Essure Litigation: MDL - 2739 to JCCP 4887
Essure is a permanently implanted birth control device for female sterilization that was approved by FDA for the use in the U.S. in November 2002 as a Class III medical device. Essure was developed by Conceptus Inc., now a fully owned subsidiary of Bayer AG. It entered the market by the Pre-market Approval (PMA) process. Promoted as a nonsurgical way of preventing pregnancies without the need for any incision or general anesthesia, it soon gained popularity, adding tremendously to the growth of the organization.
FDA Hearing and Black Box Warning
The immense volume of adverse events reports received from 2002 to 2015, forced the FDA to have a hearing on its safety and effectiveness. These injuries included severe back and pelvic pain, heavy menstrual periods, piercing of the fallopian tubes, and dislodging and injuring other organs, and many more. It was in 2016, the FDA required a physician and patient labeling updated as a ‘black box’ warning along with a ‘Patient Decision Checklist’ to be completed.
Essure: A Coordinated Approach
As the awareness about Essure’s alleged injuries along with FDA’s safety warning spread, a number of lawsuits were filed against the manufacturer in federal court in Pennsylvania and California state court.
Assistant Presiding Judge Winifred Y. Smith of the Alameda County Superior Court granted a petition to consolidate all Essure lawsuits filed which would proceed under Judicial Council Coordination Proceedings (JCCP).
Coordinating all the lawsuits was the decision as a majority of cases shared common factual and legal questions. It also gave each plaintiff control over her own lawsuit as compared to a class action wherein the representative plaintiffs had more control. Additionally, severe injuries caused by the Essure implants, which required extensive surgical removal procedures in most cases, amounted to varied and significant compensation demanded by the plaintiffs making it an ideal scenario for a coordinated action. Coordinating the pretrial proceedings also served as an efficient use of court resources, accelerating the proceedings, and reducing the chance of inconsistent rulings.
With a huge number of lawsuits being filed, a request to form a multidistrict litigation was filed by a group of plaintiffs in July 2016. However, this request was withdrawn on hearing the JCCP ruling by Judge Smith. There were at least 55 lawsuits filed by over 900 women in California, before consolidation, which were transferred to Alameda County’s Superior Court under the authority of Judge Smith.
Apart from California, several groups of Essure cases have been coordinated in other courts with additional federal lawsuits consolidated in the US District Court for the Eastern District of Pennsylvania.
Essure JCCP 4887 - As per Court Order Dec 2016
Formation of Essure Product Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887 was followed by appointments to the Plaintiff’s Steering Committee (PSC) in February 2017, to initiate, coordinate, and conduct all pre-trial discovery on behalf of the plaintiffs and also provide input to the Executive Committee.
Plaintiff Co-Liaison Counsel designated by court
William A. Kershaw - Kershaw, Cook & Talley
Elizabeth (Beth) Graham - Grant & Eisenhofer
Plaintiff's Executive Committee designated by court
Lead Counsel - Fidelma L. Fitzpatrick - Motley Rice
Erin Copeland - Houston Personal Injury Lawyer
Kimberly A. Dougherty - Partner Andrus Wagstaff
Elizabeth (Beth) Graham - Grant & Eisenhofer
Edward A. Wallace - Partner - Wexler Wallace LLP
Defendant Lead and Liaison Counsel designated by court: Alycia A. Degen - Sidley Austin LLP
An Effort to Propel Essure
What is unique about Essure lawsuits is that the awareness is propelled by thousands of injured women who took to social networks like Facebook and Twitter to come together, share their stories and coordinate their approach. In 2013, ’Essure Problems’, the largest Essure associated group on Facebook, was formed which has more than 30,000 members today. Along with this, there are other focused groups working towards the same goal.
H.R. 3920 (114th): E-Free Act was a bill introduced in 2015 as another attempt to make the nation Essure free based on complaints received from hundreds of injured women. However, it was cleared from the books on account of not being enacted.
Attorneys are waking up
Many mass tort attorneys postponed filing of Essure lawsuits due to the premarket approval shield protecting the defendant. In such scenarios, plaintiffs have to prove that the manufacturer violated a federal law to gain sales and failure to warn wasn’t enough. However, two favorable plaintiff hearings last year and more and more women coming forward to file a lawsuit against the manufacturer have made a number of attorneys reconsider their decision.
As the focus on Essure lawsuits and awareness continues, coupled with the slow but expected proceedings of the court, tens of thousands of women are waiting with cautious optimism. The initial outcome may get the ball rolling for thousands of plaintiffs. However, none of the cases has gone to trial yet, with no signs of settlement from the manufacturer.
This article was submitted by Neural IT. Neural IT provides cost effective and timely medical reviews for screening potential mass tort cases. For more information, please visit www.neuralit.com. You may email them at [email protected] or call +1-844-NIT-TEAM (648-8326).
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