By Sandra G. Boodman
Washington Post Staff Writer
Tuesday, January 31, 2006
The manufacturer of Zicam Cold Remedy has agreed to pay $12 million to settle 340 lawsuits brought by consumers who claim the popular over-the-counter zinc nasal gel damaged or destroyed their sense of smell. The Phoenix-based manufacturer, Matrixx Initatives, says the agreement announced Jan. 19 is not an admission of liability, but rather an effort to end most of the litigation over the homeopathic remedy.
"The company still stands by the product, but this made good business sense," said Matrixx spokesman Robert J. Murphy. The agreement was announced jointly by the company and Arizona lawyer Charles S. Zimmerman, on behalf of a consortium of lawyers representing plaintiffs around the country.
In the past two years, Murphy said, Matrixx has spent about $12 million in legal fees defending its flagship product, which has sold more than 10 million bottles since its debut in 1999. Five months ago Matrixx settled the only Zicam lawsuit that has gone to trial, brought by a 42-year-old Los Angeles computer consultant, with an undisclosed payment.
Approximately 400 lawsuits have been filed against Zicam since 2003, some by users who say they lost their ability to smell and taste after using the product only once. Matrixx has denied the allegations, saying no study has linked the spray with loss of smell, also known as anosmia. The company says the likely culprit is a virus, the most common cause of anosmia.
Under the terms of the agreement, 95 percent of eligible plaintiffs must accept the Arizona settlement; the average payment after legal fees would be about $21,000. Zimmerman, who called the settlement "very fair and appropriate," said the amount would vary depending on the extent of injury determined by medical tests. The settlement does not cover about two dozen claims involving Zicam nasal swabs, which also contain zinc gluconate, or 32 lawsuits outside Arizona. Plaintiffs who reject the settlement are free to pursue their lawsuits, but are likely to have trouble finding a lawyer to represent them.
Zimmerman, a veteran product liability lawyer, and his colleagues have argued that Zicam destroyed delicate smell tissue when the drug's pump bottles drove the viscous gel into the top of the nose with propulsive force. Zinc is used to destroy smell in laboratory animals and can be toxic to the sense of smell in people.
Matrixx said the spray gel, which package instructions say is supposed to be used in the lower part of the nose, does not reach high enough to inflict damage.
Last fall Matrixx introduced a new "control tip sprayer" that prevents the spray gel from being forcefully expelled. Murphy called the new tip "a product advancement that has been in the works since 2001" that is "completely unrelated" to the litigation. Production of the old sprayer has been discontinued, but those containers will be sold until supplies are exhausted, he said.
Zimmerman said the redesign was a result of the litigation and will protect consumers.
At one downtown Washington drugstore last week, only packages with the old sprayer -- bearing an expiration date of January 2008 -- were on the shelf.
In recent months Matrixx has embarked on an expensive national advertising campaign featuring testimonials from consumers, including radio talk show host Rush Limbaugh.
Officials at the Food and Drug Administration (FDA) say they have received adverse reports involving Zicam, which was invented by several California entrepreneurs with credentials unusual for drug developers. (See "The Men Behind Zicam," at right.) The agency would not disclose the number of reports or comment further.
Because Zicam contains a naturally occuring mineral -- zinc -- which is generally recognized as safe, and because it is labeled as a homeopathic remedy, it is exempt from the regulations governing safety testing and manufacturing that apply to many drugs.
"This is not an FDA-regulated product," Zimmerman said.
Another over-the-counter homeopathic zinc nasal spray, Cold-Eeze, has been the target of a small number of anosmia lawsuits. It was pulled in 2004 after a year on the market by the manufacturer, which cited disappointing sales.
Since 2000, two case reports published in medical journals have reported anosmia after Zicam use. Medical experts who are not connected to the litigation say that it has been known since 1938 that zinc can harm smell tissue in high enough doses. A year earlier, Canadian doctors had used a zinc nasal solution to kill the sense of smell in children as part of an ill-fated experiment to prevent polio.
Murphy said Zicam is safe and effective, and produced in accordance with FDA regulations. He called the case reports "anecdotal. " The Canadian study, he said, is not relevant because it involved a different zinc solution.
But some experts say they aren't so sure -- and that the question is likely to linger because there is no incentive to study whether Zicam is linked to anosmia. (Research into the effectiveness of zinc gels, sprays and lozenges in fighting the common cold have yielded mixed results.)
"There's no way to tell whether anosmia is just chance or a cause-and-effect relationship," said Ronald Turner, a prominent University of Virginia cold researcher unconnected with the lawsuits, who published a study concluding that Zicam was ineffective in preventing or treating colds.
Turner conducted one of three company-financed studies of Zicam; two others found the product was effective. None reported unusual rates of anosmia.
Because the studies involved only a total of about 400 people, some side effects might not be recognized until large numbers of people used it, Turner said.
Several plaintiffs say they are disappointed by the Arizona settlement, but have been warned by plaintiff's lawyers that talking to the media could jeopardize the agreement or their participation in it.
"It's a pittance, but I'll take it since I don't have much choice," said one plaintiff, who asked that his name not be published. "I would really like to see them have a warning label on that product. Best of all, I'd like my sense of smell back." The settlement does not provide for a warning label, the parties said.One Plaintiff's Story
Lisa Weatherington, a 50-year-old Army medical officer who lives in Bowie, is one of the 340 plaintiffs. Her case illustrates the difficulties inherent in determining what role, if any, Zicam played in her anosmia.
Weatherington said she used Zicam once two years ago to treat a burgeoning cold at the suggestion of her husband who said it worked for him. Seconds after spraying it, she recalled, she felt an intensely painful burning.
In early January 2004, Weatherington said, she realized she could no longer smell or taste anything. She said she called Matrixx to report the problem and was told the company had never heard of this problem -- although the first report of ansomia after Zicam use appeared in a medical journal in 2000 and the first lawsuit was filed in October 2003. Matrixx declined to comment on her case citing the pending litigation.
Several doctors have told Weatherington she probably will never regain her sense of smell. Her superiors have told her the problem could hamper her military career because it will prevent her deployment to places where she would need to detect poisonous fumes.
"I love food and I used to love to cook for my family, " said Weatherington who adds that she has gotten sick from eating spoiled shrimp she coudn't smell. "Sometimes I just feel like crying."
Robert I. Henkin, a neurologist who directs the Taste and Smell Clinic in Northwest Washington, said there's no way to know for sure whether Weatherington, whom he is treating, lost her sense of smell because of a virus or because she used Zicam.
Terence Davidson, director of the Nasal Dysfunction Clinic at the University of California at San Diego, said he was skeptical that Zicam could cause anosmia -- until he saw two patients in one week who were under 50 (most anosmia patients are older), had not had colds, and developed the condition hours after using the spray, an experience both described as deeply painful.
Post-viral anosmia typically occurs more gradually, said Davidson, adding that he has treated hundreds of such patients who seek treatment weeks after a severe cold. The burning pain many Zicam users describe, he said, is indicative of damage to sensitive olfactory tissue.
"The timing with these patients is very different than with post-viral anosmia patients," said Davidson, who has testified as an expert witness for several Zicam plaintiffs.
But Anthony F. Jahn, a New York otolaryngologist hired by Matrixx to review zinc studies, disputed Davidson's contentions.
The burning some patients report signals irritation -- the same thing that happens when a swimmer gets water up the nose--but does not mean damage has occurred, Jahn said. Zicam, he added, is too thick to reach high enough up in the nose to harm tissue. Said Jahn, "I don't see a mechanism by which this could happen." ·