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Zicam Recall, Drug Safety, and the Definition of Erroneous

Submitted by Anonymous on Jun 19th, 2009

This story about the Zicam recall and investigation just gets better and better. And if we weren't involved in representing clients harmed by Zicam, we'd be popping popcorn, grabbing some Junior Mints, and watching the show.

Today, the executives at Matrixx Initiatives, Inc. released a statement defending its product Zicam against increased scrutiny from the FDA. States William Hemelt, Acting President and COO:

"We are hopeful that if we can tell our story to the FDA, that maybe we can get them to change their mind," claimed the safety concerns "erroneous" and the agency made no effort to communicate its concerns with the company prior to this week.

Erroneous? That's laughable.

In 2006, the company settled approximately 300 lawsuits stemming from injuries sustained by the use of Zicam - including loss of smell. Already, this may be enough to erase erroneous from the record.

Then, in 2007, the FDA mandated that companies who receive reports of adverse reactions and injuries must report them to the FDA. Guess who decided, "on the advice of counsel," not to report more than 800 different adverse claims?

So now in 2009, when the FDA is working on about 130 claims of loss of smell, unaware of another 800 claims made to the company, a chief executive declares the safety of its product to be erroneous?

We're looking forward to this guy's day in court.

The Legal Scorecard for Matrixx Initiatives:
- Possible corporate negligence in not reporting to the FDA
- Possible corporate negligence in not researching claims that Zicam could/would/did cause a loss of smell
- Continued drug liability lawsuits and clients
- Continued buffoonery on the part of the company's executives