Failure-to-warn claims allowed when generic drugs don't follow brand-name labels.
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.
Kentucky, Michigan, Ohio, Tennessee
|Printer friendly Cite/link Email Feedback|
|Title Annotation:||6TH CIRCUIT|
|Date:||May 1, 2013|
|Previous Article:||Mississippi's $1 million cap on noneconomic damages is constitutional.|
|Next Article:||Employees have duty to notify of need for FMLA leave.|