liz-dudley-law
Facebook
Google+
LinkedIn
Yelp
316.746.3969
Call us today for your free case evaluation.
Menu
  • Home
  • About
    • Attorney Liz Dudley

      Elizabeth ‘Liz’ Dudley is an attorney and former Registered Nurse who represents/has represented injured clients from Kansas, Oklahoma, Missouri, California, Texas, Tennessee, Arkansas, Colorado, Illinois, North Carolina and other states nationwide, who are injured from harmful & defective drugs, medical devices, medical negligence and other professional negligence. Attorney Dudley also represents whistleblowers and others who have claims against the healthcare industry and the government under the False Claims Act [Qui Tam Cases].

      The Dudley Law Firm is unique in that Liz Dudley, because of her education, training, experience & knowledge of medicine and the law, she has special expertise in understanding the medical issues involved in complex medical-legal, pharmaceutical, device and mass tort cases [especially those involving women]. Ms. Dudley has access to and obtains world class experts in her cases.

      About Liz Dudley
    • Close
  • Dangerous Drugs
    • white-drugsDangerous Drugs
        • Prilosec Lawsuit
        • Taxotere
        • Actos
        • Benicar, Tribenzor, and Azor
        • Fluoroquinolones
        • Risperdal
        • Talcum Powder
        • SSRI Antidepressants
        • Testosterone
        • Viagra & Melanoma
        • Xarelto Lawsuit
        • Yaz, Yasmin, Ocella, Beyaz, Natazia
    • Free Case Evaluation

      Speak with Liz Dudley personally free of charge to evaluate your case

      Free case review
    • Close
  • Toxic Torts
    • Free Case Evaluation

      Speak with Liz Dudley personally free of charge to evaluate your case

      Free case review
    • Toxic Torts

        • Asbestosis
        • Mesothelioma
    • Close
  • Defective Medical Devices
    • Defective Medical Devices

        • Talcum Powder
        • Mirena
        • Transvaginal Mesh Implants
        • Inferior Vena Cava Filter
        • NuvaRing
        • Morcellator
        • Bair Hugger
        • Joint Implants
        • Zimmer Persona Knee
        • Metal on Metal Hip Replacement
        • DuPuy Metal-on-Metal Hip Replacement
        • Stryker Rejuvenate/ABG II Hip System
        • Wright Medical Technology
    • Close
  • Our Services
    • Legal Services

        • Publications
        • Client Representation
        • Testimonials
        • Personal Injury Cases: Litigation, Joint Ventures & Consultation
        • Mass Tort Litigation Joint Ventures, Support & Consultation
    • Close
  • Blog
    • Vaginal Mesh Lawsuits

      • Bard Vaginal Mesh Plastic Unfit for Humans
        Bard Vaginal Mesh Plastic Unfit for Humans 2016 According to unsealed court records, CR Bard Inc. sold vaginal-mesh devices made of a plastic that its manufacturer warned was not suitable for human surgical use. Managers at Bard’s Davol unit used a resin-based plastic made by a Chevron Phillips Chemical Co. unit to produce hernia-repair mesh...

      More Vaginal Mesh

      Firm News

      • Attorney/Former Nurse Liz Dudley on Generic Drug Law Injustice
        American Association for Justice ["AAJ"] Press Release: Patient Safety at Risk with SCOTUS Mutual v. Bartlett AAJ issued a national press release this afternoon on generic drug immunity and the Mutual v. Bartlett case currently before the Supreme Court.  The Court previously gave all generic drug manufacturers [drugs that are no longer subject to the original patent...
      More Firm News

      Health Alert!

      Get the latest updates from Liz Dudleyabout women’s health concerns. If you or a loved one have suffered from defective drugs or devices, contact the Dudley Law Firm for a free case evaluation. Time is limited to file a claim and you deserve compensation for your hardship..

      More Health Alert!
    • Close
  • Contact
    • Get Help NOW

      GET HELP NOW

      316.746.3969

      If you or a loved one have been affected by a recalled drug or medical device, you may be entitled to compensation

      Free case review
    • Close
  • Testimonials

Bard Vaginal Mesh Plastic Unfit for Humans

January 20, 2016Liz Dudleyvaginal mesh

bard transvaginal mesh lawsuitBard Vaginal Mesh Plastic Unfit for Humans 2016

According to unsealed court records, CR Bard Inc. sold vaginal-mesh devices made of a plastic that its manufacturer warned was not suitable for human surgical use. Managers at Bard’s Davol unit used a resin-based plastic made by a Chevron Phillips Chemical Co. unit to produce hernia-repair mesh after the material’s supplier officially registered a warning that it shouldn’t be permanently implanted in people, according to e-mails and documents in a lawsuit over Bard’s implants.

Smoking Gun Emails

In 2004 and 2007 e-mails filed in federal court in West Virginia, a Davol executive warned colleagues not to tell Chevron Phillips or other resin makers that the company was using the material in medical devices placed in humans.
Suppliers such as Chevron Phillips “will likely not be interested in a medical application due to product-liability concerns,” Roger Darois, the Davol executive , said in a March 2004 email. “It is likely they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”
Thousands of women who blame Bard’s Avaulta line of implants for their injuries said the files show Davol officials knew the resin-based mesh wasn’t proper for human implantation and tried to cover up their use of the materials.

The Polypropylene Resin MSDS Sheet used by Bard & other TVM Manufacturers noted “not for medical implantation”

Phillips Sumika, a Texas-based unit of Chevron Phillips Chemical, filed a required safety data document, called a “Material Safety Data Sheet,” with the U.S. Occupational Safety and Health Administration about the Marlex polypropylene resin used in some Bard hernia and vaginal implants. On the 2007 document’s front page, Phillips Sumika put a “Medical Application Caution” about the product.
In the MSDS sheet from Chevron [an unsealed exhibit in the Cisson v. Bard trial], Chevron stated “Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues”.

Chemical Reactions Cause Mesh Erosion

The MSDS warning stated that the resin-based plasctic “may react with oxygen and strong oxidizing agents, such as chlorates, nitrates and peroxides.” According to experts, human bodies can produce such oxidizing agents and the reaction can cause the mesh to erode.

Despite the warning, Davol officials bought Phillips Sumika’s resin-based plastic from other companies that bought it in their own names, according to testimony in the Cisson case. Davol used the material as the base for hernia repair and vaginal mesh devices according to legal filings.

Erik Gordon, Univ of Michigan business professor, noted that the Bard Avaulta TVM case shows an abuse of the 510(k) process. According to Gordon, “The alleged conduct is unconscionable — how can anyone ever trust a company that knowingly disregards safety warnings from its own supplier and covers up its conduct?”

The Federal Judge in Cisson v. Bard unsealed Bard officials’ and medical experts’ pretrial testimony on the lack of human testing of the mesh before the company began selling it in the U.S. in 2005. The mesh was cleared through the FDA’s 510(k) system, which allows medical devices to reach the market without human testing if regulators decide they are similar to products already for sale.

[See in re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 2:11-cv-00195, U.S. District Court, Southern District of West Virginia(Charleston).

FREE CASE EVALUATION

Memberships

*Past and Present

Links

  • Home
  • About
  • Dangerous Drugs
  • Toxic Torts
  • Law Blog
  • Contact

Contact

THE DUDLEY LAW FIRM, LLC
23438 SW Pilot Point Rd.
Suite A

Douglass, Kansas 67039
316.746.3969
316.746.3922
Facebook
Google+
Yelp

Nationwide Attorney

© The Dudley Law Firm, LLC
Website Design and Marketing by Now Media Group