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Generic Drug Preemption

There is an upcoming battle in the U.S. Supreme Court over generic drug preemption. The Supreme Court has asked the DOJ to file a brief about whether failure to warn claims can be brought against manufacturers of generic drugs. The generic drug manufacturers argue that their products have been pre-approved, and they should not really be responsible for knock-off products and their knocked-off warnings.

However, the contrary (and correct) trend of the U.S. District Courts, and now the 8th and 5th Circuit Courts of Appeals, is that Wyeth v. Levine controls and generic drug manufacturers may be sued based on state law for failure to warn.

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