Walgreens Listed as Defendant
In Michigan, 70 plaintiffs have filed suit against companies that failed to warn them of risk of tardive dyskinesia, the neurological movement disorder side effect of Reglan.
In addition to the drug makers, Walgreens, the national drug store chain, is listed as a defendant.The plaintiffs say Walgreens should have provided notifications once their medication regimen exceeded 12 weeks, the maximum length of time one should be on Reglan.
Patients who take Reglan long-term (12 weeks or more) are at higher risk for developing tardive dyskinesia, a neurological disorder that causes involuntary movements, like tongue thrusting, grimacing, and rapid blinking. There is no cure for tardive dyskinesia, and medications to help control the movements can be expensive.
Almost 1000 Reglan Lawsuits in NJ
As of April 2, 2011 the New Jersey State Court system has almost 1000 Reglan lawsuits centralized before Judge Carol Higbee. The majority of the 983 Reglan cases were filed since February 1, 2011. In February 2009, the FDA required that Reglan and any generic versions of it add a “black box” warning. This is the highest warning the FDA issues. The purpose here is to inform patients and doctors of an increased risk of a tardive dyskinesia (TD) side effect. If used at high doses or over a long period of time, patients may develop TD, a disorder that causes involuntary movements of the face, such as grimacing, tongue thrusting, and rapid eye movements. There is no cure for this condition.
The sudden increase in lawsuits may have to do with a state law that requires claims to be filed within two years of a cause of action. Reglan lawsuits continue to be reviewed and filed by attorneys in other states, as laws can vary state to state.
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.