A lawsuit filed in North Carolina on December 16, 2016 alleges that the use of Essure, a sterilization contraception device, caused the stillbirth of a baby girl. It was filed on behalf of Kristiana Tweed Burrell, as an individual and as the administrator of her daughter’s estate.
The daughter, Ariel Grace, inspired a bill that would have enhanced a victim’s ability to sue medical device manufacturers. Ariel Grace’s law, introduced by Reps. Michael Fitzpatrick (R-Penn.) and Louise Slaughter (D-NY) in June 2016, sought to amend a section of the Federal Food, Drug and Cosmetics Act that protects device manufacturers from liability under state law. The bill was referred to the House Committee on Energy and Commerce, but never made it to the House Floor.
The complaint names as defendants Bayer Corp., the manufacturer of Essure, Christopher Ford Williams, a sales representative for Bayer, Burrell’s obstetrician-gynecologist Dr. Stacey D. Travis, and the practice Travis founded Biltmore Ob-Gyn.
Essure works as a sterilization device consisting of tiny metal coils that are implanted in a woman’s fallopian tubes. The device causes scar tissue to grow around it, forming a barrier to block sperm and prevent eggs from being fertilized. In December 2013, Dr. Travis implanted Burrell with Essure, but subsequent tests revealed the left fallopian tube was not blocked. Despite still using other forms of birth control, Burrell became pregnant. In June 2015, Burrell began bleeding and suffering pain in her abdomen. After her water broke, she partially delivered a breech baby while still at home.
The case alleges that after the FDA approved the device in November 2002, Bayer became aware of approximately 30,000 reports of serious injuries associated with Essure. The lawsuit alleges that Bayer failed to properly revise the device’s warning label and the materials it distributes to doctors and patients. According to the case, Bayer also failed to adequately notify the FDA of the reports.
The lawsuit contains causes of action for medical malpractice, negligence, and wrongful death.
