You may have hear news reports about the Essure birth control dangerous side effects and lawsuits. You may even be someone who has been affected by Essure and its side effects. Well these cases are moving along and as will happen the courts and lawyers and trying to iron out how these cases will proceed.
During a hearing in January of 2016, U.S. District Judge John R. Padova sounded unimpressed with some of the legal arguments submitted on behalf of five women. Padova directed the lead attorney to resubmit part of the case with more specifics. Padova stated that, “In 23 years, I can’t remember a case where I had to start by asking plaintiffs what the count is all about.”
The U.S. Food and Drug Administration is reevaluating the safety and effectiveness of Essure which is made of tiny metal coils implanted in the fallopian tubes to scar them closed,in response to more than five thousand adverse events reported since the device was approved in 2002. Complaints include organ perforation, pelvic pain, unintended pregnancies, and abnormal bleeding. The U.S. Supreme Court ruled in 2008 that under federal law, medical devices that receive pre-market approval from the FDA are shielded from product liability litigation in state courts.
The five cases consolidated in U.S. District Court began with a lawsuit filed in 2014 by Heather Walsh She stated her coils migrated to her uterus, requiring hospitalizations and an eventual hysterectomy. The consolidated cases claim that Bayer invalidated Essure’s pre-market approval by being negligent and deceptive. Among other things, the lawsuit claims that Bayer inadequately trained physicians, did not report known hazards to the Food and Drug Administration, and used misleading advertising.
Bayer has denied the allegations. The company states that Essure is an important option for women who want a permanent form of birth control without conventional tubal ligation surgery.
Judge John R. Padova stated that he was provisionally rejecting one of the plaintiff legal arguments: that failure to comply with various federal requirements automatically invalidates a pre-market approval. He stated that, “We were unable to find any cases that support plaintiffs’ theory of self-invalidation.” He repeatedly asked how Bayer’s alleged misdeeds were directly linked to the individual plaintiffs’ injuries. The response was that if the women had been told about the hazards, they never would have opted for Essure.
More than twenty-three thousand women have joined a Facebook page called Essure Problems to demand that the device be taken off the market. In Congress, U.S. Rep. Mike Fitzpatrick, has introduced the “E-Free Act,” which would require the FDA to revoke its pre-market approval of Essure.
If you are one of the several women that has had adverse reactions after receiving an Essure implant or if you have had the Essure product implanted and now have concerns about your health and safety, you should contact one of our caring and skilled Ensure and dangerous device lawyers with the Higgins Firm. We know that you may be confused and unsure about what to do next. We will answer any questions and address any concerns you may have. Our legal team will then work with you to collect any medical records, treatments and other evidence that may be needed to make your case. We will then fight on your behalf to make sure you get any compensation and damages that you are entitled to for the injuries and problems you have suffered. We will also see to it the the company responsible is held accountable and made to pay for their negligence and deception.
Please contact us today online or by calling 800.705.2121 to discuss your legal options.