ParaGard MDL: Master Complaint Proposed For Direct Filing

ParaGard MDL: Master Complaint Proposed For Direct Filing

Introduction

On March 09, Judge Leigh Martin May of the U.S. District Court for the Northern District of Georgia, presiding over all ParaGard IUD injury cases, issued a case management order, asking the plaintiff to file a “Master Complaint” this month, which will allow the direct filing of future claims through a “Short Form Complaint.”

According to the order, the parties are required to meet and prepare an agreed-upon Short Form Complaint, along with a Direct File Order to streamline the process of filing new claims directly in the Northern District of Georgia.

The plaintiffs are required to file the Master Complaint by today and the defendants are also required to file any responsive pleadings by May 6, 2021.

The process is intended to assist the parties coordinate, categorize and evaluate the claims and will also help avoid costs and delays associated with transferring claims from U.S. District Courts nationwide.

Currently, around 116 complaints are pending in the multidistrict litigation (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.

The MDL 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.

Last month, 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.

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).