Zicam Class Action Lawsuits Filed Over Loss of Smell July 6th, 2009 • Matrixx Initiatives, maker of the recently recalled Zicam Cold Remedy, faces class action lawsuits in California and Missouri that allege they failed to adequately warn consumers that the nasal gel and nasal swab versions of Zicam could cause damage to the sense of smell. The California Zicam class action lawsuit was filed in federal court on behalf of lead plaintiff Barbara Sample, and others who purchased Zicam Cold Remedy nasal gel products while in California or from a California source within the four years before June 23, 2009. The Missouri class action was filed in St. Louis County Circuit Court on behalf of Gwendoly West and all residents of St. Louis County who purchased the recalled Zicam products during the year before the FDA warning.
On June 15, 2009, the FDA warned consumers to stop using the popular over-the-counter nasal products, which were marketed to treat the common cold, after receiving more than 130 reports of Zicam side effects involving people losing their sense of smell. Matrixx Initiatives was also warned at the same time that they would no longer be permitted to market the homeopathic products until they submit data establishing the safety and effectiveness for FDA review.
The Zicam class action lawsuits allege that zinc gluconate, the single active ingredient in Zicam Nasal Gel, is toxic to the tissue inside the nose and is responsible for causing users to lose their ability to smell or detect odors.
Although they voluntarily issued a Zicam recall last month, Matrixx Initiatives continues to state that their product is safe and indicates they intend to “vigorously defend each of the recently filed lawsuits.” It is their position that the zinc contained in Zicam, which has been blamed for the smell loss reported in users, is not deposited far enough up the nose or in large enough amounts to cause nerve damage.
On Thursday, the FDA released a report from a May inspection that points out that Matrixx Initiatives did not turn over consumer complaints about Zicam Cold Remedy nasal swabs and gels as required by federal regulations. The inspection discovered about 800 consumer complaints, and inspectors estimate that 3.6 out of every 100,000 users have experienced Zicam problems with loss of smell. The inspector also notes that reports peaked in 2004, with 6.7 people complaining for every 100,000 units sold.
Damage to ability to smell, known as anosmia, is a very serious side effect that causes significant loss of quality of life. It can also be potentially life-threatening, as victims may be unable to smell dangerous fumes, smoke from fire or food that has gone rotten.
The two class action lawsuits over Zicam follow other complaints filed on behalf of individuals during the weeks after the recall. Those Zicam lawsuits were filed on behalf of individuals who allege that their ability to smell was affected by Zicam, as opposed to the economic loss claims covered by the Zicam class action lawsuits filed for all individuals who purchased the potentially dangerous cold remedy.
Tags: Anosmia, California, Class Action, Matrixx Initiatives, Missouri, Nasal Swab, St. Louis, Zicam, Zicam Cold Remedy |