Lack of Warnings Leave Physicians and Patients Misled Without Critical Information
By Yusra Javed
February 14, 2026
Paragard is an FDA-approved, T-shaped copper intrauterine device (“IUD”) originally manufactured by Teva Pharmaceuticals and later acquired by CooperSurgical in 2017.1 The Paragard intrauterine device was first sold in 1998. Unfortunately, this plastic device can break when it is removed. There are over 3,600 pending lawsuits for serious injuries and infertility. The presiding judge appointed a settlement mediator in hopes of compensation for injured women.
January 2026 Bellwether Trial Upate
The first bellwether trial regarding Paragard commenced on January 20, 2026, and it unfortunately resulted in a defense victory, but there will be more trials soon. As many follow the multi-district litigation (“MDL”) of Paragard, it is severely important to understand the omnipresent role of doctors. Medical practitioners should be providing their patients with warnings about potential IUD fractures in order to act in the best interest of their patients. However, how can they if they are not made aware themselves?
One of the many people suffering from the flawed design of Paragard, Pauline Rickard, had an IUD placement in May 2012. She expected a simple removal because the label did not contain warnings, nor did it specify any adverse reactions that users of Paragard could experience in the case of a breakage. Upon scheduling her Paragard’s removal, her doctor was unable to pull one arm of the IUD. Subsequently, the plaintiff had to undergo a hysteroscopy procedure to remove the Paragard.
Rickard promptly filed suit against Teva to seek relief for her Paragard-related injuries. While the defense prevailed in the bellwether trial, the broader litigation continues to raise critical questions about warnings, device design, and physician counseling practices. The presiding judge will set more trials soon. The plaintiffs now aggressively pursue more trials now there is a deeper understanding of jury considerations.
Physician Responsibility Under the Doctrine of Informed Consent
Regardless of the manufacturer’s labeling, physicians play a key role in gatekeeping. Based on the doctrine of informed consent, it is the physicians’ obligation to explain to patients any risks and benefits of the treatment or procedure they are receiving. Along with that, patients can ask their care providers any questions regarding their procedure, which allows them to make informed decisions when considering a certain procedure.2
When documented reports of IUD breakages and fractures exist, the doctors should discuss:
- The procedure itself and what it entails
- The signs and symptoms of retained fragments
- The potential need for additional treatments
- The possibility of breakage during removal
- Reasonable alternative contraceptive options
- The risks and benefits of alternatives
- The patient’s understanding of their options
However, the plaintiff’s expert, Dr. Labib Ghulmiyyah, explained otherwise. Dr. Ghulmiyyah is a board-certified obstetrician-gynecologist and maternal-fetal medicine specialist with extensive experience. In his testimony, he highlights that the Paragard label does not warn reasonable physicians of a risk of device breakage or fracture.
While this case underlines the debated likelihood of Paragard IUD fractures, the severity of such possible consequences is sufficient to make all forms of disclosure critical. There should be clear language that explicitly alerts providers to potential complications of devices. Dr. Ghulmiyyah’s testimony shows that omissions of warnings are significant because they can lead to serious follow-up procedures, increasing risks to patients. Physicians cannot effectively counsel patients or obtain meaningful informed consent if they are not sufficiently aware of the risks associated with devices like Paragard.
If you or someone you love experienced complications after a Paragard IUD removal, you may have legal options. Contact our team for a free, confidential consultation to understand your rights and whether you may be entitled to compensation.
Sources
1 Mamah J, Dube T, Aramabi E, Unwaha E, Dagba M. Fragmentation of an in-date copper intrauterine device: an unusual complication. Cureus. 2024 Nov 9;16(11):e73344. doi:10.7759/cureus.73344. PMID: 39659323; PMCID: PMC11628203.
2 Shah P, Thornton I, Kopitnik NL, et al. Informed consent. [Updated 2024 Nov 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan–. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430827/.
