As more lawsuits continue to be filed against Matrixx Initiatives, the manufacturer of the recently recalled Zicam Cold Remedy products, the company is now being investigated by the U.S. Securities & Exchange Commission (SEC) over its handling of a warning letter issued by the U.S. Food and Drug Administration (FDA).
Securities & Exchange Commission inquiry
The SEC has sent Scottsdale Arizona based Matrixx Initiatives, the manufacturer of Zicam Cold Remedy products, an informal inquiry about how the company handled a warning letter issued by the FDA. The SEC announcement came only days after the FDA made a public warning to consumers to stop taking the following Matrixx drugs as they could lead to a loss of the sense of smell:
Zicam Cold Remedy Nasal Gel
Zicam Cold Remedy Gel Swabs
Zicam Cold Remedy Swabs, Kids Size (discontinued)
Matrixx recalled those products directly afterward.
FDA Investigation
Although the FDA says that it received numerous reports from consumers who lost their sense of smell after using Zicam products, the Administration's May 2009 inspection of Matrixx's facilities seem to be the driving force behind the FDA's warnings and the SEC's inquiry. The Wall Street Journal reported that the FDA's inspection revealed that Matrixx failed to report “several hundred cases of serious side effects, mostly involving loss of sense of smell” and that the affected products have “not been shown to be effective in the reduction of the duration and severity of cold symptoms."
Lawsuit filed on behalf of 100+ people who lost their senses of smell and taste
A product liability lawsuit was filed in Maricopa County Superior Court on June 22, 2009 on behalf of 117 people who allege that they have lost their senses of smell and taste after taking Zicam Cold Remedy products, which aren't regulated by the FDA because they are considered homeopathic and are not required to undergo clinical trials. Unfortunately for Matrixx, this is not the first lawsuit filed against it.
Matrixx settled group of lawsuits for $12M in 2006; more likely to follow
Matrixx paid $12 million in 2006 to settle a group of lawsuits concerning 340 people who claimed that they lost their sense of smell after using the company's nasal gel. Product liability lawyers say that more lawsuits against the company are imminent.
