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Essure Lawsuits Are Increasing Now That Bayer Cannot Hide Behind The FDA Any Longer

When a California judge overturned the federal preemption law the floodgates opened to sue Bayer for their Essure negligence

Friday, March 15, 2019 - Over 300 fetal deaths have been reported by women that were using the Essure birth control device. Many of these women have consulted an Essure attorney to see if they qualify to file a claim against Bayer Inc., maker of Essure. Up until recently, the problem with trying to sue Bayer over Essure injuries was that the company was protected by the federal preemption law. Bayer's argument has been that "because the FDA, a federal agency, approved the device, Bayer should not be held accountable for injuries, the company said. But in a landmark ruling in August 2018, a California state judge disagreed according to a recent article on Essure stillbirths in Modern Healthcare online.

In August 2018 a California judge approved a path for hundreds of lawsuits from women alleging Essure birth control device caused them unspeakable physical and emotional pain and suffering to file lawsuits. The judge's ruling is encouraging others to file claims against Bayer. Bayer had argued that because Essure was approved by the Food and Drug Administration, Bayer should not be held liable for injuries. As a direct result of the repeal of the federal preemption law, "U.S. lawsuits from approximately 29,400 users of Essure, a medical device offering permanent birth control with a nonsurgical procedure, had been served upon Bayer. ...Plaintiffs allege personal injuries from the use of Essure, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression, and unwanted pregnancy, and seek compensatory and punitive damages. Additional lawsuits are anticipated."

Overturning the federal preemption law could play an important role in preventing medical device manufacturers from hiding behind FDA approval when designing and marketing their products. The FDA has come under increasing scrutiny led by Essure activists on social media as well as the now award-winning Netflix documentary "The Bleeding Edge." The film held Bayer accountable for failing to warn women of the life-changing medical consequences many of them faced when Essure breaks free from the Fallopian tubes and lands in the uterus, perforating it, causing immense pain and bleeding, and necessitating having a hysterectomy. The FDA has been criticized by the movie as a mere rubber stamp to any medical device conglomerate that wants to rush a new and unproven product to market without the delays of clinical trials or human testing. In many instances, all a company had to do for the last 20 years is show that the new device was similar to one that was already on the market and they could circumvent stricter medical testing. FDA chairman Scott Gottlieb resigned suddenly last week rather than face what is certain to be an overhaul of the FDA's 501 (k) fast-track approval process and his lack of properly supervising the agency.

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. OnderLaw has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.