Table Of Contents
- Paragard’s Design and Composition
- The Hidden Defect of Paragard
- Bellwether Trials and Their Significance
- The Growth of Paragard Lawsuits
- Paragard Lawsuit Update – August 2022
- What is Paragard?
- What’s the Problem?
- Paragard May Break During Removal: Study
- Paragard IUD Side Effects
- Paragard Removal
- Paragard Breaking Treatment
- Mirena vs. Paragard
- Has There Been a Paragard Recall?
- Paragard Litigation Updates
- Is There a Class Action?
- Global Paragard Settlement
- If You Have Been Injured By Paragard
- What are Paragard Lawsuits Alleging?
- What Damages Could I Be Awarded?
- Get a Free Paragard Lawsuit Evaluation With Our Lawyers
Paragard’s Design and Composition
The Paragard IUD is a unique birth control device, distinctively Y-shaped and roughly the size of a quarter. Its design incorporates a copper coil wrapped around its center. The device’s frame is crafted from a combination of polyethylene and barium sulfate.
This IUD is strategically placed at the base of the uterus by a medical professional and is designed to offer protection against pregnancy for up to ten years. Its design also includes a removal cord, allowing for easy extraction by a doctor when the time comes.
Despite its widespread use, the Paragard IUD has come under scrutiny for a hidden design flaw that poses potential risks during the removal process. Over time, the plastic arms at the base of the Paragard can become rigid. Instead of flexing upwards during removal, these arms can break off, leaving sharp plastic fragments inside the patient’s uterus. This defect has led to numerous reports of complications and has become the focal point of ongoing lawsuits against the device’s manufacturers.
Bellwether Trials and Their Significance
In the realm of mass tort litigation, bellwether trials play a pivotal role. These are early trial dates set for a select group of representative cases. The outcomes of these trials provide valuable insights into how juries might react to evidence and testimonies that will recur throughout subsequent cases.
By gauging these reactions, bellwether trials can guide the direction of future trials and even influence potential settlements. They act as a litmus test, setting the tone for the litigation process.
The Growth of Paragard Lawsuits
The Paragard MDL (Multidistrict Litigation) has witnessed a steady influx of cases over the years. As of April 2023, the MDL housed almost 1,800 cases, all centralized in the Northern District of Georgia. This consolidation facilitates a streamlined “group discovery” process, allowing both plaintiffs and defendants to delve into the design flaw allegations and the manufacturer’s knowledge about the same. The growth in the number of lawsuits underscores the gravity of the issue and the need for a resolution.
Paragard Lawsuit Update – August 2022
Last month, at least 51 new Paragard lawsuits were transferred into the MDL, bringing the current number of pending Paragard IUD lawsuits up to 1,246.
Since May, the Paragard MDL has added about 86 new cases each month, which has been a noticeable increase in the rate of new filings compared to prior mass tort cases filed over the previous 18 months.
The Paragard MDL judge in July issued a long-anticipated order requiring the plaintiffs to submit completed fact sheets and initial discovery documents in support of their claims. This is good news for victims who have filed a Paragard IUD lawsuit. It means the class action is moving forward.
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 Paragard IUD 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 IUD device 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 / uterine cavity
- 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
Related Article: IUD Perforation Symptoms & Treatment
More common side effects of the Paragard 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 IUD 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 were 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 medical 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 Paragard Recall?
No. Despite Paragard cases 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 .
Paragard Litigation Updates
November 16, 2023: The Paragard lawsuit MDL has added at least 37 new cases so far in November, bringing the total case count up to 2,283. The volume of new cases in the Paragard litigation has been slower since the summer months, suggesting this may be a long-term trend.
November 1, 2023: All plaintiffs in the Paragard Lawsuit MDL were supposed to fill out a Plaintiff Fact Sheet (PFS). However, a number of plaintiffs missed the deadline to file the PFS.
October 16, 2023: Nearly 100 new cases were added to the Paragard lawsuit MDL since this time last month. This brings the total number of pending cases in the Paragard litigation to 2,246, approximately 1 year out from the initial bellwether trials.
October 9, 2023: The focus in the Paragard lawsuit MDL is currently on case-specific fact discovery. Depositions will soon be taken from the plaintiffs and their spouses and other fact witnesses in the bellwether cases. The focus will then shift to depositions of expert witnesses.
September 27, 2023: The Paragard litigation has been dragging lately. The MDL was initially created in Dec. 2020, and then it took several years before Judge Leigh Martin May confirmed scheduling for the bellwether test trials. The first bellwether trial is set for October 28, 2024.
Judge May then set a schedule for case specific fact discovery in the bellwether pool cases, with depositions set to be finished by the end of the year. Although this seems to indicate that things are headed in the right direction, the first scheduled bellwether trial date is almost always postponed at least once. Assuming this trend continues, it means that the first actual Paragard trial won’t take place until 2025.
September 24, 2023: Judge May addressed a discovery dispute last week concerning the Cooper Defendants’ reluctance to produce certain event documents and complaint files. In response to this dispute, the Court set this deadline at 75 days from the date of the hearing. While 75 days is a long time, Judge May appears fed up with non-compliance of the deadline, stating that unless extraordinary circumstances arise, any failure to meet the deadline will carry severe consequences.
September 20, 2023: The number of cases pending in the Paragard lawsuit MDL has grown to 2,147, after 53 new cases were added to the litigation since last month. Since the beginning of 2023, the Paragard class action has added more than 500 new cases, averaging more than 63 new cases per month.
September 1, 2023: Judge May issued a newly amended Scheduling Order, once again pushing back the dates and deadlines in this slow litigation. Per the new schedule, case-specific fact discovery has been pushed out to Feb. 9, 2024, and the expert discovery deadline in those cases has been extended to May 10, 2024. The new date for the first Paragard bellwether trial is scheduled for Oct. 28, 2024.
August 17, 2023: 31 new cases were added to the Paragard lawsuit MDL since this time last month. That is the slowest month in terms of new case volume that we have seen in this litigation since early 2022. Does this mean anything? There are now a total of 2,094 pending cases in the Paragard MDL.
August 1, 2023: A group of more than 100 plaintiffs in the Paragard MDL are close to having their cases dismissed. These plaintiffs are facing dismissal for one of two reasons: either because they failed to comply with certain mandatory procedural requirements set by the court, or because they have lost contact with their attorneys for some reason. Despite strong opposition from plaintiffs’ counsel, most of these cases should ultimately be dismissed.
July 18, 2023: With bellwether test trials set to kick off in less than 1 year, the Paragard lawsuit MDL is continuing to grow slow yet steady. Over the past month, another 53 new Paragard IUD lawsuits were added to the litigation, bringing the total up to 2,063 and marking the 14th consecutive month of no fewer than 40 new cases.
July 1, 2023: Under the Court’s Pretrial Order on Plaintiff Fact Sheets (PFS), all plaintiffs in the Paragard Class Action were instructed to complete a Plaintiff Fact Sheet along with signed authorizations by Nov. 4, 2022. It is July 2023, and there are 132 Paragard plaintiffs – so over 6% of the claimants – have not submitted a PFS.
The deadline to provide the PFS – or to explain why they have not submitted the document – expired at the end of August. So a certain number of dismissals is imminent, which is a good thing for victims with viable claims. Plaintiffs who do not have serious claims – or are not really interested in pursuing a Paragard lawsuit – are better off moving along and not dragging out the litigation process.
June 16, 2023: The Paragard litigation added another 44 new active cases since this time last month, pushing the total number of pending claims over the 2,000 mark.
June 2, 2023: The first pool of bellwether discovery cases should be finalized at the next monthly status conference in the Paragard MDL. Once this is complete, these cases will go through case-specific fact discovery, which will include depositions of the plaintiffs and their healthcare providers. This data will then be used to narrow down the bellwether pool to a half dozen cases.
May 15, 2023: At least 186 new Paragard lawsuits were consolidated into the MDL in the last month. This marks the highest volume of new monthly cases since the start of the litigation.
May 5, 2023: On Tuesday, a California woman filed a lawsuit directly in the Paragard class action in Georgia, alleging that her IUD broke during removal, requiring multiple procedures to completely remove the device. She filed her lawsuit against Teva and CooperSurgical.
May 1, 2023: There have been many recent substitutions on the short list of Paragard bellwether trials. Judge May is being very thorough and calculated as to how to approach the selection of cases for trial. May is seeking a hybrid approach for case selection, where each side chooses 3 cases and both sides get 1 veto.
April 18, 2023: Another 64 new lawsuits were transferred into the Paragard lawsuit MDL in the past month. There are now at least 1,780 plaintiffs in the Paragard class action. Assuming the trend of 50-90 new cases every month continues, the Paragard MDL will surpass 2,000 before the end of the year. Bellwether trials are 18 months out.
March 16, 2023: The Paragard MDL added 34 new cases over the last monthly period, bringing the total pending case count to 1,716. This indicates a sharp decline from last month when 105 new cases were added, the 2nd-highest monthly volume since the MDL began.
February 27, 2023: Judge May has established a procedure to choose the 10 representative cases for the first bellwether trials set to take place early next year. These cases will then go through discovery, after which 3 of the 10 cases will be selected for the 1st round of bellwether trials. The plaintiffs will pick 1 case, the defense will pick 1, and the court will pick 1. The first trial is set to kick off in March 2024.
February 17, 2023: 105 new cases were added to the Paragard class action over the past month, bringing the current total of plaintiffs with pending claims to 1,682. This marks the 2nd highest monthly total of new Paragard IUD lawsuits since the litigation started. Based on FDA adverse event reports, this steady growth in the Paragard litigation will likely continue throughout 2023.
February 1, 2023: During last week’s Paragard status conference, Judge May offered guidance to the parties on their proposals for selecting cases for bellwether trials. This issue is likely to be revisited at the next status conference.
January 25, 2023: Last week, the Paragard MDL judge formally appointed mediator M. Gino Brogdon Sr., a retired judge from Atlanta, to facilitate settlement discussions between both sides in the mass tort class action. Brogdon will be tasked with getting the two sides working toward a global settlement.
January 17, 2023: 49 new lawsuits were consolidated into the Paragard lawsuit MDL over the last month, bringing the total number of plaintiffs to 1,577. This is back to the normal monthly average of new Paragard lawsuits after a brief uptick a month earlier.
January 2, 2023: Over the past year, the Food and Drug Administration received at least 934 adverse incident reports involving the Paragard IUD breaking during removal. This is 3x as many fractures during removal reported to the FDA in 2020.
July 1, 2022: A record number of new Paragard lawsuits were transferred into the MDL in the last 2 months. The most recent monthly status conference was held on June 21.
June 23, 2022: Our Paragard lawyers have been getting more calls from victims over the last few months. The Paragard class action lawsuit is getting a second wind when it comes to new Paragard lawsuits. Over the past 30 days, Paragard has become one of the hottest mass torts in the United States. There were 177 new Paragard IUD lawsuits filed or transferred into the MDL between May 15 and June 15. This brings the total number of pending IUD removal lawsuits up to at least 1,192.
This was the largest increase in new cases of any MDL during this period. There is no obvious explanation for this sudden uptick in new cases, but it could be the result of certain Paragard lawyers filing large blocks of new lawsuits after sitting on them for months.
June 6, 2022: MDL Judge Leigh Martin May held a status conference just before Memorial Day weekend and heard from the parties regarding the Plaintiffs’ objections to the documents produced by the defendants in discovery. The status of the Plaintiff Fact Sheets was also reviewed.
May 16, 2022: Our Paragard lawyers are still getting calls almost every day from women seeking to file a Paragard lawsuit. During the first 2 weeks of May, at least 5 new Paragard IUD lawsuits were transferred into the Paragard MDL. Two new cases were added in April. Overall, there are 1,121 Paragard migration lawsuits pending in the federal class action lawsuit.
May 6, 2022: The effort to get ready for the Paragard bellwether trials continues. Toward that end, there is a Discovery Conference set for Friday, May 13, 2022, at 9:30 a.m. via Zoom. There are currently at least 1,018 Paragard lawsuits pending in the MDL class action in the Northern District of Georgia.
April 19, 2022: Judge Leigh Martin May will hold the monthly status conference in the Paragard MDL this week. One big issue at these conferences is getting a handle on how many Paragard lawsuits have been filed. This litigation has been very quiet, getting little media attention or even attention from personal injury lawyers. But based on the recent rate of new Paragard IUD lawsuits being filed, the total number of pending cases in the MDL in the Northern District of Georgia should surpass 1,000 this month.
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 defective medical devices; however, the companies failed to warn that the arms of the Paragard IUD 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 bellwether trials, third-party studies, and consumer experience and complaints.
Additionally, the complaint states that the FDA has received over 1,600 reports that the ParaGard IUD fractured, 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 by a woman in the Southern District of Illinois alleged that her Paragard IUD fractured shortly after being implanted.
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 healthcare 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 Paragard IUD lawsuit attorneys’ fees, costs, and pre-judgment. She also seeks punitive damages against the defendants for attempting to misrepresent facts concerning the safety of the device.
See More: Medical Device Lawsuits
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 multidistrict litigation (MDL).
As opposed to a class action lawsuit, which combines all the cases into one, 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.
Global Paragard Settlement
Given the mounting number of Paragard lawsuits, there’s increasing speculation about a possible global settlement. Such settlements are common in mass tort cases that aren’t dismissed by the court. A global settlement would involve the manufacturers offering a collective settlement amount to resolve a large number of cases simultaneously. This approach not only expedites the resolution process but also ensures that affected individuals receive compensation without undergoing lengthy individual trials.
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 substantially increased risk of the device fracturing upon removal (“explant”) – despite the IUD being marketed as easy to remove.
“ParaGard is contraindicated in pregnancy or suspicion of pregnancy; in women with
abnormalities of the uterus resulting in distortion of the uterine cavity; acute pelvic
inflammatory disease, or current behavior suggesting a high risk of pelvic inflammatory
disease; postpartum endometritis or postabortal endometritis in the past 3 months; known or
suspected uterine or cervical malignancy; genital bleeding of unknown etiology; mucopurulent
cervicitis; Wilson’s disease; allergy to any component of ParaGard; or a previously placed intrauterine device that has not been removed. ” DEPARTMENT OF HEALTH & HUMAN SERVICES Stated.
Under strict liability/ product liability law, a pharmaceutical company is legally responsible for injuries if the product’s design poses 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 IUD products liability litigation, 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 monetary damages
Teva and Cooper owe patients a duty to provide IUD medical 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.)
Get a Free Paragard Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at Schmidt & Clark, LLP 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 are 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 a Paragard Lawyer immediately for a free case review. You may be entitled to a settlement by filing a suit and our dangerous drugs lawyers can help.