Normally, a product liability suit alleges that a product was unsafe because it either did something it shouldn't have, or didn't do something it should have. But in Kansas City, a case is headed for trial that alleges a candle did what candles do – burned.
The case involves Anne Danaher, who sued Wild Oats Markets and Wally's Natural Products after her ear drum was burned during an ear-cleaning procedure that involved sticking a burning candle into her ear.
Danaher claims the injury occurred
because the store sold her the candle without including the warning
that the user should keep his or her head upright while inserting
the burning candle parallel to the floor. (It goes without saying,
one hopes, that the business end of the candle should not be
inserted in the ear).
Complicating the case is the involvement of one Karen Kenney, the “ear-candler.” She performed the ear-candling procedure back in 2006 and, not having access to the warning, had Danaher put her head in a horizontal position while she held the candle perpendicular to the floor, allowing hot wax to run into Danaher's ear.
Kenney, whose training apparently consisted of reading a pamphlet called “A History of Ear Candles” obtained at a health food store also did not know that the candle should not be allowed to burn down to less than four inches. Danaher says the candle was at about three inches when she was burned.
U.S. Magistrate Judge David A. Waxse partially denied Wild Oats' motion for summary judgment and ruled the case could proceed to trial to determine whether the ear candle was defective based on a warning defect.
Waxse also allowed a negligence claim against Kenney to proceed.
“Ear-candling” has become popular in some circles as an alternative to more conservative ear-wax-clearing methods, even though the Food and Drug Administration has warned that ear candles “can cause serious injuries, even when used in accordance [with] manufacturers' directions.” The procedure has been banned in Canada.
The Food and Drug Administration (FDA) also said consumers shouldn't be swayed by claims that ear candling can improve hearing, relieve headaches, sinus and ear infections, purify blood, cure cancer, or improve brain functions.
"FDA has found no valid scientific evidence to support the safety or effectiveness of these devices for any medical claims or benefits," the agency said in a statement released on Saturday.
Ear candles are hollow cones about ten inches long made from a fabric tube soaked in beeswax, paraffin, or a mixture of the two. Companies that make these products claim that burning a candle in the ear creates a vacuum that draws wax and other debris from the ear canal.
But the FDA said consumers who have used ear candles have suffered burns and perforated eardrums that required outpatient surgery. These injuries happened even when consumers used the ear candles according to the manufacturer's direction, the FDA said.
Not for children
"FDA is especially concerned because some ear candles are being advertised for use in children," the agency said. "Children of any age, including babies, are likely at increased risk for injuries and complications if they are exposed to ear candles. Small children and infants may move during the use of the device, increasing the likelihood of wax burns and ear candle wax plugging up the ear canal. "Also, their smaller ear canal size may make children more susceptible than adults to injuries."
The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) also warns consumers about the risks associated with ear candling -- even for something as simple as removing wax from the ear canal. The organization represents specialists who treat the ears, nose, throat, head, and neck.
"Ear candles are not a safe option of wax removal as they may result in serious injury," the AAO-HNS states on its Web Site. "Since users are instructed to insert the 10" to 15"-long, cone-shaped, hollow candles, typically made of wax-impregnated cloth, into the ear canal and light the exposed end, some of the most common injuries are burns, obstruction of the ear canal with wax of the candle, or perforation of the membrane that separates the ear canal and the middle ear."
An international non-profit organization that exposes health-related frauds myths, and fallacies, has also investigated ear candling.
A report on the Web site Quackwatch, titled "Why Ear Candling Is Not a Good Idea," cited many injuries associated with the practice, including external burns, ear canal obstructions, and perforated eardrums.
The report by Dr. Lisa Roazen, who practices emergency medicine in New York City, also referred to a story in the Canadian newspaper, The London Free Press , regarding a woman who experienced stuffiness in her nose and ear pains while scuba diving.
The woman went to a local health-food store and was referred to a "qualified" ear candler. During the procedure, the woman felt intense burning in her ear. She later went to the emergency room, where doctors were unable to remove the wax that had dripped from the candle into her eardrum. The woman had to undergo surgery, the story stated.
During the operation, surgeons discovered a hole in the woman's eardrum. They suspected the ear candling caused that injury. The woman later recovered and did not lose her hearing. According to the story, the ear-candling practitioner apologized to the woman and stopped performing the procedure.
Dr. Roazen's Quackwatch report also cited two fires in Alaska linked to ear candling, including one that led to a woman's death.
"On January 27, 2005 a 59-year-old woman ignited her bedding when she dropped an ear candle that she was attempting to use in the ear without any assistance," the report stated. "The candle ignited the bedding and quickly spread to curtains and other combustibles in the room. The woman did escape but suffered an asthma attack and died in a hospital emergency room."