-- Hundreds of women have already filed lawsuits over Essure, a controversial birth control implant that patients say causes horrendous side effects. But the lawsuits have always faced major hurdles, attorneys at say. At times, the very future of these cases has seemed in doubt. Essure’s manufacturer, the multinational healthcare company Bayer, argues that its medical device should be protected from product liability lawsuits. Essure was approved as a Class III, or “high-risk,” medical device by the US Food & Drug Administration. Bayer has long said that this federal approval means the implants should be immune from personal injury claims, which are usually based in state law. In a recent court decision, Judge Winifred Y. Smith of Alameda County’s Superior Court of California disagreed, rejecting Bayer’s arguments for immunity. Smith is allowing the lawsuits of 14 women, all suffering from alleged Essure side effects, to proceed. Following Judge Smith’s August 2nd decision, the women will be able to proceed on the basis of allegations that Bayer failed to warn the FDA, and therefore the public, of Essure’s potential dangers. Claims that the company misrepresented Essure’s safety and efficacy in unapproved advertisements and promotional materials will also be allowed to move forward. While the decision only applies to 11 cases filed in the California State court, attorneys close to the litigation say that it could improve the prospects for thousands of other women who believe their injuries were caused by Bayer’s birth control implant. Earlier this year, the FDA added a “black box” warning to Essure, cautioning patients and physicians about the device’s risks. A black box warning is the agency’s highest level of warning, indicating that a product may cause severe injuries or death. Bayer has also been ordered to conduct a new clinical study, research that will evaluate the potential dangers of Essure in “real world” settings. Between April and July of 2016, nearly 500 women filed Essure lawsuits against Bayer. Most of these cases are currently pending in the US District Court for the Eastern District of Pennsylvania. Severe pelvic pain, menstrual abnormalities, migraine headaches, hair loss and weight gain are the most frequently alleged side effects. Many women say they were forced to undergo a hysterectomy procedure to relieve their symptoms. With the litigation progressing swiftly, attorneys say thousands of other women may be eligible to file lawsuits of their own. But time may be limited, and they urge women who are considering hiring counsel to do so immediately.
Contact Info:
Name: Michael Monheit, Esq.
Email: [email protected]
Phone: (877) 515-3774
Organization: Birth Control Problems
Source URL: http://www.prreach.com/pr/25666
Release ID: 129169
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