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John Bair
John Bair
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Essure Litigation Update: New Safety Warnings


During Women’s History Month, we at Milestone are reflecting particularly on the ways our civil justice system works to protect women who have been harmed by negligence. The legal battle against the pharmaceutical company Bayer over its permanent birth control product, Essure, is a great example of how trial lawyers can relentlessly stand up to big corporations whose products hurt people.

essure lawsuit update

Unfortunately, the known problems for women associated with Essure seem to be growing. Reuters reported last week that the U.S. Food and Drug Administration (FDA) is now investigating nearly 12,000 new reports of issues during removal of Essure. Bayer said the new reports do not raise any new concerns. However, according to the FDA, almost 90 percent of the reports involved issues surrounding the potential removal of the device.

This new red flag comes two years after the FDA required Bayer to put a black box warning (the strongest safety label available) on Essure following thousands of complaints. The label warns of problems including abdominal pain, abnormal uterine bleeding, and device migration. The FDA also required Bayer to conduct a clinical study and implement a patient decision checklist to cover the risks before implanting the device.

Last year, attorney Fidelma Fitzpatrick was named Lead Counsel of the Plaintiffs’ Executive Committee in the California Essure litigation. The cases were previously coordinated after thousands of women in the U.S. alleged Essure caused serious and permanent injuries. Some suffered complications including ectopic pregnancy, fetal death, migration of the device causing perforation or tear of pelvic organs, additional surgeries, including hysterectomy to remove the device and repair organs, and other severe side effects, according to a press release from Fitzpatrick’s firm, Motley Rice.

Cases such as the Essure litigation illustrate how the civil justice system provides Americans a way to seek justice from negligent businesses that might otherwise be too powerful for one person to fight alone. We look forward to seeing what comes of the Essure litigation, and we hope it results in justice for thousands of women.

About John Bair

John Bair has guided thousands of plaintiffs through the settlement process as co-founder of Milestone Consulting, LLC, a broad-based settlement planning and management firm. Milestone’s approach is comprehensive and future-focused. John’s team has guided thousands of clients by taking the time to understand the complexities of each case. They assess the best outcome and find the path that enables each client to manage their many needs. Read more about Milestone Consulting at http://milestoneseventh.com/.


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