Holly Kelly Ennis
North Carolina Family Seeks Justice against Bayer for Essure Related Death of Ariel Grace.
Today, the wheels of justice moved forward for the tragic loss of life of baby Ariel Grace Burrell. On June 7, 2015, just two days after learning she was pregnant despite being implanted with the Essure Sterilization device, Krisitiana Burrell was faced with an unspeakably painful situation. She developed 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. Krisitiana was rushed to the hospital where she sadly gave birth to a stillborn baby girl at nearly 27 weeks. The bereaved parents named their daughter Ariel Grace Burrell. It is believed that the an improperly placed or migrated Essure coil, ruptured the amniotic sac causing the premature stillborn delivery.
In a landmark case filed today in Buncombe County, North Carolina, Kristiana Burrell filed a claim, individually for damages she sustained as a result of the Essure device which resulted in a full hysterectomy and as Personal Representative of the Estate of Ariel Grace Burrell. This lawsuit asserts claims against several related Bayer entities, as well as Dr. Stacy D. Travis, the physician who implanted the device and Christopher Ford Williams, the Bayer sales representative who sold the device and provided guidance and training to Dr. Travis regarding the surgical procedure.
The allegations in the Complaint maintain that Bayer had an affirmative duty under many state and federal regulations to continue to monitor and evaluate the safety of the Essure device after it received the conditional PMA approval. More importantly, pursuant to the Order granting the Conditional Premarket Approval (CPMA), Bayer was required to among other things:
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 incumbunt upon Bayer to do so.
In essence, Bayer was and is under a mandatory obligation to notify the FDA when it learns of adverse effects, injuries, reactions, device failures or device malfunctions which would like reoccur and cause injury. Notifying the FDA allows such information to be disseminated to physicians and the public to better warn and educate potential users regarding the dangers of the device. Failure to warn of such malfunctions and injuries actively misrepresents the safety of the product. Bayer was also required to update its labeling and warnings regarding the device to adequately address the dangers of the device.
Based upon several FDA inspection of the Conceptus (now a wholly owned subsidiary of Bayer) facilities, a staggering amount of complaints and adverse events, including malfunctions, perforations, and migrations were received by Conceptus and never reported to the FDA. During a 15 day FDA inspection commencing December 2010, the FDA inspector uncovered 16,581 reports of complaints regarding the Essure device from the period of 1/1/08 through 12/6/10. Said reports were never turned over to the FDA. Therefore, neither the public nor physicians were notified of theses device malfunctions and injuries. To make matters worse, another FFDA inspection in June 2013 and the FDA uncovered a list of complaints received since the prior inspection starting from January 2011. Bayer turned over another 16,047 complaints received between 1/11/11 and May 2013. Only 183 of these complaints were reported by Bayer to the FDA. (None of the 29 randomly reviewed complaints where one or more coils were imaged outside of the fallopian tubes were reported to the FDA.)
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.
Attorney Holly Ennis, one of the attorneys representing Krisitiana Burrell is, "thrilled the case is now moving forward to obtain justice for Ariel Grace and the Burrell family. Ariel Grace has a special place in the hearts of all Essure Problems members and E-Sisters." In fact, Congressman Mike Fitzpatrick sponsored a Bill to revise the Medical Device Act making is easier for Essure victims and all Class III medical device victims to seek civil remedies in court and it is aptly named in honor of Ariel Grace. It is hoped that Ariel Grace’s law will be passed next summer and will forever bear her name. In the interim, we will continue to fight on behalf of women nationwide until the device is removed from the market and all of the injured women are compensated for their injures.
If you have questions concerning Essure, please contact Holly Ennis at 800-856-6405 or visit us online at www.ennislaw.com.