BILL ANALYSIS Ó
SENATE JUDICIARY COMMITTEE
Senator Noreen Evans, Chair
2013-2014 Regular Session
SB 669 (Huff)
As Amended April 22, 2013
Hearing Date: April 30, 2013
Fiscal: Yes
Urgency: No
RD
SUBJECT
Emergency Medical Care: Epinephrine Auto-Injectors
DESCRIPTION
This bill would authorize a trained prehospital 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 would
grant them qualified immunity from liability, as specified,
unless their conduct in rendering emergency care is grossly
negligent.
This bill would also provide immunity to specified entities that
are authorized to train these persons in the emergency
administration of epinephrine auto-injectors for any civil
damages alleged to result from those training requirements or
standards. Additionally, this bill would, among other things,
provide minimal training requirements and require that the
California Emergency Medical Services Authority establish and
approve authorized training providers and minimum standards for
training and the use and administration of epinephrine
auto-injectors.
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.
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Epinephrine auto-injectors can be obtained by prescription only,
and current California law generally does not authorize
non-physicians to administer an epinephrine auto-injector to
another person. 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).)
This bill would attempt to facilitate the administration of
epinephrine auto-injectors by trained prehospital emergency
medical care persons, first responders, or lay rescuers, in
emergency situations that extend beyond school grounds. The
bill would provide these individuals with a qualified immunity
from civil liability, as specified, but would not extend this
immunity to conduct constituting gross negligence. In order to
encourage training, this bill would also provide immunity to
specified entities who train these individuals in the emergency
administration of epinephrine auto-injectors from any civil
damages alleged to result from those training programs or
standards.
This bill was approved by the Senate Committee on Health on
April 17, 2013 by a vote of 8-0.
CHANGES TO EXISTING LAW
Existing law requires the Emergency Medical Services (EMS)
Authority to establish training and standards for all
prehospital emergency care personnel, as defined, regarding the
characteristics and method of assessment and treatment of
anaphylactic reactions and the use of epinephrine. Existing law
requires the authority to promulgate regulations regarding these
matters for use by all prehospital emergency medical care
personnel. (Health and Saf. Code Sec. 1797.197.)
Existing law provides that, notwithstanding any other provision
of law, a pharmacy may furnish epinephrine auto-injectors to a
school district or county office of education pursuant to
specified law, if all of the following are met:
the epinephrine auto-injectors are furnished exclusively for
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use at a school district site or county office of education;
and
a physician and surgeon provides a written order that
specifies the quantity of epinephrine auto-injectors to be
furnished. (Bus. & Prof. Code Sec. 4119.2(a).)
Existing law , in relevant part, permits a school district or
county office of education to provide emergency epinephrine
auto-injectors to trained personnel, and permits trained
personnel to utilize those epinephrine auto-injectors to provide
emergency medical aid to persons suffering from an anaphylactic
reaction. (Ed. Code Sec. 49414(a).)
Existing law permits a school nurse, or if the school does not
have a school nurse, a person who has received training, as
specified, to do the following:
obtain from the school district physician, the medical
director of the local health department, or the local
emergency medical services director a prescription for
epinephrine auto-injectors; and
immediately administer an epinephrine auto-injector to a
person exhibiting potentially life-threatening symptoms of
anaphylaxis at school or a school activity when a physician is
not immediately available. (Ed. Code Sec. 49414(f).)
Existing law requires the Superintendent of Public Instruction
to establish minimum standards of training for the
administration of epinephrine auto-injectors that satisfy the
minimum statutory training requirements, as specified. Existing
law requires that the Superintendent consult with specified
organizations and providers with expertise in administering
epinephrine auto-injectors and administering medication in a
school environment. (Ed. Code Sec. 49414(e)(1).) Existing law
also provides minimum training requirements and standards, as
specified. (Ed. Code Sec. 49414(e)(2).)
This bill would permit a pharmacy, notwithstanding any other
law, to dispense epinephrine auto-injectors to a prehospital
emergency medical care person, first responder, or lay rescuer
for the purpose of rendering emergency care, as specified, if
both the following requirements are met:
A physician and surgeon provides a written order that
specifies the quantity of epinephrine auto-injectors to be
dispensed to a person who is either a prehospital emergency
medical care person, first responder, or lay rescuer, as
specified. That prescription may be issued only upon
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presentation of a current certificate demonstrating that the
person is trained and qualified, as specified, to administer
an epinephrine auto-injector to another person in an emergency
situation. The prescription must specify certain information
and that a new prescription be written for any additional
epinephrine auto-injectors required.
The pharmacy must label each epinephrine auto-injector
dispensed with specified information.
This bill would require that the prehospital emergency medical
care person, first responder, or lay rescuer receiving the
epinephrine auto-injector retain records for five years that
reflect specified information, including, among other things,
the name of any person to who epinephrine was administered using
an auto injector. This bill would also provide that epinephrine
auto-injectors dispensed pursuant to this bill may be used only
for the specified purpose and circumstances.
This bill would permit a prehospital emergency medical care
person, first responder, or lay rescuer to use an epinephrine
auto-injector to render emergency care to another person if
specified requirements are met, including, among other things,
that:
the epinephrine auto-injector is used on another, with the
express or implied consent of that person, for the purpose of
treating anaphylaxis; and
the person using the auto-injector has successfully completed
a course of training with an authorized training provider, as
specified, and has a current certification issued by the
provider.
This bill specifies that the authorized training providers and
minimum standards for training and the use and administration of
epinephrine auto-injectors shall be established and approved by
the California EMS Authority, as specified. This bill would
require that the minimum training and requirements include among
other things:
techniques for recognizing circumstances, signs, and symptoms
of anaphylaxis;
standards and procedures for proper storage and emergency use
of epinephrine auto-injectors; and
emergency follow up procedures, as specified.
This bill would provide that any prehospital emergency medical
care person, first responder, or lay rescuer who administer an
epinephrine auto-injector to another person who appears to be
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experiencing anaphylaxis at the scene of an emergency situation,
in good faith and not for compensation, is not liable for any
civil damages resulting from his or her acts or omissions in
administering the epinephrine auto-injector, if he or she has
complied with the requirements and standards of this bill, as
specified. This bill would not grant immunity from civil
damages to any person whose conduct in rendering emergency care
constitutes gross negligence.
This bill would provide, in relevant part, that a local agency,
governmental entity, or other organization that sponsors,
authorizes, supports, finances, or supervises the training of
those persons, or develops standards in accordance with this
bill shall not be liable for civil damages alleged to result
from those training programs or standards.
This bill provides that none of the above shall relieve a
manufacturer, designer, developer, distributor, or supplier of
an epinephrine auto-injector of liability under any other
applicable law.
This bill would specify that it does not apply to those entities
separately covered under the Education Code, as specified, and
would also state that it shall not be construed to limit or
restrict the ability of prehospital emergency medical care
personnel to administer epinephrine, including the use of
epinephrine auto-injectors, or to require additional training or
certification, if the administration of epinephrine is part of
their scope of practice, as determined by their respective
certifying or licensing entity.
This bill would provide relevant definitions and would list the
symptoms and various causes of anaphylaxis.
COMMENT
1. Stated need for the bill
According to the author,
SB 669 would create a training program for first responder and
group leader volunteers on the recognition and emergency care
of anaphylactic shock. The proposal calls for the development
of standards for the safe and proper use of epinephrine
auto-injectors (EpiPens). It would make these auto-injectors
available to trained first responders and group leaders on
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prescription, and allow them to use it in an emergency
situation on a person suffering from a potentially fatal
anaphylactic reaction. It would provide Good Samaritan
immunity from civil liability if the care is rendered at the
scene of an emergency in good faith, without gross negligence
and not for compensation.
Despite all improvements in the law expanding Good Samaritan
protection fostering trained first responders and group
supervisors to provide emergency care (first aid,
cardiopulmonary resuscitation and automatic external
defibrillation) for someone with a life-threatening allergic
reaction, there is effectively nothing anyone can do in cases
of anaphylaxis to prevent cardio-pulmonary shutdown unless the
victim happens to have an EpiPen and is able to
self-administer epinephrine before losing
consciousness-outside of a medical or school environment.
Unless specifically used by and for the person for whom it was
prescribed, an EpiPen may not be administered by
non-physicians-even if an auto-injector is on the scene.
Until recent passage of enabling legislation, this was even a
problem for school nurses. [ . . . ] Yet, death from
anaphylaxis remains a real and pervasive problem outside of
school, in the wilderness and even in the community, when
group leaders overseeing the welfare of others, and even
trained first responders at the scene of an emergency, cannot
obtain or administer this miraculous life-saving device---a
device which even little children are trained to safely use.
In the case of anaphylactic shock, death through suffocation
can occur in a matter of minutes. Definitive medical care
cannot always be timely obtained. [ . . . ]
Anaphylaxis is a pervasive lethal threat, both to those with
known allergies and those who suddenly become sensitized to a
substance - such as a simple bee-sting, ingestion of
shellfish, or coming into contact with peanuts. While an
anaphylactic attack cannot always be prevented, the worrisome
consequences of it can be.
The sponsor of this bill, the Conference of California Bar
Associations (CCBA), adds that, "SB 669 would enable California
to join a growing group of states that provide training in the
proper use and administration of epinephrine auto-injectors, and
which make these auto-injectors available by prescription to
individuals who have successfully completed the training. The
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purpose of the bill is to increase the chances that if a person
suffers life-threatening allergic reaction, there will be
someone close by with an epinephrine auto-injector who knows the
proper way to use it."
2. Immunity provisions
This bill would provide a qualified immunity to any trained
prehospital emergency medical care person, first responder, or
lay rescuer who administers an epinephrine auto-injector to
another person who appears to be experiencing anaphylaxis at the
scene of an emergency situation except in the case of gross
negligence. This bill would also provide an unqualified
immunity to any entities, as specified, that train these
individuals in the emergency administration of epinephrine
auto-injectors for damages alleged to result from those training
programs or standards. This bill specifies that nothing in this
bill relieves a manufacturer, designer, developer, distributor,
or supplier of an epinephrine auto-injector of liability under
any other applicable law.
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
measured immunity from liability to promote other policy goals
that could benefit the public.
Thus, the question is raised as to whether these two immunity
provisions would appropriately balance the ability for an
injured person to seek recourse against the public policy of
saving lives where there is a reasonable method of providing
assistance with relatively little risk involved.
a. Qualified immunity for a trained person who administers
an epinephrine auto-injector appears reasonable but should
parallel similar existing law provisions
Despite the general disfavoring of immunity provisions for the
reasons stated above, where there is a generally safe,
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reliable, and easily administrable treatment that can prevent
unnecessary death, as a matter of public policy, it may be
appropriate to confer a limited immunity as a way of
encouraging the provision of a potentially life-saving
treatment. At the same time, qualified immunity, as opposed
to blanket immunity, is preferable to ensure a party injured
in the provision of this care can seek recourse in the courts
in appropriate circumstances.
As noted above, this bill attempts to strike a balance between
competing interests and concerns, by providing a qualified
immunity from civil liability to any properly trained
prehospital emergency medical care person, first responder, or
lay rescuer who administers an epinephrine auto injector in
compliance with specified requirements, while not extending
that immunity to any conduct that constitutes gross negligence
in rendering that care. Gross negligence is a legal term that
represents an extreme departure from the ordinary standard of
conduct. It is akin to failing entirely to exercise care or
exercising so slight a degree of care as to justify the belief
that there was an indifference to the interest and welfare of
others.
Proponents argue in support that this bill, as a whole, will
help ensure that a person does not needlessly die from
anaphylaxis when there is a properly trained person nearby who
can administer an epinephrine auto-injector. Committee staff
also notes that the qualified immunity provision is arguably
an important component to this bill having the intended effect
of promoting action to prevent unnecessary deaths from
anaphylaxis, as it can help avoid a scenario in which a
properly trained person might avoid taking action to assist
another person out of fear of civil liability. At the same
time, it is equally important to maintain that a person's
grossly negligent conduct would not be shielded from civil
liability, as it incentivizes a person to act with the due
care and ensures the possibility of legal recourse for any
person injured by that conduct.
This type of qualified immunity is not without precedent under
California law. Proponents note, for example, that there is a
comparable California statute under existing law, relating to
automatic external defibrillators (AEDs), whereby this state
encourages the provision of emergency care with a reduced risk
of civil liability, in order to avoid preventable deaths.
Specifically, existing law provides qualified immunity in
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relation to the provisions of emergency care using an AED.
(See Civ. Code Sec. 1714.21.) In the AED context, 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
uses the AED to render emergency care. (Civ. Code Sec.
1714.21(f).)
Arguably, because this bill seeks to encourage the rendering
of reasonable emergency care in similar fashion (using an
epinephrine auto-injector as opposed to an AED), the scope of
the immunity should also apply in similar fashion as well. In
other words, the immunities should parallel one another
because both bills seek to reasonably promote the rendering of
emergency care. To achieve this purpose, the following
amendment is suggested:
Suggested amendment
On page 4, strike lines 38-40, inclusive, and insert: "(c)
The protections specified in subdivision (b) do 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
treatment by the use of an epinephrine auto-injector."
b. The proposed immunity for training program entities
should be narrowed
This bill would, in contrast to the immunity discussed in
Comment 2a above, provide unqualified immunity to an entity
that trains a prehospital emergency medical care person, first
responder, or lay rescuer in the administration of epinephrine
auto-injectors in emergency situations. Specifically, those
entities would not be liable for civil damages alleged to
result from those training programs or standards.
As a result, even if a plaintiff could prove that the training
programs or standards were themselves substandard and resulted
in his or her injury, the plaintiff would be precluded from
seeking a remedy in court under this bill. That would remain
the case even if the training program or standards failed to
even meet the bill's minimal statutory training requirements.
It is unclear why a training program whose training or
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certification of individuals fails to meet the minimal
training standards required by the bill, or otherwise amounts
to gross negligence, should be shielded from liability where
their training or standards could directly result in
substandard care. Accordingly, the following amendment is
suggested to ensure that the possibility of liability remains
in such scenarios:
Suggested amendment
On page 5, line 1, after "(d)" insert "(1)"
On page 5, after line 17, insert "(2) This protection shall
not apply in the case where it is alleged that the personal
injury or wrongful death was proximately caused by a
training provider's failure to meet the minimal statutory
training requirements and standards established pursuant to
subdivision (c) of section 1797.197a of the Health and
Safety Code, or it is alleged that the training provider
otherwise demonstrated gross negligence in the training or
certification of an individual whose subsequent actions
cause personal injury or wrongful death in the rendering of
emergency services by an epinephrine auto-injector."
3. Suggested clarifying amendments
The following amendments would correct drafting issues:
Suggested amendment
On page 4, line 31, after "epinephrine auto-injector" insert
", in good faith and not for compensation,"
On page 4, line 33, strike "in good faith and not for
compensation,"
On page 6, strike lines 1-3, inclusive, and insert "'(4) Lay
rescuer' means any person who has met the training standards
and other requirements of this section but who is not
otherwise licensed or certified to use an epinephrine
auto-injector on another person."
4. Consumer Attorneys of California
The Consumer Attorneys of California (CAOC) previously submitted
a letter of concern wherein they "recognize[d] the benefit to
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have appropriately trained personnel deliver life saving
injunctions," but expressed desire to work further with the
author to narrow the bill-presumably with respect to the
immunity provisions. CAOC has indicated that the amendments
suggested in Comment 2 would address their concerns.
5. Amendments taken since this bill was last heard in Senate
Heath Committee
This bill has been recently amended, in relevant part, to
address both opposition concern and suggestions made by the
Senate Health Committee. First, this bill now specifies that it
no longer applies a school district or county office of
education, or its personnel, providing and utilizing epinephrine
auto-injectors to provide emergency medical aid pursuant to the
Education Code. Second, this bill addresses a comment by the
Senate Health Committee that "some prehospital emergency
personnel already have it within their scope of practice to
administer epinephrine," and that the author may wish to
consider amending this bill to ensure that any professional who
is already licensed to administer epinephrine auto-injectors
under their current scope of practice may continue to do so
without obtaining the additional training and certification
required by this bill. The bill now contains language to that
end.
Support : Association of Regional Center Agencies (ARCA);
California Association of Joint Powers Authorities; California
Hospital Association; Hospital Corporation of America
Opposition : None Known
HISTORY
Source : Conference of California Bar Associations
Related Pending Legislation : None Known
Prior Legislation :
AB 559 (Wiggins, Ch. 458, Stats. 2001), See Background.
AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was
ultimately vetoed.
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Prior Vote : Senate Committee on Health (Ayes 8, Noes 0)
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