A Paragard IUD lawsuit is a claim for financial compensation by women who were injured by the Paragard T 380A fracturing in their uterine cavity. Plaintiffs allege that Teva Pharmaceuticals and CooperCompanies 1) created a defective contraceptive device and 2) failed to warn doctors about the substantial risk of the device breaking upon removal (“explant”) despite Paragard being marketed as easy to remove.
Shouse Law Group is representing Paragard IUD victims from all over the United States. We are bringing actions against Teva and Cooper to recover money damages for our clients’ doctor’s bills (including fertility treatments), lost earnings, and pain and suffering. We are accepting cases where the patient had their IUD break upon removal.
Potential plaintiffs are people who endured invasive procedures or surgeries following a failed removal of the Paragard T 380A. Examples of these procedures include:
- Laparotomy (similar to a Caesarean section), or
- Hysterectomy (which may be necessary after a uterine rupture)
Potential plaintiffs also include people with fractured IUD pieces still inside of them, whether or not they had a procedure in attempt to remove them.
The window to file suit is only a year or two in some states. So please consult with an attorney as soon as possible.
In this article, our Paragard IUD lawyers discuss:
- 1. What are the grounds for a Paragard IUD lawsuit?
- 2. What injuries does the Paragard T 380A cause?
- 3. Is this a class action or individual lawsuits?
- 4. Has the Paragard T 380A been recalled?
- 5. Have there been any settlements yet?
- 6. Who makes the Paragard IUD?
Four claims victims can sue Teva and Cooper for are:
- The IUD had a defective design,
- The IUD had a manufacturing defect,
- The IUD’s labeling failed to warn about its risks, and/or
- Teva and Cooper were negligent
1.1 Defective design
Under strict liability/ product liability standards, a pharmaceutical company is legally responsible for injuries if:
- The product’s design posed a foreseeable risk, and
- The product was manufactured and used as it was designed to be
Like other IUDs on the market, the Paragard IUD T 380A prevents pregnancy. But unlike other IUDs on the market, the Paragard IUD T 380A has arms that stick out at a straight 90-degree angle from the center cylinder. Arguably, Teva and Cooper should have foreseen that there was a risk of one or both arms breaking off, especially during removal. Had the design been better, the device might remain intact.
Typical evidence of design defects includes the original IUD schematics and expert witness testimony. (Note that the FDA regulates Paragard as a drug, not a medical device.)
1.2 Manufacturing defect
Under strict liability standards, a pharmaceutical company is legally responsible for injuries if:
- The product had a defect when it left the manufacturer’s possession; and
- This defect substantially contributed to the plaintiff’s harm
Perhaps Teva’s and Cooper’s poor construction caused the IUD’s arms to become brittle even if the original design was good. Typical evidence of manufacturing defects are:
- Testimony from the workers who constructed the device,
- Internal memos and communications, and
- Forensic analysis of the defective IUD itself
1.3 Improper labeling/ failure to warn
Pharmaceutical manufacturers are required to:
- Warn doctors of non-obvious hazards that the product may cause; and
- Inform physicians how to avoid these hazards
The clearest evidence of improper labeling is the Paragard IUD packaging. What it does not say suggests that doctors were not fully informed about the substantial risk of the IUD breaking during explant and how best to avoid it.3
There are four elements that plaintiffs need to prove in a negligence lawsuit:
- The defendant owed a duty of care to the plaintiff;
- The defendant breached that duty;
- The breach caused the plaintiff’s injury; and
- The injury resulted in money damages
Teva and Cooper owes patients a duty that its IUD devices are well-designed and well-made. Arguably, Teva And Cooper breached that duty by providing devices with arms that can break off. These broken pieces can cause patients to endure invasive procedures and serious injuries. And this may result in money damages, such as:
- Medical bills,
- Lost wages,
- Loss of future earnings, and
- Pain and suffering
If one or both arms of the IUD break off, an invasive procedure may be necessary to retrieve the pieces. A common example is a hysteroscopy, where the doctor inserts an endoscope through the cervix into the uterine cavity.
In more extreme cases, the patient may require either a:
- Laparotomy, a C-section type procedure to remove the pieces, and/or
- Hysterectomy, which is the removal of the uterus and causes permanent infertility
And in some cases, doctors are unable to find the pieces at all. These pieces may then become embedded in the uterine wall (myometrium) or travel. This could lead to such serious complications and adverse events as:
- Severe menstrual pain, cramps, heavy bleeding, and spotting,
- Inflammation (pelvic inflammatory disease),
- Organ perforation, uterine rupture, and other organ damage, and/or
The breakage of the IUD arms typically occurs when the doctor is removing the device. But in some women, the arms break off long before the IUD gets explanted.1
Individual lawsuits. But as of December 16, 2020, these lawsuits are being consolidated into a multi-district litigation (MDL) in the Northern District of Georgia. The name of the MDL is In Re: Paragard IUD Products Liability Litigation. The MDL number is 2974. The presiding judge is Leigh Martin.
MDLs are a legal mechanism for courts to speed up proceedings. Instead of thousands of individual cases working through the court system at once, one judge makes all the pretrial decisions for all the cases.
Ultimately, the MDL judge lets a few cases reach trial. These are called bellwether trials. If and how much the plaintiffs win in these trials will steer settlement negotiations in all the remaining cases.
Note that MDLs are not class actions. Class actions combine all the cases into one. MDLs allow the cases to remain separate.2
4. Has the Paragard T 380A been recalled?
Paragard T 380As remain on the market despite being a potentially defective medical device. One batch of the birth control device was recalled in 2019 due to sterility issues, not breakage issues.3
5. Have there been any settlements yet?
No, not for Paragard lawsuits. Negotiations usually do not start until a few cases go to trial. The results of these bellwether trials serve as the starting point for settlement talks.
Certainly, lawyers for Paragard IUD victims are pursuing the highest settlement possible. No dollar amount can make up for injuries to a woman’s reproductive health.
6. Who makes the Paragard IUD?
Teva Pharmaceuticals makes the Paragard T 380A. (Teva recently sold the Paragard brand form of birth control to Cooper Companies – CooperSurgical – for $1.1 billion.)
The FDA (Food and Drug Administration) originally approved the Paragard IUD 1984. Since 1994, the Paragard IUD has been approved for up to 10 years of use.
The Paragard T 380 A is 100% hormone-free and is inserted through a thin tube during a regular office visit with a gynecologist. It is made of polyethylene that is wrapped in copper wire with two monofilament strands at the bottom. The copper essentially causes a spermacide effect, and it has a more than 99% effectiveness rate at preventing pregnancy. It also works as emergency contraception if implanted within five days after unprotected sex.
The copper IUD Paragard is touted as being better than Bayer’s Mirena IUD, a levonorgestrel long-term birth control device that can cause pseudotumor cerebri (ptc). But Paragard’s device breakage issues – which carry increased risks of serious side effects – arguably far outweigh its benefits. Both devices are problematic.4
Are you a Paragard IUD victim? Contact us for help…
Have you or a loved one been injured by copper intrauterine device Paragard T 380A? Please contact our mass tort attorneys for a free case evaluation 24/7. Call or fill out the form on this page.
Our law firm is devoted to fighting for the largest settlement possible for you. Our free case review will determine whether you have a viable lawsuit. And we take no payment unless we win.
- During implant, some patients experience nausea or dizziness. Potential side effects of the Paragard – even if it does not break – include dysmenorrhea, dyspareunia, backaches, anemia, and vaginitis. In extreme cases, people can experience sepsis. The monofilament fibers could also retract, which may require alligator forceps or cervical dilation be used to remove the device. Paragard prescribing information. There is no evidence of Paragard IUDs causing copper toxicity, but it could exacerbate Wilson’s Disease. Krishnamurthy Prema, M.D., M.N.A.M.S.Baru Anantha Rama LakshmiM.B., B.S., D.G.O., Soma Babu M.Sc., Ph.D., Serum Copper in Long-Term Users of Copper Intrauterine Devices, Fertility and Sterility, Volume 34, Issue 1 (July 1980, pp. 32-35). Carlos M. Fernandez, MD; Marie A. Cabiya, MD; Elliot M. Levine, MD; Kemoria Granberry, MD; Stephen Locher, MD, The “Broken” IUD: Its Detection and Clinical Management, Open Journal of Clinical & Medical Case Reports, , ISSN 2379-1039, Volume 1 (2015) Issue 9. About 3.8 million women use IUDs in the United States. Contraceptive Use in the United States, Guttmacher Institute, (April, 2020)
- In September 2020, plaintiffs originally requested in its motion to transfer that the MDL be in the Central District of California with Judge John Kronstadt since there were four Paragard cases there. Plaintiffs alternatively suggested the MDL be in the Western Districtc of Missouri with Judge Stephen Bough. On December 4th at a JPML (Judicial Panel on Multi-district Litigation) hearing, one plaintiff’s attorney argued that the presiding judge should be a female who has experience with litigation involving products for women-hence the decision to consolidate in Georgia. See Transfer Order. Meanwhile, Teva opposed the MDL being formed, and they suggested alternative locations including the Southern District of New York, the Southern District of California, or the Middle District of Florida. One of the original people who sued Teva was Stephanie Ideus, who needed surgery after broken pieces of the IUD became embedded. Some of the original individual lawsuits include Arias v. Teva Pharmaceuticals and Heather Brown v. Teva Pharmaceuticals USA; Weddle v. Teva Pharmaceuticals in the Philadelphia Court of Common Pleas (PCCP).
- Pending Recalls, Pending recalls for the April 30, 2014 Enforcement Report, FDA. Note that women who get pregnant with the Paragard implanted risk ectopic pregnancy.
- Paragard website (official site). Note that the Mirena lawsuits against Bayer are out of New York: The 4,600 claims were resolved for $12.2 million. Other hormone-based IUDs include Skyla, Kyleena, and Liletta.