Daniel P. Martz, Esquire

Christie & Young PC

Philadelphia, PA

1. Discuss the medical-legal aspects of thrombolytic therapy and endovascular intervention

2. Describe the legal requirements of informed consent and use of medication and interventions

3. Discuss use of published guidelines and literature in a legal proceeding

A physician must have the same knowledge and skill and use the same care normally used in the medical profession. A physician whose conduct falls below this standard of care is negligent.

A physician who professes to be a specialist in a particular field of medicine must have the same knowledge and skill and use the same care as others in that same medical specialty. A specialist whose conduct does not meet this professional standard of care is negligent.

Under this standard of care, a physician must also keep informed of the contemporary developments in the medical profession or his or her specialty and must use current skills and knowledge. In other words, a health care provider must have up-to-date medical skills and knowledge, and if he or she fails to keep current or fails to use current knowledge in the medical treatment of the patient, the health care provider is negligent.

Pa. SSJI (Civ) 14.10

Expert witnesses- required in PA to prove a claim of professional

liability

In same or substantially similar specialty

Learned Treatises May use on cross-examination only

Clinical Practice Guidelines. How used?

“Though CPGs may provide physicians with needed guidelines and consensus on care based on clinical evidence, the use of such guidelines in medical malpractice litigation is largely dependent upon state evidentiary practices and rulings. Further, although CPGs may promote and standardize use of efficient and evidence-based clinical treatment, they may also limit physician autonomy and impose inflexible or unrealistic standards on clinical practice.”

The Role of Practice Guidelines in Medical Malpractice Litigation, Timothy K. Mackey, MAS, and Bryan A. Liang, MD, JD, PhD, AMA Journal of Ethics, January 2011, Volume 13, Number 1: 36-41.

Topic today is the

Legal Implications of Thrombolytic Therapy and Endovascular Interventions for Acute Ischemic Stroke

How clinical evidence has evolved and how that is used in legal proceedings.

ACEP (2009)

“Objective evidence regarding the efficacy, safety and

applicability of tPA for acute ischemic stroke is

insufficient to warrant its classification as standard of

care.”

Legal cases typically involved exceptions to the general

rule on case by case basis, and informed consent

2013 AHA/ASA: Guidelines for the Early

Management of Patients With Acute Ischemic

Stroke:

“Intravenous fibrinolytic therapy for acute stroke is now

widely accepted.”

Class IA recommendation for appropriate candidates

(definitely recommended)

The major risk of intravenous rtPA treatment remains

sICH.

In order to improve functional outcomes, IV tPA should be offered to patients with acute ischemic stroke who meet National Institute of Neurological Disorders and Stroke (NINDS) inclusion/exclusion criteria and can be treated within 3 hours after symptom onset. (Level A)

In order to improve functional outcomes, IV tPA should be considered in patients with acute ischemic stroke who meet European Cooperative Acute Stroke Study (ECASS) III inclusion/exclusion criteria and can be treated between 3 to 4.5 hours after symptom onset (Level B)

Ann Emerg Med. 2013;61:225-243

2015 AHA/AAN Updated Guidelines:

tPA continues to be front-line treatment for AIS

“For patients who meet national and international eligibility guidelines, intravenous r-tPA improves functional outcomes at 3 to 6 months when given within 4.5 hours of ischemic stroke onset and should be administered.”

Outside eligibility guidelines

Risk of producing an intracerebral hemorrhage

Considerations of quality of life

Patient has evidence of dementia (79% of neurologists less likely to use tPA, according to one study)

Diagnostic uncertainty in interpreting imaging and perfusion studies

Advanced directive in place

Comorbidities—number and severity

Similar to use of tPA, the clinical trials, data and related guidelines, have evolved with respect to the use of endovascular interventions in AIS

2013AHA/ASA: Guidelines for the Early Management of Patients With Acute Ischemic Stroke:

The usefulness of emergent intracranial angioplasty and/or stenting is not well established. These procedures should be used in the setting of clinical trials (Class IIb; Level of Evidence C). (New recommendation)

Conclusions— Certain endovascular procedures

have been demonstrated to provide clinical benefit

in selected patients with acute ischemic stroke.

Systems of care should be organized to facilitate the

delivery of this care.

Recommendations Endovascular Interventions- Patients eligible for intravenous r-tPA should receive

intravenous r-tPA even if endovascular treatments are being considered (Class I; Level of Evidence A).(Unchanged from the 2013 guideline)

Patients should receive endovascular therapy with a stent retriever if they meet all the following criteria (Class I; Level of Evidence A). (New recommendation): a. Prestroke mRS score 0 to 1, b. Acute ischemic stroke receiving intravenous r-tPA within 4.5 hours of

onset according to guidelines from professional medical societies, c. Causative occlusion of the ICA or proximal MCA (M1), d. Age ≥18 years, e. NIHSS score of ≥6, f. ASPECTS of ≥6, and g. Treatment can be initiated (groin puncture) within 6 hours of symptom

onset

Expert witnesses-

required in PA to prove a claim of professional liability

Clinical Practice Guidelines- recommendation, guideline or binding authority?

General Considerations:

Is written informed consent required?

Does the patient have the capacity to consent?

Is there a proxy (family member, HPOA)?

Is it an emergency?

Duty of physicians.--Except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient's authorized representative prior to conducting the following procedures: (1) Performing surgery, including the related administration of anesthesia. (2) Administering radiation or chemotherapy. (3) Administering a blood transfusion. (4) Inserting a surgical device or appliance [i.e. endovascular procedure] (5) Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner. [tPA no longer “experimental”]

(b) Description of procedure.--Consent is informed if the patient has been given a description of a procedure set forth in subsection (a) and the risks and alternatives that a reasonably prudent patient would require to make an informed decision as to that procedure. The physician shall be entitled to present evidence of the description of that procedure and those risks and alternatives that a physician acting in accordance with accepted medical standards of medical practice would provide.

40 P.S. 1303.504

The doctrine of informed (or valid) consent forms the cornerstone of the patient–physician relationship. Except in emergency circumstances (in which the doctrine of presumed consent is operational), physicians must first obtain valid consent from the patient or authorized proxy decision maker before embarking on a course of diagnostic tests or treatments.

Consent is a process and not an event. It is a dialogue and information exchange between the patient and physician leading to permission for the physician to initiate tests or treatments. The signature on a consent form is not itself the consent; it is only the formalization of a preceding consent dialogue between the patient and physician.

Consent issues in the management of cerebrovascular diseases, Neurology July 1,

1999 vol. 53 no. 1 9

If the patient has decision-making capacity or a proxy decision maker is present, a documented discussion regarding risks, benefits, and alternatives to IV tPA should take place prior to the administration of the medication. Unless required by local practices, a signed informed consent document is not a prerequisite to the administration of IV tPA in these circumstances.

If the patient lacks capacity and no proxy decision maker can be found after a reasonable effort, then the physician may administer the medication based on the principle of implied consent for emergency treatment. The physician and other members of the health care team should document the patient's absence of decision-making capacity, that attempts to contact a proxy decision maker were unsuccessful, and that there is an urgent medical need to proceed with treatment in the absence of consent AEN Policy 2011-11.

The key to defending medical-legal matters

Why?

May be legally required in some states,

especially for informed consent

Good medical documentation practices

And perhaps most importantly…..

The passage of time

ANY QUESTIONS?

Thank you.

Daniel Martz, Esq.