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Someone told me that manufacturers of generic drugs can’t change the warning labels on their medications. Is that true? What does it mean for me if I’ve been hurt?

Currently, that is true. The makers of generic medications cannot make changes to their warning labels until the maker of the brand name drug has done so. According to a 2013 ruling by the United States Supreme Court, this gives the makers of generic drugs some immunity from lawsuits brought by patients who claim they were injured by a company’s failure to warn of potential dangers on the label.

How Is That Fair?

There are many people who believe that preventing generic drug manufacturers from changing warning labels (along with the protection they get from potential lawsuits) is unfair. In November 2013, the FDA proposed a new rule that would allow generic drug manufacturers to update their warning labels when they have new safety information about their medications. If adopted, the rule could put generic drug makers at increased risk of facing failure to warn lawsuits and pharmaceutical class action lawsuits for harm done to patients. Not surprisingly, many generic drug makers are opposed to the rule. A final rule has not been issued as of October 6, 2014.

If You’ve Been Hurt, Then You Need to Know More About Your Rights

You may be able to recover for the harm that has been done to you if you’ve been hurt by a prescription drug. However, first you need to know more about your rights. Please watch our free videos and start an online chat with us today to find out more information.

Jason F. Abraham
Managing Partner, Hupy and Abraham