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Groundbreaking Legal Decision in Essure Lawsuit

Written by admin on August 9, 2016

You don’t have to make too many searches regarding the permanent birth control device, Essure, to learn of the thousands of women who are furious with the manufacturer and have filed Essure lawsuits.

From excruciating abdominal pain and trails of blood to the bathroom, to severe headaches to total hysterectomies, Essure’s side effects have prompted women to take action and file lawsuits. However, even after thousands of women had signed petitions and wanted to file a lawsuit, their claims were likely to be denied due “federal preemption.”

What is Federal Preemption in the Essure Lawsuit?

What preemption means in Essure’s case is that since the device’s marketing and warning labels were approved by the Food and Drug Administration, then there is no legal recourse. This is where the groundbreaking decision lies as a lawyer fighting on behalf of women. In three separate rulings dated Aug. 2, 2016 and authored by Judge Winifred Y. Smith, the Superior Court of California in Alameda County rejected several defenses raised by the Bayer defendants.

1st Ruling

The first ruling rejected Bayer Pharmaceuticals defense of the product due to federal preemption. This was the most important and true “groundbreaking” decision as the court demonstrates that when the FDA approves a drug or medical device, it is the manufacturers job to keep the FDA informed, allowing the FDA to update the label should additional dangers arise.

2nd Ruling

The 2nd ruling int he Essure lawsuit determined that those individuals outside of California would have to litigate in their home states. This rejects Bayer’s strategy to not allow the lawsuit to unify those who intend to file lawsuits. By allowing California to be the venue this could allow more victims to come forward and to file claims on behalf of their injuries.

3rd Ruling

The court rejected Bayer’s argument that the statute of limitations had passed. Essure had been on the market since 2002, however the court agreed with the plaintiffs’ argument that the discovery of their causes of action occurred no earlier than September 2015, when the FDA held hearings.

What Are The Other Facts About Essure?

  • There have been more than 10,000 adverse reports reported to the FDA about Essure. Ranging from headaches an abdominal pain, to perforation of the uterus.
  • Since Essure was to be a permanent birth control there has never been a plan to remove the device. Instead, a woman must go through a painful “re-surgery” to have it removed.
  • According to the medical publication, BMJ, women who were implanted with Essure were 10 times more likely to need “re-surgeries” than those who had a tubal ligation.
  • A deep data dive by Madris Tomes, CEO of Device Events, into publicly available FDA data uncovered more than 300 fetal deaths prior to February 2016.

 Can I file an Essure Lawsuit?

If you are thinking of having Essure implanted, please understand the risks involved with the device, and the potential outcomes should there be complications. If you have had the Essure device implanted and are looking for legal advice the law firm leading the Essure lawsuit can be contacted at no cost for consultations and questions.

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For sexually active women, he effectiveness of birth control depends on how perfectly they use it. For this reason, there are two kinds of effectiveness rates. One measurement is for perfect use, as the method is tested in the lab or used in real life with no mistakes.

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