Paragard Intrauterine Device Lawsuit

paragard IUD lawsuit
Last Updated: October 22, 2020

Paragard intrauterine devices are marketed as safe. While these IUDs prevent pregnancies with a high degree of reliability, the units can break apart. As a result, pieces of the IUDS have been imbedded in patients’ organs, often causing serious injuries and creating the need for surgery

Paragard intrauterine devices were made by Teva Pharmaceuticals prior to the brand’s 2017 sale to Cooper Companies. Plaintiffs in the ongoing Paragard IUD lawsuit claim that Teva Pharmaceuticals and CooperSurgical Inc. failed to warn consumers of the risk of breakage and the potential for injury even though the company was aware of the dangers posed by the IUDs.

What is the Paragard IUD?

Paragard IUDs are very small intrauterine devices, with T-shaped frames made of soft, flexible polyethylene. The lower portion and part of the arms of the “T” are wrapped with copper, which helps prevent pregnancy without exposing the wearer to hormones. Once installed by a physician, the IUD may be left in place for up to ten years.

The Food and Drug Administration (FDA) granted its approval to the Paragard IUD in 1984. The faulty IUD model is Paragard T 380A. Despite risks associated with potential breakage, it is still on the market. In 2019, a batch of Paragard T 380A IUDs were recalled for concerns over the units’ sterility. To date, though, these IUDs have never been recalled for the breakage issue.

Paragard copper IUDs are marketed as a superior alternative IUDs that rely on levonorgestrel, which is linked to pseudotumor cerebri (ptc). However, the issue with breakage and a subsequent need for emergency fragment removal means that even hormone-free IUDs carry a certain measure of risk.

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Plaintiffs: Manufacturer Failed to Provide Adequate Warning about IUD Breakage

Paragard is the only non-hormonal intrauterine device available in the United States. All options – whether hormone-infused or not – are easy for healthcare providers to install during an office visit that takes just a few minutes. As most patients find that the side effects are mild, IUDs are considered – and marketed – as an attractive contraceptive option, particularly when protection from STDs isn’t a factor. 

Women who have filed lawsuits against Paragard’s manufacturers state that potential breakage was not listed as a side effect when they had their IUDs installed, claiming that Teva made a misrepresentation when labeling the devices as being safe and effective. 

Current prescribing literature from CooperSurgical mentions the risk of breakage when a physician removes an embedded IUD, but some women have experienced complications when the arms break off the IUD before it is scheduled for removal.

CooperSurgical’s materials do not mention of how often “device breakage” occurs, however there is a warning that “breakage of an embedded Paragard during non-surgical removal has been reported.”  Instructions for removal advise healthcare providers that “The threads can retract into the uterus or break, or Paragard can break, perforate the uterus, or be expelled.”

An additional cautionary statement for physicians states that “Breakage or embedment of Paragard in the myometrium can make removal difficult. Analgesia, paracervical anesthesia, cervical dilation, alligator forceps or other grasping instrument, or hysteroscopy may assist in removing an embedded Paragard.”

paragard iud lawsuit
Paragrd IUD 

Paragard IUD Side Effects

Although Paragard does not cause mood swings or lead to weight gain like hormonal birth control can, it comes with warnings about side effects. These tend to be at their worst within the first few months of the device’s installation.

The following Paragard side effects are mentioned specifically:

  • Anemia
  • Backache
  • Dysmenorrhea
  • Dyspareunia
  • Complete or partial expulsion
  • Prolonged menstrual flow
  • Menstrual cycle pattern changes
  • Menstrual spotting
  • Pain and cramping
  • Vaginitis

At the time of insertion, women may experience dizziness, nausea or cramping and pinching. These side effects should last for just a few minutes after the Paragard IUD is inserted. 

Prescribing literature lists some rare Paragard side effects as well, including:

  • Ectopic pregnancy 
  • Sepsis 
  • Pelvic inflammatory disease
  • Embedment
  • Perforation of the uterine wall or cervix during insertion 
  • Unplanned expulsion of the IUD   

Paragard IUD Class Action Lawsuit 2020

If you have been injured, you may be able to seek compensation. At present, hundreds of individual lawsuits have been filed, naming Teva and Cooper Companies as defendants. Due to the likelihood of thousands of cases being filed, it is anticipated that this will not be a class action lawsuit.  Instead it is most likely that all the lawsuits will be combined into multi-district litigation (MDL). 

By assigning all pretrial decisions to a single judge rather than having thousands of cases heard separately, an MDL enables courts to proceed quickly. MDLs are different from class action lawsuits; in an MDL, all cases are resolved separately.

If a Paragard IUD class action lawsuit is filed, it is likely that any award will cover damages for medical bills, pain and suffering, lost wages, and loss of future earnings. To date, the U.S. Food and Drug Administration (FDA) has received over 1,600 complaints of Paragard breakage. Of those, over 700 cases are considered to be serious. 

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Paragard Lawsuit Summaries

In 2020, multiple lawsuits were filed against Teva Pharmaceuticals. Here are some examples:

  • On May 11, 2020, a plaintiff filed a ten-complaint lawsuit in the US District Court for the Eastern District of California. The lawsuit  included claims for strict liability design defect, strict liability manufacturing defect, strict liability failure to warn, and more. The plaintiff claimed that she had been implanted with the IUD for approximately two years prior to asking her physician to remove it. Her doctor removed the IUD according to the manufacturer's instructions, but one arm of the T-shaped device was missing. The doctor used a hysteroscope to remove the fragment. 
  • On May 26, 2020, another plaintiff alleged design defect, negligence, manufacturing defect, and other complaints. The plaintiff had uterine pain after having the IUD implanted for approximately 5 years. When her doctor removed the device, it was missing an arm. The physician was able to locate and remove the missing piece. The plaintiff's claim states that the defendants “knew or should have known that Paragard can and does cause serious harm to individuals who use it, due to the risk of the Paragard’s arm breaking upon removal.” 
  • On May 28, 2020, a third plaintiff alleged gross negligence, violation of consumer protection laws, negligence, and failure to warn after being implanted with the IUD in 2008. In 2018, at the 10 year mark, her physician attempted to remove the device and found that it was missing an arm. The plaintiff claimed that “Paragard is inherently dangerous and defective, unfit and unsafe for its intended use.”

In all three cases, the plaintiffs state that they were in good health at the time of implantation. All of the patients required invasive procedures to remove parts of the IUD. Last but not least, all plaintiffs claim that Teva Pharmaceuticals knew about the dangers of the Paragard device and failed to provide the public with adequate warnings about the risk of defects that could lead to injury.

paragard IUD lawsuit
 Paragard IUD Injuries

Paragard IUD Lawsuit Settlement Amounts

As more than one lawsuit against Paragard IUD manufacturers is still pending, settlement amounts remain unknown. Attorneys from legal firms representing the plaintiffs will seek maximum compensation, as no dollar amount can be placed on damages to a woman’s reproductive health. If and when they are awarded, initial compensation amounts are likely to help litigators negotiate settlement amounts in future cases.

Help for Paragard IUD Victims

Select Justice Focuses on mass tort lawsuits; however, our experts can provide guidance and help those who are considering a Paragard IUD lawsuit fight for the maximum amount of compensation and hold the manufacturers accountable for the painful injuries this product has caused. If you or a loved one has been injured by a Paragard T 380A intrauterine device, take a moment to provide details in the form. Our case review process is free, and can help you determine if your lawsuit is viable.

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