Millions of Americans take a prescription drug and experience mild side effects or no side effects at all. But a drug manufacturer can face legal action if (a) a drug causes dangerous side effects; (b) a drug has a manufacturing defect; or (c) a drug has been marketed improperly.
Drug manufacturers have been sued for promoting drugs for unapproved uses, for understating the risk of taking a particular drug, and for concealing information from patients and physicians. A drug may be effective against diabetes, for example, but increase the risk of kidney disease. (The drug Actos has that defect.) If clinical trials revealed the elevated risk of kidney damage but the drug’s manufacturer concealed it, then the manufacturer may be legally liable if kidney disease develops. Class-action lawsuits against a drug manufacturer are filed several times a year, often because of such a concealed risk.
The Food and Drug Administration (FDA) regulates drug manufacturers, and as health hazards of a particular drug are discovered, the FDA may require the manufacturer to place revised warnings on the drug’s label, or it may withdraw the drug from use altogether. But besides government action, another means of protection that people have against defective drugs is the personal-injury lawsuit. Those suits deter manufacturers from marketing dangerous drugs, because they threaten a manufacturer with a large jury award.