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Paragard Lawsuits

Paragard IUD lawsuits claim the device breaks upon removal and causes serious injuries and the need for surgery. Claimants are seeking compensation and allege Paragard is defective and manufacturers failed to adequately warn about the risk of device breakage and injury.

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Last Modified: February 24, 2021
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Paragard is a small, T-shaped plastic intrauterine device (IUD) that uses copper instead of hormones to prevent pregnancy. Doctors implant it into the uterus and it can prevent pregnancy for up to 10 years.

The U.S. Food and Drug Administration approved Paragard in 1984. According to Cooper Surgical, it has been proven safe and effective for more than 30 years.

But some women said the device broke or fractured inside them when they tried to have it removed, causing injuries. They claim the device is defective. They say manufacturers knew about the risks but failed to properly warn doctors and patients.

Paragard lawsuit claims include:
  • IUD has manufacturing and design defects.
  • Labeling doesn’t adequately warn about breakage risk.
  • Defendant manufacturers were negligent.

In December 2020, the Judicial Panel on Multidistrict Litigation consolidated dozens of lawsuits across the nation in the Northern District of Georgia under Judge Leigh Martin May. As of Jan. 28, 2021, trials have yet to be scheduled.

Injuries and Complications in Lawsuits

Injuries claimed in lawsuits stem from the device breaking upon removal.

According to Cooper Surgical’s website, “Paragard removal is nonsurgical and done by a healthcare provider during a routine office visit in just a few minutes.” The arms of the device are supposed to fold up when removed, according to the instructions for removal included in the prescribing information.

But women who filed lawsuits claim that Paragard broke during removal, leaving pieces of the IUD in their bodies. Some women required surgery to remove the device and treat complications.

Injuries claimed in lawsuits include:
  • Perforation of the uterus or cervix
  • Inflammations and allergic reactions to IUD pieces left in the body
  • IUD migration
  • IUD pieces missing or lodged in organs
  • Infertility
  • Need for surgery such as hysterectomy, laparoscopy or laparotomy
  • Pain
  • Infection
  • Broken IUD pieces cannot be removed
Suffering after a Paragard IUD broke during surgical removal?

Lawsuit Filed by Georgia Bowers

Georgia Bowers filed her suit against Teva and Cooper Surgical in September 2020. She received her Paragard in January 2017. In September 2017, she visited her doctor to have the IUD removed.

An ultrasound revealed the device was incorrectly positioned. Bowers’ doctor followed instructions for removing the IUD, but only part of the IUD was retrieved. One arm was missing. Bowers’ doctor tried to remove the broken piece by colposcopy but was unsuccessful.

“At all relevant times, the Teva Defendants had knowledge that there was a significant increased risk of adverse events associated with ParaGard IUD including arm breakage, and despite this knowledge the Teva Defendants continued to manufacture, market, distribute, sell, and profit from sales of ParaGard IUD,” Bowers’ lawsuit said.

Lawsuit Filed by Carley Tredway

Carley Tredway filed her suit against Teva and Cooper Surgical in September 2020. Tredway received her Paragard in 2008. In 2018, she went to get her Paragard removed.

Her doctor followed the instructions to remove the IUD, but upon removal one arm remained in the uterus. Tredway’s doctor removed the remaining arm via hysteroscopy a month later.

“Prior to her procedures, Plaintiff and her doctors were provided with no warning from the Defendants of the risk of ParaGard IUD failure and injury, nor were Plaintiff and her doctors provided with adequate warning of the risk of removal of ParaGard IUD,” Tredway’s complaint said. “This information was known or knowable to the Defendants.”

Is There a Recall on Paragard IUD?

Paragard has not been recalled for breakage issues and has no other recent recalls. The device is still available on the market.

In April 2014, Teva Pharmaceuticals recalled two lots of the device for “lack of assurance of sterility,” according to an archived FDA report.

Is There a Class Action?

There is no active class action for Paragard injuries. Lawyers are filing lawsuits on behalf of individuals injured by the device. Although these cases are consolidated in one MDL in Georgia, each plaintiff retains their own lawyer and each case remains an individual case.

In an MDL, not all cases go to trial. Instead, lawyers choose cases for bellwether trials. The outcome of these trials gives both sides an idea of case value and informs any potential settlements.

Paragard Lawsuit Settlement Amounts

So far, there haven’t been any trials scheduled and there have been no settlements. But Paragard isn’t the first IUD to be troubled by lawsuits.

Bayer faced lawsuits claiming its Mirena IUD perforated organs and migrated in the body. In 2018, the company offered $12.2 million to settle 4,600 claims.

Please seek the advice of a medical professional before making health care decisions.
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