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The health questions and the lawsuits may rattle consumer confidence, but the warnings from federal health authorities about advertising and quality control raise larger questions about Bayer’s approach to complying with government rules, said Michael A. Santoro, an associate professor at the Rutgers Business School who has studied ethics in the pharmaceutical industry.
The Company believes these products are safe and do not cause anosmia. The Company’s position is supported by the cumulative science and has been confirmed by a multi-disciplinary panel of scientists. (See the Company’s Report on Form 10-K under the heading "Legal Proceedings - Product Liability Matters" for additional information.)
The Company believes the FDA action is unwarranted and is in the process of determining its response, which may include removing these products from the marketplace. These products constituted approximately 40% of the Company’s net sales in 2009.
FDA's warning applies to Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kids Size, but does not affect Zicam oral zinc tablets or lozenges.
"The biggest unknown is the degree to which the sales of our products (are) maintained," Hemelt said.
Matrixx is seeking a meeting with FDA officials with the hope of reversing the agency's decision, Hemelt said, adding that several studies showed no loss of smell with nasal Zicam products and arguing that FDA's conclusions were "erroneous."
While Hemelt said Tuesday's warning came as a "complete surprise," he said the company had been visited in May by FDA inspectors who drew attention to about 800 reported complaints that had not been given to the agency.
A law passed in 2007 required wider mandatory reporting of certain products, but Hemelt said the company did not send along the reports based on the opinion of its lawyer.
If the company's efforts fail to persuade the FDA, Matrixx will have to downsize, Hemelt said. "Obviously, we have to learn how to shrink this company if we're unable to get these products back on the shelf."
Schachter, Hendy & Johnson, Attorneys At Law
909 Wrights Summit Parkway
Suite 210
Fort Wright, KY 41011
Phone: (859) 578-4444
Fax: (859) 578-4440
Toll Free: (888) 606-5297
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Schachter, Hendy & Johnson, Attorneys At Law
909 Wrights Summit Parkway
Suite 210
Fort Wright, KY 41011
Phone: (859) 578-4444
Fax: (859) 578-4440
Toll Free: (888) 606-5297