A California district judge last week remanded a case against Bayer Corp. to state court, granting a small victory to plaintiffs in the ongoing litigation against the pharmaceutical company over its sterilization device Essure, which thousands of women say has harmed them.
Judge Michael Fitzgerald, of the U.S. District Court for the Central District of California, granted a motion by plaintiffs in Jacqueline Alexander et al. v. Bayer Corp. et al. to remand the action to the Los Angeles County Superior Court.
“We were very, very happy with that ruling,” said Fidelma Fitzpatrick, an attorney with Motley Rice who is among several lawyers leading the litigation against Essure.
In response to the ruling, Bayer, a multinational company headquartered in Germany, said it would continue to defend the availability of Essure as an option for permanent contraception for women.
"This is a jurisdictional ruling and not a determination on the merits of the alleged claims, which plaintiffs still must prove,” said Rose Talarico, a spokesperson for the company. “Bayer stands by the positive benefit-risk profile of Essure,” she added, citing the fact that the Federal Drug Administration continues to describe Essure as “an appropriate option for the majority of women seeking a permanent form of birth control.”
Bayer attempted in mid-October to remove the case from state to federal court. With last week's order, the case will now join 55 others that a California state judge in September granted a motion to coordinate for pretrial purposes, the initial petition for which plaintiffs in Alexander v. Bayer had originally joined.
“There's an economy of working on those cases at the same time in the same way,” said Fitzpatrick. “It allows some control by the plaintiffs over the speed at which things are done.”
Essure consists of two tiny coils made of nickel that are inserted into a woman's fallopian tubes. Scar tissue is supposed to develop, blocking the tubes and preventing eggs from being fertilized. Part of the device's unique appeal as a form of permanent birth control is that its insertion does not require anesthesia or surgery.
But since November 2002, when the FDA approved Essure, nearly 10,000 patients have filed reports of problems to the federal agency's Manufacturer and User Facility Device Experience database. Among them were pain (6,989 reports), irregular periods (3,210 reports) and device breakage (429 instances).
In California alone more than 1,000 plaintiffs are represented in cases against Bayer over Essure, Fitzpatrick estimated.
The FDA last week updated its labeling requirements for Essure, mandating that Bayer include a black box warning and patient safety checklist. But some patient advocates, such as the support group Essure Problems, have called for a total recall of the device and a revocation of its FDA approval, saying that labeling changes would be insufficient to protect women.