BILL ANALYSIS Ó
AB 1386
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Date of Hearing: January 15, 2016
ASSEMBLY COMMITTEE ON JUDICIARY
Mark Stone, Chair
AB 1386
(Low) - As Amended January 13, 2016
SUBJECT: Emergency medical care: epinephrine auto-injectors
KEY ISSUES:
1)Should doctors be permitted to prescribe epinephrine
auto-injectors (AUTo-INJECTOR) to an entity, so long as the
entity employs at least one person trained to administer the
auto-injector to a person displaying symptons of anaphylaxis?
2)Should an entity that obtains an auto-injector pursuant to a
prescription be immune from liability for harm caused by the
good faith use of the auto-injector by one of its trained
employees, volunteers, or agents?
SYNOPSIS
This bill seeks to expand the use of epinephrine auto-injectors
(sometimes known as "epi-pens"). These relatively easy-to-use
devices are used to treat anaphylaxis, a life-threatening
condition that may result from an allergic reaction or
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hypersensitivity to a particular substance. The bill is
sponsored by Mylan, a company that manufactures epi-pens.
Prescriptions for epi-pens are typically written to persons who
suffer from an allergy or related condition that could cause an
anaphylactic reaction. Most often these persons self-administer
by pressing the device into the thigh. However, recent
legislation authorized doctors to write prescriptions for
epi-pens to prehospital emergency medical personnel and "lay
rescuers," that is, non-professionals who have undergone
prescribed training to recognize anaphylaxis and to properly
administer the device if needed. Existing law also permits an
authorized physician to prescribe epi-pens to school districts
for use by school nurses or other school staff who have
voluntarily undergone required training. Off-duty emergency
medical personnel, lay rescuers, and school personnel are
afforded qualified immunity from liability if they administer
the device "in good faith and not for compensation." This bill
would expand existing law in two ways: first, it would allow a
health care provider to prescribe, and a pharmacist to dispense,
epi-pens to an "authorized entity," which in turn is defined as
any entity that employs, or uses as a volunteer, at least one
person trained to use the epi-pen. In other words, the employee
or volunteer would need to qualify as a "lay rescuer" under
existing law. The bill would also grant the authorized entity
qualified immunity from liability for civil damages resulting
from the good faith efforts of its trained employees,
volunteers, or agents. The author and sponsor contend that such
immunities are required in order to assuage the concerns of
businesses and other entities that might otherwise stock
epi-pens, but are reluctant to do so because they fear potential
liability. The bill passed out of the Assembly Business and
Professions Committee earlier this week.
SUMMARY: Permits a medical provider to prescribe epinephrine
auto-injectors to an "authorized entity," as defined, and grants
immunity from liability to the authorized entity for any harm
caused by authorized use of the device. Specifically, this
bill:
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1)Authorizes a pharmacy to furnish an epinephrine auto-injector
(auto-injector) to an authorized entity, as specified.
Defines "authorized entity" to mean an entity that employs at
least one person, or utilizes at least one volunteer or agent,
that has voluntarily completed a prescribed training course.
2)Provides that an authorized entity shall not be liable for any
civil damages resulting from an act or omission, other than an
act or omission constituting gross negligence or willful or
wanton misconduct, related to the administration of the
auto-injector by one of its trained employees, volunteers, or
agents. Specifies that the failure of an authorized entity to
possess or administer an auto-injector shall not result in
civil liability. Specifies further that the immunity provided
by this provision does not affect any other immunity or
defense that is available under any other state law.
3)Permits an authorized health care provider to issue a
prescription for an auto-injector to an authorized entity, as
defined, if the authorized entity submits evidence that it
employs at least one person, or utilizes at least one
volunteer or agent, who is trained to administer an
auto-injector, as required under existing law.
4)Requires an authorized entity that possesses and makes
available auto-injectors to develop an operations plan that,
among other things, provides for the proper storage, regular
inspection, and replacement of auto-injectors, and requires
the authorized entity to submit to the State Department of
Public Health a report relating to the use of auto-injectors
on its premises.
EXISTING LAW:
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1)Provides that no person who in good faith, and not for
compensation, renders medical or nonmedical care at the scene
of an emergency shall be liable for any civil damages
resulting from any act or omission other than an act or
omission constituting gross negligence or willful or wanton
misconduct. (Health and Safety Code Section 1799.102.)
2)Permits a "prehospital emergency medical care person" or a
"lay rescuer," as defined, to use an epinephrine auto-injector
in order to render emergency care to another person who
appears to be experiencing anaphylaxis so long as certain
requirements are met, including, among other things, that the
person using the epinephrine auto-injector has completed a
prescribed course of training and that the epinephrine
auto-injector has been obtained by prescription from an
authorized health care provider. (Health and Safety Code
Section 1797.197a.)
3)Provides that a prehospital emergency medical care person or
lay rescuer who administers an epinephrine auto-injector, in
good faith and not for compensation, to another person who
appears to be experiencing anaphylaxis at the scene of an
emergency 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 complies with specified statutory
requirements, and so long as his or her conduct does not
constitute gross negligence or willful or wanton misconduct.
(Civil Code Section 1714.23.)
4)Requires a school district or county office of education to
provide emergency epinephrine auto-injectors to school nurses
or trained volunteers, as specified, and allows those
individuals to utilize epinephrine auto-injectors to provide
emergency medical aid to persons suffering from anaphylaxis.
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Requires a school nurse or a school administrator to obtain a
prescription for the epinephrine auto-injectors from an
authorized physician, and provides that the prescribing
physician shall not be subject to professional review, civil
liability, or criminal prosecution for prescribing the
epinephrine auto-injectors, unless the physician's issuance of
the prescription constitutes gross negligence or willful and
malicious conduct. (Education Code Section 49414(a)-(g).)
FISCAL EFFECT: As currently in print this bill is keyed fiscal.
COMMENTS: As is well-documented in a number of medical studies,
certain common foods, products, and even medications may cause
severe and life-threating allergic reactions, or anaphylaxis.
Although anaphylaxis can be fatal if untreated, a person who
experiences anaphylaxis can be kept alive by the prompt
administration of epinephrine until transported to an emergency
room. An epinephrine auto-injector is a relatively simple and
easy-to-use prescription product that provides an appropriate
dose of epinephrine, whether the auto-injector is
self-administered by the victim, or by someone else.
While all agree that epinephrine auto-injectors are relatively
simple and easy-to-use, the devices may only be obtained by
prescription under federal law. Most commonly, they are
prescribed to a person with an allergy that is known to cause
anaphylaxis. However, a person - especially a child - may not
always know that he or she has such an allergy prior to
suffering the first anaphylactic episode. To address this
dilemma, existing law in California allows doctors, in limited
contexts, to prescribe auto-injectors to persons trained to
recognize the symptoms of anaphylaxis and safely administer the
devices. For example, under the California Education Code,
doctors may prescribe auto-injectors to school districts for use
by school nurses or other school employees who have undergone
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prescribed training on how to recognize the symptoms of
anaphylaxis and administer the auto-injector. In addition, a
provision in the Health & Safety Code permits doctors to
prescribe auto-injectors to prehospital emergency care persons
and "lay rescuers" who have undergone statutorily prescribed
training and hold a current certification. Consistent with
California's general Good Samaritan statute (Health and Safety
Code Section 1799.102), existing law also affords qualified
immunity to off-duty prehospital emergency care persons and
trained lay rescuers for injuries caused by their use of the
auto-injector, so long as they act in "good faith and not for
compensation." Also consistent with other statutory immunities,
the person administering the auto-injector is only afforded a
qualified immunity from liability, meaning that immunity does
not extend to conduct that constitutes gross negligence or
willful or wanton misconduct.
This bill would expand existing law in two ways. First, it
would allow a physician to prescribe, and a pharmacist to
dispense, the auto-injectors to an "authorized entity." The
bill defines an "authorized entity" to mean any entity (whether
a private business or government agency, other than a school
district) that has at least one employee, volunteer, or agent
that has undergone prescribed training to become a lay rescuer.
Because existing law requires training before one can be
authorized to administer the device to another person, an entity
that did not have a trained employee or volunteer, therefore,
could not obtain a prescription to stock the auto-injectors.
Second, this bill would give an authorized entity qualified
immunity from liability for an injury caused by an employee or
volunteer acting in good faith and not for compensation.
Arguably, such immunity is not necessary, as the authorized
entity could only be vicariously liable for the acts of an
employee or volunteer if the employee or volunteer would have
been liable. As required by law, however, the employee or
volunteer will necessarily be a "lay rescuer," and a lay rescuer
is already protected from liability when acting in good faith
and not for compensation - unless, of course, the conduct rises
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to gross negligence or willful or wanton misconduct, in which
case the lay rescuer is appropriately subject to civil liability
for that conduct. Nonetheless, the author and sponsor contend
that entities that might otherwise keep auto-injectors stocked
for use by trained employees are reluctant to do so because of
fears of liability. The express liability afforded by this bill
is intended by the author to assuage those fears.
The "Good Samaritan" Law and the Unintended Consequences of
Express Immunities. In recent years this Committee has heard,
and the Legislature has enacted, bills seeking an express
immunity from liability for lay people (or off-duty
professionals) who voluntarily render medical aid in a specific
emergency situation, such as administering cardiopulmonary
resuscitation (CPR) or applying an automated external
defibrillator (AED), among other voluntary actions. Under
existing common law tort rules, however, a person who
voluntarily comes to the aid of another person suffering a
medical emergency would be immune from liability so long as that
person acted in a reasonably prudent manner under the
circumstances. In addition, in 2009, California adopted a
so-called "Good Samaritan" statute. (The term refers to the
parable in the Gospel of Luke about the "lowly" Samaritan who
came to the aid of a stranger left for dead while supposedly
more upstanding citizens ignored the cries of the dying man.)
California's Good Samaritan statute (Heath & Safety Code Section
1799.102) grants qualified immunity to any person who renders
medical or non-medical aid in an emergency, so long as that
person acts in good faith and not for compensation, and so long
as that person's conduct is not grossly negligent or willful or
wanton. Accordingly, provisions in existing law that have
granted immunity to persons performing CPR or administering AED
devices or epinephrine auto-injectors may be unnecessary, since
any of these acts would most certainly qualify as rendering
medical aid in an emergency. For example, it is difficult to
imagine a situation in which a person who had complied with the
requirements of this bill (or even an untrained lay person who
voluntarily renders aid to a victim of anaphylaxis by providing
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or assisting the victim with an auto-injector, which is not
specifically authorized by this bill) would not already be
protected from liability under the Good Samaritan statute.
While providing express immunity for specific medical
emergencies may be unnecessary in light of the Good Samaritan
statute, one could argue that this bill - and prior bills like
it - is a harmless and potentially useful clarification of
existing law.
ARGUMENTS IN SUPPORT: Mylan, a company that manufactures
medical products, including epinephrine auto-injectors,
sponsored this bill because it will "expand access to
epinephrine auto-injectors used to treat severe allergic
reactions or anaphylaxis." Mylan cites statistics on the number
of anaphylaxis deaths, suggesting that such tragedies might have
been avoided had the victim had timely access to an epinephrine
auto-injector. This is especially true in instances where the
victim had never experienced anaphylaxis, was not aware of his
or her allergy, and therefore would not have possessed an
auto-injector.
Mylan acknowledges that California has "made great strides to
address this issue," especially in legislation targeting schools
and the training of lay rescuers, but the company believes that
"more can be done to ensure the state is better prepared in the
event that children or adults experience an anaphylactic
reaction for the first time or in a public location." While
Mylan believes that providing auto-injectors to schools was an
important "first step," it notes that there are many other
public places - including preschools, colleges, workplaces, and
restaurants - where someone could experience an anaphylactic
reaction without having an auto-injector on hand. Finally,
Mylan notes that nineteen other states "have already passed
legislation that allows entities to stock epinephrine
auto-injectors and trained individuals to administer them."
Mylan argues that California should do the same.
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REGISTERED SUPPORT / OPPOSITION:
Support
Mylan, Inc. (sponsor)
Allergy & Asthma Network
Allergy Station
American Latex Allergy Association
American Red Cross
California ACEP
San Francisco Bay Area Food Allergy Network
Two individuals
Opposition
None on file
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Analysis Prepared by: Thomas Clark / JUD. / (916) 319-2334