‘Failure-To-Update’ Claims Against Generic Manufacturers Preempted, Texas Federal Judge Rules



DOCUMENTS
  • Order


CORPUS CHRISTI, Texas — Claims that a generic drug maker failed to update its label to match FDA-approved changes made to the brand name equivalent are federally preempted because generic manufacturers cannot act unilaterally as to any consumer warnings, a Texas federal judge has ruled.

On Jan. 27, Judge Nevla Gonzales Ramos of the U.S. District Court for the Southern District of Texas reversed her earlier finding that failure-to-update claims are preempted, citing the 5th Circuit’s recent ruling that such claims are failure-to-warn claims and are thus preempted pursuant to PLIVA v. Mensing.

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