Many cases allege Bayer hid information from the FDA and medical community about complications associated with the device, such as pelvic pain, joint pain and heavy menstrual bleeding.
Bayer allegedly failed to timely, , or accurately report their knowledge of the risks and complications associated with the Essure device.
Bayer allegedly failed to properly report more than over 15,000, adverse events involving injuries or deaths with the Essure implant. In addition, several other manufacturing violations have been found by federal regulators involving the product, leading experts to suggest that the FDA should require an Essure recall.
In February 2016, the FDA mandated much stronger Essure warnings and Bayer has also been ordered to conduct additional studies, called “522″ studies, to better understand the safety of the implant, raising questions about why Bayer failed on its own to try to learn about the safety and efficacy of Essure.
About 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.
There are problems with preemption but ones alleging negligent misrepresentation have survived.
If you want your case investigated by a Chicago attorney, contact Tom Plouff today.