Lawsuit Seeks Damages For Paragard IUD Arm Which Broke Off Inside Woman
A lawsuit filed in federal court in California on December 31 seeks to recover damages for injuries caused by a Paragard IUD arm breaking off inside a woman during removal. The lawsuit names multiple defendants, including Teva Pharmaceuticals, The Cooper Companies and CooperSurgical.
The complaint claims that the Paragard IUD, an intrauterine device which is placed in the uterus for conception prevention, “has a propensity to break at the arms upon explant resulting in serious injuries.”
The central claim of the complaint is that Teva knew that their products had a tendency to break during removal “from the trials they performed, their post-marketing experience and complaints, third party studies, and their own analysis of these studies” but instead of fixing or warning about the problem, concealed the problem instead.
The complaint alleges that Teva “knowingly, purposely, and deliberately failed to adequately warn” the public about the risk of injury associated with the Paragard IUD.
The complaint claims that, since 2010, the FDA has received more than 1,600 reports of ParaGard IUDs breaking; over 700 were considered serious.
The plaintiff, a “young and healthy woman,” was implanted with the Paragard IUD in 2009 and went to have it removed “on or about 2016,” according to the complaint.
The plaintiff’s doctor tried to remove the Paragard IUD as instructed by Teva: via grabbing it by the forceps and gently pulling, according to the complaint. The Paragard IUD was retrieved with one arm missing, according to the complaint.
The plaintiff needed another procedure “on or about 2017” to remove the broken-off arm, according to the complaint.
The complaint claims that, as a result of this breakage, the plaintiff has suffered from mental and physical injury, loss of reproductive health, pain and suffering, disfigurement, mental anguish, inconvenience, loss of enjoyment of life, embarrassment, loss of earnings and earning capacity, and past and future medical expenses.
The plaintiff’s physicians would not have prescribed the Paragard IUD to the plaintiff had the defendants adequately warned about the IUD’s risk of injury on the product’s label, according to the complaint, which claims that the defendants’ failure to warn directly caused the plaintiff’s injuries.
The complaint seeks to recover damages based on many causes of action, including negligence, strict liability – design defect, strict liability – manufacturing defect, strict liability – failure to warn, common law fraud, negligent misrepresentation, breach of express warranty, breach of implied warranty, violation of consumer protection laws, gross negligence, and punitive damages.