discussion

17 Case 3 “Loss of chance” cases “Loss of chance” cases Not in all states (in WA, PA and others) Not in all states (in WA, PA and others) For where chance of survival or good result starts <50% For where chance of survival or good result starts <50% This would normally fail for lack of proximate cause This would normally fail for lack of proximate cause Paradigm: failure to diagnose cancer cases Paradigm: failure to diagnose cancer cases

18 Case 3 “Loss of chance” cases, continued “Loss of chance” cases, continued Should require scientifically based statistical evidence Should require scientifically based statistical evidence The claim is for the % reduced chance of a good result (i.e., a loss of 10% of a $1m claim = $100,000) The claim is for the % reduced chance of a good result (i.e., a loss of 10% of a $1m claim = $100,000)

19 Case 4 Brooks vs SSM Healthcare et al (MO, ?date) Brooks vs SSM Healthcare et al (MO, ?date) tPA for stroke tPA for stroke No discussion of bleeding complications in consent No discussion of bleeding complications in consent Cervical epidural hematoma Cervical epidural hematoma Quadriplegia Quadriplegia Plaintiff verdict Plaintiff verdict $315,000 $315,000 Discussion Discussion

20 Case 4 Legal: Legal: Informed consent lawsuits: ED not exempt (although there are exceptions for emergencies w/o ability to obtain consent) ED not exempt (although there are exceptions for emergencies w/o ability to obtain consent) An “objective subjective” standard An “objective subjective” standard The reasonably prudent patient would want to have known The reasonably prudent patient would want to have known Risks, benefits and alternatives Risks, benefits and alternatives

21 Case 4 Informed consent Informed consent A process not a document A process not a document But…. But…. We need the process documented We need the process documented We need a credible basis for you testimony, and, We need a credible basis for you testimony, and, The consent form itself is evidence The consent form itself is evidence (and may create a presumption in some states)

22 Case 5 Harris vs Oak Valley Hospital (Cal., ?date) Harris vs Oak Valley Hospital (Cal., ?date) tPA for stroke (Hx HBP) tPA for stroke (Hx HBP) ICH (survived) ICH (survived) Suit alleging tPA not indicated and BP high Suit alleging tPA not indicated and BP high Defense argued that informed consent appropriate and BP controlled Defense argued that informed consent appropriate and BP controlled Defense verdict Defense verdict Discussion Discussion

23 Case 6 (a composite) White female, late 20s, presents at ED with family members Severe headache Severe headache Uncooperative Uncooperative Limited Hx given before leaving AMA Limited Hx given before leaving AMA Smoker Smoker

24 Case 6 Case 6 (a) Case 6 (a) Departure w/o signing anything Departure w/o signing anything No follow up contact No follow up contact Case 6 (b) Case 6 (b) Husband signs AMA form Husband signs AMA form

25 Case 6 Other facts Other facts + family Hx + family Hx On birth control On birth control Both cases result in suits Both cases result in suits

26 Case 6 6(a) settled 6(a) settled 6(b) dismissed on early summary judgment 6(b) dismissed on early summary judgment Discussion Discussion

27 Case 7 57 yr old WM early retired mechanic (IL, 2003) 57 yr old WM early retired mechanic (IL, 2003) Physically active Physically active 1/12/03: wife noted driving started to weave, totally blank stare, couldn’t get seat belt off 1/12/03: wife noted driving started to weave, totally blank stare, couldn’t get seat belt off Assessed as potential brain tumor Assessed as potential brain tumor 2/17/03: major stroke with hemi-paralysis 2/17/03: major stroke with hemi-paralysis Jury trial started late Oct 2007 Jury trial started late Oct 2007

28 Case 7 Discussion Discussion

29 Weekends 2007 Canadian study: 2007 Canadian study: Stroke patients presenting to ED are 14 times more likely to die if presenting on a weekend vs. weekday Stroke patients presenting to ED are 14 times more likely to die if presenting on a weekend vs. weekday

30 Conclusion You are damned if you do and damned if you don’t You are damned if you do and damned if you don’t However….. However….. Inform patient/family of options, risks, benefits Inform patient/family of options, risks, benefits DOCUMENT WELL DOCUMENT WELL


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