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Blowing The Whistle On The Essure Birth Control Device

Bayer employees with insider information on the company's unethical marketing scheme are urged to report what they know to Federal authorities

Tuesday, October 2, 2018 - Blowing the whistle and exposing the wrongdoings of company executive saves taxpayers money and also can save lives. Employees of medical device makers are encouraged to come forward to the US Department of Justice with information about insider wrongdoings under the False Claims Act (FCA). Under the FCA, company whistleblowers can earn up to 25% of the amount of money that is collected in fines and settlements. If ever there was a time for a company insider whistleblower to come forward, now would be the time concerning Bayer pharmaceutical's deceptive Essure marketing practices.

Thousands of gynecologists are being paid millions of dollars by Bayer "indirectly" for educational services which amount to nothing more than promoting phony classroom seminars to others health care professionals to learn more about Essure and to get them to sell it to their patients. Doctors report low attendance at these events. The event amount to little more than an Essure sales seminar when there actually is a meeting. Essure doctors fearing litigation and the loss of income are hesitant to acknowledge patients that come forward to present Essure complications. Most Essure patients are told by their gynecologist that their symptoms and complications must be due to other physical problems and not Essure and that any psychological effects are all in their heads. So pervasive was Essure doctor's ignorance of the devices adverse side effects that the FDA instituted special requirements for Essure doctors to comply with in order to sell and implant the device. Unfortunately, the FDA's boxed warning never reaches an Essure patient and are largely ignored by Essure doctors as Essure is not a retail item where the consumer would ever see the package that the device came in nor the warning label.

In April 2018, the FDA instituted special requirements on Bayer to implement a restriction on Essure's sale and distribution in order to fully inform potential patients of the risks. According to the FDA "On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA-approved "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement". Sale and distribution of Essure are limited to health care providers who agree to review this checklist with patients and give them the opportunity to sign it, before Essure implantation. The FDA has approved this new safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness." The problem is that all a doctor is required to do is to register with the FDA that they will present the checklist to the patient. There is no system in place to monitor their compliance nor are there penalties for failing to comply. As Essure patients attest to on social media, the majority of them have never heard of the checklist let alone of the side effects.

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Onder Law is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.