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Failure-to-warn claims allowed when generic drugs don't follow brand-name labels.

On March 13, in Fulgenzi v. PLIVA Inc., the 6th Circuit created a narrow exception to the Supreme Court's ruling in PLIVA Inc. v. Mensing, which held that failure-to-warn claims against generic-drug manufacturers are preempted.

In Mensing, the high court reasoned that because the law requires generics to have the same labels as brand-name drugs, generic manufacturers can't be subject to failure-to-warn claims.

In Fulgenzi, the brand-name drug Reglan received approval from the Food and Drug Administration to add the phrase "Therapy should not exceed 12 weeks in duration" to its label. PLIVA did not change the generic equivalent's label, and when Eleanor Fulgenzi developed tardive dyskinesia after taking the generic drug, she sued the company. The 6th Circuit found that when a generic manufacturer fails to follow the brand-name label in a timely manner, failure-to-warn claims are not preempted.

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Title Annotation:6TH CIRCUIT
Author:Beck, Julie
Publication:InsideCounsel
Date:May 1, 2013
Words:144
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