Generic Reglan Did Not Have Updated Labels

Julie deMahy from Slidell, LA is one of the women whose lawsuit has been presented to the US Supreme Court to determine if generic drug makers can be held accountable for warning of dangerous side effects.

In 2001, Julie deMahy was diagnosed with acid reflux disease and prescribed metoclopramide a generic name for Reglan. The drug worked great, relieving her of heartburn and acid reflux.  Julie went off the drug a few years later. 

After that, “her shoulders, right arm and head began to shake violently. She involuntarily blinked excessively and struggled to speak and write.”  (Associated Press)

A neurologist in Dallas asked her diagnosed tardive dyskinesia as a consequence of ingesting metoclopramide for an extended period of time.

She can no longer work effectively or drive safely and is now on a regimen of medication to help control the shaking and involuntary movements.

Her attorneys brought suit against Actavis, Inc, maker of the generic drug she took.  At the time, the label described tardive dyskinesia as a rare side effect.  But in actuality, at that point in time, there had already been medical studies showing that the risk was substantial–up to 20% of patients using it long term suffer this disorder.  

The drug makers contend that they were unable to change or update the warning labels because of a regulation that requires generic drugs have exactly the same label as their brand name counterparts.