Kristiana Tweed Burrell, whose stillborn daughter Ariel Grace inspired the name of a bill that would have enhanced a victim's ability to sue medical device manufacturers, has filed a lawsuit in North Carolina against Bayer Corp. for damages caused by its sterilization implant Essure.
The complaint alleges medical malpractice, negligence and wrongful death. It was filed Dec. 16 on behalf of Burrell, as an individual and as the administrator of her daughter's estate, in Buncombe County, N.C.
In addition to Bayer, the civil suit names Christopher Ford Williams, a sales representative of the pharmaceutical company, Burrell's obstetrician-gynecologist Dr. Stacy D. Travis, and Biltmore Ob-Gyn, the practice Travis founded in 1995, as defendants.
In other cases filed against Bayer over injuries related to Essure, the company has claimed it is not liable because a federal agency approved the device. This idea, known as federal preemption, could effectively grant Bayer immunity, but lawyers are optimistic that it won't.
Essure is a sterilization device consisting of tiny metal coils that are implanted in a woman's fallopian tubes. Scar tissue is supposed to grow around them, forming a barrier to block sperm and prevent eggs from being fertilized.
In December 2013, Travis implanted Burrell with the Essure device. Two subsequent tests, however, showed it wasn't working, with the left fallopian tube not fully blocked. Despite using other forms of birth control, she became pregnant.
Late one night in June 2015, Burrell began bleeding and suffering pain in her abdomen. Then, her water broke, and she partially delivered a breech baby while still at home. She delivered a stillborn girl, whom she and her husband named Ariel Grace, at 24 to 27 weeks.
Reps. Michael Fitzpatrick (R-Penn.) and Louise Slaughter (D-N.Y.) introduced a , Ariel Grace's law, in June 2016. It sought to amend a section of the Federal Food, Drug and Cosmetics Act, to the effect that device manufacturers were not protected from liability under state law. The bill was referred to the House Committee on Energy and Commerce and never made it to the House floor.
Bayer is liable, the case alleges, because after the Food and Drug Administration approved the device in November 2002 and women began getting the implant, the company became aware of some 30,000 reports of serious injuries associated with Essure. The company should -- and could -- have revised the device's warning label and revised the materials it distributed to physicians and patients. It also should have notified the FDA in a timely and adequate fashion, the case states.
By not doing so, Bayer “concealed and misrepresented” possible side effects and risks, even as it promoted Essure as “safe and effective for pregnancy prevention,” the complaint says.
The case alleges that Christopher Williams, Bayer Project Japan's senior sales consultant and field sales trainer in the Charlotte, N.C., area, personally failed to “provide information that was necessary for the medical and scientific community to protect each patient's interest.”
It also noted that Williams was “was physically present and training Travis on or about Dec. 20, 2013, when she implanted Burrell with the Essure birth control device,” according to operating room nursing records.
Bayer declined to offer comment on the case, as did the FDA.
Hundreds of lawsuits against Bayer alleging injury stemming from Essure have been filed throughout the country.
In its defense against some of the cases filed in California, Bayer argued that it was not liable on the grounds of federal preemption law. Because the FDA, a federal agency, approved the device, Bayer should not be held accountable for injuries, the company said. But in a ruling in August, a California state judge disagreed.
Rand Nolen, an attorney with Fleming, Nolen & Jez, a Houston-based firm that filed Burrell's lawsuit with the help of a local attorney, Jack Cloninger, said he fully expected Bayer to argue that these latest claims are preempted by federal law, but that such a position was “untenable.”
“They will have a difficult time arguing that under the specifics of this case,” Nolen said of Bayer. “No matter what a federal agency does, states have interests in protecting their citizens, and there are parallel state claims that can be brought,” he explained.
If a medical device maker claims preemption, “what they're saying is that the consumer is left without a remedy at all,” he added. “That's basically granting immunity, and we don't believe that anybody ever intended that that would happen.”
Between November 2002 and the end of 2015, the FDA received nearly 10,000 Essure-related reports listing problems including pain, bleeding, device breakage and allergic reactions to nickel. Once the device has been inserted, removing it has also proved highly problematic, doctors and patients say.
The website for Essure touts the device as the only non-surgical form of permanent birth control and says it is 99% effective at preventing pregnancy.
The website states that 750,000 women so far have used Essure. Other estimates by Bayer put the number at 900,000.