Essure is a birth control medication that was intended to be a high-powered and permanent form of contraception that would prevent pregnancy. However, thousands of women have reported serious side effects that have been attributed to Essure that have caused their bodies substantial damage. Now, the manufacturers of Essure have been hit with thousands of lawsuits alleging that the defective product caused the women to suffer immeasurable harm.
Essure was initially developed by Conceptus and was manufactured by that company until Conceptus was acquired by Bayer. The product acts as an implantable birth control device that is an alternative to having one’s “tubes tied.” The device is intended to function as a blockage that would keep sperm from reaching an egg. The device is inserted by a catheter and is intended to be a long-lasting birth control solution. Essure is intended to be a permanent solution with no follow-up birth control or other methods necessary. Essentially, Essure was regarded to be another form of female sterilization. Essure was designed to cause inflammation in the fallopian tubes that would cause them to be permanently blocked. Essure’s manufacturers marketed the drug as a quick and easy way for women to never have to worry about birth control in the future.
Essure was approved by the FDA for usage in 2002 and has been in continuous usage since then until Bayer announced in June 2018 that it was halting sales of Essure. This decision was purportedly due to declines in sales and an unsustainable business model. However, as described below, various factors led to a decline in Essure’s sales, chief of which was safety concerns.
In 2013, it was revealed that numerous women have suffered adverse side effects that have resulted from the use of Essure. After that revelation, a torrent of complaints were filed with the FDA regarding these side effects. To date, 26,000 reports have been filed with the FDA regarding Essure. In addition, many women reported that the product was not entirely effective as women have gotten pregnant after having Essure devices implanted.
Women have been reporting that the Essure implant has fractured and broken apart after it was implanted. Alternatively, even if the implant was able to remain intact, it has also been reported to move around after it has been implanted, causing damage to internal tissue and organs. In some instances, the implant has moved to the lower abdomen and pelvis, causing significant pain and bleeding. Once the implant has either moved or fractured, surgery is often required. This surgery, at the very minimum, must remove the implant. Sometimes, multiple surgeries are required depending on how badly the implant has broken. In addition, surgery is often required to repair the internal damage that has been caused by Essure. Extreme instances have required women to have a hysterectomy to remove permanently damaged reproductive organs. More mild instances of side effects have involved joint pain, fatigue, autoimmune disease symptoms and allergic reactions to the makeup of the implant.
Thousands of lawsuits have named Bayer and Conceptus as defendants due to the side effects that women have experienced. Given that Bayer only recently stopped selling Essure, it is expected that the number of lawsuits will increase. Currently, there are more than 16,000 lawsuits pending against the manufacturers, and the number grows by the day. These cases are pending in several state courts.
The lawsuits proceed from the theory of product liability. The complaints generally allege that Bayer did not properly disclose the risks that women faced from receiving an Essure implant. The complaints have usually alleged that Bayer made express warranties and misrepresentations that women relied upon when choosing to receive Essure. Bayer is alleged to have marketed Essure without the proper FDA approval. The FDA gave Essure conditional approval which prescribed specific terms that Bayer was required to follow. According to the lawsuits, Bayer did not follow these terms, thereby negating its FDA approval.
Bayer is alleged to have learned of the failure of the Essure devices. Instead of stopping to market Essure or warning potential patients of the dangers, Bayer is alleged to have said nothing and continued to market Essure as if there were no problems whatsoever. The lawsuits have alleged that Bayer learned that the composition of the Essure implant could potential be harmful, but said nothing. It was only after Bayer was ordered to do so by the FDA that it included a warning on its label of the potential risks. This was three years after it was reported that a large number of women had claimed that Essure had caused them injuries. Not only is Bayer alleged to have failed to report the harmful effects, but the lawsuits claim that Bayer took steps to actively conceal the potential harm from the public. In addition, the lawsuits have alleged that the way that the product was designed made it extremely difficult for the average doctor to properly insert Essure. In other words, Bayer was selling a product that most doctors did not have the skill to properly implant.
Most of these suits have been brought in California courts. At this point, those cases have been joined into a mass tort litigation. There are also cases that are pending in Missouri and Pennsylvania. Before these cases reach a determination on the merits, there has been procedural litigation as to the appropriate venue for the cases. For example, in Pennsylvania, the cases were filed at the state level before Bayer removed the case to federal court. However, the federal court ruled that it could not exercise jurisdiction over the claims since they involved causes of action that involve the laws of the state.
If you or someone that you know has suffered damages from Essure, you should consult an attorney as soon as possible. Each state has strict rules for the timely filing of cases called the statute of limitations. Given the timing of when women starting reporting harmful effects from Essure, the statute of limitations may be close to tolling for many of these cases.