A woman is suing the manufacturers of the ParaGard intrauterine medical device (IUD) for allegedly failing to properly warn patients of the risk of injury during the device’s removal.
Beth Parker filed the complaint on May 28 against Teva Pharmaceuticals USA, Teva Women’s Health LLC, Teva Women’s Health Inc., Duramed Pharmaceuticals Inc., The Cooper Companies Inc., and Coopersurgical Inc.
The suit states that the defendants designed, researched, manufactured, labeled, packaged, promoted, marketed, and sold the ParaGard IUD.
According to the complaint, Parker was implanted with the ParaGard IUD in 2008, which is “an intrauterine drug that can provide long term birth control, up to 10 years, without hormones.” ParaGard IUD is a T-shaped plastic device that is inserted into the uterus. The suit states that copper wire coiled around the device produces a reaction that is toxic to sperm and egg, preventing conception.
The device contains threads to aid in the detection and removal, but it “has a propensity to break at the arms upon explant resulting in serious injury.”
Parker alleges she went to have the ParaGard IUD removed by her physician in May 2018. Her healthcare provider attempted to remove the device as instructed, but only a portion of the device was retrieved with one arm missing.
In June 2018, a hysterectomy was performed to remove the missing arm, but the attempt was unsuccessful. An ultrasound performed in July 2018 revealed that the arm was in the right lower uterine region.
The plaintiff’s physician was able to remove the ParaGard IUD on Aug. 31, 2018, via hysterscope.
Parker alleges the defendants knew the device was “dangerous and unreasonably defective” and withheld safety information from health care providers and patients. The suit states that the FDA has received over 1,600 reports of ParaGard breaking since 2010. Of those cases, 700 were classified as “serious.”
“The product warnings for ParaGard were vague, incomplete or otherwise wholly inadequate to alert prescribing physicians and patients to the actual risks associated with ParaGard,” the suit states.
According to the complaint, ParaGard is currently sold only in the U.S. and earned revenues of approximately $168 million from June 2016 to June 2017.
Parker seeks compensatory damages in excess of $75,000, plus attorneys’ fees, costs, and pre-judgment. She also seeks punitive damages against the defendants for attempting to misrepresent facts concerning the safety of ParaGard.
She is represented by Allyson Romani of Shrader & Associates LLP in Glen Carbon.
U.S. District Court for the Southern District of Illinois case number 3:20-cv-494