In August 2016, Alameda County Superior Court Judge Winifred Smith ruled against Bayer on some counts from using the federal preemption law to avoid the lawsuits citing damaging side effects resulting from Essure, their permanent birth control device. This ruling helps thousands of women filing lawsuits against Bayer for the pain, suffering and injuries caused by the Essure medical device.
Ruling on all of Bayers demurrer that all of the plaintiffs claims should be blocked by federal preemption, Judge Winifred specifically overruled Bayers federal preemption claims for the plaintiffs claims of failure to warn through negligence or strict liability.
Also overruled was federal preemption claims for breach of express warranty, fraud, and claims for negligent misrepresentation. Judge Winifred allowed plaintiffs more time to amend their complaints for manufacturing defect. The Judge allowed Bayer’s federal preemption claim to block the plaintiffs claim that the doctors were negligently trained to use the device but also allowed the plaintiffs time to amend their complaints.
The Essure Controversy
Bayer’s legal team argued that the manufacturer could not be held liable in lawsuits related to device injuries because the medical device had been approved by the FDA.
The contraceptive device initially received FDA approval in November 2002, when it was ready to be distributed by its original manufacturer Conceptus. Bayer acquired Conceptus in 2013. However, industry experts considered the Essure FDA approval to be questionable for a number of reasons.
Questions Surrounding FDA Approval of Essure
Essure went through the FDA Pre-Market Approval process, which simply required Bayer to demonstrate that the medical device was substantially similar to another product already available on the market.
The FDA Center for Devices and Radiological Health issued Conceptus an expedited review primarily based on the reasoning that it could be inserted without the need for surgery. A number of issues began to arise soon after Essure was approved by the FDA.
The follow-up required of Conceptus by the original PMA was certainly lacking. The initial approval awarded to Conceptus was contingent on the manufacturer conducting two Post-Approval Studies over the course of the five years following.
Within a decade of receiving FDA approval, Conceptus received over 30,000 adverse event reports related to Essure. That volume of adverse event reports should have compelled, and actually obligated, Conceptus to modify the warning label.