The proposed rule change by the Food and Drug Administration "would be nothing short of catastrophic," said Ralph G. Neas, president of the Generic Pharmaceutical Assn., an industry trade group. It could raise healthcare costs and "create dangerous confusion" for doctors and patients, he said.
At issue is a legal loophole created by Supreme Court rulings that drew a sharp distinction between brand-name drugs and lower-cost generics, which are the same products but usually are marketed under their chemical names.
In 2009, the high court confirmed drug makers could be sued if they failed to warn patients that a brand-name drug carried a serious potential health risk.
The decision upheld a $7-million jury verdict for Diana Levine, a Vermont violinist whose lower arm was amputated after she was injected with an anti-nausea drug made by Wyeth. The drug sometimes caused gangrene if injected into an artery.
But the Supreme Court majority flipped when confronted with a generic drug that also caused a horrible side effect.
Last year, a 5-4 ruling tossed out a $21-million verdict awarded by a lower court to Karen Bartlett, a New Hampshire woman who was disfigured, badly burned and nearly blinded after she had a rare,...
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