On December 16, 2016, the woman whose tragic story inspired Ariel Grace’s Law, a bipartisan bill that would strip medical device companies of legal immunity, filed suit against Bayer.
As Modern Healthcare reports, Kristiana Tweed Burrell seeks to hold Essure’s manufacturer accountable for negligence and wrongful death in connection with the 2015 death of Burrell’s stillborn daughter, Ariel Grace. The lawsuit, filed in a North Carolina State Court, names a Bayer sales representative, Christopher Ford Williams, and Burrell’s former obstetrician, Dr. Stacy D. Travis, as additional defendants.
Mother Of Ariel Grace Files Essure Lawsuit Against Bayer
According to her complaint, Burrell received Essure implants, which are intended to prevent pregnancy permanently, in December of 2013, following the guidance of her Asheville-based OB/GYN. Two follow-up tests, however, indicated that the implantation attempt had failed. Burrell continued taking other forms of birth control, but became pregnant nearly two years later.
Only days after learning that she was pregnant, Burrell says she began to experience abnormal bleeding and abdominal pain. Her water broke prematurely, court documents state, and, still at home, Burrell partially delivered her child in breech position. After being rushed to a hospital, Burrell delivered a stillborn baby girl, who she and her husband named Ariel Grace, at 24 to 27 weeks of gestation.
In her lawsuit, Burrell suggests that an improperly-implanted Essure coil ruptured the amniotic sac, leading to her stillborn daughter’s premature delivery. Burrell says that Christopher Ford Williams, a senior sales rep and field sales trainer for Bayer, sold Travis the implants and “was physically present and training Travis on or about Dec. 20, 2013, when [the doctor] implanted Burrell with the Essure birth control device.
Mother’s Tragic Story Inspires Legislation
The filing of Burrell’s lawsuit has been called “monumental,” in large part because the bereaved mother’s story has played a central role to a growing movement that hopes to have Essure recalled from the market entirely. More than 30,000 people have thrown their weight behind Essure Problems, a grassroots organizing group that has actively lobbied Congress and won high-profile support from Pennsylvania State Representative Mike Fizpatrick.
Nearly 3,000 women have filed their own Essure lawsuits against Bayer, accusing the company of concealing the device’s link to devastating side effects. In 2016, Fitzpatrick, a Republican, accused the Food & Drug Administration of ignoring nearly 300 miscarriages, ectopic pregnancies and stillbirths linked to failures of the Essure device. The shocking statistic came from an independent review of FDA adverse event reports commissioned by Fitzpatrick and conducted by Madris Tomas, founder and chief executive of Device Events. Five months later, Fitzpatrick introduced Ariel Grace’s Law into the House of Representatives.
Ariel Grace’s Law: Strip Device Makers Of Immunity
Sponsored by Fitzpatrick and Louise Slaughter, a Democrat from New York, the bipartisan bill (H.R. 5403) seeks to amend the Federal Food, Drug and Cosmetic Act, expanding a patient’s right to sue medical device manufacturers over alleged injuries.
On the heels of a 2008 Opinion from the late Supreme Court Justice Antonin Scalia, federal law is widely interpreted to prohibit civil lawsuits involving so-called “Class III” medical devices, which come under heightened FDA scrutiny. In Riegel v. Medtronic, Justice Scalia held that a clause in the Medical Device Amendments of 1976 bars patients from filing lawsuits over potentially-dangerous medical devices that have received premarket approval from the Food & Drug Administration.
Ariel Grace’s Law was introduced in the House of Representatives on June 8, 2016. It has been referred to the House Committee on Energy and Commerce.