Photo of Eric Hudson

Sometimes opinions go entirely in favor of the defense, analyzing numerous, independent bases for the dismissal of a complaint.  Today’s decision, Doyle v. Bayer Corp., 2025 WL 1666261 (W.D. Wash. June 12, 2025), is definitely one of those. It is a perfect example of what should happen when a plaintiff files a generic, bare-bones complaint in a prescription medical product case.

Plaintiff had an intrauterine device (IUD) implanted, and after about two years was informed that the IUD had likely been expelled from her body.  More than ten years after that, plaintiff obtained an x-ray for a persistent cough.  Doctors suspected that a shadow shown on the x-ray in the plaintiff’s abdomen was the IUD.  Plaintiff subsequently had surgery to remove the IUD, and she and her husband then filed suit against the manufacturer. Plaintiffs asserted five common law product liability claims and a sixth for unfair business practices.

The defendant moved to dismiss on numerous grounds, starting with the fact that all claims for product-related harms in Washington are controlled by the Washington Products Liability Act (WPLA). Plaintiffs’ complaint did not include any claim under the WPLA. Since the WPLA subsumes all common law product liability claims, the court held that the five product liability claims should be dismissed.  The court could have stopped there on the product liability claims, but it didn’t.  Instead, it addressed all of the defendant’s arguments why the complaint should be dismissed.

The court next turned to defendant’s argument that plaintiff’s failure to warn claim was preempted under Merck v. Albrecht, 587 U.S. (2019). The defendant argued that, even if it wanted to modify the warning label, it was prohibited from doing so under federal law. Doyle, 2025 WL 1666221, at *2. To avoid preemption, plaintiffs had to plead a labeling deficiency that the defendant could have modified through the Changes Being Effected (CBE) regulation.  That required plaintiffs to identify newly acquired information that would have permitted the defendant to utilize the CBE process. Plaintiffs did not allege or identify any newly acquired information in their complaint, so the failure to warn claims were preempted and properly subject to dismissal.

Sticking with failure to warn, the court next turned to adequacy. Plaintiffs claimed the defendant failed to warn of the potential for the IUD to perforate tissue or migrate within the body.  The defendant pointed out that those risks were included in the FDA approved label, and the plaintiffs did not provide facts showing those warnings were insufficient.  Given that, the claim was subject to dismissal under an adequacy analysis.  

How about the learned intermediary? Dismissal was appropriate on that basis as well. To prove failure to warn causation in a prescription products case, a plaintiff must allege that the defendant failed to warn the plaintiff’s physician and that an adequate warning would have altered the prescribing doctor’s decision to use the product. Id. at *3. Plaintiffs’ complaint did not include these allegations.  The court held this was another, independent basis for dismissal of the failure to warn claim.

The court then moved from failure to warn to manufacturing defect. In Washington a plaintiff claiming manufacturing defect must show that the product deviated materially from its specifications and that the deviation was the proximate cause of the alleged harm. Id. at *4. Plaintiffs’ bare-bones complaint did not include any details about a specific manufacturing defect, and it did not allege how the IUD deviated from any design or performance standards. Absent that detail, plaintiffs’ conclusory allegations were insufficient to state a claim under Ashcroft v. Iqbal, 566 U.S. 662, 678 (2009).

The court next made short work of plaintiffs’ claims for negligence per se, breach of express warranty, and breach of implied warranty. Plaintiffs’ claim that the defendant failed to comply with the Food Drug and Cosmetic Act might have served as evidence of negligence, but it wasn’t a separate cause of action. Further, Plaintiffs didn’t allege the necessary elements for breach of express or implied warranties.  All of those claims were properly dismissed. Doyle, 2025 WL 1666221, at *4-5.

Finally, the court turned to the unfair business practices claim under the Washington Consumer Protection Act (WCPA).  The WCPA applies to injuries to a plaintiff’s business or property. It does not apply to physical injuries or emotional distress. This claim likewise failed and was dismissed.

Notably, the court held that its dismissal of plaintiffs’ complaint would be with prejudice without leave to amend. “Amendment is futile when a plaintiff’s claims are based on threadbare allegations and legal conclusions, the plaintiff fails to rebut any of the defendant’s arguments in the motion to dismiss, and there is an applicable defense to the claim plaintiff alleges.” Id. at * 4 (quoting Leavitt v. Credit Central, LLC, 2024 WL 4839360, at *2 (W.D. Wash. Nov. 20, 2024)). Given the court’s detailed analysis of the numerous, independent bases for dismissal—or as we sometimes call it, “belting and suspendering”—we don’t see any reason that this dismissal won’t stick.