Zicam Lawsuit Hearing Set for Thursday

Federal Zicam lawsuits could be consolidated in a Multidistrict Litigation (MDL). A hearing before the Judicial Panel on Multidistrict Litigation (JPML) will take place later this week.

Earlier this summer, the U.S. Food & Drug Administration (FDA) said it had received 130 reports of anosmia—loss of sense of smell—in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

At the same time, the FDA issued a Warning Letter to Matrixx. In the letter, the FDA said Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In the Warning Letter, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

There are currently 10 Zicam anosmia lawsuits pending in 9 federal courts. These lawsuits allege that zinc gluconate, the active ingredient in recalled Zicam products, produces a caustic action on the nasal passages that, over time, can lead to a loss of smell.

On September 24, the JPML will hear arguments in Richmond, Virginia over whether all pending and future Zicam lawsuits should be consolidated in one federal court as an MDL. MDL is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States. Such a consolidation avoids duplication of discovery, prevents inconsistent pretrial rulings, and conserves the resources of the parties, their counsel and the judiciary. The JPML was created in 1968, and since then, the Panel has consolidated hundreds of thousands of lawsuits, including litigation over asbestos, breast implants and other matters.

An MDL is not the same as a class action lawsuit. Each case in a MDL retains its own identity. If the MDL process does not resolve the cases, they are transferred back to the court where they originated for trial.

This entry was posted in Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.