Generic Drug Makers — Profit Without Responsibility

Gladys Mensing took metoclopramide, the generic form of Reglan, a nausea medication that was marketed and prescribed off-label for the treatment of reflux disease and other chronic conditions.  Unfortunately, use of metoclopramide or Reglan for more than a few months can cause patients, like Gladys Mensing, to develop severe and debilitating neurological disorders known as tardive dyskinesia.  This movement disorder includes involuntary movements of a patient’s limbs, facial tics, weakness, inability to walk, and other disabling symptoms.  In reference to her grandmother’s disease, Roxanne Mensing stated, “it’s really taken a hit on all of us, and her especially.”  Mensing hoped that justice would be served and the manufacturer, Pliva, would be held liable for failing to adequately warn of the risk of tardive dyskinesia, especially when the drug is taken for more than a few months.

But Mensing did not receive justice.

The Supreme Court of the United States ruled on June 23, 2011, that federal law makes generic drug manufacturers immune from liability for failure-to-warn claims under state law because the generic manufacturers alone do not have the power to change their labels.

State tort law requires that a drug manufacturer that is aware or should be aware of a product’s dangers must label their product accordingly.  However, the FDA requires that generic drugs must have the same warning labels as their brand-name counterparts.  The manufacturer alleged that they were unable to change the warning label because it would then differ from the brand-name version of the drug.  The court sided with the manufacturer and held that the FDA requirement preempts state law.

So what does this mean for those who have been injured by the generic form of a drug? If their pharmacist filled their prescription with a generic form instead of the brand-name, they are out of luck.  According to Justice Sotomayor’s dissenting opinion, this decision will affect 75 percent of all the prescription drugs in the country.  As a patient, do you want to take drugs manufactured by a company who has legal immunity or one that will be held responsible for providing adequate warnings for their products?  The final chapter in this area has not yet been written, and one can only hope that Congress and the FDA will find a way to close this legal loophole and ensure that personal responsibility applies not only to patients but also to generic drug manufacturers who should not enjoy this legal immunity, especially when their products have the potential to cause great harm to patients.