Minimal Concern Expressed by FDA over Poligrip Lawsuits
(New York, NY, February 9, 2011) The Food and Drug Administration (FDA) is not saying much about recent revelations that denture creams containing zinc can cause neuropathy, a disorder of the peripheral nervous system. This despite an ever-growing group of victims in the United States and Canada who have begun taking action against denture cream manufacturers GlaxoSmithKline and Procter & Gamble in the hopes that a Fixodent or Poligrip lawsuit will result in compensation for harms suffered.
Denture creams became available 30 years ago and were classified as Class I medical devices by the FDA, meaning that their ingredients were not required to be listed on their packaging. Zinc has since been added to denture cream formulations to assist in adhesion and to inhibit odors. Researchers and physicians have known for decades that high levels of zinc deplete the body of copper and can potentially cause nerve damage. When zinc was added to Poligrip and Fixodent denture creams in the 1990s, their risk profiles were never updated by the FDA. Hence, the FDA has failed to demand that appropriate warnings be issued by the manufacturers, or that their products should be recalled for reformulation. What the FDA did do is issue a statement identifying the manufacturers’ responsibilities, which include, “adverse event reporting, manufacturing controls, and labelling that is neither false nor misleading.” An argument can be made that denture cream labels are misleading, since they are not, in any way, warning consumers about the potential dangers of zinc. Fixodent and Poligrip lawsuits could prove that GSK and P&G are indeed at fault for not disclosing this information to consumers.
Consumers are urged to consult their physicians to see if their use of denture cream has caused them any harm. Since medical professionals may not be aware of the inclusion of zinc in denture creams, patients should advise of their use in order to obtain an appropriate diagnosis. The Rottenstein Law Group has set up a Web site to keep consumers updated on the details of this situation, and to help them determine whether they are eligible to participate in a Fixodent or Poligrip lawsuit.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.
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