The unusual product liability lawsuit of a woman who was injured by an ear-cleaning procedure using a special candle is heading for trial on the issue of whether a health store sold her an ear candle with inadequate instructions and warnings.

A judge ruled earlier this week that Anne Danaher cannot claim a Wild Oats Markets store in Kansas City is liable for selling what was, in and of itself, an unreasonably dangerous product. She suffered a burned ear drum when hot wax from the candle ran into her right ear.

But the store has admitted that it sold her the candle without the written instructions provided by the manufacturer, which said a user should keep the head upright, with the candle inserted parallel to the floor. Karen Kenney, the “ear-candler” who performed the procedure on Danaher in 2006, put her head in a horizontal position, with the candle perpendicular to the floor.

“[T]he Court finds that Plaintiff has demonstrated that there is sufficient evidence from which a jury could conclude that the ear candle was defective based on a warning defect,” U.S. Magistrate Judge David A. Waxse said in partially denying Wild Oats' motion for summary judgment.

He noted that the instructions from Wally's Natural Products also “warn the user never to burn the candle to less than four inches.” Danaher alleges she was injured after Kenney allowed the candle to burn down to within three inches of the tip.

Waxse also allowed Danaher to proceed with a negligence claim against Kenney, who followed the instructions for ear-candling in “A History of Ear Candles,” a pamphlet handed out at her mother's health food store.

In a deposition, Danaher was asked whether her injury was caused by the acts or omissions of Kenney or by the ear candle itself. “In reality, it was caused by Karen Kenney by how she allowed it to burn down and it started melting the wax and it rolled down into my ear,” she replied.

“Ear-candling” has become a trendy alternative to Q-tips, with advocates saying the warmth and suction from the heat generated by the flame draws wax out of the ear canal. But Canada has banned the treatment and the FDA warned last year that ear candles “can cause serious injuries, even when used in accordance [with] manufacturers' directions.”

In arguing that all ear candles are defective, Danaher cited a letter from the FDA to Wally's and the expert testimony of Dr. Richard J. Wiet, an otolaryngologist who wrote in a report that “Ear candles are unreasonably dangerous products because of the potential for damage to the structure of the middle ear associated with their use.”

But Waxse said none of that evidence was admissible. “Although it is clear that Dr. Wiet believes ear candles are not safe for use, he is simply not qualified to render such an opinion,” he said in another ruling.

Expert testimony is not required for the failure-to-warn claim. Wasxe said Danaher can also sue Wild Oats for punitive damages under the theory that it showed reckless disregard for customer safety by selling a product intended to be placed in the human ear and set on fire without proper warnings and instructions.

By Matthew Heller
3/16/11