Michigan Social Security Disability Law Blog

For years, health conscious consumers have bought automated external defibrillators, based on manufacturers’ claims that the devices would provide life-saving electric jolts to people whose hearts stopped beating or beat so irregularly that they could die within minutes.

However, the long-awaited results of a clinical trial revealed that the household version of the defibrillator was unlikely to help the victim of a sudden heart seizure. The study included more than 7,000 patients at risk of having these seizures because of previous heart attacks.

The researchers did find clear evidence that the devices saved lives when used in hospitals, emergency vehicles, and public places like airports and casinos, where trained employees were responding to the emergency. At the same time, patients in homes equipped with the gear died at the same rate as those without it.

Heart seizure, also known as sudden cardiac arrest, strikes about 125,000 Americans each year in their homes and 40,000 in public settings outside of hospitals. These seizures are not like heart attacks, which involve restriction of blood flow to the heart muscle and may not be fatal. In contrast, sudden cardiac arrest is a quick killer. Some studies have shown only a 2% survival rate for people experiencing the seizures at home.

The government-supported clinical trial used the HeartStart Home Defibrillator from Philips Medical Systems, an over-the-counter approved device sold for $1,300. Competing defibrillators from companies like Zoll Medical, Cardiac Science and HeartSine Technologies require a doctor’s prescription.

Another major competitor, the Physio-Control division of Medtronic, suspended distribution of its portable defibrillators in the United States last year, after complaints from federal regulators about its quality controls.

Patients in the recent study, both with the defibrillators and without, fared surprisingly well, with fewer seizures than expected and higher than anticipated revival rates. Everyone in the trial was trained to recognize the signs of sudden cardiac arrest, to call 911 immediately, and to give CPR. Without immediate CPR, defibrillation is less likely to succeed.

Four of fourteen patients whom the HeartStart deemed in need of a shock, and who then were given it, survived. The researchers pointed out that these numbers were too small to be statistically significant.

The authors of this online study from the New England Journal of Medicine said that the results were “fortunate” for the handful of survivors, but that any program to get defibrillators into homes would be “an inefficient strategy in public health terms.”

At the Bernstein Law Firm, we strongly encourage anyone who is facing a serious health emergency to seek medical help immediately. If you or a loved one has suffered a serious personal injury or death because of a defective product, we urge you to contact us for a free, confidential, legal consultation today.