Amidst Denture Cream Lawsuits, FDA, ADA Weigh in on Fixodent, Poligrip
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Home Page > Law > Health and Safety > Amidst Denture Cream Lawsuits, FDA, ADA Weigh in on Fixodent, Poligrip
Amidst Denture Cream Lawsuits, FDA, ADA Weigh in on Fixodent, Poligrip
Posted: Feb 18, 2011 |Comments: 0
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There is growing evidence that the zinc contained in denture creams such as Poligrip and Fixodent can cause neurological disease, and over the past year or so this has led numerous consumers to take legal action against manufacturers GlaxoSmithKline and Procter & Gamble, hoping to recover money through a denture cream lawsuit settlement. But despite the growing concern over the health risks of denture cream, the U.S. Food and Drug Administration (FDA) has yet to order a recall of Fixodent or Poligrip; nor has it issued an official warning about the products. A statement issued by the American Dental Association (ADA) has urged caution for denture wearers, but stopped short of saying that patients should stop using denture cream.
The FDA approved denture cream more than 30 years ago as a Class I medical device, meaning it has a minimal potential for harm. The manufacturers of Class I medical devices are not required to list product ingredients on the packaging, which is one of the reasons why the link between denture cream zinc and neuropathy was only discovered in 2008. Even after this connection was discovered, the FDA did not order denture cream manufacturers to reformulate their products or include warning labels on packaging. It did, however, issue a statement on denture cream, which more or less reiterated the responsibility of denture cream manufacturers, including, “…adverse event reporting, manufacturing controls, and labeling that is neither false nor misleading.” It could be argued that GSK and P&G engaged in misleading labeling by failing to list zinc as an ingredient. But as the Rottenstein Law Group has previously reported, while FDA regulations are important safety measures for consumers, a product can still be said to violate the law even if it is compliant with FDA rules (and its manufacturer can therefore be held liable for harm it cause).
The American Dental Association has no regulatory power, but as the nation’s largest dental association, it is a premier source of oral health information. In a statement issued last year, the ADA noted that it “advises denture wearers to see their dentist if their dentures do not fit well or if they have questions about the use of denture cream,” but that concerning denture cream zinc and neurological problems: “More information is needed to determine if there is a cause and effect relationship.”
Because the science on denture cream-induced neuropathy is new, it is fair to say that the medical community should exercise a healthy amount of skepticism. But two major studies from leading universities have similarly concluded that products like Fixodent and Poligrip caused nerve damage in test subjects—science that is likely to hold up in court and entitle victims to a denture cream settlement amount commensurate with their losses.
Whether this is true or not will likely be known when a Fixodent bellwether trial kicks off in June. Until that happens, it is not too late for you to file a claim against GSK and/or P&G seeking a denture cream lawsuit settlement. The Rottenstein Law Group, a firm with more than 25 years of experience in product liability law, is currently offering complimentary evaluations of denture cream injury claims.
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About the Author:
A blogger who has the passion in writing and helping people who suffer personal injury through medical malpractice and adverse effects on drugs, especially for denture cream products. This will have updates concerning the issues surrounding the product, especially about denture cream settlements.
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