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According to allegations raised in a recently filed product liability lawsuit, ParaGard IUD design defects cause the birth control implant to regularly break while doctors are attempting to remove it, leaving an Oregon woman with serious and potentially permanent injuries after a piece became lodged in her colon.
The complaint (PDF) was filed by Thien Thanh Le on April 27, in the U.S. District Court for the District of Oregon, indicating Teva Pharmaceuticals has known for years the intrauterine device (IUD) is prone to fracture or break during removal.
Paragard is a T-shaped plastic device wrapped in copper, which is intended to be placed in the uterus for up to ten years, providing a reversible form of long-acting protection against pregnancy. However, the manufacturer markets the product as an alternative to birth control pills, which can easily reversible in a doctors office procedure when a woman no longer wants the birth control.
According to the lawsuit, Le received a ParaGard implant in September 2017, as a form of temporary birth control. However, after she began to complain of pain, a physician decided to remove the IUD, which is supposed to be a relatively simple process.
After following the manufacturer’s instructions, Le indicates the physician removed the ParaGard with one “arm” of the device was missing. The IUD piece was later was detected inside Le’s sigmoid colon through X-rays and CT scans. Following at least two laparoscopic surgeries, doctors determined the fragment could not be removed in June 2020, and the piece remains lodged in Le’s body.
“Since Paragard was introduced to the market, Defendants have received reports, studies, and otherwise learned new information about Paragard’s breakage and the resulting injuries. Defendants, however, concealed this information and failed to take any action to inform patients, physicians, or the public about Paragard’s propensity to break,” Le’s lawsuit states. “This failure to act has resulted in life-altering consequences for Plaintiff, who was injured as a direct and proximate result of the breakage of the Paragard implanted in her body.”
Given common questions of fact and law raised in similar Paragard IUD lawsuits filed throughout the federal court system, centralized pre-trial proceedings have been established before U.S. District Judge Leigh Martin May in the Northern District of Georgia, where the lawsuit filed by Tlamayo will also be transferred in the coming weeks.
As part of the coordinated management of the litigation, Judge May is presiding over coordinated discovery and pretrial proceedings, and it is expected that a small group of representative claims will ultimately be prepared for early trial dates as part of a “bellwether” program, to help gauge how juries may respond to certain evidence and testimony that will be presented throughout the litigation.
While the outcome for these early trials would not be binding on other plaintiffs, they may facilitate ParaGard IUD settlements. which would avoid the need for dozens, or possibly hundreds, of additional trials to be scheduled throughout the federal court system.