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California Court Rules Essure Plaintiffs Can Move Forward With Litigation

Ennis & Ennis, P.A. Aug. 5, 2016

An important ruling was issued this week by Judge Winifred Y. Smith of the Superior Court of California, Alameda County, which permits the claims of multiple women who allege they were injured by the Essure Sterilization Device to proceed against the Bayer, the product manufacturer. Judge Smith ruled that the claims were neither expressly nor impliedly preempted under federal or state law. This ruling bodes well for hundreds of other cases recently filed in the California State Courts.

Each of the plaintiffs named in the lawsuit against Bayer was implanted with Essure and sustained significant injuries. Most women required surgical procedures, some multiple procedures, to have the devices removed. The significant complications suffered by these plaintiffs include migration, hysterectomy, abdominal pain, pelvic pain, back pain, bloating, weight gain, mental haziness, heavy menstrual bleeding, irregular menstrual cycles, perforated organs, autoimmune issues, hair loss, tooth loss, headaches and other complications.

Bayer has attempted to shield itself from all liability by maintaining that since Essure is a Class III medical device, approved by the FDA in 2002, it is therefore granted complete immunity from civil litigation, leaving its victims with no recourse. This flawed position was rejected by Judge Smith who ruled that Plaintiffs could proceed with allegations including failure to warn the FDA and thereby the public, of the dangers of Essure. Other claims may proceed against Bayer, including breach of warranties and misrepresentation. The Judge ruled that Plaintiffs would be permitted to plead with more detail; claims that Bayer negligently trained physicians and defectively manufactured the Essure product to include how those actions injured various plaintiffs. Essure victims should be encouraged by Judge Smith’s decision and should continue the fight, both to have Essure removed from the market and to seek justice as each woman deserves her day in court. Bayer should not be allowed to hide behind the dubious preemption shield to deny women compensation for injuries caused by their products. Thousands of women have been injured by the Essure device and it is time that these wrongly acts are adjudicated.

A weak attempt has been made by the FDA to warn women of the dangers of the device by announcing it will require Bayer to conduct another clinical study, require a patient decision checklist to make sure women understand the risks of the device and add a black box warning, the FDA’s most stringent warning, to Essure’s labeling. However, the FDA rendered this decision on February 29, 2016 and such requirements have yet to be put into action by Bayer or the FDA.

The lawyers at Ennis & Ennis, P.A., will continue to assist the E-Sisters in their fight against the FDA to revoke Essure’s PMA and to lobby Congress to pass two pending bills, including Ariel Grace’s law. The passage of these bills would effectively pull Essure from the market and allow victims the right to sue without the constraints of preemption.

Ennis & Ennis, P.A. has filed Essure cases in California, Missouri, New Mexico, and Illinois with more to follow. Ennis & Ennis P.A represents Essure victims in all 50 states and offers free confidential consultations. Do not wait, contact an attorney to protect your rights by calling 1-800- 856-6405 or visit us online at and fill out an online form.