Plaintiffs requested the U.S. District Court for the Eastern District of Pennsylvania, where Judge Gerald Austin McHugh, Jr. currently presides over three cases.
Approximately 30 lawsuits are pending in Pennsylvania, California, Connecticut, Missouri, and Idaho — with thousands more expected. Essure was implanted in over 750,000 women and the FDA has received 5,000 adverse event reports.
Lawyers want to create a Multi-District Litigation (MDL), which is like a class action. It helps coordinate discovery, trials, and settlements, while allowing each individual lawsuit to remain independent.
Essure is a permanent sterilization device made by Bayer that consists of two metal coils. It is inserted into the fallopian tubes, causing scar-tissue to grow and block sperm from fertilizing an egg.
Lawsuits accuse Bayer of failing to warn about side effects. In February, the FDA placed a “Black Box” warning label on Essure and ordered Bayer to conduct new safety studies.
All of the lawsuits say Essure causes severe side effects, such as chronic pain, migraines, depression, fatigue, rashes, bleeding, fibroids, ovarian cysts, and more.
As a result, many women have had surgery to remove Essure. In one recent study, 2.4% of patients had follow-up surgery, compared to 0.2% of women who had their “tubes tied” — a 10X increased risk.
Until now, victims have been unable to file lawsuits. Essure got a special approval in 2002 that also gave its manufacturers immunity from lawsuits. Many lawyers — including Erin Brokovich — have challenged the immunity with evidence that manufacturers did not tell the FDA about side effects, including over 16,000 complaints.