By John Garber, Esq.
Life-saving technology works its way into American life in distinct stages. First, the new technology — a device or process — is an idea with possibilities and no track record. Second, awareness of the technology grows, both in the industry and general public, and refinements begin to overcome practical obstacles to adoption. Third, success stories accumulate and a strong case develops for adoption; prices fall as demand escalates, accelerating the process. Finally, widespread adoption is followed by legislative mandate.
Different combinations of forces propel each stage: inventors and do-gooders carry the mantle early on; the press educates the public throughout; lawyers threaten with lawsuits as a case develops for adoption; enlightened companies break from the industry pack to adopt the technology. This article looks at the role of lawyers and the common law in the currently ongoing process of adoption of portable defibrillator technology.
Cardiac Arrest and Defibrillators
In the next three minutes, two people in the United States will suffer a sudden cardiac arrest. The heart´s electrical current will short-circuit, the heart will quiver without a regular rhythm, and the regular flow of oxygenated blood to the body and brain stops. Sudden cardiac arrest has traditionally been fatal in almost every case, 1000 times a day, 350,000 times per year, in the United States alone. No single cause kills more people than the heart´s loss of its regular rhythm during sudden cardiac arrest. It is responsible for more deaths than cancer, auto accidents, and handgun accidents combined.
Defibrillation is the sending of an electric charge into the arrested heart, which short-circuits the heart´s electrical system, and restores the heart´s normal rhythm. Machines that do this are called defibrillators. They are a hospital drama staple: the doctors on the screen yell Clear! after placing pads wired to the machine on the patient´s chest — that is a defibrillator. The idea of shocking the heart to restore the heart´s rhythm has been around since the 1700s. Cumbersome and primitive, early models were largely confined to hospital settings, and served only the hospital´s patient population.
Defibrillation technology cannot be understood without a basic understanding of sudden cardiac arrest. Generally, there are two main causes for disruptions in the heart´s regular function. Sclerotic Heart Disease is a steady accumulation of blockage in the heart´s arteries. The result, when the blockage becomes critical, is a heart attack, in which the heart muscle can no longer overcome the burden of the blockage. These are often but not always fatal. Typical treatments include bypass surgery, which redirects the flow of blood away from the blocked artery.
The other principal heart dysfunction is cardiac rhythm disorder. The heart´s beating is regulated by steady electrical impulses, which trigger and monitor the heart´s muscular contractions, to take in depleted blood and squeeze out oxygenated blood. The heart´s metronome is an electrical circuit. Usually without warning, or any prior history of heart trouble, the heart´s electrical pulse is disrupted. The result is what doctors descriptively call Sudden Cardiac Arrest (SCA). Unlike the name suggests, though, the heart does not stop beating altogether during cardiac arrest. Rather, the heart´s muscles continue to contract, but chaotically, without any regular rhythm. The condition is called arrhythmia, like a two-year old playing the drums. The result is an immediate lack of blood flow. A pulse cannot be detected. The rhythm of this spastic and irregular contraction of the heart is called ventricular fibrillation (VF). The heart´s electric beat short-circuits and the regular pumping stops. The victim of an arrest, in ventricular fibrillation, immediately becomes breathless, pulseless and unconscious.
Until recently, the reason defibrillation almost never saved lives was timing: if a heart is not defibrillated (shocked) within a few minutes, there is no realistic hope of survival. Oxygenated blood must circulate to the brain. The timing problem has a well-recognized formula: with each minute passing after the onset of the arrest, the odds of survival drop ten percent. At five minutes, the odds are fifty/fifty. After seven minutes, chances for survival become remote. With large early model defibrillators (say, in the 1970s) the answer to the problem was understood to be getting the patient to the defibrillator as quickly as possible. Despite heroic efforts, this approach was largely unsuccessful. Five minutes was too little time.
Advancement of defibrillator technology made the opposite approach a promising possibility: take the defibrillator to the victim. As with most useful computerized electronic devices, defibrillators have become smaller, cheaper and more reliable. Refinements to defibrillation technology have resulted in foolproof logarithms which determine whether a shock is appropriate and calibrate a sufficient charge. With these refinements, a defibrillator is said to be automatic. When the defibrillator is not intended to be implanted inside the body, in the manner of a pacemaker, but applied externally, it is said to be an external defibrillator. Today´s dictionary-sized machine is known as an automatic external defibrillator, or AED, and is virtually fool-proof. Hit the on button and the machine tells you what to do. They are priced between $2,000 and $3,000, with prices dropping fast.
AEDs are not yet a standard background feature of American life — like smoke alarms, pasteurized milk or seatbelts. They will be; but the question remains, where? Though not yet clearly defined, the place for AEDs is anywhere with regular large gatherings of people (a stadium) or smaller gathering places where sudden arrest is more likely (a health club) or medical help is beyond close reach (a passenger plane). We are in the midst of a transition, the end point of which is ubiquity for the AED at appropriate locations. Exactly where will be determined over the next ten or so years by technology, economics and tort law.
History Repeats Itself: A Health and Safety Technology Case Study
In the 1860s, French chemist Louis Pasteur developed the process of briefly heating fluids like beer and milk to kill bacteria and prevent them from spoiling. In what became known as pasteurization, raw milk was cooked for a short period of time. By the 1890s, this process was understood to kill disease-causing bacteria in raw milk. The process obviously added a cost to the sale of milk and was widely believed to adversely affect the taste and quality.
In New York City and elsewhere, during the 1890s and 1900s, those familiar with the technology and its benefits made initial, futile attempts to have the process adopted by the dairy industry. Nathan Straus, one of the owners of Macy´s Department Store in New York City, campaigned for pasteurized milk. By the turn of the century, Straus had set up pasteurization operations in various parts of New York City to sell low-cost pasteurized milk to the poor. In the case of an orphanage located on an island, milk had been obtained only from cows on the island, which enabled Straus to demonstrate the benefits of pasteurization. Within a year, deaths from tuberculosis and other milk borne diseases dropped almost in half, and steadily declined thereafter. The charitable milk pasteurization programs expanded to other cities.
In the first years of the 1900s, efforts to require the process by law were rebuffed by the legislature in New York, and adopted in Chicago, only to be nullified in the courts there. The dairy industry continued its active resistance. By 1911, health organizations including the American Medical Association were recommending that the process be mandatory. Legislation to require adoption was proposed and finally passed in Chicago in 1912. The New York dairies continued to resist. A 1914 typhoid epidemic in New York City prompted more wide-spread adoption, which became the norm within a year. Finally, legislation was enacted in 1921 in New York, requiring pasteurization of all milk. Since the 1930s, it has been all but impossible to buy unpasteurized milk in the United States.
It is probably superfluous to add that the child mortality rate dropped dramatically during this period. In 1885, the rate of death for children in New York City under age 5 was an astounding 273 deaths per 1,000 — over 27%. By 1915, the rate was down to 94 out of 1,000. Of course, other conditions and health improvements over the same period likely contributed to the drop; but by any measure, the savings in child lives and misery was enormous.
The Stages of Technology Adoption
The adoption of health and safety technology goes through four stages.
In the first stage, the technology is primitive but the potential benefits make their way for the first time into the public view. Advocates of the technology attempt to spur its adoption, but they have little concrete guidance to offer about the details of adoption. There is little hard information on successful use. Adoption is on a small scale, isolated and the signals are mixed. The technology is expensive and perhaps not very well understood. Adoption is not so much resisted as it is not seriously considered.
In the second stage, adoption is resisted as the technology improves. The early returns are extremely promising, but without wide-spread adoption, it is hard to say how much good the device will do. Everyone has probably heard or read about the device; a public discussion about adoption materializes, even if confined to a particular industry. A trial lawyer would face an uphill battle to persuade a jury that not having the device was unreasonable. The culprits are not necessarily profit-driven corporations. Institutional inertia, distrust of the unknown, lack of a conclusive track record, and problems with the evolving technology all play their part. Still, the momentum toward adoption is discernible.
The third stage is a period of flux. The technology becomes more effective, more uniform, better understood, and less expensive. The benefits are established and proven, even if only on a limited scale. The public has read about some dramatic successes of the device. The industry discussions become heated. Legislative action is raised as a possibility, but not seriously pursued. At this stage, a trial lawyer now has the evidence to make a plausible case to a jury that failing to have the device is unreasonable.
The fourth stage is general acceptance. The technology, once so novel, fades to the background as a ubiquitous fixture. It is universally adopted where appropriate, and usually (not always) required by law. Pasteurized milk is one of dozens of similar examples from the last century. Smoke alarms, sprinkler systems, and anti-lock brakes are others. Every industry contains its own set of examples.
We are now in the third stage of defibrillation technology. The technology is refined, in the form of the late-model AEDs. The benefits of AEDs are undisputed. AEDs have been adopted, either by custom or regulation, in limited areas and fields. The Federal Aviation Administration, for example, following years of delay through the late 1990s for largely pointless information gathering, issued a final regulation in May 2001, which now requires all larger passenger planes to carry AEDs. This followed industry adoption during the period of 1996 through 1999. The Federal government, and 48 of the 50 states, have enacted or amended Good Samaritan legislation to encompass use of AEDs.
In short, the early returns are in, and the results confirm the highest expectations of AED advocates. Use of AEDs in casinos has led to dozens of lives saved, at an unexpectedly high survival rate. After O´Hare International Airport in Chicago made AEDs available in its terminals beginning in 1998, 11 of the first 12 victims of sudden cardiac arrest were successfully resuscitated. American Airlines, the first major United States airline to carry AEDs on its passenger flights had a similar experience: by May, 2004, American had saved 50 passengers through the use of AEDs during flight.
Common Law Principles of Negligence
The common law of torts in the United States is one of the engines that drives stage three to stage four. The principle is a simple one: if a jury believes that a defendant´s failure to adopt the technology was unreasonable, the plaintiff is entitled to compensation from the defendant for injuries caused by that failure. The common law of torts performs two functions: (1) a regulatory function, enforcing reasonable behavior (adoption of the technology) through lawsuits for compensation; and (2) defining the circumstances, on a case-by-case basis, where use of the device is reasonable. Tort law fades from the picture at stage four. Potential defendants have adopted the technology where it is reasonable or required by law.
Eventually, AEDs will be readily available, whether required by law or not, at those places or events where large numbers of people congregate, and medical assistance is otherwise not close at hand: sporting events, civic centers, malls, office buildings, cruise ships, and health clubs. Until then, the common law of torts compensates those injured or killed for lack of AEDs, where circumstances would have rendered use of an AED reasonable. This, in turn, motivates potentially liable companies to reduce their legal exposure by acquiring AEDs. This is why citizens in states with tort reform caps on damages are less safe. The pressure on businesses to act reasonably to prevent foreseeable injuries is greatly reduced.
The elements of a claim for negligence have remained unchanged for over 200 years: (1) a duty owed by the defendant to the plaintiff; (2) a breach of that duty by the defendant, which (3) causes (4) injuries to the plaintiff. The typical duty of a defendant person or company is one of the reasonable duty of care, which is determined by asking whether the defendant acted reasonably in light of the circumstances. This requires consideration of any evidence indicating lack of care; whether the defendant knew of the likelihood or possibility of injury; whether the defendant ever took steps to address the danger or risk; and whether risk of harm was reasonably foreseeable by the defendant. Upham v. Chateau DeVille Dinner Theatre, Inc., 380 Mass. 350, 354 (1980); Gelinas v. New England Power Co., 33 Mass. App. Ct. 779, 785 (1992). The amount of care required to be exercised by a defendant increases along with any increase in the likelihood of harmful consequences to others if adequate care is not used. Brennan v. Ocean View Amusement Co., 289 Mass. 587, 592 (1935), quoting Adams v. Gunton, 284 Mass. 63, 66; Upham, 380 Mass. at 355-356. These basic principles are the same in all 50 states.
A strong showing on these points can now be made. The likelihood of harmful consequences in the absence of an AED is the near certainty of death. Statistically, it would be surprising if the owner of a mall, health club, sports venue or office building were not aware, from experience, of sudden cardiac arrest on its premises. Sudden cardiac arrest, in these circumstances, is all too foreseeable.
The technology is refined, foolproof, proven and fairly cheap. Yet certain industries — health club chains are a prime example — continue to ignore AEDs.
The main defense raised is that the standard of the industry did not require it, or more generally, no one else in the industry was using the device or equipment. The common law is clear on this point. The custom or practice of a trade or industry is not a substitute for the legal standard of reasonable care under the circumstances. Upham v. Chateau DeVille Dinner Theatre, Inc., 380 Mass. 350, 354 (1980). Usage and custom simply do not justify negligence. 57A Am.Jur. 2d, Negligence, § 175 at p. 230 (footnote omitted). It is basic that since an entire industry can adopt careless methods to save time, effort or money, it cannot therefore be permitted to set its own, possibly negligent, standard of care. This is true even though an entire industry follows particular standards or procedures. 57A Am.Jur. 2d, Negligence, § 179 at pp. 233-234 (footnotes omitted).
This principle, more than any other, gives the common law life to spur industry adoption of health and safety technology. Industry does not decide what is reasonably safe for customers or workers — juries do. The threat of a jury verdict, based on compelling evidence, has brought safety technology to every industry, AEDs on passenger planes being a recent example. Typically, in that case, the Federal Aviation Administration mandate followed universal industry adoption which had been brought about years earlier by lawsuits and publicity.
Application of these principles, in particular cases, will close the gap until AEDs are universally adopted where appropriate, or required by law, or both. For now, the gap remains wide open. The three biggest commercial health club chains in the country, as of May 2004, had not bought AEDs for any of their clubs. Any cardiac arrest death in those clubs which could have been prevented with an AED is now a fair basis for a potentially successful lawsuit against the health club for wrongful death. A substantial minority of clubs already have them. Continued press coverage and the common law will convert this state of affairs to a majority, and after that, legislation will require them in health clubs.
In the meantime, all lawyers — especially trust and estate probate lawyers — should respond to news that the client passed away as a result of a cardiac arrest, by asking where? If the client was in an office building, a mall, a health club, a stadium, at a sports event, at a play or movie, at an amusement park, in a plane or on a train, or any similar place, the next question should be was there an AED?