A California judge has laid out the next steps for coordinating dozens of lawsuits filed against the pharmaceutical company Bayer by hundreds of women who say they were harmed by its sterilization implant, Essure.
Judge Winifred Smith of Alameda County issued the case management order Dec. 21, 2016. The order designates which lawyers hold which responsibilities for legal procedures, coordination efforts and broader litigation strategies as attorneys seek to streamline pretrial proceedings for Essure-related lawsuits in California.
“We think it's important that these women have their claims resolved as quickly as they can be,” said Fidelma Fitzpatrick, an attorney with Motley Rice, a litigation firm headquartered in Mount Pleasant, S.C., that is representing women who claim they were injured by Essure. She will serve as the lead counsel of the Plaintiffs' Executive Committee, a group of five lawyers who coordinate the activities of pretrial proceedings.
In California, if two or more civil cases in different counties “share common questions of fact or law,” according to the state's judicial branch, coordination allows them to be brought to one court and assigned to a single judge. The judge's ruling then applies to all the cases. The process is used to keep cases organized and avoid separate, conflicting judgments.
“We'd like to see these trials get started within a year,” said Elizabeth Graham, a lawyer with the San Francisco-based firm Grant & Eisenhofer, who is one of two co-liaison counsels for the plaintiffs and a member of the Plaintiffs' Executive Committee.
The number of women represented in the coordinated cases is in the “multiple hundreds,” estimated Fitzpatrick. She could not provide a definite number because women continue to file Essure-related cases “fairly regularly” in California against Bayer, some of which are added to the group of coordinated cases.
Hundreds of Essure-related lawsuits have also been filed against Bayer in district courts and in states throughout the country, including North Carolina and Missouri.
Essure is a medical device used for permanent sterilization. It is a set of two metal coils that are implanted in a woman's fallopian tubes. Scar tissue is supposed to form around the coils, blocking the tubes and preventing eggs from being fertilized.
Bayer markets the device as “the only permanent birth control with a non-surgical procedure.” The company also says Essure is more than 99% effective.
But between Nov. 4, 2004, the day it approved the device, and Dec. 31, 2015, the federal Food and Drug Administration has received nearly 10,000 reports of problems related to Essure, including four adult deaths. Sharp abdominal pains and heavier periods are common side effects, and several hundred women reported that the device had broken or moved. Other women have encountered complications when they try to have the device removed and have undergone surgery including hysterectomy as a result.
Bayer has stood by Essure, even as the lawsuits accumulate.
Although California allowed the cases to be coordinated, that order was “not a ruling on the merits of the alleged claims, which plaintiffs still must attempt to plead and prove,” said Jennifer Brendel, a spokesperson for Bayer. “Bayer stands behind the positive benefit-risk profile of Essure, the safety and efficacy of which is supported by clinical trials, more than a decade of science and real world clinical experience.”
She added, “As FDA itself has stated recently, 'Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.' ”
In October, the FDA updated labeling requirements for Essure by including a black box warning, which in the FDA's own words, “is designed to call attention to serious or life-threatening risks.”
In the coming months, lawyers working on the coordinated California cases aim to draw together a schedule to reach trials. They will also begin the process of discovery.
“We're going to be looking at issues of what Bayer knew about problems associated with the devices, when Bayer found out…[and] what they did with the information,” Fitzpatrick said.
