Paragard IUD Breakage Lawsuit MDL 2974 — May 2026 Update

The first Paragard bellwether trial ended with a defense verdict in February 2026.

Before you read that as “the lawsuit is over,” consider the context: the J&J baby powder MDL saw multiple defense verdicts and plaintiff verdicts before a global settlement structure emerged. One jury result establishes a data point — it does not resolve 3,982 pending cases.

MDL 2974 (In re Paragard IUD Products Liability Litigation) continues before Judge Leigh Martin May in Atlanta. A second bellwether was pushed to fall 2026. A third is scheduled for earlier in 2026. Each result contributes to the settlement calculus that mediator Gino Brogdon and the parties are working through.

If you had a Paragard IUD that broke during removal and suffered resulting injuries, this guide explains where the litigation stands, what you need to qualify, and how the preemption defense could affect your case.

This is informational, not legal advice. Consult a licensed attorney for your specific situation.

What Paragard Is — And the Problem

Device Background

Paragard is a T-shaped intrauterine device (IUD) made from polyethylene with copper wire coiled around its frame. It is hormone-free and FDA-approved for up to 10 years of contraceptive use. Copper ions released by the device impair sperm motility.

Manufacturer history:

Period	Owner/Manufacturer
Pre-1988	GynoPharma, then Duramed Pharmaceuticals
Mid-1990s–2017	Teva Pharmaceuticals
November 2017–present	CooperSurgical (subsidiary of Cooper Companies), acquired for ~$1.1 billion

The manufacturing facility in Buffalo, New York was part of the Teva-to-CooperSurgical transaction. Both companies are named defendants in MDL 2974. Your primary defendant depends on your insertion date.

The Breakage Mechanism

The T-shape creates two horizontal arms designed to flex downward during removal as the device is pulled through the cervix. The design requires the arm material to have sufficient flexibility to bend without fracturing.

Plaintiffs allege the arms are too brittle — that the material composition and/or design tolerances make breakage a foreseeable risk during normal, correctly performed removal procedures.

When an arm breaks:

1. A fragment may remain embedded in the uterine wall
2. Removal requires hysteroscopic or open surgical intervention
3. The retrieval procedure carries infection risk
4. Perforation of the uterine wall is possible during fragment retrieval
5. In severe cases, hysterectomy is necessary
6. Resulting infertility is permanent

The FDA’s Adverse Event Reporting System (FAERS) contains thousands of filed reports of Paragard breakage during removal. While FAERS reports are not evidence of defect — they are unverified — the volume created a litigation record that plaintiff attorneys began building cases around.

MDL 2974: Current Status

Litigation Overview

Element	Detail
MDL Number	MDL 2974
Full Title	In re Paragard IUD Products Liability Litigation
Court	U.S. District Court, Northern District of Georgia
Judge	Leigh Martin May
Pending Cases	~3,982 (May 2026)
Mediator	Retired Judge M. Gino Brogdon Sr.
Earlier Dismissals	~236 cases dismissed on statute of limitations grounds

Bellwether Results: One Defense Win, More to Come

First bellwether (February 2026): Two weeks of trial in Atlanta. Jury returned a defense verdict for Teva Pharmaceuticals. Claims rejected: strict liability, failure to warn, defective design, fraudulent omission.

Why this happened, based on available reporting:

• The specific plaintiff’s case may have had documentation weaknesses
• Defense experts likely argued the removal procedure caused the breakage, not device defect
• The preemption argument may have partially influenced jury reasoning

Subsequent bellwethers:

• Second bellwether pushed to fall 2026 after the initial defense win
• Third bellwether tentatively scheduled for early-to-mid 2026

My analysis: Two paths emerge from here.

Path A (defense wins both remaining bellwethers): Settlement leverage shifts heavily to defendants. Plaintiff attorneys will conduct aggressive case selection, dropping weaker claims. Global settlement, if reached, will be at lower per-case values. Certain claims — particularly those with strong hysterectomy/infertility documentation — may still settle meaningfully.

Path B (plaintiff wins one or both remaining bellwethers): The February 2026 loss becomes a fact pattern outlier. Global settlement negotiations resume in earnest under mediation. Per-case values recover toward pre-verdict estimates.

Roundup MDL bellwether comparison →

The Federal Preemption Defense — Key Legal Battle

The most consequential legal issue in MDL 2974 is federal preemption.

The defense argument: Paragard received 510(k) clearance from the FDA. Under 21 U.S.C. § 360k, federal law expressly preempts state-law requirements that are “different from, or in addition to” federal device requirements. Teva and CooperSurgical argue that state-law failure-to-warn and design defect claims are preempted.

Why this argument is contested: In Riegel v. Medtronic (552 U.S. 312, 2008), the Supreme Court upheld preemption for PMA (premarket approval) devices, which undergo rigorous FDA review. Paragard entered the market through 510(k) clearance — a substantially equivalent determination, not an independent safety review. In Medtronic, Inc. v. Lohr (518 U.S. 470, 1996), the Court declined to preempt state claims for a 510(k)-cleared device.

The lower courts have split on whether 510(k) clearance triggers preemption. MDL 2974 will likely not resolve this definitively at the trial level; a circuit split could eventually draw Supreme Court review.

For plaintiffs: If preemption is denied, failure-to-warn and design defect claims proceed normally. If preemption is upheld for design defect but not failure-to-warn (a middle-ground outcome some courts have reached), plaintiffs’ theories narrow.

Paragard vs. Mirena vs. Essure: IUD/Contraceptive Litigation Comparison

Factor	Paragard MDL 2974	Mirena Litigation	Essure (Bayer)
Device type	Copper, hormone-free IUD	Progestin IUD	Permanent coil (tubal)
Primary injury	Arm breakage, retained fragment	Migration, perforation	Perforation, migration, chronic pain
Manufacturer	Teva/CooperSurgical	Bayer	Bayer
Current MDL status	Active (3,982 cases)	Separate litigation	Largely resolved via settlement
Bellwether	1 defense verdict (Feb 2026)	Case-by-case	Settlement (Bayer paid undisclosed amounts)
FDA preemption defense	Central issue	Raised but less decisive	Raised
Device discontinued?	No	No	Yes (2018)

The Essure precedent is instructive: Bayer eventually resolved thousands of Essure claims through a settlement program after years of litigation, even following some defense-favorable trial outcomes. That trajectory — sustained litigation, multiple trial results, then a global resolution — is what experienced mass tort practitioners expect for Paragard.

Who Qualifies: The Three-Part Test

1. Confirmed Paragard Insertion

Medical records documenting that you received a Paragard IUD. The insertion date determines whether Teva or CooperSurgical is your primary defendant (insertion before November 2017 = Teva; after = CooperSurgical).

2. Arm Breakage During Removal

Documentation that the device broke during an attempted removal. This should appear in the removing provider’s notes, operative reports if surgery was needed, or pathology reports if fragments were retrieved.

3. Resulting Physical Injury

One or more of the following:

• Surgical procedure to retrieve fragments (hysteroscopy, laparoscopy, laparotomy)
• Uterine perforation
• Hysterectomy
• Documented infertility attributable to Paragard complications

What Does NOT Qualify

• Paragard removed successfully without breakage, even if removal was difficult
• Pain or discomfort during normal use without breakage
• Unwanted pregnancy while Paragard was in place (separate failure-to-warn theory, not the breakage MDL)

Statute of Limitations: Act Faster Than Cancer Cases

Unlike cancer litigation where the discovery rule can extend filing windows by years, Paragard breakage cases present a different limitations dynamic:

Breakage is typically discovered at the time of removal — the patient is often told immediately that the arm broke. That means the limitations clock usually starts running at the moment of removal.

State	Period	Notes
California	2 years	From removal/discovery of breakage
New York	3 years	From removal/discovery
Texas	2 years	From removal/discovery
Florida	4 years	From removal/discovery
Georgia	2 years	MDL state

If your removal where breakage occurred was more than 2 years ago and you are in a 2-year state, you may face a statute of limitations challenge. The court has already dismissed approximately 236 Paragard cases on this ground. Do not wait.

Worked Scenarios

Scenario A: Hysterectomy After Fragment Retention (Georgia)

Keisha M., 39. Paragard inserted December 2016 (Teva period). Removal attempted October 2022 — arm fractured, fragment confirmed by imaging. Hysteroscopy failed to retrieve the fragment. Laparotomy performed; uterine wall perforation found. Hysterectomy performed January 2023.

• Insertion date: Dec 2016 → Teva is primary defendant
• Injury: Hysterectomy, infertility → severe tier
• SOL: Georgia 2 years from date of knowledge of injury → January 2023 hysterectomy → deadline January 2025. If no complaint filed, may be time-barred. Fragment discovery in October 2022 could reset the clock — verify with attorney.
• Assessment: Strongest possible claim on the merits; SOL is the only risk

Scenario B: Fragment Confirmed, Surgical Retrieval, No Hysterectomy (California)

Priya S., 33. Paragard inserted March 2020 (CooperSurgical period). Removal attempted June 2024 — arm broke; hysteroscopy performed September 2024, fragment retrieved. No perforation. Desire to have children intact.

• Insertion date: March 2020 → CooperSurgical is primary defendant
• Injury: Surgical retrieval procedure; no hysterectomy; preserved fertility
• SOL: California 2 years from June 2024 → deadline June 2026. Urgent — approaching. File by June 2026.
• Assessment: Moderate tier; good claim but lower damages than hysterectomy cases

Finding an Attorney

1. AAJ (American Association for Justice) — justice.org — directory of plaintiff trial lawyers
2. State bar referral services — all states have referral programs for civil litigation
3. Law firm directories specializing in MDL 2974 — use multiple; interview at least two firms
4. What to ask: How many active Paragard cases does your firm have? What was your assessment of the February 2026 bellwether result? What is your contingency fee percentage?

Consultations are free. Fee: 33–40% of recovery, nothing if no recovery.

Hernia mesh lawsuit for medical device comparison → Wrongful death damages guide → Camp Lejeune water contamination lawsuit →

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Understanding the 510(k) vs. PMA Framework in Depth

The federal preemption defense is the most sophisticated legal argument in MDL 2974. Understanding it clearly helps you anticipate how the case may develop at the appellate level.

FDA Device Classification Overview

Medical devices are classified under three tiers:

Class I — General controls (e.g., tongue depressors). Low risk.

Class II — Special controls + general controls. Moderate risk. Most devices enter the market via the 510(k) “substantial equivalence” pathway: the manufacturer shows the new device is substantially equivalent to a legally marketed predicate device, without requiring independent clinical safety studies.

Class III — Premarket Approval (PMA). High risk. Requires clinical data demonstrating safety and effectiveness. The most rigorous FDA review.

Paragard was cleared through the 510(k) pathway. It did not undergo PMA review.

Why This Matters for Preemption

Riegel v. Medtronic (2008): The Supreme Court ruled that the express preemption clause in 21 U.S.C. § 360k applied to PMA devices. Because PMA involves rigorous FDA review imposing specific requirements, state law that imposes different or additional requirements is preempted.

Medtronic, Inc. v. Lohr (1996): The Court held that the 510(k) process — which reviews substantial equivalence, not independent safety — does NOT trigger the same preemption. State product liability claims for 510(k) devices were not preempted.

The Paragard defendants’ counter-argument: Teva and CooperSurgical argue that Paragard’s specific labeling, approved by the FDA, cannot be altered under state-law failure-to-warn claims without contradicting that FDA approval. This is a “conflict preemption” theory (implied preemption) distinct from the express preemption argument of Riegel.

The distinction between 510(k) clearance and PMA approval, and between express and implied preemption, creates a genuine legal question that may require circuit court or ultimately Supreme Court resolution. This is part of why MDL 2974 will likely have an extended life beyond the current bellwether phase.

Daubert in Device Cases: How Paragard Expert Testimony Will Be Tested

Mass tort device cases require plaintiffs to establish through expert testimony:

1. General causation: The Paragard design can cause the injury alleged (arm breakage) in some patients
2. Specific causation: This plaintiff’s injury was caused by the Paragard device rather than by physician error, anatomical factors, or other causes

The specific causation question in Paragard is unusually challenging. Defense experts will argue:

• The breakage resulted from incorrect removal technique, not product defect
• Certain anatomical conditions (small uterus, Paragard deeply embedded in uterine wall) increase breakage risk independent of product design
• The appropriate risk information was disclosed in the product’s Directions for Use (DFU)

Plaintiff experts must counter with:

• Evidence that breakage occurred with properly performed removals
• Biomechanical analysis showing the arm material is insufficiently flexible
• Documentation that the DFU warnings were inadequate to alert providers and patients to the breakage risk

The first bellwether defense verdict suggests that in at least one case, the defense’s fact-pattern arguments persuaded the jury. Whether that was a case-specific result or signals a broader weakness in plaintiff expert testimony will become clear in subsequent bellwethers.

Paragard and Reproductive Rights: The Broader Context

Paragard is the only non-hormonal long-acting reversible contraceptive (LARC) approved in the U.S. It is frequently chosen by women who cannot or prefer not to use hormonal contraception — including women with certain autoimmune conditions, hormone-sensitive cancers in their personal/family history, or religious objections to hormonal methods.

The population choosing copper IUD specifically because they want a hormone-free option skews toward:

• Women who have experienced adverse effects from hormonal contraceptives
• Women with BRCA1/2 mutations who want to minimize exogenous hormone exposure
• Women in their late 30s and 40s seeking contraception without menstrual suppression effects

This demographic tends to be health-conscious and well-informed about their contraceptive choices. When this population experiences breakage and resulting surgical intervention or hysterectomy, the non-economic damages for loss of informed reproductive autonomy — the ability to have chosen differently if adequately warned — can be substantial.

What to Expect From MDL Mediation

The Mediation Process in MDL 2974

Retired Judge M. Gino Brogdon Sr. serves as mediator, overseeing confidential settlement discussions between plaintiff leadership counsel and defense counsel. Mediation in an MDL of this scale typically follows this structure:

Aggregate negotiation phase: Plaintiff leadership counsel (Plaintiffs’ Steering Committee, PSC) negotiates with defendants over the total settlement fund — the aggregate dollars that all eligible plaintiffs will share.

Claims matrix design: Parties negotiate the scoring criteria: injury severity weights, exposure duration factors, age multipliers, documentation requirements.

Case-specific allocation: Once the fund and matrix are established, each individual case is scored and receives an offer. Your attorney presents the offer to you.

Opt-out option: In most MDL settlement programs, individual plaintiffs retain the right to opt out and pursue individual trial. However, opting out of a negotiated global resolution is high-risk — individual trials are expensive, time-consuming, and uncertain.

What the February 2026 Defense Verdict Means for Mediation

One defense verdict does not end mediation. Mediator Brogdon and both parties understand that a single bellwether result is not statistically representative of 3,982 cases. However, it does affect the negotiating dynamics:

• Defendants will argue for a lower aggregate fund or stricter injury scoring criteria
• Plaintiff leadership counsel will argue that the February case was an outlier
• The next 2–3 bellwether results will be the more meaningful signal

The mediation process is likely to intensify after the second and third bellwether results — either direction — as both parties seek finality.

The CooperSurgical Acquisition: Why Manufacturer Identity Changes Your Case

The $1.1 billion acquisition of Paragard by CooperSurgical in November 2017 has direct consequences for MDL 2974 plaintiffs that many claimants do not understand.

The Corporate Transition and Its Legal Significance

Before November 2017 — Teva Period: Teva Pharmaceuticals manufactured and sold Paragard using the Buffalo, NY facility it had operated for years. Teva’s corporate resources are substantial — it is one of the world’s largest generic pharmaceutical companies — and it has deep experience managing product liability litigation.

After November 2017 — CooperSurgical Period: CooperSurgical, a medical device subsidiary of Cooper Companies, acquired Paragard for $1.1 billion — a premium that reflected the product’s revenue-generating potential. CooperSurgical also manufactures fertility and gynecological products. Its legal exposure in Paragard litigation is concentrated in the post-2017 period.

Why this matters for your case:

1. If your Paragard was inserted before November 2017 and removed after (a common scenario for a device that lasts up to 10 years), both Teva and CooperSurgical may be defendants — Teva for the manufacturing and design during its tenure, CooperSurgical as the entity responsible for the device at removal
2. The two companies may have different defenses and different willingness to settle
3. “Successor liability” arguments may allow plaintiffs to hold CooperSurgical liable for defects originating during the Teva period

Your attorney must identify the correct primary defendant based on insertion date and argue successor liability if applicable.

Cooper Companies’ Financial Position

Cooper Companies, the parent of CooperSurgical, has annual revenues exceeding $3 billion. Unlike some mass tort defendants facing financial distress, Cooper Companies is a solvent entity with insurance coverage and sufficient resources to fund a settlement program of substantial scale. This reduces the risk of a bankruptcy-strategy defense (the approach J&J attempted in the talc MDL) and suggests that a negotiated global settlement — rather than an endless trial-by-trial war of attrition — is Cooper’s likely preferred path once bellwether results provide adequate signal.

The FAERS Data: What FDA Adverse Event Reports Tell Us

The FDA’s Adverse Event Reporting System (FAERS) is a publicly searchable database of voluntary reports submitted by healthcare providers, patients, and manufacturers regarding adverse events associated with medical devices.

For Paragard, FAERS contains thousands of reports describing device breakage during removal. These reports are valuable in litigation for several reasons:

Documented Pattern: A large number of FAERS reports for the same event — arm breakage during removal — suggests a systematic product characteristic rather than isolated physician error. Plaintiff experts use FAERS data to argue that breakage is foreseeable from the defendant’s own required reporting.

Manufacturer Knowledge: Manufacturers are required under FDA MedWatch rules to file reports of serious adverse events (and to investigate and report device malfunctions). If CooperSurgical or Teva received hundreds or thousands of FAERS reports about breakage, they had documented knowledge of the problem. This knowledge evidence goes directly to the failure-to-warn theory.

Limitation: FAERS reports are unverified. The FDA explicitly states that FAERS data “cannot be used to determine incidence or prevalence of a problem.” Defense experts will challenge any analysis that extrapolates from FAERS report volume to actual defect rates. Plaintiff experts must use FAERS data as supporting, not primary, evidence.

State Laws That May Affect Your Paragard Claim

Consumer Protection Statutes

Some states have consumer protection statutes that provide additional remedies for deceptive trade practices beyond common law product liability. If CooperSurgical or Teva made affirmative representations about Paragard’s safety that were misleading — in product labeling, physician detailing, or direct-to-consumer advertising — state consumer protection claims may supplement product liability claims.

New York General Business Law § 349 (unfair and deceptive acts) and California’s Unfair Competition Law (Bus. & Prof. Code § 17200) are examples of broadly worded consumer protection statutes that plaintiff attorneys explore in product liability contexts.

Negligence Per Se

If CooperSurgical or Teva violated specific FDA regulations — for example, by failing to comply with required adverse event reporting obligations, or by making product changes without proper 510(k) submissions — those regulatory violations can be used as “negligence per se” evidence, potentially simplifying the jury’s task on the negligence element.

Informed Consent Claims

Some plaintiffs have raised informed consent claims alongside traditional failure-to-warn claims: that their healthcare provider was not adequately warned about Paragard breakage risk, and therefore could not obtain truly informed consent from the patient before insertion. Informed consent claims may be actionable against both the manufacturer (for inadequate physician labeling) and potentially against the healthcare provider (for not discussing the breakage risk).

Medical Monitoring Claims in Paragard Litigation

Some plaintiffs who had Paragard removed without confirmed breakage, but who are concerned about retained micro-fragments not visible on standard imaging, have raised medical monitoring claims.

Medical monitoring is a tort remedy that allows recovery of the costs of ongoing medical surveillance to detect disease that has not yet manifested but may be caused by the defendant’s conduct. Whether medical monitoring is available in MDL 2974 depends on state law and on proof that:

1. There is a significantly increased risk of harm
2. Medical surveillance can detect the harm early enough to improve outcomes
3. The monitoring protocol is medically necessary and different from standard care
4. The increased risk is caused by defendant’s conduct

Courts have split on medical monitoring in device cases. Some plaintiffs with subclinical PFAS-type concerns may raise analogous arguments in AFFF, but in Paragard the medical monitoring theory is less developed. Your attorney can advise whether your state recognizes this claim.

Practical Guidance: Questions to Ask Your Attorney Before You Sign a Retainer

Mass tort litigation is a high-volume business. Not all firms provide the same level of attention to individual clients. Before signing:

1. How many Paragard cases does your firm currently have? A firm with active MDL experience handles case-specific nuances more effectively.

2. Will I have a dedicated case manager? Large MDL firms typically assign paralegals or case managers to handle day-to-day client communication.

3. What is your assessment of my specific case given the February 2026 defense verdict? A knowledgeable attorney should give you a frank assessment, not just optimism.

4. What happens if the global settlement is reached and I want to opt out? Understand your rights before the settlement phase.

5. What is the exact contingency fee percentage — and does it increase if my case goes to individual trial? The percentage typically rises from 33% to 40% if the matter proceeds beyond a negotiated settlement.

6. How will Medicare and Medicaid liens be handled? Confirm the firm has experience resolving government health care liens.

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This article is informational only and does not constitute legal advice. MDL 2974 is an evolving litigation — case status, bellwether schedules, and settlement discussions change frequently. If you experienced Paragard breakage, consult a licensed mass tort attorney in your state promptly. Statute of limitations periods are strict and, in some states, have already run for earlier-removal cases.