No contraceptive is 100% effective, and most have at least a few minor side effects. Some are especially problematic, despite their safety claims. Bayer Pharmaceuticals manufactures and markets both the Mirena IUD (intrauterine device) and Essure permanent birth control implant. Lawsuits are underway due to life-altering Essure side effects, including ectopic pregnancy, device perforation or puncture, implant migration, and infection. Strangely enough, women report similar issues with the Mirena IUD. Much like Essure, Mirena lawsuit allegations include device perforation, migration, pelvic inflammatory disease (PID) and ectopic pregnancy. Since both devices and injury claims are strikingly similar, legal experts predict Essure litigation could follow Mirena’s pattern. This could result in a large-scale Essure settlement for negligence claims filed against Bayer.

Essure received Food and Drug Administration pre-market approval in 2002. After more than 5,000 women reported adverse events to the FDA, Heather Walsh filed the first Essure lawsuit in 2013. Because Bayer’s protected by several preemption laws, it’s been difficult for Essure victims to get the justice they deserve. Of course, that could quickly change with a jury awarding an Essure settlement due to negligence claims against Bayer.

How Preemption Laws Protect Bayer from Essure Product Liability Claims

The FDA believes that due to their rigorous approval process, device manufacturers shouldn’t be held responsible for potential side effects. Yet lawsuit filings against Bayer claim the company lied to the FDA during the Essure pre-market application process. Various claims assert Bayer violated the FDA’s premarket approval terms and withheld important data about Essure. If evidence proves this allegation true, Bayer would have to forfeit its preemption status for Essure.

In Response to Public Outcry, FDA Hold Essure Panel Over Safety Concerns

There are so many Essure plaintiffs now that neither Washington nor the FDA can just ignore the issue. In 2015, plaintiffs presented a citizen’s petition urging the FDA to further investigate Essure’s safety. The sheer number of signatures garnered from this grassroots petition prompted the FDA to respond. The agency held a public Obstetrics and Gynecology Device panel discussion about Essure on September 24, 2015.

Many scientific and clinical authorities joined the Essure panel discussion, listening to patient experiences and opinions. In addition, the FDA left a public docket open for comments about Essure from July 22, 2015 to October 24, 2015. During that time, the FDA received more than 2,800 comments from Essure victims and their families.

“The panel meeting and docket provided valuable information to inform the FDA’s decision-making and consideration of potential risk mitigation strategies for Essure,” the FDA stated. The panel propelled several orders to investigate Essure’s long-term side effect risks. It even prompted Bayer to revise their packaging to include possible complications and risks associated with Essure permanent birth control. But for thousands of women, this Essure warning came 14 years too late.

Pending Lawsuits May Still Reach An Essure Settlement, Despite Preemption Laws

Despite preemption laws, severe Essure complications convinced judges nationwide to accept lawsuit claims against Bayer. Some women allegedly lost their marriages, families, and even their lives due to Bayer’s negligence. Still, many women aren’t suing Bayer over Essure complications. Instead, accusations against Bayer include negligent manufacturing, risk management, breach of express warranty, fraudulent manufacturing and negligent training.

Bayer’s 2016 annual report shows the company lost about $413 million due to the number of lawsuits filed against Essure. So far, Bayer faces around 3,700 plaintiffs just in the U.S.

Heather Walsh filed the first lawsuit demanding an Essure settlement in July 2015. The plaintiff allegedly suffered Essure-related side effects, including device migration. But instead of filing a product liability claim (since preemption laws would protect Bayer), Walsh accused the company of negligence. She alleges Bayer didn’t provide proper physician training on safely inserting Essure. Walsh was hospitalized with severe pain and fainting spells nearly two years after undergoing the Essure procedure. Doctors found the Essure birth control implant migrated from its original location and subsequently lodged behind her colon. Walsh needed a complete hysterectomy and multiple surgeries to remove Essure.

While Wash filed the first Essure lawsuit, she certainly won’t be the last. Thousands of women report permanent Essure injuries, including autoimmune diseases, perforated organs and severe pelvic pain.

How MDL Consolidation Could Produce A Large-Scale Essure Settlement

With over 1,500 Mirena claims filed, the JPML established a Multi-District Litigation (MDL) in the Southern District of New York. This legal consolidation procedure helps speed up the litigation process in complex cases by combining materially similar cases. It keeps courts from wasting time and resources trying nearly identical lawsuits brought by different plaintiffs.

Unfortunately, the attorneys representing plaintiffs in the Mirena MDL failed to establish expert witnesses, so the judge dismissed their claims. However, new evidence could reverse that summary judgment, as the Mirena IUD MDL is reopened in federal court. Regardless, an approved MDL consolidation could still produce a large-scale Essure settlement that’s equitably distributed across all claimants.