What is Paragard?
Manufactured and marketed by The Cooper Companies, Paragard is a copper IUD used for preventing pregnancy in women. Paragard is made of a plastic base with a copper coil wrapped around it.
The reaction produced by the copper coil creates an inflammatory reaction in the uterus that interferes with the sperm. The Paragard IUD was first approved by the U.S. Food and Drug Administration (FDA) in 1984.
What's the Problem?
While the Paragard IUD is popular, it has also recently been linked to serious side effects and complications from the device’s reaction within the body, problems during removal, or from the device breaking.
Severe side effects of Paragard include pelvic inflammatory disease, infections, pain during sex, anemia, uterus perforation, and difficulty removing the copper IUD. A Paragard IUD lawsuit has been filed on behalf of women who received the device and subsequently experienced serious injuries.
Paragard May Break During Removal: Study
A 2015 study published in the Open Journal of Clinical & Medical Case Reports  looked at multiple cases of Paragard intrauterine devices breaking that occurred upon removal of the IUD. The researchers concluded that "the possibility of its breakage should be recognized by clinicians."
Paragard IUD Side Effects
Serious complications of a broken IUD may include:
- Paragard breakage upon removal
- Paragard device expulsion or falling out of the uterus
- Uterus migration
- Ectopic pregnancy (fertilized egg growing outside a woman's uterus)
- Paragard becoming embedded in the uterus
- Inflammation / allergic reactions
- Internal bleeding
- Perforation of the uterine wall / cervix
- Other organ perforation
- Scarring / damage to other organs
- Copper toxicity
- Cervical dilation
- Pseudotumor cerebri
- Device breakage
- Revision surgery
- Death caused by any of the injuries above
More common side effects of the Paragard birth control device include:
- Dysmenorrhea (pain with menstruation)
- Dyspareunia (pain during sex)
- Prolonged menstrual flow
- Menstrual spotting
- Pain and cramping
- And more
Paragard must be removed in an authorized healthcare provider's office. The provider will use forceps to grasp the IUD's strings and gently pull. The device's arms will fold upward as it is withdrawn from the uterus. Light bleeding and cramping are common during removal.
Paragard Breaking Treatment
Women who suffer breakage of the surgery copper wire typically require serious, invasive treatment including:
- Surgery to remove broken IUD pieces
- Uterine incision
- Total hysterectomy
- General anesthesia
- Ultrasound imaging prior to surgery
Mirena vs. Paragard
Mirena and Paragard are both hormone-releasing birth control devices that are placed in a woman's uterus to prevent pregnancy. The difference is that the Mirena IUD is effective for 5 years, while Paragard works for up to 10 years.
Another difference is that Mirena uses levonorgestrel, a synthetic form of the female hormone progesterone, while Paragard is hormone-free.
Has There Been a Recall?
No. Despite lawsuits alleging that the Paragard T 380A copper wire is a defective medical device, the IUD remains for sale on the U.S. market. However, 1 batch of Paragard was recalled in 2019 due to problems with sterility.
New York Woman Files Paragard Lawsuit Against Teva Pharmaceuticals, Cooper Companies
September 2, 2020 - A New York woman has filed a lawsuit against Teva Pharmaceuticals and Cooper Companies Inc. alleging that she was injured when a piece of the Paragard IUD broke during removal.
Plaintiff Vanesha Johnson claims that Teva marketed ParaGard as safe and effective, and without hormones or other side effects of other birth control medical devices; however, the companies failed to warn that the arms of the IUD could break after being implanted, according to the lawsuit.
Johnson was forced to undergo emergency surgery to have the arm of the IUD removed after she suffered injuries including loss of reproductive health, pain, suffering, mental anguish and loss of enjoyment of life, in addition to medical bills.
Plaintiff further alleges that Teva overstated the benefits of ParaGard while downplaying the risks, and failed to warn that the IUD could break during implantation. According to the complaint, Teva knew or should have known about its design problems based on trials, third-party studies, and consumer experience and complaints.
Additionally, the complaint states that the FDA has received over 1,600 reports of the ParaGard IUD breaking, with more than 700 of those reports considered to be serious.
Johnson is seeking unspecified damages for 11 separate counts, including negligence, common law fraud, breach of express and implied warranty, design and manufacturing defects, failure to warn, and violations of consumer protection laws.
Paragard Lawsuit Filed in Illinois
A lawsuit filed in May 2020 in the Southern District of Illinois alleged claims that the Paragard manufacturer failed to adequately warn of the increased risk of injury due to device breakage during the IUD removal.
Plaintiff Beth Parker filed the complaint against Teva Pharmaceuticals USA, Teva Women’s Health LLC, Teva Women’s Health Inc., Duramed Pharmaceuticals Inc., The Cooper Companies Inc., and Coopersurgical Inc.
The suit alleges that the companies designed, researched, manufactured, labeled, packaged, promoted, marketed, and sold the ParaGard IUD.
Parker alleges the defendants knew the device was “dangerous and unreasonably defective” and withheld safety information from health care providers and patients. The suit claims that the FDA has received over 1,600 reports of ParaGard breaking since 2010. Of those cases, 700 were classified as “serious.”
Parker seeks compensatory damages in excess of $75,000, plus attorneys’ fees, costs, and pre-judgment. She also seeks punitive damages against the defendants for attempting to misrepresent facts concerning the safety of ParaGard.
Is There a Class Action?
To date, only individual IUD lawsuits have been filed in the Paragard litigation. However, due to the number of claims, it is expected that these suits will eventually join a multidistrict litigation (MDL).
As opposed to a class action lawsuit, which combine all the cases into one, a multidistrict litigation allows all the cases to remain separate. There are currently more than a dozen individual IUD lawsuits pending in the Philadelphia Court of Common Pleas.
No Paragard lawsuits have yet reached the settlement phase. In most cases, negotiations do not begin until several Bellwether Trials are completed. The results of these cases typically serve as the starting point for settlement talks.
If You Have Been Injured By Paragard
If you have suffered any of the above side effects after having been implanted with Paragard, take the following steps to ensure your legal rights:
- Contact your doctor for medical records confirming your Paragard implant
- Identify your specific implant
- Specify your injury
- Contact a Paragard Attorney
What are Paragard Lawsuits Alleging?
A Paragard lawsuit is a claim for financial compensation by women who were injured by the Paragard IUD T 380A breaking apart and lodging in their uterine cavity. Plaintiffs allege that Teva Pharmaceuticals and CooperCompanies:
- Created a defective emergency contraception device, and
- Failed to warn both patients and doctors about the substantial increased risk of the device fracturing upon removal (“explant”) – despite the IUD being marketed as easy to remove.
Under strict liability/ product liability law, 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, the Paragard IUD T 380A prevents pregnancy. However, unlike other IUDs on the U.S. market, Paragard has arms that stick out at a 90-degree angle from the center cylinder. Lawsuits allege that Teva and Cooper should have known that there was a risk of the arms breaking off, especially during removal. Had the design been better, the device might remain intact, the complaints state.
Typical evidence of design defects includes the original IUD schematic plan and expert witness testimony.
(Note: The U.S. Food and Drug Administration regulates Paragard as a drug, not a medical device)
Under strict liability law, a pharmaceutical company is legally responsible for injuries from defective products if:
- The product had a defect when it left the manufacturer’s possession
- This defect substantially contributed to the plaintiff’s harm
Lawsuits allege that the IUD's poor design caused the device's arms to become brittle even if the original design was good. Typical evidence of manufacturing defects include:
- Testimony from the workers who constructed the device
- Internal memos and communications
- Forensic analysis of the defective IUD itself
Improper Labeling / Failure to Warn
Pharmaceutical manufacturers are required to:
- Warn healthcare providers of non-obvious hazards the product may cause
- Inform physicians how to avoid these risks
The clearest evidence of improper labeling is the Paragard IUD packaging. What the labeling does not say suggests that doctors were not adequately warned about the risk of the IUD breaking during IUD removal and how best to avoid it.
Plaintiffs need to prove the following 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
- The injury resulted in money damages
Teva and Cooper owe patients a duty to provide IUD devices that are safe to use and adequately designed, according to the lawsuits. The complaints further allege that Teva And Cooper breached that duty by selling Paragard IUDs with arms that can break off.
These broken pieces can cause patients to endure invasive procedures and serious adverse events, according to the lawsuits.
What Damages Could I Be Awarded?
If you or a loved one was injured by Paragard side effects, you may be entitled to compensation for the following damages:
- Current / future medical bills
- Loss of wages
- Reduced earning capacity
- Loss of consortium
- Non-economic damages (pain and suffering, etc.)
Related: Medical devices lawsuits we've already covered
Get a Free Paragard Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Paragard Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured by Paragard IUD adverse events, you should contact our law firm immediately for a free case review. You may be entitled to a settlement by filing a suit and we can help.