Essure Birth Control Lawsuit
Our team at McEldrew Young is pursuing a mass tort against Bayer Healthcare for the birth control product Essure, which is linked to serious side effects. Jim McEldrew and our Philadelphia lawyers represent victims of Essure problems nationwide. In March 2016, a federal judge in the Eastern District of Pennsylvania ruled that our clients’ lawsuits can proceed to discovery under PA law despite Bayer’s claims of express and implied preemption. The Philadelphia Inquirer reported that our cases are being “closely watched nationally” because they are “the farthest along in the litigation process.”
If you have suffered severe complications and injuries as a result of the implantation of the Essure birth control device, please call our office at (800) 590-4116 to speak to an attorney.
On Friday, July 20, 2018, pharmaceutical giant Bayer formally announced that it would discontinue sales of its Essure birth control device, no longer selling or distributing the product after December 31, 2018. This announcement comes after the Food & Drug Administration (FDA) took an extraordinary step in April of 2018 by limiting sales to doctors who ensured that they were actively informing women of the risks associated with using Essure, while simultaneously holding Bayer responsible for the implementation of this practice.
According to the New York Times, “The birth control device has been alleged to cause serious side effects. It has been the subject of an estimated 16,000 lawsuits or claims filed by women who reported severe injuries, including perforation of the uterus and the fallopian tubes. Several deaths, including of a few infants, have also been attributed to the device or to complications from it.”
Initially, Essure was FDA approved and was available in stores all over the U.S. The device was approved based on how well it prevented pregnancy, how safe the procedure to implant the inserts was, and how safe the inserts continued to be for the patient after implantation. But according to the Times report, in 2017, the FDA limited sale of the birth control to doctors offices and clinics that “agreed to fully inform women about the product’s risks.”
What is Essure and how does it work?
Essure is a surgical implant device used as a permanent form of birth control. The device consists of two metal coils inserted into the fallopian tubes. Essure prevents pregnancy as the coils provoke an inflammatory response and scar tissue grows around the devices. It is meant as a form of permanent birth control for women and takes several months to become effective.
The History of Essure and the Lawsuits against Bayer
Essure was initially designed and manufactured by Conceptus, Inc. It received conditional premarket approval from the FDA on November 4, 2002. As a Class III medical device, the FDA applied its most rigorous premarket approval process which requires review of all studies and investigations of the safety and effectiveness of the device. Bayer purchased Conceptus in 2013 for approximately $1.1 billion in cash. According to Bayer, 750,000 women worldwide have chosen to have their doctors implant Essure.
We are co-counsel in lawsuits against Bayer. The first one was filed in Philadelphia in 2014 and additional lawsuits were subsequently filed. In the first major objection to the case from Bayer, they argued that express or implied federal preemption prohibits the cases from proceeding. The doctrine attempts to ensure that the court system in each state does not apply different requirements to a medical device than that is imposed by the U.S. Food and Drug Administration through the premarket approval process. In a ruling by U.S. District Court Judge Padova, the court held that the lawsuit could proceed to discovery on a few issues that were not barred by the preemption doctrine.
Essure risks and side effects
The side effects associated with Essure are extensive. In addition to allergic reactions, the reported injuries include:
- Nickel allergy reactions
- Pain/Abdominal Pain
- Heavier/ Irregular Menstruation
- Weight Fluctuations
- Device Breakage
- Malposition of the Device
Nickel is a very common allergen and can cause contact dermatitis. Contact dermatitis causes an itchy, red rash. It can also cause dry patches of skin resembling a burn, blisters, and severe itchiness. Although the amounts of nickel released in the fallopian tubes by Essure are minute, the damage caused is severe and painful.
What should you do?
If you are experiencing any of the above symptoms or complications from Essure, the first thing you should do is visit a medical professional to identify the cause. A doctor may be able to confirm whether your complications are caused by Essure and will also be able to provide treatment to manage the conditions. If your symptoms are severe, visit an emergency room immediately.
What are your legal options?
If you decided to use Essure to prevent pregnancy and experienced serious complications or side effects, you may be entitled to compensation. Bayer Healthcare has now acknowledged that their device can cause various complications. The product has put users at risks for chronic pains and illnesses.