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Over the previous decade, a growing number of adverse events resulting from ParaGard breakage have been reported to the FDA Adverse Events Reporting System (FAERS). Upon investigation, it has been discovered that the product arms break at the shoulder during removal, which results in fragments of the IUD left in the patient. The remaining fragments often become embedded throughout the uterine cavity, sometimes puncturing through entirely. Surgical intervention is typically required to remove the retained fragments. Damage caused by the remaining fragments, and subsequent removal surgeries, often result in debilitating injuries.
Approximately 20 cases have been filed in the Philadelphia Court of Common Pleas (PCCP). In the summer of 2019, plaintiffs won specific jurisdiction over Teva Pharmaceuticals USA, Inc. Teva Women’s Health, LLC and Teva Women’s Health, Inc. permitting Pennsylvania and non-Pennsylvania plaintiffs to prosecute their cases in PCCP. The cases focus their causes of action around Design Defect, Manufacturing Defect, and other claims.