Paragard IUD Class Action Lawsuit 2020

Schmidt National Law Group is currently investigating and accepting Paragard Class Action lawsuit claims against Cooper Surgical Incorporated over the potential risks of this IUD.

Beginning in 2020 we started to receive numerous calls from women who have claimed that the copper infused Paragard IUD were causing problems and were reporting injuries.

Some women that have a Paragard IUD alleged that they experienced serious side effects, such as expulsion, perforation, or pelvic inflammatory disease (PID), some also had the device fail and ended up pregnant.   

Because of these calls we are now investigation these Paragard injury claims.

Update: June 3, 2021- Paragard IUD Breakage: We have currently updated the numbers on problems with Paragard using the FDA’s Adverse Events Reporting System (FAERS) Public Dashboard.

It’s important to note that if the device suffers from any breakage, either from failure or during removal, some parts may not be seen by the doctor or nurse. When this takes place an X-ray must be performed to locate the broken parts and surgery to remove those parts.

According to the report the following numbers show all adverse reports on the Paragard T 380A Copper IUD.

Number of Total Cases: 40,716

  • Device Expulsion – 11,054
  • Device Dislocation – 9,240
  • Device Breakage – 3,290
  • Embedded Device – 1,860
  • Device Issue – 335
  • Device Deployment Issue – 331
  • Device Material Issue – 251
  • Device Malfunction – 59

Will Paragard IUD be a Class Action Lawsuit/MDL?

Our legal team has discussed if this Paragard IUD will be a class action status, very much like we did when we began investigating the other birth control device from AG/Bayer Pharmaceuticals’ Essure product. We were the first law group to file an Essure lawsuit in California, and later went on to head the Steering Committee.  

As expected Teva and The Copper Companies Inc are opposed to an MDL status.  MDL’s can be tricky to achieve and have different variables based on what state has jurisdiction.  In California and Nebraska federal judges dismissed individual Paragard IUD cases in 2017 and 2019.

If you are reading this and have had any problems with the Paragard IUD we urge you to contact us at 1-800-631-5656 and then report the injuries you may have suffered to the FDA’s MedWatch Reporting System.

FDA’s MedWatch Reporting System

FDA Adverse Events Reporting System (FAERS) Public Dashboard. Updated on December 31, 2020 shows an almost daily reporting of injuries related to the Paragard T 380A.

FDA Adverse Events Reporting System (FAERS) Public Dashboard for ParaGard T 380A

The injuries report data from 2008 – 2021 shows most Paragard injuries were reported in 2019 was 7,159. More concerning is seeing that 15 deaths from Paragard were listed. The Serious Cases now total 16,645.

Click the link below to open the report.

https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/45beeb74-30ab-46be-8267-5756582633b4/state/analysis

About the Paragard IUD. Who makes it?

Teva Pharmaceuticals was the original developer of this copper IUD. In 2017 Teva Pharmaceuticals sold this brand to Cooper Surgical Incorporated for $1.1 billion.

Paragard was one of the earliest intrauterine devices (IUD) used for contraception introduced to the market in the United States. It earned US Food and Drug Administration (FDA) approval in 1984 and was sponsored, at the time, by the Population Council, a nonprofit headquartered in New York City that conducts research to address critical health and development issues for the world’s most vulnerable populations.

Today, Cooper Surgical Incorporated markets its Paragard IUD as “The only one for almost everyone”, and continues with: “Only Paragard® IUD, with 1 hormone-free active ingredient (copper), delivers the strongest combination of benefits for the widest range of women1,2,* Satisfy more patients with Paragard—the only highly effective, reversible birth control that is completely hormone free.”

Paragard TV Commercials have recently been seen illustrating a happy women dancing in the store, while the ads touts “No Hormones”, yet doesn’t state or mention the potential for the IUD to break, fracture or migrate.  

FDA takes action and issues warning letter for Paragard TV commercials.

“This TV ad makes false or misleading representations about the risks associated with ParaGard. Thus, the TV ad misbrands ParaGard within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative. 21 U.S.C. 352(n); 331(a); 321(n). 21 CFR 202.1(e)(1); (e)(5). This violation is concerning from a public health perspective because it creates a misleading impression about the safety of ParaGard.”   

FDA warning letter Paragard

The FDA warning letter continues with this statement(s):

”the TV ad fails to include any of the other contraindications for the product, such as acute pelvic inflammatory disease, or current behavior suggesting a high risk of pelvic inflammatory disease. Additionally, although the TV ad includes the statement as an audio voice over (VO), “If you experience pain, pelvic infection . . . call your healthcare provider,” it fails to adequately communicate the material fact that ParaGard is associated with an increased risk of pelvic inflammatory disease (PID) and that PID can have serious consequences. Moreover, the TV ad omits the warning for expulsion of the product. By omitting serious risks associated with ParaGard and material facts pertaining to the risks of ParaGard, the TV ad misleadingly suggests that ParaGard is safer than has been demonstrated.”

Paragard lawsuit settlement amounts.

Filing Paragard lawsuit claims now is at the action point since we strongly feel large cash settlements fund will provide relief for those who have entered into this potential Paragard MDL (Multidistrict Litigation). 

Settlements occur when the manufacturer decides to set aside a monetary compensation fund for victims that have filed lawsuits against the manufacturer. As of this writing no settlement amounts have been reached in these Paragard IUD litigations, but global settlements could be possible in the future.

Have you had problems with a Paragard® IUD?

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We will update this page as we learn more on the legal status of the Paragard IUD lawsuit.

Paragard IUD Class Action Lawsuit 2020 page updated for IUD breakage: June 3, 2021