A decision from the U.S Supreme Court about warning labels on generic drugs drastically restricts patients' recourse when they suffer serious harm from side effects not contained on the medicines' warning labels. The opinion acknowledged that the ruling is unfair to people harmed by generic drugs because, had they taken the brand-name drug instead, they would be able to pursue lawsuits against the manufacturers for failure to warn of the drugs' dangerous side effects.
Lawsuit Over Warning Consumers of Medicine's Side Effects
In the case before the Supreme Court, two women began taking metoclopramide, a generic version of the drug Reglan, to treat digestive tract problems. Court documents state that, after taking the medicine as prescribed for several years, both women developed tardive dyskinesia.
According to the National Institutes of Health, tardive dyskinesia is a neurological disease that causes involuntary, repetitive, purposeless movements. Symptoms of the disorder include:
- Rapid eye movements and blinking
- Grimacing
- Lip smacking, puckering and pursing
- Tongue protrusion
- Involuntary or impaired finger movement
- Rapid arm, leg or trunk movement
Soon after metoclopramide was approved by the U.S. Food and Drug Administration in the 1980s, the FDA began receiving reports of patients developing tardive dyskinesia after extended use. Studies have found that almost a third of patients who take metoclopramide for several years develop the disorder. In 2009, the FDA issued a warning against continued use of the drug to treat intestinal disorders.
Failure to Adequately Warn of Side Effect Risk
The women sued the generic manufacturer of metoclopramide, alleging that it caused them to develop tardive dyskinesia and that the warning label did not adequately warn of the risk of developing the disorder as a side effect of taking the drug. They cited state law requiring drug makers to update their warning labels with dangers of which they are or should be aware as the basis for their lawsuits.
The manufacturer countered that its warning label was exactly the same as the warning label on the brand-name version of the medicine, Reglan, and that federal law requires generic drugs' warning labels to match the brand-name drugs' warning labels. Therefore, even if it knew of an increased risk of developing tardive dyskinesia, it was bound by federal law not to change its label unless Reglan's label also was changed.
Eventually the case reached the U.S Supreme Court, which agreed to address the conflict between state law requiring drug labels to contain new warnings and federal law requiring generic and brand-name drugs' warning labels to be the same.
Federal Law Prevails Over State Law
The Supremacy Clause of the U.S. Constitution states that, whenever there is a conflict between federal law and state law, federal law must prevail. In this case then, Justice Thomas wrote in the majority opinion that the Supremacy Clause applies to resolve the issue in favor of the federal law requiring generic drugs' warning labels to be identical to the brand-name equivalents'.
This ruling is in contrast to a 2009 U.S. Supreme Court decision that held that FDA drug regulations do not prevent brand-name drug manufacturers from being sued under state law for inadequate warning labels.
The unfair result of these cases is that makers of generic drugs cannot be sued for failure to warn of dangerous side effects, but brand-name manufacturers can, leaving a patient's ability to hold a manufacturer accountable dependent upon whether he or she received generic or brand-name medicine. Considering that about 75 percent of prescriptions are filled with generic drugs, this ruling will have a significant impact and could seriously undermine drug safety.
Justice Thomas also wrote that, "We acknowledge the unfortunate hand that federal drug regulation has dealt" people harmed by generic drugs. However, "State law imposed a duty on the manufacturers to take a certain action, and federal law barred them from taking that action," and because federal law takes precedence over state law, the generic drug makers could not be sued for inadequate warning labels. In addition, the opinion noted that Congress and the FDA could change drug regulations to allow improvements in generic drug warning labels "if they so desire."
If you or a loved one suffered harm from a prescription medicine's side effects that were not adequately conveyed on the medicine's warning label or explained by the prescribing doctor, contact an experienced pharmaceutical litigation attorney. A lawyer with experience in failure to warn cases can discuss your legal options and help you obtain the relief you deserve.
