Paragard Lawsuit | Paragard IUD Lawsuits
- Last Updated: April 15th, 2024
Attorney Jessie Paluch, founder of TruLaw, has over 25 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.
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This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLaw and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.
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TruLaw does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us by using the chat on the bottom of this page. This article should not be taken as advice from an attorney.
Paragard lawsuits filed for women experiencing a break in the Paragard IUD birth control device during removal causing painful complications and removal surgery.
The Teva Paragard IUD birth control device has been linked to a defect which can cause the device to break during removal and embed in the uterus requiring a painful removal surgery.
Currently there are two FDA approved IUDs available in the U.S. today – the copper T-380A (Paragard) and the levonorgestrel intrauterine system (Mirena).
Both are now subjects of support groups and lawsuits filed by women that believe they should be removed from the market.
Although IUDs are the most widely used method of reversible contraception in the world today, women in the U.S. use them at smaller rates because of negative repercussions that started with the Dalkon Shield in the 1970’s.
The Dalkon Shield hit the market in the late 1960s and early 1970s and became known as a “veritable instrument of torture.”
The public learned very quickly that the Shield was not effective at birth control and it was dangerous.
The string that was supposed to be used in removal of the medical device deteriorated inside women’s bodies resulting in infections, sometimes deadly.
Although many argue that current medical devices face more regulation since the Dalkon Shield came to market prior to the regulation of medical devices in 1976.
This is simply not true.
Many medical devices on the market today, including Paragard, were able to avoid extensive clinical testing because they were grandfathered in through the 510(k) Clearance process.
The FDA 510(k) clearance process “lacks the legal basis to be a reliable premarket screen of safety and effectiveness” according to the Institute of Medicine (IOM).
Although IOM was appointed by the FDA in 2011 to tackle the important issue of patient safety, the recommendations that resulted have not been acted upon in any substantial way by the FDA.
For this reason, women must receive full information about the risks an IUD carries before they make important health decisions.
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Lawsuit Updates
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April 2024 Updates:
The lawsuit concerning the Paragard IUD is actively progressing, and our legal team is currently welcoming new clients.
Investigations have uncovered that the FDA was aware of issues regarding Paragard IUDs breaking as early as 2022.
A review conducted by the FDA at CooperSurgical’s production site in Buffalo, New York, resulted in a severely critical report from the Department of Health and Human Services.
Despite these findings, CooperSurgical has not addressed the increasing concerns over IUD breakages and mounting complaints linked to their Paragard product.
The FDA’s enforcement report outlines conditions or practices at the facility that may jeopardize the Paragard IUD’s safety and effectiveness.
The report specifically notes that the practices at the facility could produce products that are harmful to health or contaminated.
Approved in the United States since 1984, the Paragard IUD is promoted as a long-term, non-hormonal contraceptive option.
The information provided by Paragard does acknowledge risks of device breakage and complications during removal.
This recognition implies that the company is aware of potential integrity and performance issues with the device.
However, the provided information does not seem to fully reflect the scope of complaints and adverse events reported in recent years.
These revelations provide a strong foundation for legal action against CooperSurgical for not sufficiently addressing known risks and possibly misleading consumers about Paragard IUD’s safety.
Individuals who have suffered complications may have the opportunity to join the ongoing Paragard IUD lawsuits.
Contact us today for a complimentary consultation.
You may also use the chatbot on this page for a free case evaluation to determine if you qualify for the Paragard IUD lawsuit.
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April 2024 Updates:
The litigation concerning the Paragard IUD is currently active.
As per the latest updates from the Judicial Panel on Multidistrict Litigation (JPML), there are now 2,614 Paragard IUD Lawsuits awaiting decisions in the MDL, showing a growth of 44 cases since March 1st.
The Paragard IUD, designed for long-term contraceptive use within the uterus and does not contain hormones, has been associated with various adverse effects.
The allegations in these lawsuits primarily focus on the tendency of the device to fracture during removal, necessitating additional medical interventions, causing severe injuries, and leading to further health issues.
Due to the gravity of these potential injuries, those who have encountered issues with the Paragard IUD are advised to consult with legal counsel.
If you or someone close to you has suffered injuries from the Paragard IUD, consider reaching out for a complimentary consultation.
Additionally, for a private and free evaluation of your case, please make use of the chatbot available on this site.
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March 2024 Updates:
The Paragard Lawsuit is ongoing.
Paragard IUD lawsuits have increased by 126 in the last month.
The number of Paragard IUD lawsuits has risen from 2,444 filings in February to 2,570 filings in March, highlighting concerns of the device’s safety.
The Multidistrict Litigation (MDL) against Teva Pharmaceuticals focuses on allegations of device breakage during removal and insufficient warnings about risks.
Complications from the Paragard IUD device can include infections, organ injury, and the need for surgery to remove fragments.
Those affected by Paragard IUD complications are encouraged to explore legal options.
TruLaw offers free consultations and immediate feedback via the ChatBot on this page.
What is the Paragard IUD?
The Paragard IUD is marketed as a simple, safe, hormone free, and effective intrauterine device.
The T-shaped device is made of plastic and then wrapped with copper.
This long-term birth control device is placed in the uterus in minutes during a regular office visit to the doctor and is supposed to last for ten years.
Removal is marketed as a nonsurgical procedure done in just a few minutes during an office visit.
According to the manufacturer, the copper in Paragard interferes with sperm so that it does not reach the egg.
At over 99% effective, Teva claims Paragard prevents pregnancies as well as sterilization.
But, according to a Facebook group with more than 11,000 members, complications due to copper toxicity and breakage of the device happen more frequently than Teva warns women.
According to this Facebook page, the side effects of this medical product are not worth it – these prior users are warning other women, when it comes to Paragard – “Don’t get one”
Paragard Lawsuits Filed
Teva Pharmaceuticals USA Inc, the manufacturer of Paragard, is currently facing lawsuits alleging that it inadequately warned that its Paragard intrauterine contraceptive device could break during removal.
According to the Paragard lawsuit, the break during removal can lead to a painful removal surgery when the device ultimately embeds in the uterus.
Paragard lawsuits allege that Teva put women at risk as a result of a defect in the device. Teva continues to risk our reproductive health by not warning women of this risk.
Was Teva Warned of the Risk of Paragard Complications?
According to Paragard lawsuits, Teva knew that Paragard can and does cause serious harm to individuals who use it through undetected breakage while implanted or breakage while being removed.
Further, Teva knew of the risk from the trials they performed and post-marketing experience and complaint but took no action to adequately warn women of these dangers.
In 2015, the Open Journal of Clinical & Medical Case Reports published a study of physicians within a three-year time frame in a single gynecological practice in Chicago.
This study found seven issues over the course of three years with all but one requiring hysteroscopic removal of the IUD’s arm. One 28-year old client was unable to completely remove the broken arm, despite the use of operating room procedures.
This Chicago study suggested that, while still rare, the complications from Paragard are under reported.
Furthermore, this study found that broken IUDs present a unique challenge to practitioners because the blind removal anticipated by the manufacturer is not possible.
Studies and real-life events shared on the Facebook page similarly show that even when women follow all of the proper procedures, attempts to remove the IUD intact by pulling the threads, can be unsuccessful and may result in serious side-effects.
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With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three. She spent the first decade of her career working as an international tax attorney at Deloitte.
In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.
In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!
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