July 29, 2016 — Lawyers for over 1,000 women who were injured by Essure have asked federal judges to centralize the cases in a federal Multi-District Litigation (MDL).
In a motion (PDF) filed on July 22, lawyers said 30 lawsuits are now pending in five district courts, but the number is expected to grow substantially. At least 5,000 women have reported severe side effects to the FDA.
Lawyers requested the U.S. District Court for the Eastern District of Pennsylvania, where Judge Gerald Austin McHugh, Jr. already presides over three Essure lawsuits.
The MDL process groups individual lawsuits into one court. It is designed to improve efficiency and reduce the risk of conflicting rulings by coordinating discovery, trials, and settlements.
All of the lawsuits accuse Bayer of downplaying the risks associated with Essure. The company allegedly knew about problems and concealed 16,000 complaints about Essure from the FDA.
In February, the FDA ordered the company to add a “Black Box” warning — the strongest the agency can require — to make sure doctors and patients were aware of the risks. Bayer was also ordered to conduct new studies to better understand safety risks.
Lawyers say those risks include severe pain, migraine headaches, depression, fatigue, skin reactions, fibroids, ovarian cysts, bleeding, ectopic pregnancy, and more. As a result of these injuries, many women have needed surgery to remove Essure.
Until now, lawsuits have been prevented by federal law. Essure entered the market in 2002 with Pre-Market Approval (PMA), which gives manufacturers immunity from lawsuits so long as they follow rigorous scientific protocols in safety studies. Lawyers say PMA should be invalidated because the manufacturer hid adverse events from the FDA.