Products Liability Law Reporter

A federal district court held that the learned intermediary doctrine precluded a plaintiff’s claim alleging manufacturers of a copper IUD failed to provide adequate warnings about the product’s risks.

Here, Stephanie Ideus received the ParaGard T380 intrauterine contraceptive, a copper IUD. Four years later, while her physician was removing the IUD, a piece of the device broke off and became embedded in Ideus’s uterine wall. She required surgery to remove the broken piece of the IUD.

Ideus sued manufacturers Teva Pharmaceuticals and Teva Women’s Health, alleging the defendants had failed to provide adequate warnings that the ParaGard could break during removal and become embedded in the uterus. The defense moved for summary judgment.

Granting the motion, the district court noted that under the learned intermediary doctrine, a prescription drug manufacturer’s duty to warn is discharged when the manufacturer provides adequate warnings to a patient’s prescribing health care provider. The court added that although the Nebraska Supreme Court has adopted the learned intermediary doctrine, it has yet to decide whether the doctrine applies to prescription contraceptives. Citing case law, the court concluded that there is no reason to distinguish between a patient’s final choice to use a contraceptive and the decision to undergo other courses of medical treatment. Here, the plaintiff had significant contact with her prescribing physician and relied on her advice and the literature she provided in choosing the ParaGard IUD, the court said.

When a patient relies on a physician’s skill and knowledge in choosing any method of treatment, the court said, the learned intermediary doctrine should apply, whether the treatment pertains to prescription contraceptives or other prescription medication. Thus, the court found that the Nebraska high court would apply the learned intermediary doctrine to cases involving contraceptives if presented with such a matter.

Accordingly, the court concluded, the doctrine applies to the claims presented by the plaintiff, who has failed to offer evidence proving that her prescribing physician would have changed her prescribing decision if the defendants had provided different warnings for the ParaGard IUD.

Citation: Ideus v. Teva Pharm. USA, Inc., 2019 WL 912121 (D. Neb. Feb. 19, 2019).

Comment: In Lempa v. EON Labs, Inc., 2019 WL 1426011 (N.D. Ill. Mar. 29, 2019), a federal district court held that a question of fact existed about whether a drug manufacturer provided sufficient warnings to a patient’s doctor about off-label uses of the drug amiodarone, including amiodarone toxicity and the drug’s dangers to atrial fibrillation patients. Considering a motion to dismiss, the district court concluded that the learned intermediary doctrine did not apply because doctors who receive insufficient warnings are not considered learned intermediaries. AAJ member Bridget C. Duignan, Chicago, represented the plaintiff.

See also Urbaniak v. American Drug Stores, LLC, 2019 WL 1334968 (Ill. App. Ct. Mar. 25, 2019), holding that under the learned intermediary doctrine, a pharmacy was not liable for failing to warn a patient or his doctor about the long-term use of Reglan.