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 attorneys provide legal representation for victims harmed by Paragard defective medical devices.
Call our Chicago defective medical device attorneys at (888) 424-5757 (toll-free phone number) or use the contact form today to schedule a free consultation and free case review. All confidential or sensitive information you share remains private through an attorney-client relationship.
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 device preventing pregnancy.
However, many women complain that Paragard IUD fractured inside them while the coil was removed, leading to injuries. Paragard lawsuits claim the manufacturers, including Teva Pharmaceuticals, were already aware of these risks and continued to release defective medical 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 device adequately to warn patients and doctors about potential risks
- The manufacturers, including Teva Pharmaceuticals USA INC, are negligent
Paragard MDL Lawsuits: IUD Birth Control Serious Complications Cases - Update July 2022
The litigation has not resulted in a Paragard class action lawsuit or mass tort. Instead, each plaintiff's Paraguard 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 case to be heard and each plaintiff to be awarded individually.
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).
The MDL has grown in numbers, and from May 15 to June 15, 2022, 177 new Paragard IUD lawsuits were added to or filed in the Paragard MDL, bringing the total to 1,195 Paragard cases.
As of 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 are 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 from personal injury law firms 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.
They 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 against the company, attorneys individually represent each client in pending Paragard IUD lawsuits.
- 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 in a routine visit from the women’s body in a few minutes.
During removal, the device's arms should fold up per the company's information. However, the ParaGard lawsuits claim a ParaGard IUD break during removal, resulting in broken pieces, such as the arms of the intrauterine coil remaining 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
Apart from this, 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 Pharmaceuticals] 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 a Paragard 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 Paragard IUD was removed from her uterine cavity.
- 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.
While non-surgical ways allowed for resolving some Paragard issues, many others had to undergo invasive surgery to remove the broken pieces and pieces from the body.
Is There a Recall on Paragard IUD Medical 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 new Paragard lawsuits 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 civil 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. ParaGard does not include adequate information about possible complications arising from its use.
- Negligence: Under civil tort law, ParaGard lawsuits involving severe injuries can fall under negligence involving four elements as follows:
- 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, 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 conduct of the manufacturer 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 that ultimately led to ParaGard's 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
- Perforation pelvic inflammatory disease
- 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 to fall pregnant was 12.3 per 1000 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, pelvic inflammatory disease (PID), or uterine perforation.
The report also revealed that 40% of women who use 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 or use the contact form for additional information.
Why Is Paragard Being Sued?
Teva Pharmaceuticals is facing Paragard lawsuits because of the dangers associated with Paragard contraceptive coil while being removed.
Many women have suffered side effects and injuries due to Paragard removal when the arms of the Paragard break off. Some even had to undergo surgical procedures to remove the broken pieces of the defective Paragard intrauterine coil from their bodies.
When Should Paragard IUD Lawsuits Be Filed?
You should file a Paragard IUD lawsuit 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 in the Northern District of Georgia in December 2020.
As personal injury lawyers, we can file new Paragard lawsuits directly into the MDL and gain economic justice on behalf of Paragard victims. Contact our Paragard lawyers today to schedule a free consultation.
Are Other IUD Medical 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 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 in the body, leaving pieces behind, resulting in surgery.
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 a copper IUD (intrauterine coil or device) causing complications and risk.
In the Mirena IUD devices 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 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. There are many IUD lawsuits against the company because the broken pieces of the defective intrauterine contraceptive lodged 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.
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 a civil lawsuit or participate in a Paragard class-action suit?
At Rosenfeld Injury Lawyers, our Paragard attorneys fight aggressively for our clients to ensure they receive maximum financial compensation for their damages. Call our law firm today at (888) 424-5757 (toll-free number) or use the contact form for a free case review to file a Paragard lawsuit. We are available 24/7.
Our law office accepts all personal injury cases and wrongful death lawsuits through a contingency fee agreement. This promise ensures you pay nothing until your legal issue is resolved through a negotiated settlement or jury award. After that, you'll only pay us if we secure your compensation.