Bayer AG BAYRY -2.01% said Thursday it will pay $1.6 billion to settle claims that its birth control device Essure causes serious health complications, the latest in a string of settlements by the German company to resolve litigation it faces in the U.S.
Nearly 39,000 women had sued Bayer or hired lawyers over their use of Essure, a fallopian tube implant that prevents pregnancies. Bayer said it has already reached deals with lawyers representing 90% of those plaintiffs, and that the money is expected to cover the entirety of the claims.
Bayer stopped selling Essure in the U.S. at the end of 2018, two years after a decision by the Food and Drug Administration requiring the device to come with prominent boxed warnings about potential serious side effects.
The FDA later required patients and doctors to sign a form accepting risks associated with Essure.
The warnings caused Essure sales to drop, and Bayer said at the time it was pulling the product because of lack of consumer interest. By 2017, Bayer had already discontinued sales of the contraceptive in 20 other countries.
Thursday’s settlement came with no admission of wrongdoing or liability from Bayer. The company said it stands by Essure’s safety and efficacy and was resolving the cases so it could focus on women’s health “without the distractions and uncertainties associated with this litigation.”
Fidelma Fitzpatrick, the lead lawyer for the plaintiffs, said that while the money is a welcome result for her clients, “it’s also an incredibly important case to stress the need for full disclosure and transparency when people’s health is at stake.”
Bayer bought Essure’s creator, Conceptus Inc., for $1.1 billion in 2013, saying at the time it was looking to bolster its flagging birth-control division. The device first received FDA approval in 2002.
The U.S. litigation started around 2014, with plaintiffs alleging Essure caused complications ranging from allergic reactions and chronic pelvic pain to the need for a hysterectomy, and even death. Essure is a metal-and-polyester coiled device that gets implanted in the fallopian tubes, where it causes inflammation and tissue growth to block the pathway between sperm and egg. Unlike other permanent contraceptives, it doesn’t require any surgical incisions.
The first trial was poised to begin in March before getting delayed because of the coronavirus pandemic. Settlement talks began about a year ago, Ms. Fitzpatrick said.
Bayer has been on a settlement spree in recent months. In June, the company said it would pay up to $10.9 billion to resolve tens of thousands of lawsuits claiming its Roundup weedkiller causes non-Hodgkin lymphoma. At the same time, it also said it would pay up to $400 million to resolve legal challenges and crop-damage claims to another of its herbicides, dicamba, which the company has marketed to kill weeds that have evolved to resist Roundup.
Bayer inherited the Roundup cases with its 2018 purchase of Monsanto Co., a deal that came under intense scrutiny after three California juries returned massive awards in Roundup trials.
Write to Sara Randazzo at [email protected]
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