Generic Pharmaceutical Liability: Challenges And Changes

Law360, New York (October 24, 2012, 4:56 PM EDT) -- Generic pharmaceutical manufacturers were rewarded for their patience in the summer of 2011. They had been waiting anxiously to see how the U.S. Supreme Court would rule in two consolidated cases, which presented the question of whether federal law preempts state law product liability claims against generic drug manufacturers.

The court ruled in their favor, finding that the U.S. Food & Drug Administration labeling regulations preempt state law failure-to-warn claims. The court’s ruling provides generic manufacturers with significant protection against failure-to-warn cases, even as practitioners still...
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