Essure Claims: Good NewsOn August 2, 2016, Judge Winifred Smith in Superior Court of California, County of Alameda, allowed 14 women to proceed with their Essure claims against Bayer, the manufacturer. Their attorney, Lou Bograd, successfully argued that their claims were not “expressly or impliedly pre-empted under federal or state law,” and attorney Fidelma Fitzpatrick said that Bayer should not be allowed to hide behind pre-emption.
Plaintiffs Deanna Alonzo and Desirea Harvey are represented by the Motley Rice law firm. According to the law firm, 38-year-old Alonzo was implanted with Essure in 2013. She has since suffered migraines lasting a few days, severe pelvic pain, and chronic lower back pain. She is also suffering from a severe allergic reaction to the nickel in the device. Harvey, age 33, was implanted with Essure in 2011. She claims that Essure has caused such unbearable pain that she is no longer able to work and care for her three children. The cases are Deanna Alonzo vs. Bayer, Corp., et al, Case No. 116CV290019 and Desirea Harvey vs. Bayer, Corp., et al Case No. 116CV290017.
Essure Claims: Bad News
Despite the FDA’s announcement in February 2016 that it will issue a clinical study for Essure to determine heightened risks for particular women and a black box warning on the labelling, a federal judge dismissed a Connecticut woman’s lawsuit against Bayer. Also in February, April Norman submitted a seven-count, 29-page Essure complaint, but it only comprised four paragraphs relating to her personal injury. And it was Norman’s third amended complaint. This did not bode well with Connecticut federal judge Jeffrey Meyer. He found that Norman’s claims “are either expressly or impliedly pre-empted by federal law, or fail to establish a connection between Bayer’s alleged wrongful acts and her injuries,” according to the Connecticut Law Tribune. Norman failed to indicate that her Essure device was improperly implanted, that it broke, that it migrated from her fallopian tubes, caused a puncture, or that it was in any way defective. Meyer further wrote that neither Norman nor her doctor “consulted or relied upon any particular information or warnings about the device."
According to her first lawsuit, Norman claimed that she wanted a tubal ligation but her doctor recommended the Essure device, and she underwent the procedure in 2012. Norman alleges that she underwent the removal procedure to treat pelvic pain, weight gain, heavy bleeding, blood clots, painful intercourse, hair loss, and depression due to the Essure device.
Currently, a number of Essure attorneys are only accepting cases involving fatalities or additional surgeries such as a hysterectomy. It is unclear whether Deanna Alonzo and Desirea Harvey required a hysterectomy. However, attorneys are also reviewing Essure complaints by women who have suffered:
• chronic pelvic pain
• ectopic pregnancy
• migration of the device or a device component
• puncture or tear of the uterus or colon
Judge Smith found that the California women can proceed with their causes of action regarding:
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• Claims that Bayer breached Essure's warranties and misrepresented Essure's safety and efficacy through advertising and promotional materials that were not approved by the FDA
Essure and Pre-emption
Bayer is counting on the federal pre-emption law to bar further claims against it. The giant drug company claims that Essure was approved by the FDA in 2002 as a Class III medical device and therefore immune to lawsuits brought by Essure victims. As for the claims in 11 consolidated cases filed in California State Court by 14 women including Deanna Alonzo and Desirea Harvey, attorney Fitzpatrick said the proceeding “improves the prospects for recovery of thousands of women alleging they were seriously injured by their use of Essure.”