Philadelphia Judge Overturns Supreme Court’s Generic Reglan Decision in Lawsuit

Richard Burke | February 17th, 2012

The U.S. Supreme Court ruled in June that consumers may not sue generic drug makers under state laws for failing to warn drug side effects so long as warnings on generic labels are identical to those of their brand name counterparts. In his majority opinion, Justice Clarence Thomas said that the state laws under which such lawsuits are brought conflict with and are therefore pre-empted by federal generic drug regulations. But, despite this ruling, Philadelphia Common Pleas Court Judge Sandra Mazer Moss denied a bid by generic manufacturers to dismiss claims against them in Reglan lawsuits currently proceeding in Pennsylvania mass tort.

Reglan side effects

Reglan is used for treatment of gastrointestinal disorders. It contains metoclopramide, which works by increasing the movement of stomach muscles, speeding up the rate at which the stomach empties into the intestines. When metoclopramide-containing drugs are used at high doses or for extended periods of time, it can increase the risk of developing tardive dyskinesia resulting from Reglan, which is associated with involuntary movements, such as: movements in the body extremities, lip smacking, grimacing, repetitive chewing, pursing and puckering of the lips, tongue protrusion and rapid eye movements or blinking. Side effects from Reglan were not properly researched and evaluated by the drug makers and inadequate warnings were provided about the risk of developing this movement disorder, especially when the drug is used long-term.

Reglan only approved for short term use

Although Reglan is marketed for treatment of conditions that are often chronic and long-term problems, the medication is only approved for use of less than 12 weeks.  Since there is little benefit in treating a long term condition with a short-term treatment, many doctors continue their patients on the medications for more than three months.  In fact, about 30% of all prescribed metoclopramide drugs are taken for more than 12 months. The impact of this ruling by Judge Moss can lead to the successful filing of suits against generic manufacturers, something that had previously seemed out of reach, due to the Supreme Court’s ruling. So far, judges like Judge Moss are siding with plaintiffs when it comes to generic Reglan litigation—at least as far as pre-trial proceedings go.