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FDA Rule Could Open Door for Lawsuits Against Generic Drug Makers

Filed July 5th, 2013 Joshua Sophy

Federal health regulators have proposed a new rule that would allow makers of generic prescription drugs to alter safety and warning labels on their products.

If this rule passes, it would likely allow people who’ve been prescribed these generic drugs to pursue legal action against these companies in the event they are injured or suffer serious side effects while taking the drug. Under current rules, enforced by a 2011 Supreme Court ruling, generic drug makers are essentially exempt from legal action filed by the people who are prescribed the drugs.

According to a New York Times report this week, the U.S. Food and Drug Administration (FDA) has proposed a rule that would allow generic prescription drug makers to make their own changes to the safety labels. Currently, the FDA prohibits generic drug makers to make changes to labels. The label on a generic drug can only be changed when the maker of the name-brand version of the drug makes those changes. Making it even more difficult to hold generic drug makers accountable, the Supreme Court ruled that in addition to injury claims, a generic drug maker could also not claim the drug was defectively designed.

The New York Times reports that this proposed rule change could result in a raft of lawsuits against makers of generic prescription drugs. Since the 2011 Supreme Court decision, dozens of lawsuits against these companies have been dismissed.

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