PHILADELPHIA – Bayer Pharmaceuticals announced Thursday that it agreed to pay $1.6 billion to settle almost all litigation in the United States based upon claims that its Essure birth control tool injured women who used it.
“Bayer has reached agreements with plaintiff law firms to resolve approximately 90 percent of the nearly 39,000 total filed and unfiled U.S. Essure claims involving women who allege device-related injuries. The settlements include all of the jurisdictions with significant volumes of Essure cases, including the state of California Joint Council Coordinated Proceedings (JCCP) and Federal District Court for the Eastern District of Pennsylvania (EDPA),” a Bayer company statement said.
“The company will pay approximately 1.6 billion U.S. dollars (1.35 billion euros) to resolve these claims, including an allowance for outstanding claims, and is in resolution discussions with counsel for the remaining plaintiffs.”
Under the terms of the settlement, any claimants will be required to dismiss their lawsuits or not file one. Bayer admitted to no wrongdoing or liability in the settlement agreements, and the other terms of the settlement agreements are confidential. The company added the settlement amount is covered by existing provisions.
The U.S. settlements “have no impact on pending litigation in other countries, as Bayer’s decision to resolve these cases is based significantly upon factors that are specific to the U.S. legal system,” according to the company.
Cases involving the Essure birth control device were filed in the U.S. District Court for the Eastern District of Pennsylvania and the Philadelphia County Court of Common Pleas’ Complex Litigation Center, against defendants Bayer Corporation and Bayer U.S. LLC in Pittsburgh, plus Bayer Essure Inc., Bayer Healthcare, LLC and Bayer HealthCare Pharmaceuticals Inc. in Whippany, N.J.
The Essure device consists of metal coils placed in a woman’s fallopian tubes that serve as a blockage device to prevent pregnancy.
“Essure is a Class III medical device that received Conditional Premarket Approval from the Food and Drug Administration (FDA) before it was marketed to the public. The complainants allege that, instead of working as intended, the Essure device ‘migrates from the fallopian tubes, perforates organs, breaks into pieces and/or corrodes. Each plaintiff had Essure implanted and, as a result, suffered severe and permanent injuries,” U.S. District Court Judge John R. Padova said.
In 2018, Bayer announced it would discontinue sales and distribution of Essure in the United States, which followed a similar action in all other markets a year earlier.
“In both instances, the decision was based on a decline in sales of Essure in recent years and the conclusion that the Essure business was no longer sustainable. As a result of Bayer’s voluntary business decision to discontinue the sales and distribution of Essure, the device is no longer available for placement,” the company said.
The plaintiffs brought a number of claims sounding in negligence against Bayer – specifically, negligent training, negligent risk management, breach of express warranty, negligent misrepresentation and negligent failure to warn, alleging the company failed to warn doctors, patients or the FDA about the supposed dangers of the Essure device.
The cases filed in Philadelphia featured out-of-state plaintiffs from all across the U.S., and with legal representation again from plaintiff law firms such as Feldman Pinto in Philadelphia, and Simon Eddins & Greenstone, in Dallas.
“With the settlements, Bayer resolves virtually all of the U.S. Essure litigation so that the company can focus on its commitment to women’s health, where it has long been a leader, without the distractions and uncertainties associated with this litigation,” the company said.
“Bayer sympathizes with all women who have experienced adverse health conditions, regardless of the cause, but the company continues to stand by the science supporting the safety and efficacy of Essure. Bayer recognizes that women want safe and effective reproductive health options that best meet their individual needs and is committed to continuing its investment, innovation, and leadership in this important area of health.”
The company added that Essure users can “continue to rely on the device for their reproductive health and should speak with their healthcare providers if they have any questions or concerns”, while stating it will continue to provide support services for women with Essure and their healthcare providers and “stands behind the safety and efficacy of Essure.”
As of Thursday, 683 cases connected to the Essure device were listed in the CLC.
The CLC is a special program for the resolution of mass torts like asbestos, Risperdal and Xarelto. It has traditionally been a haven for out-of-state plaintiffs and made worldwide headlines last year when a Risperdal jury awarded a whopping $8 billion in punitive damages to one plaintiff.
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com