The 11 consolidated suits greenlighted last week represent 14 women who say that Essure, a permanent birth control device consisting of tiny metal coils inserted into the fallopian tubes, injured them in ways well beyond the risks indicated in medical literature.
They represent a fraction of the some 200 lawsuits that have been filed in California alone, Graham said. Other cases have been filed outside the state in federal court, and lawyers filed a petition before the judicial council Friday to coordinate cases in California, so they can be assigned a single judge in the hopes that rulings would be applicable to all those cases.
In one of its defenses, Bayer argued that under federal preemption law, the plaintiffs were not allowed to file suit. Because Essure was approved by the Food and Drug Administration, it said, Bayer itself should not be held liable for injuries.
But the court disagreed, in a motion that not only was vital in allowing the Essure cases to forward but could also have major implications for other medical device manufacturers, lawyers said.
“It's a court telling Bayer and other similar manufacturers that they don't have immunity,” said Fidelma Fitzpatrick, an attorney with Motley Rice, which also represented plaintiffs in the cases affected by last week's ruling. “They don't have the ability to go out and injure without consequence.”
In response to the court's rulings, Bayer cited the FDA in maintaining that Essure is both safe and effective for “the majority of women” who want permanent birth control. About 900,000 women use Essure today, a figure based on sales, it said.
The device consists of a tiny coil, made of nickel, that is inserted into each fallopian tube. As scar tissue builds around the coils, it is supposed to block the tubes and prevents eggs from being fertilized or entering the uterus. The device's straightforward insertion, done quickly and without surgery or anesthesia, is part of its appeal.
However, thousands of women have reported problems with the device such as its moving after insertion, perforating organs or causing severe pain. Essure Problems, a Facebook support group for women who have suffered after getting it implanted, has more than 12,000 likes.
“We will vigorously defend against the remaining claims and stand behind the continued availability of this important option for the many women who are seeking permanent contraception,” a spokesperson for Bayer said.
The cases move forward amid swelling controversy over the safety and efficacy of Essure that has enmeshed the FDA, physicians, thousands of patients, their advocates and one of the biggest pharmaceutical companies in the world, while raising broader questions about how the FDA approves medical devices.
The FDA approved Essure as a Class III medical device in 2002. Thirteen years later, its Manufacturer and User Facility Device Experience database had racked up more than 5,000 adverse event reports, from abnormal bleeding to “device migration," linked to Essure.
In September 2015, the FDA convened a panel of independent experts who recommended the agency limit the use of Essure because too little research had been done to prove its safety. In February, it recommended a black box warning for Essure, amid calls for it to recall the device entirely.
In the California suits, specific allegations against Bayer vary by case, but among them are negligence, fraud and negligent misrepresentation. Bayer failed, the plaintiffs claimed, across a wide spectrum, by failing to monitor and test Essure, conduct regular risk analysis, or exercise “reasonable care in its manufacturing and quality control process.” Nor did it “appropriately certify and train physicians” to prescribe and implant the device, on complaint said, according to court documents.