Claims Made by Essure Patients in Court
There have been thousands of lawsuit claims against Essure, with plaintiffs making several allegations against Bayer, which purchased Conceptus, the original manufacturer of the device, for about $1.1 billion in 2013.
Many victims claim that Bayer and Conceptus failed to provide proper warning of the dangers of Essure. Some women underwent excruciating discomfort for years before finding out that Essure was the likely reason. In some cases, they needed hysterectomies and other surgical procedures due to the damage the device allegedly caused.
These are just a few of the reasons that women are suing Bayer due to Essure-related complications:
- Designing a faulty product
- Concealing the dangers of Essure from healthcare providers and the public
- Making misleading claims regarding Essure’s effectiveness and safety
Attacking Essure’s Protection from Lawsuits Excuse
Bayer is claiming that it is protected from liability and negligence claims due to “preemption laws.” According to these laws, people are not eligible to sue a medical device manufacturer if that device is rigorously tested by the U.S. Food and Drug Administration (FDA) before it gains agency approval.
However, many plaintiffs are pushing forward with lawsuits against Bayer on the grounds that Conceptus violated the FDA premarket approval process. They claim Conceptus fraudulently withheld important test data from the FDA, and, as a result, lost its protection from lawsuits.