Paragard Lawsuit

Paragard Lawsuit Update: Recent Developments and Future Implications

In recent years, the Paragard intrauterine device (IUD) has faced mounting scrutiny as allegations of device breakage have surfaced among women across the country. Paragard, a non-hormonal copper IUD, has been a trusted form of long-term contraception for many. The device offers an alternative to hormonal birth control methods. 

However, reports of it fracturing during removal procedures, leading to serious injuries have prompted numerous lawsuits against its manufacturer.

This article provides an overview of the latest developments in the IUD lawsuits. We’ll delve into recent court rulings, consolidation efforts, and settlement activity to understand the current legal landscape. 

Background of the Lawsuits

The Paragard lawsuit has emerged as a response to a disturbing trend. Reported device breakage during removal procedures has led to severe complications for women who relied on this contraceptive method. 

According to Forbes, women have alleged that the plastic arms of the device fail to flex upward as intended during removal. Instead, it becomes rigid and prone to breakage. 

This failure mechanism can result in sharp plastic pieces becoming lodged inside the uterus, necessitating surgical intervention for removal. Some women have endured ongoing or permanent complications as a result of these broken fragments.

In response, affected women have initiated legal action against Teva Pharmaceuticals, the original manufacturer of Paragard, and CooperSurgical, which acquired the company in 2017. The lawsuits assert several key claims:

  1. Product liability: Plaintiffs argue that there is an inherent defect in the design of the Paragard IUD. This defect renders it prone to breakage during removal and poses an unreasonable risk of harm to users.
  2. Failure to warn: Allegations include a failure by Teva Pharmaceuticals to adequately warn patients. This concerns the potential risks associated with the device, particularly the possibility of breakage and subsequent complications during removal.
  3. Negligence: Plaintiffs contend that the manufacturers demonstrated negligence in the design, manufacture, and distribution of the IUD. Additionally, they failed to ensure its safety and effectiveness for users.

As the lawsuits progress, they raise critical questions about contraceptive safety, informed consent, and corporate responsibility in safeguarding public health.

Case Consolidation and Multidistrict Litigation (MDL)

In a significant development for Paragard lawsuits, all federal claims were consolidated into a Multidistrict Litigation (MDL) in December 2020. This MDL is currently overseen by Judge Leigh Martin May in the Northern District of Georgia. It aims to streamline the pre-trial process for thousands of individual lawsuits.

TorHoerman Law notes that the MDL offers several advantages. Firstly, it avoids duplicative discovery, where both sides gather evidence repeatedly in separate cases. This saves time and resources for everyone involved. 

Secondly, it allows for consistent legal rulings. By having one judge handle all pre-trial motions, the MDL ensures a unified interpretation of the law, preventing conflicting decisions across different courts. 

Finally, the MDL can facilitate earlier settlements. By bringing all parties together, the MDL creates a platform for efficient settlement negotiations, potentially expediting the resolution of these cases.

Recent updates within the MDL include a rise in the number of cases, with over 2,600 currently pending as of April 2024. This indicates the ongoing impact of Paragard and the continued consolidation within the MDL framework.

Latest Scheduling Order for New Bellwether Trial

According to, the most recent scheduling order for the new Paragard bellwether trial indicates notable modifications to the timeline of proceedings. In January 2024, Judge May issued a case management order. This order extended the close of case-specific fact discovery for the first bellwether trial pool cases by an additional two months. It is now set for April 9 instead of February 9.

Following this extension, the parties involved will convene by the specified date to engage in discussions. They will alternately strike cases from the pool until only five cases are left. 

By April 12, two more cases will be eliminated, leaving three potential bellwether cases. The parties are required to inform the judge by April 15 which of these cases should proceed as the first bellwether trial.

Moreover, the deadline for the close of expert discovery for the initial early test case has been postponed by a month. It has been shifted from May 10 to June 9. Daubert motions, aimed at challenging the admissibility of expert testimony, are now due by July 23. 

Additionally, a consolidated pretrial order deadline is set for November 15, 2024.

Specific dates for the first bellwether trial have not yet been determined. However, it is anticipated that it will likely commence in mid-2025.

FDA Actions and Warnings

According to, in 2014, the FDA issued a recall of the Paragard IUD due to sterility concerns. However, no reported injuries were attributed to this issue. Additionally, in 2019, the agency issued a warning letter to the manufacturers for disseminating false or misleading information in television advertisements.

Further exacerbating concerns, the device was added to the FDA’s Adverse Event Reporting System in 2021. This indicates a growing number of reported adverse events associated with its use. 

As regulatory scrutiny intensifies and litigation escalates, stakeholders are increasingly focused on ensuring patient safety regarding contraceptive options.

Settlement Activity in the Paragard Litigation

Settlement activity in the ongoing litigation remains a focal point as the first trial cases are slated to commence in 2024. These initial trial cases hold significant weight, as they serve as indicators of potential verdicts and settlement amounts in subsequent proceedings.

It’s essential to distinguish between verdicts and settlements in legal proceedings. Verdicts are decisions rendered by a judge or jury in court, potentially including damages. Conversely, settlements are agreements reached outside of court between parties, subject to court approval and also potentially involving damages.

Settlements may occur either before a trial commences or during its course, with monetary compensation varying based on case specifics. Typically, settlement negotiations intensify following the outcome of initial test cases, providing clarity on the court’s stance.

In parallel, past IUD litigations offer insights into potential settlement outcomes. In one instance, Bayer proposed a $12.2 million settlement to resolve 4,600 lawsuits alleging Mirena’s migration and organ-related injuries. Such precedents offer potential avenues for resolution and compensation for affected individuals.

Frequently Asked Questions

What is the status of the Paragard lawsuit?

As of April 2024, litigation against Paragard persists for injuries inflicted by its intrauterine device. With 2,614 pending lawsuits under MDL, the legal proceedings continue to address claims of harm suffered by women.

What is the success rate of the Paragard?

The IUD boasts a high efficacy rate of up to 99% in preventing pregnancy. This effectiveness, combined with its non-hormonal copper-based mechanism, has positioned Paragard as a popular choice for long-term contraception.

What causes Paragard to fail?

The device may fail due to migration or embedding in the uterine wall, resulting in injuries. Damage to the uterine lining or cavity can cause chronic pelvic pain, heavy menstrual bleeding, and complications with future pregnancies. These adverse effects underscore the importance of vigilant monitoring and prompt medical attention for Paragard users.

In conclusion, the Paragard lawsuit landscape is constantly evolving, with recent developments in case consolidation shaping the path forward. While the future implications for plaintiffs and Teva Pharmaceuticals remain to be seen, the MDL presents a potential avenue for streamlined pretrial proceedings. 

As the legal process unfolds, staying informed about these developments is crucial for women who may have experienced complications with Paragard.  This article serves as a starting point for understanding the complexities of this ongoing litigation.

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