FDA Issues Warning Letter Over A ParaGard IUD Advertisement

FDA Issues Warning Letter Over A ParaGard IUD Advertisement

Introduction

On Tuesday, the United States Food and Drug Administration (FDA) issued a warning letter to CooperSurgical, Inc., stating that the manufacturer did not communicate risk information associated with the ParaGard IUD birth control device in a direct-to-consumer video advertisement.

The warning letter states that the advertisement was titled “ParaGard: Family Planning During the Pandemic” and aired on WBTS’s The Hub Today on October 5, 2020.

According to the letter, the advertisement contained false or misleading information, and the manufacturer did not submit it to the FDA for review as per the Office of Prescription Drug Promotion (OPDP). The letter warns that this misleading presentation is particularly concerning from a public health perspective due to the serious and potentially life-threatening risks associated with the device, such as those contained in the WARNINGS AND PRECAUTIONS section of ParaGard’s PI (prescriber information).

The manufacturer is also asked to submit a comprehensive plan to disseminate truthful, non-misleading, and complete corrective communications about the concerns mentioned in the warning letter.

Meanwhile, Judge Leigh Martin May of the U.S. District Court for the Northern District of Georgia, presiding over the multidistrict litigation (MDL) docket for ParaGard IUD injury cases, appointed a group of 25 plaintiffs lawyers for various leadership roles.

The docket was formed in December 2020 when the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order confirming the centralization of all ParaGard IUD cases in the Northern District of Georgia for coordinated or consolidated pretrial proceedings.

Currently, around 116 complaints are pending in the MDL and the number of lawsuits seems to be growing, each claiming that the birth control device has a risk of breaking upon removal, causing complications and injuries, including surgeries to remove the broken piece of the device, infertility, and pain.