Why is Paragard Being Sued?
Paragard is being sued because of allegations that this birth control device can break apart when removed, causing injuries and potentially affecting long-term fertility. Many women have reported that defects in the device’s design caused it to fracture when removed, leaving pieces embedded in their uterine walls and causing pain, infection, and infertility.
If you suffer from health problems that you believe are caused by a defective Paragard device, you may be entitled to financial compensation from Teva Pharmaceuticals, the original manufacturer of Paragard, and Cooper Companies, which bought Teva in 2017. This compensation, legally known as damages, may cover your losses from medical expenses, pain and suffering, and more. A ParaGard mass tort lawyer can help you seek damages if you are unsure about how to do so on your own.
Women Chose Paragard for Long-Term Birth Control
Paragard is a type of intrauterine device (IUD) that can be used to prevent pregnancy for up to ten years. The device is a small, T-shaped piece of plastic wrapped with a thin layer of copper with threads attached for removal. The copper prevents fertilization and implantation without the use of any hormones. A healthcare provider can insert and remove the device during a routine appointment.
Paragard’s manufacturer advertises it as being over 99% effective at preventing pregnancy. It also claims that it has no impact on fertility once removed. Many women chose Paragard for long-term birth control because it was advertised as convenient, effective, reversible, and hormone-free.
Medical Evidence Suggests Paragard Can Be Dangerous
While many women chose Paragard because it was supposed to be a safe and effective method of birth control, medical evidence suggests that Paragard can be dangerous. Some of the most important medical evidence showing the problems with Paragard comes from the U.S. Food and Drug Administration (FDA). The FDA maintains a system, known as the FDA Adverse Events Reporting System (FAERS), for tracking reported adverse events caused by medications and medical devices.
Anyone who experiences an adverse effect of a medication or medical device can use this system to report it. Other parties, such as parents, caregivers, healthcare providers, and manufacturers, can use the system to report events as they become aware of them. Data from FAERS shows that since 2015, there have been 43,230 reported adverse events concerning Paragard. Of these, 18,085 were serious events, including 15 deaths. This information shows that Paragard can be dangerous.
Paragard Can Cause Unexpected Perforation and Injury
Paragard can cause unexpected perforation of the uterine wall. Perforation occurs when the Paragard IUD goes through the wall of the uterus. When this happens, it can cause injuries in other parts of the pelvic cavity and reproductive system. Once the Paragard perforates the wall of the uterus, it can cause scarring, infections, pain, infertility, and additional damage to nearby organs.
Patients who experience perforation may require surgical procedures such as laparoscopy or laparotomy to remove the Paragard IUD.
Injuries Associated With the Paragard IUD
The FDA provides information about adverse effects that may result from Paragard use:
- Perforation: The Paragard device may perforate the uterus or cervix. The device may then migrate outside of the uterine cavity, potentially causing adhesions, peritonitis, intestinal penetration, intestinal obstruction, abscesses, and damage to nearby organs. The risk of perforation is higher in women who are breastfeeding.
- Ectopic pregnancy: Although Paragard prevents most pregnancies, it increases the risk of ectopic pregnancy for women who do become pregnant while using it. According to information from Cleveland Clinic, an ectopic pregnancy occurs when a fertilized egg implants outside of the uterine wall, most often in a fallopian tube. Ectopic pregnancies are life-threatening, require emergency treatment, and can permanently damage a woman’s fertility.
- Intrauterine pregnancy: This is a typical pregnancy, which is supposed to be prevented by the Paragard IUD. If possible, the Paragard should be removed once the pregnancy is detected, but that is not always possible. A pregnant mother with a Paragard in place faces complications such as septic abortion, sepsis, increased risk of miscarriage, premature labor, and premature delivery.
- Septic abortion: Merck Manuals defines a septic abortion as a serious infection of the uterus before, during, or after an abortion. In this case, an infection related to the Paragard IUD causes the loss of the pregnancy. Symptoms include chills, fever, vaginal discharge, abdominal pain and tenderness, vaginal bleeding, and cervical dilation. The patient will require antibiotic treatment. Patients with uncontrolled infections will require a hysterectomy, which results in the permanent loss of fertility.
- Sepsis: This severe infection, including Group A Streptococcal Sepsis (GAS), occurs when bacteria are introduced during Paragard insertion. Sepsis is a rare but serious infection that can be life-threatening.
- Pelvic inflammatory disease and endometritis: Non-sterile placement of the Paragard IUD can introduce bacteria into the uterus, leading to pelvic inflammatory disease (PID) or endometritis. Symptoms include lower abdominal or pelvic pain, smelly discharge, unexplained bleeding, fever, and genital lesions or sores. PID can cause damage to the fallopian tubes, increasing the risk of an ectopic pregnancy or infertility, and may require a hysterectomy. It can also cause sepsis and death.
- Embedment: The Paragard IUD may become lodged in the myometrium, the smooth muscle lining of the uterus. Removing an embedded Paragard IUD can be difficult. Non-surgical removal can cause the device to break apart. Surgery may be required for a thorough removal.
- Expulsion: The device may spontaneously expel, either partially or completely, from the uterus. When this happens, it is no longer an effective contraceptive.
- Bleeding pattern alterations: Paragard causes some women to experience heavy, prolonged bleeding. Women with excessive bleeding may need to have the device removed.
- Dysmenorrhea or painful menstrual cramps
- Dyspareunia or painful intercourse
- Prolonged menstrual flow
- Menstrual spotting
- Pain and cramping
- Vaginitis or infection or inflammation of the vagina or vulva, often accompanied by pain, itching, and discharge
After Paragard was approved and marketed as a contraceptive, some consumers reported additional adverse effects. Research has not yet substantiated a causal link between a defective Paragard device and these health problems, but further investigation may. Reported complaints include:
- Abdominal distension
- New metal allergies
- Muscle spasms
- Amenorrhea, which is missed menstruation or absence of menstruation
- Stevens-Johnson syndrome, which is a rare but serious condition characterized by flu-like symptoms and a painful, blistering rash
Why Lawyers Are Talking About the Paragard IUD
Lawyers are talking about the Paragard IUD because more and more women are coming forward with their stories of injuries caused by this defective medical device. These injuries are not isolated events. Thousands of women nationwide have sustained varying degrees of physical injury and emotional trauma. Lawyers recognize the collective power of these women as they seek compensation from its manufacturers.
Paragard IUD Injuries Lead to Lawsuits Across the U.S.
As more women understand that their Paragard injuries were caused by a defective medical device, many women are choosing to sue Cooper Companies. These women want to hold Paragard’s manufacturers accountable for their actions. They also want to recover damages for the physical, emotional, and financial losses they have suffered because of their injuries. The damages available from a Paragard IUD injury may include:
- Medical expenses involved in diagnosing and treating complications caused by the Paragard IUD. These expenses may include diagnostic imaging, surgeries such as laparoscopy, laparotomy, and hysterectomy, antibiotic treatment, pain medication, other prescription medications, and more.
- Loss of income for patients who had to take unpaid time off work for treatment and recovery from their Paragard IUD injuries
- Pain and suffering for physical pain, long recovery, and surgical treatment
- Emotional trauma for the stress of treatment, sadness over the loss of fertility, and subsequent development of anxiety, depression, or insomnia
Women across the United States have been using Paragard for years, which means that there are Paragard lawsuits across the country. The laws and legal deadlines surrounding personal injury from a medical device vary from state to state, so get help from a lawyer familiar with the laws in your state for information about how you can join the Paragard lawsuit.
Women Say a Manufacturer Failed to Warn About Breakage
Women who were injured by a broken Paragard device claim that Teva Pharmaceuticals and Cooper Companies failed to warn them and their healthcare providers about the potential for breakage. They claim that the manufacturers knew or should have known that the IUD could become brittle over time, making it prone to breaking upon removal.
In marketing and selling a defective and dangerous medical device, Teva Pharmaceuticals and Cooper Companies placed thousands of women at risk just to make a profit. The lawsuit against Paragard’s manufacturers is a way to hold these companies accountable for their carelessness.
Who Manufactures the Paragard IUD?
Cooper Companies, a global medical device company also known as CooperSurgical, manufactures the Paragard IUD. Cooper Companies purchased Teva Pharmaceuticals Industries Ltd., the previous manufacturer of Paragard, in 2017.
Medical device manufacturers have an obligation to design and develop products that are safe to use and do not put users at risk of harm. If there are any potential side effects that may be caused by the device, the manufacturer has an obligation to disclose those side effects to consumers so that they can make an informed decision about using it. Manufacturers can be held legally liable for adverse effects caused by their products.
Who Can Join the Paragard Lawsuit?
Women who sustained injuries caused by their Paragard IUD can join the lawsuit. You may be able to join the Paragard lawsuit if:
- Your Paragard IUD migrated to other parts of your pelvic cavity, perforated your uterine wall, or fractured upon removal.
- Your Paragard IUD or its pieces had to be surgically removed.
- You had to have a hysterectomy because of complications caused by the Paragard IUD.
- You became infertile because of complications caused by the Paragard IUD.
- You developed other health problems because of the Paragard IUD.
Essentially, you will need to have evidence that a Paragard IUD was directly responsible for causing your health condition. Also, you will need to show that you suffered damages as a result, such as medical bills and lost wages.
An attorney can help you understand your eligibility and gather crucial evidence needed to make your case.
How Do I Join the Paragard Lawsuit?
You can join the Paragard lawsuit by contacting a mass tort lawyer’s office and getting a free case review. A member of our team will ask you questions about your history of Paragard use and the details of your injuries. If you have them, your records documenting Paragard implantation, removal attempts, and complications will be helpful. Our lawyer can listen to your story, review your medical records, and let you know whether you qualify to join the Paragard lawsuit.
This case consultation is confidential, free, and comes with no obligation to join the lawsuit. Our team can connect you to an attorney’s office to help you understand your legal options and make the best choice for your situation.
How Much Does it Cost to Work With a Lawyer?
Many people may hold back from hiring an attorney, as they are unsure about how much it will cost. You should know that many injury lawyers work based on contingency fees, which means that:
- You’ll pay nothing upfront to get started with a case.
- You only pay attorney’s fees if your case is successful.
- A portion of your final settlement or award goes towards your legal fees.
This means that you can get started on a Paragard lawsuit with relatively little financial risk involved. After all, an attorney who works on contingency fees will essentially finance the initial costs of your case until you receive a financial recovery.
You should clarify how an attorney’s fees work if they tell you that they work on contingency. Every lawyer charges a different percentage-based rate, for instance, so you should learn more about any fees to expect before you finalize your hiring decision.
Learn More About Filing a Paragard Lawsuit
If you sustained injuries because of Paragard, you may be entitled to damages for medical bills, pain and suffering, and more. A Paragard lawsuit attorney may be able to help you seek compensation from the manufacturer, Cooper Companies. Fill out this contact form to learn more about why Paragard is being sued and how an attorney can help you.