Breaking down the Paragard Lawsuit: What You Need to Know

Last updated on December 21, 2023

The Paragard lawsuit is one of the most talked about lawsuits in history. The controversy surrounding this birth control method has been in existence for years and continues to be a hot topic to this day. Many women were surprised when they discovered that they had been harmed by using Paragard as their primary contraception choice.

If you’re unfamiliar with the details of this lawsuit, then it’s important that you read this blog. It will help you learn more about what happened and how it might impact your life.

Understanding Paragard and Its Alleged Issues

You may have heard the news that a vaginal IUD called Paragard is being sued for allegedly causing women to become infertile. This lawsuit, if successful, could lead to millions of dollars in damages. It can even be a watershed moment for birth control access in the United States. But what exactly is Paragard? How does it work? And what are the risks associated with using this particular type of birth control?

First off, what is an IUD? An intrauterine device (IUD) is a small T-shaped device inserted into your uterus by a trained doctor or nurse practitioner. It helps prevent pregnancy by preventing sperm from reaching the egg or preventing an egg from implanting on your uterine wall.

There are two types: copper IUDs like Paragard and hormonal ones like Mirena or Skyla. The latter two are hormonal IUDs, meaning they release low doses of hormones into your body at regular intervals throughout their lifespan. Hormonal IUDs also thicken cervical mucus, so sperm have trouble swimming through it.

Paragard, on the other hand, is a non-hormonal IUD. According to the Mayo Clinic, it is the only copper IUD available in the US. Moreover, its non-hormonal nature ensures that your natural hormone flow is not impacted.

Due to these benefits, Paragard has been widely used across the US. As stated in market research by Grand View Research, Paragard’s sales increased by 16% in the US during the first quarter of 2021.

However, Paragard has been recently associated with several consequences and health problems. This has led to numerous Paragard lawsuits filed by plaintiffs.

The Origins of the Paragard Lawsuit

It’s important to note that lawsuits involving medical devices can be complex. They often involve investigations into factors such as product design, manufacturing processes, and warnings provided to users. Regulatory agencies, such as the US Food and Drug Administration (FDA), also monitor and address safety concerns related to medical devices.

The Paragard lawsuit refers to legal actions taken by individuals who claim to have suffered harm from using the Paragard IUD. Common reasons cited in these lawsuits include device breakage during removal, migration of the device, perforation of the uterus, and other complications.

The origin of the Paragard lawsuit can be traced back to complaints from users who experienced issues with the device. The alleged defects in the design or manufacturing of the device have been central to many of these legal claims.

According to TorHoerman Law, the first trial for these cases is scheduled to be heard in October 2024 in Georgia. Currently, there have been over 2,200 lawsuits filed in federal court claims. Of these, many cases have been consolidated into multidistrict litigation (MDL). A Forbes article states that this MDL was created in 2022, with around 1,314 plaintiffs as of mid-August 2022.

Key Allegations in the Lawsuit

The lawsuit alleges that Paragard can cause serious side effects, including injury to the uterus and reproductive system. The plaintiffs claim that they suffered from these injuries after using Paragard for birth control. According to katv.com, at least 3,200 women have suffered breakage of non-hormonal IUD Paragard, according to 2021 reports.

The device is a copper IUD approved by the US Food and Drug Administration (FDA) for up to 10 years of use. The allegations of the Paragard IUD lawsuit are that device breakage can lead to internal injuries and other problems.

Among the injuries mentioned in lawsuits are:

IUD fragments shatter and become stuck in organs
Unremovable IUD fragments that remain inside the body and can lead to allergic reactions and infections
IUDs moving around
Infection with Pain
Cervical or uterine perforation Infertility

In addition, women are citing organ damage, infections, scarring, ectopic pregnancies, and inflammation in their lawsuits.

Legal Developments and Class Action Status

The legal landscape surrounding Paragard lawsuits constantly evolves as more individuals claim complications and injuries related to this intrauterine device (IUD). Understanding the current legal developments and class action status is crucial for those affected and seeking justice.

In recent years, there has been a significant increase in the number of Paragard lawsuits filed across the United States. As a result, some cases have been consolidated into multidistrict litigation (MDL) or class action lawsuits. MDL allows similar cases to be centralized under one federal court for more efficient handling. On the other hand, class action lawsuits consolidate multiple individual claims into a single lawsuit representing a larger group of plaintiffs.

The current status of Paragard lawsuits varies depending on jurisdiction and specific circumstances surrounding each case. It is important for individuals who believe they have suffered harm from using Paragard to consult with an experienced attorney.

As legal developments continue to unfold in Paragard lawsuits nationwide, it is crucial for affected individuals to stay informed about their rights. Seeking professional legal guidance can help navigate complex litigation processes while ensuring justice is pursued against those responsible for harm.

Through the MDL, the plaintiffs and alleged parties will try to resolve issues through a settlement. However, if no alternative method is reached, the first bellwether trial date is scheduled for Oct. 28, 2024, as mentioned earlier.

The Role of Regulatory Bodies

The FDA and other regulatory bodies are investigating the allegations made in the lawsuit. Here’s how regulatory bodies are involved:

FDA Approval and Monitoring:

The FDA is responsible for reviewing and approving medical devices before they can be marketed and sold. Paragard received FDA approval, indicating that it met certain safety and effectiveness standards.
The FDA continues to monitor the safety of approved medical devices by collecting and analyzing adverse event reports, clinical studies, and other relevant information.

Post-Market Surveillance:

Regulatory bodies, including the FDA, engage in post-market surveillance to identify and address any safety concerns arising after a device’s approval.
Adverse event reporting by healthcare professionals, patients, and manufacturers is crucial to this surveillance process. If patterns of adverse events emerge, regulatory bodies may take action.

Product Labeling and Warnings:

Regulatory bodies work with manufacturers to ensure that product labels provide accurate and comprehensive information about potential risks and side effects.
If new safety concerns emerge, regulatory bodies may require manufacturers to update labeling or issue warnings to healthcare providers and patients.

Recalls and Enforcement Actions:

If a medical device is found to pose significant risks to patient safety, regulatory bodies have the authority to issue recalls.
These actions may involve working with manufacturers to address the issues, updating product labeling, or, in extreme cases, removing the product from the market.

Legal Actions and Lawsuits:

Regulatory bodies may become involved in legal actions related to medical devices. For example, the FDA may be called upon to provide expert testimony or information in Paragard lawsuits.
Lawsuits against manufacturers may also prompt regulatory bodies to reevaluate the safety of a device and take appropriate regulatory actions.

The Takeaway

We hope this article has helped you understand more about the Paragard lawsuit and its implications for the future. While we don’t know what will happen in court, we do know that people are taking action to protect their health and livelihoods. Many individuals who suffered from Paragard IUDs have already filed lawsuits. If you have not, consult an attorney and file your case.