Defective Medical Devices Linked to Injuries

 

Case: In re: Paragard IUD Products Liability Litigation, case number 1:20-md-2974-LMM

Court: United States District Court, Northern District of Georgia

Leadership Position: Plaintiffs’ Executive Committee

Reviewed by Molly C. Wells, Esq.

Wallace Miller is currently handling claims for individuals who have been injured by Paragard IUDs. Over the past several years, more than 1,700 individuals have come forward after the breakage of the birth control IUD caused significant health issues, including fragments migrating from the uterine cavity, organ damage, and the need for surgical removal. 

The Paragard IUD is a T-shaped device inserted in the uterus that can prevent pregnancy for up to 10 years. While the manufacturers of the device claim that it can be easily and safely removed, plaintiffs in the case have suffered complications due to the device’s arms breaking during the removal process. As a result, Wallace Miller together with other law firms from across the US are bringing a Multidistrict Litigation (MDL) to achieve financial restitution for those affected by the product. The MDL will be presided over by Judge Leigh Martin May in the Northern District of Georgia. 

Contact Wallace Miller at (312) 261-6193 or fill out our online questionnaire for a free and confidential consultation.

Paragard lawsuit updates 

September 2024 — In a recent meeting with the defense attorneys, the Wallace Miller team learned that the Paragard defendants are planning to file a motion to dismiss for some cases based on alleged issues with statutes of limitations. Such motions are often intended as delay tactics and can distract from the real issues of the case. 

If the motion to dismiss is granted, most cases listed in the motion would likely only have specific claims dismissed, rather than the entire case. Concerns raised by the defense related to data and documentation have already led to the removal of several plaintiffs from the potential dismissal list due to inaccurate information. 

The motion will likely be filed within the next week and will require additional briefings, hearings, and oral arguments later this fall. The workup of bellwether trials, which was originally slated to start this fall, will likely be pushed back to next year. 

May 9, 2023 — Paragard status conference held before Judge Martin May. 

April 2023 — The number of pending Paragard cases is now over 1,780. 

February 2023 — One of Wallace Miller’s new Paragard IUD lawsuits is chosen for the bellwether trials planned for 2024. 

January 2023 — Judge Martin May appoints a mediator to facilitate settlement discussions. 

December 2022 — The Paragard MDL continues to grow, with the number of pending IUD lawsuits passing 1,500. 

September 27, 2022 — Judge Martin May indicates she will schedule the first Paragard bellwether trial for January 2024. 

September 2022 — More than 1,300 cases have been filed. 

July 2022 — After a slowdown in May and June, the number of Paragard lawsuits filed has risen to more than 1,200. 

May 2022 — More than a thousand Paragard lawsuits have been filed as part of the MDL. 

January 2022 — There are now more than 700 pending Paragard IUD lawsuits in the MDL. 

Summer 2021 — Teva Pharmaceuticals and CooperSurgical file a motion to dismiss the cases based on federal preemption. The motion is denied by Judge Martin May. 

February 9, 2021 — The Court holds its initial conference on the Paragard MDL. Liaison counsel are assigned and the Court considers the appointment of attorneys to a Plaintiffs’ Steering Committee. 

December 2020 — The Judicial Panel on Multidistrict Litigation grants a motion to transfer Paragard IUD lawsuits to the Northern District of Georgia under Judge Leigh Martin May. Cases through Wallace Miller are brought via case number 1:20-md-2974-LMM. These Paragard cases are specifically related to damages caused by device arm breakage. 

August 2020 — Vanesha Johnson files a legal complaint against Teva Pharmaceuticals USA and CooperSurgical. 

This content was reviewed by Molly Condon Wells.

Understanding the Paragard IUD 

Paragard is an intrauterine device (IUD) that provides long term birth control for up to 10 years. It is a device comprised of a T-shaped plastic frame wrapped in copper wire that is inserted into the uterus. Unlike other IUDs on the market, including Mirena and Kyleena, the Paragard IUD is 100% hormone free and works essentially by creating an inflammatory reaction that prevents contraception. Paragard is the only copper IUD available in the United States and has been in use since the 1970s. 

 

The Paragard IUD is usually removed at a health care provider’s office via the removal cord built into the device. The device’s arms are designed to fold upward as it’s withdrawn. According to the manufacturers, this is a simple and quick procedure that rarely requires any additional physician input. 

There are currently two models of Paragard on the market: the Copper 380 Slimline and the Copper 380A. The main difference between the 380 Slimline and the 380A is that on the former, the copper coil covers the ends of the horizontal arms, rather than lining the arms’ centers (as in the photo above). No significant differences in efficacy or in side effects have been noted between the two models. 

The history of Paragard 

1968 : Inventor Howard J. Tatum, working at the nonprofit Population Council’s Center for Biomedical Research, proposes the T-shaped IUD. This IUD model is designed to better fit the shape of the uterus. 

1969: Physicist Jaime Zipper finds that copper significantly diminishes pregnancy risk and incorporates copper wire into the IUD device design. 

1984: The Paragard IUD is approved for use in the U.S. through a New Drug Application (NDA). 

1988: The TCu 380A IUD model hits the market. Initially, the device is only recommended for individuals who have at least one child and are in a stable, monogamous relationship. 

1989: Paragard is approved for up to 6 years of continuous use by the FDA. 

1991: Paragard is approved for up to 8 years of continuous use by the FDA. 

1994: Paragard is approved for up to 10 years of continuous use by the FDA. 

The Paragard IUD device remains the only copper IUD, and one of only five IUDs total, available on the U.S. market. According to the National Center for Health Statistics, between 2017 and 2019 the percent of U.S. women aged 15 to 49 using long-acting reversible contraception (including IUDs and contraceptive implants) was 10.4%, compared to 14% using the pill, 18.1% using female sterilization, and 8.4% using the male condom. 

Fractures in Paragard IUD during removal 

The manufacturers of the Paragard IUD, Teva Pharmaceuticals and CooperSurgical, attest that the device is designed to be removed safely. However, a number of patients have reported incidences of the arms breaking off upon removal, possibly due to the flexible plastic frame of the birth control device becoming rigid over time. These cases often require further medical intervention to find and retrieve the broken IUD pieces. 

Between 2013 and 2021, according to voluntary reports filed with the Food & Drug Administration (FDA), there have been 3,186 reports of Paragard IUD breakage, 1,910 of which were deemed serious and 102 of which led to hospitalization or life-threatening complications. Case studies in 2015 and 2021 indicated that the incidence of breakage is likely under-reported. 

The device manufacturers added a warning about potential device breakage in 2019, stating, “Breakage of an embedded Paragard during nonsurgical removal has been reported.” 

What injuries do fractured Paragard IUDs cause? 

When these IUDs are fractured during removal, the broken Paragard pieces can lead to serious medical complications, including: 

• Pelvic Inflammatory Disease (PID), an infection of the reproductive organs 
• Vaginal bleeding 
• Perforation of the uterus 
• Fragments embedding in the uterine wall or becoming lodged in other organs 
• Extreme and persistent pain 
• Inflammation or allergic reaction 
• Infection 
• Infertility 

Involved surgical procedures including laparoscopies, laparotomies, and hysteroscopies are often necessary to remove the pieces without organ damage, which can be painful, invasive, and expensive. And in some cases, the injuries caused by the fragments embedded in the uterus are so significant, or risk damage to other organs, that a hysterectomy is required. 

These procedures can have lasting impacts. In a hysterectomy, the uterus is removed either entirely or in part, leaving the individual permanently unable to have children. 

Recent studies on Paragard IUD defects 

A 2021 case report in the journal Case Reports in Women’s Health investigated the story of a patient who underwent a hysterectomy in order to safely remove a fractured IUD. The report found that the fracture of an intrauterine device on removal is very rare, only occurring in 1 to 2% of cases, but that the risk should be better communicated between doctors and patients. The study also noted that cases of fractured IUDs may be underreported. 

In a 2015 study, researchers at the Advocate Illinois Masonic Medical Center collected cases of possible IUD breakage discovered by clinicians within their Department of Obstetrics and Gynecology. They stated that this complication, while rare, is likely underreported and presents a unique challenge to clinicians based on the possibility of embedment and perforation. “Our findings also suggest that the duration of Paragard copper T 380A use may potentially influence the likelihood of fracture during removal, given that all of our cases ranged from 6-10 years of use.” They also said that the fracture may be unavoidable by the physician in most cases, even if special care is taken during removal. 

The researchers reached a similar conclusion as the 2021 study: that IUD breakage is likely underreported, that it can be difficult to treat, and that clinicians and patients should receive more warning about the risks of IUD breakage. 

Why are people pursuing Paragard IUD lawsuits? 

In the pending Paragard IUD lawsuits, plaintiffs allege that the product manufacturers (CooperSurgical, Teva Pharmaceuticals, and their subsidiaries) failed to warn of the risk of breakage during removal. Representatives of the companies maintain that there is no evidence of device fragility, and the first mention of breakage during removal did not appear in a warning label until 2019. 

Wallace Miller is pursuing the Paragard cases based on multiple theories: the design and manufacturing defects that caused the Paragard IUD breakage, and the failure of the defendants to properly warn their customers about the severe health problems that can result from such a breakage. 

Under U.S. law, consumers are entitled to information about the potential risks of a product before they choose to use it. That is the basis of the manufacturer’s “duty to warn,” and the case Wallace Miller is making in the Paragard lawsuit: that the defendants should have better informed their patients about the potential for harm. 

Ultimately, it is up to consumers to decide what risk they are willing to take. As a result, there is no planned Paragard recall, as consumers may decide that the advantages of a Paragard IUD are worth the risks. However, if patients would have made a different choice had they been fully informed, they should be compensated for the physical and emotional damages caused by the medical device. 

The plaintiffs in Paragard cases so far have stated that Teva Pharmaceuticals and CooperSurgical marketed the IUD device as “safe and effective,” overstating its benefits while downplaying the risks. In addition, they claim that the manufacturers withheld important safety information about the serious complications that can result from IUD breaks from health care providers and the public. 

Who are the defendants in the Paragard lawsuits? 

The defendants in the Paragard IUD defect lawsuits are the manufacturers of the device: Teva Pharmaceuticals, USA, Inc., CooperSurgical, and their subsidiaries. Teva Pharmaceuticals is an Israel-based corporation founded in 1901 whose products include pharmaceutical ingredients and over-the-counter treatments. In 2017, they announced the sale of Paragard to CooperSurgical, a company that manages a number of brands that provide medical devices and fertility products. In 2021, Teva Pharmaceuticals reported a revenue of $15.9 billion, while CooperSurgical reported a revenue of $2.92 billion. 

Do I qualify to file a Paragard IUD lawsuit? 

The number of new Paragard lawsuits continue to grow, with bellwether trials scheduled to take place in January 2024. You may be eligible to join the Paragard IUD litigation if you meet the following criteria: 

• You have used the Paragard IUD as a form of birth control. 
• Your IUD broke, either during the removal process of the device or prior to its removal. 
• The IUD was removed less than 10 years after implantation. Since the medical device is only approved for 10 years of use, cases where the IUD has been removed after that time and caused adverse events are not eligible for the Paragard MDL. 

While plaintiffs with more serious injuries are likely to receive higher compensation amounts, we are committed to pushing for the best possible result for all clients who qualify. 

Contact Wallace Miller about your potential Paragard litigation 

If you have been harmed by a broken Paragard IUD and believe you may be eligible for the litigation, contact Wallace Miller at 312-736-2697 or fill out our online questionnaire for a free and confidential consultation.

Why should I file a Paragard lawsuit? 

Wallace Miller is committed to helping clients achieve financial restitution and to holding corporations accountable for the harm caused by their products. 

By filing a lawsuit with our Paragard attorneys, you can potentially obtain compensation for harm caused by the product, including medical expenses, emotional distress, relationship and intimacy problems, and lost wages. 

Understanding my potential lawsuit 

Is this a Paragard class action lawsuit? 

Thousands of Paragard users in the US have filed claims against the defendants. However, because the specific medical circumstances differ from plaintiff to plaintiff, these cases are mass torts, rather than class actions. 

Class actions and mass torts are similar in that they enable the courts to resolve many claims at once via a consolidation process. But in order for cases to be consolidated in a class action, certain requirements must be satisfied, including a common issue or injury shared by all plaintiffs, and the eligibility of one case to act as a representative of the whole class. 

Mass tort cases, such as those in the Paragard MDL, are all filed and awarded independently. This is almost always the case for lawsuits that deal with physical (rather than economic) injuries, because the medical circumstances of every plaintiff will be unique. Since the damages in the Paragard lawsuit differ from person to person but are all being brought against the same defendants, the mass tort claims have been consolidated into an MDL. 

As a result, if a settlement is eventually reached, each plaintiff involved in one of the Paragard lawsuits will receive compensation for their individual circumstances. 

Timeline of the lawsuit 

More than 1,700 Paragard plaintiffs have joined the litigation since cases were initially filed in late 2020. While the lawsuits have been progressing slowly so far, the Paragard MDL judge recently scheduled bellwether trials for January 2024. This is a crucial step towards moving the litigation as a whole forward and will likely determine subsequent settlement amounts. 

How much will Paragard IUD lawsuits be worth? 

There are a number of factors that can influence the settlement amounts in Paragard lawsuits. The amount each plaintiff receives will depend on their situation and the extent of their injuries. As the litigation is still in its early stages, it’s difficult to estimate those amounts. Depending on the outcome of the bellwether trials in 2024, the litigation may ultimately be resolved in a global settlement with compensation determined by severity of injury. 

Your Paragard lawyer will work with you throughout the process to keep you up to speed on Paragard settlement updates. 

What evidence will I need for the Paragard IUD lawsuit? 

In order to participate in the Paragard lawsuit, you will need to provide proof of use of this specific device in the form of medical or insurance records. This is simplified by the fact that Paragard is the only non-hormonal IUD on the market in the U.S. (with the exception of grey market Canadian IUDs in Washington State). In addition, plaintiffs will need to provide proof of the implant date, removal records including records of the initial removal and subsequent removal attempts, records of any imaging performed to locate missing fragments, and records of surgeries. 

If we determine that you are eligible for a Paragard lawsuit, we will generally reach out to physicians and hospitals with your permission and request the records directly from your provider. This is a common and straightforward process that enables our Paragard lawyers to most effectively argue your case in the litigation. 

How long do I have to file a Paragard lawsuit? 

The statute of limitations, or how long an individual has to file a lawsuit after an injury, depends on the plaintiffs’ state. The countdown generally begins at the initial removal or breakage and can be only a few years in some states. If you believe you may qualify for the Paragard lawsuit, reach out to Wallace Miller as soon as possible at (312) 261-6193 or via our online questionnaire. 

Wallace Miller: Investigating claims about Paragard IUD complications 

At Wallace Miller, we believe in two things: relationships and results. Whenever people are seriously injured or killed by the negligence of others, there’s a story to tell. Our law firm builds relationships with our clients, making sure to collect information that is tailored to each case so that we can properly tell your story in order to produce results. 

Wallace Miller primarily focuses on protecting the rights of victims of negligence and fraud. We are routinely appointed by federal and state courts to serve as leaders in national litigation, and our attorneys have obtained ground-breaking verdicts in a variety of cases across the nation. But more importantly, we are committed to obtaining justice for each and every one of our clients. 

We know that there are many choices available to you when looking for a lawyer to represent you. What sets us apart from others is our commitment to our clients, our ability to handle complex high-stakes litigation, and our outstanding track record of success. We only take on cases that the firm has faith in and believe can make a difference in our clients’ lives, including the Paragard lawsuit. 

Start your Paragard lawsuit — Contact Wallace Miller now 

If you have been harmed by the Paragard birth control device, reach out to Wallace Miller at (312) 261-6193 or via our online questionnaire to discuss your potential case.