On January 7, 2014, a Louisiana federal judge denied Takeda Pharmaceuticals Inc.’s summary judgment on failure-to-warn claims in their Actos lawsuit. The judge found that these failure-to-warn claims were not preempted because Takeda was not able to produce any evidence that they brought stronger warnings to the U.S. Food and Drug Administration (FDA).
Judge Rebecca F. Doherty of the U.S. District Court for the Western District of Louisiana said that, “absent clear evidence that the FDA would not have approved a change to Takeda’s label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.”
In response to the Plaintiffs’ claims that Takeda’s Actos resulted in bladder cancer, Takeda claimed that they were federally preempted, moving for partial summary judgment, relying on their failure-to-warn theory.
Judge Doherty cited the Court’s decision in the Levine case, which found that it remains the duty of the drug’s manufacturer to appropriately warn about the potential dangers of the drug.
She continued, “Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet…it remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting and adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.”
Judge Doherty added that, although Takeda correctly stated that their labeling must not differ from the original manufacturers labeling, they still could have submitted stronger warning language for approval by the FDA, or by submitting a Changes Being Effected for approval.
She concluded that “the mere fact that the FDA approved, at various times, labeling language proposed by Takeda, such approvals of language do not offer conclusive proof of preemption.”
Judge Doherty rejected Takeda’s argument that submitting the Changes Being Effected warning label would result in a conflict between the medication insert and the Medication Guide, which violates federal law. She explained that Takeda was involved in negotiations involving the contents of the language that ended up inside the Medication Guide, so it was their responsibility to fix the inconsistencies. She added, “as discussed in Levine, it remains the duty of the manufacturer to craft and maintain adequate warnings as long as the drug is on the market.”
We will continue to keep you updated on any news on this lawsuit. For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).