October 3, 2016 — California Superior Court Judge Winifred Smith has consolidated dozens of Essure lawsuits involving around 900 women in Alameda County Superior Court.
Lawyers for women who were injured applauded the ruling. Coordinating the lawsuits into one court under one judge will streamline the proceedings and hopefully bring a faster remedy to all the women who were injured.
Lawyers say coordinating the cases in one court will help them pool their resources and add momentum to the litigation against Bayer. According to plaintiffs’ counsel Elizabeth Graham:
“Having these cases coordinated before a single judge will avoid inconsistent rulings and allow these women to prosecute their claims in a cohesive and unified manner.”
In August, Judge Smith found that lawsuits over Essure were not pre-empted under federal or state law. The decision was a major win for plaintiffs who have been challenging Bayer’s claim of immunity.
Many of the lawsuits involve women who are not from California. The litigation will test a recent California Supreme Court decision allowing drug-makers to be sued by out-of-state residents. All of the lawsuits accuse Bayer of failing to warn the FDA and doctors that Essure could cause severe side effects.
The FDA has received thousands of complaints from women who experienced severe side effects. In February, the FDA ordered Bayer to place a “Black Box” warning label on Essure to warn about its extreme risks and potentially permanent complications.
The FDA also ordered Bayer to conduct post-marketing surveillance studies and a new clinical trial to better understand the long-term risks of Essure. A six-month report will be released in March 2017, but the final report will not come until 2023.
The studies will investigate chronic abdominal pain, abnormal bleeding, allergic reactions, and surgical removal of Essure. Last year, a study published in the British Medical Journal found that women who were implanted with Essure were 10X more likely to need follow-up surgery compared to women who had a traditional “tube tying” procedure.