After hundreds of deaths and tens of thousands of injuries over the course
of more than a decade, the federal government is finally launching a formal
investigation into the safety of bed rails used by nursing homes and home
health care agencies across the country.
Product liability attorneys are carefully watching this issue, which over the years has involved a reticence on the part of federal authorities to issue recalls or even mandate warning labels, partially over how the product is classified but more due to resistance from the industry.
These are railings that are affixed to either side of the bed with the intent of preventing a disabled or elderly adult from falling out of bed. However, the product design has led to people getting their heads or necks caught either between the rails or in between the space between the rail and the mattress.
The New York Times recently chronicled the case that finally led to government action. In 2006, an 81-year-old grandmother was found dead in her bed at an assisted living home in Washington State. She had apparently been strangled after getting her neck caught in between the rails.
Her daughter, grief-stricken and angered, penned letters to both the U.S. Food and Drug Administration and the Consumer Product Safety Commission (CPSC). As it turned out, they had been aware of numerous and ongoing problems with the rails, but little action had been taken against the manufacturers.
The daughter began to conduct her own research into the number of deaths and injuries caused by the rails, and reached out once again to the CPSC. In turn, the commission has agreed to launch a formal study.
The daughter wishes it had been done sooner.
The agency has thus far determined that between 2003 and 2012, about 150 adults died after getting caught in the bed rails. During that same time frame, more than 36,000 were severely injured and taken to the hospital. Those are probably low estimates, however, as not every death and injury attributable to the bed rails was likely reported as such. Since 1995, when the commission first became aware of the issue, there have been more than 550 deaths.
Researchers familiar with the issue have said these deaths are 100 percent preventable.
The FDA first looked at the issue in 1995, after receiving a detailed report
from a bioethics professor from Minnesota. However, the agency declined
to take any action because, for starters, it couldn’t decide whether
the device should be classified as a medical device or a consumer product.
The bigger issue, however, was fierce resistance from the industry and
recent legislation passed to reduce regulatory action on businesses. It
was estimated that a move to force the manufacturers to develop better
designs, and for nursing homes to replace the older models, would have
cost hundreds of millions of dollars.
So instead, manufacturers agreed to enact voluntary guidelines.
But clearly, that hasn’t been enough, as elderly people continue to be harmed by these devices.
In 2006, the FDA gave advice to hospitals and nursing homes on how to use the rails and further recommended certain size limits, which would reduce the gaps that lead to so many injuries and deaths.
It’s unclear at this point whether the new study will result in tougher
guidelines, or more appropriately, a recall or sanctions of some form.
But if you or your loved one has been injured as a result of bed rails,
you may be entitled to compensation. As such, you should contact a law
firm with extensive experience in handling product liability cases.
The Ferraro Law Firm handles defective product litigation nationwide. Call (888) 554-2030 for a free and confidential consultation. Offices in Miami, Washington, D.C., and New York City.
After Dozens of Deaths, Inquiry Into Bed Rails, Nov. 25, 2012, By Ron Nixon, The New York Times
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