Paragard Lawsuit Lawyers
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 gynecological injury attorneys provide legal representation for victims harmed by defective medical devices, including intrauterine devices.
Call our 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 remains private through an attorney-client relationship.
Paragard is an intrauterine device 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 device is effective and safe for over 30 years.
The product's website mentions that Paragard is over 99% effective at birth control and has fewer adverse effects than other intrauterine devices. Plus, 90% of the women are satisfied with this birth control device.
However, many women complain that Paragard breaks inside them during the removal process, leading to injuries. Paragard lawsuits claim the manufacturers, including Teva Pharmaceuticals, were already aware of these risks. Still, they did not warn the patients or the healthcare providers adequately.
Claims in Paragard Lawsuit
In their Paragard birth control lawsuits, plaintiffs claim the following:
- The intrauterine medical 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, are negligent
Paragard IUD Lawsuit: Hundreds of IUD Birth Control Serious Complications Cases Filed [2021 Update]
The Paragard litigation is not a class-action lawsuit. Instead, each plaintiff's lawsuit is a separate cause of action. However, several cases from all over the country were consolidated in the Northern District of Georgia in December 2020.
Currently, lawyers 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.
If you or a close relative is a Paragard's victim, hire an attorney. Currently, there is no ParaGard class-action lawsuit against the company. Therefore, all clients are represented individually by their attorneys.
However, the Judicial Panel on Multidistrict Litigation (JPML) has consolidated some ParaGard lawsuits resulting from:
- Device breakage issue
- Organ damage
- Uterus perforation
- Internal bleeding
- Uterus migration
- Copper toxicity
- Broken IUD pieces
- Other adverse effects involving numerous complications and pending recalls
Injuries in Paragard Birth Control Lawsuits
The significant injuries resulting from the IUD allegedly occur when the device is removed. In addition, it breaks up 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 person's body in a few minutes.
During removal, the device's arms should fold up as per the company's information. However, the ParaGard lawsuits claim that the birth control device breaks during the removal process. Therefore, broken pieces of the IUD remain inside the victims' bodies.
As a result, some women have undergone surgeries to remove the broken bits of the device. Here are the injuries sustained by the plaintiffs, as per most IUD lawsuits:
- Irremovable broken IUD bits
- Pain & discomfort
- Injury infections
- IUD migration inside the body
- Surgery, like a laparotomy or hysterectomy, was necessary
- IUD bits 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?
To date, many lawsuits have been filed by affected women against Cooper Surgical and Teva. Most lawsuits argue that the company knew about the dangers associated with the device. Still, they continued to manufacture and sell the IUD.
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 the removal process.
The doctor had to perform a hysterectomy to remove 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. In an ultrasound, it was found 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. One arm remained inside the 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 Complaints to the FDA (US Food and Drug Administration)
The FDA has received over 1,600 complaints of the IUD breaking since 2010. Here are a few samples:
In one report, the woman was scheduled for a Paragard removal in the uterus after 6.5 years. However, when the doctor removed the IUD, it was missing both arms. A sonogram showed that the arms were stuck in the myometrium, which is the uterine tissue, of the woman.
Likewise, a hospital reported four Paragard 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 IUD removed. However, when the Paragard IUD was removed from her uterus, no device arms were attached.
A woman went in for her Paragard IUD removal after 8.5 years. The doctors saw that the copper coil was missing from the birth control device when it was removed.
In a 2015 report, the copper coil from the IUD was missing when removed from a patient.
While the issues could be resolved in some women through non-surgical ways, many others had to undergo invasive surgery to remove the broken bits and pieces from the body.
Is There a Recall on Paragard IUD Medical Devices?
There is no recall on Paragard IUD, and the device is still being manufactured and sold in the market. However, Teva Pharmaceuticals only recalled two Paragard lots in 2014 on claims of failing to prevent pregnancies as per an FDA report.
Legal Grounds for a ParaGard IUD Lawsuit
Victims harmed by the ParaGard IUD medical device can file a lawsuit against the device manufacturer by claiming:
- Design Defect: The design of 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 Teva Pharmaceuticals 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 about possible side effects and risks associated with the use of the device (a defective product liability claim)
- Manufacturer negligence: The company failed to provide reasonable instructions and warnings about side effects associated with the use of 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 Paragard IUD that causes injuries or other dangers to women.
It's not only defective products that cause such harm, and the 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 get 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 will 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 that could arise 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 cushion 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, 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 conclusion in 2009 indicated that the Paragard device 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 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 increasing 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 pregnancy 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 conducted by Cosmopolitan revealed that an estimated one in four women who use IUD as contraception methods experience some form of 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 methods experience side effects. The side effects include cramps, heavier periods, and bleeding that lasts longer than their usual time.
ParaGard Lawsuit FAQs
Our law firm understands 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 law office today at (888) 424-5757 (toll-free phone call) or use the contact form for additional information.
Why Is Paragard Being Sued?
Teva Pharmaceuticals is facing lawsuits because of the dangers associated with Paragard during the removal process.
A considerable number of women have suffered side effects and injuries due to Paragard removal. Some even had to undergo surgical procedures to get the broken bits and pieces of the defective medical device removed from their bodies.
When Should I File a Paragard IUD Lawsuit?
You should file a Paragard IUD lawsuit if you experience any complications or dangers during the birth control device removal process. When your doctor conducts an ultrasound, they will determine where the broken bit of the IUD is inside your body.
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 in the market. Mirena is another IUD manufactured by Bayer that 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 was associated with generating a brain condition called pseudotumor cerebri. However, Paragard does not have any neurological effects on the body. Instead, it is dangerous because it cannot come out in one piece during the removal process, leading to surgery.
What Amount Can I Get in a Paragard Settlement?
At the moment, it is hard to determine how much Teva Pharmaceuticals will have to pay as compensation. However, this case is quite similar to Mirena's, another case of a copper intrauterine device (IUD) causing complications and risk.
In the Mirena IUD litigation, the pharmaceutical company, Bayer, paid $12.2 million in settlements back in 2017.
Why Is Paragard Bad?
Paragard is dangerous because it poses complications during the removal process. Currently, there are many IUD lawsuits against the company because the broken bits of the defective medical device lodge into the surrounding organs during the removal process.
The company making Paragard is continuing to manufacture and sell it in the market despite thousands of complaints about the IUD.
Hire a Personal Injury Attorney to Resolve Your Paragard Injury Compensation Case
Are you a ParaGard victim suffering injuries from the copper intrauterine device recall by the FDA? Do you need to file a civil lawsuit or participate in a class-action suit involving the ParaGard T 380A?
At Rosenfeld Injury Lawyers, our defective product attorneys fight aggressively for our clients to ensure they receive maximum compensation for their damages. Please call our law firm today at (888) 424-5757 (toll-free number) or use the contact form for a free case evaluation. 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.