• 15
  • September
    2010

 

 

Over 500 lawsuits have been filed in the state courts of  Pennsylvannia and California, alleging neurological damages as a result the use of the drug Reglan.  Plaintiffs maintain that Reglan which is used to treat GI problems like Gastroparesis and GERD is responsible for causing Tardive dyskinesia and Dystonia. Tardive dyskinesia is a movement disorder which can produce involuntary and repetitive movements, while Tardive dystonia causes sustained muscle contractions. Tardive Dyskesia and Dystonia are caused by drugs that block dopamine Neurotransmitters. Although many studies over the years have shown that Reglan has been associated with Tardive dyskinesia, it wasn't until February 2009 that the FDA put a Black box warning on Reglan regarding Tardive dyskinesia.

 

Wyeth was the original Manufacturer of Reglan, but since 2001 when they sold the drug to Schwarz Pharmaceuticals, many generic versions of Reglan have been available. The Generic manufacturers have tried to maintain that they were prohibited by law from changing their metoclopramide labels to warn about increased risk of Tardive dyskinesia.

 

Generic manufactures have argued that Federal law preempts them from changing their label and that the FDA wouldn't approve any such changes. But recent court rulings from the 5th and 8th circuit have ruled otherwise. The 8th circuit found that, " The generic defendents were not compelled to market Metoclopramide. If they realized their label was insufficient but did not believe they could even propose a label change they could have simply stopped selling the product. Instead, they are alleged to have placed a drug with inadequate labeling on the market and profited from its sales"