Denture cream is a Class I medical device, meaning it is qualified as “low risk” by the U.S. Food and Drug Administration. This classification, however, seems inadequate after the publication of studies over the past two years that provide strong evidence linking the zinc in denture creams such as Fixodent, made by Procter & Gamble, and Poligrip, manufactured by GlaxoSmithKline, to severe neurological problems. Although Class I medical devices are not subject to stringent safety controls such as clinical trials, manufacturers still must adhere to basic requirements, including manufacturing controls and, as stated by the FDA, “labeling that is neither false nor misleading.”
It is questionable whether P&G and GSK have lived up to this last safety measure. Judging by the numerous lawsuits filed against the company by injured consumers, they have not. The plaintiffs in such lawsuits are denture cream users who developed nerve damage that they allege could have been prevented if the manufacturers of Fixodent and Poligrip had clearly warned of the dangers of zinc toxicity posed by using their products. Although both companies argued that moderate use of denture cream was not risky, GSK was by far the more proactive of the two companies, as it removed the zinc from its popular Poligrip lineup. P&G, arguing that Fixodent only contains half the zinc as Poligrip, still sells products containing the mineral. But given the fact that neither manufacturer even listed zinc as an ingredient on product labeling before the publication of a landmark 2008 study, both may have a difficult time convincing courts of their concern for public safety.
The study, conducted by researchers at the University of Texas Southwestern Medical Center in Dallas, was the first to establish a direct link between the zinc contained in denture cream and the development of neuropathy, a serious nerve disorder. The subjects of the study were four patients who shared the following characteristics: all had symptoms of nerve damage, high levels of zinc in their blood (hyperzincemia), low levels of copper in their blood (hypocupremia), and all were denture wearers who used unusually large amounts of denture cream. After evaluating extensive clinical and laboratory data that was compiled for each patients, the doctors concluded that zinc ingestion by way of denture cream use was the only logical explanation for the patients’ neurological problems. These findings were subsequently published in the scientific journal “Neurology.” The following year, Dr. Peter Hedera of Vanderbilt University conducted a study that also linked high, unexplained zinc levels to heavy denture cream use.
These findings, while certainly the first to connect the zinc in denture cream to nerve damage, merely confirmed research from years past that established the health risks of zinc poisoning. Healthy and even necessary in small doses, too much zinc can lead to copper depletion. Researchers have known this since the 1950’s, and last decade linked zinc, copper deficiency, and neurological problems. But the most recent findings by the University of Texas and Vanderbilt researchers takes these findings a step further, as they connect a product used by 30 million U.S. consumers to a life threatening condition.
Perhaps if GlaxoSmithKline and Procter & Gamble had warned the public about the risks of zinc toxicity, the many individuals who have developed the debilitating side effects of neuropathy could have been spared a lifetime of pain and suffering. For starters, they could have bothered to name zinc as an ingredient in their denture creams before the publication of scientific research forced their hands. For companies that spend millions of dollars each year on research and development, it seems implausible that they were unaware of the relationship between zinc and nerve damage. According to Dr. Hedera, the Vanderbilt neurologist who authored the 2009 study described above, such information is nothing new. “If you researched the field, you would find out,” he said.
As lawsuits continue to be filed against GSK, P&G, and other denture cream manufacturers, it will be up to the courts to decide whether these companies should have reasonably known about the potential health risks of their products, and whether they failed to properly warn of dangerous, life-threatening side effects. And it will be up to the lawyers of representing injured plaintiffs to provide evidence to the contrary.
If you are a denture cream user who developed zinc poisoning, hypocupremia, hyperzincemia, neuropathy, or other health problems related to zinc poisoning or depleted copper levels, the quality of your legal counsel could very well be the key to obtaining compensation to cover your medical bills, lost wages, and other damages. The Rottenstein Law Group has more than 25 years of experience taking on large corporations on behalf of injured clients. We treat you with the respect and sympathy you deserve while delivering the tenacious representation needed to hold a company like GlaxoSmithKline or Procter & Gamble accountable.
Have you experienced complications from using Poligrip as your denture cream? Learn more about Poligrip lawsuits and see what you can do.