Read the latest on the Paragard Intrauterine Device Lawsuits
The Paragard Intrauterine Device (IUD) is a popular choice for women who want to be on long-term birth control. However, in the last few years, there has been a huge uptick in lawsuits filed against Paragard’s manufacturer, Teva Pharmaceuticals, because of claims that the device causes serious complications and injuries. In this article, we will provide an in-depth look at the Paragard IUD, the reason for the lawsuits, the allegations, and what you can do if you were injured because of a Paragard IUD.
Updates on the Paraguard Lawsuit — October 2024
Before we get into the details of this IUD MDL, let's catch you up on the latest news about the Paragard legal action.
October 7, 2024 – New Cases Slow Down in September
The Paragard class action MDL saw its pending cases drop in September. The MDL lost 49 cases lowering the total to 274—this is the first monthly decrease for this MDL in five years. Then, 12 new cases popped up in early October. This is fairly insignificant and represents the natural fluctuations of MDLs.
On November 25, 2024, plaintiffs still plan to question Dr. Barton Cobert in Baltimore unless a global Paragard settlement happens first. Dr. Cobert's questioning will center on a pharmacovigilance check he did in 2010 for Paragard. We’ll keep you in the loop as the case moves forward.
September 28, 2024 - Deposition Scheduled for Dr. Cobert
The plaintiffs are preparing to depose Dr. Barton Cobert at the end of November over the pharmacovigilance audit he conducted in 2010 related to Paragard.
I'm sorry, pharmacovi-what?
Pharmacovigilance is a fancy word for drug safety. It's the science of ensuring the safety of medicines and vaccines and noting and reporting adverse events. These audits are critical for patient safety since they review and evaluate the steps that drug manufacturing companies are taking to ensure they are producing safe and effective medicines.
Dr. Cobert's findings will be key for the ongoing Paragard cases and will give the plaintiffs and court valuable insight into the protocols and compliance measures that were in place when the defective device was created.
September 16, 2024 – Teva Seeks Dismissal of 236 Paragard Lawsuits Over Statute of Limitations
Teva has moved to dismiss 236 lawsuits in the Paragard MDL, arguing that they are time-barred under various statutes of limitations. The challenged cases fall into three main categories: those where the statute of limitations started at the time of the Paragard removal surgery, cases blocked by the statute of repose, and claims where state law prohibits strict liability. However, the issue of fraudulent concealment may leave the statute of limitations to be decided by a jury. Even if dismissals occur—though unlikely—these cases may still carry settlement value as Teva may wish to avoid appeals. Teva’s strategy appears to be an attempt to clear out these cases ahead of a potential broader Paragard settlement.
September 6, 2024 – Missouri Woman Files New Paragard Lawsuit
A new lawsuit has been filed by a Missouri woman against Teva and Cooper, adding to the Paragard MDL. Like many others, the plaintiff alleges the Paragard device broke during removal, causing pain, suffering, mental anguish, and the potential need for further surgeries. The lawsuit includes claims of strict liability, negligence, breach of warranty, consumer protection violations, and fraud. The plaintiff has demanded a jury trial and may expand her allegations if additional complications arise.
September 3, 2024 – Paragard MDL Grows with 57 New Cases
The Paragard MDL added 57 new cases in August, reversing a slight decline from the previous month. This brings the total number of pending cases in the MDL to 2,793, reflecting continued growth in the litigation.
September 1, 2024 – Plaintiffs Push to Add Teva as Defendant
Plaintiffs have filed a motion to amend their Master Personal Injury Complaint to formally include Teva Pharmaceutical Industries Ltd. as a named defendant. Teva has pushed back, arguing that the plaintiffs have not shown the required diligence for such an amendment. However, the lack of prejudice in adding Teva, combined with recent document discoveries clarifying Teva Ltd.’s role, strengthens the plaintiffs' argument. The push to add Teva comes as the litigation progresses and the picture of corporate responsibility becomes clearer.
The Science Behind How Paragard IUDs Break and Migrate
The Paragard IUD (intrauterine device) is a flexible T-shaped piece of plastic wrapped in copper wire. It is inserted into the uterus to act as birth control and can remain in place for up to ten years. The device is designed to be durable, but it has been known to break apart inside the body and migrate deeper into the uterus, particularly during removal procedures.
The fractures typically occur when the flexible plastic arms of the T-shape, which are meant to bend during insertion and removal, experience excessive stress or become brittle. Over time, the plastic may become fragile, especially after being exposed to the body's environment for a long period, which can lead to cracks or breaks. During removal, if the device is not fully intact, the force applied can cause these already weakened areas to fracture.
Once fractured, the broken pieces of the Paragard IUD can migrate within the body. The sharp, detached fragments can then puncture the uterine wall. In addition to damaging the uterus, the fragments can move into other areas of the pelvic cavity, causing damage to organs or surrounding tissues.
Migration of the whole device or broken pieces can lead to severe pain, infection, or other complications that usually require surgery to remove the pieces and repair the damage.
The real danger is when the migration goes unnoticed until it has already caused significant damage, which usually causes much more severe injuries than when the breakage is noticed right away.
Evidence Concerning the Dangers of Paraguard IUDs
Concerns about the Paragard IUD fracturing and migrating are backed by clinical reports and studies. Here's a summary of the scientific evidence:
- Case Reports and Clinical Studies: Many case reports have documented situations where the Paragard IUD fractured during removal, leading to complications such as migration of the broken pieces and uterine perforation. These reports often make mention of the difficulty in retrieving the fractured pieces and the common need for surgery to retrieve them.
- FDA Adverse Event Reports: The U.S. Food and Drug Administration (FDA) has received thousands of adverse event reports related to Paragard. These reports describe device breaking and the subsequent complications like migration, uterine perforation, and embedment into surrounding tissues. These reports provide anecdotal evidence of the device's tendency to fracture and cause harm, which is a reliable way of determining the prevalence of a defective medical device.
- Material Science and Device Integrity: Studies on the materials used in medical devices, including those similar to Paragard, indicate that the plastic components can degrade over time when exposed to the liquids and chemicals inside the human body. This degradation can cause the plastic to become brittle and increase the likelihood of it fracturing. The copper wire, while not prone to breaking, can sometimes contribute to the problem since it can become free or unravel when the plastic breaks—exacerbating the problem.
- Biomechanical Stress Analysis: Analyses of the force used during the insertion and removal of intrauterine devices have shown that the design of the Paragard, particularly its plastic arms, may be susceptible to stress fractures. This is especially true if the device has been in place for an extended period, as the plastic may lose flexibility and strength over time. These stress fractures are what eventually lead to breakage and migration while in place or during removal.
Women’s Prefered Methods of Birth Control
In the US, 65% of women aged 15–49 in the United States are currently using contraception. There are a lot of options when it comes to preventing an unwanted pregnancy in America, and they vary quite a lot from method to method.
Here are the most commonly used birth control methods in the US, according to the CDC:
- Female sterilization, aka “tubes tied” (permanent method)
- Oral contraceptive pill (hormone-based)
- Long-acting reversible contraceptives (LARCs) like IUDs and implants (come in hormone-based and copper options)
- Male condoms (barrier method)
There's no single "best" method. Some are perfectly safe, some are super reliable, and some are inconvenient. Because of this, women often have to make a decision that is right for them based on the following factors.
- Desire for future pregnancy
- Effectiveness rate
- Potential side effects
- Frequency of sex
- Need for STI protection
- Ease of use or convenience
- Safety of method
The most common contraceptive methods that women choose are sterilization (18.1%), oral contraceptive pills (14.0%), long-acting implant contraceptives (10.4%), and require the man to use a condom (8.4%).
However, among women between 20 and 39, which is the most fertile period and common age range to have a baby, implants like Paragard’s IUD are most popular.
What is the Paragard IUD?
The Paragard IUD is a small, T-shaped device made of plastic and wrapped in copper wire. The copper wire actually acts as a natural spermicide, killing any sperm that moves past it. Since the Paragard IUD is inserted into the uterus, all sperm has to pass it to make their way to the eggs. This provides women with contraception for up to ten years.
IUDs (intrauterine devices) are also called IUCs (intrauterine contraception).
There are only five IUDs approved by the FDA for use in America. Four of them are hormonal IUDs, which use a slow release of hormones more similar to a birth control pill.
Those four are Mirena, Kyleena, Liletta, and Skyla.
The only copper IUD is the device in question, Paragard.
Unlike hormonal IUDs, Paragard relies on copper to prevent pregnancy, making it a popular option for women. There is no messing with your hormones, it’s reversible, convenient, and it’s a pretty basic and understandable product.
Paragard is also a highly effective form of contraception. In fact, Paragard is 99% effective, which is the same as a condom if they are used perfectly; in real-world situations, a condom’s effectiveness is in the 80s.
Basically, it’s perfectly effective, donesnt require daily maintenance, and it’s reversible. Sounds perfect, right?
The Lawsuits Against Paragard
Despite its benefits, Paragard has come under fire because of reports from women and doctors that say the device can cause severe complications.
Thousands of Paragard lawsuits have been filed across the country because of claims that the device caused them serious injuries, particularly during removal.
The basis of the allegations in the Paragard lawsuits involves the device breaking, perforation, migration, infection, and scarring.
Device Breakage
One of the primary allegations in the Paragard lawsuits is that the device breaks during removal. Plaintiffs claim that the Paragard IUD often breaks into fragments when a healthcare provider attempts to remove it, which leaves pieces still inside their uterus. This can lead to severe pain, heavy bleeding, and the need for additional surgeries to recover the broken parts.
Perforation
Perforation is another serious issue that has been referenced in some of the Paragard lawsuits. In these allegations, Paragard IUDs can perforate the uterine wall when it is being inserted or removed, and in some cases, when it is just sitting in position. If a woman experiences a Paragard IUD device perforation, it usually requires surgery to correct and can result in long-term damage to reproductive organs, severe pain, and other health complications.
Migration
Perforation can lead to the device migrating outside the uterus and into other areas of the woman’s body, most commonly the pelvis or abdomen. Migration of the Paragard IUD is a significant problem for lots of plaintiffs, according to all the lawsuits. Migration can cause severe pain and organ damage and requires complex surgical procedures to locate and remove the device.
If the Paragard IUD moves, it can also lead to unintended pregnancies, which contributes to the growing number of lawsuits against the manufacturer for failing to warn about this risk.
Infection
Infection is another one of the allegations in the Paragard lawsuits. Some lawsuits claim that the IUDs caused serious infections in the pelvic region and in the blood as the infection spread. Infections like this can be very painful and cause long-term reproductive health issues.
The lawsuits argue that users were not adequately informed about the risks of infection.
Scarring
The formation of scar tissue in the uterus is one of the most serious allegations in the Paragard lawsuits. Plaintiffs claim that during insertion, or whole the IUD was inside them, it caused scarring to their uterine lining. According to the lawsuits, this scarring has led to chronic pain, fertility issues, and complications in future pregnancies.
These risks were allegedly not disclosed to users well enough or not at all, which we cover below.
Allegations Against Teva Pharmaceuticals
Plaintiffs in the Paragard lawsuits allege that the maker of Paragard, Teva Pharmaceuticals, failed to warn users about the risks associated with the device. The main allegations in the Paragard lawsuits are failure to warn, defective design, and negligence.
- Failure to Warn: Plaintiffs claim that the manufacturer did not provide sufficient warnings about the potential for the device to break during removal or the possibility of pain, health risks, or major complications.
- Defective Design: Many of the lawsuits also claim that the design of Paragard is inherently flawed because it is prone to breaking and causing injuries.
- Negligence: Finally, plaintiffs also claim Teva Pharmaceuticals was negligent for failing to adequately test their products and for not continuing to monitor the product to make sure that it continued to be safe.
The allegations and lawsuits surrounding Paragard have raised significant concerns among women who have used the IUD device. The potential for severe complications and the ensuing legal battles emphasize the importance of informed decision-making regarding contraceptive choices and gender biases in healthcare.
Paragard Lawsuit Settlements and Proceedings
As of now, the Paragard lawsuits are in various stages of litigation. Most of these cases have been consolidated into a multidistrict litigation or MDL along with other similar complaints. An MDL is a legal concept that combines similar lawsuits from many different states into a single federal case. This helps in efficiently managing complex cases by centralizing them under one court, streamlines the process, and prevents contradictory decisions.
The Paragard MDL was created in December 2020 and is being overseen by Judge Leigh Martin May in the Northern District of Georgia.
While some cases may stay in their own state and be settled or go to trial, or they may be added to the MDL and go through the process.
During the MDL process, there is something called bellwether trials which act as test trials. If these test trials go well for the plaintiffs, it can cause Teva’s lawyers to want to settle.
Settlements can provide quicker resolutions for plaintiffs and help Teva Pharmaceuticals save litigation costs.
There haven't been any major announcements regarding settlements yet. However, a settlement mediator was appointed in February 2023, which could be a sign of potential negotiations.
The first bellwether trial is scheduled for October 28, 2024
As of May 18, 2024, the Paragard IUD MDL has about 2,650 cases consolidated, and the number of pending cases continues to grow.
Hiring a Paragard Lawyer to Protect Your Rights
If you are considering legal action against Teva Pharmaceuticals, it is essential that you speak to an attorney who is used to handling major pharmaceutical lawsuits.
The legal partners of Lawsuit Legal News have tried cases against some of the biggest companies and pharmaceutical corporations in America. They have held them accountable in state and federal lawsuits, handled sensitive and complicated cases, and helped thousands of people get the justice and compensation they need to rebuild their lives.
Some of the giant drug and medical device companies, insurance giants, and international corporations they have held accountable include Uber, Lyft, Johnson & Johnson, 3M, Dupont, Geico, State Farm, Progressive, Dow, Bayer, Unilever, Pfizer, and Procter & Gamble. Many of these companies have faced accountability at their behest more than once.
If you need additional information on filing a lawsuit against Teva Pharmaceuticals for a Paragard injury, use LLN’s online contact form.