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Supreme Court Split on Challenge Regarding Generic Drug Labels


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Supreme Court Split on Challenge Regarding Generic Drug Labels

The Supreme Court is split on whether it should allow generic drug manufacturers to be sued in for allegations of inadequately labeling their medications. Manufacturers have sought protection from two liability lawsuits in which consumers are claiming they developed neurological disorders after taking the heartburn medication Reglan, according to the website AutomatedTrader.

According to Seattle PI, the federal law mandates that generic drugs have the same labeling as their brand name counterparts.

"I don't see how you can hold them liable, so long as they continued to give the warnings that they had to give," Justice Antonin Scalia said in regards to the generic drug manufacturers.

In response, however, Justice Sonia Sotomayor debated whether or not it seemed likely that Congress would establish a market in which consumers were able to sue only name-brand products. She said, if that were the case, why would consumers ever take a generic medication?

"When a company doesn't make appropriate disclosures to the FDA, even if people are hurt by that, even if it causes people to be injured and states might otherwise want to compensate them for them, those disclosure obligations are up to the FDA with its discretion to enforce," said lawyer Jay P. Lefkowitz, Seattle PI reported.