AB 1166: Liability for opioid antagonist administration.
- Session Year: 2023-2024
- House: Assembly
- Latest Version Date: 2023-07-21
Current Status:
Passed
(2023-07-21: Chaptered by Secretary of State - Chapter 97, Statutes of 2023.)
Introduced
In Committee
First Chamber
In Committee
Second Chamber
Enacted
What does this bill do?
The bill protects people who, in good faith and without pay, give, use, or furnish an opioid antagonist (such as naloxone, a drug that reverses opioid overdoses) at the scene of a suspected opioid overdose from civil lawsuits for acts or omissions related to that emergency care. The protection does not apply if the person’s conduct amounts to gross negligence or willful or wanton misconduct.
The summary is provided by generative AI which can make mistakes. For original language, please view the details in the table below.
Existing law provides that a person who, in good faith and not for compensation, renders emergency medical or nonmedical care or assistance at the scene of an emergency is not liable for civil damages resulting from an act or omission other than an act or omission constituting gross negligence or willful or wanton misconduct.
This bill would provide that a person who, in good faith and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering an opioid antagonist, as defined, is not liable for civil damages resulting from an act or omission, except as specified. The bill would also provide that a person who furnishes an opioid antagonist for use at the scene of an opioid overdose or suspected opioid overdose is not liable for civil damages resulting from an act or omission, except as specified.
Existing law provides that a person who, in good faith and not for compensation, renders emergency medical or nonmedical care or assistance at the scene of an emergency is not liable for civil damages resulting from an act or omission other than an act or omission constituting gross negligence or willful or wanton misconduct.
This bill would provide that a person who, in good faith and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering an opioid antagonist, as defined, is not liable for civil damages resulting from an act or omission, except as specified. The bill would also provide that a person who furnishes an opioid antagonist for use at the scene of an opioid overdose or suspected opioid overdose is not liable for civil damages resulting from an act or omission, except as specified.
Existing law provides that a person who, in good faith and not for compensation, renders emergency medical or nonmedical care or assistance at the scene of an emergency is not liable for civil damages resulting from an act or omission other than an act or omission constituting gross negligence or willful or wanton misconduct.
This bill would provide that a person who is not trained in emergency medical services or as a health care provider and who, in good faith and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering naloxone hydrochloride an opioid antagonist, as defined, is not liable for civil damages resulting from an act or omission. omission, except as specified. The bill would also provide that a person who furnishes naloxone hydrochloride to that untrained person an opioid antagonist for use at the scene of an opioid overdose or suspected opioid overdose is not liable for civil damages resulting from an act or omission. omission, except as specified.
Existing law provides that a person who, in good faith and not for compensation, renders emergency medical or nonmedical care or assistance at the scene of an emergency is not liable for civil damages resulting from an act or omission other than an act or omission constituting gross negligence or willful or wanton misconduct.
This bill would provide that a person who is not trained in emergency medical services or as a health care provider and who, in good faith and not for compensation, renders treatment at the scene of an opioid overdose or suspected opioid overdose by administering naloxone hydrochloride is not liable for civil damages resulting from an act or omission. The bill would also provide that a person who furnishes naloxone hydrochloride to that untrained person for use at the scene of an opioid overdose or suspected opioid overdose is not liable for civil damages resulting from an act or omission.
(a)(1)A person who, in good faith and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering an opioid antagonist shall not be liable for civil damages resulting from an act or omission related to the rendering of the emergency treatment.
(2)A person who, in good faith and not for compensation, furnishes an opioid antagonist to a person for use at the scene of an opioid overdose or suspected opioid overdose shall not be liable for civil damages resulting from an act or omission related to the furnishing of the opioid antagonist.
(b)This section does not apply to an act or omission related to the rendering of emergency treatment at the scene of an opioid overdose or suspected opioid overdose by means of an opioid antagonist that constitutes gross negligence or willful or wanton misconduct.
(c)For purposes of this section, both of the following apply:
(1)A person who renders emergency treatment by means of an opioid antagonist, or who furnishes an opioid antagonist at the scene of an opioid overdose or suspected opioid overdose, and who is not compensated for doing so, but receives compensation for other actions as a result of their unrelated employment, is not rendering emergency medical care or furnishing opioid antagonist for compensation.
(2)Opioid antagonist means naloxone hydrochloride or any other opioid antagonist that is approved by the United States Food and Drug Administration for the treatment of an opioid overdose.
(a)(1)A person who, in good faith and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering an opioid antagonist shall not be liable for civil damages resulting from an act or omission related to the rendering of the emergency treatment.
(2)A person who, in good faith and not for compensation, furnishes an opioid antagonist to a person for use at the scene of an opioid overdose or suspected opioid overdose shall not be liable for civil damages resulting from an act or omission related to the furnishing of the opioid antagonist.
(b)This section does not apply to an act or omission related to the rendering of emergency treatment at the scene of an opioid overdose or suspected opioid overdose by means of an opioid antagonist that constitutes gross negligence or willful or wanton misconduct.
(c)For purposes of this section, both of the following apply:
(1)A person who renders emergency treatment by means of an opioid antagonist, or who furnishes an opioid antagonist at the scene of an opioid overdose or suspected opioid overdose, and who is not compensated for doing so, but receives compensation for other actions as a result of their unrelated employment, is not rendering emergency medical care or furnishing opioid antagonist for compensation.
(2)Opioid antagonist means naloxone hydrochloride or any other opioid antagonist that is approved by the United States Food and Drug Administration for the treatment of an opioid overdose.
(a)(1)A person who is not trained in emergency medical services or as a health care provider and who, in good faith and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering naloxone hydrochloride an opioid antagonist shall not be liable for civil damages resulting from an act or omission. omission related to the rendering of the emergency treatment.
(b)
(2)A person who, in good faith, faith and not for compensation, furnishes naloxone hydrochloride an opioid antagonist to a person who is not trained in emergency medical services or as a health care provider for use at the scene of an opioid overdose or suspected opioid overdose shall not be liable for civil damages resulting from an act or omission. omission related to the furnishing of the opioid antagonist.
(b)This section does not apply to an act or omission related to the rendering of emergency treatment at the scene of an opioid overdose or suspected opioid overdose by means of an opioid antagonist that constitutes gross negligence or willful or wanton misconduct.
(c)For purposes of this section, both of the following apply:
(1)A person who renders emergency treatment by means of an opioid antagonist, or who furnishes an opioid antagonist at the scene of an opioid overdose or suspected opioid overdose, and who is not compensated for doing so, but receives compensation for other actions as a result of their unrelated employment, is not rendering emergency medical care or furnishing opioid antagonist for compensation.
(2)Opioid antagonist means naloxone hydrochloride or any other opioid antagonist that is approved by the United States Food and Drug Administration for the treatment of an opioid overdose.
(a)A person who is not trained in emergency medical services or as a health care provider and who, in good faith and not for compensation, renders treatment at the scene of an opioid overdose or suspected opioid overdose by administering naloxone hydrochloride shall not be liable for civil damages resulting from an act or omission.
(b)A person who, in good faith, furnishes naloxone hydrochloride to a person who is not trained in emergency medical services or as a health care provider for use at the scene of an opioid overdose or suspected opioid overdose shall not be liable for civil damages resulting from an act or omission.
|
Date
|
Status
|
|---|---|
| Jul 21, 2023 | Chaptered by Secretary of State - Chapter 97, Statutes of 2023. |
| Jul 21, 2023 | Approved by the Governor. |
| Jul 11, 2023 | Enrolled and presented to the Governor at 3 p.m. |
| Jun 29, 2023 | In Assembly. Ordered to Engrossing and Enrolling. |
| Jun 29, 2023 | Read third time. Passed. Ordered to the Assembly. (Ayes 39. Noes 0. Page 1826.). |
| Jun 22, 2023 | Read second time. Ordered to Consent Calendar. |
| Jun 21, 2023 | From committee: Do pass. To Consent Calendar. (Ayes 11. Noes 0.) (June 20). |
| May 3, 2023 | Referred to Com. on JUD. |
| Apr 10, 2023 | In Senate. Read first time. To Com. on RLS. for assignment. |
| Apr 10, 2023 | Read third time. Passed. Ordered to the Senate. (Ayes 65. Noes 0. Page 1079.) |
| Mar 29, 2023 | Read second time. Ordered to Consent Calendar. |
| Mar 28, 2023 | From committee: Do pass. To Consent Calendar. (Ayes 9. Noes 0.) (March 28). |
| Mar 27, 2023 | Re-referred to Com. on JUD. |
| Mar 23, 2023 | From committee chair, with author's amendments: Amend, and re-refer to Com. on JUD. Read second time and amended. |
| Mar 2, 2023 | Referred to Com. on JUD. |
| Feb 17, 2023 | From printer. May be heard in committee March 19. |
| Feb 16, 2023 | Read first time. To print. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Jun 29, 2023 | Consent Calendar AB1166 Bains | Senate Floor |
Passed |
|
| Jun 20, 2023 | Do pass and be ordered to the Consent Calendar | Senate Standing Committee on Judiciary |
Passed |
|
| Apr 10, 2023 | AB 1166 Bains Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| Mar 28, 2023 | Do pass. To Consent Calendar. | Assembly Standing Committee on Judiciary |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| California Academy Of Family Physicians | ** Support | |
| California Academy of Preventive Medicine | ** Support | |
| California Catholic Conference | ** Support | |
| California State Association of Psychiatrists | ** Support | |
| California State Sheriffs Association | ** Support | |
| City of Alameda | ** Support | |
| City of Long Beach | ** Support | |
| Civil Justice Association Of California | ** Support | |
| County Behavioral Health Directors Association of California | ** Support | |
| Faculty Association Of California Community Colleges | ** Support | |
| Govern for California | ** Support | |
| League Of California Cities | ** Support | |
| Los Angeles Unified School District | ** Support | |
| National Health Law Program | ** Support | |
| Peace Officers Research Association Of California | ** Support |
SENATE RULES COMMITTEE Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB 1166 |
CONSENT
Bill No: AB 1166
Author: Bains (D)
Amended: 3/23/23 in Assembly
Vote: 21
SENATE JUDICIARY COMMITTEE: 11-0, 6/20/23
AYES: Umberg, Wilk, Allen, Ashby, Caballero, Durazo, Laird, Min, Niello, Stern, Wiener
ASSEMBLY FLOOR: 65-0, 4/10/23 (Consent) - See last page for vote
SUBJECT: Liability for opioid antagonist administration
SOURCE: Author
DIGEST:
This bill provides qualified immunity to those administering or providing, in good faith, emergency opioid antagonists, as defined, at the scene of an overdose, or suspected overdose.
ANALYSIS:
Existing law:
- Provides that every person is responsible, not only for the result of their willful acts, but also for an injury occasioned to another by the person’s want of ordinary care or skill in the management of their property or person, except so far as the latter has, willfully or by want of ordinary care, brought the injury upon themselves. (Civ. Code § 1714(a).)
- Provides that no person who, in good faith, and not for compensation, renders emergency care at the scene of an emergency shall be liable for civil damages resulting from any act or omission. The scene of an emergency shall not include emergency departments and other places where medical care is usually offered. This applies only to medical, law enforcement, and emergency personnel, as specified. (Health & Saf. Code § 1799.102(a).)
- Extends to all other persons not covered by the above who are rendering medical or nonmedical care or other assistance in such situations immunity from civil damages resulting from any act or omission other than acts or omissions constituting gross negligence or willful or wanton misconduct. (Health & Saf. Code § 1799.102(b).)
- Provides that notwithstanding any other law, a person who possesses or distributes an opioid antagonist pursuant to a prescription or standing order shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this possession or distribution. Further provides that a person not otherwise licensed to administer an opioid antagonist, but trained as required and who acts with reasonable care in administering an opioid antagonist, in good faith and not for compensation, to a person who is experiencing or is suspected of experiencing an overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this administration. (Civ. Code § 1714.22 (f).)
- Requires the State Department of Public Health, upon appropriation, to award funding to local health departments, local government agencies, or on a competitive basis to community-based organizations, regional opioid prevention coalitions, or both, to support or establish programs that provide FDA-approved opioid antagonists for the treatment of an opioid overdose, to first responders and to at-risk opioid users through programs that serve at-risk drug users, including, but not limited to, syringe exchange and disposal programs, homeless programs, and substance use disorder treatment providers. (Health & Saf. Code § 1179.80 (a).)
- Provides that notwithstanding any other law, school personnel who volunteer to be trained to administer naloxone hydrochloride (naloxone) or another opioid antagonist, in good faith and not for compensation, to a person who appears to be experiencing an opioid overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for their acts or omissions in administering the opioid antagonist. (Educ. Code § 49414.3(j)(1).)
This bill:
- Immunizes a person who, in good faith and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering an opioid antagonist from civil liability for damages resulting from an act or omission related to the rendering of the emergency treatment.
- Immunizes a person who, in good faith and not for compensation, furnishes an opioid antagonist to a person for use at the scene of an opioid overdose or suspected opioid overdose from civil liability for damages resulting from an act or omission related to the furnishing of the opioid antagonist.
- Provides that the above immunities do not apply to acts or omissions constituting gross negligence or willful or wanton misconduct.
- Defines “opioid antagonist” as naloxone hydrochloride or any other opioid antagonist that is approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose.
- Clarifies that a person who renders emergency treatment by means of an opioid antagonist, or who furnishes an opioid antagonist at the scene of an opioid overdose or suspected opioid overdose, and who is not compensated for doing so, but receives compensation for other actions as a result of their unrelated employment, is not “rendering emergency medical care or furnishing an opioid antagonist for compensation.”
Background
According to the Johns Hopkins Bloomberg School of Public Health, “[o]ver 500,000 people have died from opioid overdoses since 1999 [and] an estimated 93,000 people died from opioid overdoses in 2020, more than in any other year.” Opioid overdoses are characterized by central nervous system and respiratory depression, leading to coma and death. While there are various opioid antagonists, the most popular appears to be naloxone, which has the ability to counteract depression of the central nervous and respiratory system caused by an opioid overdose. Naloxone is administered by either injection into vein or muscle or via a nasal atomizer. Once administered, naloxone takes effect after around a minute, potentially saving the person’s life.
There are a host of bills making their way through the Legislature this year that attempt to address the troubling spike in opioid use and overdose. This bill seeks to address the concern that liability fears are preventing the use of opioid antagonists to prevent overdose and save lives. This bill provides a qualified immunity to those administering in good faith such drugs at the scene of an overdose, or suspected overdose, as well as to any person furnishing in good faith such drugs to the person administering them. Such immunity from civil liability for resulting damages does not attach where the relevant act or omission constituted gross negligence or willful or wanton misconduct. This bill is author-sponsored. It is supported by several groups and localities, including the California Academy of Family Physicians. There is no known opposition. (NOTE: For a more thorough discussion, see the Senate Judiciary Committee analysis of this bill.)
Comments
As stated, it is not only this state, but the entire country, that is being ravaged by opioid overdose deaths. Examples of opioids include heroin, oxycodone (OxyContin®), hydrocodone (Vicodin®), codeine, and morphine. One major cause of the dramatic rise in overdose numbers is the increasing use of one particularly dangerous iteration, fentanyl.[1]
One critical tool in the fight against opioid overdoses is an opioid antagonist, which is a drug that attaches to opioid receptors and reverses and blocks the effects of other opioids.[2] Naloxone is a popular form of this medicine that can rapidly reverse an opioid overdose. Naloxone can quickly restore normal breathing to a person if their breathing has slowed or stopped because of an overdose. Crucially, naloxone has little to no effect on someone who does not have opioids in their system. Opioid antagonists should be given to any person who shows signs of an opioid overdose or when an overdose is suspected. Naloxone can be given as a nasal spray or it can be injected into the muscle, under the skin, or into the veins.
Civil liability and immunity
As a general rule, California law provides that persons are responsible, not only for the result of their willful acts, but also for an injury occasioned to another by their want of ordinary care or skill in the management of their property or person, except so far as the latter has, willfully or by want of ordinary care, brought the injury upon themselves. (Civ. Code § 1714(a).) Liability has the primary effect of ensuring that some measure of recourse exists for those persons injured by the negligent or willful acts of others; the risk of that liability has the primary effect of ensuring parties act reasonably to avoid harm to those to whom they owe a duty.
Conversely, immunity from liability disincentivizes careful planning and acting on the part of individuals and entities. When one enjoys immunity from civil liability, they are relieved of the responsibility to act with due regard and an appropriate level of care in the conduct of their activities. Immunity provisions are also disfavored because they, by their nature, preclude parties from recovering when they are injured, and force injured parties to absorb losses for which they are not responsible. Liability acts not only to allow a victim to be made whole, but to encourage appropriate compliance with legal requirements.
Although immunity provisions are rarely preferable, the Legislature has, in limited scenarios, approved measured immunity from liability (as opposed to blanket immunities) to promote other policy goals that could benefit the public. Immunities are generally afforded when needed to ensure the willingness of individuals to continue taking on certain roles that may involve some risk and to incentivize certain conduct, such as the provision of life-saving or other critical services. Examples include protections for use of CPR (Civ. Code § 1714.2); use of an automated external defibrillator (Civ. Code § 1714.21); use of opiate overdose treatment (Civ. Code § 1714.22); providing emergency care at the scene of an emergency (Health & Saf. Code §§ 1799.102, 1799.106); and performing emergency rescue services (Health & Saf. Code § 1799.107). However, as indicated above, rarely is immunity absolute, and these immunities generally do not cover grossly negligent conduct or intentional misconduct.
Incentivizing the administration of opioid antagonists
In order to maximize the life-saving capabilities of opioid antagonists, this bill provides qualified immunity to a person who, in good faith, and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering an opioid antagonist.[3] The person is immune from civil liability for damages resulting from an act or omission related to the rendering of the emergency treatment. The immunity also covers a person who, in good faith, and not for compensation, furnishes the opioid antagonist for use in such situations. The above immunities do not apply to acts or omissions constituting gross negligence or willful or wanton misconduct.
These provisions mimic, and supplement, similar existing laws. For instance, Education Code section 49414.3 authorizes local educational agencies (LEA) to designate volunteers to train on emergency use of naloxone hydrochloride or another opioid antagonist. A school nurse or trained volunteer is authorized to administer naloxone hydrochloride or another opioid antagonist to a person exhibiting potentially life-threatening symptoms of an opioid overdose at school or a school activity. The LEA is required to ensure that each employee who volunteers will be provided defense and indemnification for any and all civil liability. A person trained to administer an opioid antagonist that, in good faith and not for compensation, provides it to a person who appears to be experiencing an opioid overdose is shielded from professional review, liability in a civil action, and criminal prosecution for their acts or omissions in administering the opioid antagonist. As here, the immunity does not apply in a case of gross negligence or willful and wanton misconduct of the person.
It also tracks with the immunity provisions of Section 1799.102 of the Health and Safety Code, often referred to as the “Good Samaritan Law.” That statute provides immunity for those rendering emergency medical or nonmedical care at the scene of an emergency, as specified. In fact, a person who, in good faith and not for compensation, renders emergency treatment by the use of an opioid antagonist at the scene of an emergency is likely already covered by the existing Good Samaritan Law. However, this provision will likely incentivize more individuals to take action when needed.
According to the author:
Hesitation at the scene of an opioid overdose can literally be the difference between life and death. California has taken several steps over the years to make naloxone more accessible and federal regulators are currently moving forward with efforts to make this prescription medication available over the counter. The Naloxone Distribution Project at DHCS supplies naloxone to numerous entities for use and distribution including EMS, harm reduction organizations, organizations that serve the unhoused populations, substance use recovery facilities, and emergency departments. The state has also repeatedly expanded the protections afforded under the Good Samaritan Law to encourage, but not require, the administration of naloxone at the scene of an opioid overdose. Unfortunately, this has resulted in a patchwork of statutes with numerous prerequisites, which must be met in order to be eligible for existing liability protections. This runs counter to the intended purpose of extending these liability protections which is to ensure no one who is able and willing to administer naloxone or opioid antagonists at the scene of an opioid overdose hesitates or withholds care for fear of wrongful prosecution. In addition, given the state’s numerous efforts to make naloxone readily available to persons at risk of overdose as well as persons who live or work in and around persons at risk of overdose, statute should be made clear that no one acting in good faith can be held liable for furnishing naloxone or other opioid antagonists to another person via secondary distribution.
FISCAL EFFECT: Appropriation: No Fiscal Com.: No Local: No
SUPPORT: (Verified 6/23/23)
California Academy of Family Physicians
California Academy of Preventive Medicine
California State Association of Psychiatrists
California State Sheriffs’ Association
City of Alameda
City of Long Beach
Civil Justice Association of California
County Behavioral Health Directors Association of California
Faculty Association of California Community Colleges
Govern for California
Los Angeles Unified School District
National Health Law Program
Peace Officers Research Association of California
OPPOSITION: (Verified 6/23/23)
None received
ARGUMENTS IN SUPPORT: The City of Alameda states:
In California, opioid-related fatalities have skyrocketed by 137% since 2000, and the number of opioid overdose deaths in the state has more than doubled since 2010. According to the National Safety Council, more than 70,000 drug overdose deaths occurred in the United States in 2019, with opioids responsible for 70% of those deaths.
AB 1166 seeks to encourage increased access to opioid antagonists, including to laypersons in the community, by clarifying that a person who in good faith and not for compensation, either renders emergency care by means of administering an opioid antagonist, or furnishes an opioid antagonist, is generally not liable for civil damages resulting from an act or omission related to such actions.
The City of Alameda supports legislation to reduce opioid overdose deaths and efforts that protect the health, safety, and welfare of residents.
ASSEMBLY FLOOR: 65-0, 4/10/23
AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bennett, Berman, Boerner Horvath, Bonta, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Connolly, Megan Dahle, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, McCarty, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Joe Patterson, Pellerin, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Santiago, Schiavo, Soria, Ta, Ting, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wood, Zbur, Rendon
NO VOTE RECORDED: Bauer-Kahan, Bryan, Chen, Davies, Dixon, Essayli, Irwin, Mathis, McKinnor, Jim Patterson, Petrie-Norris, Quirk-Silva, Sanchez, Valencia, Wilson
Prepared by: Christian Kurpiewski / JUD. / (916) 651-4113
6/23/23 12:29:12
**** END ****
Connor Sheets, As fentanyl overdose deaths keep rising, efforts to reverse trend meet liability fears (December 27, 2022) Los Angeles Times, https://www.latimes.com/california/story/2022-12-27/as-overdose-deaths-keep-rising-bold-efforts-to-reverse-the-trend-emerge. All internet citations are current as of June 13, 2023. ↑
Naloxone DrugFacts (January 2022) National Institute on Drug Abuse, https://nida.nih.gov/publications/drugfacts/naloxone. ↑
“Opioid antagonist” includes naloxone hydrochloride or any other opioid antagonist that is approved by the FDA for the treatment of an opioid overdose. ↑
Senator Thomas Umberg, Chair
2023-2024 Regular Session
Bill No: AB 1166 (Author:Bains)
Version: March 23, 2023
Hearing Date: June 20, 2023
Fiscal: No
Urgency: No
Consultant: CK
SUBJECT
Liability for opioid antagonist administration
DIGEST
This bill provides qualified immunity to those administering or providing, in good faith, emergency opioid antagonists, as defined, at the scene of an overdose, or suspected overdose.
EXECUTIVE SUMMARY
According to the Johns Hopkins Bloomberg School of Public Health, “[o]ver 500,000 people have died from opioid overdoses since 1999 [and] an estimated 93,000 people died from opioid overdoses in 2020, more than in any other year.” Opioid overdoses are characterized by central nervous system and respiratory depression, leading to coma and death. While there are various opioid antagonists, the most popular appears to be naloxone, which has the ability to counteract depression of the central nervous and respiratory system caused by an opioid overdose. Naloxone is administered by either injection into vein or muscle or via a nasal atomizer. Once administered, naloxone takes effect after around a minute, potentially saving the person’s life.
There are a host of bills making their way through the Legislature this year that attempt to address the troubling spike in opioid use and overdose. This bill seeks to address the concern that liability fears are preventing the use of opioid antagonists to prevent overdose and save lives. The bill provides a qualified immunity to those administering in good faith such drugs at the scene of an overdose, or suspected overdose, as well as to any person furnishing in good faith such drugs to the person administering them. Such immunity from civil liability for resulting damages does not attach where the relevant act or omission constituted gross negligence or willful or wanton misconduct.
The bill is author-sponsored. It is supported by several groups and localities, including the California Academy of Family Physicians. There is no known opposition.
PROPOSED CHANGES TO THE LAW
Existing law:
- Provides that every person is responsible, not only for the result of their willful acts, but also for an injury occasioned to another by the person’s want of ordinary care or skill in the management of their property or person, except so far as the latter has, willfully or by want of ordinary care, brought the injury upon themselves. (Civ. Code § 1714(a).)
- Provides that no person who, in good faith, and not for compensation, renders emergency medical or nonmedical care at the scene of an emergency shall be liable for any civil damages resulting from any act or omission. The scene of an emergency shall not include emergency departments and other places where medical care is usually offered. This applies only to medical, law enforcement, and emergency personnel, as specified. (Health & Saf. Code § 1799.102(a).)
- Extends to all other persons not covered by the above who are rendering medical or nonmedical care or other assistance in such situations immunity from civil damages resulting from any act or omission other than acts or omissions constituting gross negligence or willful or wanton misconduct. (Health & Saf. Code § 1799.102(b).)
- Provides that, in order to encourage local agencies and other organizations to train people in emergency medical services, no local agency, entity of state or local government, private business, or nonprofit organization included on the statewide registry that voluntarily and without expectation and receipt of compensation donates services, goods, labor, equipment, resources, or dispensaries or other facilities, in compliance with Section 8588.2 of the Government Code, or other public or private organization which sponsors, authorizes, supports, finances, or supervises the training of people, or certifies those people, excluding physicians and surgeons, registered nurses, and licensed vocational nurses, as defined, in emergency medical services, shall be liable for any civil damages alleged to result from those training programs. (Health & Saf. Code § 1799.100.)
- Provides that notwithstanding any other law, a person who possesses or distributes an opioid antagonist pursuant to a prescription or standing order shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this possession or distribution. Further provides that a person not otherwise licensed to administer an opioid antagonist, but trained as required and who acts with reasonable care in administering an opioid antagonist, in good faith and not for compensation, to a person who is experiencing or is suspected of experiencing an overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this administration. (Civ. Code § 1714.22 (f).)
- Requires the State Department of Public Health, upon appropriation, to award funding to local health departments, local government agencies, or on a competitive basis to community-based organizations, regional opioid prevention coalitions, or both, to support or establish programs that provide FDA-approved opioid antagonists for the treatment of an opioid overdose, to first responders and to at-risk opioid users through programs that serve at-risk drug users, including, but not limited to, syringe exchange and disposal programs, homeless programs, and substance use disorder treatment providers. (Health & Saf. Code § 1179.80 (a).)
- Provides that notwithstanding any other law, school personnel who volunteer to be trained to administer naloxone hydrochloride (naloxone) or another opioid antagonist, in good faith and not for compensation, to a person who appears to be experiencing an opioid overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for their acts or omissions in administering the opioid antagonist. (Educ. Code § 49414.3(j)(1).)
This bill:
- Immunizes a person who, in good faith and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering an opioid antagonist from civil liability for damages resulting from an act or omission related to the rendering of the emergency treatment.
- Immunizes a person who, in good faith and not for compensation, furnishes an opioid antagonist to a person for use at the scene of an opioid overdose or suspected opioid overdose from civil liability for damages resulting from an act or omission related to the furnishing of the opioid antagonist.
- Provides that the above immunities do not apply to acts or omissions constituting gross negligence or willful or wanton misconduct.
- Defines “opioid antagonist” as naloxone hydrochloride or any other opioid antagonist that is approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose.
- Clarifies that a person who renders emergency treatment by means of an opioid antagonist, or who furnishes an opioid antagonist at the scene of an opioid overdose or suspected opioid overdose, and who is not compensated for doing so, but receives compensation for other actions as a result of their unrelated employment, is not “rendering emergency medical care or furnishing an opioid antagonist for compensation.”
COMMENTS
- The opioid epidemic
As stated, it is not only this state, but the entire country, that is being ravaged by opioid overdose deaths. Examples of opioids include heroin, oxycodone (OxyContin®), hydrocodone (Vicodin®), codeine, and morphine. One major cause of the dramatic rise in overdose numbers is the increasing use of one particularly dangerous iteration, fentanyl:
The death toll has spiked in recent years, largely as a result of the growing ubiquity of the powerful opioid fentanyl.
The legally prescribed painkiller has become a popular illicit street drug over the last decade. It has also killed thousands of people who unknowingly consumed other drugs such as cocaine or heroin that were surreptitiously laced with fentanyl.
The U.S. Centers for Disease Control and Prevention has described fentanyl as up to 50 times as potent as heroin and 100 times as potent as morphine.
More than 71,000 people died in the U.S. of overdoses caused by synthetic opioids — primarily fentanyl — in 2021, an increase of more than 23% from the previous year. In 2012, the CDC recorded just 1,615 overdose deaths involving fentanyl in the U.S.
In the face of such distressing failure to reduce deaths from opioids, methods for addressing the crisis that many once considered too risky or even unthinkable are now being debated by state and local officials and rolled out in communities devastated by overdoses.[1]
One critical tool in the fight against opioid overdoses is an opioid antagonist, which is a drug that attaches to opioid receptors and reverses and blocks the effects of other opioids.[2] Naloxone is a popular form of this medicine that can rapidly reverse an opioid overdose. Naloxone can quickly restore normal breathing to a person if their breathing has slowed or stopped because of an overdose. Crucially, naloxone has little to no effect on someone who does not have opioids in their system.
Opioid antagonists should be given to any person who shows signs of an opioid overdose or when an overdose is suspected. Naloxone can be given as a nasal spray or it can be injected into the muscle, under the skin, or into the veins.
This bill responds to reports that suggest that service providers are concerned with potential legal liability for damages and want legal cover to distribute naloxone to people who may in turn share it with others who have not been trained to administer it.
- Civil liability and immunity
As a general rule, California law provides that persons are responsible, not only for the result of their willful acts, but also for an injury occasioned to another by their want of ordinary care or skill in the management of their property or person, except so far as the latter has, willfully or by want of ordinary care, brought the injury upon themselves. (Civ. Code § 1714(a).) Liability has the primary effect of ensuring that some measure of recourse exists for those persons injured by the negligent or willful acts of others; the risk of that liability has the primary effect of ensuring parties act reasonably to avoid harm to those to whom they owe a duty.
Conversely, immunity from liability disincentivizes careful planning and acting on the part of individuals and entities. When one enjoys immunity from civil liability, they are relieved of the responsibility to act with due regard and an appropriate level of care in the conduct of their activities. Immunity provisions are also disfavored because they, by their nature, preclude parties from recovering when they are injured, and force injured parties to absorb losses for which they are not responsible. Liability acts not only to allow a victim to be made whole, but to encourage appropriate compliance with legal requirements.
Although immunity provisions are rarely preferable, the Legislature has, in limited scenarios, approved measured immunity from liability (as opposed to blanket immunities) to promote other policy goals that could benefit the public. Immunities are generally afforded when needed to ensure the willingness of individuals to continue taking on certain roles that may involve some risk and to incentivize certain conduct, such as the provision of life-saving or other critical services. Examples include protections for use of CPR (Civ. Code § 1714.2); use of an automated external defibrillator (Civ. Code § 1714.21); use of opiate overdose treatment (Civ. Code § 1714.22); providing emergency care at the scene of an emergency (Health & Saf. Code §§ 1799.102, 1799.106); and performing emergency rescue services (Health & Saf. Code § 1799.107). However, as indicated above, rarely is immunity absolute, and these immunities generally do not cover grossly negligent conduct or intentional misconduct.
- Incentivizing the administration of opioid antagonists
In order to maximize the life-saving capabilities of opioid antagonists, this bill provides qualified immunity to a person who, in good faith, and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering an opioid antagonist.[3] The person is immune from civil liability for damages resulting from an act or omission related to the rendering of the emergency treatment. The immunity also covers a person who, in good faith, and not for compensation, furnishes the opioid antagonist for use in such situations. The above immunities do not apply to acts or omissions constituting gross negligence or willful or wanton misconduct.
These provisions mimic, and supplement, similar existing laws. For instance, Education Code section 49414.3 authorizes local educational agencies (LEA) to designate volunteers to train on emergency use of naloxone hydrochloride or another opioid antagonist. A school nurse or trained volunteer is authorized to administer naloxone hydrochloride or another opioid antagonist to a person exhibiting potentially life-threatening symptoms of an opioid overdose at school or a school activity. The LEA is required to ensure that each employee who volunteers will be provided defense and indemnification for any and all civil liability. A person trained to administer an opioid antagonist that, in good faith and not for compensation, provides it to a person who appears to be experiencing an opioid overdose is shielded from professional review, liability in a civil action, and criminal prosecution for their acts or omissions in administering the opioid antagonist. As here, the immunity does not apply in a case of gross negligence or willful and wanton misconduct of the person.
It also tracks with the immunity provisions of Section 1799.102 of the Health and Safety Code, often referred to as the “Good Samaritan Law.” That statute provides immunity for those rendering emergency medical or nonmedical care at the scene of an emergency, as specified. In fact, a person who, in good faith and not for compensation, renders emergency treatment by the use of an opioid antagonist at the scene of an emergency is likely already covered by the existing Good Samaritan Law. However, this provision will likely incentivize more individuals to take action when needed.
According to the author:
Hesitation at the scene of an opioid overdose can literally be the difference between life and death. California has taken several steps over the years to make naloxone more accessible and federal regulators are currently moving forward with efforts to make this prescription medication available over the counter. The Naloxone Distribution Project at DHCS supplies naloxone to numerous entities for use and distribution including EMS, harm reduction organizations, organizations that serve the unhoused populations, substance use recovery facilities, and emergency departments. The state has also repeatedly expanded the protections afforded under the Good Samaritan Law to encourage, but not require, the administration of naloxone at the scene of an opioid overdose. Unfortunately, this has resulted in a patchwork of statutes with numerous prerequisites, which must be met in order to be eligible for existing liability protections. This runs counter to the intended purpose of extending these liability protections which is to ensure no one who is able and willing to administer naloxone or opioid antagonists at the scene of an opioid overdose hesitates or withholds care for fear of wrongful prosecution. In addition, given the state’s numerous efforts to make naloxone readily available to persons at risk of overdose as well as persons who live or work in and around persons at risk of overdose, statute should be made clear that no one acting in good faith can be held liable for furnishing naloxone or other opioid antagonists to another person via secondary distribution.
Writing in support, the City of Alameda states:
In California, opioid-related fatalities have skyrocketed by 137% since 2000, and the number of opioid overdose deaths in the state has more than doubled since 2010. According to the National Safety Council, more than 70,000 drug overdose deaths occurred in the United States in 2019, with opioids responsible for 70% of those deaths.
AB 1166 seeks to encourage increased access to opioid antagonists, including to laypersons in the community, by clarifying that a person who in good faith and not for compensation, either renders emergency care by means of administering an opioid antagonist, or furnishes an opioid antagonist, is generally not liable for civil damages resulting from an act or omission related to such actions.
The City of Alameda supports legislation to reduce opioid overdose deaths and efforts that protect the health, safety, and welfare of residents.
SUPPORT
California Academy of Family Physicians
California Academy of Preventive Medicine
California State Association of Psychiatrists
California State Sheriffs’ Association
City of Alameda
City of Long Beach
Civil Justice Association of California
County Behavioral Health Directors Association of California
Faculty Association of California Community Colleges
Govern for California
Los Angeles Unified School District
Peace Officers Research Association of California
OPPOSITION
None known
RELATED LEGISLATION
Pending Legislation:
SB 234 (Portantino, 2023) requires public schools, institutions of higher education, stadiums, concert venues, and amusement parks to maintain unexpired doses of naloxone hydrochloride or another opioid antagonist on its premises and provides qualified immunity to those administering such opioid antagonists and to medical professionals for prescribing it. SB 234 is currently in the Assembly Education Committee.
SB 472 (Hurtado, 2023) requires each public school to maintain at least two doses of naloxone on its campus, and to report to the California Department of Health Care Services on why they are not exercising their authority, if applicable, to distribute naloxone and how they came to that determination. SB 472 was held in the Senate Appropriations Committee.
SB 868 (Wilk, 2023) requires local educational agencies to equip each classroom with a trauma kit and to offer training to employees on the use of such kits. Employees who render emergency care with such kits are granted qualified immunity from civil damages, as provided. AB 868 is currently in the Assembly Education Committee.
Prior Legislation:
AB 1810 (Levine, Ch. 906, Stats. 2022) authorized schools to designate and train persons to provide anti-seizure medication in an emergency involving a pupil diagnosed with a seizure disorder. The persons must be provided defense and indemnification and are granted qualified immunity, as specified.
AB 2260 (Rodriguez, Ch. 586, Stats. 2022) required certain public and private buildings to maintain a trauma kit on the building’s premises. It provided specified immunity to persons supplying trauma kits, training others on their use, and using them in emergency situations.
AB 1766 (Maienschein, Ch. 270, Stats. 2018) provided that every public swimming pool that is required to provide lifeguard services and that charges a direct fee shall provide on its premises an AED that must be readily available during pool operations and applied conditional liability protections to those acquiring or using these AEDs.
AB 635 (Ammiano, Ch. 707, Stats. 2013) afforded qualified immunity from civil liability, criminal prosecution, or professional review to licensed health care providers who issue prescriptions or standing orders, as specified; and immunity from civil action or criminal prosecution, or professional review, to any persons who possess or distribute naloxone pursuant to a prescription or standing order, or acting with reasonable care in administering naloxone, as specified.
PRIOR VOTES:
Assembly Floor (Ayes 65, Noes 0)
Assembly Judiciary Committee (Ayes 9, Noes 0)
**************
Connor Sheets, As fentanyl overdose deaths keep rising, efforts to reverse trend meet liability fears (December 27, 2022) Los Angeles Times, https://www.latimes.com/california/story/2022-12-27/as-overdose-deaths-keep-rising-bold-efforts-to-reverse-the-trend-emerge. All internet citations are current as of June 13, 2023. ↑
Naloxone DrugFacts (January 2022) National Institute on Drug Abuse, https://nida.nih.gov/publications/drugfacts/naloxone. ↑
“Opioid antagonist” includes naloxone hydrochloride or any other opioid antagonist that is approved by the FDA for the treatment of an opioid overdose. ↑
Date of Hearing: March 28, 2023
ASSEMBLY COMMITTEE ON JUDICIARY
Brian Maienschein, Chair
ABPCA Bill Id:AB 1166
Author:(Bains) – As Amended Ver:March 23, 2023
PROPOSED CONSENT
SUBJECT: Liability for opioid antagonist administration
KEY ISSUE: SHOULD THE LAW CLARIFY THAT A PERSON WHO IN GOOD FAITH AND NOT FOR COMPENSATION, EITHER RENDERS EMERGENCY CARE BY MEANS OF ADMINISTERING AN OPIOID ANTAGONIST, OR FURNISHES AN OPIOID ANTAGONIST, IS GENERALLY NOT LIABLE FOR CIVIL DAMAGES RESULTING FROM AN ACT OR OMISSION RELATED TO SUCH ACTIONS?
SYNOPSIS
Despite multi-faceted efforts to address the public health epidemic of opioid overdoses in California, the crisis continues, killing thousands of Californians, and more than 100,000 Americans every year. According to the Overdose Surveillance Dashboard of the California Department of Public Health (CDPH), opioid prescriptions have dropped by half in the last four years, but opioid overdose deaths in that same time have tripled, killing over 7,000 Californians in 2021.
Under existing common law tort rules, a person who voluntarily comes to the aid of another person suffering a medical emergency is immune from liability for injuries and even death, so long as that person acts in a reasonably prudent manner under the circumstances. In recent years this Committee has heard, the Legislature has approved, and the Governor has signed numerous bills providing express immunity from liability for lay people (as well as off-duty professionals) who voluntarily render medical aid in a specific emergency situation, such as administering CPR, using an AED, or applying a tourniquet, among other voluntary actions.
This bill seeks to encourage increased access to opioid antagonists, including to laypersons, in the community by clarifying that a person who in good faith and not for compensation, either renders emergency care by means of administering an opioid antagonist, or furnishes an opioid antagonist, is generally not liable for civil damages resulting from an act or omission related to such actions. While providing express immunity for specific medical emergencies or for using special medications or medical supplies may be unnecessary in light of the Good Samaritan statute, one could argue that bills like this one are a harmless and potentially useful clarification of existing law. The bill is supported by California Catholic Conference; Civil Justice Association of California; League of California Cities; and the National Health Law Program, and has no opposition on file.
SUMMARY: Clarifies that a person who in good faith and not for compensation, either renders emergency care by means of administering an opioid antagonist, or furnishes an opioid antagonist, is generally not liable for civil damages resulting from an act or omission related to such rendering or furnishing. Specifically, this bill:
- Provides that a person who, in good faith and not for compensation, renders emergency treatment at the scene of an opioid overdose or suspected opioid overdose by administering an opioid antagonist shall not be liable for civil damages resulting from an act or omission related to the rendering of the emergency treatment.
- Provides that a person who, in good faith and not for compensation, furnishes an opioid antagonist to a person for use at the scene of an opioid overdose or suspected opioid overdose shall not be liable for civil damages resulting from an act or omission related to the furnishing of the opioid antagonist.
- Clarifies that the bill does not apply to an act or omission related to the rendering of emergency treatment at the scene of an opioid overdose or suspected opioid overdose by means of an opioid antagonist that constitutes gross negligence or willful or wanton misconduct.
- Clarifies that for purposes of the bill, the following apply:
- A person who renders emergency treatment by means of an opioid antagonist, or who furnishes an opioid antagonist at the scene of an opioid overdose or suspected opioid overdose and who is not compensated for doing so, but receives compensation for other actions as a result of their unrelated employment, is not “rendering emergency medical care or furnishing opioid antagonist for compensation.”
- “Opioid antagonist” means naloxone hydrochloride or any other opioid antagonist that is approved by the United States Food and Drug Administration for the treatment of an opioid overdose.
EXISTING 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.” (Civil Code Section 1714 (a).)
- Provides that a “Good Samaritan” who in good faith, and not for compensation, renders medical or nonmedical care at the scene of an emergency shall not 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.)
- Provides that notwithstanding any other law, a person who possesses or distributes an opioid antagonist pursuant to a prescription or standing order shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this possession or distribution. Further provides that a person not otherwise licensed to administer an opioid antagonist, but trained as required and who acts with reasonable care in administering an opioid antagonist, in good faith and not for compensation, to a person who is experiencing or is suspected of experiencing an overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this administration. (Civil Code Section 1714.22 (f).)
- Requires the State Department of Public Health, upon appropriation in the Budget Act of 2016, to award funding to local health departments, local government agencies, or on a competitive basis to community-based organizations, regional opioid prevention coalitions, or both, to support or establish programs that provide FDA-approved opioid antagonists for the treatment of an opioid overdose, to first responders and to at-risk opioid users through programs that serve at-risk drug users, including, but not limited to, syringe exchange and disposal programs, homeless programs, and substance use disorder treatment providers. (Health & Safety Code Section 1179.80 (a).)
- Provides that notwithstanding any other law, school personnel who volunteer to be trained to administer naloxone hydrochloride (naloxone) or another opioid antagonist, in good faith and not for compensation, to a person who appears to be experiencing an opioid overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for his or her acts or omissions in administering the opioid antagonist. (Education Code Section 49414.3 (j)(1).)
FISCAL EFFECT: As currently in print this bill is keyed non-fiscal.
COMMENTS: Despite multi-faceted efforts to address the public health epidemic of opioid overdoses in California, the crisis continues, killing thousands of Californians, and more than 100,000 Americans every year. This bill seeks to encourage increased access to opioid antagonists, including to laypersons, in the community by clarifying that a person who in good faith and not for compensation, either renders emergency care by means of administering an opioid antagonist, or furnishes an opioid antagonist, is generally not liable for civil damages resulting from an act or omission related to such actions. According to the author:
California has taken several steps over the years to make naloxone more available and accessible and federal regulators are currently considering making this prescription medical available over the counter. The Naloxone Distribution Project at DHCS supplies naloxone to numerous entities for use and distribution including EMS, harm reduction organizations, organizations that serve the unhoused populations, substance use recovery facilities, and emergency departments. The state has also repeatedly expanded the protections afforded under the Good Samaritan Law to encourage, but not require, the administration of naloxone at the scene of an opioid overdose. . . . In addition, given the state’s numerous efforts to make naloxone readily available to persons at risk of overdose as well as persons who live or work in and around persons at risk of overdose, statute should be made clear that no one acting in good faith can be held liable for furnishing naloxone to another person via secondary distribution.
Background on the opioid overdose epidemic in California. According to the Overdose Surveillance Dashboard of the California Department of Public Health (CDPH), opioid prescriptions have dropped by half in the last four years, but opioid overdose deaths in that same time have tripled, killing over 7,000 Californians in 2021. (California Overdoes Surveilance Dashboard, Welcome to the California Overdoes Surveillance Dashboard (Feb. 15, 2023), available at https://skylab.cdph.ca.gov/ODdash/?tab=Home.) According to a recent study of opioid deaths during the COVID-19 pandemic, there were 8605 fatal drug overdoses in 2021—a 44% increase over the same period one year prior. (Mathew V. Kiang, et al, Sociodemographic and geographic disparities in excess fatal drug overdoses during the COVID-19 pandemic in California: A population-based study, The Lancet Regional Health - Americas, Volume 11, 2022, available at
https://www.sciencedirect.com/science/article/pii/S2667193X22000540.) Non-white populations have been disproportionately affected by this phenomenon, having fatal drug overdose rates that are roughly double those in the non-Hispanic white population. (Ibid.) According to the National Institute on Drug Abuse (NIDA) within the National Institutes of Health (NIH), more than 106,000 persons in the U.S. died from a drug-involved overdose in 2021, including illicit drugs and prescription opioids. (Trends and Statistics, Drug Overdose Drug Rates, NIH/NIDA (February 9, 2023), available at https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates.)
The number of overdose deaths in California and nationwide has continued to grow in recent years, despite numerous public health efforts to address the problem in the past decade. For example, when overdose and substance use involving prescription drugs, particularly opioids, emerged as a major public health and safety concern in both California and the United States in the early 2000s, CDPH convened a State Opioid Safety Workgroup composed of state agencies and local health jurisdictions to facilitate and coordinate state responses to the opioid epidemic. Initial efforts comprised promoting safe prescribing, increasing medication for opioid use disorder services, and reducing opioid-related overdose deaths. In 2015, the state secured funding from the Centers for Disease Control and Prevention (CDC) and the United States Bureau of Justice Assistance for the California Prescription Drug Overdose Prevention (PDOP) Initiative, a 4-year, multi-pronged effort to reduce deaths involving prescription opioids. The two major areas of focus for the PDOP Initiative were (1) leveraging recent improvements to California's prescription drug monitoring program (PDMP); and local advisory councils. Mandatory PDMP registration was associated with a 35% decrease and local advisory councils with a 21% decrease, respectively, in prescription opioid overdose deaths. Both interventions were also associated with significantly lower prescription rates, fewer deaths involving any opioid, but had no significant association with non-fatal overdose rates. (Stephen G. Henry, et al, Impacts of prescription drug monitoring program policy changes and county opioid safety coalitions on prescribing and overdose outcomes in California, 2015–2018, Preventive Medicine, Volume 153, 2021, available at https://doi.org/10.1016/j.ypmed.2021.106861.) Prescription-related opioid deaths (excluding synthetics) peaked in 2009 at 1,483 deaths, and decreased in 2018 to 1,091 deaths (a 26% decrease) indicating progress on promoting safe opioid prescribing practices. (California Overdoes Surveillance Dashboard, supra.) The total number of prescriptions dispensed has decreased 14%, from 23 million in 2010, to 19.8 million in 2018. (Ibid.) Meanwhile, overdose deaths from illicit drugs have skyrocketed: Heroin overdose deaths increased 117% between 2012 and 2018; fentanyl overdose deaths increased 858%; and amphetamine overdose deaths increased 212% during that same time period. (Ibid.)
Background on the properties of naloxone, a common opioid antagonist. An opioid overdose is characterized by central nervous system and respiratory depression, leading to coma and death. Opioid antagonists attach to opioid receptors and block the effects of opioids, enabling the ability to counteract depression of the central nervous and respiratory system caused by an opioid overdose. An opioid antagonist has no effect if administered to a person who is not experiencing an opioid overdose (because there are no opioid receptors to bind to).
Opioid antagonists are a group of drugs routinely used in hospitals and in pre-hospital settings (i.e. by paramedics in the field) on patients who are suspected to be experiencing overdose of an opioid, such as heroin, methadone, or oxycodone. The most common type of opioid antagonist is known as naloxone hydrochloride (or as "Narcan," its brand name), which is approved by the federal Food and Drug Administration (FDA) for the treatment of an opioid overdose. Naloxone is not effective, however, in treating overdoses of benzodiazepines, barbiturates, clonidine, GHB, or ketamine. It is also not effective to treat overdoses of stimulants, such as cocaine and amphetamines (including methamphetamine and MDMA). (U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA), SAMHSA Opioid Overdose Prevention Toolkit (2018), p. 2; available at https://store.samhsa.gov/sites/default/files/d7/priv/sma18-4742.pdf.)
Approved by the FDA since the 1970s, naloxone is considered to be a very safe medication. According to SAMHSA:
The safety profile of naloxone is remarkably high, especially when used in low doses and titrated to effect. [fn] If given to individuals who are not opioid intoxicated or opioid dependent, naloxone produces no clinical effects, even at high doses. Moreover, although rapid opioid withdrawal in opioid-tolerant patients may be unpleasant, it is not life threatening. (SAMHSA Opioid Overdose Prevention Toolkit, supra, at p. 13.)
While in theory, there is a risk of allergic reaction to naloxone, such allergic reactions have never been documented. On rare occasions, reviving an opioid overdose victim with naloxone may restart existing health problems or uncover the effect of other drugs the victim had taken. More commonly, the use of naloxone will send the patient into opioid withdrawal, triggering nausea/vomiting, diarrhea, chills, sweating, anxiety, and combativeness or disorientation. (New Mexico Department of Health, Overdose and Prevention Program, Epidemiology & Response Division, Opioid Fact Sheet, Are there any adverse effects from naloxone? (July 2021), available at POS-More-About-Naloxone-20210716.pdf.) When given to individuals who are not opioid intoxicated or opioid dependent, naloxone produces no clinical effects, even at high doses. Naloxone can also be used in life-threatening opioid overdose circumstances in pregnant women. Moreover, although rapid opioid withdrawal in opioid-tolerant individuals may be unpleasant, it is not life threatening. (SAMHSA Opioid Overdose Prevention Toolkit, supra, at p. 6.) Multiple models and programs cited by the National Institute of Drug Abuse have demonstrated that increasing naloxone or opioid antagonist access by increased distribution of naloxone to laypersons, could decrease opioid overdose deaths by up to 21%. (NIH/NIDA, Policy Brief, Naloxone for Opioid Overdose: Life-Saving Science (2016), available at: https://nida.nih.gov/publications/effective-treatments-opioid-addiction.)
In response to the opioid crisis, many states, including California, have expanded access to opioid antagonists. According to SAMHSA, prior to 2012, just six states had laws that expanded access to naloxone or limited criminal liability. By mid-2017, every state and the District of Columbia had enacted statutes that provide criminal liability protections to laypersons or first responders who administer naloxone. Forty-six states and the District of Columbia have statutes that provide civil liability protections to laypersons or first responders who administer naloxone. Thirty-seven states have statutes that offer criminal liability protections for prescribing or distributing naloxone. Forty-one states have statutes that offer civil liability protections for prescribing or distributing naloxone, and 46 states have statutes that allow naloxone distribution to third parties or first responders via direct prescription or standing order. (SAMHSA Opioid Overdose Prevention Toolkit, supra, at p. 3.) To find relevant laws for each state, visit the Prescription Drug Abuse Policy System at http://www.pdaps.org/.
In the past decade, California statues have expanded policies to make naloxone and other opioid antagonists more accessible in pharmacies, schools, and licensed detox facilities. Current law authorizes licensed health care providers to prescribe and distribute opioid antagonists for emergency treatment of drug overdose without being subject to civil liability or criminal prosecution. (Civil Code Section 1714.22 (f).) Current law also requires alcohol and other drug residential treatment facilities licensed by the Department of Health Care Services (DHCS) to maintain at least two unexpired doses of naloxone, a common opioid antagonist, on the premises. Pharmacists are also authorized by law to stock naloxone in their pharmacies, school districts, and law enforcement agencies. A person who possesses or distributes an opioid antagonist pursuant to a prescription or standing order shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this possession or distribution. (Business and Professions Code Section 4052.01 (a) and (c).) A person who is not otherwise licensed to administer an opioid antagonist, but trained as required and who acts with reasonable care in administering an opioid antagonist, in good faith and not for compensation, to a person who is experiencing or is suspected of experiencing an overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this administration. (Ibid.) A pharmacist may furnish an FDA-approved opioid antagonist in accordance with standardized procedures or other protocols developed and approved by both the Board of Pharmacy and the Medical Board of California, in consultation with other appropriate entities. (Ibid.) A pharmacist must complete a training program on the use of opioid antagonists that consist of at least one hour of approved continuing education on the use of opioid antagonists. (Ibid.) A pharmacist, wholesaler, or manufacturer may furnish opioid antagonists to a law enforcement agency as long as the opioid antagonist is furnished exclusively for use by employees of the law enforcement agency who have completed training provided by the law enforcement agency, in administering opioid antagonists. (Business & Professions Code Section 4119.9 (a).)
School personnel who volunteer to be trained to administer naloxone or another opioid antagonist, in good faith and not for compensation, to a person who appears to be experiencing an opioid overdose are not subject to professional review, liable in a civil action, or subject to criminal prosecution for his or her acts or omissions in administering the opioid antagonist. (Education Code Section 49414.3 (j)(1).) A pharmacist may furnish an FDA-approved opioid antagonist to a school district, county office of education, or charter school if the opioid antagonist is furnished exclusively for use at the school and a physician and surgeon provides a written order that specifies the quantity of opioid antagonist to be furnished. (Business & Professions Code Section 4119.8 (a).)
The "Good Samaritan" Law. Under existing common law tort rules, a person who voluntarily comes to the aid of another person suffering a medical emergency is immune from liability for injuries and even death, so long as that person acts 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 (Health & 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 does not constitute willful or wanton misconduct.
In recent years this Committee has heard, the Legislature has approved, and the Governor has signed numerous bills providing express immunity from liability for lay people (as well as off-duty professionals) who voluntarily render medical aid in a specific emergency situation, such as administering cardiopulmonary resuscitation (CPR), using an AED, or applying a tourniquet, among other voluntary actions. These provisions may be unnecessary given that any of these methods of administering medical or non-medical care by a lay rescuer at the scene of an emergency would most certainly qualify as rendering medical aid in an emergency by a Good Samaritan, regardless of the mechanism by which the care is administered. While providing express immunity for specific medical emergencies or for using special medications or medical supplies may be unnecessary in light of the Good Samaritan statute, one could argue that bills like this one are a harmless and potentially useful clarification of existing law.
This bill seeks to encourage increased access to opioid antagonists, including to laypersons, in the community by clarifying that a person who in good faith and not for compensation, either renders emergency care by means of administering an opioid antagonist, or furnishes an opioid antagonist, is generally not liable for civil damages resulting from an act or omission related to such actions. As introduced, the bill was problematic for a number of reasons. First, it did not exempt acts of gross negligence or willful or wanton misconduct. Therefore, a lay rescuer who administered naloxone to a person with a known allergy to naloxone (indicated by perhaps a medic-alert bracelet or necklace) or administered it to a person who clearly was not experiencing an overdose, would be immune from all liability for adverse reaction or trauma from such administration. While naloxone is generally safe, has no documented history of allergic reactions, and the alternative to administration is generally death, the likelihood of anyone being held liable for grossly negligent use of naloxone is therefore rare, it is important that the bill align with other similar Good Samaritan statutes. Second, it did not clarify that in order to qualify as a good Samaritan/lay rescuer who is entitled to immunity, that the person must, in fact, be a lay person and not a paid/professional rescuer. Finally, the introduced language used a specific name for the opioid antagonist--naloxone hydrochloride--rather than the general term “opioid antagonist” that is used in other statutes addressing the topic. Naloxone hydrochloride may not be the preferred opioid antagonist in the future. The statute should not need to be amended if and when a more popular opioid antagonist comes into widespread use.
As recently amended, the bill now addresses all of these issues. In line with existing law that deals with paid school employees who volunteer to be trained to administer an opioid antagonist, and provides immunity to those who do so in good faith and “not for compensation,” although they are paid to perform duties unrelated to emergency medical care (See Education Code Section 49414.3 (j)), it clarifies the following:
A person who renders emergency treatment by means of an opioid antagonist, or who furnishes an opioid antagonist at the scene of an opioid overdose or suspected opioid overdose and who is not compensated for doing so, but receives compensation for other actions as a result of their unrelated employment, is not “rendering emergency medical care or furnishing opioid antagonist for compensation.”
ARGUMENTS IN SUPPORT: League of California Cities cites, as a reason why the bill is needed, the unique and deadly toll that fentanyl is taking on users:
A recent study by the Center for Disease Control (CDC) names fentanyl the deadliest drug in the United States. Fentanyl is often disguised as other synthetic opioids or drugs, then sold on the street to users who are unaware that fentanyl is a key ingredient. Users who unknowingly ingest these substances believing they are taking a less powerful drug are much more susceptible to overdose or even death. When abused, fentanyl affects the brain and nervous system and is 50 times stronger than heroin and 100 times stronger than morphine.
This bill, they argue, is part of a multi-pronged public policy approach to address the public health and safety crisis:
This measure would provide that a person who is not trained in emergency medical services or as a health care provider and who, in good faith and not for compensation, renders treatment at the scene of an opioid overdose or suspected opioid overdose by administering naloxone hydrochloride is not liable for civil damages resulting from an act or omission. . . .
Cal Cities supports additional funding and resources to address the substance use crisis through appropriate prevention and intervention efforts, educational awareness campaigns, and increased access to life-saving overdose treatment aids such as naloxone. Additionally, Cal Cities supports “Good Samaritan” protections that include both medical and non-medical care when applicable to volunteer emergency, law enforcement, and disaster recovery personnel.
REGISTERED SUPPORT / OPPOSITION:
Support
California Catholic Conference
Civil Justice Association of California
League of California Cities
National Health Law Program
Opposition
None on file
Analysis Prepared by: Alison Merrilees / JUD. / (916) 319-2334
Bill Author
Bill Co-Author(s):