Paragard® Lawsuit

Paragard is a T-shaped, hormone-free, birth control device made of flexible plastic with a thin copper coil around the plastic. The copper is thought to serve as the device’s active ingredient by preventing sperm from reaching the egg and fertilizing it. Implantation of the Paragard device requires medical professionals.

The copper IUD is placed inside the uterus to prevent pregnancy. It is removable, and can last up to 10 years, according to the manufacturer. However, severe complications can happen if the device moves, breaks, falls out or pierces the uterine wall.

The Food and Drug Administration (FDA) first approved Paragard in 1984. The FDA approved revisions for Paragard’s prescribing label in 2005 and 2019. The updated 2019 label recommends prescribing to women from age 16 to menopause.

Potential Paragard complications and injuries

The lawsuits allege that design defects can lead to the device breaking. The broken device can lead to severe Paragard complications and injuries, including:

• Death
• Infertility and loss of reproductive health
• Mental anguish
• Perforation of the cervix and uterus
• Severe pain and discomfort
• The need for surgeries, including hysteroscopy and hysterectomy

Speak with a medical professional if you are concerned that you may be experiencing dangerous side effects from Paragard or complications from any other IUD. 

People with Paragard IUDs and their medical providers have made more than 50,000 reports to the FDA since Paragard was approved in 1984. This is according to publicly available data in the FDA Adverse Events Reporting System (FAERS) database.

Of the tens of thousands of reports, more than 21,000 have involved serious health problems and at least 17 deaths. In 2023 alone, FAERS received 4,134 reports of health problems in women who had a Paragard contraceptive.

In the first six months of 2024, there were 2,629 total reports involving Paragard. Of those, 1,075 were marked as “serious reports.” 

 How the FDA classifies adverse event reports

Total reports encompass all reports made to the FDA concerning a particular drug or device. 
Reports are classified as serious reports if they result in any of the following outcomes:

• Death
• A life-threatening adverse event
• Inpatient hospitalization
• Prolonging of an existing hospitalization
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
• A congenital anomaly or birth defect
• Reactions requiring intervention to prevent one of the above items

Disclaimer: Reports by themselves are not an indicator of Paragard’s safety profile. In addition, FAERS may include duplicate reports or may significantly undercount the number of women whose copper IUDs have broken during removal.

Individuals who would like to file a Paragard IUD lawsuit must meet eligibility requirements. These requirements may include:

• Implantation of the Paragard device by a healthcare provider
• Breakage of the device during IUD removal or prior to removal
• Personal injury resulting from the IUD breaking
• Removal of the device 10 years or less after it was implanted

People who wish to file a Paragard copper IUD lawsuit should be able to prove they meet the requirements. A Paragard attorney at Motley Rice can discuss what documentation you need to file a lawsuit.

Contact an attorney about filing a Paragard IUD lawsuit

If you or a loved one has or had the Paragard birth control device and experienced complications, you may have a claim. Complete this form or call 1.800.768.4026 for more information and to discuss a potential lawsuit with Paragard IUD lawyers from Motley Rice.

Many Paragard lawsuits have been filed by women alleging harm by the copper IUD breaking. The cases have been centralized into one district court in the U.S. federal court system as a multidistrict litigation (MDL). This consolidation process is designed to save resources and eases the burden on district courts.

The Honorable Leigh Martin May presides over the federal Paragard litigation in the U.S. District Court for the Northern District of Georgia. As August 1, 2024 nearly 2,775 lawsuits are pending in the Paragard IUD MDL, which is designated MDL 2974.

Motley Rice attorney Fidelma Fitzpatrick was Court-appointed to the Paragard MDL Plaintiffs’ Executive Committee (PEC) during the formation in 2021. Kristen Hermiz was Court-appointed to the Plaintiffs’ Steering Committee (PSC)in May 2024.

Keep in mind that MDLs allow multiple plaintiffs to share resources. Class action suits do something similar, but the two are not identical. The Paragard lawsuit is not a class action.

MDLs use a bellwether trial to test how future cases may turn out. This practice is common in mass torts.

Who are the named defendants in Paragard lawsuits?

The Paragard IUD device lawsuits consolidated in MDL 2974 named CooperSurgical, The Cooper Companies, Teva USA, Teva Women’s Health LLC and Teva Branded Pharmaceutical Products R&D as defendants.

CooperSurgical acquired the Paragard copper IUD from Teva in 2017. Teva may still be liable for injuries caused by Paragard that were implanted prior to the sale in 2017.

If you experienced harm as a result of your Paragard IUD, you may be able to file a lawsuit. If a favorable verdict or settlement is reached on your behalf, you may be able to receive monetary awards for:

• Emotional distress
• Loss of consortium (loss of companionship)
• Loss of income
• Medical expenses
• Physical pain and suffering
• Punitive damages

Paragard settlement amounts are never guaranteed but may be available depending on the specific circumstances of a plaintiff’s case. An attorney with experience handling medical device litigation can help you explore what financial compensation may be available for you.

There are currently no settlements or verdicts in the Paragard MDL litigation. The cases are still in the discovery phase of litigation.

Below is a timeline of the Paragard’s history, developments with the device’s approval status and legal updates. Please note that the legal updates reflect the work of several firms, not just Motley Rice.

Here are questions people frequently ask about Paragard and the associated lawsuits and MDL.

Is Paragard being recalled?

The U.S. Food and Drug Administration (FDA) has not recalled Paragard IUDs or released plans to recall the devices. Despite that, there are multiple concerns for women’s health, serious injuries and numerous deaths associated with broken pieces of the device related to a possible design flaw.

The lack of recall may result in more women experiencing injuries and serious health conditions as a result of using the device.

What is the defect of the Paragard design?

The plaintiffs allege that the Paragard IUD has a serious design flaw. This flaw causes plastic pieces of the Paragard IUD to break off during removal. These sharp plastic pieces can become stuck in the user’s uterus, causing serious or life-threatening injuries.

In some cases, Paragard users required hysterectomies or other surgeries to remove these plastic pieces. In other cases, women suffered heavy bleeding after the IUD was removed. Cases filed within the MDL also allege that the manufacturers of Paragard didn’t disclose the risks associated with this potential design defect to users and their medical providers.

Is there a Paragard IUD class action lawsuit?

There is no Paragard class action lawsuit. However, thousands of individual personal injury lawsuits are collected in a multidistrict litigation (MDL). These lawsuits aim to help affected Paragard users seek justice and compensation for their serious medical issues.

MDLs differ from class action lawsuits. Like class action suits, MDLs “combine” a number of individual cases. However, there are some technical differences. For example, plaintiffs’ cases are tried individually in an MDL, instead of as a group like a class action lawsuit.

The Paragard MDL comprises over 2,700 individual lawsuits. If the court or a jury rules in favor of one of the injured parties, the lawsuit award will go only to that individual.

The attorneys at our law firm have experience representing people alleging harmed by defective medical devices and birth control measures, including:

• Acting as court-appointed co-lead counsel for the Mirena® IUD multidistrict litigation (MDL)
• Acting as court-appointed lead-counsel for coordinated cases involving permanent birth control device Essure®
• Serving on the Plaintiffs’ Steering Committee (PSC) for the NuvaRing® MDL

In addition to being a member of the Plaintiffs’ Executive Committee (PEC) of the Paragard MDL, medical device attorney Fidelma Fitzpatrick served as court-appointed lead counsel of the Plaintiffs’ Executive Committee (PEC) for more than 32,000 Essure® cases coordinated in California state court. Motley Rice has also reviewed and researched other lawsuits related to the adverse health effects of IUDs.

Read more on our birth control litigation experience.

FAERS is intended to help identify safety concerns related to marketed products, but it does not prove any product or drug is linked or caused a particular side effect or injury. The information in the FAERS reports has not been verified.

Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death. Paragard remains approved by the U.S. Food and Drug Administration.