PRIOR PRINTER'S NO. 429
PRINTER'S NO. 616
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
425
Session of
2021
INTRODUCED BY GORDNER, MENSCH, MARTIN, BAKER AND STEFANO,
MARCH 15, 2021
SENATOR DISANTO, BANKING AND INSURANCE, AS AMENDED,
APRIL 19, 2021
AN ACT
Amending the act of March 20, 2002 (P.L.154, No.13), entitled
"An act reforming the law on medical professional liability;
providing for patient safety and reporting; establishing the
Patient Safety Authority and the Patient Safety Trust Fund;
abrogating regulations; providing for medical professional
liability informed consent, damages, expert qualifications,
limitations of actions and medical records; establishing the
Interbranch Commission on Venue; providing for medical
professional liability insurance; establishing the Medical
Care Availability and Reduction of Error Fund; providing for
medical professional liability claims; establishing the Joint
Underwriting Association; regulating medical professional
liability insurance; providing for medical licensure
regulation; providing for administration; imposing penalties;
and making repeals," in medical professional liability,
further providing for informed consent.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 504 of the act of March 20, 2002
(P.L.154, No.13), known as the Medical Care Availability and
Reduction of Error (Mcare) Act, is amended to read:
Section 504. Informed consent.
(a) Duty of physicians.--Except in emergencies, a physician
owes a duty, which may be fulfilled by a physician or by a
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qualified practitioner under subsection (b), 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.
(5) Administering an experimental medication, using an
experimental device or using an approved medication or device
in an experimental manner.
(b) [Description of procedure] Requirements to obtain
informed consent.--Consent is informed if the patient or the
patient's authorized representative 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]
A physician may delegate the task of obtaining the informed
consent of the patient or the patient's authorized
representative to a qualified practitioner for a procedure under
subsection (a) performed by a physician or performed by a
qualified practitioner. If claims for failure to obtain informed
consent are alleged, the physician or qualified practitioner
shall be entitled to present evidence of the description of that
procedure and those risks and alternatives that a physician or
qualified practitioner, acting in accordance with accepted
medical standards of medical practice, would provide.
(b.1) Consent from another qualified practitioner.--A
physician or qualified practitioner performing a procedure under
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subsection (a) may rely on information provided by another
qualified practitioner to obtain the informed consent of the
patient or the patient's authorized representative.
(b.2) Evidence.--Information provided by another qualified
practitioner under subsection (b.1) shall be competent evidence
in a proceeding in which it is alleged that a physician or
qualified practitioner performing a procedure under subsection
(a) failed to obtain informed consent.
(b.3) Construction.--Nothing under this section shall be
construed to require a physician to delegate the authority to
obtain informed consent to a qualified practitioner . OR PROHIBIT
A PATIENT OR THE PATIENT'S AUTHORIZED REPRESENTATIVE FROM
REQUESTING THE PHYSICIAN, RATHER THAN THE DELEGATED QUALIFIED
PRACTITIONER UNDER SUBSECTION (B.1), ANSWER A QUESTION
CONCERNING THE PROCEDURE, RISKS OR ALTERNATIVES TO THE PROCEDURE
OR OBTAIN INFORMED CONSENT. IF THE PATIENT OR PATIENT'S
AUTHORIZED REPRESENTATIVE MAKES A REQUEST THAT THE PHYSICIAN ACT
UNDER THIS SUBSECTION, THE PHYSICIAN SHALL OBTAIN INFORMED
CONSENT.
(c) Expert testimony.--Expert testimony is required to
determine whether the procedure constituted the type of
procedure set forth in subsection (a) and to identify the risks
of that procedure, the alternatives to that procedure and the
risks of these alternatives.
(d) Liability.--
(1) [A physician is liable] Liability under this section
for failure to obtain the informed consent only may be
established if the patient proves that receiving such
information would have been a substantial factor in the
patient's decision whether to undergo a procedure set forth
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in subsection (a).
(2) [A physician may be held liable] Liability may be
established under this section for failure to seek a
patient's informed consent if the physician or qualified
practitioner knowingly misrepresents to the patient [his or
her] the professional credentials, training or experience[.]
of the physician or qualified practitioner who performs the
procedure.
(e) Human research exception.--The requirements under this
section shall be deemed satisfied if informed consent is
obtained for human research conducted pursuant to approval by an
institutional review board or similar entity in accordance with
21 CFR Pt. 50 (relating to protection of human subjects), 45 CFR
Pt. 46 (relating to protection of human subjects) and any other
applicable Federal laws and regulations.
(f) Applicability--A physician or qualified practitioner
performing a procedure under subsection (a) shall not be
required to obtain a separate or new informed consent from the
patient or the patient's authorized representative, provided
that informed consent was already obtained by a physician or
another qualified practitioner with respect to the procedure.
(g) Definition.--As used in this section, the term
"qualified practitioner" means a:
(1) "Physician assistant" as defined in section 2 of the
act of December 20, 1985 (P.L.457, No.112), known as the
Medical Practice Act of 1985, or section 2 of the act of
October 5, 1978 (P.L.1109, No.261), known as the Osteopathic
Medical Practice Act;
(2) "Certified registered nurse practitioner" as defined
in section 2(12) of the act of May 22, 1951 (P.L.317, No.69),
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known as The Professional Nursing Law;
(3) "Midwife or nurse-midwife" as defined in section 2
of the Medical Practice Act of 1985; and
(4) Registered nurse under section 3 of The Professional
Nursing Law who is authorized under the registered nurse's
scope of practice to perform the procedure as delegated by
the physician or a registered nurse authorized to administer
anesthesia under 49 Pa. Code ยง 21.17 (relating to anesthesia)
or a successor statute or regulation.
The term shall include another physician and a physician
participating in a medical residency or fellowship training
program. A qualified practitioner shall have knowledge of the
patient's condition and the procedure enumerated under
subsection (a) to be conducted on the patient and shall be
acting under the supervision of, at the direction of, or in
collaboration or cooperation with, the physician.
Section 2. The amendment of section 504 of the act shall
apply to all pending litigation. The term "pending litigation"
means any action in which a final order has not yet been entered
prior to the effective date of this section.
Section 3. This act shall take effect immediately.
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