In recent years, a common form of birth control—the Paragard IUD—has come under scrutiny for its propensity to break upon removal, causing need for otherwise unnecessary surgeries, infertility, and pain. The Paragard IUD is a non-hormonal form of birth control that is non-surgically placed and may be used continually for up to ten years. Across the country, lawsuits have been filed against the owners of Paragard, totaling more than 250 actions. While many individual suits have been filed, there is not currently a class action. Rather, there is a consolidation order, joining Paragard actions in multidistrict litigation in the Northern District of Georgia.
Despite the number of actions filed, Paragard has not been recalled for its propensity to break. In April 2014, two lots of the Paragard IUD were recalled for “lack of assurance of sterility.” In February 2021, the Office of Prescription Drug Promotion of the FDA issued a warning letter to CooperSurgical, Inc., regarding an advertisement for Paragard. The letter indicates that a direct-to-consumer video violated federal law by presenting false or misleading information about Paragard’s safety. The video explains the use and/or benefits of Paragard, without mentioning any risks or contraindications for the device.
According to Paragard’s prescribing information, adverse reactions reported in clinical trials include anemia, backache, dysmenorrhea (intense menstrual cramps and pain), dyspareunia (painful intercourse), complete or partial expulsion (device falls out of the uterus), prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.
The consolidated cases in the multidistrict litigation of the Northern District of Georgia have yet to resolve. Cases continue to develop and be added to this mass tort, in addition to cases filed across the nation in state courts.
In re Paragard IUD Prods. Liab. Litig., 2022 U.S. Dist. LEXIS 2799 (Jan. 5, 2022).