Trial Magazine

Seeking a less-invasive, permanent birth control solution, a woman in Texas was implanted with the Essure medical device. After receiving the device, she spent months in and out of the hospital for chronic pain, abnormally heavy and constant menstrual bleeding, and intense fatigue. What she and her doctors didn’t realize was that her severe health symptoms were the result of Essure coils improperly migrating from her fallopian tubes, with one perforating her uterus and the other found floating in her stomach.

She and thousands of other women across the country implanted with Essure had critical injuries requiring extensive medical treatment, including invasive surgeries and hysterectomies, to have the device removed. These women learned that Essure was the cause of their injuries—yet many had serious questions about whether they would be able to hold the device manufacturer accountable.

Essure, a permanent birth control device approved for sale in the United States in 2002, consists of two metal coils inserted into a woman’s fallopian tubes to prevent pregnancy. Once implanted, scarring is supposed to occur around the coils, which are meant to be permanent, creating a blockage that prevents sperm from meeting the egg. In numerous women, however, the coils caused bleeding and chronic pain, a variety of autoimmune responses, and even dangerous ectopic pregnancies. For many, the coils migrated from the fallopian tubes and perforated other organs.

But what appeared to be straightforward products liability cases against a device manufacturer were complicated by the fact that Essure, which is a Class III high-risk medical device, was cleared to market through the FDA’s premarket approval (PMA) process. Under the U.S. Supreme Court’s decision in Riegel v. Medtronic, Inc. (552 U.S. 312 (2008)), the Medical Device Amendments of 1976 preempt any nonparallel common law claims related to the safety and efficacy of a medical device, including design defect claims.

“These injuries are clearly connected to flaws in the device’s design, among other things, but because Essure went through the PMA process, women are preempted from bringing design defect and other similar claims,” said Houston attorney Erin Copeland, who represents thousands of women injured by Essure. “The women were falsely told that it was an easy alternative to tubal ligation—no surgery, no incision, no need to ever worry about birth control again—and yet because of how the device reached the market, they can’t make these claims in the context of fraud or misrepresentation. Their legal recourse is severely limited.”

After hearing about Essure’s impact, Copeland and other plaintiff attorneys learned of parallel state causes of action not preempted under Riegel that would enable the women to at least have their day in court. Ultimately, these lawyers filed dozens of cases in California state court, alleging that Conceptus Inc., the California entity that created Essure, and Bayer, which purchased Conceptus in 2013, had failed to share adverse event reports with the FDA in violation of the agency’s reporting requirements and that this was a basis for a non-preempted claim. The cases were consolidated into a Judicial Council Coordinated Proceeding in Alameda County in 2016, which now includes more than 14,000 plaintiffs. It is the largest consolidation of Essure cases in the country, with more cases expected to be filed. Smaller groups of Essure cases are pending in Illinois, Missouri, and Pennsylvania.

Copeland, a member of the plaintiff’s executive committee in the California litigation, explained how these strict liability and common law claims differ from traditional products liability claims. “Because of preemption, we are generally not able to attack the manufacturer’s misconduct that occurred premarket. We can’t bring traditional products liability claims such as design defect or manufacturing defect, even though we strongly believe these defects exist,” Copeland said.

She described how the plaintiffs in California defeated a motion to dismiss based on preemption in 2016: They relied on Ninth Circuit law and, in large part, on evidence in the public realm showing that Bayer had, in fact, received thousands of complaints of injuries associated with Essure but failed to submit those reports to the FDA. “We essentially had to show that the manufacturer failed to meet its reporting obligations to the FDA concerning adverse events after the product went on the market and that such failure to report was a cause of the plaintiffs’ injuries,” she said.

Copeland credits the grassroots advocacy of the Essure plaintiffs for the strong warnings now in place about Essure. In late 2016, a “black-box” warning—considered the strictest warning put on a medical device by the FDA—was added to the label. And a “patient decision checklist,” which consists of several pages of warnings about Essure’s risks and requires the patient to initial and sign an acknowledgment of these risks, was also added to the label.

The FDA went one step further in April: It restricted the sale of Essure to health care providers who use the patient decision checklist. The FDA warned Bayer that, as the manufacturer, it could be subject to criminal and civil penalties if it failed to enforce the restriction.

To date, the FDA still has not banned Essure, but in July, after continued consumer pressure and increased media attention—including a Netflix documentary featuring the outcry against Essure and other medical devices—Bayer announced that it would stop selling the device in the United States at the end of 2018. It previously pulled Essure from all other international markets but has continued to sell the product here.

"Despite the legal limitations on their ability to seek justice, these women focused their energies on creating a movement powerful enough to push the FDA to respond and to shed light on the manufacturer's internal misdeeds."

“These women banded together on social media and in other forums, educating themselves about both medical and legal issues,” Copeland said. “They relentlessly voiced their concerns to the manufacturers, the FDA, and the public. Despite the legal limitations on their ability to seek justice, they focused their energies on creating a movement powerful enough to push the FDA to respond and to shed light on the manufacturer’s internal misdeeds. They are a formidable group who have suffered greatly, and they deserve to have their day in court.”

Mandy Brown is an associate editor of Trial magazine.