Paragard IUD Lawsuit
Were you diagnosed with pain, discomfort, or medical condition associated with your intrauterine device (IUD)? Did you experience IUD migration or perforation requiring a hysterectomy or laparotomy?
At Rosenfeld Injury Lawyers, LLC, our personal injury attorneys represent injured patients who have suffered a preventable medical condition caused by the doctor's negligence. In addition, our Paragard law firm provides legal representation for victims harmed by Paragard's defective medical devices.
Call our Chicago defective medical device lawyers at (888) 424-5757 (toll-free phone number) or use the contact form today to schedule a free consultation. All confidential or sensitive information you share with your Paragard lawyer remains private through an attorney-client relationship.
Paragard IUD Complications
Paragard is an intrauterine device or coil that uses copper wire rather than hormones to prevent pregnancy. Doctors implant the T-shaped plastic device into the uterus. It can prevent pregnancy for a decade.
The FDA (US Food and Drug Administration) approved the Paragard IUD in 1984. Since then, numerous women across the country have used it. Cooper Surgical shows the intrauterine coil has been effective and safe for over 30 years.
The product's website mentions that the Paragard IUD device is over 99% effective at preventing pregnancy and has fewer adverse effects than other intrauterine devices. Plus, 90% of the women are satisfied with this contraceptive device preventing pregnancy.
However, many women complain that Paragard IUD fractured inside them while the coil was removed, rendering the birth control ineffective, leading to injuries.
Paragard lawsuits claim the manufacturers, including Teva Pharmaceuticals, were already aware of these risks and continued to release defective medical contraceptive devices. Still, they did not warn the patients or the healthcare providers adequately.
Claims In Paragard IUD Lawsuits
In their Paragard lawsuits, plaintiffs claim the following:
- The medical intrauterine coil device has design and manufacturing defects
- The manufacturers haven't labeled the contraceptive device adequately to warn patients and doctors about potential risks
- The manufacturers, including Teva Pharmaceuticals USA INC, are negligent
Paragard MDL Lawsuits: IUD Contraceptive Device Serious Complications Cases - Updated January 2023
The litigation has not resulted in a Paragard class action lawsuit or mass tort. Instead, each plaintiff's Paragard lawsuit is a separate cause of action, combined in multidistrict litigation or MDL.
A Paragard class action would result in one compensation or settlement divided amongst all the plaintiffs. In contrast, an MDL allows each Paragard IUD lawsuit to be heard and each plaintiff to be awarded individually.
The Benefits of Paragard Class Action MDL
Several cases from all over the country were consolidated in the Northern District of Georgia federal court in December 2020 into a Paragard MDL under Judge Leigh Martin May – Re: Paragard IUD Products Liability Litigation (MDL 2974).
Consolidating multiple similar copper IUD lawsuits into one court heard by Paragard MDL Judge Leigh Martin May can ensure plaintiffs can obtain justice more quickly and efficiently than if they were to pursue each case independently.
Bellwether Trial Verdicts Set Compensation in Future Paragard Settlements
In this case, those harmed by using Paragard IUDs will be able to pursue compensation for medical bills, lost wages, pain and suffering, and other damages associated with the injuries they’ve incurred. It’s especially important as many of these individuals may not have had sufficient resources or access to counsel to pursue their claims independently after the suffered complications from using the defective IUD form of birth control.
The MDL also takes a significant burden off of the judiciary by organizing complex litigation more efficiently for lawyers and judges alike. Through pre-trial preparation, such as document exchanges and depositions, parties can work through many issues before the first Paragard bellwether trial begins – saving time and reducing costs.
At this stage in the litigation process, we can only watch as events unfold in our courts system – hoping that justice will prevail for those affected by Paragard IUDs through this multi-district litigation (MDL).
Paragard Lawsuit Update 2023: New Paragard Lawsuits Recently Filed
Paragard MDL continues as the number of cases grows. Nearly 50 Paragard IUD defect lawsuits have been added. The new Paragard lawsuits has increased the total number of claims to 1,577 as of mid-January 2023.
In early January 2023, the 2022 FDA Adverse Event Report Database year-end update had an added 934 complains, which was more than three times the number of reports submitted just two years earlier. The increasing rate suggests the number of Paragard lawsuits for 2023 will grow significantly higher and at a faster rate than anytime in the past.
In July 1, 2022, parties were still discussing details for the plaintiff fact sheets and objections to a discovery request. The bellwether trials were not scheduled, nor were the plaintiff fact sheets finalized. Bellwether trials are test cases used to determine the feasibility and value of individual lawsuits.
Currently, Paragard IUD lawsuit attorneys hold the company liable for the damage and injuries caused to plaintiffs from Paragard IUD. However, according to attorneys, the company was fully aware of the damages resulting from Paragard during the removal process.
The Dangers of Paragard
Teva Pharmaceuticals ignored the risks or deliberately downplayed them. Attorneys claim that Teva learned about the dangers of Paragard through medical product safety network data and post-marketing experience. However, they never warned the doctors or women about the risks associated with the defective device.
Hire an attorney if you or a close relative are a victim of Paragard. With no Paragard class action lawsuit or mass tort after bellwether trials against the company, attorneys individually represent each client in pending Paragard IUD lawsuits.
The Judicial Panel on Multidistrict Litigation (JPML) has consolidated some Paragard cases in a Paragard MDL (multidistrict litigation) resulting from:
- Device breakage issue
- Organ damage
- Uterus perforation
- Internal bleeding
- Uterus migration
- Copper toxicity
- Broken IUD pieces
- Other adverse effects involve numerous complications and pending recalls
Injuries In Paragard Lawsuits
The significant injuries from the IUD allegedly occur when the device is removed, fracturing upon removal, causing many health concerns.
According to Cooper Surgical, the removal of Paragard is a non-surgical process. Thus, the healthcare provider removes the device during a routine visit from the women’s body in a few minutes.
During Paragard removal, the device's arms should fold up per the company's information. However, the Paragard lawsuits claim flexible plastic device breakage during removal, resulting in broken pieces, such as the arms of the intrauterine coil remain inside the victims' bodies.
As a result, some women have surgeries to remove the broken pieces of the device. Here are the injuries sustained by the plaintiffs, as per most Paragard lawsuits:
- Irremovable broken fragments of the intrauterine coil
- Pain & discomfort
- Injury infections
- Intrauterine coil migration inside the body
- Surgery, like a laparotomy or hysterectomy, was necessary
- Paragard pieces lodged inside organs
- Allergic reactions to the broken pieces
Paragard IUD has dangerous side effects that last for the first two or three months of implantation. However, some severe side effects are long-lasting and require medical attention. Here are some of the reported adverse effects:
- Allergic reactions
- Menstrual cramps
- Spotting between periods
- Vaginal discharge
- Perforated uterine wall
- Pelvic inflammation disease
- Heavier and longer periods
- Pain during sex
Is There a Lawsuit Against Paragard Medical Devices?
There are 1,195 Paragard lawsuits from different law firms filed by affected women against Cooper Surgical and Teva, with almost 200 new Paragard IUD lawsuits filed since May 15. Most cases argue that the company knew about the dangers associated with the device. Still, they continued to manufacture and sell the intrauterine coil.
Carley Tredway received her Paragard implantation in 2008 and went to the doctor ten years later to get the IUD removed. Unfortunately, one of the IUD's arms broke off during removal.
The doctor had to perform a surgical removal as a hysterectomy to retrieve the missing arm from Tredway's body.
Her Paragard lawsuit claimed, "Before her procedures, the plaintiff and her doctors were not warned by the defendants of the Paragard IUD risks such as failure and injury. In addition, they were not notified of the Paragard IUD removal risks, yet the defendants were privy to this information."
Georgia Bowers received a Paragard implant in January 2017. In September of the same year, she went to her doctor to get the device removed. The ultrasound showed that the device had dislodged.
The doctor followed the instructions provided by the company for removing the IUD, but the device was only partially removed, with one arm remaining inside her body.
The doctor tried to retrieve it through colposcopy. However, he was not successful in the process.
Bowers' Paragard lawsuit claimed, "At all relevant times, the Teva Defendants knew of the adverse effects associated with Paragard IUD, including device breakage. Despite this knowledge, the [Teva] defendants continued to manufacture, market, distribute, sell, and profit from sales of Paragard IUD."
Paragard FDA (US Food and Drug Administration) Complaints
The FDA has received over 1,600 complaints of the Paragard breaking since 2010. Here are a few samples from the medical records of Paragard victims:
- In one report, the woman was scheduled for an IUD removal from her uterine cavity after 6.5 years. However, when the doctor removed the Paragard, it was missing both arms. A sonogram showed both coil arms stuck in the woman's myometrium (uterine tissue).
- A hospital medical records reported four Paragard IUD removal incidents in which the device came out fractured in 2014. In three of these incidents, the devices were within their lifespans.
- A woman reported cramping and got her Paragard IUD removed. However, no IUD arms were attached when the device was removed from her uterine cavity, leading to her Paragard injuries.
- A woman went in for her Paragard IUD removal after 8.5 years. When the doctors removed the device, the copper coil was found missing.
- In a 2015 report, the copper coil from the intrauterine coil was missing when removed from a patient.
Non-surgical procedures allowed for resolving some Paragard issues, many others had to undergo invasive surgery to remove the broken pieces from their body.
Is There a Recall on Paragard IUD Devices?
There is no recall on Paragard IUD, and the copper IUD device is still being manufactured and sold in the market. However, according to an FDA report, Teva only recalled two Paragard lots in 2014 on claims of failing to prevent pregnancies.
Legal Grounds for A Paragard Lawsuit For Intrauterine Contraceptive
Victims harmed by Paragard IUDs can file a Paragard lawsuit against the device manufacturer by claiming:
- Design Defect: The design of the Paragard IUD is such that even with all due care, the product will cause serious injuries and other complications because it is defective.
- Paragard IUD manufacturing defect: When Tevo created the device, they failed to include important information about the dangers associated with the Paragard device.
- Breach of express warranty: If the company promised that Paragard would be effective, safe, and non-harmful to users (they can sue under an express or implied warranty claim).
- Failure to provide adequate warnings: Possible side effects and risks associated with the use of the device (a defective product liability claim) were not disclosed.
- Manufacturer negligence: The company failed to provide reasonable instructions and warnings about side effects associated with using the Paragard device.
A Defective Design
A lawyer representing the injured victim can file a Paragard IUD lawsuit against the manufacturer based on their defective design under strict liability/product liability standards.
The manufacturer is legally responsible for any damages, injuries, or losses associated with their defective product if:
- The product was in the condition they sold it when the injury occurred or altered through normal wear and tear.
- It is the design of the Paragard IUD that causes injuries or other dangers to women.
- Defendants fail to warn consumers about their potential side effects. In this incident, the manufacturer did not provide sufficient instructions and warnings about the side effects associated with the use of their product.
Manufacturer's Deceptive or Misleading Marketing Promises
Another way a victim can receive justice from Paragard is through a deceptive marketing case, where they can sue for:
- Deceptive advertising: The medical device manufacturers' advertisements tricked her and other women into believing that Paragard would be effective, safe, and non-harmful to them.
- Misleading labeling: The FDA requires that all prescriptions, dangerous drugs, and over-the-counter drugs must have label warnings about potential side effects associated with their use. Paragard did not include appropriate instructions or warnings about its side effects on the product's label.
- A failure to warn claim: Under the federal law known as the Federal Food, Drug and Cosmetic Act (FDC Act), every prescription drug sold in the United States must have instructions or warnings about potential side effects associated with its use.
- Negligence: Under civil tort law, a Paragard lawsuit involving severe injuries can fall under negligence involving four elements:
- A duty of care to keep customers from harm.
- Dangerous conduct by the manufacturer that caused an injury.
- Proximate cause between their harmful behavior and the victim's injuries or losses. To determine this amount, Paragard lawyers will check if the manufacturer had a direct relationship with the person who suffered damages/injuries and whether it was foreseeable for them to cause harm.
- Causation between the manufacturer’s conduct and the injury or loss. Usually, causation means they must have acted with negligence, recklessness, or disregard for other people's safety and well-being, ultimately leading to a Paragard injury.
The Dangers of Paragard IUDs
Centers for Disease Control and Prevention's conclusion in 2009 indicated that Paragard pregnancy prevention is associated with many side effects and dangers, including:
- Perforation of the uterus, fallopian tubes, or cervix
- Pelvic inflammatory disease (PID) (the most common sexually transmitted infection in women) damages reproductive organs. Many victims suffer pain, permanent damage, and infertility
- Miscarriage or premature delivery in pregnant women
- Ectopic pregnancy (where the embryo does not form in the uterus but in the fallopian tubes, ovaries, or elsewhere)
- Abscesses and pelvic inflammatory disease of other organs such as bladder, bowel, vagina, and cervix
- Organ perforation/puncture occurs
- Severe abdominal pain/cramps
- Infection increases the risk of ectopic pregnancy
In a review published in the American Journal Health-System Pharmacy in May 2008, the removal rate for Paragard IUD that failed to prevent women from getting pregnant was 12.3 per 1,000 women. The report further states:
"The risk of pregnancy after the failure of a contraceptive device is not only an inconvenience; unintended pregnancies can lead to serious medical and social consequences such as anemia, endometritis (inflammation of the lining of the uterus), preterm birth, low-birth-weight infants, spontaneous abortion, and fetal death."
In May 2014, a report by Cosmopolitan revealed that an estimated one in four women who use the intrauterine coil as contraception methods experience some side effects.
These adverse effects could include deep vein thrombosis (DVT) or pulmonary embolism (PE), ectopic pregnancy, spontaneous abortion, pelvis inflammatory disease (PID), or uterine perforation.
The report also revealed that 40% of women who use Paragard IUDs for contraception experience side effects. The side effects include cramps, heavier periods, and bleeding that lasts longer than their usual time.
ParaGard Lawsuit FAQs
Our Paragard IUD lawyers understand that many families have unanswered questions about filing a Paragard lawsuit against the manufacturer or doctor for their damages. A personal injury lawyer has answered some of those questions below.
Call our Rosenfeld law office and speak to a Paragard lawyer today at (888) 424-5757 (toll-free phone call) for a free case review. We specialize in Paragard cases.
When Should Paragard IUD Lawsuits Be Filed?
Filing a Paragard IUD lawsuit is available if you experienced complications if the birth control device fragmented as a health professional removed it. When your doctor conducts an ultrasound, they will determine where the broken fragment of the intrauterine coil is inside your body.
There is no Paragard class action lawsuit; however, the JPML opened multidistrict litigation has been filed in the Northern District of Georgia in December 2020, consolidating many Paragard lawsuits.
As personal injury lawyers, we can file your Paragard lawsuit directly into the MDL and gain economic justice on behalf of injured victims. Contact our Paragard lawyers today to schedule a free consultation.
Are Other IUD Devices Safe?
While Paragard has come to the limelight in the past few years, it's not the only unsafe medical device on the market. Mirena is another IUD manufactured by Bayer that has garnered around 50,000 complaints since its approval by the FDA in 2000.
Some reports claimed that the T-shaped device was displaced from the position where it was implanted and caused perforations in other organs, such as the uterus or the fallopian tubes.
Moreover, the device generated a brain condition called pseudotumor cerebri. However, Paragard does not have any neurological effects on the body. Instead, its danger lies in its removal process, as it can fracture the body, leaving pieces behind and resulting in surgery.
In recent cases, over 2,700 Mirena users claim that the device caused pseudotumor cerebri ("false brain tumor") from poor absorption or buildup of cerebrospinal fluid (CSF). Over 4,600 Mirena lawsuits have already been resolved, where victims have received more than $12 million for medical expenses, pain and suffering.
What Amount Can I Get in a Paragard Settlement?
It is hard to determine how much Teva Pharmaceuticals will have to pay as compensation. However, the settlements were substantial in prior mass tort cases such as Mirena's, another case of an IUD (intrauterine coil or device) causing complications and risk.
In the Mirena IUD litigation, the pharmaceutical company, Bayer, paid $12.2 million in settlements in 2017 after 2,700 women sued the company over the adverse events regarding Mirena usage.
It also depends on whether a global Paragard settlement is reached in the MDL, resulting in Paragard lawsuits ranked into levels according to the severity of the plaintiff's injuries.
The first settlement level is plaintiffs who suffered permanent, life-altering injuries when the Paragard intrauterine coil device (IUD) broke, such as permanent infertility or severe infections. The second and third settlement levels are plaintiffs who only suffered pain and discomfort, with no permanent injury.
The settlement range levels are as follows, bearing in mind that these predicted settlement numbers are completely speculative:
- Level 1: $100,000 - $200,000
- Level 2: $25,000 - $75,000
- Level 3: Under $25,000
Why Is Paragard Bad?
Paragard is dangerous because it poses complications when removing the intrauterine coil device. Many IUD lawsuits against the company have been filed due to a Paragard IUD failure when broken pieces of the defective intrauterine contraceptive lodge into the surrounding organs during removal.
The company making Paragard continues to manufacture and sell it in the market despite thousands of complaints about the IUD, with no expectancy of a Paragard recall.
Has a Paragard Class Action Lawsuit Been Filed Because the IUD Breaks Unexpectedly, Requiring Revision Surgery?
Paragard class action MDL (multidistric litigation ) has been brought against Teva Pharmaceuticals and Cooper Surgical, Inc., alleging that an IUD break can occur during the entire device removal, potentially resulting in pain, infection, and costly revision surgery.
The Paragard class action lawsuit claims that the defendants did not adequately warn consumers of the potential risks involved with using the Paragard IUD device. The Paragard MDL documents allege that when this device breaks during removal it can cause serious medical complications or require additional invasive surgery to correct.
The complaint further alleges that the defendants failed to disclose these potential risks in their marketing efforts or product labeling. Furthermore, they are accused of misleading consumers into believing that the Paragard IUD was a safe and effective form of contraception when it may have caused them significant harm.
Hire a Personal Injury Attorney to Resolve Your Paragard Injury Compensation Case
Are you a Paragard victim suffering injuries from the copper intrauterine coil device recall by the FDA? Do you need to file an IUD lawsuit or participate in a class-action suit?
At Rosenfeld Injury Lawyers, LLC, our Paragard attorneys fight aggressively for our clients to ensure they receive maximum financial compensation for their damages, medical bills, and other losses. Call our law firm today at (888) 424-5757 (toll-free number) or use the contact form for a free case review to discuss filing a Paragard lawsuit.
Our law office accepts all new Paragard IUD lawsuits and wrongful death cases against Teva Pharmaceutics through a contingency fee agreement. You'll only pay us if we secure your compensation.