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 created a defective contraceptive device and failed to instruct doctors how to remove (“explant”) the IUD without causing breakage.
Shouse Law Group is representing Paragard IUD victims from all over the United States. We are fighting Teva Pharmaceuticals to recover money damages for our clients’ doctor’s bills (including fertility treatments), lost earnings, and pain and suffering.
Potential plaintiffs are people who needed surgery following a failed removal of the Paragard T 380A. Examples of these surgeries are a:
- Caesarian section, or
- Other exploratory surgery
Potential plaintiffs also include people with fractured IUD pieces still inside of 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 Pharmaceuticals 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 was negligent
1.1 Defective design
Under strict liability/ product liability standards, a medical device maker is legally responsible for injuries if:
- The device’s design posed a foreseeable risk, and
- The device was manufactured and used as it was designed to be
IUDs prevent pregnancy. Like most IUDs, Paragard IUD T 380As are in a T-shape with two arms. Arguably, Teva 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.
1.2 Manufacturing defect
Under strict liability standards, a medical device maker is legally responsible for injuries if:
- The device had a defect when it left the manufacturer’s possession; and
- This defect substantially contributed to the plaintiff’s harm
Perhaps Teva’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
Medical device manufacturers are required to:
- Warn doctors of non-obvious hazards that the device may cause; and
- Inform physicians how to avoid these hazards
With Paragard IUDs, doctors may be able to avoid causing breakage by gripping both arms of the IUD during removal. But the warning label did not provide these instructions. Had Teva supplied better instructions, perhaps more breakages could have been avoided.
The clearest evidence of improper labeling is the Paragard IUD packaging. What it does not say suggests that doctors were not fully informed about how best to explant the device.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 Pharmaceuticals owes patients a duty that its IUD devices are well-designed and well-made. Arguably, Teva 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.
If extreme cases, the patient may require either 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 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 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.
Individual lawsuits. But it is expected that these lawsuits will eventually join an MDL. MDL is the abbreviation for multi-district litigation.
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.
Currently there are more than a dozen individual Paragard IUD cases in the Philadelphia Court of Common Pleas (PCCP).1
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.2
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.
Teva Pharmaceuticals makes the Paragard T 380A. (Teva recently sold the Paragard brand form of birth control to Cooper Companies 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. It is made of polyethylene that is wrapped in copper wire with two monofilament strands at the bottom. It has a more than 99% effectiveness rate at preventing pregnancy.
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.3
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.
- See, e.g., Arias v. Teva Pharmaceuticals; Heather Brown v. Teva Pharmaceuticals USA; Weddle v. Teva Pharmaceuticals.
- 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 are out of New York.