Eighth Circuit Says IUD Manufacturers Don’t Need to Warn Users About Risks of Use

On Monday, a split appellate panel sided with defendants Teva Pharmaceuticals USA, Inc., Teva Branded Pharmaceuticals Products R&D, Inc., and Teva Women’s Health, Inc. in a question of tort law concerning whether a product manufacturer has the duty to warn a user directly about the potential risks of using an intrauterine device (IUD). The Eighth Circuit held that there was no such duty under Nebraska tort law, affirming the decision of the lower court. 

The plaintiff brought the case after suffering complications from the use of the defendants’ ParaGard T 380A IUD birth control device. Specifically, the plaintiff had the device implanted, but when she later tried to have it removed, her physicians discovered that it had broken apart and a piece had become embedded in her uterus. Removing the device required surgery.

In its decision, the Eighth Circuit considered whether the district court applied the learned-intermediary doctrine correctly. According to the decision, the doctrine operates “as a general rule allow[ing] manufacturers of certain types of medical products to discharge their duty by warning ‘medical profession[als]’ of the risks rather than the patients themselves.” The plaintiff contended that the Nebraska Supreme Court would not apply the doctrine to contraceptive devices like Teva’s ParaGard.

The opinion reviewed case law from sister states and federal courts for guidance. It found that while Massachusetts adopted an IUD exception to the doctrine, more than a dozen states and federal courts declined to do so. The court wrote, “[e]very indication is that the Nebraska Supreme Court would follow what has become an ‘overwhelming majority’ rule,” and similarly decided not to except IUDs from the rule.

One judge, however, split from the panel’s decision. In her dissent, Judge Jane L. Kelly reasoned that because the court lacked sufficient guidance from the Nebraska Supreme Court as to whether the exception would apply to IUDs and other contraceptive devices, the question should have been certified to the state’s high court before deciding the merits of the appeal.

The appellant is represented by Bennerotte & Associates, P.A. and Kutak & Rock LLP, and Teva by Ulmer & Berne LLP and Turner Legal Group, LLC.