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Understanding Legal Issues

This section was written by Richard Lazar, Esq., a legal expert on emergency medical services topics, who serves as an advisor to the National Center for Early Defibrillation.More legal medical opinion is offered here.

If you are like most people considering the implementation of an AED program, you probably have questions about laws and regulations affecting early defibrillation programs and whether or not there are any liability risks. Let's take a look at the federal and state law and regulatory framework within which early defibrillation programs operate, and review the nature and limited scope of any negligence liability risk associated with community-based early defibrillation programs1.

Federal and state laws and regulations

The purchase and use of AEDs occurs within a complex maze of federal and state laws and regulations. At the federal level, the U.S. Food and Drug Administration (FDA) oversees the manufacture of AEDs because they are medical devices. At the state level, various regulatory agencies oversee the use of AEDs. Both the FDA and state regulatory agencies determine who can use AEDs and how they may be used.

Federal regulatory oversight

The FDA is the federal regulatory agency responsible for ensuring that medical devices like AEDs are safe and effective. To achieve this goal, the FDA imposes device labeling requirements on AED manufacturers. Labels must describe the indications and conditions for AED use. Currently, AEDs are viewed by the FDA as restricted, prescription devices. This means AED labeling must indicate that the device may only be used under certain conditions: the user must be trained and under the supervision of a physician. In addition, AEDs must come with directions so they can be used safely in the manner intended, that is, to resuscitate victims of sudden cardiac arrest. All AEDs sold in the marketplace today are evaluated and cleared by the FDA.

Certain aspects of current federal law are unclear. For example, FDA regulations do not detail the precise nature and scope of medical direction or training required to use AEDs. Of some help on the question of medical oversight is a statement contained in a consumer information document published by the FDA's Center for Devices and Radiological Health (CDRH) which states that "a physician who oversees the PAD (Public Access Defibrillation) program at a facility must write a prescription for the AED in order for the facility to purchase it."2 This suggests an AED prescription is device specific rather than patient specific. On the issues of training this same document states:

Public access refers to accessibility for trained users to use AEDs in public places. Public access does not mean that any member of the public witnessing a sudden cardiac arrest should be able to use the device. AEDs are to be used only by individuals with the proper training and certification in accordance with state and local laws. 3

To the extent training is required--a question of debate in both legal and public policy circles--the CDRH document suggests training standards are governed by state and local laws rather than federal law.

The FDA is reviewing whether AEDs should remain prescription devices and whether more extensive use of these devices should be permitted. It is likely federal requirements affecting the sale and use of AEDs will change in the near future.

Federal law

Laws recently passed by the U.S. Congress could have a dramatic impact on the pace at which early defibrillation programs are adopted.

The Cardiac Arrest Survival Act (CASA)4 requires the U.S. Secretary of Health and Human Services to establish guidelines for placing AEDs in federal buildings. These guidelines are to include recommendations on the appropriate placement of AEDs including procedures for the following:

  • Implementing appropriate training courses in the use of such devices, including the role of cardiopulmonary resuscitation;
  • Proper maintenance and testing of the devices;
  • Ensuring coordination with appropriate licensed professionals in the oversight of training of the devices;
  • Ensuring coordination with local emergency medical systems regarding the placement and incidents of use of the devices5.

When published, these guidelines and recommendations may lead to community-based early defibrillation programs founded on more uniform state AED laws, regulations and training requirements.

An important provision of the CASA provides certain AED users with conditional Good Samaritan legal liability immunity for any harm resulting from the use or attempted use of the device6. AED acquirers receive similar immunity if certain requirements are met. AED trainers and medical oversight physicians do not receive immunity under this law. How CASA immunity and AED immunity under state law (see state Good Samaritan law section below) will apply in specific situations remains a complex and unanswered question.

The Rural Access to Emergency Devices Act7(also called the Rural AED Act) was passed by Congress along with the CASA. This law authorizes the appropriation of $25 million in grants to certain "community partnerships" for the purchase of AEDs and for AED training.

The Airline Passenger Safety Act8, enacted in April 1998, requires the Federal Aviation Administration (FAA) to review the contents of medical kits carried on commercial airplanes. Administrative rules proposed by the FAA as required by this law would mandate that every commercial aircraft be equipped with specified life-saving equipment and appropriately stocked first-aid and medical kits, including AEDs, and that flight crew members be trained in their use. It is estimated that 1,000 persons die each year due to cardiac arrest suffered on international commercial airline carriers. More and more airlines are equipping their fleets with AEDs.

State regulatory oversight

User classes

State laws and regulations are not uniform. Some states do not oversee the use of AEDs. Other states do, but the scope of oversight varies widely. State laws and regulations affecting early defibrillation programs address two key elements. The first element relates to those individuals specifically permitted to use AEDs, known as "user classes." User classes may include the following groups:

  • Emergency medical responders such as paramedics and emergency medical technicians (EMTs)
  • Public safety emergency responders, such as firefighters and police officers
  • Targeted emergency responders, such as security guards, industrial first aiders, flight attendants, ship crews, ski patrol, lifeguards, non-hospital healthcare facility workers, nursing home personnel, retirement community personnel, athletic trainers, etc.
  • Trained citizen responders, such as friends, relatives and co-workers of people with identified heart problems

States vary in their approaches to authorizing AED use. Some allow a broad range of individuals to use the devices. For example, California allows anyone to use an AED if the individual meets certain training and competency requirements and if there is medical oversight. A Florida law says "an automatic external defibrillator may be used by any person for the purpose of saving the life of another person in cardiac arrest," if the individual is trained in CPR and proficient in AED use.

In contrast, some states restrict the scope of user classes allowed to use AEDs. For example, a shrinking number of states allow only emergency medical responders (e.g., EMTs and First Responders) to use AEDs. In these states, other user classes are not specifically permitted to use the devices. Whether the absence of express state authorization prohibits the use of AEDs by other user classes is an open legal question.

Efforts are underway to encourage states to expand the scope of user classes allowed to use AEDs. Overall, the trend at the state level is to expand groups of individuals allowed to use AEDs.

Conditions of use

Generally, the second element addressed by state AED laws and regulations describes the conditions under which AEDs may be used, known as "conditions of use." These conditions address training, medical oversight, quality assurance, record keeping, and reporting. States vary dramatically in their approach to specifying conditions of use. Some states require very little while a diminishing number specify lengthy and burdensome conditions of use.

Summary of government oversight

It is important that your early defibrillation program follow applicable federal and state laws and regulations. Therefore, your first task as you begin the process of developing an early defibrillation program is to review the laws and regulations affecting AED use in your state. It is essential to contact your state EMS agency for information about state laws and regulations. A knowledgeable attorney can help you get your program up and running.

Legal liability risk

Individuals, agencies and companies considering the purchase and use of AEDs sometimes fear negligence liability suits. As noted by the AHA, "a potential disincentive to lay users of AEDs . . . is the threat of a personal injury claim."9 While the public's apprehension is understandable, any actual liability risk associated with early defibrillation programs appears quite small. Still, perceptions and fears must be addressed if widespread AED availability is to become reality.

The following sections provide an overview of negligence liability issues applied to the concept of early defibrillation. Armed with this background information, individuals, agencies and companies considering the purchase and use of AEDs should be reassured that any actual legal liability threat is both small and manageable. Clearly, the benefits associated with widespread early defibrillation far outweigh liability risks.

An overview of negligence

For a sudden cardiac arrest victim (or a relative) to successfully sue an AED purchaser or user for negligence, four essential legal elements must be proven. These include duty, breach of duty, causation of injury, and legally recognized damages. A negligence claim cannot succeed if any one of these elements is missing. Because an AED related claim is most likely to focus on the elements of duty and causation, these elements are discussed in detail.

The concept of legal duty

Duty in negligence law is defined as "an obligation, to which the law will give recognition and effect, to conform to a particular standard of conduct toward another."10

If a legal duty is found to exist, it is possible for liability to be imposed. In the absence of a legal duty, no liability can be imposed.

A bystander has no legal obligation to provide affirmative medical aid to an ill or injured person, even if the bystander has the ability to help. "[T]he law has persistently refused to impose on a stranger the moral obligation of common humanity to go to the aid of another human being who is in danger, even if the other is in danger of losing his life."11

Courts recognize, however, that the existence of certain relationships between a victim and one in a position to render aid may create a duty to provide assistance. Generally, EMS providers, such as paramedics and EMTs, have a legal duty to respond to and treat victims of medical emergencies. Specific responsibilities imposed on these responders vary from state to state and are influenced by court cases, statutes and regulations.

For individuals other than EMS providers, the following section, from the leading statement of general negligence law, outlines the types of relationships which may give rise to a duty to render emergency medical assistance (See Figure 1.)12 This statement of law is adopted by many courts and may become more important as the concept of public access defibrillation evolves.

Figure 1
Figure 1

Thus, in contrast to the general rule imposing no such duty on bystanders, certain groups may be compelled by law to render a reasonable level of medical aid and to quickly summon outside emergency medical assistance (Figure 2). These groups include common carriers (such as airlines, cab companies, passenger railroads and cruise ship operators), innkeepers (such as hotel and motel operators) and virtually all other commercial business establishments.

Figure 2
Figure 2

Appellate courts, trial court judges and juries define what is "reasonable," thus establishing the scope of a legal obligation or duty. The degree of reasonableness required under the facts and circumstances of a particular case evolves as society evolves. Action or inaction viewed as reasonable today may be viewed as unreasonable tomorrow.

While early defibrillation programs began to appear in the mid-1990s, only two appellate cases found to date directly address the issue of early defibrillation initiated by non-healthcare professionals and each of these deals with commercial airlines. In one case United Airlines was sued by the widow of a man who suffered sudden cardiac death on a 1995 domestic flight13. The widow alleged that United was liable "because it failed to equip its aircraft with certain medical equipment, including an automatic external defibrillator, and because her husband would have survived if the in-flight emergency medical kit had contained such equipments." The case was recently settled after United unsuccessfully attempted to have the case dismissed on technical grounds.

In another case, Northwest Airlines was sued by a woman alleging her husband died from sudden cardiac arrest because the airline failed to have a defibrillator on board a 1995 flight14. The case was dismissed because the woman failed to produce an expert who would testify that the airline had a duty to carry a defibrillator at the time of the incident.

Because they were both dismissed on technical grounds, neither the United nor Northwest Airlines cases offer much guidance on how future appellate courts might address issues surrounding public access defibrillation. Appellate courts examining notions of reasonableness in other medical contexts have, historically, been generally resistant to requiring common carriers, innkeepers and commercial businesses faced with ill or injured patrons to do more than summon an ambulance. Two recent trial court verdicts, however, suggest an evolving trend toward higher standards requiring the protection of customer health and safety in certain business contexts.

Future trial court cases will likely offer insight into society's current view of reasonableness when businesses are faced with ill or injured patrons. Modern advances in AED technology, coupled with low cost and the proven ability of these devices to save lives, may persuade trial and appellate courts to sanction businesses that fail to adopt AED programs. While the likelihood of any type of AED related claim remains extremely small, it appears that common carriers, innkeepers and commercial businesses that adopt AED programs may face a lower legal liability risk than those that fail to adopt such programs.

The concept of causation

A successful negligence lawsuit also requires proof that alleged misconduct caused legally recognized damages such as death or injury. Three possible causation theories include allegations that a death directly resulted from: 1) the failure to purchase and make available an AED; 2) the failure to use an available AED; or 3) the improper use of an available AED.

In all cases involving sudden cardiac arrest leading to sudden cardiac death, the element of medical causation will be extremely difficult to prove. The causation question likely to be considered in early defibrillation cases is whether death could have been prevented with the availability and use of an AED.

Defibrillation delivered as quickly as possible after onset of sudden cardiac arrest has the capacity to greatly improve a victim's chances of survival. Thus, common carriers, innkeepers and commercial businesses that fail to purchase and use AEDs are at greatest risk in terms of proof of causation. However, this relative risk is quite small given the generally poor survival associated with sudden cardiac arrest. Next in order of risk are those situations in which an AED is available but improperly used. This scenario is unlikely because, with proper training, the modern generation of AEDs are both easy to use and difficult to misuse. Companies that purchase and properly use AEDs are at lowest causation risk.

Overall, the prospect of proving causation in early defibrillation cases, while theoretically possible in some circumstances, will be extremely difficult given the life-threatening nature of sudden cardiac arrest. Organizations that carefully adopt and implement AED programs may well be at lowest risk of liability.

Legal risk assessment: A summary

Legal liability risks associated with early defibrillation programs are quite remote. The following factors support this conclusion:

  • Only two known appellate cases raise early defibrillation by non-healthcare professionals as an issue. A limited number of relevant trial court verdicts suggest that organizations that adopt AED programs face a lower liability risk than those that do not.
  • If sudden cardiac arrest is untreated, the victim will die. As a general rule, an AED used properly can only help.
  • Proving medical causation in an early defibrillation case will be extremely difficult.
  • Many states possess laws that limit the types and scope of negligence lawsuits permissible against individuals rendering emergency medical care, including tort limitation, Good Samaritan laws and a variety of immunity laws.
  • The modern generation of AEDs are both easy to use and difficult to misuse.
  • For these reasons, legal liability fears should not deter organizations considering the purchase and use of AEDs.

Minimizing legal liability risk

There are a variety of ways to both manage and allocate even the small legal liability risks associated with early defibrillation programs.

1. Design a careful program

  • Implementation: General rules governing negligence cases suggest that organizations that carefully adopt and implement early defibrillation programs face a lower legal liability risk than those that do not.
  • Device selection and maintenance: All AEDs on the market have been cleared by the FDA. Because device price, performance, ease-of-use characteristics and recommended maintenance procedures differ by manufacturer, and because technology is advancing rapidly, it is worthwhile to carefully consider all AED options before purchase.
  • User identification and training: Many state regulations currently require appropriate training of AED users. It is important that appropriate individuals be identified and trained.
  • Site selection: AEDs should be placed in locations that can be reached quickly and easily. If an AED is placed in a locked or secure location, it is important that designated AED users possess keys or other means of accessing the device.

2. Promote Good Samaritan laws
Most states now have laws that protect individuals from legal liability flowing from the provision of emergency medical care. A growing number of states have Good Samaritan laws that specifically protect AED users from legal liability under certain circumstances.

A review of your state's laws will help you determine whether, and to what degree, liability immunity protection exists. For further information on Good Samaritan laws, see the State AED Laws, the National Immunity/Good Samaritan Law Database, National EMS Info Exchange, NAEMT Online at http://naemt.org/nemsie/immunity.htm, and Emergency Medical Risk Management by Henry and Sullivan.

3. Explore insurance options
Negligence liability risk can be further minimized through the purchase of insurance. Private insurance companies and some AED manufacturers offer indemnification plans that protect AED purchasers from liability claims, except in cases of gross negligence, as long as certain conditions are met. Since these plans vary in scope and are continuously evolving, communities should take the time to investigate insurance options.

Summary

This section addresses laws and regulations affecting the use of AEDs. Both the FDA and state regulatory agencies determine who can use AEDs and how they may be used. State laws and regulations vary widely. Communities that implement AED programs must abide by federal and state laws and regulations and should check with state EMS agencies for information.

This section also addresses the nature and limited scope of any negligence liability risk associated with AED programs. Legal liability fears should not deter those considering the purchase and use of AEDs. Organizations that carefully adopt and implement AED programs will be at lowest risk of liability.

1Note: Information in this chapter is not intended as legal advice. While every effort is made to ensure the accuracy of information, the AED legal and regulatory landscape is evolving rapidly. Legal questions surrounding AED use can be complex. If your community needs specific advice, seek the services of a competent attorney.
2http://www.fda.gov/cdrh/consumer/AED_PAD.html.
3Ibid (emphasis added).
4Public Health Improvement Act, Sections 401-404.
5Ibid, Section 403.
6Ibid, Section 404.
7Public Health Improvement Act, Sections 411-413.
8Pub. L. 105-170, 49 USC 44701.
9Circulation. 1995;92:2740-2747
10W. Page Keeton et al., Prosser and Keeton on the Law of Torts § 53, at 356 (5th ed. 1984).
11Ibid.
12Restatement (Second) of Torts § 314A.
13Somes v. United Airlines, Inc., 33 F.Supp.2d 78 (US District Court, D. Massachusetts 1999)
14Talit v. Northwest Airlines, Inc., 58 Conn. App. 102, 752 A.2d 1131 (2000).

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