Paragard IUD: claims for a broken device

Did your Paragard IUD break? Ask your care team about the device and any retained part.

See If You Qualify

Free · No obligation · About 2 minutes

Updated 8 sources

This may apply to you if

  • These suggestions help you prepare for a claim check. They are not a firm's acceptance rules.
  • Describe the device, removal and harm you want checked.
  • Prepare the procedure note and later care records if available.

The process

What happens next

  1. 01

    You answer a few questions

    About two minutes. Nothing is sent until you agree on the last step and press submit.

  2. 02

    A lawyer looks at it

    A lawyer at the firm reads your answers and checks them against the current case criteria.

  3. 03

    The firm decides and gets in touch

    If the firm takes your case, you get the terms in writing to read before you sign. You can always say no.

A T-shaped copper IUD with a fractured arm on a lightbox (photo illustration)
Photo illustration

The short answer

Who can ask about a broken IUD claim?
If your Paragard broke, ask for a device and harm check. Bring records of the removal and later care. A lawyer must decide how the evidence and law fit your situation. [7]
What is the case status in the records?
Paragard cases share court work in Georgia. A February 2025 order gave different results for some claims. Ask a lawyer which later order applies to your case. [7]
How much money could I get?
No payment estimate for your Paragard claim is given here. The cited records do not promise you an award. Ask a lawyer to explain your losses, evidence and any actual offer. [6]
What does help with a Paragard claim cost?
Ask for the proposed fee and expense terms in writing. Ask whether first contact has a charge. Read what you could owe if the claim does not bring a payment. [1]

Who qualifies

Do you qualify?

  • These suggestions help you prepare for a claim check. They are not a firm's acceptance rules.
  • Describe the device, removal and harm you want checked.
  • Prepare the procedure note and later care records if available.
  • Ask a lawyer to check the law and dates for your situation.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

Jordan Sarver · Ohio University Heritage College of Osteopathic Medicine · First author of the cited case report

Finding: The report describes one retained fragment and a treatment decision based on several individual factors; it does not establish a population breakage rate.

Sarver: fractured copper IUD, original full case report (opens in a new tab) · Jan 23, 2021 · Checked Oct 3, 2026

Leigh Martin May · United States District Court for the Northern District of Georgia · United States district judge signing the cited order

Finding: The February 11, 2025 order resolved some limitations/repose issues and deferred others for specified claims. It is not a single national cutoff.

May: Paragard Doc868 time-limit order (opens in a new tab) · Feb 11, 2025 · Checked Oct 3, 2026

The evidence and its limits

Ohio University Heritage College of Osteopathic Medicine, lead-author affiliation · Case Reports in Women's Health · 2021

Fractured copper IUD retained in the uterine wall leading to hysterectomy: a case report

Design:
Other study design
Participants:
One 38-year-old patient.
Finding:
A copper IUD broke during removal; a fragment remained in the uterine wall near the cervix. The patient later underwent surgery after consideration of several clinical factors.
Main limitation
Single case report without a comparison group or population denominator. It cannot establish a general breakage frequency, individual legal cause, or a universal need for hysterectomy. Full original report and declarations read; authors declared no funding or conflicts.

Read the source: Fractured copper IUD retained in the uterine wall leading to hysterectomy: a case report (opens in a new tab) · Checked Oct 3, 2026

What rules a case out

Not covered by this case

  • This page cannot diagnose a retained fragment or choose a removal procedure.
  • One patient report does not supply the risk for every IUD user.
  • An old court order is not a national deadline or personal payment promise.

What it costs

Lawyer fee and case expenses
Ask for written fee and expense terms.

Ask about first contact and costs you may owe if the claim loses.

Source: ABA Model Rule 1.5: fees · as of Oct 3, 2026

What happens step by step

  1. Gather the records you have

    Keep records that describe your history and the harm you want checked. Ask the provider about missing health records.

    Source: 45 CFR 164.524: access to health records · as of Oct 3, 2026

  2. Ask for a claim and time-limit check

    Give a lawyer your dates and locations. Ask which law and claim apply before choosing a filing date.

    Source: Southern District of New York: time limits · as of Oct 3, 2026

  3. Read the agreement

    Ask about the next step, the firm handling the case, fees, expenses and privacy terms before you agree.

    Source: ABA Model Rule 1.5: fees · as of Oct 3, 2026

Injuries in this case

Public agency records

Recalls and FDA reports

MAUDE reports matching the Paragard name and intrauterine contraceptive device code HDT. Recall records match Paragard product descriptions. Reports include all reported event types, not only breakage, and may omit products recorded under different names.

FDA data updates: Oct 13, 2026. Queries refresh about once a day. Source data may lag reporting by three months or more. These records do not determine whether an individual has a legal claim.

Recall events

Latest matching enforcement records, up to ten; recall dates are initiation dates. A match does not establish that a particular unit or lot was recalled. Check the product details in the FDA source.

No matching recall records were found. This does not establish that the product has never been recalled.

MAUDE reports by quarter

Twenty completed calendar quarters (five years), grouped by date received by FDA. Counts reflect matching reports, including possible follow-up or duplicate reports, and represent neither people nor confirmed injuries. A zero means no matches in the available API data; unavailable data is shown separately.

openFDA’s data limitations: “Therefore, a causal relationship cannot be established between product and reactions listed in a report.” Reports “cannot be used to estimate the incidence” of these events (FAERS disclaimer). The MAUDE page states that “the incidence or prevalence of an event cannot be determined from this reporting system alone”.

MAUDE report counts and limitations for each quarter
QuarterReportsLimitations
2026 Q30Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2026 Q20Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2026 Q10Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2025 Q40Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2025 Q30Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2025 Q20Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2025 Q10Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2024 Q40Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2024 Q30Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2024 Q20Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2024 Q10Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2023 Q40Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2023 Q30Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2023 Q20Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2023 Q10Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2022 Q40Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2022 Q30Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2022 Q20Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2022 Q11Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.
2021 Q40Reports “cannot be used to estimate the incidence” of these events; a reported association does not establish causation.

Who can ask about a broken IUD claim?

If your Paragard broke, ask for a device and harm check. Bring records of the removal and later care. A lawyer must decide how the evidence and law fit your situation.

The Georgia court summary concerns allegations about breakage during removal. Allegations state what people claim happened; they are not a finding that every device was defective. The summary does not tell you whether a firm will take a new case.

For a first discussion, describe what the clinician told you rather than deciding why the device broke. Note whether you have a procedure report, a scan report or only a memory of the visit. Ask what else the lawyer needs and whether the exact product can be confirmed.

Keep medical and legal questions distinct. Ask your care team about a retained part or symptoms. Ask a lawyer about legal responsibility and filing time. Having the same product name as a court case does not let this page decide either question for you.

What is the case status in the records?

Paragard cases share court work in Georgia. A February 2025 order gave different results for some claims. Ask a lawyer which later order applies to your case. Teva reported that the first federal test trial ended on February 3, 2026, with a verdict in its favor. That result concerns one case and does not decide your claim.

Judge Leigh Martin May signed the cited order on February 11, 2025. It granted some parts of a motion, denied others and deferred some decisions for specified people to provide records. That result should not be reduced to every case being won or lost.

Ask whether a reported result concerns your defendant, claim, court and dates. Request the case name and actual order behind a trial headline. A result in one person's case does not establish the current result for every person who used Paragard.

If you already filed, prepare the case number and the latest notice from your lawyer. Ask whether your claim remains pending, has moved, or was resolved. For a new inquiry, ask whether the firm is accepting the kind of claim you describe rather than assuming an old court page shows an open route.

How much money could I get?

No payment estimate for your Paragard claim is given here. The cited records do not promise you an award. Ask a lawyer to explain your losses, evidence and any actual offer.

The time-limit order is a ruling on specified legal issues, not a price list for injuries. The patient report describes medical care, not a compensation award. Neither record can turn a procedure name into a personal payout estimate.

For a legal discussion, set aside bills, procedure dates and notes about effects on daily life or work. Say what costs are already known and what remains uncertain. Ask which losses the relevant law recognizes and what proof would be needed.

If someone gives you a proposed offer, ask who it covers and what rights it releases. Ask what fees and expenses would be deducted. Read the actual terms rather than assuming a figure from another person's story is your take-home amount.

What does help with a Paragard claim cost?

Ask for the proposed fee and expense terms in writing. Ask whether first contact has a charge. Read what you could owe if the claim does not bring a payment.

The ABA model rule says an outcome-based fee agreement should explain the percentages and how expenses are treated. It does not verify this site's provider or the contract you will be offered. Ask which state rules govern the lawyer and your agreement.

For a broken-device claim, ask how procedure records, imaging or expert work would be obtained. Ask who pays each cost while the claim is pending. Ask whether expenses come out before or after the lawyer's share and what happens after a loss.

Before agreeing, ask who will handle the claim and what the first review includes. Ask whether the first contact is just an inquiry or an offer of representation. Keep the written answers beside the agreement so you can compare them before signing.

Which filing deadline applies to me?

Ask a lawyer to check your claim, dates and applicable law. The February 2025 order shows why different claims can have different time issues. It does not calculate your deadline.

The court order considered both filing limits and laws that can bar older claims after a set period. Its results varied with the claim and state law. Do not take one row about someone else and assume it decides your own date.

Prepare the insertion and removal dates you know, places of care, when you learned of breakage and any earlier filing. Mark a date as uncertain if it is only a memory. Ask the lawyer which date matters for each legal question rather than choosing a deadline yourself.

The general court guide says the time limit depends on the claim and law. A product label update or a news date is a different kind of date. Ask what must be filed and where before relying on an online cutoff.

What should I do today about the IUD?

Ask your clinician about the device and any suspected retained part. Do not try to remove it yourself. Keep the care records you have and ask how to obtain missing ones.

The prescribing information describes removal by a healthcare provider and checking that the removed device is intact. It warns that an embedded or broken device can require further medical assessment. That guidance does not choose the procedure needed in your case.

For your visit, ask what the records show about the fragment, its location and your care options. Ask which symptoms need prompt attention and how to follow up. A legal claim is not a reason to choose a procedure without the care team's advice.

Ask the facility how to request the removal note and any imaging reports. The federal access rule covers specified health records with exceptions. Keep the records as received rather than adding your own medical conclusion to the report.

What does the broken IUD research show?

One published report describes a retained fragment in one patient. It helps explain a possible complication and the choices made in that case. It cannot measure how often breakage occurs for all users.

Jordan Sarver and coauthors described a 38-year-old patient whose copper IUD broke during removal. The fragment remained in the uterine wall near the cervix. The report describes investigation and later surgery for that individual case.

The choice of hysterectomy reflected several factors, including other clinical concerns and the fragment's location. Do not read that single outcome as the required treatment for every broken IUD. Ask your clinician which options and tradeoffs apply to you.

A case report has no comparison group and does not count every person who had the device. It cannot establish a general breakage rate, prove a design defect, or show what caused every person's symptoms. The label and case report support a care discussion; they do not decide legal responsibility.

What happens after I ask for a Paragard check?

Ask who will review the product and care records. Ask what remains uncertain and what the next step would be. Read the contact, privacy and fee terms before agreeing to send detailed records.

Explain whether you have already filed or signed a lawyer agreement. Ask the reviewer to confirm the device and the legal issue rather than selecting a case from symptoms alone. Ask for a list of missing records and the reason each is needed.

Ask whether the person reviewing the inquiry is offering representation or only an initial assessment. Request the firm's identity and a clear description of its role. Ask when to expect an answer, who receives the files and how to correct an error in your account.

For an existing case, ask your lawyer to explain any time-limit ruling or request for evidence that names you. The cited order shows that additional records mattered for some people. Do not assume submitting information to a website completes a court requirement.

Questions about Paragard records and claims

The answers below distinguish care, product records and legal review. They do not diagnose a fragment or decide whether a firm will accept a claim. Bring your own questions and records to the appropriate professional.

Sources and record dates

The sources include an original case report, prescribing information and a dated court order. Each has a different purpose and limit. Ask how a source fits your device, care and claim.

How the Paragard IUD Fractures and Injures Women During Removal

The Paragard T380A is a copper intrauterine device marketed as a hormone-free, long-term contraceptive. Unlike hormonal IUDs, Paragard relies on copper wire coiled around a T-shaped polyethylene frame to prevent pregnancy. While designed for up to ten years of continuous use, a significant number of Paragard devices fracture at the arms during removal — leaving plastic and copper fragments inside the uterus, fallopian tubes, and surrounding tissue that require additional surgical procedures to extract.

Arm Fracture During Removal — Brittle Polyethylene

The horizontal arms of the Paragard T-frame are made of polyethylene embedded with barium sulfate, a radiopaque filler that allows X-ray visualization. Over time — and in some cases within months — the polyethylene becomes brittle and loses its structural integrity. When a clinician applies the traction force necessary for removal, one or both arms snap off rather than bending inward as the device was designed to do, leaving fragments inside the uterine cavity or cervical canal.

Copper Wire Breakage and Fragment Retention

Fine copper wire coiled around the Paragard frame can break free from the frame during removal, particularly when the polyethylene arm fractures and alters the mechanical load on the coil. Broken copper wire segments are small enough to migrate into tissue folds, the uterine cornua, or through the fallopian tube ostia, making complete surgical retrieval difficult and sometimes requiring hysteroscopy or laparoscopy.

Device Embedment in the Uterine Wall

In some patients, the Paragard device becomes partially or fully embedded in the myometrium — the muscular wall of the uterus — through a process called myometrial penetration or intramural embedding. Embedded devices cannot be removed by standard office-based traction and require hysteroscopic or surgical extraction. Attempts to remove an embedded device without imaging confirmation of its position risk uterine perforation.

Retained Fragments Requiring Surgical Intervention

When Paragard arm fractures occur, the retained fragments do not remain stationary. Uterine contractions, patient movement, and the body's inflammatory response can displace fragments toward the cervix, into the myometrium, or through the uterine wall into the peritoneal cavity. Retrieval of retained fragments typically requires hysteroscopic surgery under anesthesia; fragments that have migrated outside the uterus may require laparoscopic or open abdominal surgery.

Uterine Perforation and Fallopian Tube Damage Causing Infertility

Attempted removal of a fractured or embedded Paragard — particularly when the location of retained fragments is not confirmed by imaging before the procedure — carries significant risk of uterine perforation. Perforating instruments or migrating fragments can damage the fallopian tubes, ovaries, and adjacent structures. Tubal damage from Paragard-related perforation or retained copper fragments is a recognized cause of pelvic inflammatory disease, ectopic pregnancy, and permanent infertility in affected women.

  • Material Degradation Over Extended Use: Polyethylene exposed to the uterine environment undergoes slow oxidative degradation. The barium sulfate filler incorporated into Paragard's arms creates stress concentration points within the polymer matrix that accelerate crack propagation under the mechanical load of removal. Devices used for longer periods — particularly those approaching or exceeding ten years — show higher fracture rates, but fractures have been documented in devices removed well before the labeled use period expired.
  • Inadequate Warnings to Clinicians and Patients: Paragard's prescribing information historically did not prominently warn clinicians that arm fracture during removal was a documented risk or describe the appropriate steps — including imaging before removal — to take when encountering resistance during removal. Clinicians unaware of the fracture risk may apply additional force when resistance is felt, increasing the probability that a partially fractured arm will complete its break.
  • Post-Acquisition Manufacturing and Design Changes: Paragard was acquired by CooperSurgical from Teva Pharmaceuticals in 2017. Plaintiffs allege that manufacturing process changes following the acquisition may have affected the material properties of the polyethylene frame, and that post-acquisition quality control failed to identify increased fracture rates in the new production lots. Internal complaint data from the post-acquisition period is central to ongoing litigation discovery.
  • Absence of Pre-Removal Imaging Protocol: Unlike other long-term contraceptive devices, Paragard has no standard clinical protocol requiring ultrasound or X-ray imaging to confirm device position, integrity, and the absence of embedment before initiating removal. This protocol gap means clinicians routinely attempt traction removal without knowledge of whether the device is properly positioned, embedded, or already partially fractured — increasing the probability of retained fragment injuries.
  • The FDA MAUDE adverse event database contains thousands of reports describing Paragard IUD arm fracture during attempted removal, making it one of the most frequently reported IUD complications in the database
  • Peer-reviewed clinical literature has documented Paragard fracture during removal as a recognized complication with rates that increase with duration of use
  • The FDA issued a labeling update in 2020 requiring Paragard's prescribing information to include warnings that the device may break during removal, and that fragments may be left inside the patient
  • MDL 2974 in the Northern District of Georgia consolidates thousands of federal Paragard fracture cases before Judge Leigh May

The Paragard litigation centers on the claim that CooperSurgical and Teva Pharmaceuticals knew or should have known that the polyethylene T-frame was susceptible to fracture during removal — a foreseeable failure mode given the material properties of the frame and the documented adverse events in the FDA reporting system. Plaintiffs allege both design defect (the frame material was inadequate for the mechanical demands of removal) and failure to warn (clinicians and patients were not given adequate information about fracture risk or guidance to prevent it). The injuries caused — retained fragments, additional surgeries, uterine perforation, and infertility — are severe and well-documented in medical records.

Device Fracture and Fragment Retention

Device fracture — the breaking of one or both horizontal arms of the Paragard T380A copper IUD during removal — is the primary injury mechanism at the center of MDL 2974 litigation. The Paragard device consists of a polyethylene frame with flexible copper-and-plastic arms. During removal, a provider grasps the retrieval strings and applies downward traction. If the arms do not flex appropriately or have become embedded in the endometrium, they can shear off from the frame. The retained plastic and copper fragments are radiopaque and detectable on ultrasound or X-ray, but may be missed if imaging is not performed following a suspected incomplete removal. Published data from the FDA MAUDE adverse event database shows that breakage is the most reported Paragard adverse event type, with 1,231 reports in 2022 alone and more than 54,000 total adverse event reports since the device's 1984 approval. Comparative device data shows copper IUD adverse events involve breakage in 9.6% of reported cases versus 1.7% for hormonal IUD devices.

  • Provider notification of arm breakage during removal attempt
  • Acute pelvic pain and cramping following removal procedure
  • Retained fragment visible on pelvic ultrasound or X-ray
  • Abnormal uterine bleeding after incomplete removal
  • Asymptomatic retention — fragment present but no immediate symptoms
  • Migration symptoms: pain extending to abdomen, bladder pressure, or bowel symptoms
  • Duration of Paragard in place — longer implant periods associated with arm embedment in endometrium
  • Retroverted or anteverted uterine position complicating retrieval angle
  • Prior uterine surgery or scarring affecting device mobility
  • Removal by provider with limited IUD removal experience
  • IUD positioned outside normal uterine placement (partial expulsion, malposition)
  • Post-menopausal removal — uterine involution increases fracture risk
  • Hysteroscopy — camera-guided intrauterine surgery to visualize and retrieve broken fragment
  • Laparoscopy — minimally invasive abdominal surgery for migrated fragments outside uterus
  • Laparotomy — open abdominal surgery in cases of extensive migration or bowel/bladder involvement
  • Hysterectomy — removal of uterus when injury is too extensive to repair
  • Imaging-guided retrieval — ultrasound or fluoroscopy-guided procedures for accessible fragments
  • Pain management and antibiotic therapy for associated infection or PID

Uterine and Organ Perforation

Uterine perforation occurs when a retained Paragard fragment — or the removal instrument used to retrieve a broken device — penetrates the uterine wall. This complication can occur at the time of the removal procedure or develop over days to weeks as a migrating fragment works through the myometrium. Perforation severity ranges from partial-thickness penetration (involving only the uterine muscle) to complete perforation with migration of device fragments into the peritoneal cavity, where contact with the bowel, bladder, fallopian tubes, ovaries, or other abdominal structures can cause adhesions, fistulas, and secondary organ damage. Laparoscopic or open surgical intervention is required for complete perforation with migration. Cases involving bowel or bladder perforation by a migrated Paragard fragment represent the most severe injury profile and carry the highest surgical risk.

  • Sharp pelvic or abdominal pain following removal procedure
  • Heavy or prolonged uterine bleeding
  • Signs of peritoneal irritation — abdominal rigidity, guarding, rebound tenderness
  • Fever and elevated white blood cell count indicating infection
  • Bladder symptoms — urgency, pain, hematuria — if bladder involved
  • Bowel symptoms — pain, obstruction signs — if bowel involved
  • Device arm fracture leaving sharp edges that can erode through uterine tissue
  • Uterine wall weakened by prior cesarean section or fibroid surgery
  • Migration of fragment from uterine cavity into peritoneum
  • Delay in diagnosis allowing migrating fragment to reach adjacent organs
  • Aggressive retrieval attempts that advance fragment position
  • Anatomical variants increasing perforation risk during retrieval
  • Emergency laparoscopy for acute perforation with peritoneal involvement
  • Laparotomy for bowel or bladder perforation requiring complex repair
  • Hysterectomy when uterine integrity cannot be restored
  • Bowel resection if bowel wall is perforated by migrated fragment
  • Bladder repair and catheterization for bladder perforation
  • Long-term pelvic floor rehabilitation following surgical repair

Infertility from Paragard Injury

Infertility resulting from Paragard IUD breakage and the associated surgical interventions is among the most serious injuries alleged in MDL 2974. The pathway from device fracture to infertility involves several mechanisms: direct scarring of the endometrium (uterine lining) from retained copper fragments and resulting chronic inflammation; damage to the fallopian tubes from migrated fragments or from adhesion formation following peritoneal contamination; and hysterectomy — the surgical removal of the uterus — which permanently and irrevocably eliminates the possibility of pregnancy. Younger plaintiffs (under 35 at the time of injury) who intended to have children and who can demonstrate that the Paragard breakage eliminated that possibility face the most significant non-economic damages and command the highest settlement and verdict values. Fertility treatment records, medical records documenting failed pregnancy attempts, and reproductive medicine expert testimony are key evidence elements for infertility claims.

  • Inability to conceive following Paragard removal and associated surgery
  • Tubal occlusion on hysterosalpingography (HSG) confirming blocked fallopian tubes
  • Endometrial scarring — intrauterine adhesions (Asherman's syndrome) on hysteroscopy
  • Failed IVF or other assisted reproduction attempts following Paragard surgery
  • Surgical menopause following hysterectomy with oophorectomy
  • Chronic pelvic pain interfering with sexual function and quality of life
  • Hysterectomy required to address Paragard removal complications — permanent infertility
  • Fallopian tube involvement from migrated fragments — tubal factor infertility
  • Extensive endometrial scarring from intrauterine fragment retention and chronic copper exposure
  • Pelvic inflammatory disease (PID) secondary to retained device causing tubal damage
  • Oophorectomy (ovary removal) performed in conjunction with complicated hysterectomy
  • Age at time of injury — younger women have longer reproductive horizon and greater loss
  • Hysteroscopic adhesiolysis (lysis of intrauterine adhesions) for Asherman's syndrome
  • Salpingostomy or salpingectomy for damaged fallopian tubes
  • In vitro fertilization (IVF) as assisted reproductive option if uterus remains intact
  • Gestational surrogacy if uterus removed but ovaries preserved
  • Hormone replacement therapy following surgical menopause
  • Psychological counseling and fertility grief support — infertility carries significant emotional damages

Corporate Accountability in the Paragard IUD Litigation

The Paragard IUD litigation holds CooperSurgical Inc. and its parent The Cooper Companies primarily liable for fracture-related injuries occurring after the 2017 acquisition, while Teva Pharmaceuticals bears potential liability for the pre-acquisition period. Internal documents obtained through MDL 2974 discovery are revealing what these companies knew about Paragard's fracture risk, when they knew it, and what corrective actions — if any — they took. The picture emerging from litigation is one of a device whose failure mode was documented in thousands of adverse event reports but never meaningfully addressed in labeling, clinical guidance, or device redesign.

Concealed Fracture Risk and Inadequate Post-Market Surveillance

Discovery in MDL 2974 has focused on what CooperSurgical and Teva knew about Paragard arm fracture before the FDA required the 2020 labeling update — and why, despite thousands of adverse event reports in the MAUDE database, neither company proactively updated the prescribing information or issued surgeon safety communications prior to the FDA mandate.

  • CooperSurgical's internal quality complaint database contains fracture reports dating to the pre-acquisition period, establishing a continuous chain of manufacturer knowledge that plaintiffs allege was never translated into adequate warnings or product redesign
  • Teva Pharmaceuticals, during its stewardship of Paragard before 2017, received mandatory MDR adverse event submissions describing arm fracture but did not update prescribing information to disclose the risk without FDA compulsion
  • Post-acquisition manufacturing changes implemented by CooperSurgical were not accompanied by adequate mechanical testing to verify that the fracture profile of post-2017 production lots matched that of pre-acquisition devices — an allegation supported by the accelerating MAUDE report volume after 2017
  • Neither CooperSurgical nor Teva issued proactive surgeon letters or patient safety communications about fracture risk prior to the FDA's 2020 mandate, despite possessing years of adverse event data establishing the prevalence of the complication

S&P Global

The Cooper Companies — litigation contingency monitoring (2024)

Paragard IUD MDL 2974 cited as a material litigation contingency in The Cooper Companies' SEC filings, with disclosure that the financial outcome of the litigation cannot be estimated at this time

Moody's

The Cooper Companies — credit stable, litigation watch (2024)

Moody's affirmed The Cooper Companies' credit rating with notation that Paragard litigation represents a meaningful contingent liability; rating stability contingent on litigation exposure not exceeding current reserves

The company's decision not to proactively update labeling, redesign the frame, or issue surgeon safety communications — until the FDA required it in 2020 — forms the core of the failure-to-warn claims that thousands of plaintiffs are pursuing in MDL 2974. The 36-year gap between market entry and the first mandatory fracture warning is the defining fact of this litigation.

FDA Regulatory History and Litigation Consolidation for Paragard IUD

Paragard has been on the U.S. market since 1984, cleared by the FDA before modern premarket approval requirements for medical devices were fully established. Its long regulatory history includes a 510(k) clearance pathway, accumulating MAUDE adverse event reports, a significant 2020 labeling update requiring fracture warnings, and eventual consolidation of federal lawsuits into MDL 2974. Each regulatory action reflects a pattern of belated acknowledgment of known device risks.

Paragard entered the U.S. market in 1984 through a clearance pathway that did not require long-term mechanical testing. For decades, arm fracture during removal accumulated in the FDA's adverse event database without triggering mandatory warnings. When the FDA finally required explicit fracture warnings in 2020, it validated what plaintiffs in MDL 2974 allege: that the risk was known, foreseeable, and inadequately communicated — and that thousands of women were harmed in the interval between when the risk was recognized and when it was disclosed.

Paragard IUD Lawsuit Filing Deadlines — Statute of Limitations by State

The statute of limitations for Paragard IUD claims is set by state law, often 2 to 3 years, and when the clock starts depends on the state and the facts. In a February 11, 2025 order on named cases in MDL 2974, the court treated the device fracture during removal as the point when those claims accrued. The order did not set one national filing date. Whether that time has passed depends on your facts, so don't rule yourself out. A lawyer can tell you.

The Breakage Date Rule — 2025 MDL Ruling

Judge Leigh Martin May's February 11, 2025 order in MDL 2974 held, for the named cases it decided, that the claims accrued at the time of device breakage, because the breakage is the injury-causing event and is typically known to the patient immediately — her healthcare provider would have informed her that the device broke during removal, or imaging would have revealed retained fragments shortly after the procedure. This 'breakage date' rule differs from the traditional 'discovery rule' used in some pharmaceutical cases, where the clock starts when a plaintiff connects her symptoms to the product. For Paragard, the event is discrete and usually documented in medical records. The order did not set one national filing date. Whether that time has passed depends on your facts, so don't rule yourself out. A lawyer can tell you.

If your Paragard IUD broke during removal, a lawyer can check which deadline applies to you. In a February 11, 2025 order on named cases, the MDL 2974 court treated the breakage at removal as the point when those claims accrued, so deadlines may run from the removal date rather than from a later diagnosis. The order did not set one national filing date. Whether that time has passed depends on your facts, so don't rule yourself out. A lawyer can tell you.

Questions people ask

Does the Georgia court record decide every Paragard claim?

No. The cited February 11, 2025 order treated specified time-limit issues differently. Ask a lawyer for the latest relevant order and the result in your own case.

Source: N.D. Georgia Paragard MDL order, February 11, 2025 · as of Oct 7, 2026

What time limit applies to a broken Paragard claim?

A lawyer must check the claim, state law and relevant dates. The cited order is not a national deadline. Prepare insertion, removal, discovery and any filing dates without guessing.

Source: Southern District of New York: time limits · as of Oct 7, 2026

Is there a set payout for a broken Paragard?

No personal payment estimate is supplied here. A time-limit order and a patient report are not award schedules. Ask about evidence, any actual offer and fee deductions in your own claim.

Source: DailyMed: Paragard prescribing information · as of Oct 7, 2026

Is a Paragard breakage warning the same as a recall?

No. The prescribing information warns about breakage and describes clinician assessment. That warning does not itself establish a recall or decide your care. Ask your clinician to check current notices for the exact product.

Source: DailyMed: Paragard prescribing information · as of Oct 7, 2026

What does the shared Paragard court proceeding concern?

The Northern District of Georgia describes allegations that Paragard breaks during removal and causes harm. Those allegations are not a finding that every device is defective or that every user has a claim.

Source: N.D. Georgia: In re Paragard IUD Products Liability Litigation · as of Oct 7, 2026

Which records can help explain a Paragard break?

Consider the insertion and removal notes, imaging reports and later care records. Ask the facility how to request missing records. These are preparation suggestions, not a firm's acceptance criteria.

Source: HHS: Your Medical Records · as of Oct 7, 2026

Does a retained Paragard part always require hysterectomy?

No universal treatment rule comes from the one-patient report. Several individual factors shaped that patient's surgery. Ask your own care team about the fragment and options for you.

Source: DailyMed: Paragard prescribing information · as of Oct 7, 2026

How do I check fees for a Paragard lawyer?

Request the actual written fee and expense agreement. Ask about first contact, expert or record costs, deductions and what you may owe if the claim loses. The ABA model rule is not the provider's contract.

Source: ABA Model Rule 1.5: Fees · as of Oct 7, 2026

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Sources

  1. ABA Model Rule 1.5: feesABA Model Rule 1.5: fees
  2. Southern District of New York: time limitsSouthern District of New York: time limits · court
  3. 45 CFR 164.524: access to health records45 CFR 164.524: access to health records · regulator
  4. Sarver: fractured copper IUD, original full case reportSarver: fractured copper IUD, original full case report · study
  5. DailyMed: Paragard prescribing informationDailyMed: Paragard prescribing information · regulator
  6. May: Paragard Doc868 time-limit orderMay: Paragard Doc868 time-limit order · court
  7. Northern District of Georgia: Paragard case summaryNorthern District of Georgia: Paragard case summary · court
  8. Teva reported that the first Paragard MDL test trial ended on February 3, 2026, with a verdict in its favor. This result concerns one case. As of October 6, 2026, ask your lawyer how it affects your claim and which later court orders apply.sahmcapital.com · Feb 3, 2026

Checked against 7 primary sources by People's Justice editors · Updated

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