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Essure Lawsuit Challenges Validity of Pre-Market Approval

Essure Lawsuit Challenges Validity of Pre-Market Approval

November 9, 2015 — Bayer HealthCare and its subsidiary Conceptus have been sued by a woman who experienced chronic pain and other side effects from Essure.

Plaintiff Danielle Patterson blames Essure for causing “severe constant daily pain,” including migraines, abdominal, ovarian, and pelvic pain. She also suffered from heavy bleeding and had a uterine ablation in September 2013. It wasn’t until 2015 that she realized Essure could be causing these side effects.

On November 4, she filed a lawsuit (PDF) accusing Bayer of concealing risks of Essure. The lawsuit (Case No. 3:15-cv-05088) was filed in federal court in San Francisco, California. According to the complaint:

“Defendants were concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do the same.”

The lawsuit challenges the validity of Essure’s Conditional Pre-Market Approval (CPMA), which gives Bayer immunity from product liability lawsuits so long as they follow strict rules during clinical trials.

Lawyers say the CMPA is invalid because Bayer failed to report eight perforations that occurred during clinical trials, which resulted in a citation from the FDA.

Bayer is also accused of downplaying the risk of pregnancy with marketing materials that claim “There were zero pregnancies in the clinical trial.” In reality, lawyers say there were four pregnancies during clinical trials and five more in the first year Essure was on the market.

Furthermore, marketing materials claim “You never have to worry about unplanned pregnancy” after a doctor confirms that a woman’s tubes are blocked. In reality, at least 30 women have gotten pregnant after receiving confirmation.

Do I have an Essure Lawsuit?

The Schmidt Firm, PLLC is currently accepting Essure induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a severe side effect or needed surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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