A Paragard lawsuit is a claim for monetary compensation by women injured when the arm of their Paragard IUD T 380A broke off and embedded in their uterine cavity.
- made a defective contraceptive device and
- failed to warn patients and physicians about the substantial risk of the device breaking upon removal (“explant”) – despite the IUD being marketed as simple to remove.
Records indicate that the manufacturers failed to conduct stability testing on the arms of the device before marketing and distributing it. Proper stability testing might have revealed the design defect and permitted for it to be fixed.
Shouse Law Group is representing Paragard IUD victims from across the United States. We are bringing legal actions against Teva and Cooper to recover the following financial compensation for our clients:
- medical bills (including fertility treatments),
- lost earnings, and
- pain and suffering.
This litigation is not a class action. Each of our client’s lawsuits is a separate cause of action. But to speed up the settlement process, the claims are joining together into multidistrict litigation (MDL).
Potential cases are ones where the arm of the device fractures when physicians or medical assistants attempt to remove it. The arm gets embedded in the uterus or cervix. Patients then need invasive procedures to locate and retrieve the missing piece, such as a:
- Laparotomy (similar to a Caesarean section), or
- Hysterectomy (which may be necessary after a uterine rupture)
The time window in which to file a claim is only one or two years in some states. So 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 claims?
- 4. Where are the Paragard lawsuits being filed?
- 5. Has the Paragard T 380A been recalled?
- 6. Have there been any settlements yet?
- 7. Who makes the Paragard IUD?
- 8. What should Paragard victims do?
Based on the current 2022 litigation, there are our claims that victims are pursuing:
- 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 made and utilized 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 this would increase the risk of one or both arms breaking off, especially during explant. 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 U.S. Food and Drug Administration regulates Paragard as a drug instead of a medical device.)
1.2 Manufacturing defect
Under strict liability standards, a pharmaceutical company is legally responsible for injuries from defective products if:
- The product had a defect when it left the manufacturer’s possession; and
- This defect substantially contributed to the plaintiff’s injuries
Perhaps Teva’s and Cooper’s poor construction caused the IUD’s arms to turn 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 healthcare providers of non-obvious hazards that the product may cause; and
- Inform doctors how to avoid these dangers
The clearest evidence of improper labeling is the Paragard IUD packaging. What its disclaimer does not say suggests that doctors were not fully informed about the substantial risk of the IUD fracturing during IUD removal and how best to avoid it.3
There are four elements that plaintiffs must prove in a negligence lawsuit:
- The defendant owed a duty of care to the plaintiff;
- The defendant breached this duty;
- The breach caused the plaintiff’s injury; and
- The injury resulted in money damages
Teva and Cooper owe its customers a duty to provide IUD devices that are well-designed and well-made. Arguably, Teva And Cooper breached that duty by providing devices with arms that can fracture. These broken pieces lead to patients enduring 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 broken IUD 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, cramping, heavy bleeding, and spotting,
- Inflammatory reactions (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 on December 16, 2020, these cases started consolidating 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 May. As of June 15, 2022, there are 1,192 cases in the Paragard MDL.
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. Where are the Paragard lawsuits being filed?
The Paragard lawsuits across the U.S. are being temporarily joined in the Northern District of Georgia federal court (not state court) as part of multi-district litigation (MDL) number 2974. The official name is In Re: Paragard IUD Products Liability Litigation. MDLs are not class action lawsuits.
Each case in the MDL remains separate. But to promote efficiency, one judge (the Honorable Leigh Martin May) will be making all the pretrial decisions for all of the cases across the board since they involve similar claims.
5. Has the Paragard T 380A been recalled?
As of 2022, 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 for breakage issues.3
6. Have there been any settlements yet?
No, not for Paragard lawsuits. Negotiations usually do not begin until a few cases go to trial. The results of these bellwether trials serve as the starting point for settlement talks. Bellwethers are expected to begin in 2023.
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.
MDLs typically resolve with a global settlement with the defendant making one big payout that the plaintiffs divide between them depending on the severity of their injuries. Plaintiffs are expected to fall within one of three tiers:
Tier 1 plaintiffs are expected to receive in the low hundreds of thousands. Tier 2 plaintiffs would receive in the mid tens of thousands. And Tier 3 plaintiffs would receive in the low tens of thousands. But this is still purely speculative at this point.
7. Who makes the Paragard IUD?
Teva Pharmaceuticals makes the Paragard T 380A. (Recently, Teva sold the Paragard brand form of birth control to Cooper Companies – CooperSurgical – for $1.1 billion.)
The FDA (Food and Drug Administration) approved the Paragard IUD in 1984. Since 1994, the Paragard IUD has been approved for up to 10 years of use. (Many doctors claim it is safe for up to 12 years. And during the pandemic, many women were forced to keep their IUDs in for longer than 10 years if they were unable to get an appointment or were too scared to break lockdown.)
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 coil essentially causes a spermicide effect, and it has a more than 99% effectiveness rate at preventing fertilization. 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 any benefits. Both devices have problems.4
8. What should Paragard victims do?
Firstly, women with broken Paragard IUDs should mitigate their damages by continuing to seek medical care. Physicians will discuss their options for how to minimize further injuries.
Then, Paragard victims are invited to contact Shouse Law Group to discuss moving forward with a lawsuit. We manage the entire investigation, litigation, and negotiation process so our clients can focus on healing and getting on with their lives and families. And we fight not only to reimburse victims for medical expenses and time away from work. The biggest ticket item we pursue a settlement for is emotional trauma (“pain and suffering”).
Paragard victims agonize over what will happen next and whether they will be able to get pregnant again and have a healthy pregnancy. This stress of uncertainty takes an immeasurable toll physically and mentally. So we fight to compensate victims financially to the fullest extent under the law.
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 and to discuss your legal options 24/7. Call or fill out the form on this page, and our Paragard lawyers will contact you about joining the 2022 lawsuit.
Our law firm is devoted to pursuing the largest settlement possible for you. Our free case review will determine whether you have a viable Paragard lawsuit against the device manufacturer. Our personal injury lawyers gather your medical records. And we take no payment unless we win your case.
Attorney advertising disclaimer: Results cannot be guaranteed.
- 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 to be used to remove the device. The official Paragard website says, “If you cannot find the threads in the vagina, check that Paragard is still in the uterus. The threads can retract into the uterus or break, or Paragard can break, perforate the uterus, or be expelled. Gentle probing of the cavity, x-ray, or sonography may be required to locate Paragard.” 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). Salvatore Giovannie Vitale, In-office hysteroscopic removal of retained or fragmented intrauterine device without anesthesia: a cross-sectional analysis of an international survey, Updates in Surgery (February 5, 2022)(“Copper T IUDs are reported to be the most commonly found retained or fragmented inside the uterine cavity.”).
- 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 District of Missouri with Judge Stephen Bough. On December 4th at a JPML (Judicial Panel on Multidistrict 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. See also Joce Sterman, Alex Brauer and Andrea Nejman, Exclusive: 3,000+ women report a popular IUD broke in their body, causing complications, ABC-13 WHAM (March 18, 2021). See also Paragard IUD Injuries Lead to Lawsuits Across the U.S., Legal Examiner (March 30, 2001).