Four Missouri women who say they suffered injuries when an intrauterine contraceptive device broke while it was being removed are suing the device’s manufacturer and its successor company.
In separate lawsuits filed in federal court in Kansas City last week and in August, the women allege the companies knew or should have known that the ParaGard IUD is defective because its arms have a tendency to break upon removal from the uterus.
The device was made by Teva Pharmaceuticals, which sold it in 2017 to The Cooper Companies Inc. for $1.1 billion. Both companies and various Teva and Cooper affiliates are named as defendants.
Teva and Cooper did not respond to requests for comment.
The plastic, T-shaped IUD provides long-term birth control for up to 10 years and was approved by the Food and Drug Administration in 1984. Unlike other IUDs, it doesn’t release hormones but rather releases copper, which produces an inflammatory reaction that interferes with egg fertilization.
According to the lawsuits, the FDA has received over 1,600 reports of ParaGuard breakage since 2010, with 700 classified as serious.
A number of lawsuits have been filed around the country alleging that the ParaGard IUD is defective and that the defendants failed to adequately warn about possible risks and complications.
Last year, a Nebraska woman lost her suit against Teva when a federal judge granted summary judgment to the company. The judge concluded there was no evidence to suggest the woman's physician would not have used ParaGard had the warnings in the package insert been stronger or more specific.
The suits are not the first over IUDs. Bayer Healthcare has faced thousands of lawsuits by women alleging its Mirena IUD migrated from the uterus and perforated their organs, requiring surgery to treat complications.
In 2016, a federal judge ruled in favor of Bayer in nearly 1,300 cases, finding the plaintiffs were unable to prove that the IUD was the cause of their injuries. In 2018, Bayer offered $12.2 million to settle 4,600 cases.
And in the 1980s, A.H. Robins, the marketer of the Dalkon Shield IUD, settled hundreds of thousands of claims alleging the device had caused septic abortions and other severe infections. A trust set up to resolve the claims paid out more than $3 billion. A.H. Robins filed for Chapter 11 bankruptcy protection in 1985.