Bayer AG May Face Criminal Charges After Essure Sales Halted in the US

By - November 30, 2018
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It has been a bad year for Bayer AG. First, the corporation bought pesticide company Monsanto, maker of controversial weed killer roundup that is connected to cancer and subject to over 9000 roundup cancer lawsuits. That connection resulted in a $289 million verdict against Bayer AG in a California courtroom in 2018, where a former groundskeeper claimed his non-Hodgkins lymphoma was caused by regular exposure to Roundup and its active ingredient glyphosate.

Now, Bayer AG is facing more headaches. This past summer, it stopped Essure sales after threats from FDA that the corporation would face criminal and civil charges if it did not begin to tell patients about the serious health risks of the birth control implant.

Bayer issued a statement in July that stated it would pull the device from the US market at the end of 2018. The healthcare company claims that a reduction in Essure sales has made the marketing of the product unprofitable. Bayer stated that it would continue to back the safety and efficacy of Essure, despite thousands of women raising regular alarms about permanent and debilitating injuries from the female sterilization implant.

The company stated that it had ceased Essure sales outside the United States this year, citing financial reasons rather than the worldwide controversy about the risky medical device.

Essure Product Details

Essure is a permanent type of contraception that Bayer has said is a non-surgical option to tubal ligation. But US regulators determined that neither Bayer or doctors were telling women about the risk factors of the device, such as heavy bleeding, debilitating pain, severe organ damage, ectopic pregnancy, allergic reactions, tooth loss, painful menstrual cycles and even perforation of nearby organs. FDA was the recipient of almost 12,000 Essure injury reports in just 2017. Most of the injuries required reproductive organs to be removed.

FDA Steps In

In 2016, the Food and Drug Administration ordered Bayer to do a safety study of patients who had received the implant, as part of several steps the agency was taking to monitor the performance of the product, in light of the increasing number of adverse event reports.

According to Commissioner Scott Gottlieb, for women who had the Essure implant, the continuing postmarket safety studies of Essure will continue to be a major priority for FDA.

After the agency noted an increase in major side effects, FDA added new warnings to the product label two years ago. This included a mandatory checklist for physicians to go through with each patient to ensure they understood the risks of the product. But injury reports continued to pour in. So, FDA started stricter regulations in April 2018. These provisions were implemented so only physicians and health facilities that document discussing the product’s risks with all patients could implant the device.

In addition, the agency stated that Bayer would be facing criminal penalties and civil lawsuits if Bayer did not ensure all patients know about the risks before implantation.

Under Commissioner Gottlieb, FDA has become more aggressive in expanding its regulatory reach. The pressure on the product’s sales in April 2018 was the first time FDA had ever really flexed its regulatory muscles and threatened these types of penalties. Essure always has a black box warning, which is FDA’s most severe safety warning. FDA first approved the device in 2002. It is the only product of its kind. But Essure sales plunged after Bayer added the warning to the device’s box and label.

Essure Lawsuits Blow Up

Thousands of victims of Essure are now taking Bayer to task for abusing their trust for the company’s financial gain. There have been more than 16,000 Essure lawsuits filed against the company as of Jan. 30, 2018. By April, the number had grown to 17,000. The biggest case group is being consolidated before a state court judge in California.

The manufacturer has spent more than $400 million this year defending Essure lawsuits in the last year. Bayer also acknowledges that it does not expect the number of women coming forward to slow any time soon.