Updated
Settlements for a Paragard IUD lawsuit are meant to compensate women plaintiffs for injuries stemming from their copper IUD device breaking during removal. Plaintiffs are suing Teva Pharmaceuticals and CooperCompanies for creating the defective product and failing to warn them about the risks. Paragard lawsuits are being consolidated into a multidistrict litigation (MDL) to expedite the settlement process.
In this article, our Paragard IUD lawyers discuss:
- 1. What Paragard IUD settlements have there been so far?
- 2. Are the lawsuits separate or a class action?
- 3. How long will the Paragard litigation take?
- 4. How big will the settlements be?
- 5. What are the grounds to sue?
- 6. How much does it cost to sue?
1. What Paragard IUD settlements have there been so far?
None, or at least none that have been made public. Paragard litigation is still in a very early phase. Settlement talks typically do not begin until after a few cases go to trial. That is probably at least another year or two down the line.
2. Are the lawsuits separate or a class action?
The plaintiffs file individual lawsuits. However, these lawsuits get consolidated into a multi-district litigation (MDL) out of the Northern District of Georgia called In Re: Paragard IUD Products Liability Litigation (MDL # 2974), presided over by Judge Leigh Martin.
MDLs are not class actions, where all the cases get combined. In MDLs, every plaintiff’s case remains separate. But the MDL serves as a legal mechanism for expediting court proceedings.
One judge makes all the pretrial decisions to apply to each of the cases. Then the judge will let a few cases go to trial. These are called bellwether trials. The result of these trials will help set the tone for settlement negotiations with all the other plaintiffs. If the plaintiffs win big in the bellwether trials, then the defendant is more likely to offer large settlements to the plaintiffs.
MDLs are beneficial to cases like Paragard where there are many plaintiffs with similar injuries against the same defendant (Teva Pharmaceuticals). And since all the cases remain separate, each plaintiff gets her own individual settlement based on the unique facts of her case. There is not one large pot where all the plaintiffs share equally.1
3. How long will the Paragard litigation take?
Since the litigation is so new, plaintiffs’ attorneys are not expecting cases to resolve for at least another couple of years. But plaintiffs’ attorneys are working to achieve a favorable resolution as quickly as possible.
4. How big will the settlements be?
Attorneys for Paragard IUD victims are fighting for as much financial compensation as possible to cover:
- Medical expenses caused by the copper intrauterine device breaking, including any medical bills for therapy
- Lost wages from missing work due to the injuries, and
- Pain and suffering, which is often the biggest expense since a woman’s health, well-being, and fertility are priceless.
Women have reported a wide array of injuries. Some are mild, including cramping and bleeding. The more serious injuries may include:
- Organ damage
- Perforation of the uterus and uterine wall
- An inflammatory reaction called Pelvic Inflammatory Disease, or PID
- Inability to get pregnant
- Ectopic pregnancy (should the woman get pregnant with broken IUD pieces inside her), which could be fatal
In general, the more severe the injuries, the higher the settlement. Therefore, women whose IUD broke but caused no injuries or complications would likely receive less than women whose broken IUD resulted in invasive surgeries, infertility, and/or a hysterectomy.2
5. What are the grounds to sue?
There are four claims victims may sue Teva Pharmaceuticals and CooperCompanies for:
- Defective design,
- Manufacturing defect,
- Failure to warn / improper labeling, and/or
- Negligence
5.1 Defective design
The FDA actually regulates Paragard as a drug and not a medical device. Under strict liability standards, a pharmaceutical company can be held liable for injuries if:
- The drug inherently posed a foreseeable risk, and
- The drug was compounded and utilized as it was designed to be
Arguably Teva and Cooper should have foreseen that the Paragard IUD’s design put it at increased risk of breaking during removal and causing serious complications. And had Teva and Cooper created a better design, perhaps the IUD would have remained intact, and none of the plaintiffs would have suffered their injuries.
5.2 Manufacturing defect
Medical device manufacturers are legally responsible when:
- Their device was defective when it left their possession; and
- This defect substantially contributed to the plaintiff’s harm
A jury could find that poor construction by Teva and Cooper caused the Paragard IUD to become brittle and break upon explant. And this manufacturing defect contributing to the plaintiffs’ physical injuries.
5.3 Failure to warn/improper labeling
Medical device makers are obligated to:
- Warn physicians of any non-obvious hazards that the device may cause; and
- Inform them of ways to avoid these hazards
The Paragard IUD packaging did not including a warning about the substantial likelihood of the copper IUD breaking during removal from the woman’s uterus. Nor did it give instructions on how to safely remove the IUD without device breakage. Since Teva and Cooper failed to provide adequate warnings and instructions, a jury could arguably find them liable for the resulting injuries.3
5.4 Negligence
The four elements plaintiffs must prove in a negligence suit are:
- 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
The duty that Teva and Cooper owes women is that their birth control devices are safe. A jury could find that Teva and Cooper breached that duty by producing a medical product with arms that can fracture during removal. These broken pieces, in turn, can lead to severe injuries, side effects, and complications.
6. How much does it cost to sue?
Legitimate personal injury attorneys offer a free case review and do not charge their clients anything to sue. They operate by contingency fee. This means that their payment comes out of the settlement. Personal injury attorneys typically take 40% of any settlement plus court costs.
If there is no settlement (or jury award if the case goes to trial), the attorney gets paid nothing and eats all the court costs. This gives personal injury attorneys an added incentive to win.3
Legal References
- See the JPML Transfer Order (12/16/20). Note that Teva has since sold Paragard to the Cooper Companies.
- See Michelle Llamas, Why Lawyers Are Talking About the Paragard IUD, Drugwatch (April 7, 2020); Paragard website (official). The Paragard IUD is a hormone-free long-term birth control device, relying on copper wires to prevent pregnancy. In contrast, the Mirena IUD relies on progestin (levonorgestrel). There is also Mirena litigation out of New York. The Food and Drug Administration (FDA) originally approved Paragard in 1998. It has a 99%-plus effectiveness rate.