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Essure Problems Cause Major Headaches For Bayer

Holly Kelly Ennis Feb. 23, 2017

This week, Bayer suffered major setbacks associated with its Essure Sterilization Device that even its strongest aspirin can’t cure.  First, much to Bayer’s surprise, Essure was banned throughout the entire country of Brazil.  The collective cheers from Essure victims were heard around the world with the hopes that other countries will soon follow suit. The National Health Surveillance Agency or ANVISA banned the sale and distribution of the device.  ANVISA determined that the contraceptive device was rated at maximum risk due to the injuries suffered by the users of the device, noting that Essure can cause changes in menstrual bleeding, allergy and sensitivity, chronic pain, perforation and migration of the device, unwanted pregnancy and/or immune-type reactions.  Due to the frequency and serious nature of the injuries, Essure was classified as a maximum risk device and unfit to be sold in Brazil. Full story at:

Also, earlier this week, Judge Padova, a Federal court judge in Pennsylvania authored a lengthy memorandum denying the majority of Bayer’s Motion to Dismiss Plaintiffs’ Second Amended Complaint.  The 41-page order sets forth in detail the Plaintiffs’ claims, which will move forward in the litigation.  These claims include: Failure to Warn, Negligent Misrepresentation, Negligent Training of Physicians, Negligent Risk Management, Breach of Express Warranty and Fraudulent Misrepresentation.  Bayer unsuccessfully argued to dismiss these claims based upon preemption and that the claims failed to allege a proper cause of action.  Of great importance to the Plaintiffs is that the case should move into the discovery phase wherein Bayer will be required to produce potentially damaging documents.  Bayer will also be required to make available Bayer and Conceptus representatives to be deposed under oath, concerning nearly all aspects of the Essure Sterilization Device.

Finally, this week Bayer released it 2016 Annual Financial Report.  Essure has become enough of a financial problem to Bayer to be discussed in the financial reports. Concerning Essure, the report states as follows.

“Essure™: As of January 23, 2017, U.S. lawsuits from approximately 3,700 users of Essure™, a medical device offering permanent birth control with a nonsurgical procedure, had been served upon Bayer. Plaintiffs allege personal injuries from the use of Essure™, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy. Additional lawsuits are anticipated. As of January 23, 2017, two Canadian lawsuits relating to Essure™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

In connection with the above-mentioned proceedings, Bayer is insured against statutory product liability claims against Bayer to the extent customary in the respective industries and has, based on the information currently available, taken appropriate accounting measures for anticipated defense costs. However, the accounting measures relating to Yasmin™ / YAZ™ and Essure™ claims exceed the available insurance coverage.”

According to the report, Bayer anticipates that the claims and defense costs already exceed the available insurance coverage.  However, Bayer reported record earnings of $4.8 billion based upon $48 billion in revenues for 2016, making it abundantly clear there are adequate assets to cover the anticipated Essure claims.  Also of great interest is that Essure is nowhere to be found in Bayer’s list of products. A recent search for Bayer’s product revealed even Bayer is loath to claim the Essure device.  See,

A recent story in Modern Healthcare shows that fewer women are opting for the procedure and that the product is on the way out.   Dr. James Greenberg, an OB/GYN at Brigham-Faulkner OB/GYN Associates in Boston said demand from patients for Essure has declined in recent years. For several years Dr. Greenberg was implanting 2-3 devices per month, until recently, noting, “If I put in one in the past year, I’d be surprised.  Demand began falling when the lawsuits started going up,” he added. Dr. Greenberg also indicated that the average medical consumer is much more savvy today searching the Internet regarding medical procedures. “You put in Essure, and the first thing that comes up is lawsuits. That’s not something that makes you super excited to have that done to you.”

 Bayer has already expended hundreds of million in expenses for “significant legal risks” tied to legal proceeding relating to three products, including Essure, according to Modern Healthcare.  Bayer has already faced substantial legal battles concerning the birth control pills, Yaz and Yasmin as well as the Mirena IUD. Perhaps it is time for Bayer to step away from women’s birth control and stick to aspirin, which it clearly will need.

If you have questions concerning Essure, contact attorney Holly Ennis at Ennis & Ennis, P.A. or visit us online at