Bayer AG last week announced a proposed $1.6 billion deal to settle U.S. claims involving the birth control implant Essure, which plaintiffs claimed caused side effects including hair and tooth loss, bleeding, chronic pelvic pain, miscarriages and death for those implanted with the device and their babies. The settlement aims to resolve about 90% of the nearly 39,000 total claims, including all the cases in venues with high volumes of cases such as the coordinated litigation in California Joint Council Coordinated Proceedings and in the U.S. District Court for the Eastern District of Pennsylvania.
Three of the lead plaintiffs lawyers driving the deal—Fidelma Fitzpatrick of Motley Rice, Edward Wallace of Wexler Wallace, and Erin Copeland of Fibich, Leebron, Copeland & Briggs—are this week’s Litigators of the Week. They recently discussed with the Lit Daily how Alameda County Superior Court Judge Winifred Smith, who was overseeing the JCCP proceedings, kept the cases moving forward even as pandemic closures pushed off scheduled trial dates this spring.
Lit Daily: Who were your clients and what was at stake?
Fidelma Fitzpatrick of Motley Rice: Our clients were women who had been permanently implanted with the Essure birth control device. Instead of experiencing worry-free, permanent birth control, they experienced a variety of unanticipated and serious injuries that affected their physical and mental health. At stake was justice for each of those individual women; in addition, the case was also about the larger need for transparency and full disclosure of risks when people’s health is at stake. Ultimately, the case was about empowering women by requiring a medical device company to provide complete information about risks associated with the device to allow women to make the best decision about their own reproductive health.
Who all is part of the plaintiffs’ leadership team and how did you work together?
Erin Copeland of Fibich, Leebron, Copeland & Briggs: Plaintiffs’ leadership was comprised of seasoned attorneys from various firms across the country. Very early on, we deliberately chose to keep the leadership structure small because of the nuances involved in this unique litigation that set it apart from a traditional medical device case. Our ultimate goal was to pursue this case methodically without wasting time and resources. We organized ourselves with a five-person executive committee overseeing litigation strategy and decisions with a slightly larger steering committee who both supported the executive committee and handled targeted tasks. I truly believe this plan and the good work of all involved led to our ultimate success.
How did your experience litigating cases against the makers of pelvic mesh inform how you managed these Essure cases?
Fitzpatrick: Pelvic Mesh informed how we managed these cases in several respects. First, it informed the staffing and the management of the project by highlighting the necessity of developing and executing on a comprehensive, yet flexible, plan for taking on well-financed corporations. It also underscored the value of having a small, yet committed team that works together at all stages of the litigation to achieve the best result possible–definitely quality over quantity. It also informed some of the substantive themes of the case as both involved women’s health care issues and the right that women everywhere have to make their own health care decisions based on full and complete information. The most important experience common to both cases, however, was to understand first-hand the profound effect that corporate decisions can have on individual women’s lives and the need for all affected to have access to the justice system.
The plaintiffs’ team had three trials on the calendar this year. How did the pandemic and courts’ difficulties conducting trials in the current climate affect your ability to negotiate this deal?
Ed Wallace of Wexler Wallace: We had the great honor of leading the first and second trials, which were to begin in March 2020. In the midst of preparing for the first trial of its kind in the country, we were simultaneously having settlement negotiations to see if a global resolution was possible. At the time, it became evident that a global resolution was not possible and we were set to go to trial. If anything, when the pandemic hit and the court closed, it allowed our team to focus on trying to find a way to deliver a resolution to tens of thousands of women who needed relief, which in many cases became more urgent as the pandemic worsened. While we could not try cases, we structured negotiations to allow us to continue to move discovery on our next wave of trial cases forward. We continued to work with experts and did the behind the scenes work that would prepare our team for trial, if and when circumstances allowed. We believe this structure afforded all of the women with cases a trial-ready team if negotiations failed. To her great credit, Judge Winifred Smith saw to it that the cases moved forward, even when trials were a distant reality. This effort ultimately resulted in an outcome that many outside of our small team believed would never happen.
The company in its press release announcing the deal continued to maintain that Essure is safe and effective. What key evidence were you and your team prepared to introduce at trial to counter those claims?
Copeland: The company has continued to tout Essure as safe and effective despite its complicated history with the FDA that ultimately ended with the product being discontinued. Essure had been on the U.S. market since 2002. Almost as soon as it went on the market, complaints started coming into the manufacturer. Those complaints increased as market share increased and that went on for decades. Once the complaints finally made their way to the FDA, the FDA convened an advisory committee in 2015 to analyze the details of those complaints and concluded that a black box warning and a rare patient decision checklist was required. The FDA also ordered the company to conduct a post-market study. In 2018, the FDA followed up with a restriction on the sale of the device and, shortly thereafter, the company discontinued U.S. sales. Notably, the Essure product had already been discontinued in all other countries except the U.S. Recently, the FDA released an interim report on the post-market study that revealed Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding as compared to women who had laparoscopic tubal ligation. Moreover, the rate of additional gynecologic surgical procedures, which includes device removal, was higher for Essure patients than tubal ligation patients. These results are in stark contrast to the company’s claims.
You touted the “expedited relief” that your clients will get from this deal when the settlement was announced last week. I know the details are in the works, but can you provide any further details about what that relief might look like?
Fitzpatrick: The settlement is not a traditional global settlement, but instead a series of settlements with individual case attorneys, each modeled off of the universally negotiated terms. Each firm is ultimately responsible for administering the settlement for their own clients. The settlement allows for the best of both worlds–the benefit of coordinated negotiations so all women and case counsel are treated equally, and the benefit of an individual firm settlement, which ensures that individual women retain, through their counsel, the flexibility to deal with their unique issues.
During the course of the litigation, thousands of Bayer’s internal documents were unsealed, including one appearing to show that the company had been tipped off to side effects reports before purchasing Essure. How did your discovery strategy help you get to this result?
Wallace: Unlike most medical device cases, we faced the ever-looming issue of preemption. This meant that we had no design defect claim and our failure to warn claim was limited to a failure to report, which was hardly a traditional route to a good outcome in medical device litigation. Our task was made more difficult by the fact that we had two different entities involved in the litigation. Therefore, we took a double-barreled approach to discovery. Of course, our discovery necessarily focused on Conceptus, the developer and long-time manufacturer of the device that was a stand-alone company until it was acquired by Bayer in 2013. This was made more difficult given the passage of time and the fact that many employees did not remain with Bayer after the acquisition. We also had to focus on Bayer, learning its systems, regulatory scheme, procedures, documents and witnesses and their role once Bayer became the legal owner of the Essure medical device. Though the task was enormous, our team deliberately decided to remain small so that we could boil down this complex story into something that we could easily tell a jury while making sure we kept within the very narrow confines of our legal claims. It required us to move as a unit from coast to coast, and across Europe, taking depositions of former Conceptus employees, as well as current and former Bayer executives who hailed from Germany, Brazil and other places around the World. In between those efforts, we would meet to synthesize what we were learning so that we could take what were two different businesses, each with their own approach, and develop an overall story. This meant we had to understand the regulatory systems and business practices of two different entities that developed and sold a Class III medical device for well over a decade. Thus, “what did they know, when did they know it and what did they do about it” was not an easy task. We are very fortunate that these women we represent persevered while we got their cases ready for trial.
What are the next steps in this litigation?
Fitzpatrick: Despite the unanticipated challenges posed by the COVID-19 pandemic, the court has been active in managing cases to resolution–through litigation or settlement. The Court has expressed a desire to have the settlement process work its way through so that it can determine the size, if any, of the remaining docket in the JCCP. Once the Court has a better handle on whether cases remain in the JCCP and the type of cases that remain, it will develop a litigation plan that is tailored to that docket.
What will you remember most about this litigation?
Fitzpatrick: I will always see this case as a study in the value of taking a chance in the face of obstacles, simply because it was the right and just thing to do. When we first filed these cases, there were many on both the plaintiff and defense sides who believed that these women could not achieve justice through the legal system; accepting that analysis would have left tens of thousands of women without a voice in the legal system. So instead, we worked methodically and carefully to craft a workable strategy that gave women an ability to speak their truth about their experiences. In the end, it turned out that there were so many more women that were affected by Essure than we originally thought–and because we were willing to take risk on this litigation, they were each given the ability to participate in the legal system.
Wallace: The phone calls with clients, trying to explain their case to them, and what preemption meant in their case and how, at the end of the day, these women just simply wanted to know they mattered and deserved full disclosure of the risks of a permanent implant.
Copeland: What I will remember most about this litigation is the tenacity and dedication of the Essure victims to seek justice for themselves. Never before in my two decades of practice have I seen such a strong group of women come together to advocate for themselves as successfully as the Essure sisters. Social media also played a heightened role in this litigation unlike any I have seen to date. I am confident we will all continue to see more of that in the future.—The American Lawyer Litigation Daily
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