Lawsuit Alleges Paragard IUD Removal Necessitated Unsuccessful Revision
A lawsuit filed in federal court in Ohio alleges a Paragard IUD’s arm broke off inside a woman necessitating an unsuccessful surgical attempt to remove it.
The woman had a Paragard IUD implanted in 2010, according to the complaint, which states she went to have it removed in 2018. Her doctor tried to remove the device as instructed by defendants Teva Pharmaceuticals, according to the complaint, by grasping the device and pulling gently. However, only the main stem and one arm of the device were successfully removed, leaving one arm inside the woman, according to the complaint.
Another doctor attempted to remove the arm via hysteroscope without success nine days later, according to the complaint.
The woman has suffered “significant bodily and mental injuries, pain and suffering, mental anguish, disfigurement, embarrassment, inconvenience, loss of earnings and earning capacity, and have and will incur past and future medical expenses,” according to the complaint, as well as a loss of reproductive health.
Lawsuit Alleges A Failure To Warn
The central claim of the complaint is that Teva knew that there was a high risk of their device’s arms breaking off inside of women during removal yet failed to warn anybody about the risk. The complaint claims they knew about this risk because of studies, trials, post-marketing complaints and post-marketing experience.
The complaint claims that, instead of warning about the risk they were aware about, Teva “concealed, suppressed and failed to disclose or fix this danger.”
The FDA has received over 1,600 reports of Paragard IUDs breaking, according to the complaint, which states that over 700 of these reports are classified as serious.
The complaint accuses Teva of negligence, stating they had a duty to exercise reasonable and ordinary care in making, marketing and selling the Paragard IUD. The complaint argues that a reasonably careful entity would warn about the risk of arm breakage during removal upon becoming aware of the risk.
The complaint argues Teva knew or should have known about the risk, and if they didn’t know about the risk, then they were negligent because they failed to exercise reasonable care in the testing of their product.
The lawsuit accuses Teva of strict liability design defect and strict liability manufacturing defect, arguing the IUD is defective because it is unreasonably dangerous when used as intended.
The lawsuit accuses Teva of fraud, negligent misrepresentation, breach of express warranty, breach of implied warranty, gross negligence, and violation of consumer protection laws, all over their alleged misrepresentation of the Paragard IUD’s safety.
The complaint seeks punitive damages, arguing Teva’s conduct was “willful, wanton, careless, reckless, conscious and deliberate.”