Bayer Essure Lawsuits Skyrocketed as FDA Pushed Stronger Warnings

(Bloomberg) -- Amanda Rusmisell wanted Bayer AG’s Essure contraceptive device to wipe out any chance of a surprise pregnancy. What she didn’t bargain for was being left in blinding pain and bleeding so badly she couldn’t leave her house.

Rusmisell is among more than 16,000 women in the U.S. suing the German drugmaker over the Essure device, marketed as a safe alternative to surgical techniques such as tying the fallopian tubes to prevent pregnancies.

The number of Essure suits has skyrocketed over the last two years after U.S. regulators forced Bayer officials to beef up warnings about the device’s risks -- including bleeding, pain and organ damage -- and put sales restrictions on the product. Bayer announced July 20 that it would stop selling the implant in the U.S. at the end of the year because of declining sales. The company had already pulled the product from all other countries.

“If I’d known I was in store for years of pain and misery, I’d have never agreed to use” the Essure implant, Rusmisell, a 45-year-old employment recruiter from Charlotte, North Carolina, said in an interview. She was forced to undergo a hysterectomy to have the contraceptive removed.

Bayer denies any safety problems with Essure, said Christopher Loder, a company spokesman. “Over the past two decades, Essure’s favorable safety profile has been confirmed in 40 published studies involving more than 200,000 women,’’ Loder said. The FDA continues to conclude that “Essure’s benefits outweigh any potential risks,’’ he said.

Bayer is battling the Essure lawsuits as the company works to remake itself as one of the world’s biggest life-sciences companies.

Integrate Monsanto

Earlier this month, Bayer completed the $63 billion acquisition of St. Louis-based Monsanto Co., becoming the world’s biggest seed and agricultural chemicals maker. With its $1.42 billion purchase of Merck & Co.’s non-prescription drug line in 2014, the company became the world’s second-largest drugmaker behind Johnson & Johnson. It also has sold off its plastics business, and wants to get half its sales from health and half from agriculture.

Essure, created by Conceptus Inc. in 1998, was first approved for sale in the U.S. in 2002. The device features two metal coils implanted into a woman’s fallopian tubes during a regular doctor’s visit. Once the coils expand, they cause scar tissue to form which blocks the tubes.

Bayer bought Conceptus in 2013 for $1.1 billion to bolster its lineup of contraceptives. At the time, Leverkusen, Germany-based Bayer’s Yaz and Yasmin oral birth-control pills were falling because of competition from low-priced copies and suits over those products.

Contraceptive Lawsuits

In multiple lawsuits, women contend Conceptus and Bayer hid that Essure implants damaged organs and caused excessive menstrual bleeding, allergic reactions and hair loss. They allege fraudulent marketing that asserted the device was safe and the “most effective method of permanent birth control available.”

Over a three-year-period starting in 2002, more than 5,000 women filed complaints with the U.S. Food and Drug Administration, saying they sustained injuries or suffered unwanted pregnancies, still births and miscarriages while using the Essure device.

Bayer maintains the company properly disclosed side effects. The complaints to the FDA were often inaccurate or incomplete and the numbers sometimes reflected multiple complaints from the same women, according to the company.

Essure’s label included warnings about pain and other risks from the beginning, Bayer said. Some of the adverse events claimed by the women can’t be caused by Essure, and the risks are below those of a tubal ligation sterilization procedure, the company contends.

“All birth-control options have risks,’’ said Loder, the Bayer spokesman. “No reliable scientific evidence exists to suggest that any new safety concerns exist with Essure.’’

Patient Miscues

The device is 99 percent effective in preventing pregnancies, Bayer officials say. Essure patients, however, are warned they must use backup birth-control methods for the first three months after installation, until the fallopian tubes can become fully blocked by internal tissue growth. Women have to be tested to confirm that the device is working before abandoning other methods, according to the company.

Bayer officials have said they’ve sold more than 1 million of the inserts worldwide, though the American market was the last where it was available. The company said last year it stopped selling Essure outside the U.S. for “commercial reasons” and not because of safety concerns.

“The overwhelming majority of Essure patients are satisfied with the device,’’ Loder said. An FDA study in 2015 reported that 99 percent of clinical trial participants rated Essure as good or excellent, he said.

American women injured by the device demanded that FDA officials force the company to take Essure off the U.S. market. Instead, the FDA required Bayer to strengthen safety warnings on the label and barred Bayer in April from selling the device to doctors and hospitals that don’t guarantee to inform women about its risks. Patients must be shown a brochure outlining the device’s potential side effects and then both she and her doctor must sign it, under the FDA mandate.

‘No Way’

“This latest FDA action underscores our failure-to-warn case’’ and “enhances our chances of prevailing on liability,’’ said George Fleming, a Houston attorney representing thousands of Essure plaintiffs in multiple courts, including more than 3,500 cases in California. “The FDA has put a black box on this, added a patient check list and now insists that doctors read it to the patient. Anyone who reads that checklist -- there’s no way they’ll allow Essure to be put in their body.’’

Bayer’s decision to stop U.S. sales at the end of the year will aid plaintiffs’ punitive damages claims, Fleming said. “The issue is when did they take it off the market -- after everywhere else and with a six-month lag time. It needed to be off the market years ago.’’

The number of Essure cases has surged since the company was forced in 2016 to beef up its safety warnings. Bayer reported it faced just 3,000 Essure suits in October 2016. As of April, that number was up 460 percent to 16,800 users, according to regulatory filings. “Additional lawsuits are anticipated,’’ Bayer said in a May 3 filing.

More Suits

The number may rise again after Netflix runs a documentary Friday called “The Bleeding Edge,’’ covering the medical device industry, which features claims about Essure. Bayer contends the documentary isn’t rooted in science.

The largest group of cases is consolidated before a state court judge in Oakland, California. Plaintiffs’ lawyers want the first test trial of their Essure claims held in that court next year.

Bayer is unlikely to agree to a multi-billion dollar settlement of women’s Essure claims until several juries rule on the strength of the women’s’ cases, said Jean Eggen, who teaches mass-tort law at Widener University in Philadelphia.

“Companies see these test cases as one of the main ways to decide whether to settle and how much to pay,” Eggen said. “It provides a key test of the strength of the plaintiffs’ claims and how much juries might award.”

Bayer is certainly no stranger to shelling out cash to resolve suits over contraceptives. The company agreed to more than $2 billion in settlements to women who contended the Yaz and Yazmin oral contraceptives caused heart attacks, strokes and gallbladder problems.

Bayer shouldn’t have been surprised to see Essure sales drop in the U.S., according to plaintiff Rusmisell.

“That’s what happens when you have a bad product, people quit using it,’’ she said. “I just wish the FDA had stepped up years ago. All these women wouldn’t have been harmed.’’

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