This is a frightening one. Remember when Zicam came onto the market, and promised it could do the impossible? It claimed it could shorten the length of the common cold. Trusting Zicam, I have used the product on at least a few occasions in the past 2 or 3 years.
The New York Times is reporting today that the FDA now believes the use of Zicam's nasal swabs and gel can result in anosmia, which is the loss of the sense of smell. The FDA has received more than 130 reports of anosmia after using the prodcucts, often after only one dose.
Matrixx, Inc., an Arizona corporation, initially decided to market the Zicam line of products as homeopathic agents. This permitted it to sell the product without prior FDA approval. Selling the product as homeopathic has been lucrative for Matrixx. In 2008, for instance, it had $40m in sales of Zicam, and a total of $101m in sales from its full lineup of products.
The product's tendency to destroy the sense of smell has also led to many lawsuits, which Matrixx has seen fit to settle. In 2006, Matrixx paid $12m in 340 settlements in which Zicam customers reported that the product ruined their ability to smell.
As the Times reports, the FDA actually lacks the ability to force a recall of Zicam. In a warning letter it sent yesterday to Matrixx, the FDA asked that Matrixx "take corrective actions" within 15 days. Those corrective actions would be to recall the product. Matrixx's response was that it
This despite the FDA's explicit conclusion, and the mounting numbers of people losing their sense of smell.
[S]tands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia.
The legal implications of the FDA's request for a recall and Matrixx's stonewalling response are interesting. In a medical products liability lawsuit, California law permits several causes of action. Among them, the plaintiff often must show that the defendant knew (or should have known) that its products were dangerous. This is called "notice," and the plaintiff usually proves it by pointing to the complaints the company previously received about its product.
With Zicam, however, it appears that the argument is much stronger: the FDA clearly warned Matrixx that its product was dangerous, and Matrixx explicitly decided not to take it off the market.
