BILL ANALYSIS Ó AB 1386 Page 1 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 AB 1386 Page 2 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: AB 1386 Page 3 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: AB 1386 Page 4 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. AB 1386 Page 5 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 AB 1386 Page 6 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 AB 1386 Page 7 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 AB 1386 Page 8 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. AB 1386 Page 9 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 AB 1386 Page 10 Analysis Prepared by: Thomas Clark / JUD. / (916) 319-2334