BILL ANALYSIS Ó
SENATE JUDICIARY COMMITTEE
Senator Hannah-Beth Jackson, Chair
2015 - 2016 Regular Session
SB 738 (Huff)
Version: April 15, 2015
Hearing Date: May 5, 2015
Fiscal: No
Urgency: No
RD
SUBJECT
Pupil health: epinephrine auto-injectors: liability limitation
DESCRIPTION
Existing law requires public schools to have a trained volunteer
to administer epinephrine auto-injectors in emergencies and
requires that each employee who volunteers is provided defense
and indemnification by the school district, county office of
education, or charter school for any and all civil liability, as
specified. Existing law requires a qualified supervisor of
health or administrator at a school district, county office of
education, or charter school to obtain the prescription for
epinephrine auto-injectors from an authorizing physician and
surgeon, as defined.
This bill would provide that an authorizing physician and
surgeon shall not be subject to professional review, be liable
in a civil action, or be subject to criminal prosecution for the
issuance of a prescription or order pursuant to this section,
unless the physician and surgeon's issuance constitutes gross
negligence or willful or malicious conduct.
BACKGROUND
An epinephrine auto-injector is a disposable medical drug
delivery device that delivers a single measured dose of
epinephrine, most frequently for the treatment of acute allergic
reactions to avoid or treat the onset of anaphylactic shock.
Anaphylactic shock can quickly result in death if untreated.
Epinephrine auto-injectors can be obtained by prescription only,
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and California law does not authorize non-physicians to
administer an epinephrine auto-injector to another person,
except in limited circumstances.
In recent years, California law has been amended to, among other
things, permit school districts or county offices of education
to provide emergency epinephrine auto-injectors to trained
personnel, and to permit trained personnel to utilize the
auto-injectors to provide emergency medical aid to persons
suffering from an anaphylactic reaction, as it is not uncommon
for children to come into contact with specific allergens (such
as bee stings) or accidentally ingest foods they are allergic to
at school. (AB 559 (Wiggins, Ch. 458, Stats. 2001).)
Last year, SB 1266 (Huff, Ch. 321, Stats. 2014) was enacted to
require, as opposed to simply authorize, school districts,
county offices of education, and charter schools to provide
emergency epinephrine auto-injectors to trained personnel who,
consistent with existing law, may use the auto-injectors to
provide emergency medical aid to persons suffering from an
anaphylactic reaction. Under that bill, each public school is
required to designate one or more school personnel on a
voluntary basis to receive the requisite training for these
purposes. In recognition that employees might otherwise
hesitate to volunteer out of fear of personal liability, SB 1266
also required that a school district, county office of
education, or charter school ensure that each employee who
volunteers is provided defense and indemnification by the school
district, county office of education, or charter school for any
and all civil liability.
This bill now seeks to address an issue of concern to the
doctors who are needed to write these prescriptions so that
schools may obtain and stock epi-pens for the above purposes.
Specifically, the bill would provide any physician or surgeon
issuing a prescription or order for these purposes immunity from
any potential civil or criminal liability or from professional
disciplinary action, unless the physician and surgeon's issuance
constitutes gross negligence or willful or malicious conduct.
CHANGES TO EXISTING LAW
Existing law requires school districts, county offices of
education, and charter schools to provide emergency epinephrine
auto-injectors to school nurses or trained personnel who have
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volunteered, as specified, and provides that school nurses or
trained personnel may use epinephrine auto-injectors to provide
emergency medical aid to persons suffering, or reasonably
believed to be suffering, from an anaphylactic reaction. (Educ.
Code Sec. 49414(a).) Existing law authorizes private elementary
and secondary school in the state to voluntarily determine
whether or not to make emergency epinephrine auto-injectors and
trained personnel available at its school. (Ed. Code Sec.
49414(c).)
Existing law provides that each public and private elementary
and secondary school in the state may designate one or more
volunteers to receive initial and annual refresher training,
based on specified standards, regarding the storage and
emergency use of an epinephrine auto-injector from the school
nurse or other qualified person designated by an authorizing
physician and surgeon. (Ed. Code Sec. 49414(d).)
Existing law , in relevant part, requires a qualified supervisor
of health at a school district, county office of education, or
charter school to obtain from an authorizing physician and
surgeon a prescription for each school for epinephrine
auto-injectors that, at a minimum, includes, for elementary
schools, one regular epinephrine auto-injector and one junior
epinephrine auto-injector, and for junior high schools, middle
schools, and high schools, if there are no pupils who require a
junior epinephrine auto-injector, one regular epinephrine
auto-injector. (Ed. Code Sec. 49414(g)(1).) Existing law
provides that if a school district, county office of education,
or charter school does not have a qualified supervisor of
health, an administrator at the school district, county office
of education, or charter school shall carry out the above
duties. (Ed. Code Sec. 49414(g)(2).)
This bill would provide that an authorizing physician and
surgeon shall not be subject to professional review, be liable
in a civil action, or be subject to criminal prosecution for the
issuance of a prescription or order pursuant to this section,
unless the physician and surgeon's issuance constitutes gross
negligence or willful or malicious conduct.
COMMENT
1. Stated need for the bill
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According to the author:
Last year, the Legislature unanimously passed and the Governor
signed SB 1266 [Huff, Ch. 321, Stats. 2014] requiring extra
epinephrine auto injectors be prescribed as a "standing order"
ensuring the lifesaving medication can be on hand in public
schools when there is a school nurse or volunteer who is
trained to administer. Epinephrine is the first line of
treatment for someone who is experiencing anaphylaxis (a
potentially lethal allergic reaction). It is easily
administered and has very little side-effect.
Once SB 1266 took effect, many physicians began raising
questions about issuing the prescription, citing liability
concerns. Unlike normal prescriptions made out to a specific
individual who physicians have a patient relationship with, a
"standing order" for epinephrine will be made out generically
so the school can keep it on hand. Physicians have stated
having liability coverage in the code (similar to what they
have for Automated External Defibrillator (AED) and opioid
antagonists) will help ease their concern.
The author reports that recent data from the California School
Nurse Organization shows that many schools who are trying to
implement SB 1266 are having difficulty doing so because they
cannot obtain the necessary prescription.
Two individual doctors write in support of this bill describing
the reasons behind the hesitation of physicians to issue
prescriptions or orders for these purposes. One doctor writes
that "[a]s a consulting physician for about 30 school districts
across California, it has been distressing to me how few of my
physician colleagues have written Epinephrine prescriptions. .
. . [P]hysicians' own medical liability insurance only covers
them for patients in their own practices, not for schools in
their neighborhoods. Understandably, physicians are currently
reluctant to assist schools with an anaphylaxis-protection
program for which they feasibly have little oversight. SB 738
should provide physicians across California with the peace of
mind they now require in order to write prescriptions for this
life-saving medication. Compliance with SB 1266 is based on
this factor."
2. Bill provides qualified immunity for physicians issuing
epi-pen prescriptions or orders
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As a general rule, California law provides that everyone is
responsible, not only for the result of his or her willful acts,
but also for an injury occasioned to another by his or her want
of ordinary care or skill in the management of his or her
property or person, except so far as the latter has, willfully
or by want of ordinary care, brought the injury upon himself or
herself. (Civ. Code Sec. 1714(a).) Although immunity
provisions are rarely preferable because they, by their nature,
prevent an injured party from seeking a particular type of
recovery, the Legislature has in limited scenarios approved
limited immunity from liability (as opposed to blanket
immunities) to promote other policy goals that could benefit the
public. Along these lines, this Legislature has on multiple
occasions, enacted legislation that encourages the use of life
saving medications or medical interventions (such as automatic
external defibrillators (AEDs), epinephrine auto-injectors
(epi-pens), and opioid antagonists) in order to avoid
preventable deaths by limiting the liability of "Good
Samaritans," as long as certain minimal requirements are met.
In most of those scenarios, however, the qualified immunity does
not apply in the case of personal injury or wrongful death which
results from the gross negligence or willful or wanton
misconduct by the person who renders the care. (See Civ. Code
Sec. 1714.21.)
With respect to the doctors who are relied upon to write the
prescription or orders for the medication or medical device,
similar liability protection has been provided in both the AED
and opioid antagonist context, but not in the epi-pen context.
This bill would add a similar provision in law for physicians
and surgeons who issue prescriptions or orders for epi-pens to
schools, in furtherance of existing California law that requires
schools to provide emergency epinephrine auto-injectors to
trained personnel who may use the auto-injectors to provide
emergency medical aid to persons suffering from anaphylactic
reaction. That provision is similar to those already in place
with respect to AEDs and naloxone.
For example, existing law provides physicians who are involved
with the placement of an AED protection against any civil
liability for any civil damages resulting from any acts or
omissions of a person who renders emergency care using that AED,
if that physician, person, or entity has complied with existing
law requirements. That law also provides that any limited
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liability protection does not apply in the case of personal
injury or wrongful death which results from the gross negligence
or willful or wanton misconduct of the person who renders
emergency care or treatment by the use of an AED. (See Civ. Code
Sec. 1714.21.)
More recently, in 2013, AB 635 (Ammiano, Ch. 707, Stats. 2013)
was enacted to provide that a licensed health care provider who
acts with reasonable care shall not be subject to professional
review, found liable in a civil action, or be subject to
criminal prosecution for issuing a prescription or standing
order for an opioid antagonist to a person at risk of an
opioid-related overdose or to a family member, friend, or other
person in a position to assist a person at risk of an
opioid-related overdose, as specified. (See Civ. Code Sec.
1714.22.)
As noted above, this bill, in the epi-pen context, would provide
that an authorizing physician and surgeon shall not be subject
to professional review, be liable in a civil action, or be
subject to criminal prosecution for the issuance of a
prescription or order pursuant to this section, unless the
physician and surgeon's issuance constitutes gross negligence or
willful or malicious conduct. In doing so, the bill would
arguably further the original intent of SB 1266 (Huff, Ch. 321,
Stats. 2014) and prior bills that have sought to ensure that
schools have epi-pens available for the emergency treatment of
children who are suffering from anaphylactic shock, in order to
avoid preventable deaths.
3. Technical amendment
The following technical amendment would address a drafting
error:
Technical amendment :
On page 5, line 12, after "unless the physician and surgeon's
issuance" insert "of the prescription or order"
The following author's amendment would also update the name of
the Stanford Allergy Center to reflect the center's current
name.
Author's amendment :
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On page 3, line 32, strike "Stanford Allergy Center" and
insert, "Sean N. Parker Center for Allergy Research"
Support : American Academy of Allergy Asthma & Immunology;
Association of Regional Center Agencies; California Chapter of
the American College of Emergency Physicians; Civil Justice
Association of California; two individuals
Opposition : None Known
HISTORY
Source : California Society for Allergy, Asthma and Immunology
(CSAAI)
Related Pending Legislation :
SB 744 (Huff, 2015) is a spot bill that makes nonsubstantive
changes to the provisions requiring schools to provide emergency
epi-pens to school nurses or trained personnel who have
volunteered and authorizing those individuals to provide
emergency medical aid to persons suffering, or reasonably
believed to be suffering, from an anaphylactic reaction. That
bill is currently in the Senate Rules Committee.
AB 1386 (Low, 2015) would add various limited liability
provisions relating to the provision or administration of an
epi-pen, as specified. One such provision provides that an
authorized health care provider that prescribes an epi-pen to
specified persons or authorized entities is not liable for any
civil damages resulting from any act or omission related to the
provision of an epi-pen. This bill is currently awaiting
hearing in the Assembly Business and Professions Committee.
Prior Legislation :
SB 1266 (Huff, Ch. 321, Stats. 2014) See Background.
SB 669 (Huff, Ch. 725, Stats. 2013), among other things,
authorized a trained pre-hospital emergency medical care person,
first responder, or lay rescuer to obtain and use epinephrine
auto-injectors to render emergency care to another person,
pursuant to specified requirements, and granted them limited
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liability, as specified.
SB 635 (Ammiano, Ch. 707, Stats. 2013) See Comment 2.
SB 161 (Huff, Ch. 560, Stats. 2011) authorized a school
district, county office of education, or charter school to
participate in a program to provide nonmedical school employees
with voluntary emergency medical training to provide, in the
absence of a credentialed school nurse or other licensed nurse
onsite at the school or charter school, emergency medical
assistance to pupils with epilepsy suffering from seizures, in
accordance with specified guidelines. SB 161 also provided each
employee who volunteers under the bill with defense and
indemnification by the school district, county office of
education, or charter school, for any and all civil liability,
as specified.
AB 559 (Wiggins, Ch. 458, Stats. 2001), was enacted to permit
school districts or county offices of education to provide
emergency epinephrine auto-injectors to trained personnel, and
to permit trained personnel to utilize the auto-injectors to
provide emergency medical aid to persons suffering from an
anaphylactic reaction.
AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was
ultimately vetoed by the Governor.
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