Meanwhile, Essure lawsuits filed against Bayer by four women have been dismissed this month. A federal judge in California ruled that plaintiff Tanya De La Paz’s state-law claims against Bayer for design and manufacturing defect, failure to warn, fraud and breach of warranty, among others, were preempted by federal law, according to Reuters (Feb. 4 and Feb. 8, 2016). However, Judge William Alsup said that plaintiff Tanya De La Paz could amend her complaint if she could address certain shortcomings in the original, Case No. 3:15-cv-03995.
Increasingly, evidence indicates that Bayer was aware of Essure adverse events before its sterilization device was granted FDA premarket approval in 2002, which means the process is subject to certain conditions. These conditions include regular reporting on efficacy, reporting of all adverse events, and seeking approval for any change to the device.
De La Paz had the Essure implanted in July 2012, but the procedure was abandoned after the device perforated one of De La Paz’s fallopian tubes. In February 2013, De La Paz underwent surgery to have her right fallopian tube removed along with the broken micro-insert that had anchored there, which she had been informed would relieve her symptoms. Again in September 2015, De La Paz underwent surgery to have the micro-insert in her left fallopian tube removed.
According to De La Paz’s complaint:
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Her claims against Bayer include design and manufacturing defect, failure to warn, fraud and breach of warranty. The FDA said that Essure “is a high priority issue for the Agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps. We anticipate communicating our actions publically at the end of February 2016.” Stay tuned...