It was a few.. 30 or so out of hundreds of thousands.. using the NASAL injector improperly.
WHO THE HELL would stick this thing up their nose but a moron looking for a settlement in the first place.
This was 8 focking years ago.. and the product is still selling in 20,000 retail units. .moron.
The sub-lingual mouth spray is fine.. and so will be the nausea product.
The case involved Zicam, a nasal spray and gel made by Matrixx Initiatives and sold as a homeopathic medicine. From 1999 to 2004, the plaintiffs said, the company received reports that the products might have caused some users to lose their sense of smell, a condition called anosmia.
Matrixx did not disclose the reports and in 2003, the company said it was “poised for growth” and had “very strong momentum” though, by the plaintiffs’ calculations, Zicam accounted for about 70 percent of its sales.
After a link between Zicam and anosmia was reported on “Good Morning America” in 2004, the company’s stock price dropped significantly. In 2009, the Food and Drug Administration warned consumers not to use the products, and Matrixx recalled them.
In the case before the justices, Matrixx Initiatives Inc. v. Siracusano, No. 09-1156, lawyers for Matrixx argued that it should not have been required to disclose small numbers of unreliable reports, which were the only ones available in 2004, they said. They added that the company should face liability for securities fraud only if the reports had been collectively statistically significant.
“All drug companies receive on an almost daily basis anecdotal hearsay reports about alleged adverse health events following the use of their products,” Jonathan Hacker, a lawyer for Matrixx, told the justices when the case was argued in January.
as usual.. that is only half of the story. there was never a problem with the medicine.. it was that a few people stuck the nasal injector into their nose TOO far thinking this would make it more effective. The sub-lingual spray application was never questioned.. and the nasal applicator has been re-designed since 7 years ago.
you can buy it on Amazon; amazon.c*m/Zicam-Intense-Sinus-Relief-0-5/dp/B001EWV07U
less than 10% of people prefer a nasal application, I'll give you this.. it's a ridiculous delivery method. I wouldn't stick ANY thing up my nose.
Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.
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A Zicam nasal gel.
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Go to Well »The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions against drug companies than the Bush administration did.
The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.
In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.
Although the F.D.A. took no action during the Bush administration, Dr. Margaret A. Hamburg, who was named the agency commissioner by President Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.”
The agency issued its consumer alert even though Matrixx refused to recall its products, a highly unusual event. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.
“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” the release said. “For this reason, Matrixx Initiatives believes that the F.D.A. action is unwarranted and will seek a meeting with the F.D.A. to review the company’s product safety data.”
Matrixx had $101 million in sales last year, of which $40 million came from Zicam products.