(This story was updated with a comment from Bayer at 6 p.m. EDT Oct. 4.)
A California state judge granted a motion Friday to coordinate 55 cases filed against Bayer by women who say the pharmaceutical company's permanent birth control device Essure caused them harm.
“I'm hoping that it'll be a quicker, more efficient, cohesive resolution to all women's cases in California,” said Elizabeth Graham, a lawyer with the firm Grant & Eisenhofer who is one of the lawyers representing the plaintiffs.
In California, the mechanism of civil case coordination allows two or more cases that “share common questions of fact or law and that are pending in different counties to be joined in one court,” according to the state's judicial branch.
With coordinated cases assigned to a single judge, one ruling applies to them all.
“One of the reasons that we requested the coordination is to avoid inconsistent ruling,” Graham said. “Why reinvent the wheel?”
To coordinate cases in California, a petition has to be submitted to the chair of the Judicial Council, who then assigns a motion judge to decide on it. For the Essure cases, that was Judge Winifred Smith of the Superior Court in Alameda County.
In her order granting coordination, Smith recommended that the coordinated proceedings be conducted in her court, a decision that now rests with the chair of the Judicial Council.
It was Smith who in early August allowed 11 consolidated suits representing 14 women who said they were injured by Essure to proceed after Bayer sought on three separate grounds to have them thrown out.
Essure is a tiny coil made of nickel that is inserted without surgery or anesthesia into each of a woman's fallopian tubes. Ideally, scar tissue develops around the coils, blocking the tubes and preventing the fertilization of eggs and their entry into the uterus.
In reality, thousands of women have reported problems. The device has moved after being inserted. It has perforated organs and caused women severe pain.
Between Nov. 4, 2002, the day the FDA approved Essure, and Dec. 31, 2015, the agency's Manufacturer and User Facility Device Experience database received 9,900 reports related to Essure, many of them detailing multiple problems. The FDA received 6,989 reports of pain, including abdominal pain, 3,210 of irregular periods, 854 of the device migrating, and 429 of the device breaking, among numerous other problems.
Graham estimated that the cases filed for coordination for pre-trial purposes represented roughly 900 women in California alone. Other cases claiming harm caused by Essure have been filed outside the state, in federal court.
Bayer, meanwhile, maintains that Essure is safe for women to use.
“Bayer stands behind the positive benefit-risk profile of Essure,” the company said in a statement. It said clinical trials supported Essure's “safety and efficacy,” citing an FDA statement that Essure was still “an appropriate option for the majority of women” who wanted permanent birth control. It added that Friday's order was “not a ruling on the merits of the alleged claims, which plaintiffs still must attempt to plead and prove.”
The device is one of several that prompted seven members of Congress, led by Rep. Mike Fitzpatrick (R-Pa.), to ask in September for a hearing on the impact of unsafe medical devices. At the same time, they called into question the effectiveness of the FDA's Center for Devices and Radiological Health. The center “is struggling to accomplish its fundamental mission to protect patient health and safety,” Fitzpatrick and others said in a Sept. 22 letter to members of the House Energy and Commerce Committee.
The FDA has not pulled Essure from the market. Instead, it convened an independent committee of experts in September 2015 to review concerns and discuss evidence of Essure's safety and effectiveness.
In February, the FDA recommended that Bayer add a black box warning, the most serious kind. It also mandated a new clinical study to determine the risks Essure might pose, for which Bayer submitted a plan in March. The FDA approved an updated version Sept. 2.
In mid-September the FDA approved another Bayer contraceptive: a flexible, plastic T-shaped intrauterine device called Kyleena.