Essure Lawsuits

As of September 2024, there are no new updates in this litigation. In 2020, Bayer settled the majority of Essure lawsuits, about 39,000 claims, for $1.6 billion. While most of these cases settled in 2020, some women continued to file Essure lawsuits in California and Pennsylvania.

For example, in June 2023, Frankie Baca and several other women sued Bayer in the Eastern District of Pennsylvania under case number 2:23-cv-02280. The judge recently stayed proceedings until September 2024 so the parties could discuss settlement.

Drugwatch’s legal partners are no longer accepting Essure cases.

Thousands of American women filed lawsuits against Bayer after they say Essure caused devastating side effects and ruined their lives. Lawsuits said Bayer failed to report serious side effects such as perforated organs and broken devices to the U.S. Food and Drug Administration and to the public.

For many women, Essure side effects started immediately after implantation. In lawsuits, some say their devices moved out of the fallopian tubes and cut into nearby organs. Others say their device broke into pieces and wreaked havoc on their bodies.

After women in the Essure Problems group met with the FDA and the agency placed sale restrictions and black box warnings on the device, Bayer announced it would stop selling it on Dec. 31, 2018 in the U.S. The company cited a decline in sales as the reason for the device’s discontinuation.

Nearly two years after Bayer stopped selling the device in the U.S., the company agreed to pay $1.6 billion to end all U.S. Essure claims. In its Aug. 20, 2020, announcement, the company denied any wrongdoing or liability.

“These U.S. settlements have no impact on pending litigation in other countries, as Bayer’s decision to resolve these cases is based significantly upon factors that are specific to the U.S. legal system,” Bayer said.

Injuries claimed by women in lawsuits range from severe pain to crippling autoimmune conditions. Several women claimed they had to get hysterectomies because of complications. Even after multiple surgeries, many women still live with chronic pain and inflammation from metal fragments of Essure left in their bodies.

Since the FDA approved Essure in 2002 to January 2018, the agency had received 26,272 adverse event reports about the device, former FDA and CEO of device events analyst Madris Tomes told Drugwatch when Essure lawsuits first started pouring in.

The number of reports has grown since then. From 2002 to 2023 the FDA received 72,875 medical device reports, according to its April 2024 report. In 2023, 76% of all reports cited litigation.

Women in the Pennsylvania lawsuits said Essure “migrates from the [fallopian] tubes, perforates organs, breaks into pieces, and/or corrodes wreaking havoc on the female body.” Manufacturing defects could cause the device to crack, injuring surrounding tissues and organs, according to one complaint. Plastic fibers and nickel in the device could also lead to autoimmune problems.

According to doctors, injuries have discouraged new patients from receiving the device.

“You put in [an internet search for] Essure, and the first thing that comes up is lawsuits,” Dr. James Greenberg, an OB/GYN at Brigham-Faulkner OB/GYN Associates in Boston, told Modern Healthcare. “That’s not something that makes you super excited to have that done to you.”

Lawsuits claim that, instead of working as intended, the device “migrates from the [fallopian] tubes, perforates organs, breaks into pieces, and/or corrodes.” These defects led to severe and permanent injuries. The lawsuits are against Conceptus, the original manufacturer of the device, and Bayer, which bought the company in 2013.

Complaints allege several counts of negligence including failing to warn about the risk of side effects. These counts include negligent training, negligent risk management and express breach of warranty.

Lawsuits say Bayer “conspired to engage in…misconduct…for the purpose of enriching themselves and creating an injustice at the expense of plaintiffs” and their health. Some women lost marriages, family and even died after complications, according to women who spoke to Drugwatch.

For many women, the Essure experience has been long and arduous. They incurred medical bills, scheduled multiple surgeries and suffered poor health for years before they filed lawsuits. The claims of Bradley Baily on behalf of his wife, Stephanie, and Amy N. Harrel are two examples out of thousands of women who filed lawsuits.

Throughout the litigation process, Bayer tried to weed out claims by using a legal defense called preemption.

A preeminent entity — the FDA — approved Essure at the federal level, giving Bayer protection from claims it failed to warn the public of risks, the company argued.

The issue of preemption made Essure cases more complicated, and some judges dismissed cases for preemption. But Alameda Superior Court Judge Winifred Smith in California allowed Essure lawsuits to proceed despite preemption.

Other judges dismissed cases for failing to meet court requirements. For example, St. Louis, Missouri-based U.S. District Judge Stephen N. Limbaugh Jr. tossed 92 out of 95 plaintiffs from a federal Essure case in January 2018 for this reason.