Paragard IUD Lawsuit
A ParaGard IUD lawsuit may be an option for women who suffered serious complications during removal surgery, which may have led to other potentially painful removal surgeries. The device’s manufacturer has allegedly failed to warn women about such risks, possibly leaving some women vulnerable to additional injuries. Affected patients and their families may be eligible to pursue compensation for damages with the help of a defective medical device lawsuit attorney.
If you or a loved one have been adversely affected by a potentially defective medical device, contact Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
Have You Seen a ParaGard IUD Lawsuit Commercial?
You may have seen a ParaGard IUD lawsuit commercial on television and wondered whether you or a loved one have been affected by the potentially defective medical devices and, if so, whether you are eligible to pursue a claim against the manufacturer or distributor. The purpose of this article is to provide you with additional information about recalls, lawsuits, and settlements involving potentially defective IUDs so that you have a better understanding of your options.
What is a ParaGard IUD and How Does It Work?
The ParaGard® Intrauterine Copper Contraceptive is a small, T-shaped intrauterine device (IUD) used to prevent pregnancy for up to ten years. Unlike other IUDs that use hormone progestin to prevent pregnancy, the ParaGard IUD is a non-hormonal IUD that releases copper to prevent fertilization.
Manufactured by Cooper Surgical, Inc., the ParaGard IUD is was approved by the U.S. Food and Drug Administration (FDA) in 1984 and made available in the United States in 1988. According to the device’s prescribing information, proports a pregnancy rate of less than 1 pregnancy per 100 women each year.
The ParaGard IUD effectiveness as a contraceptive works as copper is continuously released into the uterine cavity. According to the manufacturer’s prescribing information, the copper in the ParaGard IUD interferes with sperm movement, egg fertilization and potentially prevents implantation.
ParaGard Prescription Warnings
Potential risks and side effects associated with the ParaGard IUD include:
- Intrauterine pregnancy – ParaGard IUD should be immediately removed due to the risk of spontaneous abortion, premature delivery, sepsis, septic shock, and death.
- Ectopic pregnancy – Pregnancy in which the fertilized egg implants outside of the uterus, potentially leading to damage of nearby organs and life-threatening blood loss.
- Pelvic infection, or pelvic inflammatory disease – Uncommon risk that typically occurs within 20 days of device insertion.
- Embedment – Partial penetration or embedment of the device may make removal difficult, sometimes leading to removal surgery.
- Wilson’s disease – The ParaGard IUD can exacerbate Wilson’s disease, a rare genetic disease affecting copper excretion.
According to the device’s prescribing information, the most common side effects of the ParaGard IUD include heavier, longer periods and spotting between periods. Most side effects reportedly diminish after 2-3 months.
ParaGard IUD Broken T-Arm Injury
Due to an increase in the use of IUDs to prevent unwanted pregnancy, some health care professionals and doctors have begun to see an increase in the risks associated with the devices. In some instances, a ParaGard IUD may be difficult to remove because it is stuck in the uterus, or it may become embedded in the uterus. Injuries associated with, but not limited to, a broken T-arm potentially include impaired fertility and painful removal surgeries.
When these situations arise, surgery may be needed to remove the broken or embedded device. Types of surgical procedures used to retrieve the devices include hysteroscopy, laparotomy and in some cases, a complete hysterectomy. Risks associated with these types of surgeries may include infection, bleeding, PID, tearing of the uterus or damage to the cervix, and complications from fluid or gas used in the procedure.
Other Serious ParaGard IUD Side Effects
Serious side effects associated with the ParaGard IUD include:
- Pelvic inflammatory disease (PID) – Although uncommon, ParaGard IUD and other IUDs are associated with PID, an infection of the uterus, tubes, and nearby organs. According to the device’s prescribing information, PID is most likely to occur in the first 20 days after placement. Patients have a higher chance of getting PID if they or their partner have sex with more than one person. PID is typically treated with antibiotics. In some cases, PID can cause serious problems such as infertility, ectopic pregnancy, and chronic pelvic pain. In rare cases, PID may even cause death. More serious cases of PID require surgery or a hysterectomy (removal of the uterus). Signs associated with PID include abdominal or pelvic pain, painful sex, unusual or bad smelling vaginal discharge, chills, heavy bleeding, or fever.
- Difficult removals – Occasionally ParaGard IUD may be hard to remove because it is stuck in the uterus. Sometimes, surgery may be needed to remove ParaGard.
- Perforation – Rarely, ParaGard IUD goes through the wall of the uterus, especially during placement. If the device perforates the uterus, it should be removed, and surgery may be needed to do so. Perforation may lead to infection, scarring, or damage to other organs.
- Expulsion – ParaGard IUD may partially or completely fall out of the uterus. Women who have never been pregnant may be more likely to expel ParaGard than women who have been pregnant before.
There are other side effects associated with ParaGard, including anemia (low blood count), backache, pain during sex, menstrual cramps, allergic reaction, vaginal infection, vaginal discharge, faintness or pain.
Lauren A. on May 16, 2016
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Has There Been a ParaGard IUD Recall?
Although there has not been a ParaGard IUD recall, complications such as infection, bleeding, PID and removal surgery may lead to other serious complications and injuries.
Affected individuals who suffered serious complications as a result of a potentially defective or broken ParaGard IUD could pursue a claim against any manufacturers that failed to disclose known risks associated with the devices. Women injured may be entitled to compensation.
Failure to warn of side effects and serious risks associated with a defective medical device can be a basis of medical device company liability, regardless of whether the device has been recalled.
Is There a ParaGard IUD Class Action Lawsuit?
At the time of publication, a ParaGard IUD class action lawsuit action has not been filed. ParaGard IUD lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the device. Instead, if multiple lawsuits are filed against the manufacturers, alleging injuries and other damages caused by adjustable valves, shunts and similar medical devices, it is anticipated that these potential lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by defective medical devices.
In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments. After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
Have There Been ParaGard IUD Lawsuit Settlements?
Some defective medical device lawsuits may settle early in the claims process. However, it is not expected that there will be any ParaGard IUD lawsuit settlements at this time. Instead, it is expected that IUD lawsuits will be consolidated in federal court through an MDL. Defective medical device attorneys note that the outcome of any case is never guaranteed, and past results are not necessarily predictive of future outcomes.
ParaGard IUD Lawsuit News
- September 2017According to MarketWatch, Teva Pharmaceuticals (original manufacturer of the ParaGard IUD) sells the ParaGard IUD product to Cooper Surgical for $1.1 billion.
- July 2017Study in the American Journal of Obstetrics & Gynecology indicates that “copper intrauterine users were more likely to experience expulsion and pregnancy.”
- October 2014Study in the journal Obstetrics & Gynecology indicates that females between the ages of 14 and 19 may be more likely to experience IUD expulsion.
- March 2013Florida woman files lawsuit against Teva Pharmaceuticals after she allegedly had to have surgery to remove the device and re-section a portion of her colon.
- 1988ParaGard IUD is marketed for the first time in the United States.
- November 1984After the FDA concludes that the ParaGard IUD is safe and effective for use as recommended, the agency approves the use of the device.
How a Paragard IUD Lawsuit Attorney Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
Women injured by a defective Paragard IUD may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.