ParaGard MDL Created in Northern District of Georgia
In a much-anticipated decision, the Judicial Panel on Multidistrict Litigation (JPML) ruled on December 16, 2020 to centralize ParaGard IUD claims against Teva Pharmaceuticals in the Northern District of Georgia under Judge Leigh Martin May. The parties to the litigation have been going back and forth for months arguing about which district court is best suited to oversee the MDL which is expected to grow significantly now that a venue has been chosen.
The JPML found that “the actions involve sufficient common questions of fact and that centralization in the Northern District of Georgia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.” Centralization will avoid duplicative discovery and other pretrial proceedings, as well as the possibility of inconsistent rulings on Daubert motions and other pretrial matters.
More than 80 women across the U.S. have filed suit against Teva claiming the ParaGard 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.
From the outset, defendant Teva has fought consolidation with arguments the JPML found did not carry sufficient weight. The defense argued that each of the involved claims would turn on unique, plaintiff specific issues including whether the plaintiff’s healthcare provider would have prescribed ParaGard if the device had come with different warnings. The JPML ruled the individual case differences would not be an impediment to centralization where common questions of fact predominate.
Severe Complications Linked to ParaGard IUD
Due to its defective design, the arms of the T-shaped ParaGard IUD can break off and migrate inside the uterus causing severe damage to organs and internal tissue. Many women have experienced device arm breakage during the removal process which creates medical complications and can result in a second, more painful and complicated removal procedure. In the most severe cases, a hysterectomy may be required.
Although ParaGard is highly effective for birth control, if pregnancy does occur, the patient faces an increased risk of ectopic pregnancy. An ectopic pregnancy has serious complications for both the fetus and the mother and must be treated immediately. Ectopic pregnancy is the leading cause of maternal death in the early stages of pregnancy.
According to FDA reports ParaGard is linked to complications and injuries that include the following:
- IUD device embedded in the uterus
- Migration or arm breakage of the device causing perforation and tissue damage
- Breakage during removal procedure so parts of the device are left behind
- Inflammation from copper residue
- Uterine and organ damage
- Ectopic pregnancy
- Complications with sexual activity and reproduction after removal
Pending litigation alleges that Teva and their sales force overstated the benefits of ParaGard IUD and minimized and downplayed the risks associated with using the product. The claim further alleges Teva knew the device was defective and unreasonably dangerous and that it can cause serious harm to patients who use it due to the risk of ParaGard arms breaking upon removal.
Teva’s Long History of Ignoring Evidence
Despite numerous complaints and thousands of adverse events reported to the FDA, Teva took no action to adequately warn patients or remedy the defects. Instead, Teva concealed these facts and suppressed the information that could have helped patients make an informed decision about birth control. Since 2010, the FDA has received over 1,600 reports of ParaGard IUD arm breakage with 700 classified as serious.
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