Ennis & Ennis, P.A.
Essure Claimants At Critical Juncture In Battle Against Bayer
06/11/2015 - Essure claimants and E-Sisters across the country took one step forward in their battle against Bayer over the sterilization device, Essure, filing an extensive motion to prevent their representative cases from being dismissed. The legal battle is now at a critical juncture as a U.S. District Judge in Pennsylvania determines whether to allow five consolidated lawsuits to continue against Bayer despite Essure’s nefarious and controversial “protected” status by the Food and Drug Administration. At the heart of the challenge is the protected status or preemption protection the Essure device currently receives, insulating Bayer from liability from thousands of women injured by the defective device.
Essure is a permanent birth control device consisting of a four-centimeter coil placed into each fallopian tube to prevent pregnancy by causing severe inflammation creating a total blockage of the fallopian tubes. The coil contains nickel, which some women are unknowingly highly allergic. The coil also contains polyethylene (PET) fibers, which irritate and inflame the tubes, causing scar tissue to form over the coils, blocking subsequent fertilization. Unfortunately the PET fibers which create the irritation to form the scar tissue, often cause the body to fight what it deems to be an infection or foreign body, creating a host of other problems from autoimmune disorders, neurological problems, kidney, adrenal and thyroid disorders and even cancer. The coils often become dislodged, perforating the fallopian tubes, uterus, colon or other internal organs.
The original manufacturer, Conceptus filed for Premarket Approval (PMA) for Essure with the FDA as a Class III medical device. The FDA granted Conceptus conditional pre-market approval (CPMA). Conditional Approval provides that the device could be marketed in the US as long as the manufacturer complies with a specified list of conditions. If the conditions are complied with, the device is considered to be preempted, meaning that no state law tort claims can proceed against the manufacturer.
However, preemption is not always absolute. In order to circumvent preemption, claimants must prove that the approval process was flawed and therefore invalid. The Essure claimants maintain that preemption should not be applied due to the fraudulent conduct of Conceptus in the Premarket Approval process. (Bayer and Conceptus merged on April 28, 2013 and now is effectively Bayer). Plaintiff maintains that Defendant’s CPMA is “invalid” and Essure is an “adulterated” product per the FDA. Plaintiffs argue that the CPMA order is invalid because Conceptus and Bayer failed to comply with the following express conditions:
- Within 10 days after Defendant receives knowledge of any adverse reaction to report the matter to the FDA.
- Report to the FDA whenever it receives information from any source that reasonably suggests that the device may have caused or contributed to a serious injury.
- Failing to report and actively concealing 8 perforations, which occurred as a result of Essure
- Erroneously using non-conforming material in the manufacturing of Essure;
- Failing to use pre-sterile and post-sterile cages
- Manufacturing Essure at an unlicensed facility and
- Manufacturing Essure for three years without a license to do so.
Plaintiffs also maintain that their causes of action as pled, fall outside of the preemption protections as they are permissible state law claims including: Negligent Training of the physicians inserting the Essure, Negligent Entrustment, Breach of Express Warranty, Fraudulent Misrepresentation, Fraudulent Concealment, Strict Liability and Negligent Failure To Warn. These claims should be considered outside of the preemption context and the cases should be allowed to continue on these claims alone. Bayer has until June 30 to advise the Court if they wish to reply to the Plaintiff’s and then the judge will set a due date for Bayer’s pleadings. Thereafter, the judge must decide the fate of thousands of women whose lives were significantly altered due to the defective device; although an appeal is certain to follow regardless of the judge’s decision.
Ennis & Ennis, P.A. continues to offer free nationwide confidential consultations to anyone adversely affected by the Essure device.