Pfizer, the makers of the acid reflux drug Reglan, filed a rehearing request on February 19 that is asking the Alabama Supreme Court to reconsider one of its recent rulings that lets a plaintiff sue the brand name manufacturers of Reglan over the side effects linked to the generic version of the drugs. In the filing, Pfizer claims that “if the ruling is allowed to stand, it will drive business and jobs away from Alabama.”
This filing is in reply to a ruling the Alabama Supreme Court made in January. The ruling basically stated that brand name drug manufacturers can be held liable in failure-to-warn lawsuits over the side effects linked to their drugs, even if the plaintiff took only a generic version. The high court’s ruling was the result of a Reglan lawsuit that was filed by a man who developed tardive dyskinesia after taking the generic version of the drug and not the name brand version; both versions are known to cause tardive dyskinesia. Tardive dyskinesia is a neurological condition that is characterized by patients suffering from involuntary movements of the extremities, excessive blinking, lip smacking, grimacing and tongue protrusion.
When the high court ruled it wasn’t unfair to hold the brand name manufacturers liable, it stated that this was due to the fact that generic drug makers are required by law to duplicate the brand name warning labels exactly when creating their own. The FDA is currently thinking about changing that label requirement. All of these difficulties came about after one woman, Gladys Mensing, tried to sue Pliva, the makers of generic Reglan, after she developed tardive dyskinesia from taking the pills for an extended period time. The pills are only supposed to be used for periods lasting no more than 12 weeks. After the ruling in her case (her case was dismissed), the U.S. Supreme Court ruled that the lawsuits that were pending against generic manufacturers were dismissed all over the country.
Should the ruling made by the Alabama high court stand, injured users from generic meds will be allowed to name brand drug makers in Alabama under innovator liability.