The Food and Drug Administration approves a prescription drug when it determines the drug’s benefits outweigh the risks upon public release. However, there are cases when the FDA and drug manufacturer will not know of serious side effects until the drug has been put on the market. Clinical studies involve thousands of individuals testing a drug, but those numbers are small compared to the number of people taking the drug once it’s on the market.
The term “off label” means a drug is used for reasons other than for what the FDA approved it. A doctor may legally prescribe drugs for off-label purposes; however, it is against the law for drug manufacturers to advertise or promote drugs for unapproved use or to alter information about a medication’s off-label benefits.
Defective-drug cases are commonly litigated in class actions. Class-action lawsuits involve an individual or a group that shares common legal issues for bringing a lawsuit for harm or wrongdoing. This allows for one or more representatives to file suit for a class of people when the legal issue at hand is common to all members of the class and when the number of people affected is so numerous that it becomes impractical to bring them all before the court individually.
Legal claims have been brought in relation to the prescription drugs and medical devices listed to the right.