In a 5-4 decision, the US Supreme Court dealt victims of defective generic drugs a major blow when they sided with manufacturers over what is said, or unsaid, in labels. In essence, the Court has decided that the companies cannot be sued under state law over their abject failure to provide adequate warning labels about side effects.
The case specifically involved two women who were taking generic versions of Reglan. The drug metoclopramide is taken for nausea, heartburn, and vomiting. It can also cause a neurologic disorder known as tardive dyskinesia. This disorder causes involuntary and repetitive movements of the body, such as lip smacking, grimacing, tongue protrusion, and more.
The women first began taking the drug when the labeling stated “therapy longer than 12 weeks has not been evaluated and cannot be recommended.” In 2004, the warning was changed to say that users should not exceed 12 weeks of therapy. In 2009, the FDA ordered the warning to list specifically that it caused tardive dyskinesia, and it should be added to Reglan and metoclopramide.
The US Supreme Court overturned a US appeals court ruling that the women could sue Israel’s Teva Pharmaceutical Industries Ltd., Mylan Inc’s UDL Laboratorie,s and Iceland-based Actavis Inc. The companies argued federal law barred lawsuits because the drug was already approved by the FDA. Federal law states that generic drugs must contain the same labels as their brand name equivalents. Thus, generic drugs have received the same pre-emption shield that other companies get.
This is a serious setback not only for the many victims of metaclopramide, but for all those who may be injured in the future by generic drug side effects. Since 70 percent of drugs used in the US come in the form of generics, this will not be the last we hear of individuals injured by defective drugs.
If you or a loved one has been seriously injured or made ill by a dangerous drug, please contact an experienced defective drug attorney in your area for an initial consultation.