Last week a New York woman filed suit in federal court against Teva Pharmaceuticals after sustaining serious injuries when a ParaGard IUD broke apart when being removed by her doctor. Vanesha Johnson was forced to undergo unplanned surgery to have the broken arm of the birth control device removed, but unlike many victims, did not require a hysterectomy.
Johnson decided to have the IUD removed after an ultrasound showed the device had migrated and was out of place. When Johnson’s doctor attempted to remove the IUD by following to the manufacturer’s instructions, one of the device arms broke off and remained inside her uterus.
Johnson’s claim against Teva states she has suffered a range of serious injuries including loss of reproductive health, pain, suffering, mental anguish, loss of enjoyment of life and significant medical expenses.
The claim 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 patient complaints
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.
TEVA FAILED TO ACT OR ADEQUATELY WARN DOCTORS AND PATIENTS DESPITE KNOWLEDGE OF THE RISKS FROM THEIR OWN TRIALS AND STUDIES, AND NUMEROUS COMPLAINTS FROM PARAGARD IUD USERS.
Proving causation with defective device claims is not cut and dry
Just because an IUD breaks, does not mean it was defective or poorly manufactured. The device breakage can be caused by something that was not the fault of the manufacturer. The burden of proof is on the plaintiff to establish the device manufacturer was at fault for the injuries.
In 2018, the Seventh Circuit agreed with an Indiana federal judge in finding that a woman whose IUD broke apart during removal needed expert evidence to bring a product liability claim against Teva ruling that problems with the medical device are not obvious. Under Indiana’s state law, expert evidence is necessary to prove causation in product liability cases when a lay person would not understand the issue or would be required to speculate.
In that case, the plaintiff asserted “the fact that the IUD broke apart clearly puts the onus on Teva” The Judge’s response was “that’s exactly the sort of speculation that is insufficient to sustain a products liability action under the Indiana law.” The device could have sustained damage after coming into the possession of the physician or human error during the implantation or removal process. The causal link will not stand up on pure speculation but requires evidence.
The future of ParaGard IUD litigation against Teva
While hundreds of women have filed suit against Teva, the Judicial Panel on Multidistrict Litigation has yet to create an MDL to consolidate pretrial discovery and proceedings. As additional cases are filed the likelihood of MDL consolidation increases.
If you firm is considering joining the fight against Teva Pharmaceuticals to help victims who have been injured by the ParaGard IUD, click the button below to get in touch with us for a free consultation. The ParaGard team at Case Work can help your firm get cases proven up and ready to file.