Essure Court Cases Move Ahead, Clear Legal Obstacles
Plaintiffs in a lawsuit alleging Bayer’s Essure contraceptive device caused patient injuries filed a revised complaint in California state courts this week. The coordinated proceedings include at least 3,000 patients, though no court date has yet been sent.
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Bayer AG said Sept. 18 it will not renew a CE mark for its Essure permanent contraceptive coils for women in EU countries, effectively halting sales of the product outside the US. The firm says its decision was "unrelated to product safety or efficacy," and driven by its commercial strategy. Meanwhile, US FDA calls for warnings and black box labels for Essure in the US, and says a Sec. 522 post-market study it ordered Bayer to complete "will help us better understand" thousands of complaints about the device.
An FDA advisory panel recommended a collection of activities to mitigate risk in the use of Bayer Healthcare’s Essure permanent contraceptive device, but dozens of patients describing hypersensitivity, extreme pain, insert migration, irregular bleeding, ectopic pregnancy and perforation events urged FDA to recall the device.
The Supreme Court’s decision not to take up Stengel v. Medtronic could make device firms vulnerable to more product liability suits by leaving open questions about the federal preemption defense for PMA-approved devices. Meanwhile, the Obama administration recently issued a legal interpretation that, if adopted, would surely weaken the defense.