The National Trial Lawyers
  • Home
    • Meet Our Team
    • Contact Us
    • Mission & Goals
    • FAQ
  • Webinars
  • News
  • Membership Directory
    • Top 100 Map – Civil Plaintiff
    • Top 100 Map – Criminal Defense
    • Top 40 Under 40 Map – Civil Plaintiff
    • Top 40 Under 40 Map – Criminal Defense
  • Top 100
    • Civil Plaintiff Officers / Executive Committee
    • Criminal Defense Officers / Executive Committee
    • Benefits
    • About
    • Top 100 President’s Message
    • Diplomat
    • Membership Renewal
    • Member Profile Updates
    • Top 100 Badge
    • Media
  • Top 40
    • Civil Plaintiff Officers / Executive Committee
    • Criminal Defense Officers / Executive Committee
    • Top 40 Under 40 Trial Academy Bootcamp
    • Benefits
    • About
    • Top 40 President’s Message
    • Membership Renewal
    • Member Profile Updates
    • Top 40 Badge
    • Media
  • Specialty Assoc
    • About
    • Shop
    • Officers
    • Membership Renewal
    • Member Profile Updates
    • Media
  • Nominate
    • Top 100
    • Top 40
    • Specialty Association
    • Trial Lawyer Hall of Fame
    • Trial Lawyer of the Year
    • Trial Team of the Year
    • America’s Most Influential Trial Lawyer
    • America’s Most Influential Law Firm
    • Lifetime Achievement Award
  • Shop
  • Magazine
    • A-List
  • Education and Networking Agenda
    • Trial Lawyers Summit
      • Summit Sponsors
    • Top 40 Under 40 Trial Academy Boot Camp
    • Mass Torts Made Perfect
    • The Lanier Master Class 5.0 Trial Academy 2021
    • Webinars
  • Hall of Fame
    • Trial Lawyer Hall of Fame

Death and Injury Suits Pending against Essure Birth Control Device

Posted on May 22, 2015 by Larry Bodine

essure_birth_control_system_injuriesA Florida woman who was the first to file a lawsuit against Bayer for negligence and breach of express warranties concerning the Essure birth control device, has led the way for litigation by others who were severely injured by the implanted device.

The lawsuit, filed in Philadelphia County court, is not a products liability case, but an action for negligence because Bayer did not provide training to the physician on how to insert the device safely.

A motion for judgment on the pleadings has been filed in the case.  Depending on the outcome of this case, if the court rules that the conditional approval for Essure is no longer valid, the many other women injured by its use may also be able to bring a cause of action against Bayer.

Doctor with no training

See also:

Chicago Stroke Victim Awarded $14M after Taking Yasmin

Heather Walsh obtained the Essure implant from a physician who did not receive any training from Bayer on how to insert the device.  The device – a coil made of stainless steel, titanium and plastic — is inserted into the fallopian tubes.  The coils expand and scar tissue forms around them blocking the fallopian tubes and resulting in sterilization, according to the complaint

Walsh was hospitalized for severe pain and fainting spells two years after getting the implant.  A CT scan revealed the device had migrated in her body and lodged behind her colon.  Walsh underwent a complete hysterectomy and other surgeries to remove the device from her colon.

Walsh is not alone, as more than 4,000 reports of serious complications from use of the Essure device have been reported to the FDA, including the report of woman who died during surgery to remove the implant in January 2015.

Angie Firmalino received the implant in 2009 and after two years, had it removed because the coils broke and migrated to her uterus.  Firmalino required several operations including a hysterectomy.  She started a Facebook page to warn other women about the dangers of the device, which now has more than 17,000 followers.

Claims not preempted by Medical Device Act

Although Essure has been in use since the FDA issued a Conditional Premarket Approval (CPMA) in 2002, Walsh brought the first Essure lawsuit against Bayer in 2014. The Medical Device Act (MDA) contains a preemption provision that prevents lawsuits for injuries caused by medical device manufacturers for devices that received pre-market approval from the FDA.

In the complaint Walsh filed, she claims that her negligence and breach of express warranties claims are not preempted by the MDA because the “cause of action has nothing to do with the product itself, but rather [Bayer’s] negligence in” allowing an untrained physician use specific equipment provided by Bayer, that the physician was not qualified to use when he erroneously implanted the device, according to the court documents.

In addition, the complaint asserts that the CPMA issued by the FDA was invalid because Bayer did not comply with the express conditions set by the FDA.

Bayer violated FDA conditions

According to the complaint, the FDA and the Department of Health cited Bayer and invalidated the CPMA for its failure to report results from Essure trial studies, including failure rates.  It also “actively conceal[ed] [eight] perforations” resulting from Essure implantations.

Bayer was also required to notify the FDA when it took ownership of Essure from its previous manufacturer, Conceptus.  Because of Bayer failing to meet the conditions of the CPMA order, the complaint states that the FDA found that Essure is an “adulterated” product that violates the FDA order if it is marketed or sold.

Product pushed on physicians without training

The complaint also alleges that Bayer was neglectful in its “unreasonably dangerous distribution plan” because it failed to provide training to physicians on the insertion method of the device.

In addition, Bayer provided the untrained physicians with specialized equipment, not approved by the FDA order, required to insert the device, even though the physicians were unqualified to use the specialized equipment.  In return for the equipment, the physicians were required to purchase at least two Essure kits per month, according to the complaint.

The case is WALSH v. BAYER CORP., et al case number 2:15 – cv-00384 in the First Judicial Court of Pennsylvania Court of Common Pleas.

 

Posted in Blog, Consumer Protection, Personal Injury, Product Liability

Comments are closed.

News Categories

Subscribe to Blog and VFJ via Email

Enter your email address to subscribe to this blog, the Voice for Justice and receive notifications of new posts by email.

Read about other Top Jury Verdicts

Toyota Will Pay $180M to Settle Violations of the Clean-Air Act

Toyota Will Pay $180M to Settle Violations of the Clean-Air Act

The U.S. Department of Justice and U.S. Environmental Protection Agency (EPA) announced today that the United States has[Read More...]
Boeing's Insitu Will Pay $25M to Settle a Whistleblower Complaint About Used Drone Parts

Boeing's Insitu Will Pay $25M to Settle a Whistleblower Complaint About Used Drone Parts

Bingen, Wash.-based Insitu, a Boeing subsidiary, has agreed to pay $25 million to settle allegations that it used recycl[Read More...]
Deutsche Bank Agrees to Settle Criminal and Civil Charges for $130M

Deutsche Bank Agrees to Settle Criminal and Civil Charges for $130M

DEUTSCHE Bank AG agreed to pay US$130 million to settle criminal and civil charges that it bribed foreign officials and manip[Read More...]
Boeing Pays $2.5B to Settle Charges Tied to the 737 MAX Crashes

Boeing Pays $2.5B to Settle Charges Tied to the 737 MAX Crashes

Boeing has agreed to pay just over $2.5 billion to resolve a federal charge of “criminal misconduct” for how its [Read More...]
Texas Attorney General Seeks $43M in Google Antitrust Lawsuit

Texas Attorney General Seeks $43M in Google Antitrust Lawsuit

The mass exodus of Texas Attorney General Ken Paxton's top staff over accusations of bribery against their former boss has le[Read More...]

#LegalNews

@@TheNTLtop100

Contact Us | Terms of Use | Privacy Policy

Attorney information and content provided on this website is provided for the benefit of members of The National Trial Lawyers and as a public service by Legal Associations Management, Inc. The website and all data are the property of Legal Associations Management, Inc. Data, including without limitation attorney information and content, on the site may not be mined, sold, or used commercially for any purpose without the explicit written consent of Legal Associations Management, Inc. This site may not be accessed by any automated program for extracting data for any use. By accessing and using the site you agree that you will not develop, support or use software, devices, scripts, robots, or any other means or processes (including crawlers, browser plug-ins and add-ons, or any other technology) to scrape data or otherwise copy profiles and other data. Unauthorized use or attempted unauthorized use of this system may subject you to both civil and criminal penalties.