A federal appeals court has reinstated a lawsuit against the maker of a generic brand of ibuprofen. The lawsuit is on behalf of a child who suffered liver damage after taking the drug as prescribed after surgery. The case holds generic drug makers to the same labeling standard as makers of patented drugs. The case alleges failure to warn of ibuprofen risks by the drug maker. The court says the duty to warn applies to generic drug makers.
Drug Label Failed to Warn of Known Risk
Ibuprofen is a popular over-the-counter painkiller. The lawsuit says the drug is known to cause liver failure under some circumstances. The label contained no warnings about this potential side effect.
In 2009 the Supreme Court ruled drug makers can be sued for failing to warn of the risks of a medication even though the FDA has approved package or label warnings. This ruling makes clear the same standard applies to makers of the generic forms of the drug. Failure to warn is one of the main theories of product liability law.
By now everyone should be clear on the risks of liver damage associated with the two common aspirin alternatives. The FDA instructed drug makers to limit the amount of acetaminophen in prescription painkillers like oxycodone and hydrocodone. As this case shows, what you don’t know can hurt you.
By: Arthur Buono
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