July 29, 2016 — Lawyers representing over 1,000 women in dozens of Essure lawsuits have asked judges to create a Multi-District Litigation (MDL) to centralize the cases in one federal court.
Lawyers filed a motion (PDF) on July 22 requesting the U.S. District Court for the Eastern District of Pennsylvania, where three Essure lawsuits are already being overseen by Judge Gerald Austin McHugh, Jr.
There are 30 lawsuits pending in Pennsylvania, California, Connecticut, Missouri, and Idaho. Essure has been implanted in over 750,000 women — 5,000 of whom have filed complaints with the FDA — and lawyers expect thousands more lawsuits to be filed.
The MDL process has many advantages, like improving efficiency and reducing the risk of conflicting rulings. The parties can also coordinate pre-trial discovery, trials, and settlements.
All of the lawsuits accuse Bayer of downplaying safety risks. In February, the FDA ordered Bayer to place a “Black Box” warning label — the strongest the FDA can require — on Essure. The agency also asked Bayer to conduct new safety studies.
Plaintiffs say Essure was marketed as a quick outpatient procedure for busy women. Instead, many required surgery after suffering chronic pain, heavy bleeding, cysts, fibroids, immune reactions, and bleeding. In one study, 2.4% of Essure patients needed follow-up surgery compared to 0.2% of patients who had a “tube tying” sterilization.
But until now, lawsuits against Bayer have been pre-empted by a federal law. In 2002, Essure was approved with Pre-Market Approval (PMA), which gives manufacturers immunity from lawsuits so long as they follow rigorous scientific protocols in safety studies.
Lawyers say the PMA for Essure should be invalidated because the manufacturer falsified medical records and hid adverse events from the FDA.