The Paragard intrauterine device (IUD), a hormone-free copper contraceptive approved by the FDA in 1984, has been the subject of widespread litigation due to allegations that it has a propensity to break upon removal. This defect reportedly leads to severe complications for many women, resulting in injuries such as device retention, uterine perforation, infections, infertility, and significant pain.
Paragard IUD Lawsuit
Background of the Lawsuit
Since the late 2010s, thousands of women have reported adverse events linked to broken or fractured Paragard devices during removal procedures. The copper arms of the device sometimes detach and remain embedded within the uterus or other organs, often requiring surgical intervention to remove. Many affected women experienced physical injuries and emotional trauma as a result.
The lawsuits consolidated as multidistrict litigation (MDL 2974) in the Northern District of Georgia began gaining momentum in 2024 and 2025, with over 3,000 active cases filed by August 2025. The litigation targets the device manufacturers, CooperSurgical and Teva Pharmaceuticals, alleging negligence and failure to warn consumers of the risks associated with Paragard’s design and removal process.
Main Allegations
- Design Defect and Manufacturing Issues: The Paragard IUD allegedly has inherent design problems making it prone to breakage during removal.
- Failure to Warn: Plaintiffs argue that CooperSurgical and Teva Pharmaceutical failed to adequately warn doctors and patients about the potential breakage and the risks it entails.
- Negligence and Breach of Warranty: The lawsuits claim the manufacturers knew or should have known about the breakage risk but continued manufacturing and marketing the device without sufficient safety improvements.
- Physical and Emotional Damages: Injuries including uterine perforation, infertility, infections, severe pain, and psychological distress are widely reported among plaintiffs.
Notable Cases and Legal Developments
One landmark case, Braxton v. Teva, was selected as the first bellwether trial in the MDL and scheduled for December 2025. The plaintiff suffered severe injuries after part of her Paragard IUD broke and required surgical removal. Bellwether cases often set the tone for future settlements.
Courts have denied numerous motions to dismiss, allowing the lawsuits to proceed. Discovery phases reveal internal company documents and FDA communication pointing to ongoing concerns about IUD breakage.
FDA Involvement and Product Safety Updates
The FDA has conducted investigations into Paragard breakage reports and released updated guidelines recommending caution during removal procedures. Despite no formal recall of the device, warnings were updated to advise healthcare providers to carefully check for embedded fragments during removal.
CooperSurgical’s response has been mixed, with some updated instructions to doctors but no major design overhaul or recall. The company refutes claims that the device is inherently defective or unsafe when used according to directions.
Compensation and What Plaintiffs Can Expect
Lawsuit settlements vary widely, with estimates suggesting individual payouts ranging from $100,000 to $400,000 depending on the severity of injuries and proof provided. Compensation covers medical costs, lost wages, pain and suffering, and other damages.
Plaintiffs considering legal action are encouraged to consult experienced attorneys skilled in medical device litigation to navigate case preparation and maximize potential recovery.
What You Should Know
- Paragard remains on the market and is widely used, but users should be aware of these risks.
- Women who have experienced breakage or complications after Paragard removal may qualify for legal claims.
- Timely legal consultation is critical due to statute of limitations on medical device lawsuits.
Conclusion
The Paragard IUD lawsuit highlights critical patient safety and medical device regulation issues. With thousands pursuing litigation, the matter underscores the importance of full transparency, device testing, and careful medical guidance in intrauterine devices.
As trials move closer and evidence unfolds, the outcome will likely influence future contraceptive device manufacturing practices, regulatory policies, and patient care standards nationwide.
