Item 8.01 Other Events.
FDA Matters
Since shortly after the June 16, 2009 warning letter issued by the Food and Drug
Administration (FDA) regarding Zicam Cold Remedy nasal gel products, Matrixx Initiatives, Inc.
(the Company) has been engaged in informal discussions with the FDA. The FDA recently indicated
it is unwilling to reverse its position. The Company is currently evaluating its options. In
addition, the FDA recently issued the Company a Form 483 identifying several observations of
individual cases where the FDA indicated the Company should have filed serious adverse event
reports with the MedWatch Reporting system. The Company is reviewing the observations and will be
responding soon.
Multidistrict Litigation
As previously disclosed in the Companys Form 8-K, filed on September 2, 2009, the Company
filed a motion to consolidate and transfer all of the personal injury and consumer fraud matters,
including any purported class actions, pending against the Company in federal court to the District
of Arizona, pursuant to federal multidistrict litigation (MDL ) procedures. On October 9, 2009,
the Judicial Panel on Multidistrict Litigation (Panel) established MDL No. 2096 In Re: Zicam
Cold Remedy Marketing and Sales Practices Litigation and centralized the consumer fraud and
personal injury actions that involve common questions of fact before a federal court in the
District of Arizona. With one exception, the Panel transferred all of the consumer fraud cases at
issue in the original MDL request. The Panel also began the MDL transfer process for the remaining
consumer fraud and personal injury matters pending against the Company in federal courts across the
country. The plaintiffs in these remaining cases will have the opportunity to object to the MDL
transfer of their specific case. The Panel determined that the case of Hohman et. al. vs. Matrixx
Initiatives, Inc. et. al. (Northern District of Illinois) did not involve sufficient common
questions of fact to allow for consolidation and transfer to the MDL at the present time.
Shareholder Derivative Lawsuits
On September 11, 2009, a shareholder derivative lawsuit was filed by Timothy Hall, on behalf
of the Company, against all of the Companys current directors and the following current and former
officers of the Company: William Hemelt, Samuel Cowley and Carl Johnson. The lawsuit alleges,
among other things, that the officers and directors named in the complaint violated their fiduciary
duties to the Company by (i) misrepresenting the safety of the Zicam Cold Remedy nasal gel
products, (ii) failing to warn consumers that use of the Zicam Cold Remedy nasal products could
result in anosmia and (iii) failing to disclose reports of anosmia to the FDA and otherwise
misrepresenting the Companys compliance with FDA regulations. Timothy Hall v. William J. Hemelt,
et al., United States District Court, District of Arizona.
On September 18, 2009, a shareholder derivative lawsuit was filed by Theodore C. Klatt, on
behalf of the Company, against all of the Companys current directors and the following current and
former officers of the Company: William Hemelt, Samuel Cowley, Carl Johnson, Timothy Clarot and
James Marini. The lawsuit alleges, among other things, that the officers and directors named in
the complaint violated their fiduciary duties to the Company by (i) misrepresenting the safety of
the Zicam Cold Remedy nasal gel products, (ii) failing to warn consumers and shareholders that use
of the Zicam Cold Remedy nasal products could result in anosmia and (iii) failing to disclose
reports of anosmia to the FDA and otherwise misrepresenting the Companys compliance with FDA
regulations. Theodore C. Klatt v. William J. Hemelt, et al., United States District Court,
District of Arizona.
In accordance with and subject to the provisions of the Companys Certificate of
Incorporation, each of the named directors and current and former officers will be indemnified by
the Company for their expenses incurred in defending each of these lawsuits and for any other
losses that they may suffer as a result of these lawsuits.
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MATRIXX INITIATIVES, INC. (Registrant) |
||||
| /s/ William J. Hemelt | ||||
| William J. Hemelt | ||||
| President and Chief Executive Officer | ||||
Date: October 23, 2009
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