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Teva Pharmaceuticals has removed a product liability lawsuit recently filed in Pennsylvania to the federal court system, which involves allegations that a Paragard IUD fractured during removal, leaving a North Carolina woman with permanent injuries.
The complaint (PDF) was originally filed by Megan Stauffer in the Philadelphia County Court of Common Pleas on October 30, but the manufacturer of the controversial intrauterine device (IUD) filed notice of removal to the Eastern District of Pennsylvania this week, based on diversity jurisdiction.
Paragard involves a plastic T-shaped frame that is wrapped with copper wire coils, which are designed to produce an inflammatory reaction in the uterus that is toxic to sperm and prevents pregnancy. The birth control implant can remain in place for up to 10 years, and is supposed to be reversible, allowing doctors to safely remove Paragard IUD during an office procedure, which is supposed to allow women to conceive children in the future.
According to the lawsuit, Stauffer had a ParaGard copper IUD implanted in October 2013, which was marketed by Teva as a safe and effective form of long-term birth control for up to 10 years However, when she went to have Paragard removed in August 2017, one of the arms broke off and remained inside of her body. On two following occasions, in September 2017 and again in May 2018, doctors were unable to retrieve the broken pieces of the implant.
“Prior to Plaintiff being implanted with the Paragard IUD, Defendants knew and should have known that the drug was defective and unreasonably dangerous,” Stauffer claims in the complaint. “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 case raises allegations similar to those being presented in a growing number of lawsuits filed by women who experienced Paragard removal complications, indicating the product is defective and prone to fracture, even when doctors follow the recommended procedures to retrieve the IUD.
If one of the device’s copper-wrapped “arms” fractures, it can migrate through the body, puncturing organs, causing pain and internal injuries, and becoming extremely difficult to surgically remove or even locate in some cases.
The lawsuit filed by Stauffer notes that since 2010, the FDA has received more than 1,600 reports of ParaGard fracturing, with more than 700 of those cases having serious health consequences.
Defendants had the case removed from state court to federal court due to diversity among the parties, with Stauffer being from North Carolina and Teva Pharmaceuticals based in New Jersey.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) is scheduled to consider oral arguments on December 3, to decide whether claims pending throughout the federal court system over Paragard IUD fractures should be centralized before one U.S. District Judge for coordinated discovery and pretrial proceedings.