Generic Drugs Saved From State Lawsuits

A Supreme Court ruling on Thursday announced that people may not sue manufacturers of generic drugs under state laws despite thinking that the generic drug label did not adequately warn consumers of the possible side effects.

The Teva Pharmaceutical Industries Ltd, Actavis Inc, and Mylan Inc all went out victorious in three consolidated lawsuits against them due to the Supreme Court ruling released Thursday.

The Plaintiffs argued that they suffered from Tardive dyskinesia – a neurological disorder resulting to involuntary and uncontrollable repetitive body movements – after taking the generic drug metoclopramide. The insisted that the drug they bought were not adequately labelled and did not warn them on the possibility of such side effects.

Evidence started to surface in 1985 that long-term use of the said generic drug could have very serious side effects; however, strong warnings in the drug labels were only added by FDA in 2004 and 2009. It was only in 2009 that FDA ordered a specific box label warning that says long term use of metoclopramide may lead to tardive dyskinesia…it should not be used longer than 12 weeks except in rare cases when it is necessary.

The plaintiffs were prescribed the generic drugs even before the label was issued in 2009 but they strongly believe that the state should have taken more actions to protect their consumers. They said that since substantial evidence long suggests that long-term use of the drug is harmful, the state should have done something about it.

The Supreme Court decided in favor of the drug manufacturers because the federal law states that generic drug labels should follow the brand name labels they are copying. Doing otherwise is a violation of the federal law.


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