MARSHALL-- Shortly after voluntarily recalling their homeopathic remedy, the makers of Zicam are denying allegations that the product is the cause of hundreds of reports of anosmia, the loss of the sense of smell.
On June 16, the U.S. Food and Drug Administration released a warning for consumers to not use certain Zicam Cold Remedies as the Intranasal Zinc Product is linked to the loss of sense of smell.
According to the news release, the FDA has received more than 130 complaints regarding the product and loss of smell. The FDA told Matrixx that the products could not be marketed without FDA approval.
In a press release disagreeing with the FDA, Matrixx announced that it has formally notified nationwide retailers and distributors of its recall of all Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs.
"Matrixx Initiatives vigorously disagrees with the FDA's allegations that these products are not safe and that they were unlawfully marketed. However, the company reiterated that it is conducting this recall because of its desire to cooperate with the FDA.
"The company is also in the process of preparing a submission to the FDA and, as previously reported, will soon ask to meet with the agency to present comprehensive scientific and medical data and analyses demonstrating that these products are safe."
Responding to allegations from a recently filed Texas lawsuit, Matrixx states that it marketed Zicam based on medical and scientific knowledge that its product was at all times reasonably safe.
Mary Ann Brandon filed the personal injury lawsuit against Matrixx, Initiatives Inc. and Zicam LLC on Jan. 7 in the Marshall Division of the Eastern District of Texas.
Suffering from a cold, Mary Ann Brandon purchased the homeopathic remedy in an attempt to gain some relief. After using the product only once, Brandon states she felt an intense stinging and burning sensation in her nose and subsequently, lost all sense of smell.
Despite seeking medical treatments, Brandon's sense of smell has only partially returned.
According to the court documents, Zicam Cold Remedy Nasal Gel delivers zinc gluconate to the nasal membranes.
Causes of action filed against the defendants include strict liability through design, manufacturing, and marketing, misrepresentation by saying the product was safe and free from defect and breach of express and implied warranties.
The plaintiff believes the defendants were negligent by failing to design the product for use intranassally, failing to conduct proper and adequate testing, failing to adequately warn of the potential of anosmia, and by failing to design the product with prevailing industry and scientific standards.
Further, the plaintiff believes the defendant's conduct was negligent for "failing to conduct a minimal investigation into the historical and scientific evidence that relates intranasal zinc application to permanent, total and irreversible anosmia."
Arguing gross negligence, fraud, and malice and seeking punitive damages, the complaint asserts that the "defendants knew that Zicam could cause users to lose their sense of smell and taste because they had received hundreds of complaints of such injuries prior to Plaintiffs' use of the Zicam."
The defendants deny Brandon's allegations and state that she may have "experienced an idiosyncratic response to Plaintiff's use of the product, without any negligence or failure on the part of Defendants, or any defect attributable to Zicam Cold Remedy."
The manufacturers believe that the plaintiffs injury was caused by an independent, unforeseeable, superseding, or preexisting cause unrelated to any product or conduct of Defendants.
Further, the defendants argue that that the product was "neither defective nor unreasonably dangerous when used according to the label instructions."
The plaintiff is seeking damages for pain and suffering, loss of enjoyment of life, physical injuries, medical expenses, attorney fees, pre-and post judgment interest.
Longview attorneys Laureen F. Bagley and M. Raymond Hatcher of the Sloan, Bagley, and Perry Law Firm are representing the plaintiff.
The case is assigned to U.S. District Judge T. John Ward.
Case No. 2:09cv00008