Paragard IUD Birth Control Lawsuit and Complications
ParaGard IUD is an intrauterine device that is intended to act as a long-lasting birth control solution that can last as long as 10 years. The device is implanted into women and remains in their body, deploying a copper substance that acts as a spermicide to prevent unwanted pregnancies. However, ParaGard IUD is not without its serious side effects. Paragard side effects are a very serious matter that should be researched by both physicians and patients. Specifically, this IUD has been reported to break or migrate after it has been inserted into patients. In some instance, this has caused serious injury to internal organs. In addition, there is a speculated linkage between ParaGard and brain injuries. As a result, the manufacturer of the IUD is facing numerous product liability lawsuits. If you have received a ParaGard IUD and have experienced dangerous side effects, you should immediately seek out a Paragard IUD lawsuit attorney. A Paragard IUD lawsuit will help you get justice and hold Teva accountable for their alleged negligence. “These actions involve common allegations that the Paragard intrauterine device (IUD) has a propensity to break upon removal, causing complications and injuries, including surgeries to remove the broken piece of the device, infertility, and pain. The actions thus implicate questions concerning the device’s development, manufacture, testing, labeling, and marketing.” mdl transfer order
The 411 on the Federal consolidated lawsuit for Paragard IUD
- MDL Number: MDL No. 2974
- Read the transfer order from the UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION
- Northern District of Georgia is the transferee district in Federal Court
- Name of MDL: IN RE: PARAGARD IUD PRODUCTS LIABILITY LITIGATION
- “These actions involve common allegations that the Paragard intrauterine device (IUD) has a propensity to break upon removal, causing complications and injuries, including surgeries to remove the broken piece of the device, infertility, and pain. The actions thus implicate questions concerning the device’s development, manufacture, testing, labeling, and marketing.” Transfer order
- Assigned to the Honorable Leigh Martin May for coordinated or consolidated pretrial proceedings. Id.
- The alleged wrongdoer defendants: Defendants Teva Pharmaceuticals USA, Inc., Teva Women’s Health, Inc., Teva Women’s Health, LLC, Teva Branded Pharmaceutical Products R&D, Inc., The Cooper Companies, Inc., and Cooper Surgical, Inc.
Update- 1/4/21- “According to the plaintiff’s complaint, she was implanted with the ParaGard on May 12, 2011. She was young and healthy at the time and wanted the ParaGard because it was advertised as a reversible form of birth control. On November 20, 2018, the plaintiff went to have the ParaGard removed. Her healthcare provider attempted to do so as instructed by the manufacturers, by grasping the two ParaGard IUD threads and pulling gently. Yet the device didn’t come out as expected. When it emerged, it had one arm missing. Neither the plaintiff nor her doctors were warned that this could happen. As a result, the plaintiff states she suffered significant injuries, including pain, suffering, and loss of reproductive health, and will have to incur future medical expenses.” North Carolina Woman Says ParaGard IUD Broke Upon Removal
12-16-2020- ” WASHINGTON, D.C. –– The U.S. District Court for the Northern District of Georgia has consented to the transfer of Paragard T380A intrauterine birth control devices, according to a recent document filed with the U.S. Judicial Panel on Multidistrict Litigation. Entered in the JPML’s online docket on Dec. 16, the Consent of Transferee Court was signed on Dec. 8 and noted that the multidistrict litigation docket will be assigned to Hon. Leigh Martin May for coordinated or consolidated pretrial proceedings.” Harris Martin
9/23/2020- “Four Missouri women who say they suffered injuries when an intrauterine contraceptive device broke while it was being removed are suing the device’s manufacturer and its successor company.In separate lawsuits filed in federal court in Kansas City last week and in August, the women allege the companies knew or should have known that the ParaGard IUD is defective because its arms have a tendency to break upon removal from the uterus. The device was made by Teva Pharmaceuticals, which sold it in 2017 to The Cooper Companies Inc. for $1.1 billion. Both companies and various Teva and Cooper affiliates are named as defendants.” KBIA
9/3/2020-“UTICA, N.Y. — Teva Pharmaceuticals USA Inc. and its affiliates have been sued in New York federal court by a woman who alleges that their ParaGard Intrauterine birth control device broke apart in her uterus during removal. In an Aug. 31 complaint filed in the U.S. District Court for the Northern District of New York, Vanesha Johnson says she was forced to undergo laparoscopic surgery to remove the remnants of the device, and that defendants failed to warn doctors and patients of the risk of removal.” Harris Martin
7/19/2020- There is currently still no Multidistrict litigation for Paragard Iud lawsuits. Paragard lawsuits are being filed as individual lawsuits in State and Federal courts.
What is ParaGard IUD?
IUDs are a form of birth control that are implanted into the uterus by a doctor in a visit to their office without anesthesia. It is a small device that measures just more than an inch in both length and width. There are strings on the side that are supposed to be used to remove the IUD if necessary. ParaGard is a specific brand of IUD. It is manufactured by Duramed Pharmaceuticals who purchased the original company that developed and sold the device. Currently, Teva Pharmaceuticals owns Duramed. ParaGard has been around since the 1970s and is the only copper-based IUD that is approved for use in the United States.
ParaGard contains copper which is slowly released
ParaGard contains copper which is slowly released from the device. The copper is wrapped around the device and is intended to inflame. The copper that is released as a result of the inflammatory reaction acts as a spermicide and prevents pregnancy without raising the overall copper level in the body. The copper is toxic to the sperm and egg, but is not toxic to the overall body. This is a non-hormonal way for a woman to achieve the goal of preventing pregnancy.
The device is intended to last for up to 10 years. If ParaGard works as intended, it is supposed to be easy to remove. The physician merely uses a pair of forceps to grab onto the strings that are attached to the device. After a gentle pull, the ParaGard comes out and a new one can be inserted if the woman intends to continue IUD birth control.
Only non-hormonal option
“Paragard is one of five different intrauterine devices available in the United States and is the only non-hormonal option. Mirena, Kyleena, Liletta and Skyla are IUDs that work by using the hormone levonorgestrel.” Drug watch
“Some people prefer the copper IUD as it is non-hormonal, yet very effective at preventing pregnancy and can even be used as a form of emergency contraception if inserted within five days of having unprotected sex,” Courtney Benedict, associate director of Medical Standards Implementation at Planned Parenthood Federation of America, told Drugwatch. “Paragard is considered the most effective form of emergency contraception because it reduces the risk of pregnancy by 99 percent up to five days after having unprotected sex, and can remain inserted for up to 12 years.” Id.
Side Effects of ParaGard
Some women have reported experiencing severe side effects as a result of the insertion of ParaGard. The normal side effects are supposed to be bleeding, cramps and a heavier than usual discharge during the menstrual cycle. However, some of the complications from this device are indeed more serious than those that are advertised.
Paragard side effects
Some women have reported that ParaGsrd has caused an infection in the fallopian tubes, the uterus or nearby organs. This can lead to severe inflammation of the pelvis which can cause more serious problems that can include death in the absolute worst case scenario. If the infection cannot be treated, the IUD must be surgically removed. Other times, the device can perforate or move. The perforation also has the potential to damage nearby organs which can lead to infection or the necessity of surgery.
Finally, some patients have reported that their doctors experienced serious difficulty in removing their IUDs, requiring that they undergo surgery in order for the doctor to take out the device. The most prevalent severe complication is that the device fractures when the doctor attempts to remove it. In this event, surgery is the only option, and it is generally a complicated and invasive procedure.
linked to ParaGard, Pseudotumor cerebri
These complications are serious in themselves, but there is an even graver side effect that has been linked to ParaGard. Pseudotumor cerebri (PTC) is a condition that impacts the brain that acts similarly to a brain tumor. The symptoms of the two are alike. PTC is caused by pseudotumor cerebri gathering near the brain. Although the exact nature of the linkage is not known, birth control in general has been tied to PTC. This includes ParaGard.
Lawsuits Against Teva
The number of lawsuits against Teva have been growing in the past several years. Even if ParaGard has a low rate of severe complications, there is a large number of women who have received the device over the years, meaning that there can still be a large pool of potential claimants. The plaintiffs have alleged that the product is defectively designed and manufactured since it can either move, perforate or become extremely difficult to remove. In addition, the plaintiffs allege that Teva has known of the dangers of these products for many years, yet continues to market and sell them to women notwithstanding the danger. Even though Teva is alleged to be fully aware of the severe complications, the company has not warned women of the dangers.
Paragard IUD Lawsuit
Teva has tried to escape liability for the failure to warn allegation by arguing that it used the warning label that was approved by the FDA and it could not have changed the FDA-sanctioned label. However, courts have recently begun to hold that, even if a warning label is approved by the FDA, a company has the obligation to update the label if it comes into possession of new information. This is a potentially important development in product liability litigation as it pertains to medications since it removes one of the drugmaker’s defenses.
Many of these lawsuits are currently pending in various courts. There is no multi-district litigation in these cases so each suit is proceeding entirely on its own as of now. While there is no multi-district litigation for ParaGard, its competitor Mirena is facing this litigation for the connection between it and PTC.
STEPHANIE IDEUS, vs. TEVA PHARMACEUTICALS USA, INC. and TEVA WOMEN’S HEALTH, INC.,
- In 2019, the United States States District court of Nebraska dismissed a Teva IUD lawsuit filed by Stephanie Ideus. The Court determined that the warnings provided by Teva were sufficient and adequate. The Court granted Teva’s motion to dismiss (summary judgment) Read Stephanie Ideus’ lawsuit here
- “Briefly summarized, the plaintiff, Stephanie Ideus, received the birth control ParaGard T380 Intrauterine Copper Contraceptive. Filing 81 at 6. Four years later, as her physician was removing the ParaGard, a piece of the device broke off and embedded in the myometrium of the plaintiff’s uterine wall. Filing 81 at 7. The broken piece was surgically removed in 2016.” MEMORANDUM AND ORDER IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEBRASKA.
- “Ideus claims she was not adequately warned of the possible risks associated with ParaGard. See filing 96 at 3. To support that contention, Ideus points to an “Information for Patients” brochure she received before the device was implanted, and to the product’s package insert, which contains prescribing information for treating physicians. See filing 96 at 3. Both sets of materials, she alleges, lack any warning that the ParaGard “could break during removal, or that smaller pieces of the device (as opposed to the device as a whole) could separate and become embedded “deep in the uterus[.]” Ideus has sued the manufacturers of the device, Teva Pharmaceuticals and Teva Women’s Health (collectively, Teva), for allegedly failing to provide adequate warnings.” Id.
- “So, to avoid summary judgment, Ideus must demonstrate that had the package insert contained a different warning, the treating physician would not have used or prescribed ParaGard. See Freeman, 618 N.W.2d at 842; 772 F.3d at 1138. But here, there is no evidence to suggest that Ideus’ physician would not have inserted ParaGard had the warnings in the package insert been
stronger or more specific. In fact, Ideus has not even named the physician who prescribed and placed her IUD––much less demonstrated that had that physician been given the proper warning, she would not have placed ParaGard. See Freeman, 618 N.W.2d at 842; Brinkley, 772 F.3d at 1138; filing 95 at 19.” Id.
- “And without any evidence before the Court demonstrating that Ideus’ prescribing physician would have changed her prescribing decision if different warnings had been given, Ideus cannot carry her burden of demonstrating proximate cause. Freeman, 618 N.W.2d at 842; Brinkley, 772 F.3d at 1138; see also Estrada v. Teva, No. 3:14-CV-1875, slip op. at 25-27 (S.D. Cal. Oct. 26, 2017) (unpublished opinion); Motus v. Pfizer Inc., 196 F. Supp. 2d 984, 991 (C.D. Cal. 2001).” Id.
- “More fundamentally though, the package insert expressly warned about the possibility of breakage, embedment, and the difficulties of removing ParaGard, making the warning adequate as a matter of law. See filing 91-2 at 5. A warning is adequate if it accurately and unambiguously coveys the scope and nature of the risk to the prescribing physician. See Freeman, 618 N.W.2d at 841; Vallejo, 2014 WL 4922901, at *3; Rowland v. Novartis Pharm. Corp., 2:12–CV–01474, 2014 WL 3735622, at *12 (W.D. Pa. July 28, 2014); In re Avandia Mktg., Sales Practices & Products Liab. Litig., 817 F. Supp. 2d 535, 546 (E.D. Pa. 2011); see also Felix v. Hoffmann–LaRoche, Inc., 540 So. 2d 102, 105 (Fla. 1989).” Id.
- “Here, the package insert clearly stated that “[e]mbedment or breakage of ParaGard in the myometrium can make removal difficult” Filing 19-2 at 12. The label also warned that “[p]artial penetration or embedment of ParaGard in the myometrium can make removal difficult. In some cases, surgical removal may be necessary.” Filing 19-2 at 5. And as Teva’s experts opined, in the medical community, that warning is clearly adequate. Scelta v. Boehringer Ingelheim Pharmaceuticals, Inc., 404 F. App’x. 92, 94 (8th Cir. 2010) (in the prescription drug arena, expert medical testimony is needed to determine whether the drug manufacturer’s warning to the medical community is adequate); see also Rowland, 2014 WL 3735622, at *12.” Id.
- “And despite Ideus’ assertions, the prescribing physician was warned of the exact scenario at issue here: that embedment and breakage can make removal difficult, and in some instances, surgery may be required to remove ParaGard. See filing 57 at 5. In sum, based on the evidence before it, the Court concludes that there can be no genuine dispute of as to the adequacy of the ParaGard warning. See Freeman, 618 N.W.2d at 841; Vallejo, 2014 WL 4922901, at *3; Scelta, 404 F. App’x. at 94; Rowland, 2:12–CV–01474, 2014 WL 3735622, at *12. As such, the learned intermediary doctrine cuts off Teva’s liability. Teva’s motion for summary judgment will be granted and Ideus’ complaint will be dismissed.” Id.
Paragard IUD lawyer
If you have had a ParaGard IUD inserted and have experienced any complications or paragard side effects from the device or difficulty removing it, you should contact a Paragard IUD lawyer to discuss your legal options. The Paragard attorney can inform you as to the process for possibly receiving compensation as well as your chances of success in your case.