A woman’s choice of birth control is a deeply personal decision, particularly when choosing a long-acting form of birth control like Paragard that can remain in a woman’s body for up to 10 years. IUDs or intrauterine devices are widely recommended for women as a safe and effective form of birth control. However, recent lawsuits have revealed the hidden danger of IUDs, specifically occurring when women have the device removed. The result is that women, who are oftentimes removing the device because they are seeking to start a family, find themselves unexpectedly injured or infertile from a device that they thought was safe.
Paragard is a non-hormonal, non-surgical IUD that is placed into a woman’s uterus by a healthcare provider for the purpose of preventing pregnancy. It is composed of copper wire wrapped around a T-shaped plastic frame. The copper is intended to produce an inflammatory reaction that disrupts sperm transport and egg fertilization and prevents a woman from getting pregnant. A thin thread tied through the tip of each Paragard is intended to aid in the easy detection and non-surgical removal of Paragard from a woman’s body.
For decades, women have relied on the manufacturers representations that Paragard was a safe and dependable form of non-surgical and easily reversible birth control. Obviously it is of the utmost importance that women know all risks associated with a particular type of birth control given that a women’s choice of birth control can have long-term consequences on her fertility and potential childbearing timeline. That is particularly true here, where Paragard was intentionally marketed as a form of birth control that could easily be reversed when a woman wanted to conceive.
In fact, Defendants touted Paragard’s simplicity and effectiveness, claiming that Paragard could be removed quickly and easily, and that immediately after removal, Paragard’s contraceptive effect is reversed.
The IUD in question is Paragard IUD T 380 A, manufactured by Teva who sold the Paragard brand to Cooper Companies/Cooper Surgical for $1.1 billion in November 2017. Paragard was originally approved in 1984 with the assertion that it was safe for up to 10 years of continuous use. Paragard is 100% hormone-free and is inserted through a small tube as part of a routine office visit with a gynecologist. The product is made of polyethylene that is wrapped in copper wire with two monofilament strands at the bottom. The copper coil creates a spermicide effect resulting in a more than 99% effectiveness rate at preventing pregnancies.
Paragard as a copper IUD is typically stated as being “better” than Bayer’s Mirena IUD which is a long-term birth control device that uses hormones to prevent pregnancy and is known to cause pseudotumor cerebri (PTC). Paragard is supposed to be, and is marketed as, a safe, easy, and fully reversible form of birth control. But Paragard is not safe, easy, or fully reversible. Thousands of women have suffered injuries—including, but not limited to, permanent infertility—from using Paragard. The product is regulated by the Food and Drug Administration (FDA) as a pharmaceutical drug. Despite lawsuits and known hazards, Paragard remains on the market.
Women and their doctors depended on the manufacturers and distributors of Paragard, to be forthcoming about the safety and risks of Paragard. And this reliance on the manufacturer was warranted. The regulatory scheme that governs Paragard is premised on a system whereby the manufacturer is responsible for reporting relevant safety information to the public. A drug manufacturer oftentimes has exclusive access to post-market safety information, including the reporting of adverse events and complaints. The onus is on the manufacturer to come forward with any safety risks because the public and the U.S. Food and Drug Administration (“FDA”) otherwise have no insight into these events.
Lawsuits filed over the last several years against the manufacturers of Paragard were all filed by women who experienced the Paragard product breaking while it was still inside their body. During removal, the arms of the Paragard are supposed to fold upward at the joint, but often one or more of the arms breaks. Paragard has also shown a propensity to break prior to removal, during the normal course of use.
This dangerous breakage occurs spontaneously before or upon removal, even when the doctor carefully follows instructions without error. Plaintiffs allege that Paragard is prone to break when removed and to become embedded inside a woman’s uterus or cervix. This breaking results in patients needing a follow up procedure to locate and retrieve the missing IUD. These procedures can be very invasive and range from hysteroscopy, laparoscopy, laparotomy (similar to a C-section), or a hysterectomy. All of these have serious effects on a woman’s future fertility.
Since Paragard was introduced to the market, its manufacturers have received reports, studies, and otherwise learned new information about Paragard’s breakage and the resulting injuries. Even though over 2000 adverse event reports did or should have alerted them to a product defect causing the device to break inside the body, causing injuries, the manufacturers failed to address Paragard’s safety issues. It is anticipated that this number is a gross understatement because the manufacturer also failed to maintain a systematic reporting system for complaints, as required by law.
Defendants therefore likely underreported adverse events of Paragard breaks to the FDA, concealing this information and failing to take any action to inform patients, physicians, or the public about Paragard’s propensity to break. This failure to act has resulted in life-altering consequences for Plaintiffs, some of whom have required hysterectomies or other invasive procedures to remove the broken Paragard from their bodies. Now, women across the country seek to hold the manufacturer of Paragard accountable for their injuries.
While the lawsuit began as individual cases, in December 2020 the cases started becoming consolidated into a multi-district litigation (MDL) in the Northern District of Georgia. The MDL number is 2974. As of November 2022, there are approximately 1,400 cases in the Paragard MDL. The purpose of an MDL is as a mechanism to speed proceedings in the court system by allowing the judge to make all pretrial decisions for all the cases.
Eventually a few cases will go to trial in what is called bellwether trials. The outcome of these bellwether trials will steer the settlement negotiations in all remaining cases. Because this is an MDL and not a class action, each case remains separate, allowing injuries to be evaluated on a case-by-case basis. Bellwether trials are expected to begin in 2023.
The issues outlined against Paragard include the following claims:
It’s important to note that this lawsuit does not allege that all IUD products are faulty. However, the Paragard product (Paragard IUD T 380A) is being called into question because it is insufficiently flexible. Unlike other IUDs, Paragard’s arms have no curvature and are fixed, straight plastic arms bonded to a plastic vertical post, resulting in a less flexible product. This unique, rigid, T-shaped design is prone to snap at the arms, causing Paragard to break more than any other IUD on the market in the United States. This inflexibility is also partly caused by the raw plastic not meeting minimum flexibility requirements. Plaintiffs allege that because of these flaws, Paragard breaks in the body before or during removal and has caused their injuries.
The lawsuits against Paragard also allege that there is a manufacturing-defect claim for the product. Plaintiffs point to precise manufacturing practices Defendants were required to follow to ensure that Paragard did not deviate from design specifications, and explain how Paragard nevertheless deviated from design specifications:
Plaintiffs further allege that Defendants knew or should have known that Paragard could cause and did cause serious harm to women due to its propensity to break in utero or during removal but that Defendants failed to adequately warn of these risks. Specifically, the lawsuit details that between 2009 and 2020, Defendants received reports of over 2000 Paragard breaks, which should have put them on notice of disproportionally frequent breakage, but that Defendants failed to properly investigate, record, or submit those reports to the FDA and failed to amend the label to warn (1) that Paragard is prone to break, including during removal, even when it is neither embedded in nor has perforated the uterus; (2) of the frequency with which such breakages occur; and (3) of the severe injuries—including infertility—that can result from such breakages.
Even though Defendants had knowledge of Paragard’s defect, Defendants failed to timely update the Paragard warning label to adequately warn of Paragard’s propensity to break—a label change that is permitted by the FDA under a “changes being effected” (CBE) warning supplement that permits a manufacturer to make immediate changes, subject to FDA’s post-change review.
Despite having years of knowledge and information about the product’s propensity to break inside a woman’s body and cause injury, it was not until 2019 that Defendants used the prior approval supplement process to update the Paragard label to the Physician Labeling Rule format, which added references to Paragard breakage. Even now, however, the current label is still inadequate.
They additionally contend that Paragard undertook a concerted marketing campaign that has overstated the safety of Paragard, downplayed its risks, and portrayed Paragard as the safest form of long-lasting, nonsurgical, non-permanent birth control.
The lawsuit also alleges that the Defendants’ failed to provide adequate warnings and instructions for Paragard in that Paragard’s warnings do not include warnings of the severity and frequency of the risks associated with Paragard’s removal, which include the risk that breakage or removal may require surgical intervention and loss of reproductive health or fertility. In addition, the warnings do not provide clear and concise information regarding Paragard’s propensity to break inside the body, including during routine and non-surgical removal, even when the product is not embedded.
The warnings that were provided were obscured by misleading marketing messages claiming that Paragard is easily and immediately reversible through non-surgical means. These factual allegations are sufficient to state plausible design-defect claims, and the portion of the design-defect allegations pertaining to the lack of warnings are also sufficient to state plausible claims for failure to warn.
A similar analysis applies to Plaintiffs’ allegations regarding the Paragard labeling. Plaintiffs have alleged that Defendants made false statements in the labeling of Paragard by failing at all times to include a warning on the label that users may be injured because Paragard could break before or during removal, failing to include a warning about the frequency of such breakages, and failing to attempt to change the label to delete a false or misleading expiration date or add a proper expiration date to ensure that Paragard would not degrade and thus increase its propensity to break, despite having actual or constructive knowledge that Paragard could break before or during removal and/or that the expiration date was too long.
Issues related to Paragard typically occur when the device is removed when one or both arms of the IUD break off. When this breakage occurs, a surgical procedure may be necessary to retrieve the pieces. In some cases a hysteroscopy can be successful in removing the parts. This is when a doctor uses an endoscope through the cervix into the uterine cavity to retrieve the broken pieces. In more extreme cases, the patient may require a laparoscopy, a laparotomy or a hysterectomy (removal of the uterus/permanent infertility). On the farthest extreme of the spectrum, doctors are unable to find pieces at all as they become embedded in the uterine wall or travel to other parts of the body. This can result in serious complications such as:
The multi-district litigation (or MDL) alleges that manufacturers of Paragard intentionally concealed the risks associated with Paragard’s removal, telling women the “contraceptive effect is reversed” as soon as Paragard was removed. In other words, Defendants not only shirked their reporting responsibilities to the FDA and the public at large but also undertook affirmative steps to misrepresent the safety profile of Paragard in order to increase sales. Unfortunately for women who used this product, the manufacturers appear to have chosen greed and profits over the safety of users who suffered injuries as a consequence.
If you or a loved one suffered injury or infertility due to a Paragard IUD, you should reach out to an attorney affiliated with the MDL to understand your options for recovery. Lee Floyd, a partner at Breit Biniazan, is an appointed member of the Plaintiffs Steering Committee. We invite you to reach out via a phone call or contact form submission to tell us about your situation. Every situation is unique, but our team will be happy to review your specific case and provide options and insight into the process of recovery.
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