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Defects in drugs aren’t always about chemistry


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When Texas residents think about defective products, they likely picturing items that have some kind of physical problem with the product itself, such as a design or manufacturing defect. This is especially true when it comes to prescription medications. When the topic of ‘defective drugs’ comes up, it is common to think of drugs that don’t do what they are supposed to, or contain chemicals they are not supposed to contain. However, there is a type of defect that can occur that is as dangerous, and possibly more common when it comes to pharmaceuticals: defective labeling or instructions.

The federal Food and Drug Administration is charged with regulating the manufacture, marketing and sale of medication in the United States, and one of the things it does is require certain labeling on drugs to adequately warn potential consumers of the risks inherent in taking the medication or abusing it. For example, in March of this year, the FDA updated its labeling requirements for Immediate Release opioids. These drugs come from the same base as heroin and include pain killers such as Oxycodone, Hydrocodone and Morphine. Because of concerns about addiction and overdoses from these drugs, new warnings are required on boxes regarding the potential effects of using or misusing these powerful medications.

So what does this have to do with defects? Well, while an improperly manufactured opioid could be dangerous, so too can one that was manufactured correctly but improperly used. Generally, we want Texas consumers to be aware of how the drug is meant to be used, and the potential consequences of misuse. Thus, the warnings on the labels of these products. If a manufacturer were to leave off the labelling entirely, or substantially alter its meaning, a person may use the medication without knowing how much to take, when to take it or what could happen if it is too much is taken or it is taken too frequently. This can lead to serious injury or death.

So, when we think about defective drugs, we need to imagine not only problems in the chemical make-up of the substance, but also potential defects in the instructions and labelling for how to consume such medications.

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