P&G’s FDA Compliance and How It Affects Fixodent Lawsuit Settlements
It is interesting to note that although hundreds of people nationwide are seeking Poligrip and Fixodent lawsuit settlements, denture cream manufacturers are actually in compliance with U.S. Food and Drug Administration (FDA) regulations. This raises the question of whether GlaxoSmithKline and Procter & Gamble can be held liable for harm caused by their products even though they did not violate federal consumer safety guidelines.
Denture cream is considered a Class I medical device, a classification reserved for products that pose the least risk of injury and are not required to undergo safety testing or list product ingredients. It should be noted, however, that earned their Class I status more than 30 years ago, back when they were not formulated with zinc, an ingredient that was added to denture adhesives in the 1990s. And zinc, of course, is the very reason why denture creams are thought to be dangerous. Numerous studies have linked the ingestion of large amounts of denture paste with zinc to neurological disease, blood disorders, and other health problems, and this research has spurred the product liability lawsuits now faced by GSK and P&G.
But despite the growing body of evidence that denture cream with zinc poses serious health risks, the Food and Drug Administration has not acted to reclassify denture cream. When asked to explain this decision, Dr. Jeff Shuren of the FDA's Center for Devices and Radiological Health said that, "We're going one better. We're actually working with manufacturers on replacing the zinc in their products, and some companies have already done that."
Based on this statement, it seems that denture cream's classification will not be upgraded, and denture cream manufacturers will continue to remain in compliance with FDA regulations for Class I medical devices. So does that mean that individuals injured by denture cream cannot legitimately filed a lawsuit against GSK and/or P&G?
Although the FDA plays an important role in regulating consumer products, it is not the sole authority. By law, manufacturers have a responsibility to understand any potential risks their products pose, including those that arise by intended use and anticipated misuse, and provide sufficient warning of them to the public. It's reasonable to assume that GSK and P&G, multi-million dollar corporations, should have known about zinc's health risks and made an effort to prevent them by warning consumers. The fact that they did not, regardless of their FDA compliance, could therefore make them liable for any injury their products cause.
As one of the first denture cream lawsuits nears its trial date, it remains to be seen how the courts will actually rule in these cases. The fact remains, however, that denture cream manufacturers did not warn of their products' side effects until it was too late, and many innocent consumers were injured as a result. If you believe you or a family member suffered neurological damage caused by Fixodent or Poligrip, the Rottenstein Law Group will evaluate your claim for free. RLG's lawyers have a total of more than 25 years of experience fighting for the rights of clients who have suffered harm due to the negligence of powerful corporations like Procter & Gamble.
Denture cream is considered a Class I medical device, a classification reserved for products that pose the least risk of injury and are not required to undergo safety testing or list product ingredients. It should be noted, however, that earned their Class I status more than 30 years ago, back when they were not formulated with zinc, an ingredient that was added to denture adhesives in the 1990s. And zinc, of course, is the very reason why denture creams are thought to be dangerous. Numerous studies have linked the ingestion of large amounts of denture paste with zinc to neurological disease, blood disorders, and other health problems, and this research has spurred the product liability lawsuits now faced by GSK and P&G.
But despite the growing body of evidence that denture cream with zinc poses serious health risks, the Food and Drug Administration has not acted to reclassify denture cream. When asked to explain this decision, Dr. Jeff Shuren of the FDA's Center for Devices and Radiological Health said that, "We're going one better. We're actually working with manufacturers on replacing the zinc in their products, and some companies have already done that."
Based on this statement, it seems that denture cream's classification will not be upgraded, and denture cream manufacturers will continue to remain in compliance with FDA regulations for Class I medical devices. So does that mean that individuals injured by denture cream cannot legitimately filed a lawsuit against GSK and/or P&G?
Although the FDA plays an important role in regulating consumer products, it is not the sole authority. By law, manufacturers have a responsibility to understand any potential risks their products pose, including those that arise by intended use and anticipated misuse, and provide sufficient warning of them to the public. It's reasonable to assume that GSK and P&G, multi-million dollar corporations, should have known about zinc's health risks and made an effort to prevent them by warning consumers. The fact that they did not, regardless of their FDA compliance, could therefore make them liable for any injury their products cause.
As one of the first denture cream lawsuits nears its trial date, it remains to be seen how the courts will actually rule in these cases. The fact remains, however, that denture cream manufacturers did not warn of their products' side effects until it was too late, and many innocent consumers were injured as a result. If you believe you or a family member suffered neurological damage caused by Fixodent or Poligrip, the Rottenstein Law Group will evaluate your claim for free. RLG's lawyers have a total of more than 25 years of experience fighting for the rights of clients who have suffered harm due to the negligence of powerful corporations like Procter & Gamble.