The Food and Drug Administration has recalled the over-the-counter cold and allergy drug, Zicam.
Zicam can cause permanent damage to one’s sense of smell. Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs contain zinc. The FDA recall does not affect other Zicam products, such as tablets, “rapid melts”, and liquid forms.
The FDA says that it received more than 130 reports of consumers losing their sense of smell. It also says that there is evidence that the delivery of zinc to the nose can cause this injury. Some consumers lost their sense of smell after one use while others suffered injury after multiple uses.
The manufacturer, Matrixx Initiatives, Inc., denies that Zicam injures the sense of smell, and it is contesting hundreds of injury lawsuits.
In a products liability case, the FDA’s recall of a drug can be offered in evidence, but the jury does not have to accept the FDA’s finding. Indeed, there have been cases where juries have found for the drug company even where the FDA found the drug to be dangerous. However, the FDA’s finding is very powerful evidence before a jury that the drug was defective.
Mark E. Seitelman, 6/18/09, www.seitelman.com.