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Denture Cream Litigation POLIGRIP and FIXODENT are over the counter denture adhesive products considered FDA Class I medial products which contain a form of zinc bonded to a chemical of unknown formulation. When these products are swallowed and exposed to the user's gastrointestinal tract, zinc in excess amounts is absorbed in the body's tissues, upsetting mineral homeostasis and resulting in depleted copper levels in the body. This copper depletion results in the development of severe neurological symptoms generally referred to as myelopathy or neuropathy and other complications including anemia and neutropenia. By the time these symptoms are noticed and associated with excess zinc and copper depletion, permanent neurological and other physical injuries have already been suffered by the user. While cessation of the use of these products generally results in a return to normal zinc and copper levels, symptoms generally do not improve. The former user is thus left with permanent, profound personal injuries and disabilities. The manufacturers, Proctor & Gamble and GlazoSmithKline, knew and understood that with foreseeable use of their product as a denture adhesive, some amount would be introduced into the gastrointestinal tract and metabolized. They were aware of the significant health risks caused by the amount of zinc and the stability of the zinc in the product, and the extent to which a mineral or heavy metal is absorbed. Prior to the time zinc was added to these products, it was generally known and accepted in the scientific community that excess zinc in the body could cause significant adverse health risks in human beings including the inducement of copper depletion and deficiency, i.e. hypocupremia. It was generally known and accepted in the scientific community that hypocupremia, particularly of a chronic nature, could cause a host of adverse health effects including neurological damage and injury, which is often profound and irreversible. Myelopathy due to hypocupremia is predominantly characterized by pain, weakness, parathesia, dysthesia and numbness of the hands and arms, feet and legs, resulting in sensory loss, loss of balance and ataxia, due to dorsal column dysfunction and lower limb spasticity. In many instances, myelopathy also progresses to anemia, leucopenia, motor neuron disease, peripheral neuropathy, optic neuritis, cognitive impairment, central nervous system demyelination and injury due to falls. The manufacturers consistently failed to warn consumers or their healthcare providers that myelopathy could result when zinc based denture adhesives, such as those products, are foreseeably swallowed and exposed to the user's gastrointestinal tract. During the years that zinc based denture adhesives were manufactured, marketed, and sold there were numerous case reports, studies, assessments, papers, and other clinical data that have described and demonstrated myelopathy associated with the use of certain zinc based denture adhesives. Despite this information, defendants repeatedly failed to adequately revise their package inserts, material safety data sheets, and other product related literature, and further failed to conduct appropriate post-marketing communications in order to convey accurate warnings. Back to Top |
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