Skip to main content
Subscribe
  • Sign Up Free
  • Login
  • Subscribe
  • News
    • Current News
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • Digital Health
    • Transformation
    • ESG
    • People
    • Regional News
    • Digital Edition (Web Version)
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • Midwest
    • Northeast
    • South
    • West
  • Opinion
    • Bold Moves
    • Breaking Bias
    • Commentaries
    • Letters
    • Vital Signs Blog
    • From the Editor
  • Events & Awards
    • Awards
    • Conferences
    • Galas
    • Virtual Briefings
    • Webinars
    • Nominate/Eligibility
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • Best Places to Work in Healthcare
    • Excellence in Governance
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top 25 Emerging Leaders
    • Top Innovators
    • Diversity in Healthcare
      • - Luminaries
      • - Top 25 Diversity Leaders
      • - Leaders to Watch
    • Women in Healthcare
      • - Luminaries
      • - Top 25 Women Leaders
      • - Women to Watch
    • Digital Health Transformation Summit
    • ESG: The Implementation Imperative Summit
    • Leadership Symposium
    • Social Determinants of Health Symposium
    • Women Leaders in Healthcare Conference
    • Best Places to Work Awards Gala
    • Health Care Hall of Fame Gala
    • Top 25 Diversity Leaders Gala
    • Top 25 Women Leaders Gala
    • - Hospital of the Future
    • - Value Based Care
    • - Hospital at Home
    • - Workplace of the Future
    • - Digital Health
    • - Future of Staffing
    • - Hospital of the Future (Fall)
  • Multimedia
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Video Series - The Check Up
    • Sponsored Video Series - One on One
  • Data Center
    • Data Center Home
    • Hospital Financials
    • Staffing & Compensation
    • Quality & Safety
    • Mergers & Acquisitions
    • Data Archive
    • Resource Guide: By the Numbers
    • Surveys
    • Data Points
  • Newsletters
  • MORE+
    • Contact Us
    • Advertise
    • Media Kit
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Technology
October 03, 2016 01:00 AM

State judge grants coordination of Essure cases in California

Elizabeth Whitman
  • Tweet
  • Share
  • Share
  • Email
  • More
    Reprints Print
    hand, screw

    (This story was updated with a comment from Bayer at 6 p.m. EDT Oct. 4.)

    A California state judge granted a motion Friday to coordinate 55 cases filed against Bayer by women who say the pharmaceutical company's permanent birth control device Essure caused them harm.

    “I'm hoping that it'll be a quicker, more efficient, cohesive resolution to all women's cases in California,” said Elizabeth Graham, a lawyer with the firm Grant & Eisenhofer who is one of the lawyers representing the plaintiffs.

    In California, the mechanism of civil case coordination allows two or more cases that “share common questions of fact or law and that are pending in different counties to be joined in one court,” according to the state's judicial branch.

    With coordinated cases assigned to a single judge, one ruling applies to them all.

    “One of the reasons that we requested the coordination is to avoid inconsistent ruling,” Graham said. “Why reinvent the wheel?”

    To coordinate cases in California, a petition has to be submitted to the chair of the Judicial Council, who then assigns a motion judge to decide on it. For the Essure cases, that was Judge Winifred Smith of the Superior Court in Alameda County.

    In her order granting coordination, Smith recommended that the coordinated proceedings be conducted in her court, a decision that now rests with the chair of the Judicial Council.

    It was Smith who in early August allowed 11 consolidated suits representing 14 women who said they were injured by Essure to proceed after Bayer sought on three separate grounds to have them thrown out.

    Essure is a tiny coil made of nickel that is inserted without surgery or anesthesia into each of a woman's fallopian tubes. Ideally, scar tissue develops around the coils, blocking the tubes and preventing the fertilization of eggs and their entry into the uterus.

    In reality, thousands of women have reported problems. The device has moved after being inserted. It has perforated organs and caused women severe pain.

    Between Nov. 4, 2002, the day the FDA approved Essure, and Dec. 31, 2015, the agency's Manufacturer and User Facility Device Experience database received 9,900 reports related to Essure, many of them detailing multiple problems. The FDA received 6,989 reports of pain, including abdominal pain, 3,210 of irregular periods, 854 of the device migrating, and 429 of the device breaking, among numerous other problems.

    Graham estimated that the cases filed for coordination for pre-trial purposes represented roughly 900 women in California alone. Other cases claiming harm caused by Essure have been filed outside the state, in federal court.

    Bayer, meanwhile, maintains that Essure is safe for women to use.

    “Bayer stands behind the positive benefit-risk profile of Essure,” the company said in a statement. It said clinical trials supported Essure's “safety and efficacy,” citing an FDA statement that Essure was still “an appropriate option for the majority of women” who wanted permanent birth control. It added that Friday's order was “not a ruling on the merits of the alleged claims, which plaintiffs still must attempt to plead and prove.”

    The device is one of several that prompted seven members of Congress, led by Rep. Mike Fitzpatrick (R-Pa.), to ask in September for a hearing on the impact of unsafe medical devices. At the same time, they called into question the effectiveness of the FDA's Center for Devices and Radiological Health. The center “is struggling to accomplish its fundamental mission to protect patient health and safety,” Fitzpatrick and others said in a Sept. 22 letter to members of the House Energy and Commerce Committee.

    The FDA has not pulled Essure from the market. Instead, it convened an independent committee of experts in September 2015 to review concerns and discuss evidence of Essure's safety and effectiveness.

    In February, the FDA recommended that Bayer add a black box warning, the most serious kind. It also mandated a new clinical study to determine the risks Essure might pose, for which Bayer submitted a plan in March. The FDA approved an updated version Sept. 2.

    In mid-September the FDA approved another Bayer contraceptive: a flexible, plastic T-shaped intrauterine device called Kyleena.

    Correction: Oct. 5, 2016:

    This story has been updated to indicate

    that the judge granted a motion to coordinate 55 cases filed against Bayer.

    Letter
    to the
    Editor

    Send us a letter

    Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.

    Recommended for You
    Chat-GPT-healthcare-2.png
    Why Boston Children's wants to hire a ChatGPT expert
    Screen Shot 2018-12-19 at 1.36.49 PM.png
    GE HealthCare stock drops despite revenue growth
    Most Popular
    1
    More healthcare organizations at risk of credit default, Moody's says
    2
    Centene fills out senior executive team with new president, COO
    3
    SCAN, CareOregon plan to merge into the HealthRight Group
    4
    Blue Cross Blue Shield of Michigan unveils big push that lets physicians take on risk, reap rewards
    5
    Bright Health weighs reverse stock split as delisting looms
    Sponsored Content
    Health IT Strategist (HITS) Newsletter: Sign up for the latest IT and medical technology news delivered 3 days a week (M, W, F).
     
    Get Newsletters

    Sign up for enewsletters and alerts to receive breaking news and in-depth coverage of healthcare events and trends, as they happen, right to your inbox.

    Subscribe Today
    MH Magazine Cover

    MH magazine offers content that sheds light on healthcare leaders’ complex choices and touch points—from strategy, governance, leadership development and finance to operations, clinical care, and marketing.

    Subscribe
    Connect with Us
    • LinkedIn
    • Twitter
    • Facebook
    • RSS

    Our Mission

    Modern Healthcare empowers industry leaders to succeed by providing unbiased reporting of the news, insights, analysis and data.

    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Advertise with Us
    • Ad Choices Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2023. Crain Communications, Inc. All Rights Reserved.
    • News
      • Current News
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • Digital Health
      • Transformation
        • Patients
        • Operations
        • Care Delivery
        • Payment
      • ESG
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition (Web Version)
    • Opinion
      • Bold Moves
      • Breaking Bias
      • Commentaries
      • Letters
      • Vital Signs Blog
      • From the Editor
    • Events & Awards
      • Awards
        • Nominate/Eligibility
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • Best Places to Work in Healthcare
        • Excellence in Governance
        • Health Care Hall of Fame
        • Healthcare Marketing Impact Awards
        • Top 25 Emerging Leaders
        • Top Innovators
        • Diversity in Healthcare
          • - Luminaries
          • - Top 25 Diversity Leaders
          • - Leaders to Watch
        • Women in Healthcare
          • - Luminaries
          • - Top 25 Women Leaders
          • - Women to Watch
      • Conferences
        • Digital Health Transformation Summit
        • ESG: The Implementation Imperative Summit
        • Leadership Symposium
        • Social Determinants of Health Symposium
        • Women Leaders in Healthcare Conference
      • Galas
        • Best Places to Work Awards Gala
        • Health Care Hall of Fame Gala
        • Top 25 Diversity Leaders Gala
        • Top 25 Women Leaders Gala
      • Virtual Briefings
        • - Hospital of the Future
        • - Value Based Care
        • - Hospital at Home
        • - Workplace of the Future
        • - Digital Health
        • - Future of Staffing
        • - Hospital of the Future (Fall)
      • Webinars
    • Multimedia
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Video Series - The Check Up
      • Sponsored Video Series - One on One
    • Data Center
      • Data Center Home
      • Hospital Financials
      • Staffing & Compensation
      • Quality & Safety
      • Mergers & Acquisitions
      • Data Archive
      • Resource Guide: By the Numbers
      • Surveys
      • Data Points
    • Newsletters
    • MORE+
      • Contact Us
      • Advertise
      • Media Kit
      • Jobs
      • People on the Move
      • Reprints & Licensing