The Paragard MDL: 2025 Litigation Snapshot

The Paragard intrauterine device (IUD) is a T-shaped, plastic birth control device wrapped in copper that has been on the market since the 1980s. Its former manufacturer, Teva Pharmaceuticals, and current owner, CooperSurgical, now face thousands of lawsuits alleging that Paragard was defectively designed and prone to breaking during removal, sometimes causing injury and requiring surgical intervention.

Plaintiffs contend that adverse event reports submitted via the FDA’s Adverse Event Reporting System (FAERS) reflect thousands of complaints, including over 3,000 reports of device breakage or fracture upon removal. These reports, they assert, reflect not isolated misuse but a systematic risk; claimed injuries include organ perforation, chronic pelvic pain, infection, infertility, hysteroscopic or laparoscopic retrieval, and more complex surgery to remove retained fragments.

In defense, the manufacturers point to regulatory oversight, labeling compliance, limitations in causation evidence, and, for certain cases, statute of limitations defenses.

In late 2020, all federal Paragard IUD cases, of which there are now over 3,400, were consolidated into a single MDL in the Northern District of Georgia (In re Paragard IUD Products Liability Litigation, No. 1:20-md-02974 (N.D. Ga.) before Judge Leigh Martin May, ​​making this MDL the tenth largest ongoing MDL proceeding in the country.

Role of FDA Reporting & Labeling

The MDL leans heavily on the FDA reporting history. The fact that over 3,000 breakage or fracture reports exist supports the contention that the makers of Paragard knew the risks, or should have known the risks.

The 2019 FDA-mandated label update is particularly relevant in this case, which added language warning of the possibility that Paragard could break during removal. But plaintiffs argue the label was deficient, because it fails to spell out the full spectrum of the device’s risks.

After sustained media and plaintiff pressure, the FDA revealed in 2023 that it conducted a safety review of IUD breakage. That review resulted in a further label change in June 2023, adding removal instructions, including:

“If removal cannot be accomplished by gentle pulling, consider checking Paragard location and assess for embedment and perforation (with imaging, if necessary).” 

That said, plaintiffs will push that even this updated language is inadequate in light of the scope of injuries they experienced as well as internal company knowledge.

In 2019, the FDA's Office of Prescription Drug Promotion issued a warning letter to CooperSurgical regarding an advertisement for Paragard that failed to adequately disclose serious risks. This prior FDA interaction could provide evidentiary support for plaintiffs seeking to establish a pattern of promotional risk minimization.

Recent & Emerging Developments (2025)

In mid-2025, the court entered a series of amended scheduling orders refining deadlines for expert disclosures, privilege disputes, and document production. Among other requirements, plaintiffs’ expert reports were due July 24, 2025, followed by defense expert disclosures on August 18, 2025, and the close of expert discovery in September. 

In July, the court also ordered the production of several categories of internal company documents, including an internal audit known as the 2023 IPS audit, which addressed oversight at a Paragard manufacturing facility. When defendants sought to block additional questioning about that audit, Judge May ruled that the material was relevant and within scope, permitting plaintiffs to reopen the deposition of corporate representative William Senatore for further inquiry. 

Expert discovery has been equally contentious. Plaintiffs objected to what they described as overly broad defense document requests directed at non-party experts. Judge May subsequently issued an order clarifying that expert depositions would be limited to seven hours, that plaintiffs’ experts would be deposed before defense experts on each topic, and that attorney-expert communications would remain protected except for communications regarding compensation, key facts, or assumptions. The court also required disclosure of expert invoices before depositions and trial, an effort to maintain transparency and efficiency in the expert discovery process.

The litigation has now advanced to Daubert and summary judgment motions. Both sides filed these motions on October 6, 2025, with oppositions due by October 27 and replies expected in early November. These filings are likely to shape the upcoming bellwether trials, as the court determines which expert opinions and liability theories will reach the jury. 

Bellwether Trials & Strategic Outlook

The first bellwether trial is currently scheduled for January 20, 2026, followed by additional trials on March 3 and May 11, 2026. The initial case selected for trial, Braxton v. Teva, involves a Florida woman whose Paragard fractured during removal, allegedly causing reproductive injury and requiring surgical intervention. These trials will test the central factual and scientific disputes at the heart of the MDL, chief among them whether Paragard’s plastic arms were prone to embrittlement and breakage over time, and whether the defendants failed to adequately warn about that risk.

While no global settlement has been reached, the upcoming bellwethers are expected to help establish compensation benchmarks and shape the trajectory of the litigation. Analysts anticipate that plaintiffs with severe or surgical injuries may receive higher settlement valuations potentially reaching six-figure ranges depending on jurisdiction and injury severity. 

Broader Implications & What to Watch Next

As the MDL moves toward its first trials, attention is turning to the pending Daubert rulings and the admissibility of key expert testimony. The court’s handling of these motions, particularly those concerning biomechanical design experts and medical causation specialists, could significantly narrow or expand the issues presented to juries. Parallel disputes over privilege and production of internal corporate audits may also shape the evidentiary landscape and public perception of the defendants’ safety practices.

At the same time, the continued influx of new plaintiffs, coupled with the procedural dismissals for noncompliance, will affect the MDL’s overall size and composition. With expert discovery complete, dispositive motions pending, and trial preparation underway, the Paragard litigation is approaching a decisive stage. The outcomes of the early 2026 bellwethers will likely determine not only case valuations but also the long term strategy for both sides: whether the MDL evolves toward a global settlement or a protracted series of individual trials.

From Signals to Strategy

The Paragard MDL illustrates a familiar pattern in medical mass torts: long before litigation begins, early indicators of harm appear in adverse event data, regulatory updates, and patient reports. These signals are often fragmented across disconnected systems, making it difficult to recognize the full picture until the injuries become widespread. Legal intelligence bridges that divide, connecting regulatory filings, medical research, and public records to reveal patterns that suggest a product defect or undisclosed risk.

Darrow is the company pioneering this approach, using legal intelligence to detect potential mass torts early and provide plaintiff attorneys with evidence-backed insights before cases reach the public eye. This capability allows firms to move faster, build stronger claims, and reach victims when their stories can still be told. 

The same intelligence infrastructure illuminating the Paragard story today is already uncovering the next generation of medical device and pharmaceutical cases, giving attorneys the foresight to act where it matters most.

This Might Interest You:

• Ozempic MDL: Background, Timeline, & 2025 Updates
• Using Legal Intelligence to Detect Medical Mass Torts