Saunders & Walker, P.A. Click here to e-mail Joseph Saunders Click here to e-mail Joe Click here to e-mail Joe
Home Practice Areas About Us Client Resources Contact Us
Ask Joe a Question
Information Center Practice Areas Home
Drugs / Supplements
Medical Devices
Transvaginal Mesh Transvaginal Mesh Recall
Biomet Hip
Jack3d / OxyElite Pro Jack3d / OxyElite Pro Lawsuits
Topamax Lawsuit Topamax Birth Defects
Fosamax Recall Fosamax Recall
Zicam Lawsuit Zicam Lawsuit
Acetaminophen Acetaminophen
Hydroxycut Lawsuit Hydroxycut Lawsuit
Fen Phen Fen Phen
Zyprexa Zyprexa
Ortho Evra Ortho Evra
Levaquin Tendon Levaquin Tendonitis
Heparin Recall Heparin Class Action
Avandia Avandia Recall
Seroquel Seroquel Recall
Kava Kava Kava Kava
Oxycontin Oxycontin
Rezulin Rezulin
Medical Devices
DePuy Hip Implant Johnson & Jhonson DePuy Hip Implant Recall Lawsuit
Zimmer Knee Implant Zimmer Knee Replacement Implant
Bone Graft Lawsuit Bone Graft Lawsuit
Pain Pump Lawsuit Pain Pump Lawsuit
Gadolinium MRI Gadolinium Lawsuit
Defibrillator Leads Defibrillator Leads
Hernia Mesh Hernia Mesh
Defibrillator Defibrillator
lawyers
side effects lawyer
class action lawsuit lawyer
drug recall attorney

Zicam Class Action Lawsuit

Zicam Side Effects Lawsuit Recall

Do I Have A Zicam Lawsuit? Free Case Evaluation

 

On April 7, 2010 Attorney Joseph H. Saunders was appointed by the U.S. District Court in Phoenix, Arizona to serve on the Plaintiffs Steering Committee in the Zicam Cold Remedy Marketing, Sales Practices and Product Liability Litigation MDL 2096.

 

Zicam Side Effects LawsuitSeven researchers from the University of Washington, Seattle, found that Zicam use can irreversibly damage nasal tissue leading users to suffer a reduced or absent sense of smell, a condition known as anosmia.

On October 30, 2009, Jae H. Lim and others published the results of treating both mouse and human nasal tissue with Zicam on the Public Library of Science website.  The researchers conducted electrophysiological, biochemical, and behavioral assays and compared the effects of commonly used intranasal agents such as saline, Afrin, Nasacort, lidocaine and epinephrine to Zicam.

Unlike all other agents, Zicam caused significant atrophy of the mouse main olfactory epithelium and rapid and significant elevation of LDH levels in human nasal explant tissue consistent with cell death and necrosis.  The scientists noted a high degree of cellular damage in the deep tissue layers of the main olfactory epithelium, often rendering the injury irreversible, as well as damage that extended to many subepithelial structures such as mucosal glands, capillary networks and trigeminal nerve fibers – critical to maintaining healthy nasal function. Click Here To Read This Report In PDF Format

Zicam Cold Remedy, manufactured by Matrixx Initiatives, Inc., is a so-called homeopathic cold remedy touted for its effectiveness in reducing the severity and duration of the common cold. Zicam is a gel swab that is used as a gel swab. According to Matrixx, Zicam is effective because it attacks the entry point for the cold virus, the nasal cavity. While Zicam Cold Remedy does not purport to cure the common cold it is marketed as the only over the counter product to reduce the common cold’s severity and duration.

The active ingredient in Zicam Cold Remedy is Zincum Gluconicum (divalent ionized zinc), a form of zinc that is marketed as the reason Zicam is able to reduce the effects of the common cold. However, zincum gluconicum has also been linked to a caustic effect on the nasal passages, which if used over a length of time can cause a loss of the sense of smell, a condition known as anosmia.

According to the Anosmia Foundation, 2-5 million American adults suffer from a loss of taste or smell. On its website, the Foundation lists Zicam as well as other nasal sprays designed to treat common colds as potential causes of anosmia. The Zicam labeling instructions direct users to spray the zinc-based homeopathic remedy directly into the nasal passages. Upon entrance of the nasal passage, the chemical ingredients burn the olfactory nerves and receptors causing potentially permanent damage to one’s sense of smell.

For a free attorney case evaluation related to Zicam side effects lawsuit please contact us : Contact Us

The first FDA reported problems associated with Zicam use occurred in 1999. In 2006, Zicam’s manufacturer, Matrixx Initiatives, Inc. agreed to pay $12 million to 340 consumers who’d been injured by the nasal product. In spite of signs of problems with the nasal spray a decade ago, nothing was done about Zicam until June 16, 2009 when the FDA issued a warning letter about Matrixx’s products and its association with anosmia. The following are the zinc-based Matrixx products of which the FDA warned the company:

  • Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
  • Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
  • Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

The FDA is reporting an additional 130 complaints concerning a loss of the sense of smell. In addition to these 130, the FDA stated that Matrix has another 800 reported complaints that it has not yet handed over to the federal agency.

In its advisory, the FDA expressed concern for children who may have also been exposed to the zinc intra-nasal injectable product. Zicam Cold Remedy Swabs, Kids Size had been previously discontinued but the FDA is concerned that parents may still have remaining product in their homes. The federal agency has urged parents to discontinue use of the product as well.

As an over-the-counter cold remedy, Zicam Cold Remedy Nasal Gel and Swabs are ubiquitous. They were among the best selling products manufactured and marketed for sale in the United States by Matrixx Initiatives, Inc., a Scottsdale Arizona based healthcare company. It’s company motto, “Better Ways to Getter Better” boasts of its products ability to provide sick people with healthy alternatives to fighting sickness and colds.

For a free attorney case evaluation related to Zicam side effects lawsuit please contact us : Contact Us

In its response to the FDA warning letter, Matrixx issued a press release hours after the FDA letter was announced. In the press release, Matrixx officials acknowledge receipt of the warning letter but dispute the FDA safety claims. Additionally, they are quick to point out that the warning letter is restricted to two of its 19 Zicam products. If fails to mention the two products involved in the safety warning are the only two manufactured and designed for intra-nasal injection which is at the heart of the problem with anosmia. In the first paragraph of the company press release, officials state that they’ll seek a meeting with FDA officials to vigorously defend their scientific data refuting the safety claims made by the FDA.

The company’s initial defense of its best-selling product is sandwiched by a paragraph containing information about the recall. In it, the company offers consumers a refund and advises them to discard any of the affected product.

In the very next paragraph of the press release, Matrixx offers a preview of its defense strategy. The products have been on the market since 1999 (contradicting the Bloomberg story concerning FDA awareness of the problem in 1996) and 35 million units of the products have been sold. The company states that “under conditions of ordinary use”, consumers have benefited from the product. No mention is made of previous lawsuits or independent studies that associate zinc-based intra-nasal injectables with ansomia.
William J. Hemelt, Matrixx Initiatives, Inc. acting president is quoted in the press release and expresses surprise that the FDA did not contact the company prior to issuing the warning letter.

Ansomia is not only related to the loss of the sense of smell. It also relates to the loss of a sense of taste. The two may be concomitant. In a Zicam lawsuit filed against Matrixx Initiatives Inc. in Michigan in 2003, the injured party complains about a loss of taste as well as the loss of smell. In the lawsuit, Zicam use occurred only one time and was followed by an apparent permanent loss of both senses.

While the sense of smell may be taken for granted by those of us fortunate to not be affected by such a disorder, the loss can have harmful if not devastating consequences to the quality of life. It can also be dangerous. Anosmia’s effects are wide-ranging beyond quality of life issues. Anosmia can be dangerous. The sense of smell can alert us to potential life-threatening health dangers. The inability to detect, smoke, harmful chemicals, a gas leak, or spoiled food can have long term and devastating effects.

The FDA warning letter will now bring with it FDA scrutiny of Zicam products. In order to re-enter the marketplace, Matrixx Initiatives, Inc. will have to prove to the FDA that its products are safe. They’ll have to provide the federal agency with hard data on the scientific efficacy and safety of the nasal products. It’s an obvious blow to a company that has been able to fly under the FDA radar for years because its products have been characterized as homeopathic, thus exempt from FDA regulation. “They are to stop marketing the products. They have to provide us with a plan for inventory that’s already out there. If they want to continue marketing this product, they need to bring us a new drug application with studies and data to prove safety and efficacy,” according to FDA spokesperson Siobhan DeLancey.

While Matrixx Initiatives officials have attempted to minimize the issue, new FDA commissioner Dr. Margaret A. Hamburg highlighted the potential dangers of the nasal spray. In discussing the issuance of the warning letter, Hamburg noted the news “strikes us as a fairly large problem.” The NY Times, in its coverage of the breaking news story, pointed out that the FDA’s reaction to the Zicam suspension is a marked difference between the Bush and Obama Administrations. While the Bush Administration largely kept a distance from such issues, the new Administration has shown signs that it will not ignore or tolerate industry problems or drug inadequacy. In response, the company refused to issue a Zicam recall, offering instead a refund for unused product. The FDA does not have regulatory authority to issue product recall. However, as part of its overhaul of the FDA and healthcare, the federal agency will in the near future have such regulatory powers.


For a free attorney case evaluation related to Zicam side effects lawsuit please contact us : Contact Us

 

 

 

 

 


Home  |  Practice Areas  |  About Us  |  Client Resources |  Contact Us  |  Site Map  |  Disclaimer
©2005-2014 Saunders & Walker, P.A.