Is Good Public Health Also Good Business?

Just recently, the U.S. Food and Drug Administration approved over-the-counter sales of the portable automated external defibrillator (AED) – a medical device that is gaining increasing currency around the country in the effort to prevent death from sudden cardiac arrest.

Previously, a prescription from a physician had been required. The Boston Globe on Sept. 17 reported that the “HeartStart Home Defibrillator,” manufactured by Andover, Mass.-based Philips Medical Systems was being advertised online for approximately $2,000.

An AED is defined in federal law as being able to recognize the presence or absence of ventricular fibrillation, determine without intervention by the user whether defibrillation should be performed, and (upon determining that defibrillation should be performed) deliver an electrical shock to an individual. 42 U.S.C. §238q(e)(2)(A) (added by the federal Cardiac Arrest Survival Act, or “CASA,” Pub. L. 106-505).

Lightweight and portable, and about the size of a laptop, the AED has “one primary function: To identify the heart rhythm of a sudden cardiac arrest victim and, if necessary, to deliver a large electric shock which may correct the abnormal rhythm. (See “PAD Trial Frequently Asked Questions” at http://depts.wahsington.edu/padctc/restfaq.pdf.)

Early defibrillation, one link in the “chain of survival” process for responding to cardiovascular attack in the emergency medical system, has taken on new significance, with the wider availability of these facile AED devices, and with the increasing endorsement of “public access defibrillation” (“PAD”) programs in the health care community.

PADs are public health programs, integrated with the local Emergency Medical Services system, designed to encourage the use of AEDs by lay rescuers on victims of out-of-hospital cardiac arrest. (See “Public Training in Cardiopulmonary Resuscitation and Public Access Defibrillation” 1999 policy statement of the American College of Emergency Physicians.) The American Heart Association has produced an excellent PAD informational package, plus much additional literature on the subject.

Since 95 percent of cardiac arrests are fatal, and since defibrillation within the first few minutes of arrest is critical to the chance of survival, making defibrillation available to victims even before professional first responders can get to the scene is viewed in the heart advocacy and medical community as an optimal goal.

“By far, the most important factor for success in resuscitation is time to treatment, in particular, defibrillation. . . . Although cardiopulmonary resuscitation (CPR), particularly chest compression, is important later in the arrest sequence, defibrillation should be the primary treatment focus within the first four minutes of ventricular fibrillation.” Callans, D.J., “Out-of-Hospital Cardiac Arrest – The Solution is Shocking,” N. Engl. J. Med. 351:7; 632-34 (Aug. 12, 2004).

A recent scientific trial on PAD, reported in the New England Journal of Medicine, has boosted the argument for advancing PAD programs. Examining the use of early defibrillation by trained volunteers in public places, as part of a “structured response system,” the trial’s investigators concluded: “In public locations, where approximately 20 percent of out-of-hospital cardiac arrests occur, implementing an organized emergency-response plan and training and equipping volunteers to provide early defibrillation with an AED doubled the number of survivors to hospital discharge after out-of-hospital cardiac arrest. The PAD Trial supports the concept that trained volunteers can use AEDs safely and effectively in a variety of public locations.” Hallstrom, A., Ornato, J.P., et al., “Public-Access Defibrillation and Survival after Out-of-Hospital Cardiac Arrest” in New Engl. J. Med. 351:7; 637-46 (Aug. 12, 2004; emphasis added).

Popular Web media, such as USATODAY.com and MSNBC.com, quickly covered this PAD study. The Wall Street Journal quoted the trial’s lead co-investigator as suggesting a comparison between AEDs and fire extinguishers by way of potential future availability.

Potential Legal Liability

What might all this mean for the potential for legal exposure to those who own or manage places of public gathering (shopping malls, theaters, auditoriums, sports arenas), means of public conveyance (airlines, passenger and commuter trains, cruise ships) or even other businesses (large office buildings)?

Both Congress and the various states have enacted Good Samaritan laws that provide some form of liability protection for use of AEDs by adequately trained volunteers. The Massachusetts statute, for example, G.L.c. 112, §12V, immunizes against ordinary negligence good faith emergency defibrillation undertaken by volunteers trained according to American Heart Association guidelines in AED use.

CASA, the federal statute noted above, provides ordinary negligence immunity for those persons (e.g., businesses) who acquire AEDs used in situations of “perceived medical emergency” provided: Any resulting harm from AED use was not due to failure to notify local emergency response authorities of the most recent placement of the AED, to properly maintain and test the AED, or to provide within a reasonable time frame appropriate AED training to employees and agents expected to use the AED. 42 U.S.C. §238q(a).

Note that, generally speaking, CASA protections, which also cover the AED user, supersede state law “only to the extent” that a given state has no applicable immunity provision by statute or regulation. Id. §238q(c)(1)(A).

What lies ahead for those proprietors of public places or public conveyance who fail to acquire and place AEDs, or deploy appropriately trained AED personnel?

Given the ease and cost of AEDs, and the current medical findings as to their beneficial promise in PADs, will businesses associated with large public groupings and other employers be liable for not establishing an AED program

It is hard to see how this could not be a legal concern in the foreseeable future. The Heart Association PAD package notes several recent lawsuits involving airlines or public accommodation. This suggests that the plaintiffs’ bar will likely press the issue. Cf. Mullins v. Pine Manor College, 389 Mass. 47 (1983) (evidence sufficient to find college negligent in performing duty, undertaken for consideration, of providing security for its students).

Counsel to businesses may be well advised to examine the issue in order to assist their organizations with the benefits of risk management that would likely flow from admirable proactive programs to implement these life-saving devices in places of significant population.

At a recent conference organized by the City of Worcester, Mass. Department of Public Health, it was observed that a major Worcester-based law firm had successfully completed AED training. This may be an important signpost to others.

Dean Nicastro is of counsel to Pierce & Mandell. P.C. in Boston. A former vice president and general counsel of the Massachusetts Medical Society, he practices health care and non-profit law.