A settlement has been reached by Matrixx Initiatives to resolve Zicam lawsuits filed by a group of plaintiffs who alleged that the company misrepresented the safety of their nasal sprays and gels, which federal regulators have indicated may cause people to lose their sense of smell. The company continues to face hundreds of Zicam injury lawsuits filed on behalf of consumers who have actually suffered loss of smell after using the cold remedy.
The Zicam settlement was reached last week, resolving 18 relatively small class action lawsuits filed by plaintiffs who purchased the product. The complaints alleged that Matrixx Initiatives misrepresented the safety and efficacy of Zicam prior to its removal from the market in June 2009.
A Zicam recall was issued last year after the FDA indicated that it had identified at least 120 reports of loss of smell with Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kids Size. Within hours of the warning, Matrixx Initiatives agreed to remove the over-the-counter cold remedy from the market, and has seen a growing number of injury suits and class action lawsuits over Zicam filed in courts throughout the United States.
In the aftermath of the recall, FDA inspectors discovered 800 reports of Zicam problems that Matrixx Initiatives failed to forward to the agency, in violation of federal regulations.
Matrixx Initiatives announced the Zicam lawsuit settlement in a regulatory filing after the deal was signed on Thursday. Under the agreement, the company will pay $35,000 to lead plaintiffs in the class action lawsuits, and will pay attorney fees to be determined by the court. In addition, the company agreed to place certain warnings on the packages, should its nasal spray and gel products ever return to the market.
There remain at least 231 lawsuits over Zicam filed on behalf of nearly 800 plaintiffs involving loss of smell allegations that have yet to be resolved. Most allege that the company knew the products were dangerous and continued to market them anyway, causing plaintiffs to lose their sense of smell and taste or diminish it.
Last October, the U.S. Judicial Panel on Multidistrict Litigation consolidated the federal Zicam litigation for pretrial proceedings in the District of Arizona. All of the lawsuits over Zicam contain similar arguments that zinc gluconate, the single active ingredient in nasal Zicam cold remedies, is toxic to the tissue inside the nose and can cause damage to a user’s ability to smell, detect odors or taste.
Matrixx Initiatives has attempted multiple times to get the FDA to withdraw its warning on Zicam, claiming that the agency does not have the scientific data to make a determination that Zicam causes anosmia, loss of the sense of smell. However, the FDA has refused. And while Zicam nasal sprays and gels were sold as an unregulated herbal supplement, the FDA has determined that the health risks of Zicam nasal products means that the nasal sprays and gels will first have to get FDA approval before returning to shelves.