Essure is a permanent contraceptive medical device manufactured by Bayer Healthcare. The device is a flexible, nickel-based coil that is permanently placed into each of the female fallopian tubes. Thereafter, the device works to induce scar tissue formation and form a barrier that inhibits sperm from reaching an egg, thereby preventing pregnancy. The procedure usually takes less than 15 minutes, and over the course of approximately three months, scar tissue forms around the coil inserts, effectively blocking the fallopian tubes and thereby keeping pregnancy from occurring.
Essure was first approved by the FDA in 2002, and was designed as a less-invasive alternative to tubal ligation, a standard procedure for surgical sterilization. Essure has remained the only FDA-approved non-surgical, permanent birth control method. However, women implanted with Essure have experienced some of the following:
perforation of the fallopian tube or uterine wall; migration of Essure inserts through the fallopian tubes or uterus into the lower abdomen and pelvis; pelvic pain; infection; miscarriages; allergic reactions; abnormal bleeding; joint or muscle pain; muscle weakness; excessive fatigue; hair loss; weight changes; mood changes; and persistent fever.
In some cases, women have had to undergo surgical procedures to remove the device, including hysterectomies. After years of receiving thousands of injury complaints, the FDA finally responded. The FDA, based on concerns for serious risks associated with Essure, has mandated that a special “Black Box” warning should be added to packaging for Essure. As we have previously mentioned, a “Black Box” warning is the most serious warning required by the FDA.
Additionally, the FDA now requires a new, extensive “patient checklist” discussing the risks associated with Essure that women must sign prior to undergoing an Essure implant procedure. The FDA’s response further mandates that Bayer must conduct a new study following at least 2,000 women for a minimum of three years, which is designed to evaluate Essure’s risks “in a real-world environment.” Even though the FDA recently responded strongly to concerns regarding risks associated with Essure, the device remains on the market today.
As we mentioned in another section of this issue, a number of lawsuits have been filed against Bayer for injuries related to Essure following the FDA’s “Black Box” warning announcement and more are expected to be filed. However, hurdles have been and continue to be experienced by claimants. Federal preemption continues to be the primary obstacle in the newly filed cases. Although the Medical Device Act (MDA) contains a preemption provision, the clause does not expressly prohibit lawsuits that hinge on state tort law claims, such as general negligence, products liability or fraud. That should allow the claimants to avoid preemption.
Additional complexities for Essure claimants stem from allegations that Bayer failed to report known complications from implantation of the device and that the company actively concealed perforations. As a result, claimants have encountered challenges tiptoeing around federal preemption while still specifically pleading state law causes of action. Pleading around preemption and alleging non-preempted versions of state law claims requires careful consideration and deliberation, as three categories of preemption (express, field, and conflict) necessitate the framing of complex issues by courts with the MDA.
Nevertheless, Essure lawsuits continue to be filed with increasing hope and potential for sustainability. In April 2016, complaints filed by Essure claimants in Alameda County Superior Court (California) received complex case designation. In the Court’s discretionary ruling, complex designation assures that Essure claims will receive exceptional judicial management due to the difficult or novel legal issues inherent in the claims as well as expedition of the litigation overall.
If you need more information on the Essure litigation, contact Roger Smith, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Roger.Smith@beasleyallen.com.
Sources: Washington Post and FDA