No question, things can go wrong during a stressful emergency event such as a sudden cardiac arrest (SCA). Equipment may malfunction. The victim may not survive. It is understandable that a business considering an AED program is concerned about the possibility of a lawsuit. You need to know your liability risks.
To alleviate this concern and encourage public access to automatic external defibrillators (AEDs), the federal government and most states have enacted legislation that legally protects first responders and owners of AEDs.
Both the FDA (Food and Drug Administration) and state regulatory agencies determine who can use AEDs and how they may be used. State laws and regulations vary widely. Businesses that implement AED programs must abide by federal and state laws and regulations and should check with state EMS agencies for information.
The liability risks associated with owning or operating an AED are generally quite small. Legal liability fears should not deter organizations considering the purchase and use of AEDs, because the benefits associated with widespread early defibrillation far outweigh liability risks.
Let’s take a look at the legal considerations of acquiring an AED and implementing an early defibrillation program.
Good Samaritan Laws
Good Samaritan laws offer legal protection to people who give reasonable assistance to those who are injured, ill, in peril, or otherwise incapacitated. The intention of this protection is to reduce bystanders’ hesitation to assist, for fear of being sued or prosecuted for unintentional injury or wrongful death.
Good Samaritan in legal terms is “someone who renders aid in an emergency to an injured person on a voluntary basis. Usually, if a volunteer comes to the aid of an injured or ill person who is a stranger, the person giving the aid owes the stranger a duty of being reasonably careful. A person is not obligated by law to do first aid in most states, not unless it’s part of a job description.”
Good Samaritan statutes vary from state to state, but they all offer some level of immunity to a bystander who helps a victim. It is important to know what the laws are in your state.
The Federal Cardiac Survival Act (CASA) was enacted in the year 2000 with the purpose of improving the dismal survival rates of sudden cardiac arrest victims. This act provides for strategic placement of AEDs in federal buildings.
Additionally, the Department of Health and Human Services (HHS) and General Services Administration (GSA) developed guidelines for Public Access Defibrillation (PAD) programs in federal facilities.
To encourage placement and use of AEDs in public locations, CASA provides protections from civil liability when an AED is used in an emergency. CASA extends the protection offered through the Good Samaritan Act to protect users of AEDs. AED acquirers receive similar protection as long as they follow legal requirements, such as proper upkeep and documentation of the device.
This means they will not be held liable for any damages that may result from the use of an AED in a public setting, except in cases of gross negligence or willful misconduct. This protection includes all fifty states and the District of Columbia.
All fifty states and the District of Columbia have specific AED laws and regulations that limit liability in the use of an AED in an emergency. Each state also has its own law(s) that protect organizations that own AEDs. These laws typically mirror CASA of 2000 and expand on Good Samaritan laws.
State Legislators are actively involved with PAD policies and regulations. State laws encourage broader availability, rather than creating new regulatory restrictions. According to the National Conference of State Legislatures (NCSL), most of the bills enacted from 1997 to 2001 included one or more provisions to:
- Establish legislative intent that an “automatic external defibrillator may be used by any person for the purpose of saving the life of another person in cardiac arrest.” Encourage or require training in the use of AED devices by potential users.
- Require AED devices to be maintained and tested to manufacturer’s standards.
- Create a registry of the location of all such defibrillators, or notification of a local emergency medical authority.
- Allow a “Good Samaritan” exemption from liability for any individual who renders emergency treatment with a defibrillator.
- Authorize a state agency to establish more detailed requirements for training and registration.
Since 2001, all states have further instituted PAD policies recommending or requiring certain organizations and facilities to place AEDs on site. Some have laws that require medical oversight, documentation, collaboration with local emergency medical services, and/or training.
Since each state has different requirements and laws, it is important to contact your state’s regulatory authority to learn the requirements and laws governing your state.
Manufacturer Indemnification Policies
Some AED manufacturers, such as Philips Medical Systems, provide an additional level of protection by offering limited indemnity to users of their AEDs.
The freedictionary.com legal dictionary defines indemnity as “recompense for loss, damage, or injuries; restitution or reimbursement.” An indemnity contract is “when one individual takes on the obligation to pay for any loss or damage that has been or might be incurred by another individual.”
An indemnification policy offers protection to the owner or user in the remote chance the defibrillator (AED) fails. Each indemnification policy is different, so it is important to understand the protection provided by the manufacturer of your AED model.
Typically, the policy states that you will be held harmless from claims, losses or expenses related to a claim of personal injury resulting from mechanical or electrical malfunction of the device. The unit must have been purchased, leased or rented from the manufacturer or authorized distributor.
Protection does not cover claims in which the AED was not properly maintained, not in compliance with state/local laws, non-manufacturer supplies were used, or the unit was not used as intended. The policy will state that the claim can not result from negligence or improper acts and that the event must be recorded.
“Do No Harm”
You’ve probably heard this phrase. It is part of medical doctors’ Hippocratic Oath. “Do No Harm” is one of the fundamental principles of medicine according to which the physician should not cause harm to the patient.
This doctrine is a cornerstone of the legal argument in support of AEDs in public venues.
Today’s AEDs are designed for layperson use and extremely safe. An AED accurately assesses the heart rhythm and only delivers a shock only if the victim needs it. The design makes it impossible to deliver a shock to someone not in cardiac arrest. An AED will not cause harm to the victim.
Quick access to an AED is the only chance of survival for a victim of SCA (sudden cardiac arrest). In such a rescue situation, you cannot harm the victim; you can only save the victim.
Businesses and organizations considering the implementation of an AED program often fear negligence liability suits. The AHA (American Heart Association) acknowledges that “a potential disincentive to lay users of AEDs . . . is the threat of a personal injury claim.”
According to Richard Lazar, Esq., a legal expert on emergency medical services topics, who serves as an advisor to the National Center for Early Defibrillation, states that “while the public’s apprehension is understandable, any actual liability risk associated with early defibrillation programs appears quite small.”
He addresses the perceptions and fears that inhibit widespread AED availability and offers reassurance that any actual legal liability is small and manageable.
Mr. Lazar points out that “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.”
- Duty — in negligence law defined as “an obligation, to which the law will give recognition and effect, to conform to a particular standard of conduct toward another.” In the absence of a legal duty, no liability can be imposed.
Current laws protect bystanders by protecting them from any legal obligation to come to the medical aid of and ill or injured person.
- Breach of Duty — 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. The specific responsibilities required of these responders vary from state to state.
As PAD policies expand, the laws regarding negligence are evolving. Laws may mandate certain groups to render a reasonable level of medical aid and summon emergency medical assistance.
Mr. Lazar points out two appellate cases directly addressing the issue of early defibrillation initiated by non-healthcare professionals — each with commercial airlines.
In one case, the widow of a man who suffered an SCA on a flight in 1995 sued United Airlines. 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 equipment.” The case settled after United unsuccessfully attempted to have the case dismissed on technical grounds.
In the other case, a woman sued Northwest Airlines alleging her husband died from SCA because the airline failed to have a defibrillator on board a 1995 flight. This 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 both cases were dismissed on technical grounds, it cannot be determined how future courts will address issues regarding public access defibrillation.
Evolving technology coupled with a successful track record of saving lives could mean that businesses and organizations who do not adopt an AED program could face a higher liability risk than those that do not, resulting in a “reverse liability” situation.
- Causation / Legally Recognized Damages — 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.
Medical causation is extremely difficult to prove in early defibrillation cases, because it needs to be proved that the death could have been prevented with the availability and use of an AED.
Businesses and organization that are required by law to implement an AED program, but fail to purchase and use AEDs are at greatest risk in terms of proof of causation. Currently, the overall risk is quite small given the generally poor survival associated with sudden cardiac arrest.
The liability risk in situations in which an AED is available but improperly used is small 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.