A trial date for the next pelvic mesh trial is set for September 21, 2015 in Dallas. The 95th Judicial District Court will hear the case with Judge Ken Molberg presiding. The plaintiff alleges that she was injured by a defective Ethicon Prosima mesh which was placed in her to treat pelvic organ prolapse. Ethicon recalled the Prosima sling from the market in 2012. The trial is expected to last 4-6 weeks.
Texas Lawyers represent Plaintiff
The plaintiff, a Texas woman, is represented by Matthews & Associates and Freese & Goss. The firms have previously won several cases against Johnson & Johnson and Ethicon, which made and marketed the pelvic mesh at issue in this case.
Monetary Damages exceed $1 Million
The plaintiff seeks monetary relief over $1 million. She is a resident of Hunt County, Texas. Defendants in addition to Johnson & Johnson and Ethicon, Inc., are Teresa Kowalcyzk, M.D., Hunt Regional Healthcare a/k/a Hunt Memorial Hospital District, Hunt Regional Medical Center at Greenville, Baylor Healthcare System.
Plastic Mesh insults Human Tissue
The plaintiff’s petition states: “Despite claims [by defense] that the monofilament polypropylene mesh in the Pelvic Mesh Products is inert, the scientific evidence shows that this material is biologically incompatible with human tissue and promotes an immune response,” which promotes degradation of pelvic tissue and can contribute to severe adverse reactions to the mesh.
J&J Marketing Exaggerated, Misleading
The petition further claims that J&J and Ethicon used aggressive marketing and the “provision of valuable cash and non-cash benefits” to entice doctors into using Ethicon plastic mesh on women whom it failed to inform of the product’s problems. It claims further that these defendants “utilized documents, patient brochures, and websites, offering exaggerated and misleading expectations as to the safety and utility of these products.”
High Failure Rates
Contrary to J&J and Ethicon’s misleading marketing, “pelvic mesh products have high failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating revision surgeries, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women, including Plaintiff.”
There follows a laundry list of problems that include debunking the very idea of putting this material into the human vagina where pathogens adhere to the mesh and cause immune system reactions, tissue breakdowns; mesh contraction and shrinkage; biomechanical issues with the mesh’s friction with human tissue that triggers degradation; the use and design of mesh anchors that can injure major nerves in the pelvic region; degradation of the mesh over time; the welding of the mesh during production which creates a toxic reaction; the design of trocars (used to place the mesh) which penetrate and damage “nerve-rich environments.”
J&J misled Public
Johnson & Johnson and Ethicon also stand accused in the petition of consistently underreporting and withholding information about the propensity of pelvic mesh products to fail and cause injury and complications. The petition states that J&J and Ethicon have “misrepresented the efficacy and safety of these products, through various means and media, actively and intentionally misleading the public.” If true, it would not be the first time Johnson & Johnson has misled the public with fraudulent marketing.
Causes of Action
The petition lists several other reasons for the lawsuit. They include:
• some predicate devices had high failure rates, resulting in their recall
• significant differences between pelvic mesh products and some or all predicate devices, making them unsuitable as “predicate devices” for which J&J/Ethicon claimed them.
• these significant differences rendered J&J’s disclosures to FDA incomplete and misleading.
• pelvic mesh products are causing many patients severe injuries and complications
• J&J, Ethicon suppressed this information, failed to share it, intentionally misled/mislead.
• failed to perform adequate safety tests to assess risks and benefits
• failed to design and establish a safe, effective procedure for (failed) mesh removal. . .