Zicam Litigation Heats Up

Multidistrict litigation proceedings against Matrixx Initiatives, Inc., the manufacturer of the over-the-counter cold product Zicam, are heating up.

This is a process known as multidistrict litigation (or an MDL) and is often utilized in mass tort cases where a number of claimants have been injured in a similar fashion by a drug, medical device, other product, airline crash, etc. MDL cases often include class action claims, but are generally aimed at managing a large number of individual lawsuits filed by plaintiffs who have all suffered harm due to the same general conduct of the Defendants.

Currently, there are more than 300 MDL cases pending in federal court jurisdictions all over the country involving a number of different products, corporate fraud and other wrongdoing, and accidents, such as:

• Chantix (MDL No. 2092 in Birmingham);
• Prempro (MDL No. 1507 in Little Rock);
• Air Crash in Madrid on August 20, 2008 (MDL No. 2135 pending in California);
• Chinese-Manufactured Drywall Products (MDL No. 2047 in New Orleans);
• Gadolinium-Based Contrast Agents (MDL No. 1909 in Cleveland);
• Terrorist Attacks of September 11, 2001 (MDL No. 1570 in New York City);
• Yasmin and Yaz (MDL No. 2100 in East St. Louis);
• General Motors Vehicle Plan (MDL No. 1392 in Illinois).

In November of 2009, the Judicial Panel for MultiDistrict Litigation assigned all of the Zicam cases to Judge Frederick Martone in Phoenix, who will oversee pretrial proceedings, discovery and the bellwether trial process for all of the lawsuits pending in the federal court system.

Judge Martone held his first status conference on February 25, 2010. As of early March 2010, nearly 100 individual lawsuits have been filed in the federal court system by plaintiffs who have suffered injuries that they attribute to their use of Zicam. It is anticipated that hundreds of additional lawsuits will be filed in the coming months by victims who lost their sense of smell, a condition known as anosmia, or have suffered other serious injuries attributable to Zicam. Case management orders (establishing procedures for the MDL litigation process) are expected to be issued shortly.

In the coming months, the parties in the MDL will be focusing on discovery:

• Providing information about each Plaintiff;
• Providing information and documents about each plaintiff’s injuries and other damages;
• Establishing procedures for generic depositions;
• Establishing procedures for document production relating to liability and scientific issues.
• It is hoped that the first trials in the MDL might be conducted in 2011.

On June 16, 2009, the FDA issued a warning letter to Matrixx, manufacturer of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size. The FDA concluded “that these products may pose a serious risk to consumers who use them.” The FDA warning letter was sent to the drug manufacturer after a review of the Agency’s adverse event database noted more than 130 reports of patients suffering anosmia, or loss of sense of smell (which was permanent or long-lasting in some patients) as a result of their use of this over-the-counter cold product. In its heyday, the manufacturer of Zicam promoted the product as a cure-all that would reduce the duration of the common cold and the severity of cold symptoms. The FDA warning letter notes that these claims were unsubstantiated by science and improper under food and drug regulations, essentially rendering the products unbranded and the marketing and promotion improper. Ultimately the FDA concluded that Matrixx did not have sufficient proof that its products were “safe and effective”, but rather there was “evidence that these products pose a serious safety risk to consumers.” Given this, the FDA imposed a requirement that the manufacturer undergo the same rigorous review that would be required for a new drug to be approved for marketing and sale in this country, and noted that the manufacturer’s claims that the product was homeopathic or the fact that the product had been sold over-the-counter did not excuse the requirement that the manufacturer comply with federal law in order to protect consumers. The FDA also noted that its adverse event database did not reveal similar problems with other over-the-counter cold remedies that did not contain Zicam’s active ingredient of zinc gluconate (listed on the product as zinc gluconicum).

As the MDL process becomes more clear and established, we will continue to provide the status of progress being made.