On December 19, Holly Ennis of Ennis & Ennis P.A., as one of the lawyers working for justice for Essure baby Ariel Grace and her family, filed suit in Buncombe County, North Carolina. The plaintiff, Kristiana Burrell, is suing over injuries she experienced thanks to Bayer’s “permanent” birth control device, Essure, including a full hysterectomy. She is also suing as Personal Representative of her daughter, Ariel Grace’s, estate. The Essure device cost little Ariel Grace her life. Other named defendants include the implanting doctor, Dr. Stacy D. Travis and the Bayer sales representative, Christopher Ford Williams, who sold Essure to Dr. Travis and trained her as to proper implantation procedures.BackgroundKristiana Burrell is a victim of Bayer’s greed. She had the Essure device implanted in December 2013 to prevent pregnancy. Bayer hid the 9.6% failure rate of the device from the public, including Kristiana, who eventually became pregnant. June 7, 2015 is a date that will be forever etched in Kristiana’s and her family’s memories.According to Ms. Ennis, Kristiana began experiencing “abdominal pain and bleeding and was both stunned and shocked by the spontaneous rupture of membranes and partial delivery of a footling breech while at home.” For those who don’t know, a footling breech occurs when one or both of the infant’s feet emerge as opposed to the head.At the hospital, little Ariel Grace Burrell was born only 27 weeks into the pregnancy at 1 pound, 5.3 ounces. In her case, it is believed that Essure caused a placental abruption – the detachment of the placenta from the womb. This can occur when the Essure coils are improperly placed or migrate from a woman’s fallopian tubes, two situations that happen quite often. Ariel Grace was stillborn the next day.

Ariel Grace's Ribbon; image courtesy of Red's channel 44 on YouTube.

The LawsuitThere is no denying that Bayer and its subsidiary Conceptus (the original Essure manufacturer) have a duty to ensure the device’s safety. The FDA granted Essure conditional pre-market approval, meaning that the device was supposedly subjected to the Agency’s most rigorous evaluation process. Under the PMA, Bayer had the following responsibilities, according to Ms. Ennis:

• “Ensure that any warranty statements are truthful, accurate, not misleading and are consistent with applicable federal and state laws;

• Submit a PMA supplement when unanticipated adverse effects or increases in the incidences of adverse effects occur or when device failures require a labeling, manufacturing or device modification;

• Submit a report to the FDA within 10 days after Bayer receives or has knowledge or information of any adverse reaction, side effect, injury, toxicity, or sensitivity reaction that has not been addressed by the device’s labeling or has been addressed but is occurring with more than expected severity or frequency;

• Submit a report to the FDA within 10 days after Bayer receives or has information of any failure of the device to meet specification established in the PMA;

• Report to the FDA whenever it received information from any source that reasonably suggested that the device may have caused or contributed to a serious injury; and

• Report to the FDA within thirty days whenever Bayer receives information, from any source that suggest a device has malfunctioned and would be likely to cause or contribute to serious injury if the malfunction were to reoccur. Bayer did not need prior FDA approval to update its warnings at any time and it was incumbent upon Bayer to do so.”

Meeting those responsibilities would make possible the education of healthcare providers and their patients regarding the risks of the Essure device. Instead, both Bayer and Conceptus withheld this critical information from the FDA. Prior to Bayer’s 2013 purchase of Conceptus, FDA inspectors found a staggering 16,581 complaints about Essure that were never given to the FDA. The complaints spanned two years, from January 1, 2008 to December 6, 2010.Post-Bayer acquisition, a second FDA inspection found another 16,047 complaints from January 11, 2011 to May 2013. Bayer only notified the FDA of 183 of these reports and none of them included complaints - supported with medical imaging - of the Essure device migrating.Again, according to Ms. Ennis, “The lengthy complaint alleges various causes of action including: Negligence, Strict Products Liability, Breach of Express Warranty, Breach of Implied Warranty, Fraud and Medical Negligence. It seeks both compensatory and punitive damages against the various defendants. The complaint alleges far too many examples of breach of warranty to be set forth herein, however the allegations in the complaint leave no doubt that Bayer was under a continuing duty under both federal and state law to disclose the true character, quality and nature of the risks, adverse events and dangers associated with Essure and they negligently or intentionally failed to do so.”In addition to the Burrell suit and others by Ms. Ennis’ firm, suits have been filed across the nation on behalf of injured women. However, that is not the only action being taken to right the wrongs perpetrated on innocent women by Bayer’s Essure device. Representative Mike Fitzpatrick (R-PA) has authored two pieces of legislation designed to address the Essure issue specifically and the issue of dangerous medical devices in general.The E-Free Act would remove the PMA protection the FDA granted to Bayer for Essure. The PMA currently prevents anyone from suing Bayer for injuries sustained from Essure. Injured women have been allowed to bring only a handful of causes of action against the Big Pharma giant, thanks to a ruling by a federal judge in Pennsylvania. These causes include:

• Negligent misrepresentation

• Negligent failure to warn

• Negligent training

• Negligent risk management count, and

• Negligent manufacture

If passed, the E-Free Act would allow injured women full access to the legal system in pursuit of justice.Rep. Fitzpatrick also introduced Ariel Grace’s Law, an amendment to the Federal Food, Drug, and Cosmetic Act, which would make the process of seeking justice for Essure victims and all who have been injured by a Class III medical device, easier. Both Ariel Grace’s Law and the E-Free Act are currently in committee and we hope to see them signed into law next year.My thanks to Holly Ennis for letting me know of Kristiana’s lawsuit and for all of the tireless work she does on behalf of the E-Sisters and their families. It is an honor to stand with her and the E-Sisters in this fight for justice. We will not stop. We will not surrender. Justice will be done.

Sources:

NORTH CAROLINA FAMILY SEEKS JUSTICE AGAINST BAYER FOR ESSURE RELATED DEATH OF ARIEL GRACE.Bayer and FDA – No Family Should Suffer This Pain