After committing to fight each of the thousands of transvaginal mesh cases it is facing, healthcare giant, Johnson and Johnson (J&J) quietly settled three mesh-injury cases in Joplin, Missouri last month. The three women had all gone to the same doctor and the same healthcare system. All three claims say Johnson & Johnson marketed a defective product and the company was negligent and concealed the dangers.
Many women who are sick from transvaginal mesh cannot afford to have mesh removal surgeries. A settlement gives them some funding to finally try and seek relief from the pain, nerve entrapment, mesh erosion and migration and constant infections they are experiencing.
In the two transvaginal mesh trials won by plaintiffs so far the jury awards of $11.1 million and $1.2 million are on appeal.
The Case of L. Hartman
On February 18, 2010, L. Hartman had a Prolift +M implanted to treat prolapse. The following month she had a second surgery during which time the doctor implanted a second mesh, a transobturator suburethral sling to treat incontinence. By April, the transvaginal mesh had eroded into her vagina and she continued to have incontinence and pain. By June she had a partial removal but the doctor put in a third mesh – a TVT-O. The pain continued and she had difficulty defecating. Another doctor found mesh in her rectum, a very dangerous situation that can lead to sepsis or bacterial contamination throughout the body and death.
Now this poor woman has three transvaginal meshes. She accused the first doctor of medical malpractice for failing to recommend a less-invasive treatment and failing to provide adequate informed consent and failing to obtain the proper specialized training.
The Case of C. Schubert
C. Schubert and her husband sued their Joplin, Mo doctor and the healthcare system where he worked. The couple filed a medical malpractice claim against the doctor who implanted Ms. Schubert on December 8, 2008 with an Ethicon Prolift during a pelvic organ prolapse repair. By March 2009, she had a partial excision of the transvaginal mesh. That would not be the end of her surgeries. In June of that year, C.S. had a third surgery with the same doctor. This surgery was a paravaginal suspension with an anterior Prolift +M and partial excision of mesh.
The doctor failed to obtain proper informed consent. Ms Schubert is permanently disabled and disfigured and faces future surgeries and medical care.
The couple was seeking punitive damages as well as compensation for her pain and suffering.
The medical malpractice claims that the doctor failed to implement a less invasive and less risky method to treat prolapse, failed to do any pre-operative urodynamic testing, failed to adequately perform the procedure then failed to perform the excision of mesh erosion.
To make things worse the defendant doctor had a pattern of hurting women with flawed and unnecessary vaginal procedures. He has faced a dozen medical malpractice claims in the last ten years.
The Case of S. Wilkins
The third lawsuit was filed by a S. Wilkins against the same doctor and healthcare system. Because he works for the health system that triggered something called “vicarious liability” meaning they would be brought into any malpractice action.
Johnson & Johnson’s Ethicon Women’s Health and Urology division, based in Somerville, New Jersey developed, designed and marketed the Gynecare TVT Secur system used to treat stress urinary incontinence (SUI). On May 28, 2010 Wilkins had the surgery and by June she complained to the doctor about trouble urinating, pain and urinary retention. By July, the doctor operated again this time incising the TVT mesh but the pain continued, particularly on her left side and she had dyspareunia or painful sex.
In her lawsuit Wilkins said the doctor failed to recommend less invasive procedures, failed to obtain the necessary training, negligently performed the incision of the TVT mesh in July, failed to obtain appropriate informed consent and did not inform her of the risks of multiple procedures such as painful sex.
Wilkins claims she had incurred costs of follow-up surgery in ST. Louis and suffers emotional distress and a loss of quality of life. She also suffers permanent injury to her vagina and bladder which has required further medical care, expense, pain and suffering as well as permanent disability and disfigurement.
The lawsuit also names Ethicon, Gynecare and Johnson & Johnson in a product liability action for selling a defective and dangerous product that it knew, or should have known, would cause “severe bodily injury.” Specifically, the action says the TVT Secur was made with materials “That were not adequate to remain safely in the human body;” that “eroded into nearby structures;” that “calls for too much mesh to be inserted into the patient;” that “failed to include adequate instructions to the physicians using it,” and that the Defendants “failed to adequately test the long term effects of having a TVT Secur system in the human body.
J&J removed the TVT Secur from the market in June 2012 along with three other transvaginal meshes.
Transvaginal Mesh Settlements
There is no word on what these cases settled for – that is always confidential- and there is always a failure to admit any liability in these actions. Unfortunately with the record sealed we will never know what the company felt was adequate compensation and unfortunately the plaintiffs will never be able to freely speak about their injuries again.
At least there will be no appeals process which means they can get on with their lives to some degree and not wait for the appeals process to run its course which can take years.