Producers of food, drugs, and medical devices must comply with regulations promulgated by the U.S. Food and Drug Administration (FDA). These regulations vary, depending on the type of product and its intended use. For example, the FDA classifies medical devices according to their associated risks into one of three categories. Class I devices (products such as dental flosses) are considered low risk and are subject to minimal regulation, while Class III devices (such as replacement heart valves) carry much greater risks and are subject to high levels of regulation.
Sometimes, however, even a product that is considered “low risk” by the FDA can turn out to be dangerous. And when it does, because it is minimally regulated and may not have the warnings that a more strictly controlled product does, it can result in great (and unexpected) harm to users.
One type of Class I medical device for which this is true is denture cream. Denture cream manufacturers such as GlaxoSmithKline (which makes Poligrip) and Procter & Gamble (maker of Fixodent) started adding zinc to their products in the 1990s to aid in adhesion and odor control, but did not list the mineral as an ingredient because according to the FDA, Class I medical devices are not required to list product ingredients on their labels.
Zinc, while required by the body in small amounts, can lead to copper deficiency and in turn, nerve damage, when consumed in great quantities. As a result, many denture cream users have developed a debilitating disorder called neuropathy that can cause numbness in the extremities, a loss of motor skills, paralysis, and death. Although researchers have known for decades about the link between excess zinc, copper deficiency and nerve damage, it wasn’t until the publication of a 2008 study in the journal Neurology that a definitive connection between the zinc in denture cream and neuropathy was established. With science on their side, hundreds of injured denture cream users are now taking legal action against GSK and P&G.
But a common concern among denture cream litigants (and potential litigants) is this: If denture cream manufacturers were in compliance with FDA regulations, can they be considered blameworthy for the harm their products cause? The answer is “Yes.” The FDA is an important authority on the regulation of consumer products, but not the only one. A product can still be in violation of the law even if it complies with the FDA’s rules.
The most obvious types of product defects are those related to an inherently dangerous design or a flaw in the manufacturing process. But a product can also be considered defective if has any feature that makes its unsafe for an intended use or anticipated misuse. A third type of defect, a so-called “marketing” defect, could be said to exist if a product does not provide ample warning of its dangers or does not have proper instructions for safe use.
In terms of denture cream, GSK and P&G had a responsibility to understand and express the risks of its products. It is reasonable to expect they would know that zinc, when consumed in high doses, could be dangerous, and warn about misusing denture cream (in other words, using it in large amounts). But not only did these manufacturers fail to list zinc as an ingredient, they did not (until recent pressure from lawsuits caused them to) specify how much denture cream to use, and some people applied huge amounts of the cream and ended up suffering nerve damage.
Until denture cream cases go to trial, it remains to be seen how the courts will rule on a manufacturer’s duty to consumers, and whether or not they are blameworthy for harm suffered. But it seems likely that courts will find that GSK and P&G should have reasonably known of the dangers of zinc poisoning and taken measures to reduce its risks. If you have any more questions on this matter, or want to speak with a lawyer about pursing a denture cream lawsuit settlement, contact the Rottenstein Law Group. Our experienced product liability attorneys are currently providing complimentary evaluations of denture cream claims. To get started, fill out this form or call 1 (888) 976-8529.