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Trump Judge Writes Decision Excusing Manufacturer for Failing to Warn Consumers of Risks of Using Medical Product: Confirmed Judges, Confirmed Fears

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Confirmed Judges, Confirmed Fears” is a blog series documenting the harmful impact of President Trump’s judges on Americans’ rights and liberties. Cases in the series can be found by issue and by judge at this link.

Trump Eighth Circuit judge David Stras wrote a decision that excused a manufacturer from failing to warn a woman who suffered injury after implantation of an intrauterine device (IUD) of the risks of using its product. The February 2021 decision was in Ideus v Teva Pharmaceuticals USA Inc.

Stephanie Ideus decided to have her physician implant a Teva IUD for birth control purposes. When she later decided to have it removed, however, her doctor discovered that “it had broken apart” and “a piece had become imbedded in her uterus.” The result was pain, discomfort and surgery in order to remove it.

Ideus then sued Teva for breach of its duty to warn her of the potential risks of the IUD. The district court granted summary judgment for the corporation without a trial, ruling that under Nebraska law, which applied in the case, Teva’s duty was satisfied by warning the physician of the risks through medical literature, “rather than the patients themselves,” under the so-called “learned intermediaries” doctrine. Ideus appealed.

In a 2-1 decision written by Trump judge Stras, an Eighth Circuit panel affirmed the dismissal of the complaint against the corporation. Although acknowledging that the Nebraska courts had not directly ruled on the issue, Stras maintained that the “learned intermediaries” doctrine, which clearly applies to prescription drugs under state law, also applies to medical devices and products “like IUDs.” He rejected the argument, accepted by some courts in other states, that there is a “prescription contraceptive exception,” and affirmed the dismissal of Ideus’ case.

Judge Jane Kelly dissented. She pointed out that the single Nebraska Supreme Court decision that applied the doctrine to prescription drugs “does not tell us one way or the other” whether it would recognize the contraception exception. In fact, Kelly noted, the Nebraska court had specifically recognized that some courts had ruled that exceptions should apply “where special facts require a direct warning to the consumer.” This includes situations where a manufacturer has “advertised directly to consumers,” she continued, which was “one of the very exceptions sought by Ideus in this case.” Kelly maintained that the court should have certified the issue to the Nebrasks Supreme Court for its direct views, a procedure allowed under federal law, after which the federal appellate court could have decided the case based on a much more clear understanding of Nebraska precedent.

Trump judge Stras rejected this alternative, however, and decided in the corporation’s favor against Stephanie Ideus. The result could well also harm other women seeking to sue IUD manufacturers for failure to warn them directly of potential risks and defects relating to their products.