In a significant procedural decision impacting thousands of lawsuits, a Georgia federal judge has declined Teva Pharmaceutical Industries Ltd.'s bid to delay the inaugural trial concerning the Paragard copper intrauterine device (IUD). The trial is scheduled to commence on January 20 under the oversight of U.S. District Judge Leigh Martin May, who presides over the multidistrict litigation (MDL) centralized in federal court.
Teva had sought to suspend the proceedings while it pursued an appellate review of an earlier ruling that dismissed its motion to throw out the consolidated claims. Their legal counsel contended that a favorable outcome on appeal might have resolved the ongoing litigation, which encompasses approximately 3,800 lawsuits all alleging that Paragard can fracture during removal, resulting in potential harm to users.
Despite the company's request, Judge May determined the trial should move forward as planned, describing the delay motion as unsupported by the necessity for judicial or procedural economy. The plaintiffs countered that Teva's appeal attempt chiefly served as a tactic to postpone legal accountability and to stall progress in addressing the substantial volume of claims.
Paragard, developed originally by Teva, is a non-hormonal contraceptive device composed primarily of copper. Its design permits it to be implanted within the uterus for extended periods. Since 2017, ownership of the Paragard product shifted to The Cooper Companies, which contests responsibility for incidents predating the acquisition.
The upcoming January trial is designated as the initial "bellwether" proceeding, serving as a representative case anticipated to guide the trajectory of the MDL by providing insights into how juries may respond to the claims. These focus on allegations that breakage of the device during removal can cause bodily injury, complications affecting fertility, and necessitate surgical interventions to retrieve fragments.
In parallel legal maneuvers in November, both Teva and Cooper Companies filed motions for summary judgment in the Georgia federal court, seeking dismissal of the claims ahead of the bellwether trials. Their legal argument hinges on federal preemption — asserting that existing U.S. Food and Drug Administration (FDA) approvals for Paragard render state law claims regarding product design and labeling impermissible.
The companies maintain that any adjustments to Paragard's design or warning labels must be consistent with FDA-approved specifications, and unilaterally altering the device based on plaintiffs' allegations would conflict with those regulatory clearances. They further argue that the risk of breakage has been known to the manufacturers for an extended period, dating back before the contested legal claims, and therefore changes proposed are unwarranted without fresh FDA authorization triggered by new data.
However, Judge May has expressed skepticism about the defense's claims. She noted an apparent five-year delay by Teva in updating Paragard's warning labels after a 2010 FDA directive. This delay raised judicial concern that Teva’s compliance efforts may have been intentionally deferred, potentially undermining the company's attempt to use such noncompliance as part of its preemption defense strategy.
The court has allowed specific claims from named plaintiffs Pauline Rickard, Alisa Robere, and Melody Braxton to advance through to the bellwether phase. Cooper Companies, in a separate action in November 2025, has petitioned for dismissal from the bellwether panel, citing that they acquired Paragard only after the devices were distributed to plaintiffs.
Claims against Cooper Surgical in the Rickard case were dismissed independently, though Teva continues to be named as a defendant for individuals who received Paragard devices while under its ownership. The December ruling by Judge May also rejected Teva's argument that federal law categorically bars claims related to Paragard’s warning labels, especially since evidence suggests the company had access to new safety information that could have warranted label modifications regardless of timing.
As of the latest market activity, shares of Teva Pharmaceutical Industries are trading slightly lower, reflecting a modest decrease of 0.21% at $32.72 during premarket hours.