For more than three decades, millions of American women have been using Paragard IUD as a birth control means. Although everything has been fine, the copper birth control device has been in the news since last year because of numerous Paragard lawsuits that claim the device can break and embed in other body organs, causing a wide range of health complications.
The U.S Food and Drug Administration (FDA) has received many reports of Paragard breakage. Further research has also revealed that the device may have an increased risk of expulsion, and women using it can still contract unwanted pregnancies.
A significant number of women have started filing Paragard lawsuits, claiming that the IUD manufacturer intentionally failed to warn users about potential side effects.
If you or your loved one were implanted with the device and suffered harm after that, you may qualify for Paragard lawsuit litigation. Read on to find out if you are eligible for legal action.
What Is Paragard IUD?
Intrauterine devices (IUD) are small, T-shaped devices usually placed in the uterus to offer long-term protection against unwanted pregnancies.
Unlike other IUDs that use artificial hormones to prevent pregnancy, Paragard IUD is 100% hormone-free. Instead of hormones, the device uses copper. The copper lining produces an inflammatory reaction in the uterus that acts as a spermicide, preventing fertilization.
Paragard was approved for use in the United States in 1984, weighs less than one gram, and is approximately the height of a sugar packet.
Doctors carefully insert it into the cervical opening in a simple process that only takes a few minutes to complete. After placement, the patient is expected to go back to the hospital for a second visit to ensure the IUD is in the correct position. The second visit is usually one month after insertion.
According to the official Paragard website, the IUD is 99% effective at preventing unwanted pregnancy. The site also states that the device has fewer side effects than other birth control methods, and over 90% of women report complete satisfaction after using it.
However, conspicuously absent from the site is any mention of the potential side effects and complications that have led to Paragard lawsuits.
Potential Injuries from Paragard IUD
Based on FDA reports and several lawsuit filings, there are many types of injuries and health complications that may result from the use of Paragard IUD. They include:
- Perforation of the uterus.
- IUD embedded in the uterus.
- Device breakage requiring surgery.
- Migration of the IUD or part of it to other body organs leading to perforation and organ damage.
- Loss of reproductive health.
- Ectopic pregnancy.
- Copper wire left in the body may cause severe inflammation.
- Scarring
Furthermore, the findings of a study published in the American Journal of Obstetrics & Gynecology show that Paragard users may experience relatively higher expulsion rates and unwanted pregnancies compared to users of the other IUDs.
What Are the Grounds for Filing Paragard Lawsuits?
An IUD lawsuit would fall under a personal injury/tort realm of law. Product liability is a doctrine that gives plaintiffs a cause of action if they encounter a defective consumer item.
Generally, one aspect of product liability is the failure to warn, where a manufacturer does not adequately inform the public of the potential risks that may occur when their product is used.
Women filing Paragard lawsuits against Teva Pharmaceuticals claim that the company failed to provide sufficient warning about the possibility of Paragard IUD breakage. They also say that the manufacturer misrepresented the IUD as 100% safe and effective.
The latest prescribing information on the device’s package lists “device breakage” under the post-marketing events section but fails to reveal how often it occurs and the effects it causes.
It casually warns that “breakage of an embedded Paragard IUD during non-surgical removal is possible.”
Under the instructions for doctors on how to safely remove the IUD, it reads: “The threads may retract into the uterus or break.” It goes on to say that “The IUD can break or perforate the uterus.”
There have been several reports of Paragard breakage documented in different studies. In one of the studies, the researchers concluded that “although the safe and effective use of IUDs has been fully demonstrated in the U.S, the possibility of breakages needs to be fully recognized by clinicians and users.”
Plaintiffs also claim that Paragard has a manufacturing defect that causes its arms to break. The manufacturer doesn’t warn about the risks of breakages or inform clinicians on the best way to avoid potential breakages.
Is the Litigation Class Action?
Unfortunately, Paragard lawsuits litigation isn’t classified as a class action. Instead, these are individual personal injury claims filed against the manufacturer.
But since most of the Paragard lawsuits filed have similar complaints and facts against the IUD’s manufacturer, judges are consolidating them into multidistrict litigation to streamline the hearing process and make it less time-consuming.
However, each plaintiff in the MDL has their own Paragard IUD attorney and claim for unique injuries.
Has FDA Recalled Paragard IUD?
Despite several reports and lawsuits claiming the birth control device is defective and can cause a wide range of injuries, the FDA hasn’t issued a recall. The manufacturer hasn’t also issued a voluntary recall over the breakage issues.
However, the FDA issued the manufacturer with a warning letter in 2019 over false and misleading information contained in Paragard television ads.
“The television ad is highly misleading because it includes claims about the uses and benefits of your IUD but fails to include any essential risk information associated with the birth control device,” read the letter in part.
Have There Been Any Settlements Yet?
Unfortunately, Paragard IUD is still in its early stages, and there have been no settlements yet. No trials have been scheduled either.
In most cases, settlement talks begin after the first few lawsuits go into the trial stage. The first cases, usually referred to as “bellwether cases,” serve as a basis for informing both parties about the potential value of the cases.
However, in other IUD lawsuits, several women filed cases against Bayer, claiming that Mirena IUD moved around the body, causing severe injuries to other body organs. After numerous tussles, Bayer offered to settle approximately 4,600 lawsuits for about $12.2million.
Have You Suffered Paragard Breakage Injuries? You May Have a Valid Case!
Have you or your loved one received Paragard IUD for birth control and suffered any of the side effects we have highlighted in this post? If so, you may have a valid claim.
Talk to an experienced defective medical products attorney who will assess your condition and advise you on the next course of action.
Our attorneys are at the forefront of holding medical device manufacturers such as Teva Pharmaceuticals fully accountable for the harm their products cause.
Contact us today and let us help you find the justice you deserve.
