Judge in California Essure Lawsuit Denies Bayer’s Motions to Dismiss.
Bayer’s Motions to Dismiss Essure Lawsuit as Preempted Are Denied
Aug. 4, 2016 Essure Lawsuit — “Judge Winifred Y. Smith in Superior Court of California, County of Alameda, issued a decision on Aug. 2, 2016, permitting the claims of 14 women who believe they were injured by Essure to proceed against the manufacturer, Bayer, finding that the claims were not expressly or impliedly preempted under federal or state law.”
While this proceeding directly addressed claims in 11 consolidated cases filed in California State Court by the 14 women, it improves the prospects for recovery of thousands of women alleging they were seriously injured by their use of Essure, including hundreds of women represented by Unglesby + Williams.
Thousands of women across the U.S. claim the permanent birth control device Essure has caused serious and permanent injuries. Essure manufacturer Bayer asserted that the Plaintiffs, and similarly situated women, are barred from bringing claims against it due to federal preemption law. Bayer claims that because Essure is a Class III medical device that was approved by the FDA in 2002, it is immune from lawsuits brought by the victims of the device.
Judge Smith rejected Bayer’s request for immunity, instead finding that the Plaintiffs could proceed with the causes of action related to:
- Bayer’s alleged failure to adequately warn the FDA, and thereby the public, of Essure’s potential dangers and adverse side effects;
- 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.
The Judge stated that the Plaintiffs’ claims that Bayer negligently trained physicians and manufactured the Essure device improperly could also survive preemption, but that Plaintiffs must replead those claims with more details on how Bayer’s conduct caused the Plaintiffs’ injuries.
“I am disgusted there is a device on the market where women have to take drastic action and have a hysterectomy. No woman should have to lose her organs because of a medical device. I believe Essure side effects are under-reported, partly because they can mimic menopause. But they can be life-threatening,” said Lance Unglesby of Unglesby Williams.
In February 2016, the FDA announced it will require Bayer to conduct a clinical study, implement a patient decision checklist to make sure potential users of Essure understand the risks of the product, and add a black box warning to Essure’s labeling. A black box warning is the FDA’s highest warning level and indicates that a product may cause serious injuries or death.
“I’m still waiting on Bayer to say that they’re interested in fixing this product and protecting the health of these women, but I haven’t heard that yet,” Unglesby continued.
ESSURE LAWYERS | ESSURE LAWSUIT
Unglesby + Williams is at the forefront of Essure litigation. While fighting Bayer in the courts on behalf of over 1000 women, we have continued to uncover more and more alarming data about Essure, Essure Problems, and how Essure Problems are being reported by Bayer to the FDA. If you or someone you know has been injured or experiencing side effects from the ESSURE Birth Control Implant, contact Unglesby + Williams or call 844-ESSURE-LAW today.