Paragard IUD Lawsuit Dismissed on Summary Judgment

A federal judge has granted a motion for summary judgment in a Paragard lawsuit filed in 2016, indicating that the manufacturer of the copper intrauterine device (IUD) provided adequate warnings, and that the plaintiff failed to establish that her doctor would have chosen another form of birth control if other risk information had been provided. 

Stephanie Ideus filed the complaint (PDF) against Teva Pharmaceuticals, alleging that a ParaGard IUD failed when she went to have it removed, causing the device to break and pieces to embed in her uterine wall. As a result of the complications, she required surgical removal in 2016.

ParaGard is a copper IUD, where a T-shaped plastic frame is wrapped with copper wire coils, which are designed to produce an inflammatory reaction in the uterus that is toxic to sperm. The device is supposed to remain in place for up to 10 years, providing protection against pregnancy.

Ideus’s lawsuit alleged that Teva failed to provide adequate warning about the risks of the ParaGard breaking and potentially perforating the uterus. The lawsuit claimed she would not have gotten the implant, and her physician would not have recommended it, had the warnings adequately described risk information that was known to the manufacturer.

In a memorandum and order (PDF) issued on February 19 by Chief U.S. District Judge John Gerrard, a motion for summary judgment filed by Teva Pharmaceuticals was granted, resulting in dismissal of the case.

“(T)he package insert expressly warned about the possibility of breakage, embedment, and the difficulties of removing ParaGard, making the warning adequate as a matter of law,” the judgment indicates. “A warning is adequate if it accurately and unambiguously coveys the scope and nature of the risk to the prescribing physician.”

Only one day later, Ideus filed an appeal (PDF) of the ruling, in an attempt to restore her ability to pursue damages from the manufacturer.

Ideus’s case was one of several Paragard IUD lawsuits filed in recent years. However, far more complaints were filed over problems with the Mirena IUD, which is a competing birth control implant manufactured and sold by Bayer.

Thousands of Mirena lawsuits were filed over problems where the levonorgestrel-releasing implant migrated out of position or perforated the uterine wall, raising similar allegations that the manufacturer withheld important safety warnings from women and doctors.

In August 2016, a federal judge granted summary judgment in the Mirena migration and perforation injury litigation, resulting in the dismissal of all claims. However, during the appeal process the parties reached a global settlement to resolve the cases.