Latest Updates in Paragard Lawsuits
As of Nov. 16, 2023, there are 2,283 pending cases in multidistrict litigation against Paragard. MDL 2974 is before Judge Leigh Martin May in the Northern District of Georgia.
Plaintiffs are seeking compensation for injuries sustained as a result of Paragard’s copper intrauterine device. Suits allege that the manufacturers failed to warn users of the risks of a design flaw that resulted in serious complications and in some cases required surgery.
- November 2023: Plaintiffs were required to submit their Plaintiff Fact Sheet.
- September 2023: The first bellwether trial date was announced for Oct. 28, 2024.
- June 2023: Bellwether cases were being discussed with the discovery process, including depositions, that will help narrow down the pool.
- February 2023: Judge May outlined the bellwether selection process. The first MDL lawsuits will go to trial in 2024 unless parties settle first.
- January 2023: Judge M. Gino Brogdon Jr. (retired) was appointed as a settlement mediator.
Because these lawsuits are MDLs, claimants keep their status as plaintiffs when the case goes before the courts or to mediation. This differs from class-action lawsuits, where one or more representative plaintiffs file a lawsuit on behalf of a group of injured parties. MDLs only exist in the federal justice system.
Why Are People Filing Paragard IUD Lawsuits?
The Paragard IUD lawsuits all focus on an alleged design flaw that led to the IUD device breaking during removal and leaving part of the device lodged in the uterus. As a result, users claim to have endured a number of debilitating effects from the IUD, in some instances requiring surgery.
- IUD pieces breaking and getting lodged in organs
- IUD pieces that cannot be removed from the body
- IUD pieces left in the body, causing infections and allergic reactions
- IUDs shifting position
- Need for surgical intervention such as laparoscopy or laparotomy and hysterectomy
- Perforation of the cervix or uterus
In addition to these risks of injury, research indicates women who use copper IUDs may experience an increased risk of side effects, including bacterial vaginosis and irregular menstrual bleeding. Medical researchers investigating IUD side effects have recommended improved protocols when removing Paragard IUDs.
Claims Against Manufacturers
- Cooper Surgical and Teva Pharmaceuticals are negligent because they presented their device as safe.
- Paragard has a manufacturing defect.
- Paragard IUD has a defective design.
- Paragard’s label doesn’t clearly warn about the risks of breakage during removal.
In 2021, the U.S. Food and Drug Administration registered more than 3,290 instances of Paragard devices breaking, with 2,000 of those cases listed as serious. However, at this time, Paragard and its owners, Cooper Surgical and Teva Pharmaceuticals, continue to make claims about the device’s safety and benefits.
Has There Been a Paragard IUD Recall?
The Paragard IUD was recalled in 2014 because of problems with sterility. No injuries were reported because of this recall.
In 2019, the FDA issued the company a warning letter for false or misleading information presented in Paragard television ads. The device was placed in the FDA’s Adverse Event Reporting System in 2021.
Who Qualifies to File a Paragard Lawsuit?
If your Paragard IUD broke upon removal and you experienced serious injury or Paragard side effects, you may be eligible for compensation.
Compensation can be for injuries that cause physical, financial and emotional hardship. It can also help pay for medical treatments, replace lost wages and ease any pain or suffering.
It is important to speak with a lawyer to review your options and the specifics of your case.
Paragard Lawsuit Settlement Amounts and Verdicts
The Paragard litigation is in progress, and the first trial cases will begin in 2024 if an out-of-court settlement isn’t reached.The result of these first trial cases, called bellwether cases, will provide an indication of the court’s verdict and possible settlement amounts.
It is important to remember that a verdict is the decision in a court proceeding. A judge or a jury can deliver it, and it can include damages. A settlement is an agreement reached out of court between the two sides. The court approves it, and it can also include damages.
Settlements can be reached before a trial begins or once it is underway. Monetary settlements for damages can vary significantly based on the details of an individual case. Settlement negotiations usually begin after the first test cases go to trial and the court’s position has been made clear.
In other IUD lawsuits, women sued Bayer for claims that its Mirena IUD moved around in the body and punctured or injured organs. Bayer offered a settlement of $12.2 million to settle 4,600 lawsuits.
15 Cited Research Articles
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- 1. United States Judicial Panel on Multidistrict Litigation. (2023, August 15). Pending MDLs. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-August-15-2023.pdf
- United States Judicial Panel on Multidistrict Litigation. (2023, July 17). Pending MDLs. Retrieved from https://www.jpml.uscourts.gov/pending-mdls-0
- Shandruk, E. & Cellucci, L. (2023, May 20). MDL vs. Class Action: Place, Plaintiffs and Procedure. Retrieved from https://www.americanbar.org/groups/young_lawyers/resources/tyl/practice-areas/mdl-vs-class-action-place-plaintiffs-and-procedure/
- Daniel, A. et al. (2023, April). An Integrative Review of the Relationship Between Intrauterine Devices and Bacterial Vaginosis. Retrieved from https://www.sciencedirect.com/science/article/abs/pii/S1751485123000399?via%3Dihub
- Baker, C. & Creinin, M. (2022, November). Long-Acting Reversible Contraception. Retrieved from https://journals.lww.com/greenjournal/Abstract/2022/11000/Long_Acting_Reversible_Contraception.24.aspx
- Christelle, K., Norhayati, M. & Jaafar, S. (2022, August 26). Interventions to prevent or treat heavy menstrual bleeding or pain associated with intrauterine-device use. Retrieved from https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006034.pub3/full
- Lanzola, E. & Ketvertis, K. (2022, July 4). Intrauterine Device. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK557403/
- U.S. Food and Drug Administration. (2022, April 6). October - December 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS). Retrieved from https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/october-december-2021-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
- Valderrama, S. (2022, February 12). I-Team investigates after thousands of women file lawsuit against IUD maker. Retrieved from https://weartv.com/news/local/i-team-investigates-after-thousands-of-women-file-lawsuit-against-iud-maker
- Sterman, J., Brauer, A. & Nejman, A. (2021, August 2). As reports of IUD breakage piled up, maker changed label but many women still unaware. Retrieved from https://katv.com/news/spotlight-on-america/as-reports-of-iud-breakage-piled-up-maker-changed-label-but-many-women-still-unaware
- Sarver, J., Cregan, M. & Cain, D. (2021, January 23). Fractured copper intrauterine device (IUD) retained in the uterine wall leading to hysterectomy: A case report. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7851793/
- United States Judicial Panel on Multidistrict Litigation. (2020, December 16). In RE: Paragard IUD Products Liability Litigation. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2974-Transfer%20Order-12-20.pdf
- Dubovis, M. & Rizk, N. (2020, April 24). Retained copper fragments following removal of a copper intrauterine device: Two case reports. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7180360/
- U.S. Department of Health and Human Services. (2017, February 15). Human Drug Product Recalls Pending Classification. Retrieved from https://wayback.archive-it.org/7993/20170403231827/https://www.fda.gov/Safety/Recalls/EnforcementReports/ucm310739.htm
- Cooper Surgical. (n.d.). Paragard (Intrauterine Copper Contraceptive) The Only One for Almost Everyone. Retrieved from https://www.coopersurgical.com/our-brands/paragard/