Washington (CNN) — Two women who say they suffered severe medical complications from a generic drug lost their Supreme Court appeal Thursday, essentially ending their separate lawsuits against pharmaceutical manufacturers.
The justices in a 5-4 ruling said generic drug companies do not share the same level of responsibility as makers of brand-name equivalents, to update their warning labels when significant new risks emerge.
The financial and safety implications from the court’s ruling, could prove enormous. Generic drugs currently account for more than 70% of prescriptions filled in the United States. That number is expected to rise in the coming years, with patent protection due to expire on several popular and lucrative consumer drugs, including Lipitor and Viagra. The blockbuster health care reform bill championed by President Barack Obama would also encourage greater use of generics. About a third of generic drugs have no brand name competitors.
The court split along conservative-liberal lines. “It is beyond dispute that the federal statutes and regulations that apply to brand-name drug manufacturers are meaningfully different than those that apply to generic drug manufacturers,” said Justice Clarence Thomas. “Indeed it is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing drugs more quickly and cheaply to the public.”
In dissent, Justice Sonia Sotomayor countered, “These divergent liability rules threaten to reduce consumer demand for generics… Nothing in the court’s opinion convinces me that, in enacting the requirement that generic labels match their corresponding brand-name labels, Congress intended these results.” Justices Ruth Bader Ginsburg, Stephen Breyer, and Elena Kagan supported Sotomayor.
Gladys Mensing of Minnesota and Julie Demahy of Louisiana both were prescribed metoclopramide — marketed as Reglan by Wyeth Pharmaceuticals — to treat their heartburn and acid reflux. Their pharmacists separately filled the prescription with a generic equivalent made by PLIVA, Inc. and Actavis, Inc.
After four years of taking the drugs, the women each developed tardive dyskinesia, a severe longterm neurological disorder that causes involuntary muscle movements.
They sued the generic manufacturers of the metoclopramide, claiming that inadequate warnings were provided about the long-term risks of taking the medicine. It was also alleged there was growing evidence of the dangers posed by the drug, but that the companies took no steps to change the warning labels.
In 2009, the FDA acted on its own and issued an order to the makers of both brand-name and generic versions of metoclopramide to add a specific warning about the increased risks of developing tardive dyskinesia.
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