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Monsanto v. Durnell · ¶155

But Monsanto overstates the difficulty of adding a cancer warning to Roundup’s label. In PLIVA, Inc. v. Mensing, 564 U. S. 604 (2011), we explained how true impossibility works in the labeling context. There, a plaintiff alleged that a generic drug manufacturer had failed to include adequate warnings on its label. Id., at 610. Federal law, however, required the label on a generic drug to match exactly the label on the brand-name drug. Id., at 612–613. So, for a generic manufacturer to add a warning, it would have to ask the FDA to ask the brand-name manufacturer to add the warning. Id., at 616. We explained that the state-law claim was preempted because it was impossible for the generic manufacturer to add the required warning without the “special permission and assistance” of the Government. Id., at 623–624.
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