Ennis & Ennis, P.A.
Can Essure Claimants Override Preemption?
03/27/2015 - A close study of the evolution of the Essure birth control device leads one from disbelief to outrage. How this device has flourished in the marketplace despite the serious and widespread injuries inflicted on its users is both heartbreaking and anger provoking. The entire process by which Essure has been implanted in hundreds of thousands of women is egregiously flawed and needs to be changed. The approval of Essure was wrong from its inception.
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. PMA is the FDA process of regulatory and scientific review to determine the safety and effectiveness of Class III medical devices. Class III medical devices are ones that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of injury. It was the first time in FDA history that any birth control or female sterilization device was approved for as 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 complied 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. While the Medical Device Amendments Act does not expressly prohibit lawsuits based on state law claims, a 2008 US Supreme Court decision interpreted the statute to mean preemption applies and remains the current prevailing law.
However, preemption is not always absolute. In order to circumvent preemption, claimants must prove that the approval process was flawed and therefore invalid. Thousands of women injured by Essure are fighting for their rights to pursue claims against Bayer. Essure’s protection under preemption is being attacked on two fronts. First, a petition signed by more than 2,100 women was sent to the FDA claiming Conceptus, Inc., committed fraud during the clinical trials, violated the terms of the FDA’s conditional premarket approval of the device and violated several federal laws in the manufacturing and marketing of Essure. Accordingly, the petition maintains that the Conditional Approval is invalid and Essure should be removed from the market and lose any protection under the Medical Device Act. The petition was accepted yesterday and forwarded to the FDA Office of Compliance, which will now investigate these claims.
Similar arguments are currently before a Pennsylvania court, advocating that preemption does not apply due to the fraudulent conduct of Bayer’s predecessor 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. Similar to the FDA Petition, plaintiff argues that the CPMA order is invalid because 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.
If claimants can prove what they allege, it appears that the resolute group of women spearheading the fight against Essure may well attain their goal. Essure in no way deserves the protection afforded by preemption and there exists more than enough evidence to override preemption . The indomitable group of E-Sisters have worked tirelessly to bring national attention to this travesty by Bayer. Bayer’s deceptive manufacturing and marketing of Essure has put thousands of women as risk for serious, even life threatening injuries, which can last for years, even after removal of the product. It stops now.