Essure Plaintiffs Score Major Victory As Lawsuits Can Proceed Against Bayer

03/31/2016 - Last week, women injured by the controversial Essure sterilization device scored a major victory as Pennsylvania federal judge John Padova ruled that five Pennsylvania Essure plaintiffs can proceed with their lawsuit. Although Judge Padova dismissed several allegedly preemptive claims, more importantly for thousands of women nationwide, he ruled the PMA ostensibly protecting Bayer from litigation does not prevent plaintiffs from pursuing certain claims against Bayer. This ruling potentially opens the door for thousands of lawsuits to be filed nationwide by women significantly harmed by the device.

Judge Padova’s 54-page ruling provides a highly informative roadmap for future pleadings against Bayer. Judge Padova allowed causes of action for negligent misrepresentation and negligent failure to warn to proceed and accordingly highly important and informative discovery should be allowed for plaintiffs to obtain necessary documents and data necessary to prove their case. Judge Padova also allowed plaintiffs leave to amend their complaint to more accurately plead causes of action for negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation and negligent manufacturing. If these five causes of action are appropriately amended, it is likely the case will be going forward on some, if not all, of these five additional counts.

Bayer will be facing a barrage of lawsuits across the country, as it should be for the injuries caused by the device. As of February 29th a staggering 10,887 adverse events have been filed with the FDA, complaining of problems associated with the device. Additionally, information received from a recent Freedom of Information Act (FOIA) request revealed thousands of other complaints were received by Bayer and predecessor, Conceptus and revealed during facility inspections by FDA investigators. During an inspection ending on January 6 2011, FDA investigator, Timothy Grome, reviewed an excel spreadsheet containing 16,581 complaints received on Essure during a 24 month period from 1/1/2008 through 12/6/2010. Additionally, on a subsequent inspection ending on January 26, 2013 the FDA investigator also reviewed an excel spreadsheet depicting complaints received during the 24 month period from 1/1/2011 and there were 16,047 additional complaints.

This information is highly disturbing. First, it is disturbing that the reports were not being reported by Conceptus to the FDA and were discovered during two separate facility inspections. However, even more disturbing is the FDA’s continued recalcitrance in refusing to recall the device or revoke the PMA in the face of over 10,000 adverse event reports it has received directly as well as an additional 32,628 complaints it uncovered during inspections of Conceptus’ facilities years ago. The FDA’s recent actions are simply unacceptable to fix the Essure problem. After 5 months of deliberation, the best the FDA could muster is to require a “black box” warning on the device’s labeling and a Patient Decision Checklist to help ensure women receive and understand the dangers and benefits of the Essure device. Finally, despite an abundance of information made available to the FDA and Bayer concerning “real-world” risks and injuries supplied by thousands of women, the FDA ordered Bayer to conduct a new study to collect more information regarding Essure’s risk in the real world. The FDA gave Bayer 15 months to even commence the study, which will take another few years to complete. Meanwhile, the device remains on the market, potentially injuring thousands more women while Bayer and the FDA further “study” the harmful effects. We need the courts to do what the FDA simply refuses to accomplish. Both the medical industry and the FDA have failed the Essure women. It is now up to the Courts and Congress to make things right.


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