Item 8.01 Other Events.
Recent Lawsuits Filed Against the Company
Following 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") announced that it expected additional lawsuits
would be filed against the Company, which has been the case.
On June 22, 2009, a personal injury lawsuit was filed against the Company
involving 117 plaintiffs who allege that the Company's Zicam Cold Remedy nasal
gel products have caused the permanent loss or diminishment of the sense of
smell or smell and taste. Marilyn Adams et al. vs. Matrixx Initiatives, Inc., et
al., Superior Court of the State of Arizona, Maricopa County. Additional
lawsuits involving individual plaintiffs making similar allegations have also
been filed.
On June 18, 2009, an economic class action lawsuit was filed against the
Company, purportedly on behalf of all persons in the States of Illinois,
California, Florida, Texas, Minnesota, Wisconsin and Missouri who, at any time
within the applicable statute of limitations of their respective state,
purchased zinc-based nasal and oral Zicam products. The lawsuit alleges, among
other things, that the Company falsely represented the effectiveness of these
products. Thomas Hohman et al. vs. Matrixx Initiatives, Inc. et al., United
States District Court, Northern District of Illinois (Eastern Division).
On June 23, 2009, an economic class action lawsuit was filed against the
Company, purportedly on behalf of all persons who purchased Zicam Cold Remedy
nasal gel products while in California or from a source in California within the
four years prior to June 23, 2009. The lawsuit alleges, among other things, that
the Company concealed or omitted material information regarding the safety of
the nasal gel products. Barbara Sample et al. vs. Matrixx Initiatives, Inc. et
al., United States District Court for the Central District of California. The
Company is aware of four other economic class action lawsuits, involving
plaintiffs making similar allegations, which have been filed against the Company
since the FDA's issuance of the warning letter. Teperson et al. vs. Matrixx
Initiatives, Inc. et al., United States District Court for the Southern District
of California, filed June 24, 2009 (purportedly on behalf of all California
residents who purchased Zicam nasal gel products from and after June 24, 2005);
Floyd Fessler et al., vs. Matrixx Initiatives, Inc. et al., United States
District Court for the Southern District of Illinois, filed June 25, 2009
(purportedly on behalf of all Illinois residents who purchased Zicam nasal gel
products); Stewart Roper et al., vs. Matrixx Initiatives, Inc. et al., United
States District Court for the District of Arizona, filed June 25, 2009
(purportedly on behalf of all purchasers of Zicam nasal gel products in the
United States); and Stefanie Riepe et al., vs. Matrixx Initiatives, Inc. et al.,
United States District Court for the Western District of Missouri, filed
June 22, 2009 (purportedly on behalf of all Missouri residents who purchased
Zicam nasal gel products).
The Company expects additional lawsuits of the types described above, as well
as potentially other types of lawsuits.
The Company's Position
The Company intends to vigorously defend each of the recently filed lawsuits.
FDA Warning Letter. As previously announced, the Company strongly disagrees
with the FDA's allegations that Zicam Cold Remedy nasal gel products are unsafe
and that they were unlawfully marketed. However, the Company is conducting a
recall of its Zicam Cold Remedy nasal gel products because of its desire to
cooperate with the FDA. Soon, the Company will formally respond to the FDA's
warning letter and will request a meeting with the FDA to present comprehensive
scientific and medical data and analyses demonstrating that these products are
not unsafe. For additional information regarding the FDA warning letter and
related matters, see the Company's Reports on Form 8-K filed with the SEC on
June 16, 17, 19, and 23, 2009.
Product Safety. There is no known causal link between the use of Zicam Cold
Remedy nasal gel and impairment of smell or smell and taste. To date, no
plaintiff has ever won a product liability case against the Company on those
grounds. The Company believes that upper respiratory infections and nasal and
sinus disease are the causes of the smell dysfunctions reported by some
consumers. One of the most common causes of smell disorders is the cold itself,
the very condition our product is used to treat. Other causes are sinusitis and
rhinitis, conditions that are sometimes present when our product is used.
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Federal law requires that the testimony of a scientific or medical expert
witness be reliable and based on valid scientific data and analysis before it
can be allowed into evidence. To date, the Company has submitted motions in ten
federal lawsuits against the Company challenging the reliability and
admissibility of the testimony of expert witnesses who claim that Zicam Cold
Remedy is capable of causing or has caused smell and taste loss. To date, the
courts have ruled in the Company's favor on all ten motions. Each court has
ruled that the theory that Zicam Cold Remedy nasal gel causes smell loss, as
promoted by the plaintiffs' experts, has no reliable scientific support and was
reached without application of proper scientific standards and procedures.
In addition, on April 3, 2008, jurors in a California case unanimously found
that Zicam was not the cause of the plaintiff's smell loss.
For additional information regarding outstanding product liability litigation
and the Company's position regarding these lawsuits, see "Legal Proceedings -
Product Liability Matters" in Item 3 of the Company's Annual Report on Form 10-K
for the fiscal year ended March 31, 2009.
Product Effectiveness. Our claims and advertising are subject to the
requirements of the Federal Trade Commission Act, which is enforced by the
Federal Trade Commission (the "FTC"). As previously disclosed, on March 21,
2006, the FTC's East Central Region (Cleveland, Ohio office), initiated a
detailed inquiry to determine whether the Company engaged in unfair or deceptive
acts or practices in violation of the Federal Trade Commission Act in connection
with the Company's advertising and promotional activities for several of the
Company's nasal and oral cold remedy products, including, Zicam Cold Remedy
Nasal Gel and Zicam Cold Remedy Swabs - the products that are the subject of the
FDA warning letter. As part of the inquiry, the FTC requested and received,
among other things, the Company's documentation regarding product safety,
including side effects, adverse events and consumer complaints, and efficacy,
including the scientific proof establishing the efficacy claims made by the
Company. Following a nearly year-long process, during which the Company provided
the FTC with over 65,000 pages of documentation and met with the FTC to discuss
the information, on March 5, 2007, the FTC notified the Company that it was is
no longer pursuing the inquiry.
Also as previously disclosed, on March 10, 2005, the National Advertising
Division (NAD) of the Council of Better Business Bureaus, an investigative arm
of the advertising industry's voluntary self-regulation program, issued a press
release announcing the results of a review of Matrixx's advertising claims. The
NAD determined, among other things, that Matrixx's claims that its product,
Zicam Cold Remedy Nasal Gel, resolves colds three times faster when taken at the
first sign of a cold, that using the product results in a less severe cold, and
the promise that these benefits are clinically proven, were substantiated by
competent and reliable scientific evidence.
Most recently, on May 12, 2009, the NAD issued a press release announcing the
results of a review of the Company's advertising claims related to its oral
forms of Zicam Cold Remedy products. The NAD determined, among other things,
that the Company's advertising claims were supported - that the Company's oral
Cold Remedy products are effective in shortening the duration of the common
cold.
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