Recalled drugs have the potential to cause serious harm if used. The FDA identifies several kinds of defects giving rise to the recall of drugs. Some of these defects include lack of sterility, sub-potency, incorrect labeling, wrong ingredients or contamination with bacteria or some particulate matter. Other drugs are recalled because they have been unapproved as a new drug or contain undeclared drugs.
When a drug has been recalled, either by order of the FDA, by FDA request, or at the initiative of a drug company, it will be listed as a Class I, Class II, or Class III recall. On its website, the FDA lists recalls, many of which are Class I, which is the class of recalled drugs most likely to cause harm when used. As defined by the FDA, a Class I recall means “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Unfortunately, not all drugs with defects will be promptly identified before causing harm to a consumer. Some drug companies or firms may fail to report defects to the FDA or request a recall. Other drug recalls have been reported but are pending classification. These are published “in an effort to expedit[e] notifications of human drug product recalls.” The seriousness of these recalls may range from Class I to Class III.
Notwithstanding this effort to recall defective drugs, there may be a lack of communication when it comes to informing the people who use or consume the drugs. As reported by U.S. News customers must be notified of drug recalls, but a customer may be defined as “a pharmacy, physician, insurance company, pharmacy benefit manager or other entity.” This disconnect between the definition of a customer and the identity of the consumer who takes a drug reveals an additional layer of risk and vulnerability to consumers who take drugs that are subject to recall.
Attorneys and consumers can work together to obtain relief for users who have been harmed by defective drugs. While it may not be easy to identify a defect after use, consumers and their attorneys can review the FDA website and publications to stay informed.