BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                    AB 1386


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          Date of Hearing:   January 15, 2016


                           ASSEMBLY COMMITTEE ON JUDICIARY


                                  Mark Stone, Chair


          AB 1386  
          (Low) - As Amended January 13, 2016


          SUBJECT:  Emergency medical care:  epinephrine auto-injectors


          KEY ISSUES:


          1)Should doctors be permitted to prescribe epinephrine  
            auto-injectors (AUTo-INJECTOR) to an entity, so long as the  
            entity employs at least one person trained to administer the  
            auto-injector to a person displaying symptons of anaphylaxis?   



          2)Should an entity that obtains an auto-injector pursuant to a  
            prescription be immune from liability for harm caused by the  
            good faith use of the auto-injector by one of its trained  
            employees, volunteers, or agents? 


                                      SYNOPSIS


          This bill seeks to expand the use of epinephrine auto-injectors  
          (sometimes known as "epi-pens").  These relatively easy-to-use  
          devices are used to treat anaphylaxis, a life-threatening  
          condition that may result from an allergic reaction or  








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          hypersensitivity to a particular substance.  The bill is  
          sponsored by Mylan, a company that manufactures epi-pens.   
          Prescriptions for epi-pens are typically written to persons who  
          suffer from an allergy or related condition that could cause an  
          anaphylactic reaction.  Most often these persons self-administer  
          by pressing the device into the thigh.  However, recent  
          legislation authorized doctors to write prescriptions for  
          epi-pens to prehospital emergency medical personnel and "lay  
          rescuers," that is, non-professionals who have undergone  
          prescribed training to recognize anaphylaxis and to properly  
          administer the device if needed.  Existing law also permits an  
          authorized physician to prescribe epi-pens to school districts  
          for use by school nurses or other school staff who have  
          voluntarily undergone required training.  Off-duty emergency  
          medical personnel, lay rescuers, and school personnel are  
          afforded qualified immunity from liability if they administer  
          the device "in good faith and not for compensation."  This bill  
          would expand existing law in two ways: first, it would allow a  
          health care provider to prescribe, and a pharmacist to dispense,  
          epi-pens to an "authorized entity," which in turn is defined as  
          any entity that employs, or uses as a volunteer, at least one  
          person trained to use the epi-pen.  In other words, the employee  
          or volunteer would need to qualify as a "lay rescuer" under  
          existing law.  The bill would also grant the authorized entity  
          qualified immunity from liability for civil damages resulting  
          from the good faith efforts of its trained employees,  
          volunteers, or agents.  The author and sponsor contend that such  
          immunities are required in order to assuage the concerns of  
          businesses and other entities that might otherwise stock  
          epi-pens, but are reluctant to do so because they fear potential  
          liability.  The bill passed out of the Assembly Business and  
          Professions Committee earlier this week. 


          SUMMARY:  Permits a medical provider to prescribe epinephrine  
          auto-injectors to an "authorized entity," as defined, and grants  
          immunity from liability to the authorized entity for any harm  
          caused by authorized use of the device.  Specifically, this  
          bill:  








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          1)Authorizes a pharmacy to furnish an epinephrine auto-injector  
            (auto-injector) to an authorized entity, as specified.   
            Defines "authorized entity" to mean an entity that employs at  
            least one person, or utilizes at least one volunteer or agent,  
            that has voluntarily completed a prescribed training course. 


          2)Provides that an authorized entity shall not be liable for any  
            civil damages resulting from an act or omission, other than an  
            act or omission constituting gross negligence or willful or  
            wanton misconduct, related to the administration of the  
            auto-injector by one of its trained employees, volunteers, or  
            agents.  Specifies that the failure of an authorized entity to  
            possess or administer an auto-injector shall not result in  
            civil liability.  Specifies further that the immunity provided  
            by this provision does not affect any other immunity or  
            defense that is available under any other state law. 


          3)Permits an authorized health care provider to issue a  
            prescription for an auto-injector to an authorized entity, as  
            defined, if the authorized entity submits evidence that it  
            employs at least one person, or utilizes at least one  
            volunteer or agent, who is trained to administer an  
            auto-injector, as required under existing law.


          4)Requires an authorized entity that possesses and makes  
            available auto-injectors to develop an operations plan that,  
            among other things, provides for the proper storage, regular  
            inspection, and replacement of auto-injectors, and requires  
            the authorized entity to submit to the State Department of  
            Public Health a report relating to the use of auto-injectors  
            on its premises. 


          EXISTING LAW:  








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          1)Provides that no person who in good faith, and not for  
            compensation, renders medical or nonmedical care at the scene  
            of an emergency shall be liable for any civil damages  
            resulting from any act or omission other than an act or  
            omission constituting gross negligence or willful or wanton  
            misconduct.  (Health and Safety Code Section 1799.102.)  


          2)Permits a "prehospital emergency medical care person" or a  
            "lay rescuer," as defined, to use an epinephrine auto-injector  
            in order to render emergency care to another person who  
            appears to be experiencing anaphylaxis so long as certain  
            requirements are met, including, among other things, that the  
            person using the epinephrine auto-injector has completed a  
            prescribed course of training and that the epinephrine  
            auto-injector has been obtained by prescription from an  
            authorized health care provider.  (Health and Safety Code  
            Section 1797.197a.) 


          3)Provides that a prehospital emergency medical care person or  
            lay rescuer who administers an epinephrine auto-injector, in  
            good faith and not for compensation, to another person who  
            appears to be experiencing anaphylaxis at the scene of an  
            emergency is not liable for any civil damages resulting from  
            his or her acts or omissions in administering the epinephrine  
            auto-injector, if he or she complies with specified statutory  
            requirements, and so long as his or her conduct does not  
            constitute gross negligence or willful or wanton misconduct.   
            (Civil Code Section 1714.23.)


          4)Requires a school district or county office of education to  
            provide emergency epinephrine auto-injectors to school nurses  
            or trained volunteers, as specified, and allows those  
            individuals to utilize epinephrine auto-injectors to provide  
            emergency medical aid to persons suffering from anaphylaxis.   








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            Requires a school nurse or a school administrator to obtain a  
            prescription for the epinephrine auto-injectors from an  
            authorized physician, and provides that the prescribing  
            physician shall not be subject to professional review, civil  
            liability, or criminal prosecution for prescribing the  
            epinephrine auto-injectors, unless the physician's issuance of  
            the prescription constitutes gross negligence or willful and  
            malicious conduct.  (Education Code Section 49414(a)-(g).)  


          FISCAL EFFECT:  As currently in print this bill is keyed fiscal.  



          COMMENTS:  As is well-documented in a number of medical studies,  
          certain common foods, products, and even medications may cause  
          severe and life-threating allergic reactions, or anaphylaxis.   
          Although anaphylaxis can be fatal if untreated, a person who  
          experiences anaphylaxis can be kept alive by the prompt  
          administration of epinephrine until transported to an emergency  
          room.  An epinephrine auto-injector is a relatively simple and  
          easy-to-use prescription product that provides an appropriate  
          dose of epinephrine, whether the auto-injector is  
          self-administered by the victim, or by someone else. 


          While all agree that epinephrine auto-injectors are relatively  
          simple and easy-to-use, the devices may only be obtained by  
          prescription under federal law.  Most commonly, they are  
          prescribed to a person with an allergy that is known to cause  
          anaphylaxis.  However, a person - especially a child - may not  
          always know that he or she has such an allergy prior to  
          suffering the first anaphylactic episode.  To address this  
          dilemma, existing law in California allows doctors, in limited  
          contexts, to prescribe auto-injectors to persons trained to  
          recognize the symptoms of anaphylaxis and safely administer the  
          devices.  For example, under the California Education Code,  
          doctors may prescribe auto-injectors to school districts for use  
          by school nurses or other school employees who have undergone  








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          prescribed training on how to recognize the symptoms of  
          anaphylaxis and administer the auto-injector.  In addition, a  
          provision in the Health & Safety Code permits doctors to  
          prescribe auto-injectors to prehospital emergency care persons  
          and "lay rescuers" who have undergone statutorily prescribed  
          training and hold a current certification.  Consistent with  
          California's general Good Samaritan statute (Health and Safety  
          Code Section 1799.102), existing law also affords qualified  
          immunity to off-duty prehospital emergency care persons and  
          trained lay rescuers for injuries caused by their use of the  
          auto-injector, so long as they act in "good faith and not for  
          compensation."  Also consistent with other statutory immunities,  
          the person administering the auto-injector is only afforded a  
          qualified immunity from liability, meaning that immunity does  
          not extend to conduct that constitutes gross negligence or  
          willful or wanton misconduct. 


          This bill would expand existing law in two ways.  First, it  
          would allow a physician to prescribe, and a pharmacist to  
          dispense, the auto-injectors to an "authorized entity."  The  
          bill defines an "authorized entity" to mean any entity (whether  
          a private business or government agency, other than a school  
          district) that has at least one employee, volunteer, or agent  
          that has undergone prescribed training to become a lay rescuer.   
          Because existing law requires training before one can be  
          authorized to administer the device to another person, an entity  
          that did not have a trained employee or volunteer, therefore,  
          could not obtain a prescription to stock the auto-injectors.   
          Second, this bill would give an authorized entity qualified  
          immunity from liability for an injury caused by an employee or  
          volunteer acting in good faith and not for compensation.   
          Arguably, such immunity is not necessary, as the authorized  
          entity could only be vicariously liable for the acts of an  
          employee or volunteer if the employee or volunteer would have  
          been liable.  As required by law, however, the employee or  
          volunteer will necessarily be a "lay rescuer," and a lay rescuer  
          is already protected from liability when acting in good faith  
          and not for compensation - unless, of course, the conduct rises  








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          to gross negligence or willful or wanton misconduct, in which  
          case the lay rescuer is appropriately subject to civil liability  
          for that conduct.  Nonetheless, the author and sponsor contend  
          that entities that might otherwise keep auto-injectors stocked  
          for use by trained employees are reluctant to do so because of  
          fears of liability.  The express liability afforded by this bill  
          is intended by the author to assuage those fears. 


          The "Good Samaritan" Law and the Unintended Consequences of  
          Express Immunities.  In recent years this Committee has heard,  
          and the Legislature has enacted, bills seeking an express  
          immunity from liability for lay people (or off-duty  
          professionals) who voluntarily render medical aid in a specific  
          emergency situation, such as administering cardiopulmonary  
          resuscitation (CPR) or applying an automated external  
          defibrillator (AED), among other voluntary actions.  Under  
          existing common law tort rules, however, a person who  
          voluntarily comes to the aid of another person suffering a  
          medical emergency would be immune from liability so long as that  
          person acted in a reasonably prudent manner under the  
          circumstances.  In addition, in 2009, California adopted a  
          so-called "Good Samaritan" statute.  (The term refers to the  
          parable in the Gospel of Luke about the "lowly" Samaritan who  
          came to the aid of a stranger left for dead while supposedly  
          more upstanding citizens ignored the cries of the dying man.)   
          California's Good Samaritan statute (Heath & Safety Code Section  
          1799.102) grants qualified immunity to any person who renders  
          medical or non-medical aid in an emergency, so long as that  
          person acts in good faith and not for compensation, and so long  
          as that person's conduct is not grossly negligent or willful or  
          wanton.  Accordingly, provisions in existing law that have  
          granted immunity to persons performing CPR or administering AED  
          devices or epinephrine auto-injectors may be unnecessary, since  
          any of these acts would most certainly qualify as rendering  
          medical aid in an emergency.  For example, it is difficult to  
          imagine a situation in which a person who had complied with the  
          requirements of this bill (or even an untrained lay person who  
          voluntarily renders aid to a victim of anaphylaxis by providing  








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          or assisting the victim with an auto-injector, which is not  
          specifically authorized by this bill) would not already be  
          protected from liability under the Good Samaritan statute.   
          While providing express immunity for specific medical  
          emergencies may be unnecessary in light of the Good Samaritan  
          statute, one could argue that this bill - and prior bills like  
          it - is a harmless and potentially useful clarification of  
          existing law.  


          ARGUMENTS IN SUPPORT:  Mylan, a company that manufactures  
          medical products, including epinephrine auto-injectors,  
          sponsored this bill because it will "expand access to  
          epinephrine auto-injectors used to treat severe allergic  
          reactions or anaphylaxis."  Mylan cites statistics on the number  
          of anaphylaxis deaths, suggesting that such tragedies might have  
          been avoided had the victim had timely access to an epinephrine  
          auto-injector.  This is especially true in instances where the  
          victim had never experienced anaphylaxis, was not aware of his  
          or her allergy, and therefore would not have possessed an  
          auto-injector. 


          Mylan acknowledges that California has "made great strides to  
          address this issue," especially in legislation targeting schools  
          and the training of lay rescuers, but the company believes that  
          "more can be done to ensure the state is better prepared in the  
          event that children or adults experience an anaphylactic  
          reaction for the first time or in a public location."  While  
          Mylan believes that providing auto-injectors to schools was an  
          important "first step," it notes that there are many other  
          public places - including preschools, colleges, workplaces, and  
          restaurants - where someone could experience an anaphylactic  
          reaction without having an auto-injector on hand.  Finally,  
          Mylan notes that nineteen other states "have already passed  
          legislation that allows entities to stock epinephrine  
          auto-injectors and trained individuals to administer them."   
          Mylan argues that California should do the same.  









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          REGISTERED SUPPORT / OPPOSITION:




          Support


          Mylan, Inc. (sponsor)


          Allergy & Asthma Network 


          Allergy Station 


          American Latex Allergy Association 


          American Red Cross


          California ACEP 


          San Francisco Bay Area Food Allergy Network 


          Two individuals 




          Opposition


          None on file 








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          Analysis Prepared by: Thomas Clark / JUD. / (916) 319-2334