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A number of women implanted with the birth control IUD Paragard have suffered a broad range of medical issues caused by the intended use of the product, including fractures, ectopic pregnancy and other complications.
Plaintiffs are claiming that the grievous injuries they endured resulted from certain copper based IUDs like Paragard being defective and prone to breakage, resulting in these dangerous side effects.
If you or a loved one suffered an injury after receiving a Paragard IUD implant for preventing pregnancy, you may be eligible for compensation.
Paragard is a long-term birth control method known as an intrauterine device (IUD). The basic design includes a copper wire coiled around a T-shaped plastic base, which is inserted into a woman’s uterus by a doctor. Paragard is a medical device that prevents pregnancy with alleged effectiveness of 99%. The mechanism for the IUD to work is a slow release of copper over 10 years.
Once the device is implanted in the uterine cavity, it interferes with the fertilization of the egg by blocking sperm movement after intercourse. In addition to simply blocking sperm from reaching the uterus, Copper is somewhat toxic, and according to the manufacturer’s published instructions and warnings, Paragard’s copper is designed to cause an inflammatory reaction in the uterus, preventing the egg from attaching. This is not a side effect or complication, but the very method through which Paragard is designed to prevent pregnancy by stopping egg fertilization.
There are two different models of Paragard: the Copper 380 Slimline and the Copper 380A. The device is manufactured by Teva Pharmaceuticals, and it was first released it into the American market in 1988.
According to recently filed complaints, the Paragard intrauterine contraceptive device is prone to breaking inside the body of the woman who had it implanted. This may lead to the device becoming embedded inside the uterus, perforating it and causing serious injuries to the patient due to fragment migration.
Many Paragard users reported that the device can also break during the removal procedure, and when that happens, the broken pieces must be painfully removed one by one with a complicated medical procedure necessary to avoid organ damage.
In some instances, these fragments can become embedded so deeply inside the woman’s tissue that a total hysterectomy (removal of the uterus) is required, with devastating psychological and physical consequences.
If a Paragard IUD breaks, the risks of additional side effects rise dramatically. Some related side effects are infection, scarring, idiopathic intracranial hypertension, and ectopic pregnancy. This type of pregnancy occurs outside the uterus, most often in a fallopian tube. Since the fetus can’t develop normally, it may cause potentially fatal internal bleeding in the mother and must be removed as urgently as possible.
Paragard isn’t the only dangerous IUD device that hit the American market. Mirena, a similar device manufactured by Bayer, has been associated with a staggering number of complications and adverse reports (nearly 50,000) since the U.S. Food and Drug Administration (FDA) approved it back in 2000.
Although Mirena’s contraceptive power is based on a different principle (using small quantities of the hormone levonorgestrel in the bloodstream rather than copper), this alternative device is no less dangerous. In fact, this T-shaped device may also detach from its implanted position, causing gruesome organ injuries such as the perforation of the fallopian tubes or the uterus. Mirena is also associated with another serious condition called pseudotumor cerebri (PTC), a buildup of pressure in the brain. It is also known as idiopathic intracranial hypertension (IIH).
The main difference between Paragard and Mirena is that Paragard uses copper to prevent pregnancy while Mirena uses synthetic hormones. Both are made primarily of plastic, but Paragard incorporates copper wire coiled around the frame. Paragard lasts 10 years – twice the 5 years of Mirena’s duration.
Currently, attorneys are trying to hold Teva Pharmaceuticals liable for injuries sustained through the use of the Paragard IUD. Lawyers accuse the pharmaceutical company of releasing a defective medical device to market, focusing squarely on Teva’s negligence in warning the public about Paragard’s potential dangers. In December 2020, the JPML centralized all Paragard cases to be tried together in the Northern District of Georgia in front of Judge Leigh Martin May. This may facilitate settlement discussions, but the process is just beginning.
This process may mirror the Mirena litigation, where, due to the large number of women injured by the device, a plethora of lawsuits had already reached a number of district federal courts. The Judicial Panel on Multidistrict Litigation (JPML) consolidated them into the MDL No. 2434 in the Southern District of New York back in 2017. At least 2,700 women have sued Bayer over these adverse events. Some of these cases settled in 2018 for $12.2 million, but the settlement only included claims related to IUD migration and perforation. Bayer’s 2018 settlement did not settle any cases related to pseudotumor cerebri.
According to court filings, Teva was fully aware of the risks associated with the use or removal of Paragard, and willfully downplayed or ignored them. While the manufacturer described Paragard as a safe method of birth control, important data about its numerous complications has never been fully disclosed. Attorneys allege that the manufacturer obtained sufficient information about the alleged dangers of the IUD device from both post-marketing experience, medical product safety network data, and clinical trials. However, Teva remained focused on the bottom line, never warning women about potentially serious risks of using Paragard for contraception. The device has never been subject to either a manufacturer or FDA recall.
Medical device manufacturers like Teva must be held liable for the injuries they caused you or your loved one. Litigation is often the only way to seek justice. Importantly, if you or someone you love has been impacted by using Paragard or any other IUD, a lawyer may help you receive adequate compensation for your pain and suffering. But the clock is ticking. Call today if you believe you or someone you love has been injured by using the Paragard IUD.
As of today, it’s difficult to estimate just how much Teva Pharmaceuticals may pay if the mass tort is eventually settled. Settlement discussions are unique for each mass tort case, so predicting settlements is usually a fool’s errand. Usually, the manufacturers of allegedly defective devices offer an individual agreement to each injured victim only if the first few bellwether cases do not end in their favor. Judge May is likely to set a schedule for these bellwether trials and the case generally in the first quarter of 2021.
However, due to the striking similarities with the Mirena litigation, we may expect the trials to end in a similar way. During the ongoing Mirena litigation, Bayer paid $12.2 million to settle devices migration cases in August 2017.
Awards in this kind of case are unpredictable and will be based on the specific facts of your specific case. In other words, even if your case is successful, and a court awards you damages, the individual payout you will receive will vary significantly. While global settlements are a possibility, it remains much more likely that each IUD lawsuit will be analyzed separately, and the value of your claim will depend on the details of your particular situation.
Your lawyer will be able to help you recover more if you suffered more economic, personal, physical or emotional damage. Factors such as pain and suffering, loss of consortium, loss of wages and medical expenses need to be considered before your financial reward is calculated under the terms of a settlement agreement or a verdict at trial.