Defendant: Bayer AG
Defense Law Firm: Sidley Austin LLP
Defendant Lead and Liaison Counsel: Alycia A. Degen - Sidley Austin LLP
Allegations: More than 17,000 lawsuits have been filed against Bayer Healthcare blaming the company for negligent conduct, failure to warn the public about the health risks, breach of implied and express warranty, fraud, willfully hiding the health hazards of Essure, misrepresenting the safety and effectiveness of the device and improperly training health care providers on how to use Essure.
Plaintiffs’ Steering Committee:
The California Court appointed the below-listed counsel as Plaintiffs’ Steering Committee on February 16, 2017, before Honorable Judge Winifred Y. Smith for Essure Product Cases Judicial Council Coordination Proceeding (JCCP) No. 4887:
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Sindhu Daniel - Baron & Budd
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Will Moody - The Moody Law Firm Inc.
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Martin Schmidt - Schmidt National Law Group
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Karen Schroeder - Schroeder Law Office PLLC
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Laura Yaeger - Morgan & Morgan
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Yvonne Flaherty - Lockridge Grindal Nauen PLLP
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Jennifer Lenze - Lenze Kamerrer Moss PC
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Sean Jez - FLeming Nolen Jez LLP
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Fred Hagans - Hagans Montgomery & Rustay PC
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Lori Andrus - Andrus Anderson LLP
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Steven Rotman - Hausfeld LLP
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Justin Browne - Janet, Jenner & Suggs LLC
Lawsuit Status:
California Essure lawsuits are under Judicial Council Coordinated Proceedings (JCCP), which will facilitate efficient adjudication and coordinate efforts on behalf of the plaintiffs, and presided by Superior Court Judge Winifred Y. Smith. The Plaintiff Fact Sheet (PFS) for lawsuits filed under JCCP has been released by the Court.
In 2017, the company reports quoted a loss of about $413 million in revenue in 2016 because of Essure lawsuits and was facing about 3,700 lawsuits.
Timeline:
Verdicts & Settlement: To date, there have been no Essure lawsuit settlements.
November 2002: FDA approved Essure as a Class III medical device for permanent birth control.
June 2008: Bayer was notified by the FDA for marketing Essure implants in an unlicensed factory till 2005 and failed to document the procedures appropriately.
January 2011: FDA warned Bayer for violating the premarket approval and making design changes with seeking additional permission.
February 2016: Based on adverse event reports from women who were affected by the birth control device, FDA ordered Bayer to conduct a new clinical trial to analyze the risks involved in using the device.
August 2016: Presiding Judge Winifred Y. Smith of the Alameda County Superior Court allowed consolidating all Essure lawsuits filed under Judicial Council Coordination Proceedings (JCCP) in August 2016. This was followed by appointments to the Plaintiff’s Steering Committee (PSC) in February 2017 to initiate, coordinate, and conduct pre-trial case discovery.
November 2016: The FDA ordered Bayer to update their Essure's product label with a black box warning indicating the risks of internal organ perforation, chronic abdominal pain, and allergy associated with the use of the birth control method.
February 2017: Formation of Essure Product Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887 was followed by appointments to the Plaintiff’s Steering Committee (PSC) in February 2017, to initiate, coordinate, and conduct all pre-trial discovery on behalf of the plaintiffs and also provide input to the Executive Committee.
April 9, 2018: FDA restricted the sale of Essure device to only those doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”.
July 2018: Reports from CNN revealed that Bayer influenced several doctors by paying about $2.5 million to suggest Essure as a birth control method to patients.
July 2018: Bayer announced Essure would be wiped out of the market by December 31, 2018.
