Fda, Ada Statements Express Minimal Concern Over Poligrip Lawsuits

In response to new research that indicates the zinc in denture cream can cause neuropathy, a disorder of the peripheral nervous system, victims throughout the country have been taking legal action against manufacturers GlaxoSmithKline and Procter & Gamble, hoping that a Fixodent or Poligrip lawsuit will result in monetary compensation for their losses. With more than 30 million denture wearers residing in the United States, the findings on denture creams health risks have caused significant concern. But two leading sources on public health, the Food and Drug Administration (FDA) and the American Dental Association (ADA) have issued only muted statements in response to the denture cream controversy.

Denture cream received FDA approval more than 30 years ago, when the agency approved it to be sold as a Class I medical device, a qualification that indicates its minimal likelihood to cause harm. It should be noted, however, that denture creams Class I designation was made before manufacturers GSK and P&G started adding zinc to their products.

For decades, researchers have known that excessive zinc intake can deplete the body of copper, potentially resulting in nerve damage. Despite this, the FDA never updated denture creams risk profile in the 1990s, when zinc was added to Fixodent and Poligrip. And even now, after the publication of no fewer than two scientific studies implicating denture cream zinc as the cause of severe nerve damage, the FDA has failed to order a recall or demand additional denture cream warning labels. What it did do was issue a statement identifying the responsibilities of denture cream manufacturers, among which are adverse event reporting, manufacturing controls, and labeling that is neither false nor misleading.

Were Fixodent and Poligrip labels false and/or misleading? The argument could certainly be made due to the omission of zinc as an ingredient, especially because scientific literature on the dangers of excess zinc consumption is readily available. But as previously reported by the Rottenstein Law Group, a product manufacturer that complies with FDA regulations can still violate the law and be found blameworthy by the courts for the harm that product causes.

The American Dental Association, while not holding the regulatory sway of the FDA, is influential in the field of dentistry. Its ADA Seal of Approval is regarded as a leading indicator of dental care product quality, and the Journal of the American Dental Association is the best-read scientific journal in dentistry. In response to the recent controversy over denture cream safety, the ADA has issued a statement that says more information is needed before a cause and effect relationship between denture cream zinc and neurological problems can be determined. It recommends that denture wearers visit their dentist if they have ill-fitting dentures or questions about dental cream use.

For those seeking financial compensationthrough a denture cream lawsuit, a firm denouncement of denture cream zinc by the FDA and the ADA would most likely strengthen their case. The absence of stronger statements by these organizations, however, should by no means be seen as a hurdle to success in a denture cream lawsuit. The science is so far clear on the very dangerous health risks of denture cream, and this information should hold up in a court of law.

If you have any questions about a denture cream claim, or youre ready to take legal action, dont hesitate to contact the Rottenstein Law Group. For more than 25 years the lawyers of RLG have been helping clients injured by corporate negligence recover the compensation they deserve.