We are in the midst of litigation in Arizona against Matrixx Initiatives, the makers of Zicam Nasal Gel.On the heels of the success of the Cold-Eeze zinc cold lozenges in the late ‘90's, Matrixx hoped to carve out a niche in the market for a zinc-based nasal spray that could be marketed as a cold remedy.
The product was quite successful, even though studies did not strongly support Matrixx’s claim that Zicam reduced the severity and duration of the common cold.
Had Matrixx done some basic research, they would have learned that numerous studies had shown a connection between zinc (when delivered through the nose) and anosmia (loss of the sense of smell).
Zicam was a “homeopathic” remedy, meaning that the active ingredient (zinc) was heavily diluted. As a result, it fell within an exception to the normal rules requiring a drug manufacturer to prove to the FDA that a medication is safe and effective before it can be marketed.
Sure enough, within a short time after the launch of ZIcam Nasal Gel, complaints of anosmia began pouring in. A first wave of litigation resulted in a mass settlement of hundreds of cases in 2006. Matrixx altered the bottle design slightly, but kept marketing the product.
Finally, in June 2009, the FDA -- which had received over 100 anosmia complaints associated with Zicam -- intervened and ordered Matrixx to either submit a new drug application or recall the product.
Matrixx chose a recall, while continuing to market zinc lozenges and non-zinc-based cold and allergy remedies.
There are now hundreds of cases pending in Arizona state and federal court that are in the early stages of discovery. In the meantime, we continue to review potential new cases, focusing on those in which we can prove that the plaintiff took Zicam, an ENT has diagnosed anosmia, and other possible causes of anosmia can be ruled out.
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