BILL ANALYSIS                                                                                                                                                                                                    






                             SENATE JUDICIARY COMMITTEE
                             Senator Noreen Evans, Chair
                              2013-2014 Regular Session


          SB 669 (Huff)
          As Amended April 22, 2013
          Hearing Date: April 30, 2013
          Fiscal: Yes
          Urgency: No
          RD


                                        SUBJECT
                                           
                 Emergency Medical Care: Epinephrine Auto-Injectors

                                      DESCRIPTION  

          This bill would authorize a trained prehospital emergency  
          medical care person, first responder, or lay rescuer to obtain  
          and use epinephrine auto-injectors to render emergency care to  
          another person, pursuant to specified requirements, and would  
          grant them qualified immunity from liability, as specified,  
          unless their conduct in rendering emergency care is grossly  
          negligent.  

          This bill would also provide immunity to specified entities that  
          are authorized to train these persons in the emergency  
          administration of epinephrine auto-injectors for any civil  
          damages alleged to result from those training requirements or  
          standards. Additionally, this bill would, among other things,  
          provide minimal training requirements and require that the  
          California Emergency Medical Services Authority establish and  
          approve authorized training providers and minimum standards for  
          training and the use and administration of epinephrine  
          auto-injectors. 

                                      BACKGROUND  

          An epinephrine auto-injector is a disposable medical drug  
          delivery device that delivers a single measured dose of  
          epinephrine, most frequently for the treatment of acute allergic  
          reactions to avoid or treat the onset of anaphylactic shock.   
          Anaphylactic shock can quickly result in death if untreated.  

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          Epinephrine auto-injectors can be obtained by prescription only,  
          and current California law generally does not authorize  
          non-physicians to administer an epinephrine auto-injector to  
          another person.  In recent years, California law has been  
          amended to, among other things, permit school districts or  
          county offices of education to provide emergency epinephrine  
          auto-injectors to trained personnel, and to permit trained  
          personnel to utilize the auto-injectors to provide emergency  
          medical aid to persons suffering from an anaphylactic reaction,  
          as it is not uncommon for children to come into contact with  
          specific allergens (such as bee stings) or accidentally ingest  
          foods they are allergic to at school.  (AB 559 (Wiggins, Ch.  
          458, Stats. 2001).)  

          This bill would attempt to facilitate the administration of  
          epinephrine auto-injectors by trained prehospital emergency  
          medical care persons, first responders, or lay rescuers, in  
          emergency situations that extend beyond school grounds.  The  
          bill would provide these individuals with a qualified immunity  
          from civil liability, as specified, but would not extend this  
          immunity to conduct constituting gross negligence.  In order to  
          encourage training, this bill would also provide immunity to  
          specified entities who train these individuals in the emergency  
          administration of epinephrine auto-injectors from any civil  
          damages alleged to result from those training programs or  
          standards. 

          This bill was approved by the Senate Committee on Health on  
          April 17, 2013 by a vote of 8-0.

                                CHANGES TO EXISTING LAW
           
           Existing law  requires the Emergency Medical Services (EMS)  
          Authority to establish training and standards for all  
          prehospital emergency care personnel, as defined, regarding the  
          characteristics and method of assessment and treatment of  
          anaphylactic reactions and the use of epinephrine.  Existing law  
          requires the authority to promulgate regulations regarding these  
          matters for use by all prehospital emergency medical care  
          personnel.  (Health and Saf. Code Sec. 1797.197.)  

           Existing law  provides that, notwithstanding any other provision  
          of law, a pharmacy may furnish epinephrine auto-injectors to a  
          school district or county office of education pursuant to  
          specified law, if all of the following are met:
           the epinephrine auto-injectors are furnished exclusively for  
                                                                      



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            use at a school district site or county office of education;  
            and
           a physician and surgeon provides a written order that  
            specifies the quantity of epinephrine auto-injectors to be  
            furnished.  (Bus. & Prof. Code Sec. 4119.2(a).) 

           Existing law  , in relevant part, permits a school district or  
          county office of education to provide emergency epinephrine  
          auto-injectors to trained personnel, and permits trained  
          personnel to utilize those epinephrine auto-injectors to provide  
          emergency medical aid to persons suffering from an anaphylactic  
          reaction.  (Ed. Code Sec. 49414(a).) 

           Existing law  permits a school nurse, or if the school does not  
          have a school nurse, a person who has received training, as  
          specified, to do the following:
           obtain from the school district physician, the medical  
            director of the local health department, or the local  
            emergency medical services director a prescription for  
            epinephrine auto-injectors; and
           immediately administer an epinephrine auto-injector to a  
            person exhibiting potentially life-threatening symptoms of  
            anaphylaxis at school or a school activity when a physician is  
            not immediately available.  (Ed. Code Sec. 49414(f).)  

           Existing law  requires the Superintendent of Public Instruction  
          to establish minimum standards of training for the  
          administration of epinephrine auto-injectors that satisfy the  
          minimum statutory training requirements, as specified.  Existing  
          law requires that the Superintendent consult with specified  
          organizations and providers with expertise in administering  
          epinephrine auto-injectors and administering medication in a  
          school environment.  (Ed. Code Sec. 49414(e)(1).)   Existing law  
          also provides minimum training requirements and standards, as  
          specified.  (Ed. Code Sec. 49414(e)(2).)

           This bill  would permit a pharmacy, notwithstanding any other  
          law, to dispense epinephrine auto-injectors to a prehospital  
          emergency medical care person, first responder, or lay rescuer  
          for the purpose of rendering emergency care, as specified, if  
          both the following requirements are met:
           A physician and surgeon provides a written order that  
            specifies the quantity of epinephrine auto-injectors to be  
            dispensed to a person who is either a prehospital emergency  
            medical care person, first responder, or lay rescuer, as  
            specified.  That prescription may be issued only upon  
                                                                      



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            presentation of a current certificate demonstrating that the  
            person is trained and qualified, as specified, to administer  
            an epinephrine auto-injector to another person in an emergency  
            situation.  The prescription must specify certain information  
            and that a new prescription be written for any additional  
            epinephrine auto-injectors required. 
           The pharmacy must label each epinephrine auto-injector  
            dispensed with specified information. 

           This bill  would require that the prehospital emergency medical  
          care person, first responder, or lay rescuer receiving the  
          epinephrine auto-injector retain records for five years that  
          reflect specified information, including, among other things,  
          the name of any person to who epinephrine was administered using  
          an auto injector.  This bill would also provide that epinephrine  
          auto-injectors dispensed pursuant to this bill may be used only  
          for the specified purpose and circumstances. 

           This bill  would permit a prehospital emergency medical care  
          person, first responder, or lay rescuer to use an epinephrine  
          auto-injector to render emergency care to another person if  
          specified requirements are met, including, among other things,  
          that: 
           the epinephrine auto-injector is used on another, with the  
            express or implied consent of that person, for the purpose of  
            treating anaphylaxis; and
           the person using the auto-injector has successfully completed  
            a course of training with an authorized training provider, as  
            specified, and has a current certification issued by the  
            provider.  

           This bill  specifies that the authorized training providers and  
          minimum standards for training and the use and administration of  
          epinephrine auto-injectors shall be established and approved by  
          the California EMS Authority, as specified. This bill would  
          require that the minimum training and requirements include among  
          other things:
           techniques for recognizing circumstances, signs, and symptoms  
            of anaphylaxis;
           standards and procedures for proper storage and emergency use  
            of epinephrine auto-injectors; and 
           emergency follow up procedures, as specified. 

           This bill  would provide that any prehospital emergency medical  
          care person, first responder, or lay rescuer who administer an  
          epinephrine auto-injector to another person who appears to be  
                                                                      



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          experiencing anaphylaxis at the scene of an emergency situation,  
          in good faith and not for compensation, is not liable for any  
          civil damages resulting from his or her acts or omissions in  
          administering the epinephrine auto-injector, if he or she has  
          complied with the requirements and standards of this bill, as  
          specified.  This bill would not grant immunity from civil  
          damages to any person whose conduct in rendering emergency care  
          constitutes gross negligence.  

           This bill  would provide, in relevant part, that a local agency,  
          governmental entity, or other organization that sponsors,  
          authorizes, supports, finances, or supervises the training of  
          those persons, or develops standards in accordance with this  
          bill shall not be liable for civil damages alleged to result  
          from those training programs or standards.  

           This bill  provides that none of the above shall relieve a  
          manufacturer, designer, developer, distributor, or supplier of  
          an epinephrine auto-injector of liability under any other  
          applicable law. 

           This bill  would specify that it does not apply to those entities  
          separately covered under the Education Code, as specified, and  
          would also state that it shall not be construed to limit or  
          restrict the ability of prehospital emergency medical care  
          personnel to administer epinephrine, including the use of  
          epinephrine auto-injectors, or to require additional training or  
          certification, if the administration of epinephrine is part of  
          their scope of practice, as determined by their respective  
          certifying or licensing entity.

           This bill  would provide relevant definitions and would list the  
          symptoms and various causes of anaphylaxis. 

                                        COMMENT
           
          1.    Stated need for the bill  

          According to the author, 

            SB 669 would create a training program for first responder and  
            group leader volunteers on the recognition and emergency care  
            of anaphylactic shock.  The proposal calls for the development  
            of standards for the safe and proper use of epinephrine  
            auto-injectors (EpiPens).  It would make these auto-injectors  
            available to trained first responders and group leaders on  
                                                                      



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            prescription, and allow them to use it in an emergency  
            situation on a person suffering from a potentially fatal  
            anaphylactic reaction.  It would provide Good Samaritan  
            immunity from civil liability if the care is rendered at the  
            scene of an emergency in good faith, without gross negligence  
            and not for compensation. 

            Despite all improvements in the law expanding Good Samaritan  
            protection fostering trained first responders and group  
            supervisors to provide emergency care (first aid,  
            cardiopulmonary resuscitation and automatic external  
            defibrillation) for someone with a life-threatening allergic  
            reaction, there is effectively nothing anyone can do in cases  
            of anaphylaxis to prevent cardio-pulmonary shutdown unless the  
            victim happens to have an EpiPen and is able to  
            self-administer epinephrine before losing  
            consciousness-outside of a medical or school environment. 

            Unless specifically used by and for the person for whom it was  
            prescribed, an EpiPen may not be administered by  
            non-physicians-even if an auto-injector is on the scene.   
            Until recent passage of enabling legislation, this was even a  
            problem for school nurses. [ . . . ]  Yet, death from  
            anaphylaxis remains a real and pervasive problem outside of  
            school, in the wilderness and even in the community, when  
            group leaders overseeing the welfare of others, and even  
            trained first responders at the scene of an emergency, cannot  
            obtain or administer this miraculous life-saving device---a  
            device which even little children are trained to safely use.   
            In the case of anaphylactic shock, death through suffocation  
            can occur in a matter of minutes.  Definitive medical care  
            cannot always be timely obtained. [ . . . ] 

            Anaphylaxis is a pervasive lethal threat, both to those with  
            known allergies and those who suddenly become sensitized to a  
            substance - such as a simple bee-sting, ingestion of  
            shellfish, or coming into contact with peanuts.  While an  
            anaphylactic attack cannot always be prevented, the worrisome  
            consequences of it can be.  

          The sponsor of this bill, the Conference of California Bar  
          Associations (CCBA), adds that, "SB 669 would enable California  
          to join a growing group of states that provide training in the  
          proper use and administration of epinephrine auto-injectors, and  
          which make these auto-injectors available by prescription to  
          individuals who have successfully completed the training.  The  
                                                                      



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          purpose of the bill is to increase the chances that if a person  
          suffers life-threatening allergic reaction, there will be  
          someone close by with an epinephrine auto-injector who knows the  
          proper way to use it."   

          2.    Immunity provisions  

          This bill would provide a qualified immunity to any trained  
          prehospital emergency medical care person, first responder, or  
          lay rescuer who administers an epinephrine auto-injector to  
          another person who appears to be experiencing anaphylaxis at the  
          scene of an emergency situation except in the case of gross  
          negligence.  This bill would also provide an unqualified  
          immunity to any entities, as specified, that train these  
          individuals in the emergency administration of epinephrine  
          auto-injectors for damages alleged to result from those training  
          programs or standards.  This bill specifies that nothing in this  
          bill relieves a manufacturer, designer, developer, distributor,  
          or supplier of an epinephrine auto-injector of liability under  
          any other applicable law.

          As a general rule, California law provides that everyone is  
          responsible, not only for the result of his or her willful acts,  
          but also for an injury occasioned to another by his or her want  
          of ordinary care or skill in the management of his or her  
          property or person, except so far as the latter has, willfully  
          or by want of ordinary care, brought the injury upon himself or  
          herself.  (Civ. Code Sec. 1714(a).)  Although immunity  
          provisions are rarely preferable because they, by their nature,  
          prevent an injured party from seeking a particular type of  
          recovery, the Legislature has in limited scenarios approved  
          measured immunity from liability to promote other policy goals  
          that could benefit the public.  

          Thus, the question is raised as to whether these two immunity  
          provisions would appropriately balance the ability for an  
          injured person to seek recourse against the public policy of  
          saving lives where there is a reasonable method of providing  
          assistance with relatively little risk involved.  

              a.   Qualified immunity for a trained person who administers  
               an epinephrine auto-injector appears reasonable but should  
               parallel similar existing law provisions

             Despite the general disfavoring of immunity provisions for the  
            reasons stated above, where there is a generally safe,  
                                                                      



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            reliable, and easily administrable treatment that can prevent  
            unnecessary death, as a matter of public policy, it may be  
            appropriate to confer a limited immunity as a way of  
            encouraging the provision of a potentially life-saving  
            treatment.  At the same time, qualified immunity, as opposed  
            to blanket immunity, is preferable to ensure a party injured  
            in the provision of this care can seek recourse in the courts  
            in appropriate circumstances. 

            As noted above, this bill attempts to strike a balance between  
            competing interests and concerns, by providing a qualified  
            immunity from civil liability to any properly trained  
            prehospital emergency medical care person, first responder, or  
            lay rescuer who administers an epinephrine auto injector in  
            compliance with specified requirements, while not extending  
            that immunity to any conduct that constitutes gross negligence  
            in rendering that care.  Gross negligence is a legal term that  
            represents an extreme departure from the ordinary standard of  
            conduct.  It is akin to failing entirely to exercise care or  
            exercising so slight a degree of care as to justify the belief  
            that there was an indifference to the interest and welfare of  
            others.

            Proponents argue in support that this bill, as a whole, will  
            help ensure that a person does not needlessly die from  
            anaphylaxis when there is a properly trained person nearby who  
            can administer an epinephrine auto-injector.   Committee staff  
            also notes that the qualified immunity provision is arguably  
            an important component to this bill having the intended effect  
            of promoting action to prevent unnecessary deaths from  
            anaphylaxis, as it can help avoid a scenario in which a  
            properly trained person might avoid taking action to assist  
            another person out of fear of civil liability.  At the same  
            time, it is equally important to maintain that a person's  
            grossly negligent conduct would not be shielded from civil  
            liability, as it incentivizes a person to act with the due  
            care and ensures the possibility of legal recourse for any  
            person injured by that conduct.   

            This type of qualified immunity is not without precedent under  
            California law.  Proponents note, for example, that there is a  
            comparable California statute under existing law, relating to  
            automatic external defibrillators (AEDs), whereby this state  
            encourages the provision of emergency care with a reduced risk  
            of civil liability, in order to avoid preventable deaths.   
            Specifically, existing law provides qualified immunity in  
                                                                      



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            relation to the provisions of emergency care using an AED.   
            (See Civ. Code Sec. 1714.21.)  In the AED context, however,  
            the qualified immunity does not apply in the case of personal  
            injury or wrongful death which results from the gross  
            negligence or willful or wanton misconduct by the person who  
            uses the AED to render emergency care.  (Civ. Code Sec.  
            1714.21(f).)

            Arguably, because this bill seeks to encourage the rendering  
            of reasonable emergency care in similar fashion (using an  
            epinephrine auto-injector as opposed to an AED), the scope of  
            the immunity should also apply in similar fashion as well. In  
            other words, the immunities should parallel one another  
            because both bills seek to reasonably promote the rendering of  
            emergency care.  To achieve this purpose, the following  
            amendment is suggested: 

                Suggested amendment
                
               On page 4, strike lines 38-40, inclusive, and insert: "(c)  
               The protections specified in subdivision (b) do not apply  
               in the case of personal injury or wrongful death which  
               results from the gross negligence or willful or wanton  
               misconduct of the person who renders emergency care  
               treatment by the use of an epinephrine auto-injector." 

             b.    The proposed immunity for training program entities  
               should be narrowed  

            This bill would, in contrast to the immunity discussed in  
            Comment 2a above, provide unqualified immunity to an entity  
            that trains a prehospital emergency medical care person, first  
            responder, or lay rescuer in the administration of epinephrine  
            auto-injectors in emergency situations.  Specifically, those  
            entities would not be liable for civil damages alleged to  
            result from those training programs or standards.  

            As a result, even if a plaintiff could prove that the training  
            programs or standards were themselves substandard and resulted  
            in his or her injury, the plaintiff would be precluded from  
            seeking a remedy in court under this bill.  That would remain  
            the case even if the training program or standards failed to  
            even meet the bill's minimal statutory training requirements.   


            It is unclear why a training program whose training or  
                                                                      



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            certification of individuals fails to meet the minimal  
            training standards required by the bill, or otherwise amounts  
            to gross negligence, should be shielded from liability where  
            their training or standards could directly result in  
            substandard care.   Accordingly, the following amendment is  
            suggested to ensure that the possibility of liability remains  
            in such scenarios:

                  Suggested amendment
             
               On page 5, line 1, after "(d)" insert "(1)"
                
               On page 5, after line 17, insert "(2) This protection shall  
               not apply in the case where it is alleged that the personal  
               injury or wrongful death was proximately caused by a  
               training provider's failure to meet the minimal statutory  
               training requirements and standards established pursuant to  
               subdivision (c) of section 1797.197a of the Health and  
               Safety Code, or it is alleged that the training provider  
                                                                         otherwise demonstrated gross negligence in the training or  
               certification of an individual whose subsequent actions  
               cause personal injury or wrongful death in the rendering of  
               emergency services by an epinephrine auto-injector." 

          3.    Suggested clarifying amendments
           
          The following amendments would correct drafting issues: 

             Suggested amendment
             
            On page 4, line 31, after "epinephrine auto-injector" insert  
            ", in good faith and not for compensation,"

            On page 4, line 33, strike "in good faith and not for  
            compensation," 

            On page 6, strike lines 1-3, inclusive, and insert "'(4) Lay  
            rescuer' means any person who has met the training standards  
            and other requirements of this section but who is not  
            otherwise licensed or certified to use an epinephrine  
            auto-injector on another person."  

          4.    Consumer Attorneys of California  

          The Consumer Attorneys of California (CAOC) previously submitted  
          a letter of concern wherein they "recognize[d] the benefit to  
                                                                      



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          have appropriately trained personnel deliver life saving  
          injunctions," but expressed desire to work further with the  
          author to narrow the bill-presumably with respect to the  
          immunity provisions.   CAOC has indicated that the amendments  
          suggested in Comment 2 would address their concerns. 

          5.    Amendments taken since this bill was last heard in Senate  
          Heath Committee 
           
          This bill has been recently amended, in relevant part, to  
          address both opposition concern and suggestions made by the  
          Senate Health Committee.  First, this bill now specifies that it  
          no longer applies a school district or county office of  
          education, or its personnel, providing and utilizing epinephrine  
          auto-injectors to provide emergency medical aid pursuant to the  
          Education Code.  Second, this bill addresses a comment by the  
          Senate Health Committee that "some prehospital emergency  
          personnel already have it within their scope of practice to  
          administer epinephrine," and that the author may wish to  
          consider amending this bill to ensure that any professional who  
          is already licensed to administer epinephrine auto-injectors  
          under their current scope of practice may continue to do so  
          without obtaining the additional training and certification  
          required by this bill.  The bill now contains language to that  
          end.  


           Support  :  Association of Regional Center Agencies (ARCA);  
          California Association of Joint Powers Authorities; California  
          Hospital Association; Hospital Corporation of America

           Opposition  :  None Known 

                                        HISTORY
           
           Source  :  Conference of California Bar Associations

           Related Pending Legislation  :  None Known

           Prior Legislation  :

          AB 559 (Wiggins, Ch. 458, Stats. 2001), See Background. 

          AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was  
          ultimately vetoed. 

                                                                      



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           Prior Vote  :  Senate Committee on Health (Ayes 8, Noes 0) 

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