Medical Device MDL-2974 • Northern District of Georgia •
Actively Recruiting

Paragard IUD Lawsuit (Breakage During Removal)

Federal litigation alleging the Paragard copper IUD is defectively designed and prone to breaking during removal, leaving fragments in the uterus and requiring additional surgeries.

Last Updated: October 1, 2026
14 min read
JPML Data Verified
8 sources cited

Key Takeaways

  • Over 4,200 cases pending as of October 2026 with 47% growth since January 2025
  • Paragard is the only copper IUD available in the United States
  • Allegations claim T-junction design is prone to fracture during removal
  • The first federal bellwether ended in a complete defense verdict for Teva on February 3, 2026 (a defense-selected case); the second bellwether, Robere v. Teva, is set to begin April 12, 2027 under a September 16, 2026 scheduling order; no global settlement yet
  • Cases involve retained fragments, additional surgeries, and infertility
4,224
Pending Actions
4,552
Total Filed
10yr
Approved Duration
Only
Copper IUD in US

Key Facts (October 2026)

Pending Actions 4,224 cases in federal MDL
Total Actions Filed 4,552+ cases historically
Defendants CooperSurgical, Inc. / The Cooper Companies (NYSE: COO); Teva Pharmaceuticals for Teva-era devices (before the 2017 sale to Cooper)
Presiding Judge Hon. Leigh Martin May (N.D. Georgia)
MDL Created December 2020
Key Allegation T-junction design prone to fracture during removal
Settlement Status No global settlement announced
Can You Still File? Yes — actively recruiting cases

Steady Case Growth

Cases continue to be filed as women report IUD breakage during removal. Case count has grown 47% since January 2025.

Jan 25
2,882
Feb 25
2,937
Mar 25
2,965
Apr 25
3,036
May 25
3,252
Jun 25
3,330
Jul 25
3,474
Aug 25
3,529
Sep 25
3,569
Oct 25
3,595
Nov 25
3,658
Dec 25
3,749
Jan 26
3,800
Feb 26
3,867
Mar 26
3,926
Apr 26
3,982
May 26
3,984
Jun 26
4,071
Jul 26
4,111
Aug 26
4,156
Sep 26
4,185
Oct 26
4,224

Source: JPML MDL Statistics Reports, January 2025-October 2026

2024 Study: Paragard Generates Higher Stress During Removal

A peer-reviewed study in Contraception (2024) compared IUD designs during simulated removal:

Paragard T-junction
1.70 MPa stress at arm-stem junction
Other IUDs (Nova-T)
0.36-0.79 MPa stress (significantly lower)

Source: La Saponara V, et al. Contraception. 2024;133:110399 (PMID: 38369271)

1 What Is Paragard?

Paragard T 380A is the only copper-containing intrauterine device (IUD) available in the United States. It's a T-shaped device inserted into the uterus to prevent pregnancy for up to 10 years.

Unlike hormonal IUDs (Mirena, Liletta, Kyleena, Skyla), Paragard is hormone-free, making it the preferred choice for women who cannot or choose not to use hormonal contraception. It works by releasing copper ions that are toxic to sperm and create an inflammatory response that prevents fertilization.

Paragard Components

  • T-shaped polyethylene frame
  • Barium sulfate (for x-ray visibility)
  • Copper wire wound around frame
  • Monofilament removal strings
FDA Approved Since 1984: Originally approved for 4 years, duration was extended to 10 years by 2005. Over 40 years on the market.

2 The Alleged Defect: Breakage During Removal

Plaintiffs allege that Paragard is prone to breaking during removal attempts, with the arms of the T-shaped device fracturing and separating from the frame. This leaves fragments inside the uterus.

T-Junction Stress Point

The junction where the horizontal arms meet the vertical stem is a stress concentration point. The 2024 study found Paragard generates 1.70 MPa of stress at this junction during removal—significantly more than other IUD designs (0.36-0.79 MPa).

Material Degradation Over Time

Plaintiffs allege the polyethylene frame degrades over the 10-year approved duration, and copper corrosion may further weaken the device structure, increasing breakage risk for devices left in place longer.

FDA MAUDE Database Reports

The FDA's adverse event database contains numerous reports of Paragard breakage during removal with problem codes for "Break" and "Entrapment of Device," resulting in "Foreign Body In Patient."

3 Alleged Injuries

Immediate Complications

  • Retained device fragments in uterus
  • Fragment migration through uterine wall
  • Chronic pelvic pain
  • Infection / sepsis

Long-Term Consequences

  • Infertility
  • Ectopic pregnancy
  • Scarring and adhesions
  • Hysterectomy (loss of fertility)

Additional Surgeries Required

  • Hysteroscopy (camera-guided removal)
  • Laparoscopy (small incision surgery)
  • Laparotomy (open abdominal surgery)
  • Hysterectomy (in severe cases)

4 FDA Label Warnings

The FDA-approved Paragard label includes warnings about several complications, though plaintiffs allege the breakage risk during removal is inadequately warned:

Expulsion (§5.7)
Partial or complete expulsion may occur
Perforation (§5.6)
Device may perforate uterine wall
Embedment (§5.5)
May become embedded, requiring surgical removal
PID/Infection (§5.4)
Risk of pelvic inflammatory disease

5 Litigation Timeline

Nov 1984
FDA Approval

Paragard originally approved (NDA 018680), initially for 4 years.

2005
Duration Extended to 10 Years

FDA approves extended duration, increasing time device remains in body.

2017
CooperSurgical Acquires Paragard

The Cooper Companies acquires Paragard from Teva Pharmaceuticals.

Dec 2020
MDL-2974 Created

JPML centralizes cases in Northern District of Georgia before Judge Leigh Martin May.

Feb 2024
Key Study Published

Peer-reviewed study in Contraception shows Paragard generates significantly higher stress during removal than other IUDs.

Feb 2026
First Bellwether: Defense Verdict

On February 3, 2026, the first federal bellwether ended in a complete defense verdict for Teva. It was a defense-selected case.

Jun 2026
Preemption Ruling Certified for Appeal

On June 1, 2026, the court certified its preemption ruling for interlocutory appeal. The third bellwether, Braxton, had been stayed on April 24, 2026.

Aug 2026
Next Bellwethers Selected

On August 6, 2026, the court selected the next bellwether cases, in this order: White, Gutierrez, Rodriguez and Rounds. On August 26, defendants filed a second motion to dismiss cases they argue are barred by statutes of limitations and repose.

Sep 2026
Robere Trial Set for April 12, 2027

A September 16, 2026 scheduling order sets the second bellwether, Robere v. Teva, to begin April 12, 2027. Motions in limine are due October 22, with responses due November 5.

Present
Actively Recruiting

4,224 cases pending. No global settlement announced. Cases continue to be filed.

6 Do You Qualify?

Eligibility Requirements

  • Had a Paragard IUD (the copper IUD, not Mirena or other hormonal IUDs)
  • Device broke during removal — arm(s) fractured or separated from the frame
  • Fragments retained — pieces of the device remained in your body
  • Required additional procedure(s) — surgery to remove fragments, or other medical intervention
Still Have Paragard? If you currently have a Paragard IUD and are considering removal, discuss options with your healthcare provider. This litigation does not mean all removals result in breakage.

7 Frequently Asked Questions

Is Paragard still available?
Yes. Paragard remains FDA-approved and commercially available. It's the only hormone-free IUD option in the US and serves an important role for women who cannot use hormonal contraception. The litigation focuses on the breakage issue, not the device's contraceptive effectiveness.
What makes Paragard different from other IUDs?
Paragard uses copper (non-hormonal) while Mirena, Liletta, Kyleena, and Skyla use hormones. Paragard also has a different "Tatum-T" frame design compared to the "Nova-T" design of hormonal IUDs. The 2024 study found this design generates significantly more stress during removal.
Is there a recall on Paragard?
No recall has addressed breakage. FDA records show two lot-specific non-sterility recalls (2014, Class II; 2022, Class I), both closed; Paragard remains on the market. The litigation involves claims of defective design, not a regulatory recall.
Has there been a settlement?
Bellwether trials are underway. The first federal bellwether concluded on February 3, 2026 with a complete defense verdict for Teva, the jury declining to hold Teva liable, though it was a defense-selected case, which limits how much it signals about the broader docket. The second bellwether, Robere v. Teva, is set to begin April 12, 2027 under a September 16, 2026 scheduling order. The third bellwether, Braxton, was stayed on April 24, 2026, and on June 1, 2026 the court certified its preemption ruling for interlocutory appeal. On August 6, 2026, the court selected the next bellwether cases, in this order: White, Gutierrez, Rodriguez and Rounds. No global settlement has been announced as of October 2026; the MDL continues with active case filings, and individual settlements, if any, would typically be confidential.
What are the legal claims?
Plaintiffs allege: design defect (T-junction stress concentration), manufacturing defect, failure to warn (inadequate warning about breakage risk), negligence, and breach of warranty. Some complaints include fraud/misrepresentation claims.
Who are the defendants?
The primary defendants are CooperSurgical, Inc. and The Cooper Companies, Inc. (current manufacturer). Teva Pharmaceuticals (former owner) and entities in the earlier ownership chain may also be named depending on when the plaintiff's device was manufactured.

Sources & References

8 official sources cited

• Judicial Panel on Multidistrict Litigation (JPML) — MDL Statistics Report (October 1, 2026)

• In re: Paragard IUD Products Liability Litigation, MDL No. 2974 (N.D. Ga.) — bellwether selection order (August 6, 2026, Doc. 1258); defendants' second motion to dismiss on limitations and repose grounds (August 26, 2026, Doc. 1260); Robere v. Teva scheduling order (September 16, 2026)

• FDA Enforcement Reports (openFDA) — Paragard recalls D-1354-2014 (Class II, March 2014) and D-0643-2022 (Class I, February 2022, lot 517001), both for non-sterility, both closed

• La Saponara V, et al. "Understanding the mechanical behavior of intrauterine devices during simulated removal." Contraception. 2024;133:110399 (PMID: 38369271)

• FDA Drugs@FDA Database — NDA 018680

• FDA-approved Paragard Prescribing Information (June 2024)

• FDA MAUDE Database — Adverse Event Reports

• CDC U.S. Selected Practice Recommendations for Contraceptive Use (2024)

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