Last week, the Rottenstein Law Group discussed how companies like GlaxoSmithKline and Procter & Gamble can be made to pay Poligrip and Fixodent lawsuit settlements despite the fact that they are in compliance with Food and Drug Administration (FDA) safety guidelines for denture creams. In this post, RLG will answer the question of whether the FDA itself can be held liable for damages caused by denture adhesives.

Denture creams are considered Class I medical devices by the FDA, meaning they pose minimal health risks and are subject to the least amount of regulatory oversight. As a result, most Class I devices are not required to undergo clinical testing or list product ingredients. One consequence of denture cream's Class I status is that it did not name zinc as an ingredient when it was added to denture creams beginning in the 1990s. Zinc, as you probably already know, is associated with a number of health risks when it is consumed in large amounts, including neurological and blood disorders. Although research has only recently linked zinc with severe side effects, researchers have long known that excessive zinc intake can cause a copper deficiency, which can lead to nerve damage. But because consumers and the medical community were not aware that zinc was contained in many leading denture pastes, even when patients were exhibiting symptoms of neurologic impairment, its source remained unknown.

One might reasonably wonder, then, whether reclassification of denture cream by the FDA could have prevented people from suffering debilitating injuries from products like Fixodent and Poligrip. Because data linking zinc to health problems did not surface until 2008, the FDA could not have reasonably been expected to know about the risks of denture adhesives prior to then. But even now, after multiple studies linking denture cream to severe side effects have been published, the FDA has failed to reclassify the adhesives. Does that mean that federal agency can be held liable through a lawsuit for injuries?

While the argument can be made that the FDA should upgrade the classification of denture cream and subject it to more rigorous regulatory standards, the FDA cannot be targeted in a product liability lawsuit. The responsibility of ensuring a product is safe for consumers ultimately lies with that product's manufacturer. In the denture cream lawsuits against GSK and P&G, plaintiffs have argued that the companies are negligent because they failed to warn of their products' side effects. Similar charges, however, cannot be leveled against the FDA. At most, the agency could be petitioned to demand greater scrutiny of denture pastes. And the FDA does have the power to demand that product manufacturers perform safety testing on their products, a power that officials say it may eventually exercise with regards to denture cream.

To summarize, only a manufacturer such as GlaxoSmithKline or Procter & Gamble can be sued for losses resulting from a denture cream injury. If you believe you or a family member suffered neurological damage caused by Fixodent or Poligrip, the Rottenstein would like to help you file charges against a blameworthy company.

To find out for free whether you are eligible for a Fixodent lawsuit settlement.