On Monday, the 8th Circuit U.S. Court of Appeals affirmed that Teva Pharmaceuticals, the manufacturer of ParaGard intrauterine contraceptive device (IUD), was not required to warn a woman directly over the risks associated with using the birth control device as the company warned her physician.
The lawsuit was filed by a Nebraska woman after her physicians discovered that the device had broken apart and a piece had become embedded in her uterus. The plaintiff in her lawsuit had cited a Massachusetts case and two cases from Michigan in which the consumers had to be directly warned about the risks for prescription contraceptives.
According to the opinion dated February 8, the decision was a split where the panel majority asserted that like any other state, Nebraska requires manufacturers to warn consumers directly about any design risks in their products. However, there is an exception called the learned-intermediary doctrine for prescription drugs, as per which the manufacturers are allowed to warn medical professionals of the risks, instead of the patients themselves.
The Nebraska Supreme Court did not state whether it would apply the doctrine to other medical products like ParaGard, but the panel said that the court would do it.
U.S. Circuit Judge Jane Kelly, in a dissent, stated that the panel should not venture into an uncertain area of tort law without seeking guidance from the Nebraska Supreme Court. She further added that the question of whether the learned-intermediary doctrine covers prescription contraceptives should be sent to the Nebraska Supreme Court.
In December, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order confirming centralization of all ParaGard IUD cases in the Northern District of Georgia. The cases will be presided by Honorable Leigh Martin May for coordinated or consolidated pretrial proceedings.
