Product News and Recalls

Judge’s Decision Could Lead to Flood of Essure Lawsuits

judge clears Bayer legal protection in essure lawsuitOne of the key components of Bayer’s Essure defense has been to shift blame for injuries away from itself and onto other entities. However, with the latest decision by Alameda County Superior Court Judge Winifred Y. Smith, the pharmaceutical company’s ability to do that has become seriously impaired.

Federal preemption invalidates any state law that runs contrary to federal law. Put simply, it says that the law of the federal government is the law of the land.

Bayer has attempted to use this idea to assert that because Essure was approved for use by the federal government, that Bayer is not responsible for claims of injury, and that lawsuits against it claiming injuries should be dismissed.

This idea has been flatly rejected by Judge Smith. Bayer failed on three separate grounds to have the cases thrown out of California state court.

Some 900,000 women have been implanted with Essure; a permanent sterilization device presented as an option to tubal ligation surgery. The device works by triggering the body’s production of scar tissue around the implantation site. This scar tissue eventually blocks the woman’s fallopian tubes.

Complaints over Essure complications have been recorded seemingly since the first day the device was available. Horror stories presented by tens of thousands of women tell of a device that has migrated to other organs in their bodies, perforated organs, and caused horrendous pain, bleeding, and even life-threatening injuries.

What is most disconcerting however, is that even in the face of such horrific claims, Essure remains available to this day. A black box warning has been recommended for the device (the FDA’s strongest warning reserved for drugs and devices that can cause great harm to patients) and was even the subject of a congressional investigation and faced calls for a federal ban. The agency, however, still failed to impose a recall; nor did it act to remove legal shields in place that protected Bayer from liability.

The FDA’s failure to act in response to Essure dangers seemingly leaves the job of protecting American women from this device to the country’s legal system. Indeed, it was a judge and not the FDA who removed legal protections from Bayer that cleared the way for this and future lawsuits.

It is sad that the entity responsible for the safety of the food and medications we use to keep ourselves healthy and safe refused to take action on behalf of the American people it is sworn to protect.