A staggering 40,000 women search ‘non hormonal birth control’ every month as they increasingly recognize the harms of hormonal birth control. While these women would ideally land on fertility awareness methods as their side effect-free and hormone-free family planning method of choice, the reality is that many of them will opt for the hormone-free copper IUD instead (known in the United States as Paragard). Ongoing lawsuits, scheduled to go to trial in 2025 and centering on risk of IUD breakage, should give all of these women pause.
What is the Paragard copper IUD?
The Paragard IUD, a small T-shaped device wrapped in copper, is a form of long acting, reversible birth control that is inserted into the female reproductive system and designed to stay there for up to 10 years. The copper-wrapped device causes inflammation that creates a hostile environment for sperm and embryo implantation.
Paragard is the only non-hormonal IUD approved for use in the United States, and is popular with women between the ages of 20-39, because it’s both “set-it-and-forget-it” and hormone-free. The copper IUD is consistently reported as a highly effective form of birth control with reported success rates of up to 99%.
What are the risks of the copper IUD?
Unfortunately, despite being hormone-free, the copper IUD does not come without side effects and even serious risks. Many women using a copper IUD experience pain and increased uterine bleeding [1]. At least one study found that Ibuprofen use didn’t improve the pain enough to prevent IUD removal [2]. And while the copper IUD is currently enjoying renewed popularity because of modern women’s desires to avoid hormones, the copper IUD isn’t a new phenomenon–nor are its risks. In a 1984 study, 60% of women using a copper IUD reported heavier periods, and 50% reported more days of bleeding [3].
While pain and heavy bleeding may improve with time (or simply be ignored when they don’t improve), a long term study (1998-2022) from the FDA shows that other risks, like IUD breakage during removal, can affect at least 9.6% of users and cause permanent damage [4]. Furthermore, copper IUDs are disproportionately more likely to break than hormonal IUDs, according to the same study [4].
When an IUD breaks, surgery may be required for removal. Some of these removal procedures may be minor, but sometimes major surgery (along the lines of total hysterectomies or invasive abdominal surgery) is required, depending on if (or where) the IUD has migrated, and if it has become embedded in other organs or tissues. Yolanda Hudson, the plaintiff in one ongoing lawsuit against Teva Pharmaceuticals (the manufacturer of the Paragard copper IUD), required major surgery and the removal of part of her colon after the IUD perforated her uterus and embedded in her large intestine.
While nothing can reverse the pain and damage from these events, thousands of women are currently seeking compensation from Teva Pharmaceuticals (the original manufacturer of Paragard) and CooperSurgical (which acquired the Paragard from Teva in 2017) because of adverse events related to their use of the Paragard copper IUD.
Undisclosed breakage risk at center of Paragard copper IUD lawsuits
The majority of the plaintiffs in ongoing lawsuits against Teva Pharmaceuticals and/or CooperSurgical claim that when their doctor removed the Paragard copper IUD, it broke and left behind copper pieces in their reproductive system, causing damage and often requiring major surgery. Occasionally a hysterectomy was required, which left them unable to have biological children in the future.
The lawsuits state that Teva Pharmaceuticals and/or CooperSurgical should have known of the potential for IUD fracturing with removal after seeing results from clinical trials, patient feedback, third party studies, and their own internal analysis. However, the lawsuits allege, the manufacturers did nothing to “adequately warn or remedy the defects and instead concealed, suppressed, and failed to disclose or fix this danger.”
Lawsuits joined together in Multidistrict Litigation
Because there are so many similar complaints against the manufacturers of Paragard, all cases concerning copper IUD breakage were joined together as part of a Multidistrict Litigation (MDL) back in 2020. This consolidated approach is designed to “avoid conflicting pretrial rulings from different courts, avoid duplicative discovery, and serve the convenience of common witnesses, parties, and the judicial system.”
According to Motley Rice LLC, one of the legal firms representing plaintiffs in the Paragard MDL, “the Paragard IUD device lawsuits consolidated in MDL 2974 named five defendants: CooperSurgical, Teva USA, Teva Women’s Health LLC, Teva Branded Pharmaceutical Products R&D, and the Cooper Companies. CooperSurgical acquired the Paragard copper IUD from Teva in 2017. Teva may still be liable for injuries caused by Paragard that were implanted prior to the sale in 2017.”
At the time of the MDL consolidation, Teva claimed that there were only a large number of complaints because attorneys had advertised and sought out potential plaintiffs, not because there were genuine concerns (though a 2024 safety investigation by the U.S. Food and Drug Administration suggests the FDA believes otherwise). Teva’s claims were not deemed significant enough to affect the proceedings, and the MDL was approved. The initial trial was scheduled for January 2024—a surprising 4 years later.
After the individual cases were joined under a Multidistrict Litigation, the U.S. district judge presiding over the MDL decided that several cases would be selected as “bellwether” trials. These sample cases, which are deemed to best represent the plaintiffs’ claims, are often used when many individual cases are involved, because the outcome can be a good indicator for plaintiffs and their attorneys of how future cases may go. The outcomes of bellwether trials can influence settlement discussions and potentially eliminate the burden of the remaining cases needing to go to trial.
Why is progress on the Paragard copper IUD lawsuit so slow?
As mentioned, these bellwether trials were first scheduled for January of 2024. Since then, they have been delayed multiple times. As of this writing, they are currently set to begin December 2025 and February 2026, with the caveat that even these dates may be pushed back if requested by the legal counsel for Teva Pharmaceuticals.
As it stands, the first trial is set to begin six years after the cases (which numbered 2,682 as of December 2024) were joined together.
While reasons for the delay haven’t been shared publicly, we do know that Teva Pharmaceuticals has filed at least one Motion to Dismiss during that time. It was denied.
Will the Paragard lawsuits turn out like the Mirena cases?
Teva Pharmaceuticals and CooperSurgical may have hoped that all claims related to the copper IUD would be dismissed, as happened with similar lawsuits against Bayer, the company behind the Mirena hormonal IUD. Mirena lawsuits alleged failure to disclose a link between the IUD and uterine perforation, idiopathic intracranial hypertension, and cancer. While the Mirena case was dismissed due to a lack of adequate medical experts for testimony, Bayer chose to settle perforation-related claims for $12.2 million. If this is how much they were willing to pay with the claims dismissed, one wonders how much they might have had to pay if they had been found responsible.
Could the copper IUD go the way of the Essure coils?
Another birth control device owned by Bayer, Essure, received almost 30,000 complaints that began litigation in 2014. Over the next 6 years, the case would result in a black box warning label added to the product, then restrictions on its sale and distribution in the United States and, eventually, a $1.6 billion settlement in 2020. No doubt Teva Pharmaceuticals and CooperSurgical are hoping to avoid a similar outcome.
Will women injured by the Paragard copper IUD receive compensation?
It’s too early to tell what will happen in the litigation against Teva Pharmaceuticals and/or CooperSurgical regarding claims about the copper IUD. Will they seek a settlement with the plaintiffs? Will the FDA restrict Paragard from sale and distribution in the United States, like Essure, or will it require manufacturers to add a black box warning to the product packaging warning users about the potential for perforation or fragmentation?
For answers to these questions and others, we’ll likely have to wait for the results of the copper IUD bellwether trials, which are scheduled to begin in December 2025 (unless, of course, they are delayed yet again).
