A defective drug is a prescription or over-the-counter medication that causes physical, psychological or emotional injury. These injuries may be a result of a defect in the drug, or because of incomplete labeling or insufficient warnings.
Defective drugs can be either over-the-counter medications or prescription drugs. Sometimes it can take years to determine that a drug is dangerous. When this occurs, it is often too late for the people who have suffered as a result.
It is the drug manufacturer’s responsibility to authorize the appropriate tests before submitting the drug for approval by the Food and Drug Administration (FDA). A drug manufacturer must also include any potential side effects and warnings on the label, so consumers are made fully aware of any risks associated with that product.
Product liability laws hold the manufacturers, wholesalers, and distributors responsible for developing and dispensing defective drugs. A drug may be defective because of design flaws, manufacturing defects, and insufficient labels and warnings.
The FDA will investigate a potentially dangerous drug, and determine whether its side effects outweigh the drug’s intended benefits. When this happens, the FDA will issue a drug recall. Sometimes the recall will remove a drug from the market; other times the recall will require additional warnings on the labeling information.