On January 7, 2014, Judge Rebecca H. Doherty of the Western District of Louisiana issued an order denying Takeda’s motion for partial summary judgment. Takeda had requested that the Court dismiss the plaintiffs’ failure-to-warn claims against the pharmaceutical company in the Actos federal multidistrict litigation (MDL), In re: Actos (Pioglitazone) Products Liability Litigation (MDL No. 2299). Specifically, Takeda argued that a conflict between state and federal drug labeling requirements made it impossible for Takeda to comply with both (conflict preemption).
In denying Takeda’s request, the Court looked to the United States Supreme Court precedent of Wyeth v. Levine for guidance. The Levine case emphasized a brand-name drug manufacturer has a duty to create and maintain adequate warnings for a drug as long as that drug is on the market. In order for a drug manufacturer defendant to use preemption as a defense, it has to clearly show that it proposed a stronger warning to the FDA but was rejected. In other words, it was impossible for the defendant to comply with its duty to warn because its attempt to do so was rejected by the FDA.
Judge Doherty: Takeda Could Have Submitted Stronger Warning Labels
In Judge Doherty’s order, she wrote that “the defendants appear to misunderstand their federal labeling-law duties as they might relate to preemption.” She noted that Takeda did not claim that it had proposed a stronger warning about the possible link between Actos and bladder cancer to the FDA. In fact, there was no evidence in the record that showed that Takeda made such a proposal. The Court found that Takeda could have submitted “stronger warning language for FDA approval,” and that unless it could prove that the FDA would not have approved that language, Takeda had not shown that compliance with federal and state laws was impossible.
First Federal Actos Lawsuits to Begin Trial
The first Actos bellwether trial, Terrence Allen, et ux. v. Takeda Pharmaceuticals North America, Inc., et al. (Civil No. 12-0064), is scheduled to begin on January 27, 2014. The second bellwether trial will start on April 14, 2014. There are currently about 2,800 cases that have been filed in the MDL.
Injured by Actos? Free and Confidential Consultation
The Actos lawyers at Girard Gibbs represent people from across the country who have contracted bladder cancer while taking Actos. If you had bladder cancer after taking Actos or other medications containing pioglitazone, you may have a legal right to pursue financial compensation for your injuries or other damages. Fill out the form to the right or call (866) 981-4800 for a free confidential consultation concerning your possible Actos bladder cancer lawsuit.