A California State Court Judge is pushing to standardize the case against Bayer, ordering personal injury attorneys to create a master complaint that would incorporate the allegations of more than 13,000 women who claim to have suffered severe injuries due to the birth control implant Essure.

Judge Winifred Y. Smith of the Alameda County Superior Court made the order during a hearing in Oakland on March 27, 2018, Law360 reports.

California Judge Guides 13,000 Essure Claims

Judge Smith has presided over Essure lawsuits for two years now; in August 2016, she allowed 11 consolidated claims against Bayer to continue, dismissing defense arguments that the women’s allegations were preempted by federal law.

Gavel In Courtroom

That was a major development; women across the country, along with their attorneys, had long-feared that, because Essure had been cleared for sale through the FDA’s controversial Pre-Market Approval pathway, their state common law claims of negligence and failure to warn would be barred.

To the contrary, Judge Smith ruled that Bayer could be held accountable for Essure-linked injuries, despite federal oversight.

Coordination Led To Explosion In Lawsuits

Two months later, the Judge granted plaintiffs another victory, allowing for the coordination of 55 separate Essure lawsuits (representing around 900 women) in her Court.  This decision laid the groundwork for efficient legal proceedings in which plaintiffs could pool their resources.

Since then, Judge Smith’s case load has grown by leaps and bounds. Today, the claims of over 13,000 current and former Essure patients are consolidated before Judge Smith.

Judge Smith Coaxes Essure Litigation Toward Trial

Now, the Judge has signaled her intention to speed the legal process along even further, telling plaintiffs’ and defense counsel in a hearing that it’s time to begin thinking about going to trial. To be sure, trials still lie far in the future; no one can yet predict when any one of these cases will be heard before a jury. But Judge Smith’s order to work up a master complaint (a measure she’s been “gently” requesting for a while) is a clear sign that the Court’s mind is set on resolution.

In synthesizing the diverse allegations contained in over 13,000 unique lawsuits, the Court, along with all parties to the dispute, will be allowed to focus in-depth on the common questions of fact and law that all of the claims share in common. It could also make it easier for women who have yet to come forward to join the litigation themselves in the future.

FDA Chief: 12,000 Essure Side Effect Reports In 2017

News of Judge Smith’s new order comes on the heels of a statement from FDA Commissioner Scott Gottlieb, who updated the public on the federal agency’s evaluation of Essure. Gottlieb says the agency received nearly 12,000 reports of Essure-related complications in 2017 alone, 90% of which “mentioned issues involving potential device removal.” Thousands of women have been forced to undergo invasive and life-altering hysterectomy procedures to stem the side effects.

Yet Gottlieb, along with the FDA, remain hopeful. America is the only nation in the world where Essure continues to be an option for women; Bayer withdrew the product from every other market in September 2017. The device’s persistence in the USA is largely attributed to support from the federal government. In his statement, Gottlieb wrote, “the FDA continues to believe that Essure may be appropriate for some women based on our current information.”