Companies that make food, drugs, and medical devices are required to comply with U.S. Food and Drug Administration (FDA) regulations, which vary depending on the type of product and its intended use. The FDA classifies medical devices into one of three categories based on their associated risks. For example, a Class I device such as dental floss is considered low risk and is only minimally regulated , while a Class III device such as replacement heart valves has many potential risks and is therefore highly regulated.
There are instances, however, where a "low risk" device is actually quite dangerous. It could be the case that a product's hazards were unknown when it was classified, or else a product's composition has changed, making it more dangerous, but its classification was never updated to reflect this shift. Whatever the case may be, when a minimally regulated but dangerous product does not receive the scrutiny and warnings a more strictly regulated product does, great (and unexpected) harm can befall users.
Such is the case with denture cream, classified as a Type I medical device by the FDA but recently found to be a potential source of debilitating nerve damage. Denture cream received its low risk classification more than 30 years ago, but manufacturers only started adding zinc to it in the 1990s. And because Class I devices are not required to list ingredients on the label, the public was not aware that the mineral was contained in denture cream.
This is a problem because zinc, though necessary in small doses, is toxic when too much is consumed. Zinc can caused the body to purge itself of copper, a lack of which can cause severe nerve damage known as neuropathy that has side effects such as numbness in the extremities, difficulty walking, paralysis, and death. The link between zinc toxicity, copper deficiency, and nerve damage has been well documented for decades, but only in 2008 was it discovered that the zinc in denture cream could cause neuropathy. These findings have led to hundreds of lawsuits being filed against manufacturers such as GlaxoSmithKline (which makes Poligrip) and Procter & Gamble (maker of Fixodent).
You may have a claim pending against one of these companies, or are considering taking legal action, and rightly wonder about the following question: If GSK and P&G did not violate FDA regulations, can they be held liable for the harm caused by their products? The answer is "Yes." Although the FDA is one of the primary regulators of consumer products, it is not the sole authority. A product that complies with FDA regulations can therefore still cause legally recognized (and compensable) harm.
A product that has an inherently dangerous design or a flaw in the manufacturing process is obviously defective. But a product can also be defective if any of its features make it unsafe for an intended use or an anticipated misuse. A so-called "marketing" defect may exist if a product does not come with sufficient warning of its dangers or instructions that specify safe use.
When applying this reasoning to denture cream, it is clear that manufacturers had a responsibility to know that using too much of their product could cause zinc toxicity and catastrophic injury and warn about such risks. So while not listing zinc as an ingredient may let them off the hook with the FDA, failure to provide instructions about not ingesting large amounts of denture cream (something they finally did only after the pressure from lawsuits mounted) could very well make them blameworthy in the eyes of the law.
Until lawsuits against GSK and P&G go to trial (the first of which is scheduled for June 6), it's impossible to say how the courts will rule. It is reasonable to assume, however, that they will find that these manufacturers should have reasonably known about the health risks posed by zinc toxicity and made strides to prevent consumer injury.
Any further questions about a possible Fixodent or Poligrip lawsuit can be directed to the lawyers of the Rottenstein Law Group. With more than 25 years of experience handling product liability claims, our attorneys know what it takes to succeed against a large corporate interest. For a free evaluation of your case, start by filling out this form.