The makers of Paragard intrauterine device (IUD) claim that the device has been proven safe and effective since its original approval in 1984. The device uses copper instead of hormones to prevent pregnancy.
Teva Pharmaceuticals and Cooper Surgical marketed the device as convenient, easy to insert and easy to remove.
But dozens of lawsuits claim there are problems with the device’s development, manufacturing, testing, labeling and marketing. Despite knowing that the device could break upon removal, manufacturers continued to sell the device.
In December 2020, the Judicial Panel on Multidistrict Litigation consolidated Paragard lawsuits in the Northern District of Georgia. As of Feb. 17, 2021, there are over 120 lawsuits pending in MDL 2974 before U.S. District Judge Leigh Martin May, according to the MDL Statistics Report.
Claims Against Manufacturers
According to court documents, people who have filed Paragard lawsuits make four main claims against Cooper Surgical and Teva Pharmaceuticals.
- Paragard has a defective design because its design contributed to the tendency for its arms to break upon removal.
- Paragard has a manufacturing defect that could have caused its arms to break.
- Paragard’s label doesn’t properly warn about the risks of breakage or tell doctors how to avoid breakage.
- Cooper Surgical and Teva Pharmaceuticals are negligent because they presented their devices as safe and effective but the devices caused harm to users.
Is the Litigation a Class Action?
This litigation is not a class action. These are individual Paragard injury claims.
Because many of these cases have similar facts and claims against manufacturers, judges consolidated these lawsuits into multidistrict litigation to make the process more efficient. But each plaintiff has their own lawyer and claim for unique injuries.
Lawyers are pursuing cases where Paragard broke during removal and the pieces are missing or lodged in an organ. But there are several injuries and complications resulting from breakage mentioned in lawsuits.
- Allergic reactions to copper or IUD pieces left in the body
- Hysterectomy, laparoscopy or laparotomy because of broken IUD pieces left in body
- Inability to remove IUD pieces
- Inflammation caused by IUD pieces
- IUD migration
- IUD pieces missing or lodged in organs
- Loss of fertility
- Perforation of organs, including uterus or cervix
- Surgery to remove broken pieces
Despite several lawsuits claiming the device is faulty and can cause injuries, Cooper Surgical hasn’t issued a recall because of breakage issues.
In 2014, Teva recalled a few batches of IUDs because of problems with sterility. No injuries were reported because of that recall.
The FDA hasn’t issued any recent safety communications or warnings for breakage. But the agency issued a 2019 warning letter for false or misleading information about Paragard television ads.
“The TV ad is misleading because it includes claims and representations about the uses and benefits of Paragard but fails to include important risk information associated with the drug,” according to the letter.
The Paragard litigation is in the early stages, and there have been no settlements. As of February 2021, no trials have been scheduled.
Settlement talks typically begin after the first few cases go to trial. These first trial cases, called bellwether cases, inform both sides about the potential value of cases.
In other IUD lawsuits, women sued Bayer for claims that Mirena moved around in the body and punctured or injured organs. Bayer offered to settle 4,600 lawsuits for $12.2 million.
5 Cited Research Articles
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- Bowers v. Teva et al. (2020, September 11). Complaint for Damages. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2020-9-11-paragard-bowers-complaint.pdf
- U.S. Food and Drug Administration. (2017, February 1). Pending Recalls. Retrieved from https://wayback.archive-it.org/7993/20170403231827/https:/www.fda.gov/Safety/Recalls/EnforcementReports/ucm310739.htm
- U.S. Food and Drug Administration. (2019, July 25). Letter to Kyle Hooper, Cooper Surgical. Retrieved from https://www.fda.gov/media/129526/download
- United States Judicial Panel on Multidistrict Litigation. (2020, December 16). Transfer Order. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2974-Transfer%20Order-12-20.pdf
- United States Judicial Panel on Multidistrict Litigation. (2021, February 17). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-February-17-2021.pdf