Paragard Lawsuit: A Comprehensive Guide (2024)

What Is a Paragard Lawsuit? (2024)

A Paragard lawsuit is a type of product liability claim, and it targets a company called Teva Pharmaceuticals. There are thousands of active lawsuits of this nature, and plaintiffs are seeking compensation for alleged injuries caused by a copper IUD manufactured by Teva. To achieve success in these product liability claims, plaintiffs generally need to establish several factors:

• The Paragard IUD was defective

• Teva Pharmaceuticals was aware or should have been aware of these defects

• Teva Pharmaceuticals breached their duty of care to consumers

• Teva failed to warn consumers of the risks posed by Paragard

• The plaintiffs suffered legitimate injuries

To fully understand this controversy, it is necessary to review the history of Paragard. The first Paragard model was developed in the 1970s by a company called Finishing Enterprises Inc. (FEI), which subsequently began manufacturing and selling the device in the United States during the 1980s. Various other companies acquired the rights to sell and manufacture Paragard over the next few decades, and in 2008 a company called Teva Pharmaceutical Industries Ltd. took over. Over the next nine years, Teva worked with CooperSurgical to manufacture and sell the device to countless American women. Although companies have been manufacturing Paragard devices in the United States for decades, mass injuries and recalls only occurred after Teva became involved in the manufacturing process.

By 2014, Teva was forced to recall two batches of Paragard devices that were not fully sterile. Two years later, a Nebraska woman claimed that her device broke apart during the removal process – leaving pieces of copper trapped within her uterus. She was the first of many to sue Teva Pharmaceuticals for this type of injury. Over the next few years, thousands of other women came forward with similar stories, and Teva now faces about 2,500 lawsuits from plaintiffs claiming that the company failed to warn them about the risk of breakage. Faced with excessive debt and countless unresolved lawsuits, Teva completely backed out of the IUD industry and sold the rights to Paragard for $1.1 billion.

To this day, many women are still unable to remove pieces of copper from their bodies after attempting to remove their Paragard devices. While some women have successfully extracted these fragments via surgical procedures, others may need to live with this issue for the rest of their lives. Some plaintiffs may lack the funds to pay for expensive surgical procedures, while others may avoid surgery due to various risks. Even if surgery is successful in removing Paragard fragments, these procedures are traumatic and painful. A common technique for removing broken Paragard pieces is a hysterectomy – an invasive procedure associated with chronic levels of pain.

Paragard lawsuits are proceeding, and they have consolidated in multi-district litigation (MDL) courts. A “bellwether trial” will soon commence, and this will help determine the pathway to justice for thousands of injured women. In general, the purpose of a bellwether trial is to assess a controversial, disputed legal issue. Paragard lawsuits in the past have been dismissed due to Teva’s assertion that they adequately warned consumers of the risks. However, mounting legal pressure and worrying investigations cast doubt upon the viability of this defense strategy. If you have suffered an injury due to a Paragard device, you may have the ability to join this legal process. Contact ConsumerShield to learn more about joining a Paragard lawsuit.

The goal of every Paragard Lawsuit is to facilitate compensation for plaintiffs. Compensation levels depend on the damages of each woman, and these losses can vary. Perhaps the most obvious issue plaintiffs struggle with is the cost of their medical treatments. According to a National Institutes of Health paper from 2012, robotic hysterectomies can cost almost $50,000. The average cost of a vaginal hysterectomy is about $32,000. In addition to medical expenses, plaintiffs may claim damages such as missed wages, pain & suffering, and emotional distress.

What are Paragard's Side Effects? (2024)

Internal copper fragments pose a serious risk to women. These sharp foreign objects can lacerate internal organs – including those responsible for reproduction. This could potentially leave a woman infertile. Women who conceive with internal Paragard fragments have reported ectopic pregnancies – a potentially life-threatening issue. In some cases, fragments have migrated to different parts of the body, putting vital organs at risk. The many thousands of active Paragard lawsuits detail a wide range of symptoms, complications, and injuries, including:

• Excessive bleeding

• Damage to internal organs

• Pelvic inflammatory disease (PID)

• Punctures or lacerations of the uterine wall or cavity

• Perforated cervix

• Complications with pregnancy, fertility, and birth

• Infections

• Chronic and severe levels of pain

• Pseudotumor cerebri (PTC)

• Fetal fatalities

• Fatal injuries

• Allergic reactions

• Hysterectomies

• Laparoscopies

• Laparotomies

Copper toxicity is another major concern associated with defective Paragard devices. Also known as copperiedus, this is a legitimate medical illness that can cause various issues. These include:

• Severe headaches

• High fevers

• Loss of consciousness

• Excessive vomiting of blood

• Chronic abdominal pain

• Depression

• Mood disorders

• Diarrhea

• Kidney failure

• Anemia

• Chills

• Convulsions

• Early-onset dementia

• Speech problems

• Liver failure

• Heart failure

• Brain damage

Many of these issues are associated with long-term copper poisoning. Although many women have inserted their Paragard devices fairly recently, these copper poisoning symptoms could theoretically begin to manifest if IUD fragments remain embedded for the foreseeable future. Paragard lawsuits seek compensation not only for current medical issues, but also costly, serious ailments that plaintiffs may develop over the next few decades.

In 2021, the award-winning news series Spotlight on America launched an investigation into Paragard injuries. As a result, investigative journalists discovered thousands of documented cases of Paragard devices breaking apart inside women’s bodies. Journalists also documented countless, serious health complications associated with Paragard. Many of these women reported their injuries to the Adverse Event Reporting System of the Food and Drug Administration (FDA).

It is not clear why Paragard devices are still available in the United States. Putting aside the countless reports of injuries, the FDA is supposed to enforce strict regulations on pharmaceutical advertisements – particularly when it comes to communicating risks, side effects, and contraindications. In many of Paragard’s advertisements, warnings about breakage and copper toxicity are completely absent.

How Many People are Affected by Paragard Issues?

The Paragard lawsuit has garnered significant attention due to the breadth of its potential impact. As an FDA-approved contraceptive option available since 1984, Paragard has been a choice for millions of women seeking a long-term, non-hormonal birth control method.

However, the exact number of affected individuals can be broken down into several categories:

Reported Incidents

While it's challenging to pinpoint an exact number of complications directly attributable to Paragard, thousands of adverse event reports have been submitted to the FDA concerning the device. These reports range from device fracture to more severe complications like organ perforation.

Legal Claims

As awareness of the potential complications associated with Paragard has grown, so too has the number of legal claims. Hundreds, potentially even thousands, of women have either filed lawsuits or are in the process of doing so, alleging harm from the device.

Potential Future Claims

Given the widespread use of Paragard over several decades, it's plausible that many affected individuals are yet to come forward, either because they haven't connected their complications to the device or are unaware of the ongoing lawsuit. As publicity around the Paragard lawsuit continues to grow, the number of claimants might rise significantly.

Medical Professionals

This lawsuit doesn't just affect the patients; medical professionals who have recommended or inserted the Paragard IUD may also feel the repercussions. They might face questions and concerns from current patients, reconsider their device recommendations, and even potentially become involved in the legal processes if they treated patients who experienced complications.

General Public Perception

Beyond the direct victims, the broader public's trust in medical devices and the processes that approve and monitor them can be impacted by large-scale lawsuits like the Paragard case. Such controversies often ignite discussions about the balance between innovation, regulation, and patient safety.

In essence, while the direct number of individuals experiencing complications from Paragard might be in the thousands, the ripple effects of the lawsuit touch many more lives. Medical professionals, legal practitioners, researchers, and anyone with a vested interest in public health should keep a close eye on the developments of the Paragard IUD lawsuit.