Supreme Court Rules Against Patient Injured by Generic Drug ? Toledo personal injury attorney

The case of PLIVA Inc. v. Mensing involved Ms. Mensing was suing the manufacturer of the generic drug, metoclopramide. She said that they failed to warn her in her developing of tardive dyskinesia, which is a disabling neurological condition. PLIVA argued that there was a conflict between state and federal law that dismissed the suit in state court and that under the Hatch-Waxman Amendments that generic drugs are approved once they have the same active ingredients, are bioequivalent in terms of the subscribers absorption in the body, and the packaging has warning and labeling that matches the name-brand’s word for word. So there for could not change any warnings on their packaging. Ms. Mensing then argued that with the “Changes Being Effected” CBE regulations that a generic manufacturer can change warning before approval by the FDA. She also stated that the manufacturer admitted to not taking the steps for a stronger warning to the FDA.

 

The Supreme Court sided with the manufacturers because of they by federal law could not change the warning labels from the name-brand product even with the CBE process.

Many think that this is bad news for patients who take generic products, because 70% of prescriptions are generic drugs and this could lead to millions of people being injured from this.

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