Defendants Teva Pharmaceuticals, USA, Inc.; Teva Women’s Health, LLC; Teva Branded Pharmaceutical Products R&D, Inc.; The Cooper Companies, Inc.; and CooperSurgical, Inc. were sued in the Northern District of West Virginia last week for allegedly marketing and selling a defective contraceptive device. The personal injury suit contends that plaintiff, Ashley Sigley, was injured after the companies’ ParaGard intrauterine device (ParaGard IUD) broke apart and became embedded within her uterus.
The filing explains that the ParaGard IUD is meant to provide “long-term, yet reversible, ‘non-surgical’ contraception for women.” The Nov. 13 complaint describes the ParaGard IUD as “a T-shaped plastic frame made of polyethylene and barium sulfate that is inserted into the uterus by a healthcare provider.” Allegedly, the ParaGard IUD is marketed to provide pregnancy protection for up to ten years, for removal at any time, and allows users to become pregnant as soon as it is removed.
According to the filing, several pharmaceutical companies have owned the drug since its U.S. Food and Drug Administration (FDA) approval in 1984. The plaintiff asserts that “[t]he liability of these companies has passed on through various business instruments and now lies with Defendants.”
Reportedly, from September 2009 to August 2017, Teva Women’s Health, Inc. held the ParaGard new drug application (NDA), and “designed, developed, manufactured, tested, labeled, packaged, distributed, marketed and/or sold the ParaGard IUD throughout the United States.” The filing states that in August 2017, Teva Women’s Health, Inc. converted into Teva Women’s Health, LLC and held the NDA until November 2017, when The Cooper Companies acquired Teva Women’s Health, LLC’s assets. Presently, the filing states, The Cooper Companies, and its subsidiary CooperSurgical hold the ParaGard NDA.
This spring, the plaintiff, then 19 years old, had a ParaGard IUD inserted by a physician. In July, the plaintiff wanted it removed and went to her gynecologist to have it done. After two attempts, the gynecologist was unable to remove the T-shaped device using the manufacturers’ instructions.
Allegedly, in September, the plaintiff went to a West Virginia hospital complaining of severe abdominal and pelvic pain. Her healthcare provider purportedly advised her that she would need to have the ParaGard IUD surgically removed because an arm had broken off and became embedded in her uterine cavity. She reportedly underwent surgery a few weeks later.
The plaintiff claims that as a result of the faulty device, she suffered injury, “including but not limited to pain, suffering, mental anguish, loss of enjoyment of life, medical expenses and other out of pocket losses and loss of income.” The plaintiff further contends that the defendants knew or should have known about the elevated risks of ParaGard IUD use and had a duty to protect users.
The complaint points to a July 2019 letter allegedly sent to the defendants by the FDA, condemning them for making misleading statements about ParaGard’s safety. The letter stated, “[t]he TV ad misbrands ParaGard within the meaning of the Federal Food, Drug and Cosmetic Act and makes its distribution violative. 21 U.S.C. 352(n); 331(n). 21 C.F.R. 202.1(d) (1); (e) (5). This violation is concerning from a public health perspective because it creates a misleading impression about the safety of ParaGard,” the complaint recited.
The twelve-count complaint accuses the defendants of gross negligence, negligence, negligence per se, strict liability for manufacturing, design defects, and failure to warn, common law fraud, negligent misrepresentation, breaches of warranty, violation of the West Virginia Consumer Credit and Protection Act, and punitive damages.
The plaintiff is represented by Motley Rice, LLC.