Paragard Lawsuit Design Defect Claims Against CooperSurgical Thrown Out by Federal Judge

Lawsuits also involve claims against Teva Pharmaceuticals for their role in designing and selling the Paragard IUD before it was acquired by CooperSurgical.

The U.S. District Judge presiding over all Paragard IUD lawsuits has agreed to dismiss design defect claims against CooperSurgical, which argued that all three bellwether plaintiffs in the federal litigation had the birth control implant placed in their body before they acquired an interest in the product. However, the Court is continuing to evaluate whether failure to warn claims can move forward against Cooper, as well as Teva Pharmaceuticals, which previously manufactured the device.

The Paragard IUD is a small plastic birth control implant that is wrapped in copper, which has been marketed for decades as a safe and effective means of preventing pregnancy for up to 10 years.

Although the IUD is supposed to be easily removable when women no longer want the birth control protection, medical providers have noted a growing number of reports involving Paragard arms breaking during routine removal. Many women have described sudden pain, bleeding, or pieces of the device becoming lodged in the uterus, sometimes requiring emergency procedures to retrieve the fragments and prevent further complications.

As a result of these problems, CooperSurgical and Teva Pharmaceuticals now face more than 3,700 product liability lawsuits brought throughout the federal court system, with plaintiffs alleging the Paragard IUD was defectively designed and prone to breaking, and that the manufacturers failed to adequately warn doctors and patients about the risk of fracture during removal.

Given common questions of fact and law raised in Paragard lawsuits brought in federal district courts nationwide, consolidated pretrial proceedings have been established in the Northern District of Georgia, where U.S. District Judge Leigh Martin May is presiding over coordinated discovery and pretrial proceedings in a federal MDL (multidistrict litigation).

To help the parties gauge how juries may respond to evidence and expert testimony that will appear throughout thousands of claims if Paragard settlements are not reached, Judge May has established a bellwether program, where three representative Paragard cases have been prepared for early trial dates next year.

The first Paragard IUD bellwether trial is scheduled to begin on January 12, 2026, with a second trial set to start on March 3, 2026, and a third trial scheduled to begin on May 11, 2026. However, CooperSurgical has filed a motion for summary judgment, seeking to have itself dismissed from both design defect and failure to warn claims in each of the bellwether trials.

CooperSurgical argued that those three plaintiffs were each implanted with the Paragard implants at a time when only Teva Pharmaceuticals had the federal New Drug Application (NDA) for the birth control implant. According to the manufacturer, the three bellwether plaintiffs received their Paragard implants in a time period between 2011 and 2013, and Cooper did not purchased the Paragard NDA from Teva until November 2017.

In an order (PDF) issued late last month, Judge May granted summary judgment on the design defect claims, agreeing that Cooper could have done nothing to fix the design in a way that would have avoided the plaintiffs’ injuries. However, the judge deferred a ruling on dismissal of the failure to warn allegations, since they did hold the NDA for a period of time before the failed Paragard removals.

The Court has given plaintiffs additional time to file supplemental briefing, since they maintain that Cooper did control the label for at least a few years before each of their failed attempts to remove the IUD. Therefore, plaintiffs argue that Cooper’s failure to warn was relevant to informing Plaintiffs and their medical providers about the risks, as well as the potential need for additional steps to be taken at the time of removal to prevent the Paragard from breaking.

The ruling is not expected to affect the bellwether trials at this time, which also name Teva Pharmaceuticals as a defendant.

Although the outcome of the Paragard bellwether trials will not have any binding impact on these other claimants, the cases will be closely watched and are expected to have a large impact on any negotiations for a potential global Paragard IUD settlement that would avoid the need for each individual case to be remanded back to U.S. District Courts nationwide for individual trial dates in the coming years.