Bayer Seeks Dismissal of IUD Lawsuit Over FDA Preemption

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Bayer Seeks Dismissal of IUD Lawsuit Over FDA Preemption

Bayer Corp. is requesting a federal court in Washington to dismiss a lawsuit filed by Bridget Doyle, who claims that the company should be held liable after a Mirena-brand intrauterine device (IUD) allegedly failed and migrated to her abdominal cavity. Bayer contends that Washington law preempts Doyle’s claims, and that the company had already provided sufficient warnings regarding the risks of the product.

In a motion filed Tuesday, Bayer asserted that the Washington Products Liability Act (WPLA) governs all product liability claims in the state, and thus Doyle’s allegations must be dismissed. The company further argued that even if the WPLA did not preempt the suit, the claims would still fail due to insufficient factual support and the preemption of the lawsuit by the U.S. Food and Drug Administration’s (FDA) approval of the product and its labeling.

The lawsuit, filed in December 2024, alleges that Doyle’s Mirena IUD, implanted in 2010, was no longer in the uterus after an ectopic pregnancy in 2012, and was later found in her abdomen via X-ray in 2023. Doyle underwent surgery to remove the device, leading to physical pain and additional damages.

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Bayer’s motion emphasizes that the statute of limitations for Doyle’s claims expired, as she was informed of the IUD’s displacement in 2012, but did not file suit until 2024. The company also noted that the FDA-approved labeling for Mirena already included warnings about the risks of IUD migration and perforation, thus preempting any claims related to failure-to-warn allegations.

The motion also challenges Doyle’s claims of manufacturing defects, asserting that the complaint lacks specific allegations regarding how the IUD was improperly manufactured or deviated from its design. Additionally, Bayer argues that the claim for negligence per se must be dismissed, as Washington law no longer recognizes it as a separate cause of action, except in specific cases such as electrical fire safety or driving while intoxicated.

Bayer further stated that Doyle’s breach of warranty claims are unsupported by any specific allegations regarding warranties and that the claim for unfair business practices should be dismissed due to a lack of any injury to Doyle’s business or property. Finally, the company requested that Doyle’s loss of consortium claim, which relates to emotional distress suffered by her husband, be dismissed for lack of factual support.

The case, Doyle et al. v. Bayer Corp., is currently pending in the U.S. District Court for the Western District of Washington, under case number 2:24-cv-01973.