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Generic Drug Makers Can't Be Subject to State Labeling Lawsuits


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Generic Drug Makers Can't Be Subject to State Labeling Lawsuits

The Supreme Court has ruled that generic drug manufacturers can't be subject to state lawsuits alleging they failed to properly label side effects. The court rejected all debates that claimed drug manufacturers Teva Pharmaceutical Industries, Mylan and Actavis had failed to properly warn consumers about the contents of their drugs, Reuters reports.

According to Justice Clarence Thomas, federal law, which requires generic drugs to have the same warning labels as their brand-name counterparts, preempted any state lawsuits.

"The Supreme Court hit the nail on the head today by making clear that federal law does not permit states to hold generic drug manufacturers liable for using the very warnings federal law required them to use," explains Jay Lefkowitz, an attorney representing Teva.

According to the CEO of Actavis, Doug Boothe, the Food and Drug Administration should now look to regulate the medicinal label structure - which has not been updated since the 1980s. Boothe says the current structure is "incompatible with the realities of the 21st century healthcare marketplace," and the FDA should make an effort to ensure the rule reflects the changes that have taken place in the past several decades.