Gabriel Mejia, Esq.: October 2009 Archives

October 27, 2009

FDA Sticks to Zicam Cold Remedy Warning Letter on Loss of Smell

The U.S. Food and Drug Administration (FDA) has refused to back down from a warning letter sent to Zicam manufacturers, Matrixx Initiatives, Inc., regarding the potential dangers of its over-the-counter cold medication.  In June 2009, the FDA warned consumers that three Zicam products -- Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, Kids Size (discontinued product) -- were associated with 130 reports of the loss of sense of smell (also known as anosmia).  According to the FDA, the loss of sense of smell reportedly occurred after the first dose of the drug, but is also known to occur after multiple doses.

The potentially dangerous Zicam products contain zinc gluconate (labeled "zincum gluconicum") as the active ingredient.  The FDA warns on its website that although these products are marketed to reduce the duration and severity of the common cold, the products have not been shown to be effective in doing so.  Consumers are advised not to use the potentially dangerous drugs for any reason and to throw away any remaining product.  Matrixx Initiatives has since pulled the products in question from the market, but the FDA fears that unknowing consumers will use products still stored in their medicine cabinets.

In the June 2009 warning letter, the FDA accused Matrixx Initiatives of failing to provide any data to establish that Zicam Cold Remedy intranasal products are safe and effective for the uses identified in their labeling.  On the contrary, the FDA said that there is published scientific literature that evidences various salts of zinc can damage olfactory function in humans.

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October 12, 2009

Target Settles Automatic Door Injury Lawsuit for $7 Million

Target Corp., the owners of Target locations nationwide, recently settled an automatic door personal injury lawsuit filed against them by an 80-year-old customer.  According to reports, the customer claimed that Target had failed to inspect and maintain a set of automatic doors that malfunctioned and injured her.  The customer was injured after the automatic door struck her and knocked her to the ground causing her to hit her head.  She was then struck in the head again by the door when it continued to open and close while she was on the ground.  The customer also claimed that Target did not follow the safety guidelines set out by the automatic doors' manufacturer, Besam USA, who was also named in the lawsuit.  The injured party also claimed that the doors did not have a proper fail-safe system which would alarm to obstructions.

The elderly customer suffered brain injuries that prevented her from taking care of her eldest daughter with special needs.  The injured customer also claimed that she had to enter a nursing home to obtain the proper daily care after her injuries.  According to the Center for Disease Control (CDC), the second leading cause of nonfatal injuries in the United States among people 65 years of age or older in 2007 was being unintentionally struck by or crushed by a human, animal, or inanimate object other than a vehicle or machinery.

Of course, the technology behind these doors that open and close based on sensors or the push of a button is quite helpful in everyday life.  Automatic doors provide access to people carrying objects into and out of buildings, large crowds, physically challenged individuals, and have numerous other useful applications.  However, when these doors are not maintained properly or designed defectively, they can be extremely dangerous and cause serious injuries such as broken bones, traumatic brain injury, and severed fingers or limbs.  Automatic door injuries are often caused by defective or poorly maintained systems closing with excessive force or closing unexpectedly.

Traumatic brain injuries are more prevalent than one might imagine.  According to the CDC, approximately 1.4 million people in United States suffer traumatic brain injuries each year.   Of those, approximately 50,000 die from their injuries, 235,000 are hospitalized, and 1.1 million are treated and released from the emergency department.  Injuries to the brain can be difficult to self-diagnose as the signs and symptoms may be subtle and not appear until days or weeks after the injury.  People that have suffered a traumatic brain injury may appear fine, but changes in their behavior or health may signify injury.

Some signs of traumatic brain injury include:

  • headache or neck pain that does not subside
  • difficulty remembering, concentrating or making decision
  • slowness in thinking, speaking, acting, or reading
  • see more signs and symptoms at CDC.gov

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